抗内异合剂质量标准研究

目的：建立抗内异合剂的质量控制方法。方法采用薄层色谱法对抗内异合剂中的莪术、三棱进行定性鉴别，采用高效液相色谱法测定制剂中丹参素的含量。色谱柱为Waters SymmetryC18（4．6mm ＆#215;250mm，5μm），流动相为甲醇∶水∶冰醋酸＝20∶80∶0．5，流速为1．0mL· min －1，检测波长为281nm。结果薄层色谱鉴别方法专属性强。丹参素在0．322～1．932μg范围内线性关系良好，r＝0．9996。丹参素加样回收率为97．18％，RSD为0．94％（n＝6）。结论该方法可行，结果准确，重复性好，可有效控制抗内异合剂的质量。

Studies on QuaIity Standard of Anti Endometriosis Mixtures

OBJECTIVE To establish the quality standard of Anti endometriosis Mixture .METHODS Curcu-ma,Spargan were identified by thin-layer chromatography （ TLC）.HPLC method was established for the determina-tion of danshensu performed on Symmetry C 18 column （4.6mm ＆#215;250mm,5μm） with methanol-water-acetic acid （20∶80∶0.5） as the mobile phase at the flow rate of 1.0mL· min -1 ,column temperature at 30℃,and detection wave-length was 281nm.RESULTS The TLC method has high specificity .Within the range of 0.322~1.932μg,dansh-ensu presented a fine linear relationship ,r=0.9996.The recovery of danshensu was 97.18% with RSD 0.94%（ n=6 ） respectively.CONCLUSION The methods are reliable ,accurate ,reproducible ,and can be used for the quali-ty control of Anti endometriosis Mixtures .