红花注射液质量控制研究

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,Agilent SB C₁₈色谱柱(5 μm,4.6 mm×250 mm),含量测定以甲醇-乙腈-0.1%磷酸(24∶ 2∶ 74)为流动相,流速1 mL·min^-1,检测波长403 nm,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(0~20 min,100%A→98%A;20~60 min,98%A→80%A),流速1 mL·min^-1,检测波长270 nm。 结果: 羟基红花黄色素A进样量在0.39~4.91 μg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.