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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。
This article takes the compound Danshen Dripping Pill as an example to discuss the modernization of the quality standard of traditional Chinese medicine. It is believed that a series of quality control standards from medicinal materials to semi-finished products to finished products must be established, and strict control must be imposed on the content of active ingredients, the proportion of pesticide residues, and the content of heavy metals. The article also introduced the current state of the United States Food and Drug Administration (FDA) policy.