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目的:制备盐酸黄连素生物黏附包衣片并研究其性质。方法:采用正交设计法,确定生物黏附材料羟丙基甲基纤维素、卡波姆934P的用量及配比与制剂体外释放度及黏附力的关系,并对释放度进行释药动力学模拟,根据各模型拟合的残差平方和(Re)、赤池信息准则计算值(AIC)和拟合度(r)值来研究其释药规律。根据Peppas方程特征参数判断其释药机制。结果:羟丙基甲基纤维素与卡波姆对阻滞药物的释放及黏附力影响较大,且卡波姆的效果强于羟丙基甲基纤维素。生物黏附包衣片以Hixson-Crowell方程拟合最佳,药物释放机制为非Fick扩散。结论:盐酸黄连素生物黏附包衣片具有良好的黏附性能和pH依赖性。
Objective: To prepare berberine hydrochloride bioadhesive coated tablets and study its properties. Methods: The orthogonal design method was used to determine the relationship between the dosage and ratio of bioadhesive material hydroxypropyl methylcellulose, Carbomer 934P and in vitro release and adhesion of the preparation, and the release kinetics simulation , The release rule was studied according to the squares of the residuals (Re), the information of AIC and the fitting degree (r) of each model fitting. The mechanism of drug release was judged according to the characteristic parameters of Peppas equation. Results: Hydroxypropylmethylcellulose and carbomer had a significant effect on the release and adhesion of block drugs, and the effect of carbomer was better than that of hydroxypropyl methylcellulose. Bioadhesive coated tablets were best fitted by the Hixson-Crowell equation and the drug release mechanism was non-Fick diffusion. Conclusion: Berberine hydrochloride bioadhesive coated tablets have good adhesion and pH dependence.