CRUDE DRUGS

PREPARED BY: SIDDHENDU BHATTACHARJEE1 SAMPRITI JANA2 M.PHARM (AYURVEDA) REG NO: 110040221 111062312 LOVELY PROFESSIONAL UNIVERSITY

INTRODUCTION: Herbs are staging a comeback and herbal renaissance is happening all over the globe. The herbal products today symbolize safety in contrast to the synthetics that are regarded as unsafe to human and environment. Although herbs had been priced for their medicinal, flavouring and aromatic qualities for centuries, the synthetic products of the modern age surpassed their importance, for a while. However, the blind dependence on synthetics is over and people are returning to the naturals with hope of safety and security. A major lacuna in Ayurveda is the lack of drug standardization, information and quality control. Most of the Ayurvedic medicines are in the form of crude extracts which are a mixture of several ingredients and the active principles when isolated individually fail to give desired activity. This implies that the activity of the extract is the synergistic effect of its various components. In the absence of Pharma--copoeia data on the various plant extracts, it is not possible to isolate or standardize the active contents having the desired effects. Ayurvedic Pharmacopoeia compiled on modern lines and updated periodically is an urgent requirement. A combination therapy integrating Ayurveda and allopathy whereby the side effects and undesirable reactions could be controlled can be thought of. Studies can show that the toxic effects of radiations and chemotherapy in cancer treatment could be reduced by Ayurvedic medications and similarly surgical wound healing could be accelerated by Ayurvedic medicines. Modern science and technology have an essential role to play in the process. An integrated approach for the cultivation, conservation and preservation of important plant species through plant molecular biology, plant tissue culture; research on the rationale and methodology of Ayurvedic medical practice; isolation of active constituents and their development into new therapeutics; standardization and validation of known herbal medicines and other related aspects need to be focused upon. Despite the diverse nature of crops grown in the country and the existence of a fast growing pharmaceutical sector, the share of India in world trade is quite insignificant considering the large geographical area. However, this is bound to rise rapidly with better research inputs and efficient management of the farm sector. So far, India has been involved in the export of only large volume raw
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material. To achieve competitive advantage we need to resort to low volume high cost (value) trade through value addition to the raw and unfinished products. It is therefore, necessary to develop genetically superior planting material for assured uniformity and desired quality and resort to organized cultivation to ensure the supply of raw material at growers end. Post harvest storage and process technologies need to be developed to produce the value added finished products that may be directly utilized by the industry. Inventorisation of herbal drugs used in traditional and modern medicines for a country like India, appears to be a stupendous task, where a number of well established indigenous or traditional systems, including Ayurveda, Unani, Siddha, Homoeopathy, Tibetan, Amchi, Yoga and Naturopathy are practiced along with modern medicine for the management of total health care system. In all these systems a large number of plant drugs are used, although there may be some common plants. Another problem in correct identification of plants is that the plant drugs in those systems of medicine are known by their classical, Shastriya or vernacular names. It is not easy to correlate these names with acceptable scientific names. One plant species can have many vernacular classical names and one name may refer to different plant species.

CRUDE DRUG: Crude drugs are the drugs, which are obtained form natural sources like plant. Animals, minerals and they are used as such as they are used as they occur in nature without any processing except,drying and size reduction. Vegetable source: Fennel, Clove Animal Source: Honey, Bees wax Mineral Source: Talc, Chalk.

PRODUCTION OF CRUDE DRUGS: The crude drug which reaches the pharmaceutical manufacturing line will have passed through various stages all of which influence the nature and amount of active constituents present. These aspects will be considered under the headings Enviourmental conditions, cultivated and wild plants collection, drying, storage.

