INTRODUCTION:

“Nothing supports the life better than nature”

Nature is defined as the space outside the spectacle; People are living in an age where much attention is being built on the usefulness of natural resources. Herbal products and healthy foods supplements are necessary. Herbal medicine doctors; homoeopathic physicians, as well as many healthcare professionals, are continuing to gain attention. Each person appears to be curious, "What should we use to aid the body cure itself in a much more healthy way?”

Drugs of natural origin play a significant role in the public health care system of any nation. Indian Materia Medica includes about 2000 drugs of natural origin of which approximately 400 of animal sources including minerals whereas the others are the sources of vegetable. As in modern world, consumers are fully aware about the synthetic drugs, efficacy and side-effects. There is a

growing interest in natural medications in a simple natural way. In general, the Indian people have a great extent of awareness over the ancient application of various natural remedies. This is in addition to the structured Indian approach of medicine, ayurvedic medicine. All this has attracted worldwide interest. In the past few years tampering / substitution has been performed in the production of certain formulations. This terminology adulteration/substitution itself means that the ' activity of creating a fallacious quality material by replacing the original herbal plant/part with an exact size and form, even though it provides a poor or low quantity of product content, which results in the customer getting cheated.

Every composition in olden history had its specific evaluation method. Ayurveda's result showed it has its specific evaluation method regarding Banslochan as an example (practiced for the preparation of Sitopaladi churan). Through hands, Banslochan cannot be broken quickly and transformed into transparent material by washing with water. But the large proportion of the methods weren’t completely practiced in the modern development of such an ancient classical test technique.

Many herbal manufacturers already created its modern method, merging in the old techniques for the fusion analysis of their products, hence how spurious natural resources of low therapeutic value was combined in certain preparations. Therefore, the various regulatory authorities with WHO came into action to overcome the issue involved in natural products, because then buyers cannot be fooled by adulterated materials. For controlling substitution, several measures have taken by the WHO. Several specific techniques for quality control and standardisation have implemented and acquired by the WHO for herbal drugs. Around the same period, the WHO has instructed the member countries to provide advice and support on quality assurance of herbal products and also proposed a few modern methods, tools and specifications of herbal preparations towards standardisation and production. Guidelines recommended fingerprinting methods for the identification of plants and their constituents.

Quality control is a tedious and challenging task for the natural remedies. Natural products are different from traditional medicines and hence, for this good cause, assessing the quality of natural products, several novel approaches are emerging.

For controlling the quality of natural products, chromatography i.e. fingerprint analysis approach has proven the best effective method due to its reliability and easiness. Chromatographic fingerprint produces a chromatogram that represents the chemical characteristics of herbal medicines. This strategy can serve as the proper monitoring of the quality and safety of medicinal herbs.^{1, 2}

Chromatographic Fingerprint

There are certain methods which shown there usefulness in the past. But now one has to develop newer methods and parameters to reinstate our own TIM (s) (traditional Indian medicines) by chromatographic fingerprinting. Chromatographic fingerprint analysis is a rational and practical analytical strategy to assess. The authenticity quality and stability of (TIM) as well as other herbal medicines considered.³

The information gathered from the fingerprint is more comprehensive than that provided from the typical approaches. Chromatographic fingerprints sometimes exhibit variation in peak height and retention time of a given sample running through identical columns under the same separation condition, for the complex or multi-herbal formulation, multiple chromatographic fingerprinting which consist of more than one chromatographic and represent the whole characteristics of chemical constitutions of the complex medicine is proposed as a potential strategy.

Chromatographic fingerprint produces a chromatogram that represents the chemical characteristics of herbal medicines. Chromatographic fingerprint has potential to determine the identity, authenticity and lot-to-lot consistency of herbal formulation. It is inadequate to represent all chemical patterns of characteristics when the compositions of herbal Medicines are too complex.^4-9

Patho-physiology of traditional system of medicines

Ayurveda and Siddha the oldest Indian Systems of Medicines in which the human body was understood using the Tri-Dosha (Humors) concept. i.e., Pitta, Kapha and Vata. Hence by knowing the therapeutic efficacy of a medicine about what dosha it is going to cure, an excellent therapy was possible. In most of the Indian Materia Medica books and the literature of various traditional medical philosophies world over, a clear mention was made about the therapeutic efficacy of the herbal medicines using the study of their physico-chemical properties. A detailed mention was provided in the ancient literature about herbal medicines on what doshas they are going to act and how to use them.. In almost all the traditional system of medicines the basic concepts include the nature and its role on the humors of the human beings. Using the properties like Tri Doshas, Panchabhutas, Saptadhatus, and physico chemical properties like shape, texture, taste and color etc., the medicines were selected for specific efficacy.

