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目的:建立咳喘宁颗粒的质量标准。方法:采用TLC法对制剂中百部、麻黄、苦杏仁进行定性鉴别;采用HPLC-DAD法对制剂中盐酸麻黄碱、盐酸伪麻黄碱、苦杏仁苷进行定量分析。色谱柱:Tech Mate C18-ST(250 mm×4.6 mm,5μm),流动相:甲醇(A)-0.1%磷酸(B),梯度洗脱,流速:1.0 ml·min~(-1),检测波长:207 nm,柱温:35℃。结果:TLC法专属性强,阴性无干扰;盐酸麻黄碱、盐酸伪麻黄碱和苦杏仁苷分别在1.826~182.600μg·ml~(-1)(r=0.999 7)、1.848~184.815μg·ml~(-1)(r=0.999 7)、2.981~298.069μg·ml~(-1)(r=0.999 6)浓度范围内线性关系良好;回收率分别为97.00%、97.40%、98.30%(RSD分别为3.7%,2.5%,1.6%)(n=9)。结论:该法科学、准确、简便、重复性好,可用于咳喘宁颗粒质量控制。
Objective: To establish the quality standard of Kechuanning granules. Methods: TLC, HPLC and DAD were used to qualitatively identify Baihuapu, Ephedra and Amygdalin. Quantitative analysis of ephedrine hydrochloride, pseudoephedrine hydrochloride and amygdalin was carried out by HPLC-DAD. Column: Tech Mate C18-ST (250 mm × 4.6 mm, 5 μm), mobile phase: methanol (A) Wavelength: 207 nm, column temperature: 35 ° C. Results: TLC method was of high specificity and negative without interference; ephedrine hydrochloride, pseudoephedrine hydrochloride and amygdalin were respectively in the range of 1.826-182.600 μg · ml -1 (r = 0.999 7), 1.848-184.815 μg · ml -1 (R = 0.999 7), 2.981 ~ 298.069μg · ml -1 (r = 0.999 6), the recoveries were 97.00%, 97.40% and 98.30%, respectively 3.7%, 2.5%, 1.6%) (n = 9). Conclusion: The method is scientific, accurate, simple and reproducible. It can be used to control the particle quality of Kechuanning.