阿莫西林胶囊在不同介质中的溶出度考察  

Comparison of Dissolution for Amoxicillin Capsules in Different Mediums

作　　者：潘强[1] 徐秋阳[1] 潘智鹏[2] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]辽宁省肿瘤医院

出　　处：《中国药事》2012年第3期238-240,共3页Chinese Pharmaceutical Affairs

摘　　要：目的比较国内3个药厂阿莫西林胶囊剂在4种不同溶出介质中的溶出情况。方法参照日本在"药品品质再评价"拟定流程中对溶出度试验条件的规定,分别考察3个药厂阿莫西林胶囊在水、pH 1.2人工胃液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,溶出方法采用转篮法,转速为100r.min-1,同时和《中国药典》2005年版规定的阿莫西林胶囊剂溶出方法进行比较。结果按照《中国药典》方法进行溶出时,3个药厂的阿莫西林胶囊在10min内溶出均超过90%;在其他介质中溶出时,3个药厂产品在10min内溶出也均超过90%。结论同一批阿莫西林胶囊在不同溶出介质中溶出差异很小;不同药厂阿莫西林胶囊剂的溶出参数无显著性差异,国产阿莫西林胶囊的总体质量较好。Objective To compare the dissolution of Amoxicillin Capsules which came from three domestic manufacturers in four different mediums.Methods The in vitro dissolution of Amoxicillin Capsules from three manufacturers was inspected in the following mediums：water,pH 1.2 artificial gastric juice,pH 4.0 acetate buffer solution and pH 6.8 phosphate buffer solution（the above 4 mediums were used according to the project of drug quality＇s re-evaluation in Japan）.The dissolution tests were proceeded with stirring basket method at 100r·min-1,compared with that according to ChP 2005.Results The dissolution of Amoxicillin Capsules from three manufacturers in 10 min was all over 90% according to the method in ChP 2005.However,the products of all manufactures could dissolved over 90% in 10 min in other mediums.Conclusion The dissolution of the same batch of Amoxicillin Capsules in different mediums verifies no significant differences.There are no significant differences in the quality of Amoxicillin Capsules from different manufacturers.The Amoxicillin Capsules is superior in quality.

关 键 词：阿莫西林胶囊 溶出度 紫外分光光度法 

分 类 号：R943.3[医药卫生—药剂学]