小儿咳喘灵颗粒质量标准的研究

Study On Quality Standard of Xiao'erkechuanling Granules

目的:制定小儿咳喘灵颗粒的质量标准。方法:采用薄层色谱法对金银花、苦杏仁、板蓝根、甘草进行定性鉴别;采用高效液相色谱法测定麻黄中盐酸麻黄碱的含量。色谱条件为:phenomenex C18柱(4.6mm×250mm,5μm),流动相为甲醇-水(50∶50),流速1.0mL.min-1,检测波长254nm。结果:所采用的薄层色谱鉴别方法专属性强,阴性对照无干扰;盐酸麻黄碱在1.6μg^200μg范围内呈良好的线性关系(r=0.9999),平均回收率100.22%,RSD为2.90%。结论:所建立的方法简便、准确,专属性、重现性好,可作为该制剂的质量标准来全面控制、评价其内在质量。

Objective ：To establish the quality standard of Xiao＇ erkechuanling Granules. Method ：The Lonicerae japonicae, Semen Armeniacae Amarum, Radix Isatidis, Radix Et Rhizoma Glycyrrhizae were identified by TLC, and the content of ephedrine hydrochloride in Hebar ephedrae were determined by HPLC. The phenomenex C18 column（4.6 mm ×250 mm, 5 μm） was used with the methanol-water（50： 50） as mobile phase, the flow rate was 1.0 mL · min^-1 ,and the detective wavelength was 254 nm. Result：The method of TLC was specific, and the negative control was not be disturbed; The linear range of ephedrine hydrochloride were at 1.6 -200 mg · L^-1 （r =0. 999 9）. The average recovery was 100. 22% and RSD was 2.90%. Conclusion：The method is simple, accurate , specific and with good reproducibility. It can be used for the quality standard of Xiao＇ erkechuanling Granules to control and evaluate its internal quality roundly.