Abstract: Due to their numerous benefits, herbal medications have recently gained popularity. Formulations made from herbs are now widely accepted as effective treatments for many ailments. Although the majority of these uses are unconventional, it is a known fact that more than 80% of the world's population relies on herbal goods and medications to maintain a healthy lifestyle. The increased usage of herbal goods has also led to a variety of product abuses and adulterations, which have disappointed customers and producers and, in some cases, had disastrous results. The creation of reliable analytical techniques that can accurately profile the phytochemical composition, including quantitative studies of key elements and flag bioactive chemicals is a difficult task for scientists. For the manufacture and manufacturing of herbal medications, standardization is a crucial step in establishing a uniform biological activity, consistent chemical profile, or even just a quality assurance programed. Various diverse assessment techniques are presented in the current review paper.

Introduction:

The first treatments that mankind is aware of are herbal medicines. Throughout history, people from various cultures have utilized herbs, but India has one of the oldest, wealthiest, and most diversified societies with active traditions related to using medicinal plants. The oldest kind of medicine known to humans is the use of herbs, and it has been practiced throughout history in all societies. Since ancient times, herbal medicines have been used to treat a variety of illnesses. The world's health has benefited greatly from medicinal plants. Plants continue to play a significant part in healthcare despite the significant advancements in modern medicine that have been seen in recent years. Herbal drug technology is used to transform botanical resources into medications, and it's crucial to maintain standards of quality control while also properly integrating current scientific methodology and traditional expertise. Worldwide, herbal preparations are now widely accepted as effective treatments for conditions such as diabetes, rheumatoid arthritis, liver illness, cough and cold, and memory improvement. Herbs have always been considered safe, and more individuals are consuming them without a prescription. 1-6

The main problem with current medications is that they might have adverse effects that put patients' lives in danger. The list of adverse effects for herbal medications is the same as for synthetic pharmaceuticals. At least 120 different chemical compounds produced from plants are being used as significant pharmaceuticals across the world, while many more medications are straightforward synthetic adaptations of the natural products.7

Herbs are unprocessed plant parts that may be whole, broken up, or ground up, such as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes, or other plant parts. Along with plants, herbal materials also include fresh juices, gums, fixed oils, essential oils, resins, and dry powders of various herbs. These materials may be prepared locally in some nations by different methods such steaming, roasting, or stir-baking them with honey, alcoholic drinks, or other ingredients. Herbal preparations, which can comprise comminuted or powdered herbal components as well as extracts, tinctures, and fatty oils of herbal materials, serve as the foundation for completed herbal medicines. They are created by various physical or biological processes, including as extraction, fractionation, purification, and concentration. Additionally, they consist of concoctions created by heating or steeping herbal components in alcoholic drinks, honey, or other substances.8

Herbs are unprocessed plant parts that may be whole, broken up, or ground up, such as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes, or other plant parts.

Along with plants, herbal materials also include fresh juices, gums, fixed oils, essential oils, resins, and dry powders of various herbs. These materials may be prepared locally in some nations by different methods such steaming, roasting, or stir-baking them with honey, alcoholic drinks, or other ingredients. Herbal preparations, which can comprise comminuted or powdered herbal components as well as extracts, tinctures, and fatty oils of herbal materials, serve as the foundation for completed herbal medicines. They are created by various physical or biological processes, including as extraction, fractionation, purification, and concentration. Additionally, they consist of concoctions created by steeping or heating herbal components in alcoholic drinks, honey, or other substances.

Herbal preparations created from one or more plants make up finished herbal goods. The phrase "mixture herbal product" may also be used if more than one herb is utilized. Excipients may also be present in finished herbal products and herbal blends in addition to the active components.

