聚山梨酯-80对盆炎康栓中有效成分体外溶出度的影响

Effect of Polysorbate-80 on in Vitro Dissolution of Active Ingredients in Penyankang Suppositories

目的:考察聚山梨酯-80对盆炎康栓中有效成分丹酚酸B体外溶出度的影响,为该制剂的工业化生产提供参考。方法:以溶出时间和溶出率为指标,采用HPLC检测山梨酯-80加入量对盆炎康栓中丹酚酸B溶出率的影响,Comatex ODS C18色谱柱(4.6 mm×150 mm,5μm),流动相1%甲酸-甲醇-乙腈(66∶20∶14),流速1 m L·min-1,柱温30℃,检测波长286 nm。结果:聚山梨酯-80加入量为1%,1.5%,2%时,盆炎康栓中丹酚酸B在120 min内的的累积溶出率分别为80.33%,95.63%,98.43%。结论:聚山梨酯-80可促进盆炎康栓中有效成分丹酚酸B的体外溶出度,为了保证该制剂的质量,确定聚山梨酯-80加入量1.0%,为该制剂的临床应用与推广提供参考。

Objective： To investigate effect of polysorbate-80 on in vitro dissolution of salvianolic acid B in Penyankang suppositories. Method： With dissolution time and dissolution rate as indexes,HPLC was used to calculate cumulative dissolution rate of salvianolic acid B in Penyankang suppositories with different amount of polysorbate-80,mobile phase was 1% formic acid-methanol-acetonitrile（ 66∶ 20∶ 14）,flow rate was 1 m L·min- 1,column temperature was set at 30 ℃,detection wavelength was 286 nm. Result： Within 120 min,cumulative dissolution rates of salvianolic acid B from Penyankang suppositories with polysorbate-80 addition amount of 1. 0%,1. 5% and 2. 0% all can reach more than 80%. Conclusion： Polysorbate-80 can promote dissolution of salvianolic acid B in Penyankang suppositories. In order to guarantee quality of this preparation,the amount of polysorbate-80 chooses 1. 0%.