指纹定量法评估射干抗病毒注射液指纹归属度和药效物质工艺收率

Evaluation of fingerprint attribution ratio and process recovery of medicinally effective components for Shegankangbingdu injection by quantified fingerprint method

目的应用指纹定量法建立评估射干抗病毒注射液(SGKBDI)化学指纹成分归属度和药效物质工艺收率的有效控制方法。方法采用反相高效液相色谱法,以水(含1%醋酸)-乙腈(含1%醋酸)为流动相,线性梯度洗脱,以紫外波长265 nm检测市售SGKBDI、单味药材及自制模拟样、自制SGKBDI指纹图谱。用归属度pi、宏定性相似度Sm、拟合定性相似度Ssyn、宏定量相似度Pm等指标进行评价,解决SGKBDI化学指纹归属的定量问题和测定其药效物质工艺收率。结果以S10自制模拟样为参照,评价出S11射干对SGKBDI化学成分贡献最大,为其君药,臣药是S12金银花、S14茵陈和S18大青叶。用宏定性相似度及宏定量相似度,评价出9批市售SGKBDI药效物质工艺收率均很低。结论指纹定量法能够客观、准确地定量描述单味药对复方制剂化学指纹的贡献大小和定量评价中药复方药效物质的工艺收率,是射干抗病毒注射液指纹归属定量控制以及工艺优化的可行方法。

Objective To set up an effective method to evaluate the fingerprint attribution ratio and process recovery of medicinally effective components for Shegankangbingdu injection （SGKBDI） by quantified fingerprint method. Methods The chromatographic fingerprints of SGKBDI, each crude drug, simulated samples and self-prepared SGKBDIs were obtained with the gradient elution solvent system consisting of 1% acetic acid solution and acetonitrile containing 1% acetic acid, and the detection wavelength was 265 nm. The fingerprints were evaluated by attribution ratio Pi, macro qualitative similarity Sm, fitting similarity Ssyn, macro quantitative similarity Pm, and other indexes to disclose the results of attribution ratio and determine the process recovery of the medicinally effective components for SGKBDI. Resuits Taking the self-made sample （S10） as referential model, Sll （Rhizoma belamcandae） was found to be the monarch drug in the compound; S12 （Flos lonicerae japonicae）, S14 （Herba artemisiae scopariae）, and S18 （Folium isatidis） were minister drugs. The values of macro qualitative similarity and macro quantitative similarity showed lower process recovery of the medicinally effective components for 9 batches of market SGKBDIs. Conclusion Quantified fingerprint method can objectively and accurately reflect the contribution of single crude drug to the compound, and quantitatively evaluate the process recovery of medicinally effective components. It is feasible to quantitatively control the attribution ratio of chemical fingerprints and to optimize the technology of SGKBDI.