However, completed goods or herbal mixtures that contain chemically defined active ingredients, such as synthetic compounds and/or separated herbal elements, are not regarded as being herbal (WHO recommendation, 2000).9

Concept of standardization of drug

The process of prescribing a set of standards or intrinsic qualities, consistent parameters, and unambiguous qualitative and quantitative values that convey an assurance of quality, effectiveness, safety, and repeatability is known as standardization of herbal medicines. The process of creating and approving technical standards is called this. Experimentation and observation are used to develop precise criteria, which then serve as the basis for prescribing a particular herbal medicine's characteristic set. Standardization is a tool for quality control hence.9-10 For the sake of both public health and pharmaceutical firms as well as to assure repeatable quality of herbal medicine, the authentication of herbal medications and the detection of adulterants from genuine medicinal plants are crucial.11

Standardization of Herbal Drugs:

Herbal medicine quality control is a laborious and challenging job. The quality of these medicines has decreased as a result of commercialization of their production to meet the growing demand, primarily as a result of a lack of appropriate medical regulations. The need of great importance is to develop a precise methodology and to foster very much planned strategies for the normalization of natural unrefined substances and home grown formulations.12-15

India can arise as the significant nation and play the lead job underway of normalized, remedially powerful Ayurveda plan. India must investigate medicinally valuable plants. This can only be accomplished by evaluating and analyzing herbal products using sophisticated modern standardization techniques like UV-Visible, TLC, HPLC, HPTLC, GC-MS and others.

Herbal medicines differ from conventional medicines, and numerous novel methods are being developed for the purpose of quality assessment of herbal medicines. Due to its simplicity and dependability, the fingerprint analysis method with chromatography has emerged as the most effective method for quality control of herbal medicines. It can act as a device for distinguishing proof, validation and quality control of natural medications. Fluorescence quenching, the use of biomarkers in fingerprinting, biological assays, and the combination of chromatographic and spectrophotometric methods are just a few of the more cutting-edge approaches currently available for standardizing herbal medicines. Bioassay can assume a significant part in the normalization of home grown medicates and can likewise turn into a significant quality control strategy as well with respect to legitimate solidness testing of the product.16-17

Evaluations & Quality control of Herbal Drugs parameters 18, 19, 20 21, 22

• Morphological Evaluation
• Microscopic Evaluations
• Physical Evaluation
• Chemical Evaluation
• Biological Evaluation
• Morphological Evaluation:

This approach looks at morphological or exterior characteristics. Organoleptic Character is the term for the aroma and flavor in this hue. These characters are modified from elements of the plant.

1. Size
2. Odor
3. Shape
4. Color
5. Taste

• Microscopic Evaluation : This approach allows for the thorough study of microscopic characteristics. This approach entails histological investigation using a compound microscope.

Additionally, it entails researching other cell components found in crude drugs, such as lignin starch grains, calcium oxalate crystals, and aleuronic grains (a kind of plant protein). This approach provides an understanding of ordered and disorganized systems that microscopic analysis cannot provide. Using this technique, it is possible to examine the contents of cell walls, starch grains, lignin, calcium oxalate crystals, trachoma’s, stomata, fiber, etc.

Eg.

• Lignified Trichomes of Nux-Vomica
• Covering Trachoma’s of senna

Quantitative Microscopic Evaluations:

1. Stomata Number
2. Stomatal Index
3. Vein - Islet Number
4. Vein Termination number
5. Palisade Ratio
6. Lycopodium Spore method

1) Stomatal Number: It is defined as average number of Stomata per sq. mm of epidermis of leaf

2) Stomatal Index: The stomatal Index of the leaf is the ratio of the no of Stomata to the total number of Stomata of epidermal cells

• Formula
• SI = S/E+S x100
• Where,
• SI: Stomatal Index
• S: No of Stomata per 59 mm
• E: No of epidermal cell in the same unit area.

3) Vein-islet Number: It is Ven-islet defined as the average no of Pex sq.mm of the leaf surface midway between the midrib of margin.

4) Vein Termination Number: It is defined as the average no of veins termination pex sq. mm of the leaf Surface midway beth the midrib of margin

5) Palisade Ratio: Define as the average no of Palisade cell bene each epidermal cell. It is determined by Powder drugs.

6) Lycopodium Spore Method: It Is compose of spores of Lycopodium clavatum. Each spore is tetrahedral in shape Lycopodium Spores are very characteristic in shape & Uniform in size (25 mm) Average 94000 spores per mg of Powdered Lycopodium are present Lyospores method is used for those crude daug powder samples .

