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目的:研制罗布麻压制包衣脉冲片。方法:采用干法压制包衣法制备罗布麻脉冲片,以释药时滞和7 h累积释放率为评价指标,采用Box-Behnken设计试验考察羧甲基淀粉钠-甘露醇、氢化蓖麻油-聚乙二醇6000及包衣重-片芯重对处方工艺的影响,通过二项式方程拟合建立指标与因素之间的函数关系,效应面法优化罗布麻压制包衣脉冲片处方,并对优选处方进行验证。结果:释药时滞和7 h累积释放率与考察因素间均可用二项式方程拟合,相关系数分别为0.979 8,0.955 4。最佳处方为羧甲基淀粉钠-甘露醇(1∶1),氢化蓖麻油-聚乙二醇6000(5.38∶1),包衣片重-片芯重(1∶1),制备的罗布麻压制包衣脉冲片时滞约5 h,药物在6~8 h内近似零级释放,释药时滞和7 h累积释放率实测值与预测值的偏差分别为3.61%,-1.42%。结论:按Box-Behnken设计-效应面法优选处方制备的罗布麻压制包衣脉冲片具有良好的定时脉冲效果。
Objective: To develop Apocynum Pulp tablets. Methods: Apocynum pulsatil tablets were prepared by dry compression coating method. With the delay of release and the cumulative release rate at 7 hours, the Box-Behnken design test was used to investigate the effects of sodium carboxymethyl starch-mannitol, hydrogenated castor oil- Polyethylene glycol 6000 and coating weight - core weight on the prescription process, through the binomial equation fitting to establish the functional relationship between the indicators and factors, effect surface optimization of opiate compressed coated pulse tablets, and Validation of preferred prescriptions. Results: The release delay and the cumulative release rate at 7 h were all fitted by the binomial equation with the correlation coefficients of 0.979 8 and 0.955 4, respectively. The best prescriptions were sodium carboxymethyl starch-mannitol (1: 1), hydrogenated castor oil-polyethylene glycol 6000 (5.38: 1) The time-delay of pulse-pressing coated tablets was about 5 h, and the drug release was approximately zero-order within 6-8 h. The deviations of measured release value and cumulative release rate from 7 h to 7 h were 3.61% and 1.42%, respectively. CONCLUSION: Apocynin coated pulsatile tablets prepared by the Box-Behnken design-response surface method have good timing pulse effect.