中国兽医科学2026，Vol.56Issue(1)：128-137,10.DOI:10.16656/j.issn.1673-4696.2026.0002
倍他米松固体分散体的制备工艺优化与应用研究
Optimization of the preparation process and application research of betamethasone solid dispersions
摘要
Abstract
Betamethasone(BMS)is a long-acting glucocorticoid drug,currently mainly used for treat-ing active rheumatism,rheumatoid arthritis,lupus erythematosus,etc.Due to its low solubility and poor oral efficacy,its bioavailability is relatively low,severely restricting its application as an oral formulation.This paper uses the solvent evaporation method to prepare BMS solid dispersions to increase its solubility,dissolution rate,and bioavailability.Hydrophilic polymers such as polyvinyl pyrrolidone,hydroxypropyl methylcellulose,and polyethylene glycol were selected as carrier materi-als to prepare the solid dispersions.The dissolution rate and cumulative dissolution rate were used as evaluation indicators,and single-factor screening,combined carrier screening,and orthogonal experi-ments were carried out for prescription screening and preparation process optimization.The BMS solid dispersions were characterized by scanning electron microscopy,powder X-ray diffraction,differen-tial scanning calorimetry,and Fourier transform infrared spectroscopy.The in vivo pharmacokinetic experiments of BMS raw material and solid dispersion in rats were conducted to evaluate the absorption,distribution,metabolism,and excretion process of BMS in rats.The results showed that the BMS solid dispersions could significantly increase the dissolution and absorption in both in vivo and in vitro conditions.Among them,BMS-PVP K13-18(1∶3),with a magnetic stirring time of 4 hours,a rotary evapora-tion temperature of 65 ℃,and a drying time of 24 hours,had the best effect,with a relative bioavail-ability of 554.9％.Therefore,the BMS solid dispersions prepared by the solvent evaporation method can significantly improve the solubility and dissolution rate,providing new ideas and methods for the new formulation of BMS.关键词
倍他米松/固体分散体/聚乙烯吡咯烷酮K13-18/药代动力学Key words
betamethasone/solid dispersion/PVP K13-18/pharmacokinetics分类
农业科技引用本文复制引用
练婷婷,章瑾怡,魏霞丽,嵇欣雨,郭紫萱,金庆日..倍他米松固体分散体的制备工艺优化与应用研究[J].中国兽医科学,2026,56(1):128-137,10.基金项目
浙江省基础公益研究计划项目(LGN20C180001) （LGN20C180001）