CULTIVATION OF CRUDE DRUGS: Most of medicinal plants, even today, are collected from wild. The continued commercial exploitation of these plants has resulted in receding the population of many species in their natural habitat. Vacuum is likely to occur in the supply of raw plant materials that are used extensively by the pharmaceutical industry as well as the traditional practitioners. Consequently, cultivation of these plants is urgently needed to ensure their availability to the industry as well as to people associated with traditional system of medicine. If timely steps are not taken for their conservation, cultivation and mass propagation, they may be lost from the natural vegetation forever. In situ conservation of these resources alone cannot meet the ever increasing demand of pharmaceutical industry. It is, therefore, inevitable to develop cultural practices and propagate these plants in suitable agro climatic regions. Commercial cultivation will put a check on the continued exploitation from wild sources and serve as an effective means to conserve the rare floristic wealth and genetic diversity. It is necessary to initiate systematic cultivation of medicinal plants in order to conserve biodiversity and protect endangered species. In the pharmaceutical industry, where the active medicinal principle cannot be synthesized economically, the product must be obtained from the cultivation of plants. Systematic conservation and large scale cultivation of the concerned medicinal plants are thus of great importance. Efforts are also required to suggest appropriate cropping patterns for the incorporation of these plants into the conventional agricultural and forestry cropping systems. Cultivation of this type of plants could only be promoted if there is a continuous demand for the raw materials. There are at least 35 major medicinal plants that can be cultivated in India and have established demand for their raw material or active principles in the international trade. It is also necessary to develop genetically superior planting material for assured uniformity and desired quality and resort to organized cultivation to ensure the supply of raw material at growers end. Hence, small scale processing units too
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have to be established in order that the farmer is assured of the sale of raw material. Thus, cultivation and processing should go hand in hand in rural areas. In order to initiate systematic cultivation of medicinal and aromatic plants high yielding varieties have to be selected. In the case of wild plants, their demonstration would require careful development work. Sometimes high yielding varieties have also to be developed by selective breeding or clonal micropropagation. The selected propagation materials have to be distributed to the farmer either through nurseries or seed banks. Systematic cultivation needs specific cultural practices and agronomical requirements. PROCESSING AND UTILIZATION Medicinal principles are present in different parts of the plant like root, stem, bark, heartwood, leaf, flower, fruit or plant exudates. These medicinal principles are separated by different processes; the most common being extraction. Extraction is the separation of the required constituents from plant materials using a solvent. In the case of medicinal plants, the extraction procedure falls into two categories. a) Where it is sufficient to achieve within set limits equilibrium of concentration between drug components and the solution. Eg. Tinctures, decoction, teas, etc. b) Where it is necessary to extract the drug to exhaustion, ie., until all solvent extractable are removed by the solvent. Both the methods are employed depending on the requirement although in industry the latter method is mostly used. In all industrial procedures, the raw material is pre-treated with solvent outside the extractor before changing the latter. This prevents sudden bulk volume changes (which are the main cause of channeling during extraction) and facilitates the breaking up of the cell walls to release the extractable. To facilitate the extraction, the solvent should diffuse inside the cell and the substance must be sufficiently soluble in the solvent. The ideal solvent for complete extraction is one that is most selective, has the best capacity for extraction and is compatible with the properties of the material to be extracted. These parameters are predetermined experimentally. The cost and availability of the solvent are also taken into account. Alcohol, though widely used, because of its great extractive power it is often the least selective, in that it extracts all soluble constituents. Alcohol in various ratios is used to minimize selectivity. The ideal alcohol ratio for woody or bark material is 75%. For leafy material, it is often less than 50% thus avoiding extraction of the chlorophyll which makes purification difficult. Some materials such as alkaloids being soluble in acids, their extraction is
