11厂家国产头孢氨苄片的溶出度比较

目的:比较国内11个厂家头孢氨苄片的溶出情况。方法:参照《中国药典》2005年版和日本在"药品品质再评价"拟定流程中对溶出度试验条件的规定,分别考察不同批次头孢氨苄片在水、pH1.2人工胃液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液4种溶出介质中的体外溶出度,溶出方法采用转篮法,转速为100r·min-1,测定方法为紫外分光光度法,检测波长为262nm;以其中溶出效果最优的E厂家样品为对照采用相似因子法进行各厂家样品间溶出行为的比较。结果:在上述4种溶出介质中,分别只有4个、3个、5个、8个厂家的样品在45min时累积溶出度在80%以上;多数厂家样品的相似因子结果都远小于50。结论:不同厂家样品的溶出行为不但有显著性差异,且溶出度不符合质量要求。

Comparison of the Dissolution Rates of Domestic Cefalexin Tablets from 11 Manufacturers

OBJECTIVE： To evaluate the dissolution of Cefalexin tablets from 11 domestic manufacturers. METHODS： The dissolubility of different batches of Cefalexin tablets was invesitgated in the following 4 kinds of mediums： water, pH 1.2 artificial gastric juice, pH 4.0 acetate buffer solution, pH 6.8 phosphate buffer solution according to Chinese Pharmacopeia （2005 edition） and Drug Quality Re-evaluation in Japan. The dissolution tests were preceded by rotating basket at 100 r·min^-1 and UV spectrophotometry was used to determine dissolution rate at detection wavelength of 262 nm. The dissolution of samples from different manufacturers was compared by similar factor method using sample from manufacturer E as control. RESULTS： The accumulative dissolution rate of Cefalexin tablets from 4 manufacturers in water, 3 manufacturers in pH 1.2 artificial gastric liquid, 5 manufacturers in pH 4.0 acetate buffer solution, 8 manufacturers in pH 6.8 phosphate buffer solution were more than 80%. Similar factor of sample from many manufacturers was less than 50. CONCLUSION： There is significant difference among the dissolution of Cefalexin tablets from different manufacturers and their dissolution rates aren＇t in line with quality standard.