复方甲硫酸新斯的明眼用原位凝胶的质量控制  

Quality Control of Compound Neostigmine Methylsulfate in situ Ophthalmic Gel

作　　者：夏苗芬[1] 李士敏[2] 

机构地区：[1]浙江医药高等专科学校,浙江宁波315100 [2]浙江大学分析测试中心,浙江杭州310058

出　　处：《中国医药工业杂志》2014年第7期652-654,共3页Chinese Journal of Pharmaceuticals

基　　金：浙江省优秀青年教师资助计划项目(编号2009-266);浙江省高职院校专业带头人专业领军项目(lj2013011)

摘　　要：复方新斯的明眼用凝胶是由甲硫酸新斯的明（1）、牛磺酸（2）、马来酸氯苯那敏（3）和维生素B6（4）等组成的复方制剂，主要用于治疗儿童及青少年视疲劳等症。该组方可消除眼部疲劳、降低眼压、缓解和消除眼部的调节紧张，The compound neostigmine methylsulfate in situ ophthalmic gel containing neostigmine methylsulfate, taurine, chlorphenamine maleate and vitamin B6 was prepared with poloxamer P407 and P188 as matrices. The product was clear and transparent solution with suitable gelation temperature an pH value, which was in accordance with the general requirements of ophthalmic preparations and gels in China pharmacopeia. The contents of the four ingredients and related substances in the product were determined by HPLC. The results of eye irritation in rabbits showed that the product had no significant irritation.

关 键 词：甲硫酸新斯的明 复方制剂 质量控制 凝胶 马来酸氯苯那敏 原位 视疲劳 牛磺酸 

分 类 号：R944[医药卫生—药剂学]