除湿丸质量评价方法研究  

Quality Evaluation Method of Chushi Pills

作　　者：周德勇 龚韬[1] 杨薇 严文利[1] 朱青[1] 王夏 宋京美[1] ZHOU Deyong;GONG Tao;YANG Wei;YAN Wenli;ZHU Qing;WANG Xia;SONG Jingmei(Institute of Clinical Pharmacy of Beijing Municipal,Beijing,China 100035)

机构地区：[1]北京市临床药学研究所,北京100035

出　　处：《中国药业》2021年第20期57-60,共4页China Pharmaceuticals

摘　　要：目的探讨除湿丸的质量评价方法。方法采用高效液相色谱法测定制剂中5种主成分的含量,色谱柱为DIKMA Spursil 5 C_(18)柱(150 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为1.0 mL/min,检测波长为238 nm,柱温为40℃,进样量为5μL;采用聚类分析法和主成分分析法对不同批次样品的质量进行分析与评价。结果栀子苷、连翘酯苷A、黄芩苷、黄芩素、丹皮酚进样量分别在0.03724~0.7448μg、0.0252~0.504μg、0.021444~0.42888μg、0.04048~0.8096μg、0.0261~0.522μg范围内与相应峰面积线性关系良好(r均大于0.9996),精密度、稳定性、重复性试验的RSD均小于2.0%,平均加样回收率分别为100.49%,100.86%,99.81%,100.08%,101.67%,RSD分别为2.50%,2.87%,2.13%,1.70%,1.83%(n=9);15批样品按5种主成分含量之和可聚为两类;主成分黄芩素、丹皮酚、栀子苷为影响除湿丸质量评价的主要因子。结论该方法简便、快速,结果准确、可靠,可用于评价除湿丸的质量。Objective To investigate the quality evaluation method of Chushi Pills.Methods The contents of five principal components in the preparation were determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was DIKMA Sprirsil 5 C18 column(150 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(gradient elution),the flow rate was 1.0 m L/min,the detection wavelength was 238 nm,the column temperature was 40℃,and the injection volume was 5μL.Cluster analysis and principal component analysis were used to analyze and evaluate the quality of different batches of samples.Results The linear ranges of geniposide,forsythoside A,baicalin,baicalein and paeonol were 0.03724-0.7448μg,0.0252-0.504μg,0.021444-0.42888μg,0.04048-0.8096μg,0.0261-0.522μg(r>0.9996),respectively.The RSDs of precision,stability and repeatability tests were less than 2.0%.The average recoveries of geniposide,forsythoside A,baicalin,baicalein and paeonol were 100.49%,100.86%,99.81%,100.08%and 101.67%with RSDs of 2.50%,2.87%,2.13%,1.70%and 1.83%(n=9),respectively.According to the total content of five principal components,15 batches of samples could be grouped into two categories.Baicalein,paeonol and geniposide were the main factors affecting the quality evaluation of Chushi Pills.Conclusion The method is simple,rapid,accurate and reliable,which can be used for the quality evaluation of Chushi Pills.

关 键 词：除湿丸 高效液相色谱法 聚类分析 主成分分析 质量评价 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]