红花口服液的稳定性研究

Study on stability of Honghua Oral liquid

目的:考察红花口服液的稳定性。方法:利用加速试验、长期试验对红花口服液的稳定性进行考察,采用高效液相色谱法测定红花口服液中羟基红花黄色素A的含量,色谱条件:Hypersil ODS C18(250mm×4.6mm,5μm)色谱柱,流动相∶甲醇∶乙腈∶0.02%磷酸水溶液(14∶2∶84);流速:1.0m L·min-1;柱温:25℃,检测波长:402nm。结果:加速试验、长期试验稳定性良好,产品外观、p H值、吸收度及有效成分含量等项目没有显著变化,结果均符合要求。结论:红花口服液在室温条件下贮存,24个月内各项指标可符合质量标准要求。

Objective to research the stability of honghua oral liquid. Methods： Determining the effect of accelerating experiment, long-term experiment. Change trends of HSYA were determined by HPLC. The Agilent Hypersil ODS C18 column was used with gradient elution, taking methanol ∶acetonitrile ∶0.02% phosphoric acid solution（14 ∶2 ∶84） as mobile phase. The flow rate was 1.0m L·min-1.The column temperature was 25℃.The wavelength of detector was 402 nm. Results： Honghua Oral liquid was stable to accelerating experiment, long-term experiment. The Appearance,p H, absorbance and the HYSA have no notable changes. Conclusions： Honghua Oral liquid was stored at room temperature for 24 months, The test items were consistent with the satandard.