摘要
目的建立冠心苏合丸(Guanxin Suhe pill-GXSHP)数字化定量指纹图谱,从数字化和整体角度对冠心苏合丸进行质量控制。方法采用RP-HPLC法,以Agilent Poroshell 120 SB C18色谱柱(4.6 mm×150 mm,2.7μm)和0.2%醋酸溶液-0.2%醋酸甲醇溶液为流动相,线性梯度洗脱,流速为0.5 mL·min-1,柱温(25±0.15)℃,紫外检测波长275 nm,进样量10μL。应用46个数字化参数定量揭示GXSHP-HPLC指纹谱特征,从每个指纹的整体角度定量鉴定12批次GXSHP质量。结果以桂皮酸和苯甲酸为双参照物峰,确定36个共有指纹峰,建立了GXSHP-HPLC数字化定量指纹图谱。用系统指纹定量法鉴定12批GXSHP中质量极好1批,质量很好2批,4批质量好,质量良好、中、一般、差、劣的各1批。结论所建立GXSHP-HPLC数字化定量指纹图谱可有效反映各批次GXSHP质量差异。
Objective To establish an HPLC digitized quantified fingerprints（FP） to entirely evaluate and control the quality of Guanxin Suhe pill-GXSHP（GXSHPs）.Methods High performance liquid chromatography was used to develop the digitized quantified fingerprints and Agilent Poroshell 120 SB C18（4.6 mm×150 mm,2.7 μm） used as the separation column,0.2% mol·L-1 ethylic acid-water and 0.2% mol·L-1 ethylic acid-methanol as the mobile phase that were eluted with linear program.The flow rate was 0.5 mL·min-1,the UV absorbance was monitored at 275 nm by injecting 10 μL of the sample solution each time and the column temperature was maintained at（25±0.15） ℃.The GXSHP-HPLC fingerprints were assessed by 46 digitized parameters and entirely quantified all fingerprint method was performed to identify the quality.Results The digitized high performance liquid chromatography fingerprints were established with 36 co-possessing peaks while choosing benzoic acid（BC） peak and cinnamic acid（CA） as the referential peaks.The GXSHP-HPLC-FPs were evaluated by 46 digitized parameters,in which the quality of 12 batches of GXSHPs were assessed by systematically quantified fingerprint method（SQFM）.The quality of 1 batch was best,2 batches were better,4 batches were good,and the others were all lower than good.Conclusion The developed quantitized digital HPLC fingerprint can effectively and quantitatively reflect the differences among each batch of GXSHPs.
出处
《中南药学》
CAS
2013年第1期40-44,共5页
Central South Pharmacy
基金
国家基础科学人才培养基金资助(No.J1103606)
国家自然科学基金重大研究计划课题(No.90612002)
关键词
冠心苏合丸
高效液相色谱数字化定量指纹图谱
系统指纹定量法
Guanxin Suhe pill
digitized and quantified HPLC fingerprint
super information characteristics
systematically quantified fingerprint method
