系统指纹定量法评价益脑宁片的整体质量和化学指纹归属度及药效物质工艺收率

目的建立益脑宁片（YNNT）HPLC指纹图谱并测定其化学指纹归属度和药效物质工艺收率。方法采用反相高效液相色谱法,以系统指纹定量法的Sm和Pm等参数对自制样品、市售YNNT及其各单味药指纹进行定性定量分析。结果以丹参素峰为参照物峰,确定45个共有指纹峰,以5批制剂按平均值法生成对照指纹图谱（RFP）;就紫外吸收成分来说,该法评价出S14丹参为YNNT的君药,S15赤芍和S5党参为臣药;评价出5批市售YNNT药效物质工艺收率约为50%。结论系统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。

Overall quality,HPLC fingerprint attribution ratio,and process recovery of medicinal effective components of Yinaoning tablets by systematic quantified fingerprint

Objective To assess the quality of Yinaoning tablets (YNNT) through establishing the HPLC fingerprints and studying the fingerprint attribution ratio and process recovery of medicinal effective components.Methods The fingerprints of self-made samples, YNNT and each crude drug were analyzed by macro qualitative similarity(Sm) and macro quantitative similarity(Pm),and other parameters of the systematic quantified fingerprint method based on RP-HPLC.Results A total of 45 co-possessing peaks were selected as the fingerprint peaks while taking tanshinol peak as the reference peak and the referential fingerprint (RFP) of 5 batches of YNNTs was established by the mean model. In terms of components absorbing ultraviolet light, S14(Radix Salviae Miltiorrhizae ) was found to be the monarch drug,while S15 (Radix Paeoniae Rubar) and S5 (Radix Codonopsis) were minister drugs.The process recovery of the medicinal effective components for the 5 batches of marketed preparations was about 50%.Conclusion Systematic quantified fingerprint method can objectively and accurately reflect the contribution of single crude drug to the compound, and quantitatively evaluate the process recovery of medicinal effective components.