● Physical Method Evaluation.

Qualitative Physical Evaluation

Solubility, Refractive index, melting point, boiling point, viscosity, optical rotation, density, spectroscopy evaluations, chromatography evaluations

Quantitative physical Evaluations

1) Ash value determination: The byproduct of the interaction between the crude drug and the ash drug using the powder-drug interaction, one may ascertain the powder's composition. To burn all biological materials. Ash Value is essential for determining the identification or purity of powdered drugs. Within specified drug limits, it varies depending on the solids. Carbonate, phosphate, silica, and silicates make up the ash.

Types of Ash value: Total ash, Acid insoluble ash, water soluble ash, dry ash, wet ash

2) Extractive value determination: Chemical constituents, together with any contaminants, are removed during the extraction process. Because of various chemical properties, Different polar and non-polar solvents are utilized throughout the extraction procedure.

The Extractive Valve can be classified on the basis of solvent

• Water soluble extractive
• Alcohol soluble extractive
• Ether soluble extractive

3) Moisture content determination

A medicinal plant's excess water content will be discovered through microbial development. Every plant should get a specific amount of water.

Method of determination of moisture content

• Loss of drying
• Azeotropic method
• Karl fischer reaction

Chemical Evaluation :

Qualitative chemical evaluations:

This test can perform on both crude drug powder sample this involves various chemical the to identify different phytochemicals

Eg. Alkaloids, glycosides, protein, alcohol

Quantitative chemical evaluations:

In this Evaluation Assay of (Radio immuno assay Enzyme include immuno sorbent assay), It involves Acid value, Iodine value, Saponification Value, Ester value, RM value,Acetyl Value For fats and oils. White Ester value Acetyl Value Aldehyde content for Volatile oil.

Pharmacological Evaluations:

Strength of rough medication or readiness is estimated by Its impact of miniature organic entity organs of Tissue of creature known as natural Assessment On the off chance that on entire creature known as Rat, mice, monkey, Hare, Guinea Pig it is Pharmacological Assessment. When a material's chemical or physical evaluation is insufficient, this method is preferred.

Methods:

• Agar well method
• Turbidimetric method
• Bio autographic method

Bioassay:  At the point when the Strength of unrefined medication is continued living creatures like Microbes, Contagious development, creature tissue is known as Bioassay. Bioassay is used to verify the therapeutic activity and effect of crude drugs.

There are 3 methods.

• CD TOXIC Method
• Symptomatic method
• Tissue Method.

Application of herbal drug technology:

Herbal Remedies for Psoriasis Diseases:  Psoriasis is without a doubt troubling and skin medicines utilizing home grown cures can conquer the unfavorable and hostile impacts and furthermore work on the bioavailability of medications. Herbals drugs like Aloe, Cayenne, Chamomile, Dong Quai, Emu oil, Night primrose oil, Fish oil, Tea tree oil, Turmeric, Dangerous elm, Wintergreen, Shark ligament, Milk thorn, Glucosamine, Flaxseed oil are for the most part utilized for the treatment of psoriasis.

Herbal drugs for disorders caused by "cellphones”

Brain tumors, cancer, infertility, memory loss, depression, as well as issues with sleep and behavior can all be brought on by exposure to radiation from cell phones and telephone towers. The body, particularly the electrical organ known as the brain, is affected by prolonged exposure to cell phone radiation. Nowadays, herbal medicines are widely used to treat disorders brought on by cellphones. Radix Curcume, Herba Agrimonia, and Fructus Aurantii are all drugs used to treat brain cancer that are sold under the brand name "Canelim Capsules." Other drugs, such as Hypericum perforatum, Passiflora, Valerian, Lemon medicine tea, and so on are utilized in restoring a sleeping disorder.

