摘要
采用高效液相色谱法测定小儿氨酚黄那敏颗粒中对乙酰氨基酚和马来酸氯苯那敏的含量均匀度。结果显示收集的10批样品中对乙酰氨基酚的含量均匀度A+2.2S在2.4~7.1之间,马来酸氯苯那敏的含量均匀度A+2.2S在11.8~49.4之间。部分小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量均匀度较差,需进一步提高生产工艺,以保障药品的安全有效性。本方法操作简便、准确,能用于同时测定小儿氨酚黄那敏颗粒中对乙酰氨基酚和马来酸氯苯那敏的含量均匀度。
The content uniformity of paracetamol and chlorphenamine maleate in Pendiatric Paracetamol,Artificial Cow-bezoar and Chlophenamine Maleate Granules were determinated by HPLC method.The test result of 10 bathes samples showed that the content uniformity of paracetamol and chlorphenamine maleate A+2.2S were 2.4~7.4 and 11.8~49.4 respectively.The content uniformity of chlorphenamine maleate in some tested sample still had defect.Its production process need to be further improved to ensure the safety and effectiveness of drugs.This method was accurate and simple.It was suitable for simultaneous determination of the content uniformity of paracetamol and chlorphenamine maleate in pendiatric paracetamol,artificial cow-bezoar and chlophenamine maleate granules.
作者
陈烨
黄晓纯
郑阳波
CHEN Ye;HUANG Xiao-chun;ZHENG Yang-bo(Jieyang Institute of Drug Control,Guangdong Jieyang 522000;Medical College of Jiaying University,Guangdong Meizhou 514031,China)
出处
《广州化工》
CAS
2024年第6期131-133,194,共4页
GuangZhou Chemical Industry
关键词
小儿氨酚黄那敏颗粒
对乙酰氨基酚
马来酸氯苯那敏
含量均匀度
pendiatric paracetamol
artificial cow-bezoar and chlophenamine maleate granules
paracetamol
chlophenamine maleate
content unifomity
