Standardization of Herbal Drugs in Traditional Medicine Systems

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.

部门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:

• 交付优质Ayush医疗保健服务
• 高质量的教育和对Ayush医生和科学家的培训
• Ayush作为印度和国外的替代医学系统的传播和普及
• Ayush药物的药典标准化
• 关于阿育吠陀，悉达多，Unani和顺势疗法系统的最低标准法规通知
• 良好的临床实践（GCP）指南，Siddha和Unani药物

谁与AYUSH合作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.

草药药物和制剂可以标准化，以实现化学功效，物理化学和药理学参数，以验证整个制造过程。

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.
• 安全评估文档基于经验或毒理学研究。
• Assessment of efficacy and biological activity

目前参与原油标准化的技术：

宏观方法includes identification of herbs based on shape,size,color,texture,fracture and appearance

微观方法include identification of powder material on the basis of treatment with chemical reagents and analysis of their special characteristics.

物理方法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

化学方法包括各种化学测试和测定，例如酸值，皂化值，过氧化物值等。

生物学方法include the estimation of crude drugs or preparations on living organisms like bacteria, fungi or animal tissue called BIOASSAY.

分析方法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.

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关于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.