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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。
Vitamin E solidified granules were prepared by using different types of silica powder or β-cyclodextrin respectively. The drug loading, vitamin E utilization and particle yield were selected as the evaluation indexes. The results showed that vitamin E particles with 60% drug loading could be obtained with S80 type silica powder, which is obviously superior to β-cyclodextrin particles (about 6%). With its direct powder tablet, the resulting tablets are in line with the Chinese Pharmacopoeia 2010 edition of the standard. The tablets showed no significant changes in appearance and content after being stored for 10 days at high temperature (60 ° C); however, the tablets were hygroscopic under high humidity (90 ± 5%, 25 ° C) 4 500 ± 500) 1x] content decreased.