头孢克肟胶囊剂的制备及其质量研究

Preparation and quality evaluation of cefixime capsules

目的:研制头孢克肟胶囊并对其质量进行考察。方法:采用单因素试验筛选头孢克肟胶囊的处方工艺,建立质量控制方法,并进行稳定性考察和人体相对生物利用度试验。结果:所研制产品的处方工艺简单,质量稳定,45min时的溶出度达95%以上,与进口分装产品世福素的人体相对生物利用度为(112.0±26.8)%。结论:本实验研制的头孢克肟胶囊适合工业化生产,产品质量稳定。

Objective: To optimize the quality control of the cefixime capsules manufactures. Methods: The formulation and preparation parameters were optimized, and the quality control was monitored by gross deviation, stability test and relative bioavailability. Results: The dissolution rate of cefixime capsules was 95% or up after 45min and the relative bioavailability was (112.0±26.8)%, compared to the reference cefixime capsules. Conclusion: The simple and reliable pilot procedure is applicable to the large-scale manufacture,and the quality control to the procedure is attained.