维生素E固化颗粒的制备及质量评价

Preparation and Quality Evaluation of Solidified Granules of Vitamin E

分别采用不同型号的微粉硅胶或β-环糊精制备了维生素E固化颗粒,并以载药量、维生素E利用率和颗粒收率为评价指标进行筛选。结果表明,采用S80型微粉硅胶可制得载药量达60%的维生素E颗粒,明显优于β-环糊精颗粒(约6%)。用其直接粉末压片,所得片剂各项指标均符合中国药典2010年版标准。该片在高温(60℃)条件放置10 d,外观和含量未见明显变化;但在高湿[相对湿度(90±5)%、25℃]环境下片剂会吸潮,强光[(4 500±500)1x]条件下含量下降。

The solidified granules of vitamin E β-cyclodextrin as the excipient. The excipient was screened were prepared with different types of microsilica gel or with drug loading, utilization rate of vitamin E and yield as indexes. The results showed that the drug loading of granules with type S80 microsilica gel （about 60 %） was superior to the granules with β-cyclodextrin （about 6 %）. The quality of the tablets prepared by the direct power compression method with the above granules was complied with the requirement of ChP 2010. The obtained tablets stored at 60 ℃ for 10 d could maintain stable, while in the high humidity [RH （90±5） % and 25 ℃] or highlight E （4500±500） lx] environment, the tablets absorbed moisture or the content decreased.