2015年全国中药材及饮片质量状况分析与探讨

National Quality Evaluation and Analysis of Chinese Medicinal Materials and Decoction Pieces in 2015

目的:探讨与分析我国中药材及饮片质量总体状况。方法:针对2015年全国中药材及饮片的专项抽验工作,结合各省市药品监管部门的监督检查和抽验工作,对发现的中药材及饮片的质量情况进行了汇总、分析。结果:随着中药产业的快速发展,中药材及饮片的质量问题近几年逐渐呈现出来:近缘品种冒充正品药材或饮片使用,外观性状难区分的药材混用,非药用部位大量存在,药材提取后染色,加工过程中增重情况严重等。结论:本研究可为相关部门制定监管策略、提高和完善标准提供参考。

Objectives： To evaluate and analyze the quality of national Chinese medicinal materials and decoction pieces. Methods：Summarizing and analyzing all the experimental data of national Chinese medicinal materials and decoction piece of special testing,combined with the inspection and testing work of drug administration department. Results： With the traditional Chinese medicine industry development,a series of problems had been found as follows： non-standardized harvest and original process of Chinese herbal medicines,illegal dyeing,addition and weight gain of Chinese medicine decoction pieces,and illegal production and business of counterfeit decoction pieces. These problems seriously influenced the quality and safety of Chinese medicinal materials and decoction pieces. Therefore some suggestions and opinions were put forward. Conclusion： This study provides the advice to the relevant departments of Chinese Food and Drug Adiministration.