聚乙二醇6000修饰超氧化物歧化酶肠溶胶囊的研制

Study on the Preparation of PEG-SOD Enteric-coated Capsuls

目的 :研究聚乙二醇 (PEG) -超氧化物歧化酶 (SOD)肠溶胶囊的制备及其质量控制方法。方法 :以正交试验进行制备条件的筛选 ,得出制备PEG -SOD肠溶胶囊的最佳组合 ;按照《中国药典》2000年版标准进行质量控制研究。结果 :制备PEG -SOD肠溶胶囊的最佳组合为 :每1粒肠溶胶囊内装PEG -SOD40000IU ,稳定剂乳糖重量比为2 5 % ,填充剂为羧甲基淀粉钠 ,内容物干燥时间为20min ,干燥温度为60℃ ,所制PEG -SOD肠溶胶囊符合《中国药典》2000年版相关质量标准。结论 :该制剂制备工艺可行 ,质控方法可靠 ,制剂质量稳定。

OBJECTIVE:To study the method of preparing PEG-SOD enteric-coated capsuls and quality standard.ME_ THODS:Orthogonal design was used to select the optimal conditions for preparing PEG-SOD enteric-coated capsuls and the relevant quality standard of PEG-SOD enteric-coated capsuls was established according to the China Pharmacopoeia(2000). RESULTS:The optimal conditions were as follows:the content of PEG-SOD per capsule was40000IU;the weight ratio of stabilizer lactose was2.5%;filler was carboxymethyl starch;drying process was at60℃for20min.The preparation was acˉcorded with the relevant quality standard.CONCLUSION:The technic of preparation is feasible,the method of quality control is reliable and the quality of preparation is stable.