金银花配方颗粒评价性抽验结果分析与建议-中国药事.pdf

528 金银花配方颗粒评价性抽验结果分析与建议 * * 王赵，李耀磊，李静，许玮仪，金红宇 ，马双成 （中国食品药品检定研究院，北京 100050） 摘要 ：目的 通过开展金银花配方颗粒评价性抽验，比较分析不同厂家金银花配方颗粒的质量情况，并 提出监管建议。方法：收集各企业金银花配方颗粒质量标准，依据企业标准进行法定检验。结果：共抽 验 117 批金银花配方颗粒，涉及 9 家生产企业。按各自企业标准进行检验，总体合格率为 100%。但是 各企业之间金银花配方颗粒含量差异较大且每克颗粒相当的药材（饮片）量不同，转移率不同。结论： 通过本次抽验发现金银花配方颗粒的整体质量较高，但是不同厂家之间所用原料药材及生产工艺存在一 定差异，导致最终产品质量参差不齐。因此，有必要规范中药配方颗粒生产工艺，尽快统一标准，加强 监管。 关键词： 中药饮片；金银花配方颗粒；企业标准；质量分析；监管建议 R927.1 A 1002-7777(2019)05-0528-06 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2019.05.006 Analysis and Suggestions to the Sampling Inspection Results of Jinyinhua Formula Granules * * Wang Zhao, Li Yaolei, Li Jing, Xu Weiyi, Jin Hongyu , Ma Shuangcheng (National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To compare and analyze the qualities of Jinyinhua formula granules from different manufacturers through the nationwide sampling inspection of Jinyinhua formula granules, and to propose some regulatory suggestions. Methods: Quality standards of Jinyinhua formula granules from different manufacturers were collected, and the statutory inspection was carried out according to standards of the manufacturers. Results: A total of 117 batches of Jinyinhua formula granules were collected from 9 manufacturers. The overall pass rate of the inspections carried out according to standards of the manufacturers was 100%. However, the content of chlorogenic acid and cynaroside in the Jinyinhua formula granules varied greatly among different manufacturers and the amount of medicinal prepared slices (yinpian) equivalent to one gram granule was different. The transfer rate was also different. Conclusion: The overall qualities of the Jinyinhua formula granules are proved good through the sampling inspe