银黄口腔崩解片的质量控制方法研究  

Study on Quality Control of Yinhuang Orally Disintegrating Tablets

作　　者：干红女[1] 吴敏[1] 陈红梅[1] 叶凤[1] 刘陶世[2] 程建明[2] 

机构地区：[1]杭州市中医医院,浙江杭州310007 [2]南京中医药大学药学院,江苏南京210023

出　　处：《中华中医药学刊》2017年第4期1023-1026,I0010,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：南京中医药大学横向合作项目(2014023)

摘　　要：目的:建立银黄口腔崩解片的质量控制方法。方法:采用薄层鉴别方法鉴别银黄口腔崩解片的黄芩和金银花药材,采用反相高效液相色谱法测定君药黄芩主要有效成分黄芩苷的含量。结果:薄层色谱同时检出黄芩苷和绿原酸斑点,阴性无干扰。银黄口腔崩解片崩解时限小于1 min。黄芩苷HPLC测定的条件为:十八烷基硅烷键合硅胶为填充剂,甲醇-水-磷酸(47∶53∶0.2)(v/v)为流动相;检测波长为280 nm;黄芩苷线性回归方程为Y=8 177 827X-34 818,r=0.999 5(黄芩苷进样量范围1.24~0.04μg),平均回收率为100.03%(RSD为2.32%);本品每片含黄芩苷(C_(21)H_(18)O_(11))不得少于18.0mg。结论:建立的质量控制方法简单方便、科学可行。Objective： To develop an assay for the determination of Yinhuang Orally Disintegrating Tablets. Methods：Flos lonicerae and radix scrtellariae of Yinhuang Orally Disintegrating Tablets were identified by TLC. The content of baicalin from radix scrtellariae was determined by HPLC. At the same time the disintegration was analyzed by Chinese Pharmacopeia. Results： The thin layer chromatography identified the blots of baicalin and chlorogenic acid. The disintegration time of Yinhuang Orally Disintegrating Tablets was less than 1 minute. The chromatographic system involved a C18 prepared column and a UV spectrophotometric detector which was set at 280 nm. The mobile phase was composed of methanol-water-phosphoric acid（ 47 ∶ 53 ∶ 0. 2）. The sample size of baicalin was linear in the range of 1. 24 - 0. 04 μg.The relative coefficient of standard curve was 0. 999 5 and the average recovery was 100. 03%,RSD = 2. 32%. The content of baicalin must be more than 18. 0 mg per tablet. Conclusion： A convenient,selective and reproducible method for quality control was established.

关 键 词：银黄口腔崩解片 黄芩苷 绿原酸 

分 类 号：R284.1[医药卫生—中药学]