Roxithromycin Capsules

roxithromycin capsules microbial limit test method

罗红霉素胶囊微生物限度检查法的验证

objective: in order to examine the intrinsic quality and homogeneity of roxithromycin tablets ( capsules) and to provide methods and parameters for evaluating quality of products.

目的：为评价罗红霉素内在质量、控制药品的均匀性，评价该制剂质量提供方法与参数。

methods 20 male healthy subjects received a single dose of 150 mg roxithromycin enterosoluble capsules.

方法20名志愿者单剂量口服150mg的罗红霉素肠溶胶囊，采用LC-MS法测定其血清中罗红霉素浓度。

the relative standard deviation ( rsd) in peak area for injection of roxithromycin standards was 4.3%. the mean recovery of roxithromycin in roxithromycin tablets, roxithromycin dispersible tablets, and roxithromycin capsules was 97.7%, 94.8%, 93.6%, respectively.

3种供试品中罗红霉素的平均加标回收率分别为97.7%、94.8%、93.6%。

comparisons between dissolutions of roxithromycin tablets ( capsules) from four producers

四厂家罗红霉素片剂（胶囊）溶出度比较

in order to obtain the optimum formula and preparing techniques of roxithromycin capsules, the effects of different excipients and techniques were studied with orthogonal test.

为筛选罗红霉素胶囊的最佳处方和制备工艺，用正交试验法，考察不同辅料和制备工艺对罗红霉素胶囊的质量影响。