炎宁颗粒质量标准提高研究

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RPHPLC法对制剂中的槲皮素和木犀草素进行含量测定。色谱柱:AgilentHCC18(250mm×4.6mm,5μm);流动相:甲醇∶0.4%磷酸水溶液(48∶52);检测波长:350nm。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。

Studies on Elevating Quality Standard of Yanning Granule

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.