孟鲁司特钠咀嚼片的处方工艺研究  

Prescription and preparation of montelukast sodium chewable tablets

作　　者：李宛择 陈永 刘芳洁 郭丹峰 康婷 高翔 袁金桥 LI Wan-ze;CHEN Yong;LIU Fang-jie;GUO Dan-feng;KANG Ting;GAO Xiang;YUAN Jin-qiao(Hunan Academy of Chinese Medicine,Changsha 410006;Harvest(Hunan)Pharmaceuticals Co.,Ltd.,Changsha 410217)

机构地区：[1]湖南省中医药研究院,长沙410006 [2]嘉实(湖南)医药科技有限公司,长沙410217

出　　处：《中南药学》2022年第11期2520-2526,共7页Central South Pharmacy

基　　金：湖南省自然科学基金项目(No.2020JJ9018)。

摘　　要：目的研究孟鲁司特钠咀嚼片的处方工艺。方法采用单因素控制变量法逐一考察可能影响孟鲁司特钠咀嚼片溶出曲线和有关物质的因素,如原料药粒径、填充剂比例、崩解剂用量、遮光剂用量、矫味剂芳香剂用量、压片硬度等。结果优选所得处方:微晶纤维素/甘露醇1∶3、交联羧甲纤维素钠3%、红氧化铁0.30%、樱桃香精0.5%、阿司帕坦0.5%;处方所制得样品相似因子f_(2)值均大于50,溶出曲线与参比制剂基本相似,有关物质的量低于参比制剂。结论自研孟鲁司特钠咀嚼片处方合理,制备工艺可行,所制备的孟鲁司特钠片质量符合要求。Objective To determine the formulation and preparation of montelukast sodium chewable tablets.Methods The formulation and preparation of montelukast sodium chewable tablets were screened by single-factor test.Factors such as particle size,proportion of fillers,dosage of disintegrating agents,sunscreen,flavoring agents and aromatics,and hardness of the tablets were studied.The disolution profiles and impurities were tested.Results The optimized formulation was as follows:microcrystalline cellulose/mannitol 1∶3,3%croscarmellose sodium,0.30%red iron oxide,0.5%cherry flavor and 0.5%aspartame.The f_(2) was over 50.The dissolution curve was similar to the reference tablets.The related substance was less than reference tablets.Conclusion The formulation of montelukast sodium chewable tablets is reasonable,the preparation is feasible,and the quality of montelukast sodium meets the related standards.

关 键 词：孟鲁司特钠咀嚼片 溶出曲线 处方工艺筛选 相似因子 

分 类 号：R943[医药卫生—药剂学]