摘要
目的:研究湿法制粒法制备小儿氨酚黄那敏颗粒的影响因素及制备工艺。方法:采用正交试验设计,使用高效液相色谱法(HPLC)同时测定对乙酰氨基酚和马来酸氯苯那敏的含量均匀度,并通过综合评分优选制备工艺。结果:最佳制备工艺为:物料过100目筛,采用三维混合方式混合20 min,马来酸氯苯那敏以黏合剂方式加入,所制备的颗粒符合质量要求。结论:本研究所得最佳制备工艺操作简便,对乙酰氨基酚和马来酸氯苯那敏的含量均匀度较高,工艺稳定性较好。
Objective：To study the preparation technology and the influencing factors of wet granulation method for the preparation of xiao＇er anfen huang namin granules. Methods：Using orthogonal experiment design,the content uniformity of acetaminophen and chlorphenamine maleate was determined by HPLC, and the preparation process was optimized by means of comprehensive score. Results：The optimized preparation process was passing the materials through a 100 mesh sieve,using three-dimensional mixed mode blending for 20 min,adding chlorphenamine maleate as the adhesive. The prepared granules met the quality requirements. Conclusion： The optimized preparation process is convenient for operation, the high uniform of contents of paracetamol and chlorphenamine maleate is obtained and the production technology is stable.
出处
《中国执业药师》
CAS
2014年第7期14-19,共6页
China Licensed Pharmacist
基金
北京市优秀人才资助项目(2011G003034000002)
