Standardization of Herbal Drugs in Traditional Medicine Systems

Standardization of Herbal Drugs in Traditional Medicine Systems
Spoonful of various drugs
Herbal Medicines

Traditional systems of medicine based on herbal sources have contributed to welfare of human society from time immemorial. However, due to their diverse range and complexity it was a challenge to establish quality control standards as in the case of allopathic medicines.

Department of AYUSH (Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homeopathy)under Ministry of Health & Family Welfare, Govt of India has made significant contributions in this direction leading to:

  • Delivery of Quality AYUSH healthcare services
  • Quality education and training to AYUSH doctors and scientists
  • Propagation and popularization of AYUSH as an alternate system of medicine in India and abroad
  • Pharmacopoeial standardization of AYUSH drugs
  • Minimum standard regulation notifications on Ayurveda,Siddha,Unani and Homeopathic systems
  • Good Clinical Practices(GCP)guidelines in Ayurveda,Siddha and Unani medicines

WHO in collaboration with AYUSH is establishing protocols or monographs for the world wide acceptance of traditional plant medicines. Continuous efforts of APC (Ayurvedic Pharmacopeia Committee) & PLIM (Pharmacopoeial Laboratory for Indian Medicines) have resulted in publication of several monographs .

Standardization of drugs confirms identity, determination of quality, purity and detection of adulteration by various parameters. It also maintains consistency of claimed efficacy of the product and its batch to batch reproducibility.

Herbal drugs and formulations can be standardized for chemical efficacy, physicochemical and pharmacological parameters to validate the whole manufacturing process.

WHO stresses the importance of the qualitative and quantitative characterization and has set specific guidelines for the assessment of safety, efficacy and quality of herbal drugs covering :

  • Quality control of crude drug material, plant preparations and finished products.
  • Stability assessment and shelf life.
  • Safety assessment documentation based on experience or toxicological studies.
  • Assessment of efficacy and biological activity

Techniques currently involved in standardization of crude drugs:

Macroscopic Methods includes identification of herbs based on shape,size,color,texture,fracture and appearance

Microscopic methods include identification of powder material on the basis of treatment with chemical reagents and analysis of their special characteristics.

Physical Methods include viscosity, melting point, solubility, moisture content, volatile matter, specific gravity, density, optical rotation, refractive index, bitterness value, hemolytic activity, swelling index, foaming index, ash value&extractable via hot extraction or cold maceration

Chemical methods include various chemical tests and assays such as acid value, saponification value, peroxide value, etc.

Biological methods include the estimation of crude drugs or preparations on living organisms like bacteria, fungi or animal tissue called BIOASSAY.

Analytical methods include both  qualitative and quantitative estimations.The bioactive extract is standardized on the basis of chromatographic fingerprints using TLC.HPTLC, HPLC and GC.

In the coming time collaboration between national and international bodies will result in evolution of a universally acceptable standards code .This global effort will go a long way in making life easy for manufacturers who still do not have documented standards to this day for some products and make herbal medicines accepted in households across the world.

Please share your opinion and offer your comments on this article which concerns all of us.

About the Author:

Mahima Agarwal is a pharma professional specializing in Pharmacognosy. After her postgraduation from Rameesh Institute, Greater NOIDA, India she is working with Arbro Pharmaceuticals, New Delhi for last 2.5 years. Mahima has rich exposure to analysis and standardization of herbal medicines and health supplements.

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  1. Is there any harbal drug which is well known side effect on human body?

    1. Hi,
      Herbs used in combination are more effective and may have fewer side effects. Health care providers must take many factors into account when recommending herbs, which include the species and variety of the plant, the plant’s habitat, how it was stored and processed, and whether or not there are contaminants (including heavy metals and pesticides).
      Here are some examples which can tell you about the adverse effects caused by the herbs: :
      Aloe vera juice and senna causes abdominal pain and diarrhea in some peoples.
      Ginkgo (Ginkgo biloba) has been used in traditional medicine to treat circulatory disorders and enhance memory in the same time ginkgo may also increase the effect of some blood thinning medications, including aspirin. People taking blood thinning medications should ask their doctor before using ginkgo.

    1. Hello Pritam,
      UPLC provides high-quality separations and detection capabilities to identify active compounds in highly complex samples that results from natural products and traditional herbal medicines.
      One example is analysis of components in Angelica Sinensis, carried out on UPLC. For method details you can refer to some journals.

  2. greetings
    your aeticle topic is very valuable the qc of unani herbal mrdicine. your kijndness will help me a lot to know the guide to produce quality produs for the suffering people,
    sincierely yours


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