多元指纹图谱分析复方银杏通脉胶囊的质量评价研究  

Study on quality evaluation of compound Ginkgo Tongmai Capsules by multiple fingerprints

作　　者：盛家峰 李晓霞 张海涛 Sheng Jiafeng;Li Xiaoxia;Zhang Haitao(Department of Pharmacy,Luohe City Second People＇s Hospital in Henan Province,Luohe 46200)

机构地区：[1]河南省漯河市第二人民医院药剂科,漯河462000

出　　处：《陕西中医》2018年第10期1483-1486,共4页Shaanxi Journal of Traditional Chinese Medicine

基　　金：河南省卫生政策研究课题(YWZY201421)

摘　　要：目的:采用多元指纹图谱分析复方银杏通脉胶囊的质量评价研究。方法:制备复方银杏通脉胶囊,试验相关的混合对照品溶液和供试品溶液,通过文献检索和预实验确定色谱洗脱梯度的条件,采用高效液相(HPLC)多元指纹图谱分析进行线性关系分析、精密度、重复性和稳定性试验以及加样回收率试验考察HPLC的严谨性,检测样品中银杏叶提取物和丹参酮ⅡA的含量,并测定所制备的复方银杏通脉胶囊是否符合《中国药典》的胶囊制剂、重金属和砷盐等相关规定。结果:(1)在线性关系考察回归方程y=2581530.89X-12670.48,r=0.9999(n=5),结果表明,混合对照品在0.06432~0.1456μg范围内线性关系良好。(2)精密度、重复性和稳定性试验中相对标注偏差RSD分别是0.83%、1.05%和0.80%,精密度、重复性和稳定性均良好。(3)加样回收率试验结果中平均回收率为99.07%,RSD为0.75%,显示加样回收率试验良好。(4)多元指纹图谱分析显示,结果显示银杏叶提取物RSD为3.81%,丹参酮ⅡA的RSD为4.96%。(5)根据《中国药典》中对胶囊制剂水分、装量差异和崩解时限进行检查,测定重金属和砷盐含量,结果均符合国家相关规定。结论:复方银杏通脉胶囊制备工艺简单,可操作性强,样品质量可控性、稳定性和安全性均较好。Objective：To analyze the quality evaluation of compound Ginkgo Tongmai capsules by multiple fingerprints. Methods： First,the preparation of compound Ginkgo Tongmai capsule,the related test mixed standard solution and the test solution,through literature search and pre experiment to determine the condition of gradient elution chromatography,HPLC fingerprint analysis （HPLC） multivariate analysis,precision,repeatability and stability test and recovery test HPLC the rigor of the linear relationship between the content of Ginkgo biloba extract samples detection and tanshinone A,and determination of the compound ginkgo Tongmai capsule was in accordance with the ＂Pharmacopoeia＂ of the China capsule,heavy metal and arsenic salt and other related provisions. Results：①The online relationship examined the regression equation y=2581530.89X-12670.48 and r=0.9999 （ n =5）. The results showed that the mixed reference products had good internal relations in the 0.06432-0.1456ug range. ②The relative labeling errors in precision,repeatability and stability tests were 0.83%,1.05% and 0.80%,respectively. The accuracy,repeatability and stability of RSD were good. ③The average recovery was 99.07% and RSD was 0.75%,which showed that the recovery rate of samples was good. ④Multivariate fingerprinting analysis showed that the RSD of Ginkgo biloba extract was 3.81,and that of tanshinone II A was 4.96%,RSD. （5） The contents of heavy metals and arsenic in the capsules were examined according to the differences in the amount of water,the amount of loading and the time limit for disintegration of the capsules prepared in the Chinese Pharmacopoeia,and the results were in line with the relevant regulations of the state. Conclusion： The preparation process of Compound Ginkgo Tongmai capsule is simple,the operation is strong,the quality of sample is controllable,stability and safety are better.

关 键 词：色谱法 高压液相 @多元指纹图谱 @复方银杏通脉胶囊 @质量评价 

分 类 号：R94[医药卫生—药剂学]