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目的:探讨气管炎合剂的质量控制方法。方法:采用薄层色谱法对气管炎合剂中麻黄、川贝母进行定性鉴别。采用高效液相色谱法测定气管炎合剂中盐酸麻黄碱和盐酸伪麻黄碱的含量:色谱柱为Diamonsil C18(150mm×4.6 mm,5μm),流动相为甲醇-0.2mol/L磷酸二氢钠(0.3%三乙胺,磷酸调pH值2.5)(6∶94,V/V),流速1.0 mL/min,检测波长是210 nm。柱温为25℃,检测波长为210 nm。结果:麻黄、川贝母的TLC鉴别具有较好的专属性,阴性对照无干扰。盐酸麻黄碱和盐酸伪麻黄碱的进样量分别在0.229 0~0.687 6μg、0.2544~0.7632μg范围内与各自峰面积积分值呈良好的线性关系(r均为0.999 9);二者精密度、稳定性、重复性试验的RSD均<3%;平均加样回收率分别为102.22%和101.55%,RSD分别为2.63%和1.50%(n=6)。结论:所建标准可用于气管炎合剂的质量控制。
Objective: To explore the quality control method of TCHG. Methods: Thin layer chromatography was used for the qualitative identification of Ephedra and Fritillaria in bronchitis mixture. The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in TCH were determined by HPLC: Diamonsil C18 column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase, and the mobile phase was methanol-0.2 mol / L sodium dihydrogen phosphate (0.3% Triethylamine and phosphoric acid were adjusted to pH 2.5) (6:94, V / V) at a flow rate of 1.0 mL / min. The detection wavelength was 210 nm. The column temperature was 25 ℃ and the detection wavelength was 210 nm. Results: TLC identification of Ephedra, Fritillaria cirrhosa had better specificity, negative control without interference. The injection volume of ephedrine hydrochloride and pseudoephedrine hydrochloride showed a good linear relationship with the integral value of their peak areas (r 0.999 9) in the range of 0.229 0-0.6687 6μg and 0.2544-0.7632μg, respectively; both the precision and the stability , RSD of repeatability test were all less than 3%. The average recoveries were 102.22% and 101.55%, respectively, with RSDs of 2.63% and 1.50%, respectively (n = 6). Conclusion: The established standard can be used for the quality control of bronchitis mixture.