INTRODUCTION:

Medicine's basic resources are found in nature and have been employed as medicines since ancient times. People all across the world have distinct understanding of the natural resources they rely on, including extensive botanical knowledge. Traditional medicines meet the health needs of around 85 percent of the world's population. To avoid major health problems, it is critical that the plant and its products retain their safety, quality, and efficacy¹ In comparison to modern medicine, ayurveda still reigns supreme in Indian healthcare, particularly for the treatment of a variety of chronic illness conditions². Traditional medicine is defined by the World Health Organization as a collection of health practices, approaches, knowledge, and beliefs that include plant, animal based medications, spiritual therapies, manual procedures. According to their definitions, the WHO has offered certain words connected to herbal medications. Herbal medicines are made up of herbs, herbal materials, herbal preparations, and herbal finished products. Herbal medications in some places may contain natural organic or inorganic active components that are not derived from plants (e.g. animal and mineral materials). Herbs are whole, fragmented, or powdered plant parts, such as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes, or other plant parts. Fresh juices, gums, fixed oils, essential oils, resins, and dry powders of herbs are all examples of herbal materials. These materials may be prepared in some nations using a variety of local methods, such as steaming, roasting, or stir-baking with honey, alcoholic beverages, or other components. Herbal preparations, which can comprise comminuted or powdered herbal ingredients, as well as extracts, tinctures, and fatty oils of herbal materials, form the foundation for finished herbal medicines. Extraction, fractionation, purification, concentration, and other physical or biological procedures are used to create them. Preparations created by steeping or heating herbal components in alcoholic beverages, honey, or other materials are also included. Herbal preparations created from one or more herbs make up finished herbal products. The term “mixture herbal product” can be used when more than one herb is employed. Excipients may be present in finished herbal products and combination herbal products in addition to the active components. However, finished goods or herbal mixtures that have been added chemically defined active ingredients, such as synthetic chemicals³

The following is a classification of standardising techniques:

· Chemical assessment.

· Physical assessment.

· Microscopical assessment.

1. Chemical Assessment:

Chemical parameters include limit tests, chemical tests, chemical assays etc.Chemical analysis of the drug is done to assess the potency of vegetable material in terms of its active principles. It covers screening, isolation, identification, and purification of the chemical components. It help to determine the identity of the drug substance and possible adulteration. Biological Evaluation- Pharmacological activity of certain drugs has been applied to evaluate and standardize them. The assays on living animals and on their intact or isolated organs can indicate the strength of the drug or their preparations. Analytical Methods- It helps in determining identity, quality and relative potency. The most important step in the development of analytical methods for botanical and herbal preparations is sample preparation. The basic operation includes steps such as pre- washing, drying of plant material.

2. Physical Analysis:

Physical evaluation is a critical component of the process. Standardization of unprocessed pharmaceuticals This strategy is beneficial. In the assessment of crude pharmaceuticals with regard to Moisture content, viscosity, melting point, pH, and so on are all factors to consider.⁴

Significance – Physical evaluation is a useful tool. For determining quantity and purity of quality of unprocessed medicines.

2.1 Determination of foreign organic matter:

Foreign organic matter refers to sections of the crude drug’s organic compounds that aren’t listed in the label. Drug definition and description The maximum amount of foreign biological materials allowed If it surpasses the boundaries, it is defined in a monograph. Then it’s a sign that the quality of the medications is deteriorating.

Physical examination is a critical component of crude medication standardization. This method aids in the evaluation of crude pharmaceuticals in comparison to Moisture content, viscosity, melting point, pH, and so on are all factors to consider.

Significance -Physical evaluation is a useful tool. For determining quantity and purity of quality of crude medicines. ⁴

Methods:

Weigh 100 – 500g of the drug sample that will be examined. Make a thin layer with it. F.M.O. should be used.

Be discovered by visual inspection or the use of A lens (6x) (6x). Take it apart and weigh it. N W = percentage of foreign organic matter.

94,100 × 100 / S × M × P.

Where

N = number of chart particles in 25 fields.

S = number of spores in the same 25 field.

