色谱指纹图谱法在参麦注射液质控中的应用

Application of Fingerprint Chromatogram in Quality Control of Shen-Mai Injection

中医药理论和实践要求综合评价中药的质量 ,色谱指纹图谱法是对中药制剂进行综合宏观分析的可行手段之一 ,因此采用反相高效液相色谱建立了参麦注射液的特征指纹图谱。色谱条件 :Hypersil C18(4 6mmi d × 2 5 0mm ,5 μm)反相色谱柱 ,流动相由水 (A)和乙腈 (B)组成 ,B的体积分数在 5 0min内由 5 %线性增长到 95 % ,流速为1 0mL/min ;紫外检测 ,波长为 2 0 2nm。 2 3个特征指纹峰与内标 (联苯 )的峰面积比作为指标 ,结合主成分分析 投影判别法比较了同一厂家不同批次产品和不同厂家同类产品的化学指纹差异。结果表明该法简便、可靠、专属性强 。

The theory and practice of traditional Chinese medicine require some comprehensive methods to assess quality of the Chinese herbal medication. Fingerprint chromatogram is one of the feasible approaches to evaluate the quality of Chinese herbal medication. So the fingerprint chromatogram of Shen Mai injection was established by using reversed phase high performance liquid chromatography. The chromatographic conditions were as follows: a Hypersil C 18 column was used; the mobile phase was composed of water (A) and acetontrile (B) with linear gradient elution (0-50min, 5%-95% B, volume fraction); the flow rate was 1 0 mL/min and the UV absorbance detection was set at 202 nm. The peak area ratios of twenty three fingerprint peaks and internal standard (diphenyl) were taken as the criteria for quality control. The quality differences in various batches and various manufacturers of Shen Mai injections were investigated by projection discriminance based on principal component analysis. The results show the method developed is convenient, reliable and applicable for the quality control analysis of Shen Mai injection.