f_2因子法评价头孢克洛干混悬剂溶出曲线的相似性

Comparison of dissolution profiles of different cefaclor products for suspension using similarity factor f_2

目的:评价自制粉末状头孢克洛干混悬剂与市售颗粒状头孢克洛干混悬剂体外溶出行为的相似性。方法:参考2010年版《中华人民共和国药典》规定的头孢克洛干混悬剂溶出方法,分别考察自制受试制剂和市售头孢克洛干混悬剂在纯水、pH 1.2人工胃液、pH 5.5与pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,以高效液相色谱法进行测定,并采用f2相似因子法评价受试制剂和市售参比制剂溶出曲线的相似度。结果:在4种溶出介质纯水、pH 1.2人工胃液、pH 5.5与pH 6.8磷酸盐缓冲液下,受试制剂与参比制剂的f2因子分别为66.81,58.25,60.19和68.19。结论:两种组方及制法不同的头孢克洛干混悬剂的溶出曲线相似,初步提示受试制剂的处方及工艺合理。

Objective：To compare the dissolution profiles of two cefaclor products for suspension with dif ferent properties, of which one is powder （ the test formulation） , the other one is granules （ the reference formula tion）. Methods：The oar method for dissolution test in Chinese pharmacopoeia 2010 edition was consulted. To de termine the rate of dissolution of the test and reference formulations, four dissolution media Were selected, including water, pH 1.2 artificial gastric juice, pH 5.5 and pH 6.8 phosphate buffer. The samples were determined using high performance liquid chromatography （HPLC）. Similarity factor f2 was used to compare the dissolution profiles be tween the test and reference formulations. Results：The f2 were 66.81,58.25,60.19 and 68.19 when the dissolu tion media were water,pH 1.2 artificial gastric juice, pH 5.5 and pH 6.8 phosphate buffer, respectively. Conclu sion：The dissolution profiles of the test and reference formulations are similar. The results demonstrate that the composition and manufacturing technique of the test formulation ere rational.