不同厂家小柴胡汤丸的溶出度研究  

Study on the Dissolution of Xiaocaihu Pill from Different Manufacturers

作　　者：唐富山[1] 张晓慧[1] 兰雪[1] 孟翠[1] 王玉和[2] 

机构地区：[1]遵义医学院药学院临床药学教研室,贵州遵义563003 [2]遵义医学院附属医院药剂科,贵州遵义563003

出　　处：《中国药房》2016年第30期4272-4274,共3页China Pharmacy

基　　金：贵州省科学技术基金项目(No.黔科合J字〔2013〕2323号);贵州省科技合作专项资金项目(No.省市科合〔2015〕53号);遵义医学院临床药学新兴扶持学科

摘　　要：目的：建立小柴胡汤丸溶出度的测定方法,并比较不同厂家制剂的差异。方法：以0.1 mol/L盐酸为溶出介质,采用转篮法测定制剂的溶出度;采用高效液相色谱法测定制剂中黄芩苷的含量：色谱柱为TSKgel ODS C_（18）,流动相为甲醇-水-磷酸（65∶35∶0.7,V/V/V）,流速为1 ml/min,检测波长为280 nm,柱温为30℃,进样量为5μl。结果：黄芩苷检测质量浓度线性范围为0.488-124.8mg/L（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈2.0%;加样回收率试验为100.14%-104.78%（RSD=1.58%,n=9）。小柴胡汤丸中黄芩苷50%溶出时间（t_（50））平均值为85.81 min。结论：该方法操作简便,精密度、稳定性、重复性较好,可用于小柴胡汤丸溶出度的测定。不同厂家小柴胡汤丸溶出差异较大,制剂制备和临床用药中均需重视固体制剂的溶出状况。OBJECTIVE：To establish a method for the determination of dissolution of Xiaocaihu pill,and compare the difference of preparation from different manufacturers. METHODS：Using 0.1 mol/L HCl as dissolution medium,rotating basket method was used to determine the dissolution of preparations. HPLC was adopted to determine the content of baicalin：column was TSKgel ODS C_（18） with mobile phase of methanol-water-phosphoric acid（65 ∶ 35 ∶ 0.7,V/V/V） at a flow rate of 1 ml/min,detection wavelength was 280 nm,column temperature was 30 ℃,and injection volume was 5 μl. RESULTS：The linear range of baicalin was0.488-124.8 mg/L（r=0.999 9）;RSDs of precision,stability and reproducibility tests were lower than 2.0%;recovery was100.14%-104.78%（RSD=1.58%,n=9）. The average t_（50）（50% dissolution time）of baicalin was 85.81 min. CONCLUSIONS：The method is simple with good precision,stability and reproducibility,and can be used for the dissolution determination of Xiaocaihu pill. Xiaocaihu pill from different manufacturers shows great differences,both preparation formulation and clinical use should attach importance to the dissolution of solid preparations.

关 键 词：小柴胡汤丸 黄芩苷 溶出度 

分 类 号：R945[医药卫生—微生物与生化药学]