浅谈中药质量控制与国际接轨

简要阐述了中国中药质量控制的特点、现状和发展趋势。认为随着中国加入世贸组织,中药行业将更有机会进入国际医药市场。作为有着悠久历史的中药,其安全、有效已经过历史的验证,但均一稳定,即质量可控的问题则是一个目前制约中药走向国际的瓶颈问题。对照国际上(以欧盟为例)对草药质量标准的要求,提出面对中药行业加入世贸组织的机遇与挑战,中药必须形成国际性的质量管理标准与规范,真正达到国际上通用的中药的“安全有效、均一稳定”的“适用性质量”的水平上来,进一步贯彻GMP以及其它相关的标准,才能使中药更好地与国际接轨,发挥中国传统医药的优势。

Quality Control of Traditional Chinese Medicine and Joint Track with International Standards

After entering WTO, there' re more and more chances for industry of Traditional Chinese Medicine to come into the international market. Though the sa fety and effectivity of traditional medicine have been testified over a long his tory, its uniformity and stability, namely, the quality control is the bottlenec k holding back its internationalization. This article mainly discusses the trait , current situation and developing trend of quality control of traditional medic ine. Comparing it with international standards of quality (taking example of the EU's), we pointed out that: Faced with the opportunity and challenge, we must s et up a series of international quality standards and criterions to achieve the level of "safe, effective, uniform and stable" and go further to carry out GMP a nd its related standards. Thus, Chinese Traditional Medicine will take joint tra ck with international standards and bring its advantages into play.