摘要
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.
作者
符海郯
汪慧
余平
姚里程
刘亚丽
Fu Haitan Wang Hui Yu Ping Yao Lieheng Liu Yali(Wuhan Institute for Drug and Medical Device Control, Wuhan 430075, China Hubei University of Chinese Medicine)
出处
《中国药师》
CAS
2017年第3期573-576,共4页
China Pharmacist