基于对照制剂的大七厘丸含量考察和等级初评价  

Content Determination and Primary Grade Evaluation of Daqili Pills Based on Reference Preparation

作　　者：吴良发 袁铭铭 徐菲 许妍 Wu Liangfa;Yuan Mingming;Xu Fei;Xu Yan(Jiangxi Institute for Drug Control/NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine/Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院国家药品监督管理局中成药质量评价重点实验室江西省药品与医疗器械质量工程技术研究中心,南昌330029

出　　处：《中国药师》2022年第4期713-716,共4页China Pharmacist

基　　金：江西省药品监督管理局科研项目(编号:2019JS07)。

摘　　要：目的:对大七厘丸进行含量研究和等级初评价。方法:研制大七厘丸对照制剂,应用于HPLC法测定血竭素含量和转移率,对大七厘丸的质量等级进行初评价。结果:血竭素在0.015 9~0.797 4μg范围内呈良好的线性关系(r=1.000 0),平均回收率为100.7%(RSD=1.1%,n=6)。20批样品的质量等级初评价结果为3批一等,8批二等,6批三等,3批等外(不合格),不同批号样品的质量差异较大。结论:通过修订完善方法,提高了血竭素含量测定结果的重现性和准确性,并为进一步建立药品等级标准提供研究思路和理论依据。Objective:To study on the content determination of Daqili pills and give primary grade evaluation.Methods:Daqili pills reference preparation was developed and applied for the content determination and transfer rate detection of dracorhodin by HPLC and primary grade evaluation of the samples.Results:Dracorhodin curve was linear within the range of 0.015 9-0.797 4 μg(r=1.000 0),and the average recovery was 100.7%(RSD=1.1%,n=6).According to the results of 20 samples by primary grade evaluation,3,8,6 and 3 samples were classified into the first grade,the second grade,the third grade and the substandard grade(unqualified),respectively.The quality of samples with different batches varied greatly.Conclusion:The reproducibility and accuracy of the determination results of dracorhodin are improved by revising and perfecting the determination methods,and the methods provide research strategy and theory basis for further work on the grade standard establishment.

关 键 词：大七厘丸 等级初评价 对照制剂 血竭素 

分 类 号：TQ460.72[医药卫生—药物分析学]