炎宁颗粒质量标准提高研究

Studies on Elevating Quality Standard of Yanning Granule

目的：提高炎宁颗粒的质量标准。方法：采用TLC法对制剂中的白花蛇舌草进行定性鉴别;用RP-HPLC法对制剂中的槲皮素和木犀草素进行含量测定。色谱柱：Agilent HC C18（250 mm×4.6 mm,5μm）;流动相：甲醇∶0.4%磷酸水溶液（48∶52）;检测波长：350 nm。结果：TLC法能对白花蛇舌草进行专属性定性分析;槲皮素和木犀草素分别在0.141~0.705μg（r=0.9994）和0.101~0.505μg（r=0.9995）范围内线性关系良好,槲皮素和木犀草素的加样回收率分别是98.51%（RSD为1.82%）和98.30%（RSD为1.40%）。结论：本文所建立的质量控制方法可准确地进行定性和定量检测,方法可靠,重复性好,对进一步完善炎宁颗粒的内在质量控制标准具有重要的参考价值。

Objective：To elevate the method for quality control of Yanning Granule. Methods： TLC was used to identify Herba Hedyotis. The content of quereetin and luteolin in the preparation was determined by RP-HPLC. The samples were separated by Agilent HC Cl8 （250 mm × 4.6 mm,5 μ m ）, and the mobile phase was methanol - 0.4% phosphoric acid water（ 48 ： 52 ）with the flow rate of 0.8 mL ＂ rain-I and the detection wavelength was set at 350 nm. The column temperature was maintained at 30 ℃ . Results ： Herba Hedyotis diffusa could be identified by TLC. The calibration curves were linear in the range of 0.141-0.705 μg for quercetin （ r=0.9994 ） and 0.101-0.505 μg luteolin （ r=0.9995 ）, respectively. The average recoveries of compound quereetin was 98.51% and 98.30%, respectively. Conclusion ： The method is accurate with high sensitivity and is of great value to control the quality of Yanning granule.