Study on quality standard of compound Heishen granules
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摘要: 目的 建立复方黑参颗粒的质量标准。 方法 采用TLC法对复方黑参颗粒中玄参和射干进行定性鉴别，应用HPLC法同时测定肉桂酸、射干苷和次野鸢尾黄素的含量，色谱柱为Kromasil C18柱（150 mm×4.6 mm，5 μm），流动相为乙腈（A）-0.1%磷酸（B）水溶液，进行梯度洗脱；柱温30℃，检测波长270 nm；流速1.0 ml/min。 结果 采用TLC法对玄参和射干进行定性鉴别具有良好的专属性，阴性对照无干扰。肉桂酸、射干苷、次野鸢尾黄素分别在16.22~113.57 μg/ml（r=0.999 8）、48.19~337.34 μg/ml（r=0.999 8）、16.40~114.80 μg/ml（r=0.999 9）范围内与峰面积呈良好的线性关系，平均加样回收率分别为99.23%、98.82%、99.17%。 结论 本实验建立的方法快速、简便、重复性好，可用于复方黑参颗粒的质量标准控制。Abstract: Objective To establish a quality standard for compound Heishen granules. Methods Scrophulariae Radix and Belamcandae Rhizoma were identified by TLC.HPLC was used to determine the content of cinnamic acid,tectoridin and irisflorentin.The HPLC was performed on a column of Kromasil-C18(150 mm×4.6 mm,5 μm)with a mobile phase of acetonitrile(A)-0.1% hydrochloric acid(B)at a temperature 30℃. The detection wavelength was set at 270 nm and the flow rate at 1 ml/min. Results The TLC method had good specificity without interference from negative control.The calibration curve showed a good linear relationship within the range of 16.22-113.57 μg/ml for cinnamic acid(r=0.999 8),48.19-337.34 μg/ml for tectoridin(r=0.999 8)and 16.40-114.80 μg/ml for irisflorentin(r=0.999 9). The average recoveries were 99.23%,98.82%,99.17%. Conclusion The established method is rapid,accurate and reproducible. It can be used in the quality control of compound Heishen granules.
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Key words:
- compound Heishen granules /
- cinnamic acid /
- tectoridin /
- irisflorentin /
- HPLC /
- TLC
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