牛黄解毒片溶出度测定方法的研究  

Study on the Method of Determination the Solubility of Niuhuangjiedu Pills

作　　者：马宁[1] 龚秋红[1] 欧燕[2] 黄海萍[3] 李焕德[4] 

机构地区：[1]中南大学药学院,湖南长沙410009 [2]湖南医药工业研究所,湖南长沙410014 [3]湖南省药品检验所,湖南长沙410001 [4]中南大学湘雅二医院,湖南长沙410011

出　　处：《湖南中医药导报》2004年第5期71-73,共3页Hunan Guiding Journal of Traditional Chinese Medicine and Pharmacology

摘　　要：目的 :建立牛黄解毒片中黄芩苷的溶出度测定方法 ,为评价和控制药品质量提供方法和参数。方法 :以 1 %乙醇溶液作为溶出介质 ,按桨法操作 ,用高效液相色谱法测定 ,色谱柱 :ZirchromC1 8柱 (2 5 0× 4 .6mm ,5 μm) ;流动相为甲醇 -水 -磷酸 (4 5 :5 5 :0 .2 ) ;流速是 1 .0ml·min-1 ;检测波长为 2 78nm ;柱温为 30℃。绘制牛黄解毒片的累积溶出度曲线 ,并运用电子表格Excel软件处理药物溶出度数据 ,提取参数 (Td ,m)并对参数进行相关性检验。结果 :本法平均回收率为 1 0 2 .5 % ,RSD为1 .6 0 % (n =9) ;在 1～ 1 0 μg·ml-1 范围内 ,浓度与峰面积呈良好线性 ,r=0 .9994 ;本品受转速影响较小 ,受溶剂影响较大。对不同厂家不同批次的牛黄解毒片进行了溶出度测定 ,溶出参数差异有极显著性意义 (P <0 .0 1 )。结论 :本方法具有灵敏、准确、快速的优点 。Objective: To establish the method of determination the solubility of Baicalin in Niuhuangjiedu Pills, and provide methods and parameters for the evaluation and controlling of medicine quality. Methods: The medium was 1% ethanol solutions. The determination method was high performance liquid chromatography. The chromatography glass column was Zirchrom C18 (250×4.6mm,5μm). The movement phase was methanol - water - phosphoric acid (45:55:0.2). The flow-rate was 1.0ml·min-1. The detect wave-length was 278nm. The temperature was 30℃. Drawing the solubility curve, the data of drug solubility was processed by Excel for calculating parameter, with the test of correlation. Results: The average recover rate of Baicalin was 102.5%,RSD=1.60% (n=9), r=0.9994. The concentration has linearity relation to peak area. It was minor affected from flow-rate, while much affected by solvent. The solubility of pills produced in different factories has significantly difference after detection. Conclusion: The method is sensitive, accurately and quickly for the quality control of Niuhuangjiedu Pills.

关 键 词：牛黄解毒片 黄芩苷 溶出度 高效液相色谱法 

分 类 号：R943[医药卫生—药剂学] TQ460.7[医药卫生—药学]