复方马来酸氯苯那敏凝胶剂的制备及质量控制

Preparation and Quality Control of Compound Chlorphenamine Gel

目的 :制备以马来酸氯苯那敏和盐酸麻黄碱组成的复方凝胶剂。方法 :以卡波姆 -940为乳化剂 ,三乙醇胺调节 pH ,丙二醇作防腐剂 ,制备水溶性透明凝胶。采用一阶导数光谱法和双波长分光光度法分别测定复方凝胶剂中马来酸氯苯那敏和盐酸麻黄碱的含量。结果 :制得的凝胶剂质地均匀、细腻 ,粘稠度适中。马来酸氯苯那敏含量为101 0 % ,平均回收率为100 4 % ,RSD为0 99 % ;盐酸麻黄碱的含量为100 4 % ,平均回收率为101 3 % ,RSD为1 7 %。结论 :该制剂性质稳定 ,无刺激性 。

OBJECTIVE:To prepare a compound gel composed of chlorphenamine(CH) and ephedrine hydrochloride(EP) METHODS:The gel was prepared by taking carbomer 940 as emulgator,trolamine as pH adjuster and propylene glycol as preservative The contents of CH and EP in gel were determined with the first order derivative spectroanalysis and dual-wave_length spectrophotometry RESULTS:The prepared gel exhibited fine consistency and moderate viscosity The content of CH was 101 0% with an average recovery of 100 4%,RSD 0 99% and the content of EP was 100 4% with an average recovery of 101 3%,RSD 1 7% CONCLUSION:This preparation is stable and non-irritative It is a newly developed preparation for tre_ating allergic rhinitis