1. PHR103 Nishat Jahan

2. The term crude drug generally applies to the products from plant and animal origin found in a raw form. However, the term is also applied to include pharmaceutical products from mineral kingdom in original form and not necessarily only of organic origin such as kaolin, bentonite etc. Crude drugs can thus be defined as to the natural products that has not been advanced in value or improved in condition by any process or treatment beyond that which is essential for its proper packing and prevention from deterioration.

3. The natural or biological origin: Botanical origin is used for a plant and Zoological origin is used for of animal.

4. Knowledge of the biological origin enables one to indicate the proper right material and precise the source. Strophanthus is used as a heart tonic and includes about 30 species, all species from the same district in central Africa. One year, the drug is active, even poisonous and in other cases it is inactive.

5. This is due to the fact that the drug is gathered from any species, which collectors may find. If the drug is obtained from one and the same species the supply of the drug will be always of the same potency. So the identification of the exact origin of the drug needs comparison with authentic or genuine samples or identification by comparison with herbarium or referring to gardens or museums.

6. In earlier days, most of the plant drugs were derived from the medicinal plants naturally growing in the wilderness and the collectors were mostly uneducated and unskilled local people. As a result, there used to be several cases of adulteration like Inferiority- refers to any substandard drug Substitution- totally different substance in added in place of original drug Admixture- addition of one article to another partly due to ignorance and carelessness on the part of the collector and partly due to his bad intention to defraud. This was particularly true in cases of the drugs, which were expensive, or sparsely distributed, or were very rare to find, or which were very difficult to collect from their natural sources.

7. These problems associated with wild medicinal plants have necessitated systematic cultivation of many medicinal plants for production of good quality plant drugs. Thus most of the plant-derived drugs, which include drugs like Cardamom, Cinnamon, Ginger, etc., are now obtained almost exclusively from cultivated plants. In fact some drug plants, such as Opium poppy and Flax, have been cultivated from time immemorial.

8. What are the types of adulteration? What are the reasons of adulteration?

9. 1. It ensures a correct natural source of the drug. 2. The process of collection and harvesting of the drugs can be effectively monitored under cultivation, i.e., they can be collected at the right time and in the proper manner. 3. Drying and storage of the drugs from cultivated sources can be more effectively regulated and controlled ensuring the production of good quality drugs. 4. Purity of the finished product is assured under cultivation as weeds and other contaminants can be removed.

10. 5. Quality and production of the drug can be improved under cultivation by: (a)the selection of high-yielding and disease resistant seeds and varieties. (b) the use of natural and synthetic fertilizers, which increase the total yield of the plants and their active constituents. (c) the production of hybrids with high yielding and disease resistant properties. 6. Cultivation ensures constant and regular supply of genuine drugs. 7. Prices of Crude drugs and monopolies of their production can be controlled and reduced. 8. Illegal trade of dangerous drug like Cannabis can be restricted by controlled cultivation of such drugs.

11. Write down some of the advantages of cultivation.

12. Cultivation of medicinal plants is not totally free from some serious drawbacks. The principal disadvantages of cultivation of medicinal or drug plants may be summarised as follows:

13. Failure of crops due to adverse weather conditions such as flood, drought, frost or heavy rain during growth and harvesting season. Failure of crops due to adverse weather conditions such as flood, drought, frost or heavy rain during growth and harvesting season.

14. 1. Failure of crops due to fungal and viral diseases which spread rapidly amongst closely growing plants of the same species, e.g., attack of Belladonna by Phytophthora species. 2. Large scale damage of the crops by the attack of insects (flea beetle) and rodents in the field. 3. Higher cost of production. 4. Lack of required environmental conditions for cultivation of a particular medicinal plant.

15. The factors that often create great problems for cultivation may be roughly divided into two groups: 1. Climatic factors 2. Ecological factors. 1.Climatic factors: Climatic conditions under which a plant naturally grows must be available but these are not readily available everywhere and are not easy to reproduce. The climatic factors that directly affect the growth of a plant include a. Altitude refers to the specific elevation of a land surface in comparison with the sea level. This factor influences the growth of plants very seriously and thus plants of different altitudes vary greatly from each other in type, nature and constituents. b. Temperature influences plant growth considerably. Plants growing in a tropical climate do not normally survive in a temperate region.

16. c. Sunlight or length of day or photoperiod plays a significant role in plants' growth and production of chemical constituents. d. Rainfall determines the type of vegetation of a region. Rainfall is an important factor for plant growth, heavy rainfall or drought is highly detrimental to their growth, particularly under cultivation. 2.Ecological factors like soil condition, soil pH and associated plant growth (weed) are of great importance in the cultivation of plants. Soils differ from each other both in physical and chemical properties and may be a clay or loamy soil. Selection of the correct type of soil, which is not always practicable, is very important in the cultivation of various plants including the medicinal ones.

17. Weeds often pose a serous problem in the cultivation of medicinal plants. They affect the crop adversely in a number of ways: a) use up the essential food elements and manures used for cultivation and thus compete with the drug plant; b) prevent sunlight reaching the drug plant; c) choke the drug plant by occupying essential land space; d) introduce difficulty in collection and contaminate the collected drug, e) and attract and harbour insects, fungus and other microorganisms.

