影响煎煮汤剂质量的多因素分析及规范化管理研究

Analysis on multi-factors affecting quality of Chinese materia medica decoction and standardization of management

我国对中药汤剂质量控制一直没有实行科学规范化的管理,这与我国传统的汤剂用药意识有关。通过对汤剂管理现状分析,并以银杏叶为研究对象,比较煎药器具、煎药火候、煎药时间、煎药次数、冷浸时间等因素对汤剂质量的影响。提出中药汤剂应该以最终汤剂剂型,由专业煎煮机构按照汤剂煎煮质量管理规范(Good Decocting Practice,GDP)生产出质量可控的汤剂,实现对中药汤剂的全过程质量控制。

There has been no scientific and standardization management to the quality control of Chinese materia medica （CMM） decoction in our country, which related to the consciousness of using traditional CMM decoction. It is difficult to control the quality of the medicinal broth. Through the analysis about the present situation of native quality, taking ginkgo leaf as the research object, the effects of tisane apparatus, tisane temperature, tisane time, tisane times, cold soak time, and other factors on the quality of the CMM decoction were compared. The idea was put forward that the CMM decoction forms should be a final oral dosage. According to the native decoction and the quality control standard for Good Decocting Practice （GDP）, the quality controlled CMM decoction dosage by professional decoction organization could be produced, so as to realize the quality control in the whole process of CMM decoction.