维生素B_1缓释片的制备工艺研究

Preparation of Vitamin B_1 Sustained-release Tablets

目的:筛选维生素B1(VB_1)缓释片的最佳处方及制备工艺。方法:采用单因素试验对填充剂的种类、骨架材料羟丙基甲基纤维素(HPMC)的型号及用量、阻滞剂的种类及用量、片重及片芯硬度进行考察,并采用正交试验对骨架材料HPMC的用量、阻滞剂乙基纤维素(EC)的用量及片芯硬度进行考察。结果:确定最佳处方工艺为:HPMC K15M用量占片重50%,EC用量占片重20%,填充剂为乳糖,片重为200 mg,压制片芯硬度为50 N。结论:所制备的VB_1缓释片缓释效果显著,为其新剂型的开发提供了理论参考和试验基础。

Objective： To screen the optimal formula and preparation process of vitamin B1 （ VB1 ） sustained-release tablets. Methods： The single-factor tests were used to investigate the type of filler, type and amount of matrix material hydroxypropyl methycel- lulose （HPMC）, type and amount of retarder, tablet weight and core hardness. The orthogonal tests were used to.investigate the amount of HPMC and ethyl cellulose（EC） and the core hardness. Results： The optimum formula was as follows： HPMC accounted for 50% of the tablet weight, EC accounted for 20%, the filler was lactose, the tablet weight was 200 mg and the tablet core hardness was 50 N. Conclusion： The prepared sustained-release tablets have significant controlled-release property, which provides reference for the devel- opment of new dosage form for VB1.