咪唑斯汀缓释片的制备及质量研究  

Preparation and Quality Study of Mizolastine Sustained-release Tablet

作　　者：苗健伟[1] 孙建绪[2] 刘亚琴 胡音[2] 高永良[2] 

机构地区：[1]北京积水潭医院,北京市100035 [2]军事医学科学院毒物药物研究所,北京市100850 [3]国家发改委药品价格评审中心,北京市100045

出　　处：《中国药房》2009年第28期2209-2210,共2页China Pharmacy

摘　　要：目的:制备咪唑斯汀缓释片并对其质量进行评价。方法:以羟丙基甲基纤维素为控释剂、酒石酸氢钾为制酸剂、咪唑斯汀为主药制备缓释片,并考察所制片剂的主药含量、有关物质含量、在不同介质(水、盐酸及磷酸盐缓冲液)中的体外释放度及制剂稳定性(10d)。结果:所制制剂外观成型好,主药标示含量为99.56%～102.39%,有关物质含量小于0.2%,在3种介质中2h后的体外释放度均大于80%,稳定性试验中各检测指标均合乎要求。结论:所制制剂处方合理、工艺可行,各项质量指标均符合设计要求。OBJECTIVE： To prepare mizolastine sustained - release tablet and evaluate its quality. METHODS： The tablet was prepared with hydroxy propyl methylcellulose as controlled release agent, bitartaricum kalium as antacid and mizolastine as principal agent. The contents of mizolastine and the relative substances, the drug release rate in different medium （water, hydrochloric acid, and buffer phosphate）, and the stability of the preparation were investigated （within 10 days）. RESULTS： The preparation was well- formed in shape, the labeled content of the principal agent was 99.56%- 102.39%; the content of the relative substances was less than 0.2% ; its in vitro release rates in 3 different medium, were all above 80% after 2 h, and its stability was up to the standard. CONCLUSION ： The prepared mizolastine sustained - release tablet is reasonable in formulation, feasible in preparation process and its quality is up to the standard.

关 键 词：咪唑斯汀缓释片 制备 含量测定 释放度 

分 类 号：R943[医药卫生—药剂学] R976[医药卫生—药学]