国产麦迪霉素胶囊的溶出度研究

Investigation on dissolution of midecamycin capsules

目的研究国产麦迪霉素胶囊的溶出度。方法通过稳定性试验考察处方组成、制粒工艺及不同包装材料对麦迪霉素胶囊溶出度的影响。结果表明不同处方、工艺所制备的国产麦迪霉素胶囊的初始溶出度,在20m in时几乎都达100%,但经加速试验30d或长期试验90d后,其溶出度急剧下降,在60m in时仍低于50%。而用日本进口的麦迪霉素原料制备的胶囊,其溶出度及稳定性均很好,经加速试验30d或长期试验90d后,经时20m in的溶出量均大于90%。结论在同样的处方工艺条件下,国产麦迪霉素胶囊放置后溶出度下降较快,而日本进口原料制备的麦迪霉素胶囊稳定性良好。

OBJECTIVE To investigate the dissolution of midecamycin capsules. METHODS The dissolution of midecamycin capsules, prepared by different formulations, granulating technologies and packages, were evaluated during stability experiment. RESULTS The initial dissolution of midecamyein capsules, prepared by different formulations, granulating technologies and packages, were approximate 100% of the dosage within 20 minutes, but the dissolution rate decreased to below 50% within 60 minutes in every formulation with midecamycin produced in China after storage, and at the same time the dissolution rate was above 90% within 20minutes in every formulation with midecamyein produced in Japan after storage. CONCLUSION The dissolution rate of the capsules, which prepared with midecamyein produced in China, decreas rapidly after storage. But the capsules, which prepared with midecamycin produced in Japan, are stable after storage.