摘要
目的对江西省内19家生产企业生产的42批清热解毒口服液进行质量分析。方法按《中国药典》2015年版一部收载清热解毒口服液质量标准对42批样品进行检验,制定了HPLC法同时测定黄芩苷、栀子苷含量的方法再按其进行检验,并统计检验结果。结果按现行标准检验,所有批次样品均符合规定;按修订标准检验,7个厂家21批次样品栀子苷含量不符合要求。结论江西省内市售清热解毒口服液的总体质量一般,现行标准检验项目设置不够完善,有必要对其进行提高完善。
Objective Quality analysis of 42 batches of qingre jiedu oral liquid produced by 19 manufacturers in Jiangxi Province.Methods According to the 2015 edition of"Chinese Pharmacopoeia",42 batches of qingre jiedu oral liquid were tested.A HPLC method for the simultaneous determination of baicalin and geniposide was developed,and then the test results were statistically analyzed.Results According to the revised standard,the content of geniposide in 21 batches of samples from 7 manufacturers did not meet the regulations.Conclusion The overall quality of qingre jiedu oral liquid sold in Jiangxi Province is general,and the current standard test items were not perfect,so it is necessary to improve it.
作者
肖芳红
方慧琼
廖宝源
吴应帅
吴晓勇
李功辉
XIAO Fanghong;FANG Huiqiong;LIAO Baoyuan;WU Yingshuai;WU Xiaoyong;LI Gonghui(Ganzhou Comprehensive Inspection and Testing Institute,Ganzhou Jiangxi 341000,China)
出处
《药品评价》
CAS
2023年第5期540-543,共4页
Drug Evaluation
关键词
清热解毒口服液
质量分析
栀子苷
黄芩苷
Qingre jiedu oral liquid
Quality analysis
Geniposide
Baicalin
