万氏牛黄清心片质量标准研究  

Study on Quality Standard of Wanshi Niuhuang Qingxin Tablets

作　　者：肖丽和[1] 关潇滢[1] 韩东岐[1] 黎雪清[1] 

机构地区：[1]深圳市药品检验所,广东深圳518029

出　　处：《中国药师》2013年第2期239-241,共3页China Pharmacist

摘　　要：目的:建立万氏牛黄清心片的质量控制方法。方法:采用薄层色谱法对制剂中的人工牛黄、黄连、黄芩、栀子进行定性鉴别;采用高效液相色谱法测定制剂中胆红素的含量。结果:薄层色谱显色清晰且阴性对照无干扰。胆红素在1.076～53.800μg·ml^(-1)浓度范围内呈良好的线性关系,平均回收率为96.2%,RSD=0.9%(n=6)。结论:本法操作简便,结果准确、重复性好,可用于万氏牛黄清心片的质量控制。Objective： To develop the quality control for Wanshi Niuhuang Qingxin tablets. Method： Boris Calculus Artifactus, Coptidis Rhizoma, Scutellariae Radix and Gardeniae Fructus were identified by TLC. HPLC was used for the determination of bilirubin. Result： The chromatographic spots were clear without any interference of the negative control. Bilirubin had a good linearity over the concentration range of 1. 076-53. 800 μg ml - 1, and the average recovery was 96.2% with RSD of 0.9% （ n = 6）. Conclusion ： The method is reliable, accurate and specific, and can be used in the quality control of Wanshi Niuhuang Qingxin tablets.

关 键 词：万氏牛黄清心片 高效液相色谱 薄层色谱 质量控制 

分 类 号：TQ460.72[医药卫生—药物分析学]