小儿氨酚烷胺颗粒中马来酸氯苯那敏含量均匀度研究

Study on the Content Uniformity of Chlorpheniramine Maleate in Children’s Acetaminophen Alkylamine Particles

研究了提高小儿氨酚烷胺颗粒中马来酸氯苯那敏含量均匀度的工艺方法。对小儿氨酚烷胺颗粒处方中纯化水量、湿混时间、纯化水温度这3个因素采用正交试验的方法进行统计学研究。实验通过优化处方中纯化水量(A)、湿混时间(B)、纯化水温度(C)取得最佳工艺参数,最佳组合为(A2,B1,C2),即纯化水用量为3.8 L,湿混时间为8 min,纯化水温度为40～45℃。结果表明,该制备方法提高了小儿氨酚烷胺颗粒马来酸氯苯那敏含量均匀度,优化了制备工艺,提高了产品质量,提高了生产效率。

In order to study the processing technology in increasing the content uniformity of chlorpheniramine maleate in Children’s acetaminophen alkylamine particles,orthogonal test was adopted in the statistic study of three factors,amount of purified water,wet mixing time,temperature of purified water in the prescription of Children’s acetaminophen alkylamine particles.Best technological parameter was achieved by optimizing the amount of purified water（A）,wet mixing time（B）,and the temperature of purified wate（r C）in the prescription.The best combination was A2,B1,C2,i.e,the amount of purified water was 3.8 L,wet mixing time was 8 min,and the temperature of purified water was 40～45 ℃.The results showed that this preparation method could increase the content uniformity of chlorpheniramine maleate in Children’s acetaminophen alkylamine particles,and optimize the preparation process,improve the quality of product,and improve the production efficiency