18. What are the types of problems of cultivation of medicinal plants? Discuss some of the problems.

19. They can be raised both from- Seeds and by vegetative propagation. Propagation from Seeds: Like any other crops drug plants are raised from seeds. This method of propagation involves the following steps: 1. Selection of seeds: Mature and healthy ripe seeds are selected from high yielding and disease resistant plants. 2. Preparation of seedbeds: Ideal seedbeds or lands are prepared by thoroughly irrigating and manuring the soil where the seeds are sown. 3. Sowing of seeds: The selected seeds are then sown in the prepared seedbed or land at the proper season and in the proper manner.

20. 4. Transplantation of the seedlings: Where applicable, the seedlings are uprooted from the seedbeds at their proper stage of growth and transplanted to the permanent land, prepared properly to afford luxuriant growth of the transplanted seedlings. 5. Irrigation and weeding: Proper irrigation and weeding of the crop are done at regular intervals to ensure uncontaminated healthy growth. Protection of the crop against drought and disease is ensured by irrigation and spraying the crop with insecticides, fungicides and herbicides. 6. Harvesting: Finally the crop is harvested in the proper manner at the proper time.

21. What are the two types of cultivation system? What types of seeds are selected for cultivation? How are plants protected from drought? How are plants protected from disease?

22. Write down the definitions of the following, and also include pictures. Bulb Corms Stolon Runner Sucker Tuber rhizome

23. This involves a number of methods, of which the following may be mentioned: By the development of various vegetative organs, which give rise to new plants, like (i) bulbs (e.g., onion); (ii) corms (e.g., Colchicum, taro); (iii) tubers (e.g., potato), and (iv) rhizomes (e.g., Ginger). These vegetative organs are planted in large numbers to raise a crop.

24. By division or separation of a plant into its individual constituent aerial stems or buds and planting them separately, as is done in the propagation of Garlic, Rhubarb By runners as produced by many plants like Cocoyam, Mints, etc. The runners with the daughter plants are detached from the mother plant and planted. By suckers: In this case the suckers are separated from the mother plant and planted separately, e.g., Liquorice.

29. By the use of cuttings: Cuttings are made by severing a stem into many parts, each having at least one node. On dipping into soil, roots and buds develop from the nodes.

30. By layers: Stems still attached to their parent plants may form roots where they touch a rooting medium. Severed from the parent plant, the rooted stem becomes a new plant.

31. By grafting and budding: Grafting is a method of growing the foliar parts of one plant, termed as scion, on the main or side stem of another related plant, called the stock. In budding, a piece of bark bearing a bud is removed from one plant and is introduced into a suitable cavity or a T­shaped slit made in the bark of another plant or stock, which finally bears the developed bud.

33. The most important natural sources of drugs are higher plant, microbes and animals and marine organisms. Some useful products are obtained from minerals that are both organic and inorganic in nature. In order to pursue (or to follow) the study of the individual drugs, one must adopt some particular sequence of arrangement and this is referred to a system of classification of drugs. A method of classification should be (a) Simple (b) Easy to use (c) Free from confusion and ambiguities.

34. Crude drugs are broadly divided into the following two main groups on the basis of their apparent morphological forms of occurrence and structural organisation of the plant or animal parts and their natural products, which constitute the crude drugs. (i) Organised crude drugs, which are composed of definite organised histological or cellular structures and tissues. They are therefore made up of whole plants or animals or any of their organs or any morphological or anatomical parts derived from them. (ii)Unorganised crude drugs, which are devoid of any definite histological or cellular structures and are derived from plants and animals by different extraction processes or as natural secretions.

35. The Organised crude plant drugs are again further divided into the following two groups according to position of the plant organs that constitute the crude drugs: The Organised crude plant drugs are again further divided into the following two groups according to position of the plant organs that constitute the crude drugs: (a) Drugs from Overground organs, which include all drugs that are derived from the overground or aerial parts or organs of plants. These are further divided into herb, leaf, flower, fruit, seed, bark and wood drugs (b) Drugs from Underground organs, which include all drugs that are derived from underground or subterranean parts or organs of plants. Again they are divided into root. rhizome. bulb and corm drugs on the basis of their morphological identity. (a) Drugs from Overground organs, which include all drugs that are derived from the overground or aerial parts or organs of plants. These are further divided into herb, leaf, flower, fruit, seed, bark and wood drugs (b) Drugs from Underground organs, which include all drugs that are derived from underground or subterranean parts or organs of plants. Again they are divided into root. rhizome. bulb and corm drugs on the basis of their morphological identity. However, the Unorganised drugs are also similarly divided into smaller groups on the basis of the nature of the natural product, such as juices. latices. extracts. gums. resins and balsams. fats. oils. waxes. alkaloids. glycosides. etc.

37. Latex- a milky fluid found in many plants, such as poppies, which exudes when the plant is cut and coagulates on exposure to the air The picture shows a opium poppy exuding fresh latex from a cut

38. Alkaloids- A class of naturally occurring organic nitrogen-containing bases. Alkaloids have diverse and important physiological effects on humans and other animals. Well-known alkaloids include morphine, strychnine, quinine, ephedrine, and nicotine. Glycosides- Compounds which upon hydrolysis give rise to one more sugars (glycone) and a compound which is not a sugar (aglycone) Tannins- Tannins are complex phenolic compounds which are soluble in water and have astringent properties (causes contraction and shrinkage of tissues) and bitter taste.

39. Resins and balsams- clear or translucent, yellowish or brownish substances that ooze from certain trees and plants. Gums & Mucilages- a sticky substance obtained from plants. Gums are considered to be pathological products following injury to the plant while, mucilages are generally normal products of metabolism.

