鼻炎灵滴鼻液的制备及质量控制  

Preparation and Quality Control of Biyanling Nasal Drops

作　　者：李芳[1] 陈克金[1] 何家田[2] 

机构地区：[1]兰州大学第二医院,兰州市730030 [2]兰州军区联勤部药品仪器检验所,兰州市730050

出　　处：《中国药房》2009年第7期530-531,共2页China Pharmacy

摘　　要：目的:制备鼻炎灵滴鼻液并建立其质量控制方法。方法:以盐酸麻黄碱、马来酸氯苯那敏等为主药制备滴鼻液;采用高效液相色谱法同时测定2种主药的含量。结果:所制制剂为黄色乳浊液,鉴别、检查均符合2005年版《中国药典》中的相关规定。盐酸麻黄碱、马来酸氯苯那敏检测浓度的线性范围分别为0.210～2.096mg·mL-1(r=0.999 8)、79.6～796.0μg·mL-1(r=0.999 9),平均回收率分别为98.83%(RSD=1.45%)、99.19%(RSD=1.37%)。结论:本制剂制备工艺简便可行,质量稳定可控。OBJECTIVE： To prepare Biyanling nasal drops and establish a method for its quality control. METHODS： Biyanling nasal drops was prepared with ephedrine hydrochloride and chlorpheniramine maleate etc, and an HPLC method was established for the determination of chlorpheniramine maleate and ephedrine hydrochloride in Biyanling nasal drops. RESULTS： The Biyanling nasal drops were yellow emulsion and in line with the related standard specified in Chinese Pharmacopeia （2005 Edition） in identification and tests. The linear ranges of ephedrine hydrochloride and chlorpheniramine maleate were 0.210--2.096（r =0.999 8）μg·mL^-1and 79.6--796.0（r 0.999 9）μg·mL^-1, respectively, and the average recoveries of ephedrine hydrochloride and chlorpheniramine maleate were 98.83% （RSD = 1.45% ） and 99.19% （RSD = 1.37% ）, respectively. CONCLUSION： The preparation of nasal drops is feasible in technique, stable and controllable in quality.

关 键 词：鼻炎灵滴鼻液 制备 质量控制 

分 类 号：R927.2[医药卫生—药学] R987