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facilitated by adjusting the pH in the acidic range. A number of alkaloids can be extracted easily with hydrocarbons after they have been released from combination with organic acids by grinding with alkali. It is first ground with moist calcium oxide and extracted with chloroform. A large number of alkaloids can be extracted directly with aqueous acids, organic or inorganic acids, and the alkalized extracts counter extracted with hydrocarbons or other apolar solvents. STORAGE OF MEDICINAL PLANTS OR CRUDE DRUGS Dry extracts are usually very hygroscopic and should therefore be ground, mixed under conditions, which exclude moisture as much as possible. Intermediate and end products must also be stored under dry conditions. Annealing or sealing of the products in suitable moisture tight synthetic foils has proved a good method for this. REQUIREMENT OF PACKAGING MATERIALS: The general requirements of packaging materials are the following1. Economical or low cost 2. Impermeable as glass or metal or of acceptable permeability to moisture, gases, volatile solvents etc. 3. Nonreactive-relatively inert with no extraction, exchange or interaction 4. Easy to manufacture in a wide range of shapes, preferably by a number of manufacturing processes. 5. Easy to decorate and /or print by a range of processes 6. Good production line efficiency-performance, with the minimum of rejects or wastage. 7. Effective as a pack (container and closure), i.e., easy to open and reclose and use if multidose; or open if single dose, whilst meeting any special requirements such as child resistance, tamper evidence or resistance, etc. 8. Easy to produce and maintain clean 9. Preferably readily available both in terms of source of supply for raw materials and as a converted item component from several suppliers. 10. Environmentally friendly 11. Able to optimize use of space when stacked or during transportation. QUALITY AND EVALUATION: A major lacuna in Ayurveda is the lack of drug standardization, information and
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quality control. Most of the Ayurvedic medicines are in the form of crude extracts which are a mixture of several ingredients and the active principles when isolated individually fail to give desired activity. This implies that the activity of the extract is the synergistic effect of its varies components. In the absence of pharmacopeic data on the various plant extracts, it is not possible to isolate or standardize on the active contents having the desired effects. Ayurvedic Pharmacopoeia compiled on modern lines and updated periodically is an urgent requirement. Research on the rationale and methodology of Ayurvedic medical practice; isolation of active constituents and their development into new therapeutics; standardization and validation of known herbal medicines and other related aspects are needed. These are some problems concerning the proper identity of a number of drug species. In many cases, a single plant species has several different commercial or medicinal names in different regions. Several distinct species are often used under the same drug name. Another problem relates to adulteration in the market samples. In other words, authentication of the botanical identity and ascertaining the genuineness of drug is great concern in practical situation. To some extent, it can be overcome by drug characterization which is done by estimating their active principles, recording the anatomical features under microscope and their curative effects by clinical trials. When the botanical identity of the plant is controversial, it is better to go for estimation of the therapeutic agent responsible for the curative effect ascribed to the species. The species rich in the ascribed compound should be taken as the genuine drug, those with relatively small amounts may be accepted as substitute of the original drug, and those lacking the required constituents may be rejected. GENERAL SCHEME FOR QUALITY ASSURANCE OF CRUDE DRUGS AND RAW MATERIALS: 1. Importance of quality assurance of crude drugs and raw material: a) Guarantee the best final pharmaceutical products. b) Environmental protection c) Sustainable utilization and development of natural resource. 2. Criteria of good quality: a) Good efficacy- high active ingredient, high yield b) Good safety-less toxicity and side effects, minimum pesticide residues, minimum heavy metals
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c) Purity d) Stability 3. Gene bank conservation: a) Biodiversity conservation b) To store plant germplasm for future uses c) To make germplasm available to create new cultivars d) Insitu conservation- gene banks of medicinal and aromatic plants in Asia e) Invitro conservation f) Breeding 4. Biotechnology a) Plant cell culture eg. Digitalis, Catharanthus b) Hairy root culture eg. Salvia, Glycyrrhiza uralensis, Datura stramoniun, Artemesia annua c) Tissue culture eg. Aloe, Crocus sativa, Mentha d) Genetic engineering: Isolation and purification of an antifungal protein from Phytolacca americana against American ginseng pathogens and synthesis of its gene and expression in E. coli. 5. Suitable growth region: In order to get higher quality of crude drugs and raw materials selection of the most suitable growth region for relevant medicinal plant is quite important. According to the ecological conditions, flora and other criteria, several regions of crude drug development have been identified. 6. GAP: Good Agrotechnological Practices. Large cultivation of medicinal plants relies upon strong and continuing research. Plant varieties with an abundance of desired constituents can be reproduced and improved upon under cultivation even in an entirely different area. Eg. Cultivation of American ginseng (Panax quinquefolia) in China. Attempt should be made to select appropriate region based on similar ecological conditions to introduce good cultivated variety, improve yield of the desired secondary metabolite and reduce the undesirable constituents. 7. Non polluted cultivation: In order to protect the environment, to sustainably utilise the resources and to get a good quality of crude drug, non-polluted agrotechnology is rapidly developed in recent years. These products are commonly called as Green crude drugs This involve biological control of insects and pathogens and use of botanical pesticides for the control of pest and diseases.
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8. Post harvest technology: Right time harvesting, good processing, good storage, extraction or distillation, quality control.

