阿苯达唑原料药粒度对其片剂体外溶出度的影响  

Effect of the Particle Size of Albendazole Raw Material on Its Tablet Dissolution in Vitro

作　　者：罗炳华 LUO Binghua(The Drug R&D Center of Fujian Tianquan Pharmaceutical Co.,Ltd.,Longyan,Fujian 364000,China)

机构地区：[1]福建天泉药业股份有限公司,福建龙岩364000

出　　处：《今日药学》2021年第10期753-755,共3页Pharmacy Today

摘　　要：目的研究原料药粒度分布对阿苯达唑片溶出的影响,考察仿制片与原研药的体外溶出曲线一致性。方法通过对原料药进行不同处理,对比仿制片与原研药的溶出曲线相似因子f^(2)值。结果控制原料药粒度d(0.5)为5~10μm,d(0.9)为10~20μm,可使仿制片与原研药的体外溶出相似。结论确定适宜的原料药粒度控制范围,产品稳定性良好。OBJECTIVE To study the effect of the particle size of the raw material drug on the dissolution of albendazole tablets,and to investigate the consistency of the in Vitro dissolution profiles of the self-made tablets and the reference tablets.METHODS Different methods were used to process the raw materials,and the similarity factor f^(2) value of the dissolution curves of the self-made tablets and the reference tablets were compared.RESULTS The particle size d(0.5)of the raw material drug were controlled at 5-10μm and d(0.9)at 10-20μm,which could make the in Vitro dissolution of the self-made tablets and the reference tablets similar.CONCLUSION The appropriate particle size control range of the raw material drug is determine,and the product stability is good.

关 键 词：阿苯达唑片 原料药粒度 溶出曲线 相似因子f^(2) 

分 类 号：R917[医药卫生—药物分析学]