参杞益脑胶囊中β-细辛醚的溶出度研究

Study on Dissolution of β-asarone in Shenqiyinao Capsules

目的:建立了高效液相色谱法测定参杞益脑胶囊中β-细辛醚溶出度的方法。方法:色谱柱为Lichrospher(r)100RP-18e(4.6 mm×250 mm,5μm),流动相为甲醇-0.1%冰醋酸溶液(60∶40),柱温35℃,流速1.0 mL.min-1,检测波长257nm,采用转篮法,以0.5%十二烷基硫酸钠溶液500 mL为溶出介质,转速100 r.min-1。结果:β-细辛醚线性范围0.007～0.352μg,胶囊在30 min的溶出度均大于70%。结论:结果准确可靠,可用于参杞益脑胶囊的质量控制。

Objective：To establish a high performance liquid chromatographic method to determine the dissolution of β-asarone in Shenqiyinao Capsules.Method：The column was Lichrospher（r） 100 RP-18e（4.6 mm × 250 mm,5 μm）.The mobile phase composed of methanol-0.1% glacial acetic acid solution（60∶ 40） and the temperature of column was 35 ℃.The flow rate was 1.0 mL·min^-1 and the detective wavelength was at 257 nm,external method.The dissolution of the β-asarone was determined by basket stirring technique with 0.5% sodium dodecyl sulfate 500 mL at a speed of 100 r·min^-1.Result：The linear range of β-asarone was 0.007 ～ 0.352 μg.The dissolution of β-asarone was above 70% at 30 minutes.Conclusion：The method is sensitive,accurate and suitable for the quality control of Shenqiyinao Capsules.