FACTORS INFLUENCE THE CULTIVATION, COLLECTION AND STORAGE OF CRUDE DRUGS: Factors affecting cultivation:

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A.

Altitude: It is a very important factor in cultivation of medicinal plants. Tea, cinchona, eucalyptus etc are cultivated favourably at an altitude of 1000-2000 meters. Cinnamon and cardamom are grown at a height of 500-1000 meters, while senna can be cultivated at sea level. Atmospheric pressure, humidity, temperature, rainfall, soil status etc are the co-factors which directly related with altitude. Temperature: Temperature is another factor affecting the growth of a plant. Excessive temperature as well as frost also can affect quality of medicinal plants adversely. The following are few examples of ranges of temperature necessary for luxuriant growth of certain medicinal plantsCinchona-60-75 F Coffee- 55-70 F Tea- 70-90 F Cardamom- 50-100 F

B.

C.

Rainfall: Expect the Xerophytic plants like aloe, acacia and few others, most of the plants need either proper arrangements for irrigation or sufficient rainfall for their favourable development. Soil and soil fertility: Soil is the most important natural resource as it supports growth of all plants. Soil provides mechanical anchorage, as well as water and essential plant food elements for plant growth. Plant growth depends upon physical arrangement and nature of soil particles, organic matter content of soil and living organisms.

D.

Particle size Less than 0.002 mm 0.002-0.02 mm 0.02-0.2 mm 0.2-2.00 mm

Types of soil Fine clay Coarse clay or silt Fine sand Coarse sand
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Any type of soil containing less than 0.5% of organic matter is described as poor. If more than 1.5-5% of organic matter is present, it is described as rich soil. The pH of soil is another important factor for the developments of plant. The maximum availability of plant nutrient is in between the range of 6.5-7.5.
E.

F.

Fertilizer and Manures: There is various kinds of fertilizers which can affect cultivation like Chemical fertilizers. Biofertilizers are the most suitable forms that can be tried in case of inadequate supply, high cost and undesired effects in the field. Farm Yard Manure (FYM), poultry manures, vermin composed etc are the examples of various manures. Pest and pest control is also a very big factor for the cultivation of plants.

Factors affecting collection: Drugs may be collected from wild or cultivated plants and the task may be undertaken by casual, unskilled or skilled workers in a highly scientific manner. The main objective is to collect the crude drug with maximum concentration of active constituents. The drugs which constitute leaf and flowering tops of plants are collected just before they reach their flowering stage (Senna, digitalis, vinca) while the leaf of aloe are collected when they are thick enough. Crude drugs from flower need to be collected just before pollination or before their full expansion (Saffron, clove buds). Flowers are generally collected in dry weather. Barks are generally collected in spring or early summer when cambium is active, as it is easy to detach them from stem. There are also 3 different methods of collecting barks like i) felling, ii) uprooting, iii) coppicing. The fruits are collected depending upon the parts of fruits used like ripe or half ripe or fully grown. Cardamom fruit collected just before dehiscence, tamarind after their full maturity, fennel and coriander are collected when they are fully ripe. The roots are collected in spring, before the vegetative process stops. Rhizomes are collected when they store maximum food. Unorganized drugs such as resins, gums, lactases are collected as soon as they ooze out from the plants.
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Factors affecting storage of crude drugs: Prevention of crude drugs needs sounds knowledge of their physical and chemical properties. A good quality of the drugs can be maintained if they are preserved properly. There are various factors which can affect the storage of drugs. A. Drug should be preserved in well closed containers. B. Should store in water-proof, rodent-proof places. C. Storage container should be moisture proof. D. Crude drug should be preserved in dark because direct radiation can cause destruction of active chemical constituents. E. Atmospheric oxygen is also destructive to several drugs & hence they are filled completely in well closed containers. F. Temperature is also a very important factor in preservation of the drugs, as it accelerates several chemical reactions leading to decomposition of quality. These are some of the major factors which can affect the cultivation, collection, storage of Crude drugs.

