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目的:研制白芍总苷微孔渗透泵片,考察白芍总苷微孔渗透泵片主要成分体外释药的同步性。方法:以白芍总苷累积释放度为指标,分别采用单因素及正交试验得到白芍总苷微孔渗透泵片的最佳处方。以芍药苷、芍药内酯苷、苯甲酰芍药苷的释放度为指标,考察最佳处方中3个主成分的同步释放性。结果:衣膜增重、衣膜中PEG 400及邻苯二甲酸二乙酯的用量是影响药物释放行为的主要因素。优化后的微孔渗透泵片中白芍总苷累积释放度约为90%,3个主成分呈良好的零级释放特征,同步释放性较好。结论:制备的白芍总苷微孔渗透泵片重复性较好,可以实现其多组分同步释放。
OBJECTIVE: To develop a microporous osmotic pump tablet of total glucosides of paeony et al. To study the synchronicity of drug release in vitro from the main components of total osmotic pump tablet of total glucosides of peony root. Methods: According to the cumulative release of total glucosides of paeony as an index, single prescription and orthogonal test were used to get the best prescription of total perfusion of paeoniflorin. The paeoniflorin, paeoniflorin and benzoyl paeoniflorin were used as indexes to investigate the simultaneous release of the three main components in the optimal prescription. Results: The weight gain of membrane and the dosage of PEG 400 and diethyl phthalate in the membrane were the main factors affecting the drug release behavior. The cumulative release of total glycosides in paeoniflorin in the optimized microporous osmotic pump tablets was about 90%. The three principal components showed good zero-order release characteristics and good simultaneous release. CONCLUSION: The prepared total glucosinolate microporous osmotic pump tablet has good reproducibility and can achieve simultaneous release of multiple components.