不同厂家小柴胡汤丸的溶出度研究 点击下载
论文标题: | 不同厂家小柴胡汤丸的溶出度研究 |
英文标题: | |
中文摘要: | 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 C18,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5 μl。结果:黄芩苷检测质量浓度线性范围为0.488~124.8 mg/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(t50)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。 |
英文摘要: | 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 C18 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 was 0.488-124.8 mg/L (r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 2.0%; recovery was 100.14%-104.78%(RSD=1.58%,n=9). The average t50(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. |
期刊: | 2016年第27卷第30期 |
作者: | 唐富山,张晓慧,兰雪,孟翠,王玉和 |
英文作者: | TANG Fushan,ZHANG Xiaohui,LAN Xue,MENG Cui,WANG Yuhe |
关键字: | 小柴胡汤丸;黄芩苷;溶出度 |
KEYWORDS: | Xiaochaihu pill; Baicalin; Dissolution |
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文件大小: | 619.60Kb |
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