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目的:制备头孢地尼胶囊,并考察自制样品与原研市售品的释放度一致性,确保自制样品与原研市售品释放度相似。方法:采用湿法制粒和流化床干燥法制备头孢地尼胶囊;采用紫外分光光度法,测定自制样品与原研市售品在盐酸溶液(pH1.2)、pH4.0缓冲溶液、pH6.8缓冲溶液和水等4种溶出介质中的溶出曲线,并进行相似性评价。结果:自制样品与原研市售品在4种溶出介质中溶出曲线f1均低于15,f2均高于50。结论:该制剂制备工艺操作简便,释放度相似,自制品与市售品的质量趋于一致。
OBJECTIVE: To prepare cefdinir capsules and investigate the consistency of the release of self-made samples with those of the original products to ensure that the self-made samples are similar to those of the original products. Methods: Cefdinir capsules were prepared by wet granulation and fluidized bed drying method. UV spectrophotometry was used to determine the purity of cefdinir capsules in the presence of hydrochloric acid solution (pH 1.2), pH 4.0 buffer solution, pH 6.8 Buffer solution and water four dissolution medium dissolution curve, and the similarity evaluation. Results: The dissolution curves of homemade samples and commercial products were less than 15 and f2 were higher than 50 in four dissolution media. Conclusion: The preparation process of the preparation is simple, the release degree is similar, the quality of self-made products and commercial products tend to be consistent.