复方解热凝胶溶出度方法研究

Dissolution Study of Compound Antipyretic Gelatin

目的 :建立复方解热凝胶的溶出度标准。方法 :采用《中华人民共和国药典》(2 0 0 0年版 )二部附录X溶出度测定第二法 ,以 0 .0 62mol·L 1 盐酸为溶剂 ,测定复方解热凝胶溶出度。结果 :复方解热凝胶溶出度均一性好 ,累积溶出百分率在 3 0min内达 89.8%;经后差检验 ,C =0 .0 0 0 98,P =1。结论 :该剂型溶出度标准 3 0min内确定为标示量的 85 .0 %。

Objective:To establish a dissolution standard for compound antipyretic gelatin. Methods:The dissolved effective ingredient was determined with 0.062 mol·L -1 hydrochloric acid as the solvent according to the method in Chinese Pharmacopoeia. Results:The dissolved effective ingredient of compound antipyretic gelatin in 30 min was 89.8%. The test of post-difference was C= 0.009 8, P=1. Conclusion:The Dissolution of compound antipyretic gelatin in 30 min should be 85.0%.