细辛脑片溶出度的研究

Study on Dissolution Test of Asarone Tablets

目的建立细辛脑片溶出度的测定方法。方法采用桨法,考察以0.3%吐温水溶液等溶剂为溶出介质,用高效液相色谱法和紫外分光光度法的测定方法。结果 0.3%吐温水溶液为溶出介质,转速75 r·min-1,取样时间为45 min等溶出度条件可以使细辛脑有效地溶出;采用高效液相色谱法,用C18色谱柱(5μm,250 mm×4.6 mm),甲醇∶水(70∶30)为流动相,流速1.0 mL·min-1,检测波长258 nm等测定条件可以满足细辛脑片溶出度的测定。结论该方法简便有效,测定结果准确,可用于细辛脑片的溶出度检查及含量测定。

Objective To establish a method for the determination of the dissolution of Asarone tablets. Methods Detection was carried out according to the procedure described in the second method in appendix XC of 2010 edition of Chinese Pharmacopoeia. With 0.3 % Tween water solution as the dissolution medium, the analysis was performed byhigh performance liquid chromatography with ultraviolet spectrophotometry. Results Asarone tablets had a high dissolution rate when the dissolution conditions were set as follows： the dissolution medimn was 0.3 % Tween, the rotation speed was 75 r·min-1, and sampling time was 45 minutes. The chromatographic conditions for the determination of dissolution rate were Agilent C18 （5 μm, 250 mm x4.6 mm）, the mobile phase consisting of methanol-water（70 ： 30）, the flow rate being 1.0 mL/min, and detection wavelength being 258 nm. Conclusion The established method is reliable and accurate. It can be used for the determination of dissolution of Asarone tablets.