According to the above philosophies, pharmaco-dynamic and genetic principles vary from person to person and situation to situation according to doshic predominance. In other words there is a relation between the dravya gunas (medicinal properties) and doshas (Properties, disorders). Addition or deletion of one or more drugs may be necessitated to treat identical disease in patients, with different individual doshas or combination of doshas. Hence Ayurvedic pharmaco-therapy is more individualistic according to dosha predominance of the patient. Identification of properties (Rasa (Taste), Guna (Property), Veerya (Potency), Vipaka (Post assimilative effect) and Prabhava (Any Special property) compatible to doshas is unique and more reliable. Thus knowing the chemistry of the medicines with specific taste will help to know the efficacy of the respective medicine. The diseases produce when the Tridoshas Viz., Vata, Kapha and Pitta individually or in combination with one another disturbed in the body.

Standardization

A system to ensure that every packet of medicine that is being sold has the correct substances in the correct amount and will induce its therapeutic effect this is known as standardization. For advancing the standardization and safety aspects of herbal products there are two main reasons for the consideration.⁹

First, the usage of natural herb, including, nutritional supplements, food and beverage product, current remedies and phytomedicines.

Secondary, herbal products are an essential resource for novel medicine development. The quality is the average of the different results that have a direct impact on the material. Standardization and quality evaluation of natural ingredients according to regulatory standards would be unavoidable to overcome these challenges. Optimization of natural resources is a dynamic challenge owing to its heterogeneous nature present in the form of individual plant parts. To make sure the validated efficiency of natural medicine, careful control of the precursor material is necessary.^{2,
10, 11}

Standardization of products

For Standardization, no comprehensive description is there. Quality of a final product of each batch is guaranteed by the standardized product. The concept of standardization used by the NHPD is considered in this article. Standardization needed under particular conditions for the determination of unique compounds (as well recognized as markers) which can be utilized to produce a high-quality product. The standardization approach also allows measuring of the product quality. ¹²

Standardization of Extracts

Standardization of Extracts describes a material with a defined minimum level or a large number of one or even multiple components of biochemical or marker chemicals, thus retaining the maximum characteristics of a product comprising non - human animal material or plant material, fungi, bacteria, algae. It was accomplished via recognizing and assessing one or multiple genetic markers of any identified biological activities (active compound or medicinal) or unidentified biological activities. Biomarkers are categorized as:

1. Active constituent: A recognized and effective biochemical therapeutically active product. This particular biochemical component could be modified through standardization to a quality level that is demonstrable-either present naturally in an herb or more in a concentrated extract.

2. Marker compound: When a biochemical active product not identified. The recognized marker component, which is a natural health product with defining characteristic, though, it does not lead to pharmacological activity and is modified to fulfill the experimental goal. The marker component can be used to monitor the quality of the final product of each batch. It sets out a standardization method to ensure that manufacture product of each batch provides a similar quantity of the marker material.²

Non- Standardization of Extracts

The extract of non-standardized is produce by immersing the herb, herb parts, bacterium, algae, fungus and material of non - human animal in a solution which separates particular constituents. The solution can be taken as it is or evaporated to obtain a dry extract of non-standardized.²

Standardization criteria for raw drugs / medicinal herbs (as per WHO)^{13, 14}

Evaluation of Herbal Drugs^{15, 16, 17}

Herbal process control

Drugs are manufactured from different raw materials by using different methods or process. Some impurities are incorporated into the material during the manufacturing process. Multiple-step procedure, which produces intermediate compounds. In- process control provides information on general characters, identification test and other applicable tests such as inorganic and heavy metal impurity, microbial limit, and pesticide reside besides, safety, assay and stability. In addition to the foregoing portions of the initial final and in process samples are used for collecting average run samples for the quality control laboratory to perform final batch analysis and release. The followings are the flow chart of process control of herbal drugs.

Advancement in standardization

Most of the modern methods like TLC, HPTLC and HPLC Gas chromatography and Hyphenated procedures HPLC-DAD, CE-DAD, GC-MS, LC-MS, HPLC-MS, HPLC-DAD-MS and LC-DAD-MS. HPLC-UV (DAD)-FTIR-NMR-MS used for the quality control of herbal medicines are based on the modern methods of chemical analysis and could not explain the chemical and therapeutic properties of the medicines in terms of traditional parameters like Taste, Color and Doshas. When a medicine is standardized the protocol for the preparation and quality control and administration should be the same. Moreover, the recent methodologies with the application of hyphenated chromatography and spectroscopy, such as gas chromatography-mass spectroscopy (GC-MS), capillary electrophoresis-diode array detection (CE-DAD), high-performance liquid chromatography diode array detection (HPLC-DAD), , HPLC-NMR and HPLC-MS, also give significant spectral details that would be extremely effective for structural elucidation and qualitative analysis. With the help of the spectral information the hyphenated instruments show greatly improved performances in terms of the elimination of instrumental interferences, retention time shift correction, selectivity, chromatographic separation abilities, and measurement precision. If hyphenated chromatography is further combined with chemometric approaches, clear pictures might be developed for chromatographic fingerprints obtained. A chemical fingerprint obtained by hyphenated chromatography, out of question, will become the primary tool for quality control of herbal medicines.^18,
19

Market Potential of herbal medicine

Certain Indian plants have shown their high therapeutic value global market that’s why they are the plant of choice in different formulations.

