咽灵合剂的质量标准研究

Study on Quality Standard of Yanling Mixture

目的:建立咽灵合剂的质量标准。方法:采用薄层色谱(TLC)法对处方中玄参、麦冬、赤芍进行定性鉴别;采用高效液相色谱法测定制剂中丹参酮ⅡA与牛蒡苷的含量:色谱柱为Welchrom-C18(250mm×4.6mm,5μm),流动相为甲醇-水,流速为1.0ml/min,柱温为30℃,检测波长为270nm(丹参酮ⅡA)和280nm(牛蒡苷)。结果:TLC鉴别分离度好、专属性强。丹参酮ⅡA与牛蒡苷的进样量分别在0.4205～5.2560、0.1281～3.2030μg范围内与各自峰面积积分值呈良好的线性关系(r均为0.9999);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100.41%和100.83%,RSD分别为1.98%和2.44%(n均为6)。结论:所建标准可用于咽灵合剂的质量控制。

OBJECTIVE ： To establish the quality standard for Yanling mixture. METHODS ： TLC was used to identify Scrophularia ningpoensis, Ophiopogon japonicus and Paeoniae Radix Rubra; the content of tanshinone II A and arctiin were determined by HPLC： the determination was performed on Welchrom-Cjs（250 min×4.6 mm, 5 μm） column with mobile phase consisted of metha- nol-water at the flow rate of 1.0 ml/min. The column temperature was 30 ℃, and the detection wavelength was set at 270 nm for tanshinone II A and 280 nm for arctiin. RESULTS： The identification by TLC was well-separated and highly specific. The linear ranges of tanshinone II A and arctiin were 0.420 5-5.256 0 Ixg（r=0.999 9） and 0.128 1-3.203 0 μg（r=0.999 9）, respectively. RSDs of precision test, stability test and reproducibility test were all lower than 3%. The average recoveries were 100.41% （RSD= 1.98, n=6） and 100.83% （RSD=2.44% ,n=6）, respectively. CONCLUSION： The established standard can be used for the quality control of Yanling mixture.