40. Because of their wide distribution, each arrangement of classification has its own merits and demerits, but for the purpose of study and convenience the drugs are also classified in the following ways: 1. Alphabetical classification 2. Morphological classification 3. Taxonomic classification 4. Pharmacological classification 5. Chemical classification 6. Chemotaxonomical classification

41. It is the simplest way of classification of any disconnected items. Crude drugs are arranged in alphabetical order of their Latin and English names (common names) or sometimes local language names (vernacular names). Some of the pharmacopoeias, dictionaries and reference books which classify crude drugs according to this system are as follows. 1. Indian Pharmacopoeia 2. British Pharmacopoeia 3. British Herbal Pharmacopoeia 4. United States Pharmacopoeia and National Formulary 5. British Pharmaceutical Codex. 6. European Pharmacopoeia

42. Merits: It is easy and quick to use. There is no repetition of entries and is devoid of confusion. In this system location, tracing and addition of drug entries is easy. Demerits: There is no relationship between previous and successive drug entries. Examples: Acacia, Benzoin, Cinchona, Dill, Ergot Find out the medicinal use of the above examples.

43. Grouping of drug according to their pharmacological action or of most important constituent or their therapeutic use is termed as pharmacological or therapeutic classification of drug. Grouping of drug according to their pharmacological action or of most important constituent or their therapeutic use is termed as pharmacological or therapeutic classification of drug. This classification is more relevant and is mostly followed method. This classification is more relevant and is mostly followed method. Merits: This system of classification can be used for suggesting substitutes of drugs if they are not available at a particular place or point of time. Merits: This system of classification can be used for suggesting substitutes of drugs if they are not available at a particular place or point of time. Demerits: Drugs having different action on the body gets classified separately in more than one group that causes ambiguity and confusion. Demerits: Drugs having different action on the body gets classified separately in more than one group that causes ambiguity and confusion. Cinchona is antimalarial drug because of presence of quinine but can be put under the group of drug affecting heart because of anti-arrhythmic action of quinidine. Cinchona is antimalarial drug because of presence of quinine but can be put under the group of drug affecting heart because of anti-arrhythmic action of quinidine.

44. In this system, the drugs are arranged according to the morphological or external characters of the plant parts or animal parts i.e. which part of the plant is used as a drug e.g. leaves, roots, stem etc. The drugs obtained from the direct parts of the plants and containing cellular tissues are called as organized drugs e.g. Rhizomes, barks, leaves, fruits, entire plants, hairs and fibres.

45. The drugs which are prepared from plants by some intermediate physical processes such as incision, drying or extraction with a solvent and not containing any cellular plant tissues are called as unorganized drugs. Aloe juice, opium latex, agar, gambier, gelatin, tragacanth, benzoin, honey, beeswax, lemon grass oil etc. are examples of unorganized drugs.

46. Merits: Morphological classification is more helpful to identify and detect adulteration. This system of classification is more convenient for practical study especially when the chemical nature of the drug is not clearly understood. Demerits: The main drawback of morphological classification is that there is no correlation of chemical constituents with the therapeutic actions. Repetition of drugs or plants occurs.

47. Organised Drugs Woods– Quassia, Sandalwood, Red Sandalwood. Leaves– Digitalis, Eucalyptus, Gymnema, Mint, Senna, Spearmint, Squill, Tulsi, Vasaka, Coca, Buchu, Hamamelis, Hyoscyamus, Belladonna, Tea. Barks– Arjuna, Ashoka, Cascara, Cassia, Cinchona, Cinnamon, Kurchi, Quillia, Wild cherry. Flowering parts– Clove, Pyrethrum, Saffron, Santonica, Chamomile. Fruits– Amla, Anise, Bael, Bahera, Bitter Orange peel, Capsicum, Caraway, Cardamom Unorganised Drugs. Dried latex– Opium, Papain Dried Juice– Aloe, Kino Dried extracts– Agar, Alginate, Black catechu, Pale catechu, Pectin Waxes - Beeswax, Spermaceti, Carnauba wax Gums – Acacia, Guar Gum, Indian Gum, Sterculia, Tragacenth.

48. Organized DrugsUnorganized Drugs These may be of plant or animal origin. These may be of plant, animal or mineral origin. These are direct part of plant or animal. These are the product of plant or animals. These have cellular structure.These do not have well defined cellular structure. Generally identified by morphological character. Generally identified by organoleptic properties. Examples: Digitalis leaf, cinchona bark and ephedra stem. Examples: Agar, gelatin, honey

49. Taxonomical classification is purely a botanical classification and is based on principles of natural relationship and evolutionary developments. They are grouped in Kingdom, phylum, order, family genus and species. As all the entire plants are not used as drugs, part of the plant is used as a drug, for example, cinnamon bark. Thus it is of no significance from identification point of view to put plants in a taxonomic order. Merits:- Taxonomical classification is helpful for studying evolutionary developments. Drawback: This system also does not correlate in between the chemical constituents and biological activity of the drugs.

50. The crude drugs are divided into different groups according to the chemical nature of their most important constituent. Since the pharmacological activity and therapeutic significance of crude drugs are based on the nature of their chemical constituents. The chemical classification of drugs is dependent upon the grouping of drugs with identical constituents.

