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Quality control or standardization of drug means confirmation of its identity and determination of its quality and purity and detection of nature of adulterant by various parameters like morphological, microscopical, physical,
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Quality control of crude drugs is an essential process to ensure the purity, safety, and efficacy of herbal formulations. 

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Adulteration is defined as partial or complete replacement of original crude drug with impure, cheap, filthy, defective, harmful or putrid substances. In simple terms adulteration means debasement of original materials. The substances which are added or replaced are known as adulterants.
The adulterants generally do not possess any chemical or therapeutic properties but only resembles the original drug in respect to its morphological appearance. Herbal adulteration is common malpractice associated with herbal drugs to increase weight or decrease the cost.
The extent of adulteration depends upon whether the drug is indigenous or obtained from other countries.
An adulteration of a drug may be deliberate or accidental.

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Deliberate adulteration:

The roots of Hemidesmus indicus (Indian sarsaparilla) are sometimes substituted with the roots of other plants, such as Cryptolepis buchanani, to increase their weight and bulk. Similarly, the roots of Glycyrrhiza glabra (liquorice) are sometimes adulterated with the roots of other plants, such as Hemidesmus indicus, to increase their potency.

Accidental adulteration:

Terminalia chebula (haritaki) were contaminated with fungi and bacteria due to poor storage conditions. Cassia angustifolia (senna) were contaminated with pesticides and heavy metals due to poor harvesting and processing practices.

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Reasons for adulteration

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Following are the reasons of crude drugs adulteration.

  1. Scarcity of the drug.
  2. High price of the drug in the market, Eg: Clove(लवंग), cinnamon(दालचिनी), cardamom(वेलची).
  3. Adulteration is very common with the contraband drugs/drug which are sold illegally, Eg: Opium(अफू).
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  2. Spoilage
  3. Deterioration
  4. Admixture
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\n A\n d\n m\n i\n x\n t\n u\n r\n e\n \n
\n
\n
\nAdmixture is the addition of one article to other through ignorance, carelessness or an accident.\n
\n\n
\n
\n
\n S\n o\n p\n h\n i\n s\n t\n i\nc\n a\n t\n i\n o\n n\n \n
\n
\n
\nSophistication means intentional or deliberate kind of adulteration.\n
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\n
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\n S\n u\n b\n s\n t\n i\n t\n u\n t\n i\n o\n n\n \n \n
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\n
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In this type of adulteration, the original substances are adulterated by materials that are artificially manufactured. The materials are prepared in a way that their general form and appearance resemble the original crude drug
morphologically.


Examples:
• Artificial invert sugar is used in place of honey.
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In this type of adulteration, the original drugs are substituted using inferior quality drugs that may be similar in morphological characters, chemical constituents or therapeutic activity.


Examples:
• Hog gum or hog tragacanth for tragacanth gum(Ghost Tree, bhutyā, भुत्या).
• Mangosteen fruits(Kokum fruit) for bael fruits.
• Arabian senna, obovate senna and provence senna are used to adulterate      senna. (Marathi names of Senna - Bhitar-vada, Mulkacha, सोनमुखी                  Sonamukhi)
• Medicinal grade ginger being adulterated with cochin, african and japanese    ginger.

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In this type of substitution, the active medicaments of the main drugs are extracted out and are used again. This could be done for the commodities that would retain its shape and appearance even after extraction, or the appearance and taste could be made to the required state by adding coloring or flavoring agents. This technique is frequently adopted for the drugs containing volatile oil, such as clove, Fennel, etc.


Examples:
• After extraction, Saffron(केसर, Kesar) and red rose petals are recolored by      artificial dyes.
• The bitterness of exhausted gentian is restored by adding aloes.

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Here the adulterants/substituents used may be morphologically similar but will not be having any relation to the genuine article in their constituents or therapeutic activity.

Examples:
• Ailanthus leaves(मरुख Marukh, माहरुख Mahrukh) are substituted for                belladonna.
• Senna leaves, Saffron mixed with safflower.
• Peach kernels and apricot(जर्दाळू) kernel for almonds.

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The presence of vegetative parts of the same plant are mixed with the drug in excessive amount due to their resemblance in morphology and sometimes constituents.


Examples:
• Epiphytes, such as mosses, liverworts and lichens that grow over the barks     are incorporated in unusual amounts with the original crude drugs.
• Excessive number of stems incorporated in leaf drugs like lobelia,                     stramonium, hamamelis leaves, etc.

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In this type of adulteration, the adulterants are toxic in nature and may be harmful to the body if taken internally. They are mixed due to their morphological resemblance.


Examples:
• Amber coloured glass pieces in colophony.
• Pieces of lime stone found with asafoetida.
• Lead shots in opium.
• Big masses of stones found mixed with liquorice roots.

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Powdered drugs are found to be adulterated very frequently. Adulterants used for powders are generally powdered waste products of a suitable colour and density.


