INVESTIGATE INDIAN HERBAL

PRODUCTS

Introduction of Indian Herbal Industries• The World Health Organization (WHO) has listed 21,000 plants, which are

used for medicinal purposes around the world. Among these 2500 speciesare in India, out of which 150 species are used commercially on a fairlylarge scale.

• India is the largest producer of medicinal herbs and is called as botanicalgarden of the world

• India has a unique position in the world, where a number of recognizedindigenous system of medicine viz., Ayurveda, Siddha, Unani, Homeopathy,Yoga and Naturopathy are being utilized for the health care of people.

• The major pharmaceuticals exported from India in the recent years areisabgol, opium alkaloids, senna derivatives, vinca extract, cinchonaalkaloids, ipecac root alkaloids, solasodine, Diosgenine/16DPA, Menthol,gudmar herb, mehdi leaves, papian, rauwolfia guar gum, Jasmine oil, agarwood oil, sandal wood oil, etc

• Herbal industry in India uses about 8000 medicinal plants. However,none of the pharma has standardized herbal medicines using activecompounds as markers linked with confirmation of bioactivity ofherbal drugs in experimental animal models

• From about 8000 drug manufactures in India, there are however notmore than 25 manufactures that can be classified as large scalemanufactures

• also called Ayurveda. • It is a system of medicine that originated in India several thousand years

ago. • The term Ayurveda combines two Sanskrit words: ayur, which means life,

and veda, which means science or knowledge. Ayurveda means "the science of life.“

• Ayurveda is a whole medical system which integrates and balances the body, mind, and spirit (holistic)

• A primary aim of Ayurvedic medicine is to cleanse the body of substances that can cause disease. This helps re-establish the harmony and balance necessary for optimal health.

• About 70 percent of India's population lives in rural areas; about two-thirds of rural people use Ayurveda and medicinal plants to meet their primary health care needs.

• In addition, most major cities have an Ayurvedic college and hospital. There are 587,536 registered traditional medical practitioners, 2,860 hospitals providing Ayurvedic treatment, and 22,100 dispensaries for traditional medicine in India.

• This allows over 500 million people in India to rely solely on Ayurveda today.

• In Ayurveda, the distinction between food and medicine is not as clear as inWestern medicine.

• Food and diet are important components of Ayurvedic practice, and sothere is a heavy reliance on treatments based on herbs and plants, oils(such as sesame oil), common spices (such as turmeric), and othernaturally occurring substances.

• The following are examples of commonly used herbs:üThe spice turmeric has been used for various diseases and conditions,

including rheumatoid arthritis, Alzheimer's disease, and wound healing.üAn extract from the resin from a tropical shrub (Commiphora mukul, or

guggul) has been used for a variety of illnesses. In recent years, there hasbeen research interest in its use to lower cholesterol.üThe essential oil extracted from Holy Basil is used as counteract depression

and mental stress.

Reference: Indian Herbs. Retrieve from http://www.india-herbs.com/pages/about_ayurveda

EXAMPLES OF INDIAN HERBAL

Amalaki (amla or indian gooseberry)Dhavana (Artemisia pallens)Yashtimadhu (liquorice)

Sugar Apple (Annona squamosal)Semu (Bombax ceiba)Coccinia grandis (Ivy gourd)

EXAMPLES OF INDIAN HERBS

Mangifera indica (Mango) Azadirachta indica (Neem)

Pterocarpus marsupium (Indian Kino tree)Ocimum sanctum (holy basil)

Momordica charantia (bitter gourd)

But how they evaluate the quality, safety and efficacy of those products ??????

QUALITY

TLC

HPLC

GC

METHODS IN DETERMINE QUALITY OF HERBAL PRODUCTS

Quality of Herbal Products

• Due to the complex nature and inherent variability of the chemicalconstituents of plant-based drugs, it is difficult to establish qualitycontrol parameters

• Quality of the crude drug used in manufacturing of such formulationsdepends on the amount of active ingredient presents.

• Standardization of these crude drugs has become necessary beforetheir use for preparing formulations. Moreover, standardization offinished product is of equal importance to be considered in assumingthe safety and efficacy product before use.

Phytochemical Profiles –Fingerprinting• The construction of chromatographic fingerprints plays an important

role in the quality control of complex herbal medicines• By definition, a chromatographic fingerprint of herbal medicine is, in

practice, a chromatographic pattern of pharmacologically active andor chemically characteristic constituents present in the extract

• Thus many kinds of chemical fingerprint analysis methods to controlthe quality of herbal drugs have gradually come into being, such asthin layer chromatography, gas chromatography, high performanceliquid chromatography etc.

Thin Layer Chromatography (TLC)• In its traditional form, thin layer chromatography (TLC) is frequently used for the

analysis of botanical raw materials. Thin layer chromatography has a long recordin almost all pharmacopoeias for its use in the identification of herbal medicines.

• The visualization of the entire pattern of compounds present in an herbal drug(so called fingerprinting) is important in the quality and stability testing of herbalproducts.

• The TLC fingerprint with a visible pattern of bands provides fundamental data andis typically used to demonstrate the consistency and stability of herbal materials.

• The advantages of using TLC to construct the fingerprints of herbal medicines areits simplicity, versatility, high velocity, specific sensitivity and simple samplepreparation. Thus, TLC is a convenient method of determining the quality andpossible adulteration of herbal products.

