卵巢护养膏的质量标准研究

Study on quality standard of Ovarian Care Ointment

目的研究卵巢护养膏的定性定量检测方法,建立质量标准,稳定药品质量。方法采用薄层色谱法对淫羊藿及黄柏进行定性鉴别;采用高效液相色谱法对6批卵巢护养膏样品中的淫羊藿苷进行定量分析,采用Sepax Bio-C18色谱柱;以乙腈-水为流动相(梯度洗脱);流速1.0 ml/min;柱温30℃;检测波长280 nm;进样量10μl。结果淫羊藿及黄柏薄层色谱专属性强,斑点清晰,分离度好,阴性对照无干扰,可作为定性鉴别依据。淫羊藿苷浓度在6.4~161.2μg/ml(r=0.9994,n=5)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于3.0%;平均加样回收率为100.07%;RSD为2.80%(n=6),可作为定量检测的依据。6批样品淫羊藿苷含量在1.10 mg/g以上。结论该法可操作性强、专属性高、重现性好,为卵巢护养膏的质量标准建立提供了科学依据。

Objective To study the qualitative and quantitative detection methods of Ovarian Care Ointment,establish the quality standard and stabilize the quality of drugs.Methods Thin layer chromatography(TLC)method was used for qualitative determination of Epimedii Folium and Phellodendri Chinensis Cortex.High-performance liquid chromatography(HPLC)method was used for quantitative determination of icariin in 6 batches of Ovarian Care Ointment samples.This method was employed on an Sepax Bio-C18 column with the temperature was 30℃.The mobile phase was acetonitrile-water(gradient elution)at the flow rate of 1.0 ml/min.The detection wavelength was 280 nm.The injection volume was 10μl.Results TLC has strong specificity,clear spots without negative control,which can be used as the basis for qualitative identification.The contents of icariin had good linearity within the range of 6.4-161.2μg/ml(r=0.9994,n=5),whose average recoveries was 100.07% with the RSD of 2.80%(n=6).The content of icariin in 6 batches of samples was more than 1.10 mg/g.RSD of precision,stability and repeatability tests were less than 3.0%.Conclusion The method has high operability,specificity and reproducibility,which provides a scientific basis to establish the quality standards of ovarian care ointment.