51. An outline of this classification is as follows: 1. Carbohydrates– Carbohydrates are polyhydroxy aldehydes or ketones containing an unbroken chain of carbon atoms. Gums Acacia, Tragacanth, Guargum 2. Glycosides – Glycosides are compounds which upon hydrolysis give rise to one or more sugars (glycone) and non- sugar (aglycone). Anthraquinone Glycosides, Aloe, Cascara, Rhubarb, Senna 3. Tannins– Tannins are complex organic, non-nitrogenous derivatives of polyhydroxy benzoic acids. Examples- Pale catechu 4. Volatile oils– Monoterpenes and sesquiterpenes obtained from plants Examples- Cinnamon

52. 5. Lipids- Esters of long-chain fatty acids and alcohols, or of closely related derivatives. Fixed oils – Castor, Fats – Theobroma Waxes – Beeswax, Spermaceti 6. Resins– Complex mixture of compounds like resinols, resin acids, resinotannols, resenes. Examples Cannabis, Jalap 7. Alkaloids – Nitrogenous substance of plant origin Pyridine and Piperidine – Lobelia, Nicotiana Tropane - Coca, Belladonna, Datura, Stramonium, Hyoscyamus, Henbane Quinoline – Cinchona Isoquinoline – Opium, Ipecac, Calumba Indole – Ergot, Rauwolfia Amines – Ephedra Purina – Tea, coffee 8. Protein – Gelatin, Ficin, Papain 9. Vitamins - Yeast 10. Triterpenes – Rasna, Colocynth

53. Merits : It is a popular approach for phytochemical studies. Demerits: Ambiguities arise when particular drugs possess a number of compounds belonging to different groups of compounds.

54. This system of classification relies on the chemical similarity of a taxon i.e. it is based on the existence of relationship between constituents in various plants. There are certain types of chemical constituents that characterize certain classes of plants. This gives birth to entirely new concept of chemotaxonomy that utilizes chemical facts/characters for understanding the taxonomical status, relationships and the evolution of the plants. For example, tropane alkaloids generally occur among the members of Solanaceae thereby, serving as a chemotaxonomic marker. It is the latest system of classification and gives more scope for understanding the relationship between chemical constituents, their biosynthesis and their possible action.

55. Before sending a crude drug for sale to the local or international market it should be properly prepared so that the active constituents and the appearance of the drug do not deteriorate before being used. The preparation of a crude drug for the market depends on a number of factors: such as its morphological nature, the nature of its constituents, the geographical source and many other factors

56. These factors should be taken care of in its preparation, which involves the following steps: CollectionDryingGarblingQuality determination andPackaging.

57. Drugs destined for commercial markets should be of highest quality and best in appearance to attract good prices. So, it should be collected in the proper manner and at the proper time, especially when collected from wild sources. Commercial crude drugs from cultivated sources always attract more customers and good prices because procurement of crude drug from cultivated plants ensures good quality pure samples.

58. Since the growth and development of a plant can be effectively controlled and improved under cultivation, the quality of the drug obtained from such a plant is generally better than that obtained from a wild source. Thus efforts should always be made to procure drugs for commercial market from cultivated plants.

59. Various factors related to the process of collection of crude drug from their natural sources are discussed below: Methods of collection: The method of collection either from wild or cultivated source depends on the type of the drug and also on the pharmaceutical requirement of the drug. Drugs may be collected by hand labour or by mechanical means. Hand picking is used when a drug is collected from a mixed vegetation and where skilled selection of plant parts is an important factor.

60. Mechanical means are particularly used where speed and reduced cost of production are required. Different types of device are used for collecting various plant organs. For example, fruits and seeds are cut with a combination mower and binder; flowers by the use of hand scoop or seed stripper or rotary flower picker, and barks are removed by hand stripping using ordinary cutting tools. Underground plant drugs are collected by manual or mechanical digging tools like ploughs, hoes, potato diggers or tractors.

61. The proper time is that period of growth or development of the plant when it contains the highest quantity of the medicinal principles and when the collected material will dry to give a good appearance and ensure an improved keeping quality of the drug. The following are general rules for collection of the plant drugs: Leaves and flowering tops should be collected during the active reproductive process of the plant, i.e. from the beginning of the flowering to early fruiting. Flowers Flowers should be collected prior to or just about the time of pollination

62. Fruits may be collected when they are fully mature but unripe (Black pepper,) or when fully ripe (Umbelliferous fruits) Seeds should be collected when they are fully mature and have ripened, but before the fruits open. Barks are generally collected at the end of the winter season and before the new growing season or vegetative process starts. Roots and rhizomes are collected at the end of the vegetation period, i.e. usually in the autumn. In most cases they must be washed free of adhering soil and sand.

63. Certain treatments are required for some drugs prior to drying. For most roots and rhizomes the following treatments are often necessary: (a) removal of adhering soil by washing and brushing, (b) cutting into pieces or slicing to assist drying large and fleshy roots and rhizomes (c) peeling and washing of fleshy rhizomes. For leaves: a) removal of large stalks and (b) a brief process of fermentation or curing in some cases, e.g. Tea leaves. For barks (a) scrapping off of the cork and (b) covering the bark for a certain period of time to induce slight fermentation in cases like Cinnamon. Many other similar treatments are done to various drugs before they are subjected to drying.

64. Immediately after collection crude drugs should be dried to stabilize the condition of the drug and to fix their chemical constituents. Drying is also necessary to ensure good quality of the drug, To prevent moulding, To stop enzymatic hydrolysis, To discourage growth of bacteria and insects and To stop chemical and other changes in the drug. In order to preserve good quality in drug sent to the commercial market it should be dried in the proper manner using the correct temperature and the proper method.