Table: 1:

S. No.

Common name

Biological Source

(Family)

Major Chemical Constituents

Analytical Method/ figure printing method developed

Medicinal uses

References

Amla

Embelicaofficinalis

(Euphorbiaceae)

Tannins (Gallic acid, ellagic acid)

Chebulinic acid

Phenolic compound

Amino acids

Carbohydrates

Vitamin C

HPLC

HPTLC

GCMS

Anti-fungal,

Diuretic,

Anti-inflammatory, Laxative, Hepatoprotective,

Anti-oxidant

Ashwgandha

Withaniasomnifera

(Solanaceae)

alkaloids(isopelletierine, anaferine, cuseohygrine, anahygrine, etc.)

steroidal lactones (withanolides,withaferins)

saponins

HPLC

Anti-inflammatory, Sedative,

Anti-stress,

Anti-rheumatic,

Anti-tumor, Diuretic,

Rejuvenator,

Hemopoetic, Immunomodulator, Hypotensive

21, 22

Ashoka

Saracaindica (Leguminosae)

Epicatechin

Catechin

Procyanidin

Oleic acid

HPTLC

HPLC

Uterine tonic, Gynecologic disorders,

In menorrhagia,

Sedative

Atis

(Aruna)

Aconitum heterophyllum

(Ranunculaceae)

12 secohetisan-2-ol

N-succinoylanthranilate

Atesinol

6-benzoylheterastine

N-diethyl-N-formyllaconitine

Methyl aconitine

Aconitine

Anthorine

HPLC

TLC

Tonic, Anti-cough,

For curing fever and stomach ache,

Febrifuge

Daruharidra

Berberisaristata

(Berberidaceae)

Phenolic compounds

Tannins

Flavonoids

Phytosterols

TLC

HPTLC

HPLC

Febrifuge, Astringent,

In menorrhagia,

Laxative,

In spleen and Liver Diseases

Garlic

Allium sativum

(Liliaceae)

S-allylcysteinesulfoxide (alliin)

allicin (DATi)

diallyldisul􀂦de (DADS)

S-allylcysteine (SAC)

organo-sulphur compounds (OSC)

ion pair HPLC

HPLC-UV

Anti-hyperlipidemic, Anti-hypertensive,

Suppressant,

Platelet aggregation

26,27

Gudmar

Gymnemasylvestre

(Asclepiadaceae)

Charantin

polypeptide-p

vicine

gymnemic acids

gymnemasaponins

polypeptide gurmarin

HPLC

Cardiac stimulant, Diarrhea,

Anti-diabetic,

Stomach ache,

Larvicidal

28, 29

Guduchi

Tinosporacordifolia

(Menispermaceae)

Alkaloids

Diterpenoid lactones

Glycosides

Steroids

Polysaccharides

HPLC

HPTLC

Anti-spasmodic,

Anti-malarial,

Anti-cancer,

Anti-allergic,

Anti-inflammatory,

Anti-periodic,

Anti-oxidant,

Anti-leprotic

Guggul

Commipphoraweightii

(Burseraceae)

Myrcene

Dimyrcene

Polymyrcene

Terpenoids

Steroids

Flavonoids

Guggultetrols

Lignans

Sugars

Amino acids

HPLC

UPLC

HPTLC

Anti-rheumatic, Hypolipidemic, Hypocholesteremic,

Anti-inflammatory

31,32,33

10.

Holy basil

Ocimumteniflorum

(Labiatae)

Oleanolic acid

Ursolic acid

Rosmarinic acid

Eugenol

Carvacrol

Linalool

β-caryophyllene

GC-MS

HPLC

Anti-diabetic,

Stimulant,

Aromatic,

Tonic,

Anti-inflammatory,

Anti-oxidant

34,35

11.

Isabgol

Plantagoovata

(Plantaginaceae)

Moisture

Albumin

Globulin

Linoleic acid

Carbohydrates

Swelling factor

Moisture content

Gelling property

Diarrhea,

Anti-inflammatory,

Aphrodiasic,

Emollient,

Laxative, Demulcent

36, 37

12.

