氯苯那敏小儿栓制备及质量控制

Preparation and quality control of chlorphenamine maleate suppositories

目的研制马来酸氯苯那敏小儿栓剂。方法采用紫外分光光度法测定氯苯那敏含量，并进行稳定性考察。结果含量测定平均回收率为99．95％，RSD分别为1．04％（n=3）、1．12％（n=3）、1．25％（n=3）。结论该制剂制备工艺简便可行，质量控制可控。

Objective To preparation chlorphenamine maleate suppositories and to establish a method for its quality control. Methods The content detemination of Chlorphenamine Maleate was performed by ultraviolet spectrophotometry, and the stability was investigated as well. Results The average recovery was 99.95%,RSD of 1.04%（n=3）, 1.12% （n=3）, 1.25%（n=3）.Conclusion The preparetion technique of Suppositories is simple and practicable, and its quality is reliable.