曲尼司特滴鼻液的制备及其质量控制  

Preparation and Quality Control of Tranilast Nasal Drops

作　　者：金伟华[1] 刘永胜[1] 谭永红[1] 陈华[1] 邱维[2] 

机构地区：[1]成都军区总医院药剂科,成都610083 [2]泸州医学院药学系,四川泸州646000

出　　处：《中国药房》2013年第13期1205-1207,共3页China Pharmacy

摘　　要：目的:制备曲尼司特滴鼻液,并对其进行质量控制。方法:以水为溶媒、葡甲胺为助溶剂进行制备;采用高效液相色谱法测定其中曲尼司特的含量;并进行制剂的稳定性试验。结果:所制备的曲尼司特滴鼻液的物理、化学性质稳定。曲尼司特检测质量浓度在5～40mg/L范围内与峰面积积分值线性关系良好(r=0.9999,n=5),平均回收率为98.53%,RSD=1.69%(n=6)。本品在6个月内稳定性较好,有效期可暂定为6个月。结论:该制剂配方合理,制备工艺简单,稳定性良好,质量控制方法简便、准确。OBJECTIVE：To prepare Tranilast nasal drops,and to control the quality.METHODS：Water was used as menstruum,and meglumine was used as cosolvent to prepare Tranilast nasal drops;the contents of tranilast were determined by HPLC;and the stability of Tranilast nasal drops was investigated.RESULTS：The physico-chemical property of Tranilast nasal drops was stable.The linear ranges of tranilast were 5-40 mg/L（r=0.999 9,n=5）with an average recovery of 98.53%（RSD=1.69%,n= 6）.The nasal drops were stable within 6 months,and period of validity should be 6 months tentatively.CONCLUSIONS：The preparation is rational in formula,simple in preparation,good in stability,simple and accurate in quality control.

关 键 词：曲尼司特 滴鼻液 制备 质量控制 高效液相色谱法 稳定性 

分 类 号：R944.9[医药卫生—药剂学]