复方北豆根氨酚那敏片溶出度测定考察  

Dissolution Test of Compound Asiatic Moonseed Paracetamol and Chlorphenamine Maleate Tablets

作　　者：王斌 李琦 陈传品[1] Wang Bin;Li Qi;Chen Chuanpin(School of Pharmaceutical Science,Central South University,Changsha 410013,China;Hunan Food and Drug Vocational College;Hunan Institute for Drug Control)

机构地区：[1]中南大学药学院,长沙410013 [2]湖南食品药品职业学院 [3]湖南省药品检验研究院

出　　处：《中国药师》2020年第5期958-961,共4页China Pharmacist

摘　　要：目的:建立复方北豆根氨酚那敏片溶出度的测定方法,并对不同厂家的产品进行溶出度考察。方法:采用桨法,以水1000 ml为溶出介质,转速100 r·min-1,取样时间60 min;HPLC法同时测定对乙酰氨基酚和咖啡因的溶出量,色谱柱为Thermo C18(250 mm×4.6 mm,5μm);流动相A为0.05 mol·L-1磷酸二氢钾溶液-三乙胺(70∶0.05)(用磷酸调节pH至4.0),流动相B为甲醇,梯度洗脱;流速为1.0 ml·min-1,检测波长为273 nm,柱温为30℃,进样量为20μl。结果:对乙酰氨基酚、咖啡因的浓度线性范围分别为60.48~604.80μg·ml-1(r=0.9999)、3.12~31.20μg·ml-1(r=0.9999);平均回收率分别为99.8%,99.6%,RSD分别为0.56%,0.53%(n=9);不同企业的样品在60 min时对乙酰氨基酚、咖啡因的溶出量均达75%以上。结论:所建立的方法准确可靠,可用于复方北豆根氨酚那敏片对乙酰氨基酚和咖啡因的溶出度测定。Objective:To establish a method for the dissolution test of compound asiatic moonseed paracetamol and chlorphenamine maleate tablets,and to determine the dissolution of samples from different factories.Methods:Rotating paddle method was applied using 1000 ml water as the dissolution medium at the rotation speed of 100 r·min-1,and the dissolution time was 60 min.The contents of acetaminophen and caffeine were determined by HPLC,and the determination was performed on a Thermo C18 column(250 mm×4.6 mm,5μm)with potassium dihydrogen phosphate solution-triethylamine(70∶0.05)(adjusting pH to 4.0 with phosphoric acid)as the mobile phase A and methanol as the mobile phase B with gradient elution.The flow rate was 1.0 ml·min-1,the detection wavelength was 273 nm,the column temperature was 40℃,and the injection volume was 20μl.Results:The calibration curve for acetaminophen and caffeine was linear over the range of 60.48-604.80μg·ml-1(r=0.9999)and 3.12-31.20μg·ml-1(r=0.9999),respectively.The average recovery was 99.8%(RSD=0.56%)and 99.6%(RSD=0.53%)(n=9),respectively.Conclusion:The established dissolution determination method is accurate and reliable,which can be used to determine the dissolution of compound asiatic moonseed paracetamol and chlorphenamine maleate tablets.

关 键 词：复方北豆根氨酚那敏片 对乙酰氨基酚 咖啡因 溶出度 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]