维生素E微囊片的研制及其质量考察

 目的：研制Vit E微囊片，以延缓Vit E释放，提高制剂稳定性。方法：以明胶、阿拉伯胶为囊材，聚丙烯酸树脂Ⅳ为致密剂，复凝聚法得Vit E微囊后，加入微晶纤维素压制成片。用气相色谱法进行含量测定，进而研究其载药量、包封率、溶出度、稳定性等质量指标。结果：Vit E在0.01～4 g·L^-1浓度范围内线性回归方程为：Y=0.5827C+5.552×10^-3，r=0.9999，低、中、高3种浓度回收率分别为（99.2±0.6）%，（100.70±0.28）%，（98.60±0.17）%。微囊平均载药量为66.5%（n=3)，RSD%=1.8，平均包封率为83.4%（n=3)，RSD%=0.75。微囊片体外缓释特征符合Higuchi方程。与市售Vit E软胶囊相比对湿、光、热稳定性显著提高。结论：Vit E微囊片制备工艺简单，质量易控，延缓了Vit E的释放，并提高了其稳定性，应进一步研究。

Study on preparation of Vitamin E microcapsule tablets and its quality control

OBJECTIVE To develop VE microcapsule tablets with sustained-release property and better stability.METHODS The microcapsule was prepared using gelatin and araban as main materials, and acrylic resin Ⅳ as sustained-release materials. Mixed with microcrystalline cellulose, the tablets were made by all-powder direct compressing technique. The concentration was determined by GC. Its quality, such as drug loading, embedding ratio, dissolution rate in-vitro and stability etc, was also studied.RESULTS Vitamin E showed good linearity in the concentration range of 0.01～4 mg·mL^-1, r=0.9999. The average rate of recovery of low，medium，high concentration was (99.2±0.6)%，(100.7±0.28)%，(98.6±0.17)% respectively. Its dissolution rate in-vitro could be described well by Higuchi equation. The stability against light, heat and humidity was better than Vitamin E soft-capsules.CONCLUSIONS This production was easy and the quality could be controlled.