红花注射液质量控制研究

Study on quality control of Honghua injection

目的:建立红花注射液中羟基红花黄色素A的含量测定和特征图谱检测方法。方法:采用HPLC方法,AgilentSBC18色谱柱(5μm,4.6mm×250mm),含量测定以甲醇-乙腈-0.1%磷酸(24∶2∶74)为流动相,流速1mL.min-1,检测波长403nm,柱温30℃;特征图谱检测以1%醋酸溶液(A)-乙腈(B)为流动相,梯度洗脱(0～20min,100%A→98%A;20～60min,98%A→80%A),流速1mL.min-1,检测波长270nm。结果:羟基红花黄色素A进样量在0.39～4.91μg范围内线性良好,r=0.9999;平均回收率(n=9)为103.2%;特征图谱能较全面地反映产品质量。结论:各企业的红花注射液的羟基红花黄色素A含量和特征图谱相似度均存在较大差异。

Objective：To establish a method for determination of hydroxysafflor yellow A and characteristic chromatography of Honghua injection.Methods：The HPLC method was adopted.Analytical column was Agilent SB C18（5 μm,4.6 mm×250 mm） column.For determination of hydroxysafflor yellow A,the mobile phase was composed of methanol,acetonitrile and 0.1% phosphoric acid aqueous solution（24：2：74） at a flow rate of 1 mL·min-1,the UV detection was set at 403 nm and the column temperature was maintained at 30 ℃;For specific chromatogram,the mobile phase was composed of 0.1% acetic acid aqueous solution（A） and acetonitrile（B） with gradient elution（0-20 min,100%A→98%A;20-60 min,98%A→80%A） at a flow rate of 1 mL·min-1,the UV detection was set at 270 nm. Results：The linear ranges of hydroxysafflor yellow A was 0.39-4.91 μg（r=0.9999） and the average recovery（n=9） was 103.2%;the characteristic chromatography could reflect the quality of the injection in an all-around way.Conclusion：The content of hydroxysafflor yellow A and similarity of specific chromatogram of Honghua injections from different manufactures are significantly different.