65. In order to prevent changes and to ensure good quality of the drugs in transport and storage, they are dried to remove most of their water content. Drying stabilizes the drugs by fixing their constituents and facilitates grinding and milling as well as render the drug into a more convenient from for commercial handling. Methods of drying: Depending on the type of the drugs and their chemical constituents, plant drugs may be dried by any of the following two methods: (a) Drying in open air by natural heat (b) Drying indoor by artificial heat.

66. a. a. Open air drying- Open air drying by natural heat may be done either in the sun or in the shade, depending on the material to be dried. Sun drying is used for those drugs whose constituents are not adversely affected by the direct action of sunlight. Shade drying is employed for those drugs in which retention of the natural color is desirable and whose constituents are adversely affected on exposure to direct sunlight. The material is spread in thin layers, and turned over occasionally to expose fresh surfaces to the natural heat and air movements. The destruction of the active constituents is less in shade drying than in drying by direct sunlight

67. b ) Indoor drying by artificial heat is the most commonly used method for drying plant, particularly the fleshy ones. Because of following two advantages over the open air drying method; (i) it stops enzymatic action more rapidly, and (ii) it is less time consuming as the desired heat and air flow can be effectively controlled and manipulated.

68. A device or heating chamber consists of a closed space provided with a number of movable screen trays to hold the drug material is used. In drying drugs by this method, the following general rules are followed: Leaves, barks and woods are spread in thin layers in the screen trays and dried at a temperature of about 40° to 60 0 C. They are thoroughly exposed to the heated air by occasional stirring. Leaves and barks containing volatile principles are also dried by this method, but a much lower temperature is used to protect the volatile constituents.

69. Roots and rhizomes are first thoroughly washed and then spread on the screen trays after removing the excess water Large fleshy roots (e.g. Belladonna) or rhizomes (e.g. Ginger, Rhubarb) or corms (e.g., Colchicum) are usually split or sliced to facilitate drying. They are then dried in the same way as the leaves and barks.

70. Flowers require greater care when drying by artificial heat as they contain less thermo stable constituents. They are usually dried at a very low heat and the exposure time for their drying is usually much less than that of other plant parts. Dried plant drugs often reabsorb moisture quickly when exposed to air. They should therefore be properly stored so that they are not spoiled by absorbing excessive moisture from the atmosphere.

71. Garbling is an important process in the preparation of drugs for commercial market and should be carefully done for producing a quality drug. Garbling of a crude drug sample involves: the removal of extraneous matters and adulterants from it by suitable means to produce a clean pure drug. The common extraneous matters in crude plant may include other parts of the same plant, same parts of other plants, same parts of other plants growing together, rotten, discolored or dried plant parts, dirt, soil particles and accidental or added adulterants. Partial garbling can be done during or after collection, but a thorough garbling should be done after drying process and before it is baled or packed.

72. Garbling can be done manually by simple hand picking or by the use of some simple devices like bars of magnet for removing adhering iron particles, sieves for separating dirt and small pieces of the same or other parts of the plant, or by using currents of air to remove lighter substances present in the drug material. Garbling is absolutely essential for producing a clean drug sample and to minimize damage to the grinding machine and to the dies and punches of the tablet machine by which some of the powdered crude drugs may be compressed into tablets.

73. Some preliminary quality control measures should be adopted to most crude drugs before they are packed and sent to the commercial market. These measures ensure marketing of a good quality product to the advantage of the prospective buyers, who may also adopt some other quality control measures before or after buying the material. This preliminary evaluation also helps to elevate or maintain the good reputation of a crude drug selling company.

74. During the preparation of a crude drug for commercial market the following simple tests may be employed: (i) Preliminary examination for the general appearance of the sample by using macroscopical and sensory characters (ii) Determination of foreign organic matters by manually picking out the extraneous matters from the sample and finding out their proportional quantity

75. (iii) Determination of the amount of moisture present in the dried drug by a simple "loss on drying" method to ensure lower moisture, and (iv) Some quantitative chemical tests to determine the amount of the active principles in the sample. This type of information supplied by the seller about a drug not only attracts more customers for the drug but also fetch good price. Thus it is desirable that some quality control measures are adopted in preparing drugs for the commercial market preferably before packaging.

76. In order to send the prepared crude drug to the commercial market it must be put in some convenient containers or packages. The principal aim of packaging is to provide ample protection to the drug as well as to give economy of space. However, the choice or the type of package to be used depends on the nature of the crude drug, the extent of handling it may undergo and its final disposition.

77. Drugs, which are traded in nearby markets and which do not involve transportation or much handling or storage, may be packaged loosely in temporary ordinary packages. But the drugs that undergo transportation, much handling and storage should be packed in waterproof and strong containers or packages in a very compact way. If this involves a leaf or herb material it should be baled with power balers into a solid compact mass and covered by suitable strong water proof covers.

78. Drugs susceptible to deterioration by re-absorption of moisture should be packed into moisture proof cans. Extracts, gums and resins should be shipped in barrels, tin lined boxes and tin can or metallic containers. Cowhides and skins of other animals, water -proof or waxed papers, leather bags or even wooden and hardboard boxes may be used as packaging materials for crude drugs as long as the protection of the quality of the drug guaranteed. The outfit of the packages should be convenient for easy handling in transportation and stacking in storehouses.

