消淤降脂胶囊中丹参素钠溶出度测定研究

Study on Dissolution of Sodium-tanshinol in Xiaoyujiangzhi Capsules

目的对消淤降脂胶囊中丹参素钠的溶出度进行测定,以控制其内在质量。方法应用转篮法,以高效液相色谱法(HPLC)测定丹参素钠的含量为指标,对消淤降脂胶囊中丹参素钠溶出度进行测定。结果以0.5%聚山梨脂80磷酸盐缓冲溶液为溶出介质,转速150r/min,采用Elite Hypersil C18柱(5μm,25cm×4.6mm),乙腈-1%磷酸二氢钾-10%四丁基氢氧化铵(10∶87∶2.5)为流动相,流速:1.0ml·min-1,检测波长281nm,柱温40℃,进样量为10μl。平均回收率100.6%(RSD0.44%),溶出度为标示量的70.0%以上。结论HPLC法测定消淤降脂胶囊中丹参素钠的含量是控制该制剂内在质量的一种简便、快速、可行的方法。

Objective To determine the dissolutions of sodium - tanshinol in Xiaoyujiangzhi Capsules in order to analyze its inner quality. Methods With roiling basket method, the content of sodium - tanshinol determined by HPLC was used to assess the dissolution of sodium - tanshinol in Xiaoyujiangzhi capsules, Results 0.5% Polysorbate 80 PBS was used as solvent. Rolling basket method was used with rotation rate of 150r/min for 120min; Elite Hypersil C18 Column（5 μm,25 cm × 4.6 mm） was used with AN - 1% KDP - 10% quadr - Bu - ammonium hydroxide as mobile phase, the flow rate was 1.0 ml · min^-1 ,detection wavelength was 281nm,column temperature was 40℃ ,and the sample size was 10 μl. Result Average recovery was 100. 6% （RSD 0. 44% ） , and dissolution was more than 70.0% labelled amount. Conclusion HPLC is a convenient, quick and feasible method for controlling the inner quality of Xiaoyujiangzhi Capsules.