摘要
目的建立人参归脾丸(Renshen Guipi Wan,RSGPW)HPLC数字化指纹图谱,为其整体质量控制提供评价方法。方法采用Centurysil C18BDS柱(200mm×4.6mm,5μm),以0.1%磷酸溶液(A)-0.1%磷酸乙腈溶液(B)为流动相,梯度洗脱:0～80min,10%～90%B,;80～90min,90%B,流速1.0mL.min-1,检测波长203nm,柱温(35.0±0.15)℃,进样量5μL。用"中药色谱指纹图谱超信息特征数字化评价系统3.0"软件对RSGPW进行数字化评价,并对制剂化学指纹成分归属。结果用16个数字化指数鉴别出2批样品不合格;用系统指纹定量法鉴别出3批样品质量极好,2批样品质量很好,5批样品质量好,2批质量劣;从化学指纹贡献率来说白术为该复方主要药味。结论所建立的RSGPW-HPLC数字化指纹图谱能反映RSGPW质量变化,用数字化指纹图谱控制RSGPW质量可行。
Objective To develop a digitized HPLC fingerprint to control the overall quality of Renshen Guipi Wan（RSGPW）.Methods Chromatographic fingerprints（CFPs） were obtained on a Centurysil C18 BDS column（200 mm×4.6 mm,5 μm） with the gradient elution program（0-80 min,10%-90% B;80-90 min,90%B） consisting of 0.1% phosphoric acid solution（A） and 0.1% phosphoric acid-acetonitrile solution（B） under 203 nm.The flow rate was 1.0 mL·min-1 and the column temperature was（35.0±0.15）℃.The software of digitized evaluation system for super-information characteristics of traditional Chinese medicine fingerprint was used to evaluate the CFPs and disclose the results of attribution ratio in RSGPW.Results The CFPs were completely established,in which 2 batches of RSGPW were unqualified by the 16 digital indice.Identification by systematic quantified fingerprint method indicated that the quality of 3 batches was the best,that of 2 batches was better,5 batches was good while 2 batches was inferior.Atractylodis Macrocephalae Rhizoma was the most important crude drug in RSGPW.Conclusion RSGPW digitized HPLC fingerprints can reflect the variation of RSGPW quality and can control the quality of RSGPW.
出处
《中南药学》
CAS
2011年第10期784-789,共6页
Central South Pharmacy
基金
国家自然科学基金重大研究计划课题(No.90612002)
关键词
人参归脾丸
超信息特征
高效液相色谱数字化指纹图谱
系统指纹定量法
Renshen Guipi Wan
super information characteristics
digitized HPLC fingerprint
systematic quantified fingerprint method