Polyherbal Therapies

The paradigm shift from single-target drugs to multi-target drugs has taken place over the past ten years. Instead of destroying the agent that causes the damage, multi-target approaches target the body's defense, protective, and repair mechanisms. A drug combination may be used to accomplish this. Traditional medical treatments employ multi-component extracts of natural products that simultaneously act on multiple targets. This is known as multi-targeted therapy. Phytosomes are a novel concept in herbal delivery systems because they contain the synergistic, potentiate, agonistic/antagonistic pharmacological agents that work together dynamically to produce therapeutic efficacy with minimal side effects.23-26 A novel herbal drug delivery system known as a "Phytosome" is produced by morally complexing the polyphenolic phytoconstituents with phosphatidylcholine. Some refers to being cell-like, while "phyto" refers to a plant. Phytosomes are novel herbal products that have a better pharmacokinetic and therapeutic profile than traditional herbal extracts because they are more easily absorbed and utilized. Herbal extracts' bioavailability has increased in phytosome-based clinical trials. Systemic antioxidants (mainly flavonoid and terpenoid components) are delivered through the phytosomal drug delivery system, which is also used to treat blood pressure, liver disease, cancer, skin disease, and brain lining protection.26

DNA Microarrays in Herbal Drug Technology and Research

An orderly arrangement of thousands of oligonucleotides or identified sequenced genes printed on an impermeable solid support, typically glass, silicon chips, or nylon membrane, is known as a DNA Microarray (also known as gene chips or biochips). DNA microarrays are necessary for quality control of herbal drugs and extracts because they offer a revolutionary method for studying gene expression and are suitable high-throughput tools for simultaneously analyzing multiple genes. An extensive report of chemical entities working together on multiple targets in natural products necessitates simultaneously studying gene expression changes. The following are three major uses for DNA microarrays:

Pharmaceutical dynamics: for the purpose of discovering novel therapeutic response biomarkers and diagnostic and prognostic indicators; elucidation of a plant's molecular mechanism of action, as well as the identification and validation of new molecular targets for the development of herbal drugs.

• Pharmaceutical genomics: 

For expectation of likely side-impacts of the home grown drug during preclinical action and security studies; distinguishing proof of qualities engaged with giving medication responsiveness or obstruction and forecast of patients probably going to profit from the medication and use overall pharmacogenomics studies.

In pharmacognosis: For right herbal distinguishing proof and verification of unrefined plant materials as a component of normalization and quality control.

Toxicogenomics and quality control of herbal drugs and extracts are two more uses for DNA microarrays.27-31

Herbal Cosmeceuticals

A-hydroxy acids, retinoic acid, ascorbic acid, and coenzymes are examples of plant-based active ingredients that are added to over-the-counter skin care products to increase skin elasticity, delay skin ageing by reducing wrinkles, protect against UV radiation, and stop collagen degradation, respectively. These ingredients are also known as cosmeceuticals. These are used topically for skin care, acne treatment, and hair development and care. They may also be found in soaps, shampoos, and fragrances. Today's most popular herbs are Aloe, Almond oil, Mehandi, Neem, Sandalwood oil, Coconut oil, and others.

Additionally, Gaultheria Fragmatisma and Thuja Occidentalis (which aid in UV absorption and are used to whiten skin) are utilised as natural skin care products.

Conclusion:

Modern pharmaceutical research has been given a priceless gift in the form of herbal drug technology. In India, more than 70% of people utilize herbal medicines for medical purposes. Numerous of these medications are supported by a wealth of experience-based data. It is vital to grasp standardization and assessments better. It could offer a good high-throughput platform for the study and creation of pharmaceuticals derived from natural sources. Utilizing domestic production, biotechnology research, and genetic advancements as opposed to utilizing wild plants although there is some use of herbal medication technology, this article uses distinct assessment techniques to authenticate the identity of the medicine and determine its quality and purity.

