氨咖黄敏胶囊中2种组分质量控制方法的建立及9厂家产品质量评价  

Establishment of Quality Control Methods for 2 Components in Anka Huangmin Capsules and Quality Evaluation of the Products from 9 Manufacturers

作　　者：丁苏苏 王威 王玉[2,3] 李倚云 闻琍毓 

机构地区：[1]江苏省扬州药品检验所,江苏扬州225009 [2]中国药科大学,南京210009 [3]江苏省药品检验所,南京210008

出　　处：《中国药房》2013年第5期438-440,共3页China Pharmacy

摘　　要：目的:建立氨咖黄敏胶囊中对乙酰氨基酚和咖啡因的含量测定及体外溶出度检查方法,并评价9厂家该产品的质量。方法:采用高效液相色谱法。色谱柱为菲罗门Gemini-C18,流动相为磷酸盐缓冲液-乙腈(82:18,V/V),检测波长为262nm。溶出度采用篮法,以水为溶出介质,转速100r/min,分别在不同时间取样计算各组分的累积溶出百分率,并采用相似因子(f2)进行溶出曲线的相似性比较。结果:对乙酰氨基酚和咖啡因的检测质量浓度线性范围分别为0.1002～0.5008mg/ml、6.332～63.320μg/m(lr均为0.9999);平均回收率分别为100.81%(RSD=1.4%)、101.10%(RSD=0.7%),n=9。9厂家95批样品比较2种组分含量统计检验P值均<0.05;与原研厂样品比较,二者f2值低于50者分别占60%和56%。结论:不同厂家样品中2种组分含量和溶出均存在差异;有必要在该产品标准中增加溶出度检查项目,以全面控制该药品的质量。OBJECTIVE： To establish a method for the content and in vitro dissolution determination of acetaminophen and caf- feine in Anka huangmin capsules, and to evaluate the quality of the products from 9 manufacturers. METHODS： HPLC method was adopted. Gemini-C18, column was used with mobile phase consisted of phosphate buffer solution-acetonitrile （82： 18, V/V） at wavelength of 262 nm. Dissolution test was conducted by rotating basket method using water as dissolution medium at rotation speed of 100 r/min. Accumulative dissolution percentages of each component were calculated at different time, and then the similari- ty of dissolution curves were compared by similarity factor （f2）. RESULTS： The linear ranges of acetaminophen and caffeine were 0.100 2-0.500 8 mg/ml and 6.332-63.320 ktg/ml （all r=0.999 9）; average recoveries were 100.81%（RSD=1.4%）,101.10% （RSD=0.7%）, n=9. Statistical test P value of acetaminophen and caffeine in 95 batches of samples from 9 manufacturers were less than 0.05, and 60% and 56% of2 of them were lower than 50, compared with original manufacturers. CONCLUSIONS： The content and dissolution of 2 components are different in samples from different manufacturers. It is necessary to establish dissolution determination in the standard in order to control the quality of the preparation completely.

关 键 词：氨咖黄敏胶囊 高效液相色谱法 溶出 对乙酰氨基酚 咖啡因 含量测定 

分 类 号：R927.2[医药卫生—药学] R971.1