咳喘宁颗粒质量标准的建立

Establishment of Quality Standard for Kechuanning Granules

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 for Kechuanning granules. Methods： A TLC method was used for the qualitative study on the main ingredients, Radix stemonae,ephedra and bitter almond. An HPLC method was used to determine the con- tents of ephedrine hydrochloride,pseudoephedrine hydrochloride and amygdalin. The separation of targeted compounds was performed on a Tech Mate C18-ST column （250 mm ×4.6mm,5μm） . The mobile phase consisted of methanol（A） and 0.1% phosphoric acid （B） with gradient elution at a flow rate of 1.0 ml min-1. The detection wavelength was 207nm and the column temperature was 35℃. Results： The spots in TLC were quite clear without any interference from negative control. The linear relationship of ephedrine hydrochloride, pseudoephedrine hydrochloride and amygdalin was 1. 826-182.600 μg ml - 1 （ r = 0.999 7 ）, 1. 848 - 184.815 μg ml - 1 （ r = 0.999 7） and 2.981-298. 069 μg ml - 1 （ r = 0.999 6）, respectively. The average recovery was 97.00% ,97.40% and 98.30% （RSD = 3.7% ,2.5%, 1.6% ） （ n = 9 ）, respectively. Conclusion： The method is sensitive, accurate, simple and reproducible, which can be used for the quality control of Kechuanning granules.