79. During storage many undesirable changes may occur in the crude drugs if they are not properly stored and preserved against reabsorption of moisture, oxidation, excessive heat or humidity, direct sunlight, growth or moulds and bacteria and infestation by insects and rodents. All efforts towards proper storage should be geared to protect the drugs from all the above deteriorating factors and agents.

80. 1. They should be well built with steel, concrete or brick. 2. They should be unheated and rodent proof. 3. In order to protect the stored drugs from excessive light and heat, undesirable oxidation and re- absorption of moisture, the storehouses should be cool, dark, and well ventilated with dry air.

81. 4. Drugs in cardboard boxes, wooden cases, sacks and paper bags re absorb up to 12 percent of moisture and become ‘air-dry'. Most drugs maintain their good quality in their air-dry condition, if protected from other deteriorating agents. 5. Tin cans, covered metal bins and amber glass containers are most suitable for storing drugs which are easily oxidised or adversely affected by light and moisture.

82. 6. Drugs like Digitalis, Cannabis, Volatile and fixed oils are liable to oxidation and lose a considerable part of their activity when they become air dry. They should therefore be kept in sealed containers with a dehydrating agent or any air in the container should be replaced by an inert gas. 7. Attack by beetles, moths and mites may be prevented by storing drug in air tight containers and in a dry cool atmosphere.

83. 8.Attacks on stored drug by insects, fungi and bacteria can also be effectively prevented by exposing the drugs periodically to a temperature of 60 to 65°C. This method is also very effective in exterminating the insects and the microorganisms from the infested drug samples. 9. Fumigation of storehouses with methyl bromide, ethylene oxide and other similar toxic gases and vapors effectively destroy insects and microorganisms and controls their further growth in stored drug.

84. 10. Chloroform and carbon tetrachloride have also been found to be useful in controlling insect pests in stored plant drugs. 11. Drugs like enzymes, vaccines, toxins and toxoids should be stored in deep freezers at a temperature of 0°C to 4°C and in some cases even below 0 0 C.

85. Evaluation of drug means confirmation &compliance of drug &determination of its quality, purity &detection of nature of adulteration. Evaluation of crude drug is necessary because of three reasons: 1-biochemical variation in the drug. 2-deterioration due to treatment &storage 3-substitution &adulteration present,as a result of carelessness Evaluation of Crude Drugs Means to identify and to determine quality, safety and purity. safety and purity.

86. 1. Organoleptic 2. Microscopic 3. Chemical 4. Physical Evaluation of drugs involves the following methods:

87. : Description of the macroscopic characteristics of a drug include: 1.Shape and size. 2.Colour and external markings 3.Fracture and internal colour. 4.Odour and taste. I- ORGANOLEPTIC EVALUATION Organoleptic refers to evaluation by means of the organs of sense which includes: - The macroscopic appearance of the drug, - The macroscopic appearance of the drug, - Its odour and taste and the feel of the drug to the touch. - Its odour and taste and the feel of the drug to the touch.

88. II-MICROSCOPIC EVALUATION   The microscope is essential in the identification of powdered drug and in the detection of the adulterants in powdered plant OR animal drugs.  Microscopical description of the drug in sectional view and powdered form is listed in official monograph.

89. ■ Histology refers to the character & arrangement of the tissues in a drug. ■ Some drugs have no cellular structure (gums, resin). ■ Some are composed of microscopic units, such as diatoms (kieselguhr) or hairs (Lupulin, kamala). ■ Histological studies on very thin transverse (TS) or longitudinal (LS) sections properly mounted in suitable stains, reagents or mounting media.

90.  In the powdered drugs the cells are mostly broken, except those with lignified walls, but the cell contents (starch, calcium oxalate, aleurone grains …etc) are scattered in the powder and become very evident in the mounted specimen.  Microscope can be used for a quantitative microanalysis of admixed or adulterated powders.  This study is done by counting a specific histological feature (stomatal index, palisade ratio) in a measured quantity of the unknown powder and comparing the count with that obtained for the same feature in a known standard sample.

92.  Chemical tests are employed to identify crude plant drugs. E.g. characteristic red colour developed in Cascara on addition of NH 3 test solution.  To ascertain the purity of certain drugs E.g. to detect the presence of inorganic iodine in thyroid tablets by adding a starch test solution. III-CHEMICAL EVALUATION

93.  Chemical assays are dependent on the pharmaceutical extractive processes with subsequent purification of the main constituent.  In many drugs the chemical assays represent the only method of determining the official potency.

94.  Typical physical constants is very rare.  The specific gravity is used with nutgalls, where the galls that will not sink in H 2 O are considered to be of inferior quality.  In jalap and clove, the specific gravity should be higher than that of water.  The elasticity of certain fibers, such as cotton, is a physical constant of importance. IV-PHYSICAL EVALUATION

95.  Alkaloids aconitine (light blue), berberine (yellow), emetine (orange).  Alkaloid quinine has blue fluorescence in acid solution in UV or even in daylight.  The use of physical constants on active constituents.:  Solubility, specific gravity, optical rotation, melting point… etc IV-PHYSICAL EVALUATION

96.  The response of some drugs in powdered form or in their smooth section surface to the UV  e.g. in detecting of adulteration of genuine rhubarb (brown color) from rhapontic rhubarb (blue fluoroscence) IV-PHYSICAL EVALUATION

97.  The morphological and anatomical evaluation are not sufficient but nature or the amount of the active substances are the most important  Chromatography (TLC, PC and GC) is really a finger print technique, where the individual substances to which the activity is due, can be tested rapidly.

