哮喘口服溶液的质量标准研究

目的:建立哮喘口服溶液的质量标准。方法:采用高效液相色谱法分别测定制备哮喘口服溶液中3主药的含量。结果:所制制剂为棕色液体,鉴别、检查项均符合2005年版《中国药典》中的相关规定;愈创木酚甘油醚、盐酸麻黄碱、氨茶碱(以茶碱计)检测浓度的线性范围分别为7～13(r=0.999 9)、4.55～8.45(r=0.999 8)、10.64～19.76μg·mL-1(r=0.999 9),平均回收率分别为99.35%(RSD=0.97%)、100.40%(RSD=1.02%)、100.57%(RSD=1.08%)。结论:所建立的标准可用于该制剂的质量控制。

Quality Standard of Xiaochuan Oral Solution

OBJECTIVE： To establish xiaochuan oral oral solution quality control method. METHODS： Three kinds of main components＇ contents in xiaochuan oral solution were determined by HPLC. RESULTS： The prepared oral solution was brown liquid, with identification and tests all up to the standards specified in Chinese Pharmacopeia （2005 edition）. The linear ranges of guaifenesin, ephedrine hydrochloride, and aminophylline （theophylline） were 7- 13μg · mL^-1（r = 0.999 9）, 4.55- 8.45 μg · mL^ -1（r = 0.999 8 ）, and 10.64- 19.76 μg · mL^-1（r = 0.999 9）, respectively, with the average recoveries at 99.35% （RSD = 0.97% ）, 100.40% （RSD = 1.02% ）, and 100.57% （RSD = 1.08% ）, respectively. CONCLUSION： The established quality control method could be used for quality control of it.