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目的制备日服2次的氧化苦参碱(OMT)缓释微丸。方法以挤出滚圆法制备速释丸心,包衣锅包衣法包衣;单因素法考察增塑剂用量、致孔剂种类及用量、包衣增重对微丸溶出的影响。结果优选出包衣处方为5%乙基纤维素(EC)的乙醇溶液,增塑剂邻苯二甲酸二乙酯(DEP)用量为20%,致孔剂PVPK30用量为2%,包衣增重10%。所制备的氧化苦参碱缓释微丸在1、4、8 h的体外释度分别在30%~33%,60%~66%,80%以上,符合《中国药典》2005年版要求。结论该实验工艺稳定,重现性良好。
OBJECTIVE To prepare oxymatrine (OMT) sustained-release pellets on a daily basis. Methods Rapid injection pill coating and coating pan coating were prepared by extrusion spheronization method. The effects of plasticizer dosage, porogen type and dosage, coating weight gain on dissolution of pellets were investigated by single factor method. The results showed that the optimum conditions were as follows: ethanol solution of 5% ethyl cellulose (EC), 20% plasticizer diethyl phthalate (DEP) and PVPK30 2% Weight 10%. The prepared oxymatrine sustained-release pellets released in vitro in 1, 4 and 8 h were 30% -33%, 60% -66% and 80%, respectively, which met the requirements of 2005 edition of Chinese Pharmacopoeia. Conclusion The experimental process is stable and reproducible.