98. Adulteration of Herbal Drugs The term 'adulteration' of an article covers a number of conditions, which may be deliberate or accidental. Usually in crude drugs, this practice includes substitution of the original crude drugs partially or fully with other substances which is either free from or inferior in therapeutic and chemical properties. Inferiority is a natural substandard condition (e.g. where a crop is taken whose natural constituent is below the minimum standard for that particular drug) which can be avoided by more careful selection of the plant material.

99. Spoilage is a substandard condition produced by microbial or other pest infestation, which makes a product unfit for consumption, which can be avoided by careful attention to the drying, and storage conditions. Deterioration is an impairment of the quality or value of an article due to destruction of valuable constituents by bad treatment or aging or to the deliberate extraction of the constituents and the sale of the residue as the original drugs. Admixture is the addition of one article to another through accident, ignorance or carelessness. e.g. inclusion of soil on an underground organ or the co-collection of two similar species.

100. Sophistication is the deliberate addition of spurious or inferior material with intent to defraud; such materials are carefully produced and may appear at first sight to be genuine e.g. powder ginger may be diluted with starch with addition of little coloring material to give the correct shade of yellow colour. Substitution is the addition of an entirely different article in place of that which is required. e.g. supply of cheap cottonseed oil in place of olive oil.

101. Different methods used for adulteration may be grouped as follows: 1. Substitution with Inferior Commercial Varieties Due to morphological resemblance to the authentic drugs, different inferior commercial varieties are used as adulterant which may or may not have any chemical or therapeutic potential as that original natural drug. e.g. Arabian Senna (Cassia angustifolia), dog Senna (Cassia obovata) and avaram (Cassia auriculata) have been used to adulterate Senna (Cassia senna); [Senna leaves give laxative effect] Japanese ginger (Zingiber mioga) to adulterate medicinal ginger (Zingiber officinale).

102. 2. Adulteration by Artificially Manufactured Substitutes To provide the general form and appearance of various drugs, some materials are artificially manufactured and are used as substitute of the original one, e.g. artificial invert sugar for honey; paraffin wax after yellow coloration substituted for bees wax. 3. Substitution by Exhausted Drugs Here the same plant material is mixed which is having no active medicinal components as they have already been extracted out. This practice is most common in case of volatile oil containing materials like clove, fennel etc., where the dried exhausted material resembles the same like original drug. Sometimes when coloring matters have been extracted or removed during exhaustion, the residue is re-colored with artificial dyes as is done with saffron and red rose petals.

103. 4. Substitution by Superficially Similar but Cheaper Natural Substances Usually here the adulterated product has no relation with the genuine article, may or may not have any therapeutic or chemical component desired. e.g. leaves of species - Ailanthus are substituted for belladonna, senna, mint etc.; 5. Adulteration by Addition of Worthless Heavy Materials A large mass of stone mixed with Liquorice root, pieces of limestone are found in asafoetida and lead shot has occurred in pieces of opium etc.

104. 6. Addition of Synthetic Principles Sometimes to fortify inferior natural products, synthetic principles are added e.g. adding citral to oil of lemon; benzyl benzoate to balsam of Peru etc. 7. Usage of Vegetative Matter from the Same Plant This is done by mixing adventitious matters or naturally occurring with the drug in excessive amount or parts of plant other than that which constitutes the drugs. For example liver warts and epiphytes growing in bark portion are mixed with Cascara or Cinchona; Stems of buchu are sometimes cut into short lengths and added to the drug.

105. Besides being adulterated by different means as discussed earlier, the crude drugs are prone to deterioration on storage. The shelf-life of crude drugs are influenced by many factors which include not only the quality of storage conditions but also the stability of the secondary (2°) metabolites present therein. Several factors are to be considered for the detrimental effects on the stored products.

106. Several environmental factors relating to storage e.g. light, humidity, oxygen, temperature etc. can produce detrimental effects on stored products, but more deterioration usually results from a combination of these factors, which leads to the development of living organism including molds, mites, bacteria etc. The primary factors leading to the deterioration can be summarized as follows:

107. 1. Light Photo-decomposition occurs with santonin, the principal constituents of wormseed, which on exposure to light darkens and eventually becomes black. In general, drugs should be protected by suitable light-proof wrapping or by the use of amber colour containers. Powdered rhubarb stored in clear glass jars rapidly changes as the exposed surfaces turning from yellow to more reddish colour.

108. For these detrimental effects, WHO has specified that medicinal plant materials requiring protection from light should be maintained in a light resistant container that shields the contents from the effects of light. Alternatively, the container may be placed inside a suitable light resistant (opaque) covering and/or stored in a dark place.

109. Moisture present in drugs depends largely upon the amount of moisture in the atmosphere, which is usually expressed in the terms of humidity. When the atmosphere is completely saturated, the humidity is 100%, when half saturated it is 50% and so on. Drugs stored in non-airtight containers are termed air-dry and contain about 10-12% of water depending on the humidity of the atmosphere. This amount of water is sufficient to activate the enzymes present in some dried plant materials, such as Digitalis and bring about the decomposition of the active glycosides. Such drug should therefore be stored with a dehydrating agent or in sealed containers immediately after drying. Moisture/ Humidity

110. Squill contains a hygroscopic mucilage and the powder therefrom, if exposed to the atmosphere, will pickup moisture and become a sticky mass. Therefore strict humidity control is necessary while storing; low moisture may be maintained, if necessary by the use of desiccant in the container provided that direct contact with the product is avoided.