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CLASSIFICATION OF CRUDE DRUGS: 1. Alphabetic method of classification: In this method drugs are classified according to first alphabet of their English or Latin name. This method is adopted in many books like I.P (Indian Pharmacopoeia), N.P (National Formulary), and U.S.P (United States Pharmacopoeia) Advantages: A. If we know the name of drug, we can study it properly. Eg: Acacia changed into Indian gum. 2. Chemical method of classification Drugs are classified according to their active chemical constitute. Drugs which contain similar chemical are grouped in one place. Chemical Content Volatile oil Alkaloid Lipid Drugs Fennel oil, Coriander Rauwolfia, Datura, vinca Castor oil, Peanut oil

Advantages: A. Knowing the chemical constituent of a drug it is easy to study the drug. Disadvantages: A. This method does not give any idea about source of drugs. B. Some drugs also contain 2 important chemical constituent, so it is difficult to classify them. C. No idea can be obtained whether drug is organized or not organized.
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3. Pharmacological method of classification The drugs having similar pharmacological effect in body are grouped together. Class Carminatives Purgatives Cardio tonic Anthelmintic Anti cancer Expectorant Drug Fennel, Dill Senna Digitalis, squill Artemisia Podiphyllum, Vinca Vasaka

Disadvantages: A. Some crude drugs have 2 different pharmacological classifications like Nux vomica is CNS stimulant as well as bitter tonic. B. This method does not give any idea about source of drugs. C. No idea can be obtained whether drug is organized or not organized. 4. Morphological method of classification In this method drugs are divided into parts of plants like roots, flowers, Leaves, Wood, Gum bark. Part of Plants Fruit Seed Bark Latex Advantages: A. More convenient in practical purpose.
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Drugs Caraway Nux vomica Arjuna Opium

B. Can give idea about source of drugs. C. Gives idea about organized/unorganized drug. Disadvantages: A. During collection, drying and packing morphology of drug changes. 5. Taxonomical method of classification: It is purely biological classification. Drugs are placed according to position of plant in plant kingdom. Eg: Fennel. Division: Angiosperm Class: Dicotyledonate. Order: Umbelliflorae. Family: Umbelliferae. 6. Chemo-taxonomical method of classification: This is the recent type of classification in which equal importance have been given to family and its chemical constituent. It has been noticed that there is a close relation between chemical composition in plant and its position of plant kingdom. Eg: Plants of Umbelliferae contains volatile oil.

REFERENCE:
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1. Kar Ashutosh (2007): Pharmacognosy and Pharmacobiotechnology. New age International publishers. p. 105-110.

2. Evans W.C (15th edition): Trase and Evans Pharmacognosy.W.B.Saunders.p.5760.

3. P.P.Joy, J.Thomas, Samuel Mathew, Baby P.Skaria (1998): Medicinal Plants. Kerala Agricultural University, Kerala. p. 25-30. 4. Dr. Showkat Rasool Mir (2007): Different Systems of Classification of Crude Drugs. 5. Xiaoyang Mou, Santosh Kesari, Patrick Y. Wen, Xudong Huang (2011): Crude drugs as anticancer agents. Int J Clin Exp Med 2011;4(1):17-25.

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