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Reference:

• Heinrich M. Ethnobotany and natural products: the search for new molecules, new treatments of old diseases or a better understanding of indigenous cultures. Curr Top Med Chem. 2003:3:141154.
• Vuorela P, Leinonen M, Saikku P, Tammela P, Rauha JP, Wennberg T. Natural products in the process of finding new drug candidates. Curr Med Chem. 2004:11:13751389.
• Patwardhan B. Ethnopharmacology and drug discovery. J Ethnopharmacol. 2005:100:5052.
• Schmidt B, Ribnicky D. M, Poulev A, Logendra S, Cefalu W. T, Raskin I. A natural history of botanical therapeutics. Metabolism. 2008:57:S39.
• Brower V. Back to nature: Extinction of medicinal plants threatens drug discovery. J Natl Cancer Inst. 2008: 100:838839.
•  Calapai G. European legislation on herbal medicines: A look into the future. Drug Saf. 2008:31: 428431.
• Farooqi A.A. and Sreeramu B.S. Cultivation of medicinal and aromatic crops. University press, Delhi, 2001, 9-10.
• Calixto J.B, Barz J., Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents), Med Biol Res, 2000, 33: 179-189
• Zafar R, Panwar R, Sagar Bhanu PS. Herbal drug standardization: The Indian Pharmacist 2005; 4(36): 21-25.
• Patra KC, Pareta SK, Harwansh RK, Jayaram Kumar K Traditional approaches towards standardization of herbal medicines -A review. J Pharm Sci Technol 2010; 2 (11): 372-379
• Straus SE. Herbal remedies. New Engl J Med 2002;347:2046
• Bent S. Herbal medicine in the United States: Review of the Efficacy, Safety, and Regulation. J Gen Intern Med. 2008:23(6):854-859.
• Sahoo N, Choudhury K, Manchikanti P. Manufacturing of biodrugs: Need for harmonization in regulatory standards. BioDrugs. 2009:23(4):217229.
• Sahoo N, Manchikanti P, Dey S. Herbal drugs: Standards and regulation. Fitoterapia. 2010:81(6):462471.
• Kantor M. The role of rigorous scientific evaluation in the use and practice of complementary and alternative medicine. J Am Coll Radiol. 2009:6:254262.
• De Smet P. Herbal medicine in Europe: Relaxing regulatory standards. N Engl J Med. 2005:352:11761178.
• Vlietinck A, Pieters L, Apers S. Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European Union. Planta Med. 2009:75:68368
• Indian Herba Pharmacoeia Indian drug manufacturer’s association Mumbai 2002
• British Herbal Pharmacopeia,British Herbal Medicine Association,1996
• Herbal Drug Technology Dr.G.Arunachal,Dr.V.E.Ida Christi Dr.Prashant Kumar Edition 2019-20 Page No.194-204
• Textbook of Pharmacognosy and Phytochemistry Biren Shah , A.K.Seth 2nd Edition
• A Textbook of Pharmacognosy & Phytochemistry Prof.Dr.Md.Rageeb Md.Usman Everest Publishing House
• Ernst E. Herbal medicine in the treatment of rheumatic diseases. Rheum Dis Clin N Am. 2011:37:95-102.
• Andreescu C, Mulsant BH, Emanuel JE. Complementary and alternative medicine in the treatment of bipolar disorder-A review of the evidence. Journal of Affective Disorders. 2008:110:16-26.
• May BH, Xue CC, Yang AW. Herbal medicine 26.Rishton G. M. Natural products as a robust source of new drugs and drug leads: Past successes and present day issues. Am J Cardiol. 2008:101:43D49D.
• Csermely P, Agoston V, Pongor S. The efficiency of multi-target drugs: the network approach might help drug design. Trends Pharmacol Sci. 2005:26:178182.
• Wagner H, Steinke B, Allescher HD. Multitarget Therapy in Functional Dyspepsia. Phytomedicine. 2006:13(V):1-130.
• Williamson EM. Synergy and other interactions in phytomedicines. Phytomedicine. 2001:8:400-409.
• Imming P, Sinning Ch, Meyer A. Drugs, their targets and the nature and number of drug targets. Drug Discovery. 2006:5:821-834.
• Roy S, Khanna S, Shah H, Rink C, Phillips C, Preuss H, etal. Human genome screen to identify the genetic basis of the anti-inflammatory effects of Boswellia in microvascular endothelial cells. DNA Cell Biol. 2005:24:244255.