W = weight in mg of lycopodium taken.

M = weight in mg of the sample (calculation on the Sample dried at 105.c

P = number of characteristics particles per mg of the Pure foreign matter.

94,000 = number of spores per mg of lycopodium.⁵

2.2 Loss on drying (LOD):

LOD is the weight loss expressed as w/w and can be calculated using the procedure below. The Chemical elements in crude drugs as a percentage Air dried foundation is given⁶.

Significance: This test is that it determines the amount of water and oxygen in the air. The crude drug’s tile content.

Table 2: Crude drugs with moisture content analysis7.

Name of drugs	Moisture content (%W/W)
Rauwolfia serpentine	Not more than 12%
Acacia	Not more than 15%

Method: Weigh out around 10g of medication and place it in a tared evaporating dish. After you’ve placed the Above mentioned medication quantity in the tared evaporator Dry the dish at 105°F for 5 hours and weigh it. Continually dry and weigh at one-hour intervals. Until the weightings of two succeeding weightings diverge Equates to a maximum of 0.25percent. When two successive events occur, a constant weight is obtained. Weightings after 30 minutes of drying and cooling Show no more than 0.01g difference after 30 minutes in a desiccator (8).

2.3 Ash value:

The residue remaining after incineration is the ash Content of the drug. Significance- Ash value is an important parameter To prove acceptability and purity in case of drugs. That are collected or stored by incorrect way. ⁶High ash value is indicative of contamination, Substitution, adulteration in crude drug.⁹ E.g. Inorganic salts, naturally occurring in drug in The form of adulteration. Ash value is determinant of identity or purity of drug. The ash value is determined by three methods-Total ash, acid insoluble ash, water soluble ash.

2.3.1 Acid insoluble ash:

This ash influences the amount of silica present, particularly in sand siliceous earth. Procedure: Bring the ash to a boil with 25mL dil. HCL. In a crucible, collect the insoluble materials. Clean using hot water and light to maintain a steady weight. Calculate the percent acid-insoluble ash using the air dried medication as a reference.⁹

2.3.2 Water soluble ash:

Method: Boil the ash for 5 minutes with 25ml of water. Collect insoluble matter in a crucible wash and ignite For 15 minutes at a temp not exceeding 450ºC. Cal-culate the percentage of water-soluble ash with Reference to the air dried drug. (Subtract the Weight of the insoluble matter from the weight of The ash; the difference in weight represents the Water soluble ash⁹.

Refractive index: 2.5

The refractive index indicates cleanliness.

When a ray of light goes through a rarer medium and into a denser medium, it bends, which is known as refraction. The refractive index of the second medium is defined as the ratio of light’s velocity in vacuum to its velocity in a substance. It is constant for a liquid at a certain purity level, which is why it is a crucial instrument for standardisation. It is influenced by the incident light’s wave length, temperature, and pressure.¹⁰

Table 7: Examples of drugs showing refractive Index.

Drug	Refractive index
Caraway oil	1.4838-1-4858
Clove oil	1.527-1.535

2.4 Specific optical rotation determination:

It is determined by the polarisation phenomena. When polarised light flows through liquid, it rotates clockwise and anticlockwise, resulting in polarisation. ¹¹ It can be calculated using the following formula:

D25 = 100 × φlc

Where,

Φ=Observed rotation in drug at 25°.

D = sodium light d line

l = polarimeter tube length

C = Substance concentration in percent by volume.¹¹.

2.5 pH measurement:

The negative logarithm of hydrogen ion concentration to the base can be used to calculate pH. 10. A glass electrode and an appropriate pH metre are used to determine the pH value potentiometrically. [22] The pH of most of the extracts is between 5 and 7, which can be used as a quality indicator. Andrographis paniculata, for example, is 7.33.¹¹

2.6 Contamination by microorganisms:

The soil and the atmosphere are the principal sources of bacterial and mould contamination in medicinal plants. The limits of E. coli and moulds are determined in part by harvesting and production practises. If ingested alongside crude medications, the chemical known as afflatoxins will cause serious side effects, hence it should be fully removed or not present.¹⁰

2.7Viscosity:

Because the viscosity of a liquid remains constant at a given temperature and is an indication of its composition, it is a significant tool for standardising liquid medications. ¹⁰ Its significance is that it provides information on the drug’s composition and stability.

