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目的:制备难溶性药物岩白菜素高载药量单室单层渗透泵型控释片。方法:以渗透泵片常用辅料为混合载体材料制备固体分散体,利用等渗原理优化片芯处方;以岩白菜素累积释放度为指标,采用星点设计-效应面法优化包衣处方。结果:PEG 1500质量分数1.30%,包衣增重9.5%时,制得的岩白菜素高载药量渗透泵片累积释放度接近80%,符合零级释药特征。结论:充分发挥辅料多种功能可有效提高渗透泵片载药量;优化片芯与衣膜处方的方法能显著缩短试验周期,为渗透泵制剂处方设计提供一种新思路。
OBJECTIVE: To prepare single-compartment monolayer osmotic pump controlled release tablets of hardly soluble drug bergenin. Methods: The solid dispersions were prepared by using the common excipient of osmotic pump as the mixed carrier. The prescription of core was optimized by the principle of isotonicity. The cumulative release of bergenin was used as index to optimize the coating formulation by the method of star point design and response surface. Results: When the mass fraction of PEG 1500 was 1.30% and the weight gain of coating 9.5%, the cumulated release of Bergenin-loaded high osmotic pump tablets was close to 80%, which was consistent with the zero-order drug release characteristics. CONCLUSION: Taking full advantage of multiple functions of excipients can effectively improve the loading capacity of osmotic pump tablets. The optimized method of tablet core and membrane prescribing can shorten the test period significantly and provide a new idea for prescription design of osmotic pump formulations.