复方氨酚葡锌片质量标准的提高研究  

Improvement of Quality Standard for Compound Paracetamol and Zinc Gluconate Tablets

作　　者：张平 俞永梅 

机构地区：[1]上海市松江食品药品检验所,上海201600

出　　处：《中国药师》2012年第11期1577-1579,共3页China Pharmacist

摘　　要：目的:建立同时测定复方氨酚葡锌片中对乙酰氨基酚含量及溶出度和盐酸二氧丙嗪含量及含量均匀度的HPLC方法。方法:色谱柱为ZORBAX SB-C_(18)(150 mm×4.6 mm,5μm)柱,流动相为乙腈-0.5%磷酸二氢钾溶液(50:50),流速为1.0ml·min^(-1),检测波长为226 nm。结果:对乙酰氨基酚的线性范围为8.09～80.88μg·ml^(-1)(r=1.000 0);平均回收率为100.36%,RSD为0.6%(n=6);盐酸二氧丙嗪的线性范围为4.00～40.00μg·ml^(-1)(r=0.999 9);平均回收率为99.74%,RSD为1.3%(n=6);对乙酰氨基酚溶出度和盐酸二氧丙嗪的含量均匀度均符合要求。结论:该方法简单,快速,准确,可为复方氨酚葡锌片的质量控制提供依据。Objective：To develop an HPLC method for the determination of the content and dissolution rate of paracetamol and the content and content uniformity of dioxopromethazine hydrochloride in compound paracetamol and zinc gluconate tablets.Method：The chromatographic analysis was carried out on a ZORBAX SB-C_（18） column（150 mm×4.6 mm,5μm）with acetonitrile-0.5%potassium dihydrogen solution（50：50） as the mobile phase.The flow rate was 1.0 ml ？ min~ and the detection wavelength was 226 nm.Result; The linear range of paracetamol and dioxopromethazine was 8.09-80.88μg ？ ml^（-1）（r = 1.0000） and 4.00-40.00μg ？ ml^（-1）（r = 0.999 9）,respectively.The mean recovery of paracetamol and dioxopromethazine was 100.36%with RSD of 0.6%（n =6） and 99.74%with RSD of 1.3%（n =6）,respectively.Both the dissolution rate of paracetamol and the content uniformity of dioxopromethazine were conformed to the quality standard.Conclusion：The method is simple,fast and accurate.It can be used to control the quality of paracetamol and zinc gluconate tablets

关 键 词：复方氨酚葡锌片 质量标准 对乙酰氨基酚 盐酸二氧丙嗪 含量 溶出度 

分 类 号：TQ460.72[医药卫生—药物分析学]