Table: Examples of drugs with their kinematic Viscosities. ¹⁰.

Drug	Kinematic viscosity
Liquid paraffin	Not less than 64centistokes
Pyroxylin	1150 -2450 centistokes

2.8 Melting point:

Pure chemicals or phytochemicals have a constant melting point, while crude medications derived from animals or plants have mixed compounds, which is why they are given a melting point range. ¹⁰ Importance-It is one of the criteria used to determine the purity and stability of crude medicines.

Significance:

It is one of the parameters used to determine the purity and stability of crude medicines.¹¹

Table: Examples of drugs with their respective Melting Point.

Drug	Melting point.
Colophony	75-85°C
Kokum butter	39-42°C

3. Microscopic Evaluation:

Herbal drug quality control has always been dependent on appearance, however microscopic examination is now required for initial identification. Plants, as well as detecting rudimentary bits Detection of foreign substances and powdered herbs Adulterants. A primary visual assessment, A basic magnifying lens, which rarely requires more than that, can be used to confirm that the plant is of the desired species and that the correct section of the plant is being used.¹² At other Microscopic investigation is sometimes required to determine the cause. Proper species and/or correct species portion Is available. Pollen morphology, for example, could be exploited. In the case of flowers, to determine the species The existence of tiny structures such as leaves Stomata can be used to determine which plant portion is being used. Although it may appear obvious, it is crucial. Relevance, particularly when several parts of the same Plants will be employed for various therapies. For the treatment of benign prostate hyperplasia. Stinging Nettle (Urtica urens) is a classic example where the aerial Parts are used to treat rheumatism.¹³.

4. Chromatography:

Herbals can be analysed using TLC, HPLC, HPTLC, GC, UV, GC-MS, and fluorimetry, among other methods.

Herbal drug standardization:

Standardization of herbal medications is difficult since many factors influence bio efficacy and therapeutic effect reproducibility. In order to acquire Herbal products of high quality should be handled with caution. Starting with correct plant identification, season and the collection area, as well as their extraction Method of purification and rationalisation of the mixture When it comes to polyherbal medications¹⁴.

2. Identification and standardisation of botanical drugs using fingerprinting and marker compounds: To aid in the identification of a herbal material or extract, chemical and chromatographic procedures can be used. For fingerprinting, chromatographic techniques such as HPLC, TLC, GC, and capillary electrophoresis, as well as spectroscopic approaches such as IR, NMR, and UV, may be utilised. DNA fingerprinting has been employed in a variety of species, including Panax species and associated adulterants ¹⁵. Marker compounds can be used to help identify herbal materials, specify raw material criteria, standardise botanical preparations throughout the production process, and obtain stability profiles ¹⁶.

The steps for standardizing crude drug ingredients are as follows: -\

authentication: - Each and every step must be meticulous Authenticated.

1. The collection stage.

2. Plant parts that have been harvested.

3. Geographical location.

4. Botanical characteristics such as phytomorphology Histological and microscopical examination (features of cell walls, cell contents, etc.) Calcium oxalate crystals, starch grains Trichomes, fibres, vessels, and other structures).¹⁷

The following histology parameters are investigated:

a) Leaf constants: Palisade ratio, Vein islet number, Vein termination, Stomatal number, and Stomatal termination. Index.

b) Trichomes are a type of fungus. Stomata are a type of stomata.

d) Quantitative microscopy is a type of microscopy that measures the size of a sample.

e) Taxonomic similarity.

f) Extraneous stuff.

g) Organoleptic assessment.

h) Values of ash and extractive values

I) Determination of moisture content.

j) Spectroscopic and chromatographic analysis

k) Determination in heavy metal.

l) Residues of pesticides.

m) Contamination by microorganisms.

n) Contamination with radioactive material.

