Rajiv Gandhi School of Intellectual Property Law, IIT Kharagpur, Kharagpur 721302, West Bengal, India.
Fitoterapia. 2010 Sep;81(6):462-71. doi: 10.1016/j.fitote.2010.02.001. Epub 2010 Feb 13.
The use of herbal drugs for the prevention and treatment of various health ailments has been in practice from time immemorial. Generally it is believed that the risk associated with herbal drugs is very less, but reports on serious reactions are indicating to the need for development of effective marker systems for isolation and identification of the individual components. Standards for herbal drugs are being developed worldwide but as yet there is no common consensus as to how these should be adopted. Standardization, stability and quality control for herbal drugs are feasible, but difficult to accomplish. Further, the regulation of these drugs is not uniform across countries. There are variations in the methods used across medicine systems and countries in achieving stability and quality control. The present study attempts to identify the evolution of technical standards in manufacturing and the regulatory guideline development for commercialization of herbal drugs.
草药被广泛用于预防和治疗各种健康疾病，从远古时代开始，这种做法就一直存在。人们普遍认为草药的风险很小，但有关严重不良反应的报告表明，有必要开发有效的标记系统，以分离和鉴定个别成分。目前正在全世界范围内制定草药标准，但对于如何采用这些标准，尚未达成共识。草药的标准化、稳定性和质量控制是可行的，但很难实现。此外，这些药物在各国的监管并不统一。不同医学体系和国家在实现稳定性和质量控制方面的方法存在差异。本研究试图确定制造技术标准的演变以及商业化草药的监管指南的制定。
