蛤蚧定喘丸含量测定方法的改进  

Discussion on the Assay Method of Gejie Dingchuan Pills in Chinese Pharmacopoeia 2010 Edition

作　　者：张伟[1] 陈娟[1] 顾利红[1] 

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药品标准》2013年第1期40-42,共3页Drug Standards of China

摘　　要：目的:改进《中国药典》2010年版蛤蚧定喘丸的含量测定方法。方法:采用高效液相色谱法同时测定盐酸麻黄碱和盐酸伪麻黄碱的含量,色谱柱为Waters SunFire C18柱(4.6 mm×150 mm,5μm),流动相为乙腈-0.1%磷酸(4∶96),流量1.0 mL.min-1,检测波长207 nm,柱温25℃。结果:盐酸麻黄碱在0.025 1～0.502μg,盐酸伪麻黄碱在0.025 03～0.500 6μg范围内浓度与峰面积呈良好的线性关系(r=0.999 9),二者平均回收率(n=6)分别为100.3%(RSD=0.75%)、100.9%(RSD=0.79%)。结论:该方法简便、准确,重现性好,可同时测定盐酸麻黄碱和盐酸伪麻黄碱的含量,改进了2010年版《中国药典》该药品的质量控制方法。Objective： To improve the assay method of Gejie Dingchuan Pills in Chinese Pharmacopeia 2010 edition. Methods： RP- HPLC was used to the determination of ephedrine hydrochloride and pseudoephedrine hydroehloride in Gejie Dingehuan Pills simultaneously. The waters SunFire Clscolumn（4. 6 mm × 150 mm, 5 μm）was used and maintained at 25 ℃with the mobile phase consisting of acetonitrile -0. 1% phosphoric acid solution （4： 96）. The flow rate was 1.0 mL · min- 1 and the UV detection wavelength was 207 nm. Results ： The linear ranges of ephedrine hydroehloride and pseudoephedrine hydrochloride were good in the range of 0. 025 1-0. 502 μg and 0. 025 03-0. 500 6 μg respectively （ r = 0. 999 9）. Their recoveries were 100. 3% （ RSD = 0. 75% ） and 100. 9% （ RSD = 0. 79% ） respectively. Conclusion： The improved method was simple, accurate and reproducible, and can be used for the quality control of Gejie Dingchuan Pills.

关 键 词：蛤蚧定喘丸 高效液相色谱法 含量测定 中国药典 

分 类 号：R921.2[医药卫生—药学]