不同晶型阿莫西林原料对制剂溶出行为的影响

Effect of Different Crystal Type of Amoxicillin Raw Material on the Stripping Behavior of Preparation

目的:测定3个企业阿莫西林原料药的晶型与体外的溶出度,阐述原料药晶型对制剂溶出行为的影响。方法:通过显微镜检观察原料药的晶型,采用药典溶出度测定法测定阿莫西林胶囊的体外溶出曲线。结果:3个企业的阿莫西林用同一配方制备的胶囊,虽然45min的溶出累积量均符合药品标准要求,但溶出行为有较大的差异。结论:原料药的晶型对药物制剂的溶出有较大的影响,原料药和制剂新产品仿制过程应当对溶出曲线进行对照研究,制剂生产企业生产过程应当注意选择品质优良的原料,当前制剂溶出度单点法测定不足以反映药品的内在质量。

Objective ：To determine the three drng companies amoxicillin crystal dissolution and in vitro on the crystalline form on dissolution behavior of agents.Methods ：By microscope API crystal type,using the USP dissolution delermination method for determination of Amoxicillin Capsules in vitro dissolution curves.Results：The 3 enterprises with the same formula preparation of amoxicillin capsule.although 45 minutes of stripping cumulants are consistent with standard reqnirements, but the dissolution behavior have bigger difference.Conclusion：API rryslal type try. sial type on drug dissolution had bigger effect, raw material andpreparation of new product imitation process should be the solution curves were ease-control study, preparation production enterprise production process should pay greatattention to the ohoice of high quality raw materials, the preparation of single point method for the determination of dissolution is not enough to reflect its intrinsic qualily.