益肾安神口服液特征图谱研究

目的建立益肾安神口服液的特征图谱检查方法,整体评价益肾安神口服液质量。方法采用Kromasil100-5 C18色谱柱(4.6 mm×250 mm,5μm);以乙腈为流动相A,以水为流动相B,梯度洗脱;流速1.0 mL/min;检测波长210 nm。采用中药指纹图谱计算软件进行计算,建立其特征图谱,进行特征峰归属,并在此基础上考察益肾安神口服液批次间相似性。结果益肾安神口服液特征图谱有10个共有峰,其精密度、重复性、稳定性试验中各共有峰的相对保留时间的RSD均小于0.5%。10批样品的图谱相似度较好,相似度达0.85以上。在已建立特征图谱基础上,对10个特征峰进行峰归属。结论方法重复性较好,操作简单、准确易行,为进一步控制益肾安神口服液质量提供依据及方法。

Study on the characteristic spectrum of Yishen Anshen oral liquid

Objective To establish a method of characteristic atlas for Yishen Anshen oral liquid,and to evaluate the quality of oral liquid entirely. Methods Kromasil 100-5 C18 chromatographic column was used (4.6 mm×250 mm, 5 μm); acetonitrile was used as mobile phase A, and water was used as mobile phase B, gradient elution. The flow rate was 1.0 mL/min and the detected wavelength was 210 nm. The traditional Chinese medicine fingerprint calculation software was used to calculate, establish the characteristic atlas, and classify the characteristic peaks, and on this basis,investigate the similarity between the batches of Yishen Anshen oral liquid.Results There were 10 common peaks in the characteristic spectrum of Yishen Anshen oral liquid.The relative retention time of the common peaks in the precision, repeatability and stability tests were all less than 0.5% RSD. The similarity of the 10 batches of samples was good, and the similarity was over 0.85. On the basis of the established characteristic map, the peaks of 10 characteristic peaks are assigned. Conclusion The method is simple, accurate and easy to operate, and provides the basis and method for further controlling the quality of Yishen Anshen oral liquid.