摘要
本文以复方丹参滴丸为例,讨论了中药质量标准的现代化问题。认为必须建立从药材到半成品到成品的系列质量控制标准,并且,从有效成分的含量、比例到农残、重金属的含量都须有严格的控制。文中还介绍了美国食品和药品管理局(FDA)有关政策的近况。
Taking Danshen Pills of compound prescription as an example, this paper discusses the problem of modernization of quality standard for CMM, and suggests that the standard system be set up to apply to all the raw materials, semifinished products and end produdts, and a strict control system be set up for the contents and proper - tions of active components as well as the contents of pesticide residues and heavy metals. An account on the current policies for management of foodstuffs and dings in USA is also given.