摘要
目的对国内16家不同生产企业的38批清火片的质量进行对比研究,评价该品种的质量现状。方法综合考察不同厂家的质量标准,制定出包括性状、重量差异、崩解时限、土大黄苷检查、显微鉴别、薄荷脑薄层色谱、大青叶薄层色谱、大黄素及大黄酚含量测定等8个项目的检验内容,再按其进行检验,统计检验结果。结果 6个厂家20批次按新建标准检验方法检验不合格。结论为达到临床疗效的一致性,有必要对清火片原料药进行严格质量控制,对制剂工艺进行标准化研究,建立统一完善的质量标准。
Objective To evaluate the quality of 38 batches of Qinghuo tablets produced by 16 different manufacturing enterprises in China through comparative study. Methods Comprehensive quality standards of different manufactures, a standard has been developed which contained appearance, weight difference, disintegration time, microscopic identification, rhaponticin examination, TLC of menthol, TLC of folium isatidis and contents of Emodin and Chrysophanol, then inspected according it and counted the test results. Results 20 batches of 6 manufacturers are not qualified according to the new standard. Conclusion In order to obtain the similar clinical effect, it is necessary to carry out strict quality control on the raw materials of the Qinghuo tablets, standardize the preparation process and establish an unified and perfect quality standard.
作者
张楠
杨媛媛
谢志民
ZHANG Nan;YANG Yuan-yuan;XIE Zhi-min(Xi＇ an Municipal Institute for Food and Drug Control, Xi＇an 710054, China)
出处
《现代中药研究与实践》
CAS
2018年第2期54-57,共4页
Research and Practice on Chinese Medicines
关键词
清火片
质量评价
质量标准
生产工艺
Qinghuo Tablets
quality evaluation
quality standard
production process
