盐酸小檗碱树脂复合物的制备、表征及其体外释放

Preparation,characterization and in vitro release of berberine hydrochloride resin complex

制备具有掩味效果的盐酸小檗碱树脂复合物。以盐酸小檗碱为模型药物,Amberlite IRP69为载药树脂,通过阐明一定温度范围内盐酸小檗碱在潜溶剂中的溶解度与温度关系曲线,指导复合物制备过程中盐酸小檗碱的加入量及反应温度等参数的研究。对制得的复合物进行物性表征和体外释放研究,验证复合物的形成并预测复合物的体内释放行为。实验结果表明,用60%乙醇作为潜溶剂在50℃下恒温搅拌1 h,制得的复合物载药量和药物利用率分别为35%和64%,且具有较好的掩味效果。本研究提供了一种制备盐酸小檗碱掩味制剂的方法。

The object of this study is to preparate the berberine hydrochloride(BBH)resin compound with taste masking effect.We took the BBH as the model drug and Amberlite IRP69 as the drug carriers,uncovered the curve of solubility of BBH in different cosolvent with a certain range of temperature,and then used it to calculate the parameters during the preparation of the complex such as adding quantity of BBH and the reaction temperature.Afterwards,the characteristic and in vitro release experiments were studied to verify the formation and predict the in vivo release behavior of the complex.The results showed that in the condition of using 60%ethanol as a cosolvent and stirring at 50℃for 1 h,the drug loading and drug availability of the complex are at about 35%and 64%,respectively,and has a better taste-masking effect.In this study,a method was provided for preparing a taste-masking preparation of BBH.