不同厂家奥美拉唑肠溶胶囊释放曲线评价  

Evaluation of release curve for omeprazole enteric-coated capsules made by different manufacturers

作　　者：王震红[1] 杨永刚[1] 薛娇[1] 王新意[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《实用药物与临床》2013年第3期237-239,共3页Practical Pharmacy and Clinical Remedies

摘　　要：目的通过分析奥美拉唑肠溶胶囊释放曲线,全面评价国产奥美拉唑肠溶胶囊的质量。方法测定52家生产企业的奥美拉唑肠溶胶囊的释放曲线,进行批内均一性、批间均一性及释放曲线相似性比较。结果 52家生产企业中32家批内均一性较差;5家生产企业中2家生产企业批间均一性较差;20家RSD符合要求的生产企业中,11家企业的产品与原研制剂释放曲线相似度较差。结论上市后的产品可采用集中抽验方式进行释放曲线评价,促进生产企业严格规范的生产,保证国内产品与原研产品质量的一致性和等效性。Objective To evaluate the quality of omeprazole enteric-coated capsules overall by analyzing release curve. Methods Release curve of omeprazole enteric-coated capsules in 52 manufactures was determined to study single batch consistency,consistency between batches and similarity of release curve. Results Single batch consistency of 32 manufactures was lack in 52 manufactures.Consistency between batches of 2 manufactures was bad in 5 manufactures.The similarity of release curve of 11 manufactures was poor in 20 manufactures of good RSD comparing with first investigative manufacture. Conclusion The release curve should be evaluated by centralized operating to promote standard work and to ensure the equivalence with first investigative manufacture.

关 键 词：奥美拉唑肠溶胶囊 释放曲线 

分 类 号：R94[医药卫生—药剂学]