Examples:
• Powdered olive stones for powdered gentian, liquorice(ज्येष्ठमध), pepper.
• Brick powder mixed with powdered barks.

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This type of adulteration is also known as admixture and occur unintentionally. They occur naturally due to carelessness, negligence, due to improper methods or accidental. Unintentional adulteration may occur due to the following reasons.

  1. Confusion in vernacular names between indigenous systems of medicine and local dialects.
  2. Lack of knowledge about the authentic plant.
  3. Non availability of the authentic plant.
  4. Similarity in morphology/aroma.
  5. Careless collection.
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Evaluation of a drug ensure the identity of a drug and determines the quality and purity of drugs.
• Identity - identification of biological source of the drug.
• Quality - the quantity of the active constituents present.
• Purity the extent of foreign organic material present in a crude drug.

The evaluation of herbal drugs is necessary because of three main reasons.
a. Biochemical variation in the drug.
b. Deterioration due to improper processing and storage.
c. Adulteration and substitution.

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Methods of Evaluation

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There are five methods by which the drug can be evaluated:
1) Morphological/Organoleptic Evaluation
2) Microscopical Evaluation
3) Chemical Evaluation
4) Physical Evaluation
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CharacterDrug Example
Brown colour: Cinnamon
Aromatic odour:Umbelliferous fruits eg. Fennel,coriender, caraway, dill,
Sweet taste: Liquorice
fractured surface: Cinchona
Wavy shape: Rauwolifia
7-8mm width and 25-60 mm length (size): Senna leaf
Ovoid tears:Gum acacia
Tragacanth: Vermiform ribbon
Quills(tightly rolled): Cinnamon
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  1. Examples
    Lignified trichomes in nux vomica,
    warty trichomes of senna,
    wavy medullary rays of cascara bark

  2. The techniques like microscopic linear measurements, determination of leaf constants and quantitative microscopic are also used in this evaluation.

  3. Linear measurements include size of starch grains, length and width of fibres, trichomes, etc.
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  1. Determination of leaf constants include stomatal number, stomatal index, vein islet, veinlet termination number and palisade ratios. Stomatal number is average number of stomata per sq. mm of epidermis of the leaf.

  2. Stomatal index: it is the percentage which the numbers of stomata form to the total number of epidermal cells, each stoma being counted as one cell. Stomatal index can be calculated by using the following formula:

  3. Stomatal index(S.I.)= S/(E+S)×100
    Where,
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Chemical tests are also helpful for the identification of crude drugs. e. g.
1.Van urk’s test for Ergot.
2. Halphenes test for Arachis oil.
3. Borntrager tests for Anthraquinone Glycoside.

Ex. Starch gives blue color with iodine. It forms a thick viscous solution with water.
The estimation of chief constituents or group of active constituents is an integral part of chemical evaluation e.g. total sennosides in senna, morphine in opium, citral in lemongrass oil etc.

The chemical tests also help in proper identification of varieties of the crude drugs eg. the solution of lead acetate or lead subacetate is used specifically for chemical identity of gums.

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A) Determination of moisture content
B) Determination of Viscosity
C) Determination of Melting point.
D) Determination of Optical rotation.
E) Determination of Refractive Index
F) Determination of ash content
G) Determination of Extractives
H) Determination of volatile oil content

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A) Determination of moisture content
Water content is determined by removing moisture and then by measuring weight loss;


B) Determination of Viscosity
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C) Determination of Melting point.
Most basic method determination is the capillary method. Placing the sample in a capillary tube. Heat the sample until it reaches melting point. Record the temperatures at which melting begins.


D) Determination of Optical rotation.
Measured with an instrument called a polarimeter. Light Emitting Diode (LED) produces a beam of ordinary light. This light first passes through a polarizer (polarization filter) in order to obtain a defined orientation of the plane of polarization. The polarized light then passes through the sample cell.

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E) Determination of Refractive Index
Measured with an instrument called a refractometer. Calculated from the ratio of the speed of light in a vacuum to that in a second medium of greater density.

F) Determination of ash content
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G) Determination of Extractives
Extractives amount was calculated as the percentage weight loss based on the initial dried biomass used for extraction.


H) Determination of volatile oil content
Volatile oil is separated by water distillation, water-oil distillate, saturated with salt then extracted with ether. Solvent; evaporated in a tared container. The weight of the remaining volatile oil is calculated and % volatile oil is calculated.

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The specific biological activity contained in each I.U. of the few drugs is mentioned as under:
Digitalis- 1IU is contained in 76 mg of standard preparation
VitA- 1 IU is present in 0.344 micrograms of standard preparation

Biological assy methods are mainly of 3 types
• Toxic
• Symptomatic
• Tissue methods

In toxic and symptomatic techniques, the animals are used, whereas in tissue method, the effect of a drug is observed on isolated organ or tissue. Among the drugs that are subjected to bioassay are cardiac glycosides, natural pesticides and antibiotics.

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