Who Guidelines:

The following WHO technical guidelines have been published:

WHO guidelines on assessing quality and safety of herbal medicines with reference tocontaminants and residues.

WHO GACP monograph for Artemisia Annua L.

WHO draft guidelines for the selection of substances for quality control of herbal

Medicines (outline and key technical issues discussed at two WHO working group meetings in 2004 and 2005).

WHO GMP: Updated supplementary guidelines for manufacture of herbal medicines.

Support to national capacity building on quality control of herbal medicines.

WHO Interregional Training Workshop on GACP and GMP for Herbal Medicines, held in China, September

CONCLUSION:

Given the global adoption of herbal products as medicines, standardisation of herbals is increasingly critical. cures for a variety of diseases and conditions Modern analytical instruments are being used in testing. The many quality standards for a high-quality product The importance of using a herbal control product cannot be overstated. The assurance of a natural drug's safety and efficacynecessitates that the product's quality be monitored from start to finish. from the initial collection to the final packaged product. It is suggested that multiple government agencies collaborate. Agencies should take a more general approach to data collection. By following the WHO criteria, you can improve the quality of your herbs. Creating monographs with a variety of high-quality sources the aforementioned parameters This will help to improve the relationship. Quality breaches are minimised by following the regulatory process.

REFERENCES:

1. Peter AGM & De Smet, Herba remedies. New Eng J Med,347,(2002), 2046-2056.

2. Waxler-Morrison, N. E., Plural medicine in India and Sri Lanka: do ayurvedic and Western medical practices differ? Soc. Sci. Med.,27, (1988), 531–544

3. General guidelines for methodologies on research and evaluation of traditional medicine. Geneva, World Health Organization, 2000 (WHO/EDM/TRM/2000.1

4. Kokate CK, Purohit AP, Gokhale SB. 2005. Pharmacognosy, 50^th edition Nirali Prakshan, Volume 1. Page no.7.4- 7.28

5. Khandelwal KR. Practical Pharmacognosy Techniques &Experiments. 24^th edition, Nirali Prakashan (2002) Page no.24.1-25.

6. Kokate CK, Purohit AP, Gokhale SB. 2005. Pharmacognosy, 50^th edition Nirali Prakshan, Volume 1. Page no.7.4- 7.28

7. K.Kirtikar and B.D.Basu, Indian medicinal Plants, V-1,p-503-507.

8. Liang YZ, Xie P, Chan K, J., Quality control of herbal medicines, Chromatography B, 2004; 812: 53–70.

9. Nitin V, Kiran A. Wadkar, Manish S. Konda War. Review on Standardization of Herbal Churna. Int.J. Res Ayurveda Pharm.2014;5(3):397-401.

10. Bhutani KK, Finger-Printing of Ayurvedic Drugs, The Eastern Pharmacist, 2000; 507: 21-26.

11. S Shrikumer; U Maheshwari; A Sughanti; TK Ravi. WHO guidelines for herbal drugs standardization .2006.

12. Liang YZ, Xie P, Chan K, J., Quality control of Herbal medicines, Chromatography B, 2004; 812: 53–70.

13. OAC (2005). Official Methods of Analysis of AOAC International, 18^th Edn. AOAC International, Gaithersburg, MD.

14. Patel, P.M., Patel, N.M., Goyal, R.K. (2006). Quality control of herbal products. The Indian Pharmacist, 5 (45): 26-30.

15. Shaw, P.C., But, P.P. (1995). Authentication of Panax species and their adulterants by random-Primed polymerase chain reaction. Planta Medica, 61: 466-469.

16. Lazarowych, N.J., Pekos, P. (1998). Use of fingerprinting and marker compounds for identification and standardization of botanical drugs: Strategies for applying pharmaceutical HPLC analysis to herbal products. Drug Information Journal, 32: 497-512.

17. Shrikumar, S., Maheshwari, U., Sughanti, A., Ravi, T.K. (2006). WHO guidelines for herbal Drug standardization.

Received on 13.06.2022 Modified on 17.08.2022

Research J. Science and Tech. 2022; 14(4):247-252.

DOI: 10.52711/2349-2988.2022.00040