111. 3. Temperature It has a marked effect which is sometimes unsuspected. Many enzymatic changes in the plant secondary metabolites proceed more rapidly at the slightly raised temperature up to about 45°C. Obviously those drugs containing volatile constituents in unprotected structures, e.g. plants belonging to Labiatae family and the petals of rose and chamomile all loose oil with an increase in temperature.

112. Absorbent cotton wool contains a small amount of fatty material which is the residual component from the natural fiber. At a raised temperature this molecules become re- orientated, spreading themselves over the surface of the fiber to form an impervious layer. Thus cotton wool, once fully absorbent will gradually become completely non-absorbent because of the effect of temperature.

113. 4. Airic Oxidation Direct oxidation of the constituents of crude drug is sometimes brought about by the oxygen of the air, e.g. Linseed oil rapidly become resinified as like the oil of Turpentine and oil of Lemon. Usually this conversion is applied to the essential oil with terpenoid derivatives and we can find the resinous deposit build-up around the stoppers used in dispensing bottle containing this oil. Beside this, the rancidification of fixed oils e.g. cod-liver oil, which involves the formation of unstable peroxides, is also an oxidative process. Thus, these types of materials require storage in a well-filled, airtight container.

114. Living organisms usually develop in stored drugs where the conditions are satisfactory for them. From a hygienic point of view, such contaminated material should be destroyed irrespective of whether or not the active principles of drug have been affected. The more common of such organisms belongs to the groups of bacteria, moulds, mites, nematodes, worms, insects etc.

115. 1. Bacteria and Moulds Dried herbs are particularly liable to be contaminated with the spores of the bacteria and moulds, which are always present in the air. Under satisfactory storage conditions their presence causes no problem, but it is generally accepted that the viable count permissible for crude drugs should be the same as that for the food stuff. The effect produced by bacteria are not always very visible with the exception of some chromogenic species of bacteria, e.g. Bacillus prodigious, which produced red patches in starchy materials. However, bacterial growth is usually accompanied by growth of moulds whose presence is quickly evident by the characteristic smell and by the mass of clinging particles entrapped in the mycelial hyphae.

116. Dusty cotton wool, which is formed by bacterial attack causing the trichomes to break into short length, rendered it to be very brittle. In order to identify a particular mould or bacteria, which is proliferating in a stored product, it is necessary to culture it on a suitable medium with a view to obtain fruiting bodies for examination. However, if the drug to be examined is infested rapidly, then it may be possible to make microscopical preparation directly from the sample.

117. 2. Mites and Nematode Worms If found in stored drugs, mites are usually present in countless numbers upto 1.0 mm in length. Different mites found usually include Tyroglyphces siro (Cheese mite); Aleurobius farinae (Flour mite) and Glycyphagus spinipes (Cantharides mite). All these mites can be examined microscopically by clearing the sample of powder containing them with chloral hydrate reagent. The best known examples of nematode worms are "Vinegar eel"  Turbatrix aceti, Anguillula aceti, Anguina tritici which are found in wheat flour or in the crude drug containing starchy materials. These worms are visible to the unaided eye as minute threads continually curling and twisting in the medium they inhabit.

118. 3. Insects/Moths A few species of the Lepidoptera attack the stored crude drugs and cause damage at the larval stage, where the infestation can spread rapidly due to the mobility of the adults. The moths involved are unspectacular in appearance, 22-30 mm in length with off-white wings e.g. Ephestia kuehniella (Flour moth); E. ellutella (Cocoa moth). Besides this some other insects, cockroaches, ants and others are sometimes found to cause deterioration to the stored products.

119. 4. Coleoptera or Beetles These are the insects that constitute the largest order of the animal kingdom comprising about 2,50,000 species of which about 600 have been found to be associated with stored food product or drugs. Stegobium paniceum is one beetle, which is found in many drugs including gentian, liquorice and rhubarb as well as leafy drugs and seeds. Belonging to the same family is Lasioderma serricorne (tobacco or cigar beetle) which is reddish brown in colour, 2 to 2.5 mm in length and found in many stored crude drugs including ginger and liquorice.

120. The container used for storage and its closure must not interact physically or chemically with the material within in any way which would alter its composition. A well closed container must protect the contents from extraneous matter or from loss of the material while handling and a tightly closed container must protect the material from efflorescence, deliquescence or evaporation under normal condition of handling or storage. Storage area should be kept clean and spillages not allowed to enter cracks or in accessible crevices. Periodic spraying of the premises with insecticides will help to prevent the spread of infestation.

121. The principles, which apply to the control of infestation in warehouses, are equally applicable to small-scale storage. Good house keeping is utmost essential. Each stock should be inspected regularly and the material found to be contaminated is best to be destroyed by burning. In this respect the effects of deterioration due to both the primary and secondary factors can be eliminated.

122. Cool, dry condition is the most suitable for the retardation of living organisms. As all living organisms require water for the development, perfectly dry drugs should be immune from secondary deterioration. Sometimes the crude drugs purchased by the herbalist may already have been sterilized, which is most commonly achieved by treatment of the bulk consignment with ethylene oxide or methyl bromide under controlled conditions. Drugs so treated, should comply with an acceptable limit for toxic residues e.g. for Senna pods 50 ppm of ethylene oxide is the limit.