• Quantitative TLC measurements are performed by densitometric scanning.

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)

• HPLC is a popular method for the analysis of herbal medicinesbecause it is easy to learn and use and is not limited by the volatilityor stability of the sample compound.

• In general, HPLC can be used to analyse almost all the compounds inthe herbal medicines.

• Reversed- phase (RP) columns may be the most popular columnsused in the analytical separation of herbal medicines.

• It is necessary to notice that the optimal separation condition for theHPLC involves many factors, such as the different compositions of themobile phases, their pH adjustment, pump pressures etc.

HPLC Analysis of Withania somnifera Roots • Roots of Withania somnifera are widely used in Indian herbal formulations. Withaferine A and

withanolide A are two pharmacologically important withanolides present in the roots of the plant.• HPLC method using DAD and ELSD detector was developed for simultaneous determination of

withaferine A and withanolide A from the roots and herbal formulation of the plant.• Coarse powder of root was extracted with methanol by shaking for 30 minutes and sonication for

45 minutes. Herbal formulation was first extracted with chloroform and then with ethyl acetate,extracts were combined, evaporated and reconstituted with methanol.

• Retention time of both the compounds was vary with detector to detector and it was found forwithaferine A (3.74, 3.84 min) and withanolide A (4.51, 4.60 min) with DAD and ELSD detector,respectively. Amount of withanolides in each sample were calculated from the regressionequations of standard calibration graphs. The results showed that the HPLC method is suitable forthe determination of withaferine A and withanolide A from the roots and herbal formulation ofW. somnifera.

Contents (µg/mL)

Root Extract

Withaferine A 35.22

Withanolide A 29.06

Table 1: Withanolides content in the roots of the plant were quantified using HPLC

Gas chromatography (GC)• Gas chromatography (GC), is a technique for separation of mixtures into

components by a process which depends on the redistribution of thecomponents between a stationary phase or support material in the form of aliquid, solid or combination of both and a gaseous mobile phase

• The GC analysis of the volatile oils has a number of advantages.üthe GC of the volatile oil gives a reasonable “fingerprint” which can be used to

identify the plant. The composition and relative concentration of the organiccompounds in the volatile oil are characteristic of the particular plant and thepresence of impurities in the volatile oil can be readily detected relativeconcentration of the organic compounds in the volatile oil are characteristic ofthe particular plant and the presence of impurities in the volatile oil can bereadily detected.üthe extraction of the volatile oil is relatively straightforward and can be

standardized and the components can be readily identified using GC-MS analysis.The relative quantities of the components can be used to monitor or assesscertain characteristics of the herbal medicines.

Product Name: Dia-CareManufactured by: Admark Herbals Ltd.- is claimed to be effective for both Type 1, Type 2 diabetes

within 90 days of treatment and cures within 18 months.- Persons taking insulin will eventually be liberated from the

dependence on it. The whole treatment completes in 6 phases,each phase being of 90 days. Approx. 5 grams (1 tea spoon)powder is mixed with 1/2 glass of water, stirred properly andkept overnight.

- Only the water and not the sediment must be taken in themorning on empty stomach. To the remaining medicine freshwater is added and kept for the whole day and is consumed halfan hour before dinner. The taste of the drug is very bitter. It is apure herbal formula without any side effects.

Products name: Ashvaganda

Brand : Himalaya

Action:

A unique herb with antistress adaptogenic action that leads to better physical fitness and helps cope with life's daily stress. It is especially beneficial in stress related disorders such as arthritis, hypertension, diabetes, general debility.

Indications:

Arthritis, hypertension, diabetes, general debility.

Use Directions:

Take 1 or 2 capsules twice daily with meals.

Hair growth Herbs• Herbs : Nardostachys jatamansi rhizomes• Common Name: Indian spikenard• Origin: Himalayas• Therapeutic activities : antifungal, antimicrobial,

antioxidant, hepatoprotective, cardio protectiveproperties,treatment of insomnia and CNSdisorders

• Major Bioactive Compound : Jatamansone,nardostachone and actinidine

• Bioactive compound for Hair growth: :nardal, jatamansic acid, and nardin

Nardostachys jatamansi rhizomes

Nardostachys jatamansi flower

Nardostachys jatamansi wholeplant

Chemical Structure of Bioactive Compound

Effect on estrogen and hair growth-:

Nardostachys jatamansi was studied for the growth ofhairs due to cancer treatment. The results confirmed hairgrowth promotion activities of this plant. The hair growthstudy was design not only to see effect of extract on hairgrowth but also on isolated fraction named as nardal,jatamansic acid and nardin

Gotumukkala, V.K.; Annamalai, T.; Mukhopadhyay, T.K.; Phytochemical investigation and hair growth studies on the rhizome of N. jatamansi DC. Pharmacognosy magazine, 2011, 7(26), 146-150.

• Further readings:1) REGULATORY ASPECT FOR HERBAL MEDICINES

http://www.slideshare.net/vis1231/regulatory-aspect-of-herbal-medicines

2) Evaluation of Herbal Medicinal Products Perspectives on quality, safety and efficacy By P .K. Mukherjee and Peter J HoughtonISBN 978 0 85369 751 0