Jatamansi

Nardostachysjatamansi

(Valerianaceae)

Isovaleric acid

3-Methylvaleric acid

Patchoulol

GC-MS

NMR

HPTLC

In constipation, Stomachic,

Diuretic,

In menstruation,

Anti-spasmodic,

13.

Kalmegh

Andrographispaniculata

(Acanthaceae)

bitter principles andrographolide

a bicyclic diterpenoid lactone

Kalmeghin (upto 2.5%)

HPLC

HPTLC

Hepatoprotective, Stomachic,

Anthelmintic,

Dyspepsia,

Febrifuge, Bitter tonic

39, 40

14.

Kokum

Garciniacamboga

(Guttiferae)

Garcinia

Anthocyanin

Garcinol

Polyisoprenylatedbenzophenone

LCMS

UPLC

HPLC

TOF-MS

Anti-ulcer, Hypolipidemic,

Anti-obesity,

Anti-fungal

41, 42

15.

Kutuja

Holarrhenaantidysenterica

(Apocynaceae)

Concessidine

Connessimine

Conkurchine

Holadiene

Holarrhenine

HPTLC

Anti-protozoal, Amoebicidal,

In facial acne Anti-tuberculous

16.

Kutki

Picrorhizakurroa

(Scrophulariaceae)

Picroside-I

Picroside-II

HPLC

Anti-inflammatory, Immunomodulatory, Hepatoprotective, Jaundice, Fever,

In periodic, Dyspepsia, In Nausea and anorexia, In bronchial asthma

17.

Kuth

Saussureacostus

(Asteraceae)

Saussurea lactone

Costunolide

Palmitic acid

Linoleic acid

HPTLC

HPLC

Anti-septic,

Anti-arthritic,,

Anti-inflammatory, Cytotoxic,

Carminative, Aphrodisiac,

Antioxidant

45, 46

18.

Makoy

Solanumnigrum

(Solanaceae)

Solamargine

Solasonine

Solanine

α and β solamagrine

solasodinsolanidine (0.09-0.65%)

Diosgenin

Rutin

GC-MS

Hepatoprotective, Diaphoretic,Sedative, Diuretic,

Expectorant, Hydragogue,

In dysentery,

In stomach ulcer,

In Piles, Fever,

Antioxidant, Hypotensive

47, 48

19.

Neem

Azadirachtaindica

(Meliaceae)

Isomeldenin

Nimbin

Nimbinene

6- desacetyllnimbinene

Nimbandiol

HPLC

UHPLC-MS/SRM

Anti-plaque,

Astringent,

Purgative,

Anti-septic,

Emollient, Anthelmintic

49, 50

20.

Saffron

Crocus sativus

(Iridaceae)

Crocin

α-crocin

lycopene

zeaxanthine

alpha- and beta- carotenes

crocetin

picrocrocin

Safranal

UHPLC

MS-HPLC

DAD-HPLC

Anti-tumor,

Flavouring agent and Colouring (Food Dye), Anti-spasmodic, Emmenagogue, Stimulant

51, 52

21.

Satavatri

Asparagus recemosus

(Liliaceae)

Shatvarin I to IV

Sarsapogenin

Aspargamine

Racemosol

Racemofuran

HPLC-Q-TOF-MS

LC-MS

HPLC-UV

Nervine disorder, Diurectic,

Galactogogue,

Anti-dysenteric

53, 54

22.

Vatsnabh

Aconitum ferox

(Ranunculaceae)

Aconitine

Pseudo-aconitine

Bikhaconitine

Chasmaconitine

Catecholamine

Isoquinolines

TLC

HPLC

Anti-inflammatory,

Anti-rheumatic,

Cardiac stimulant,

CONCLUSION

Traditional Indian Medicine (TIM) includes several botanicals, each containing several compounds that are important to the potential action of the medicinal product. Thus, analytical methods that aim at a collection of compounds, along with their respective ratio values, help in providing a further strategic way to the identification and assessment of the quality of TIM. This paper provides many references for the use of chromatographic fingerprint methodology to assess the durability, identity, and stability of TIM, along with the detection of impurities as specified. The problem of quality assurance of herbal medicines has been solved to a great extent with the help of chromatographic fingerprint analysis. The variation determination of common peaks/regions in a set of chromatographic fingerprints could provide useful qualitative and quantitative information on the characteristic components of herbal medicines investigated. On the other hand, whether the real samples were identified as the herbs with the same quality grade could be determined successfully by way of comparing the chromatographic fingerprints with the similarity index and linear correlation analysis. Henceforth, recognition can be used to discriminate different kinds of samples of herbal medicines investigated. Thus chromatographic fingerprint analysis serves as a promising quality control tool for herbal medicines.

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Received on 29.09.2020 Modified on 28.12.2020

Research J. Pharm. and Tech. 2021; 14(7):4003-4010.

DOI: 10.52711/0974-360X.2021.00694