摘要
目的应用指纹定量法鉴定龙胆泻肝丸化学指纹归属度和药效物质差异归因。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265 nm检测波长检测LDXGP(模拟样和市售品)、单味药HPLC指纹图谱。用归属度pi、逸出度qi、宏定性相似度Sm和宏定量相似度Pm等指标鉴定LDXGP化学指纹归属度和测定药效物质工艺收率。结果以S1模拟样为参照,鉴定出S3黄芩对LDXGP化学指纹贡献最大,其次是S2龙胆。用系统指纹定量法鉴定12批市售LDXGP大部分质量较差,用Sm相对误差分析各批市售LDXGP药效物质差异原因和可能的解决方案。结论指纹定量法可清晰鉴定LDXGP质量和鉴定化学指纹归属度及药效物质差异归因,可为LDXGP生产质量控制提供新的指导方法。
Objective To set up an effective method to identify the fingerprint attribution ratio and the origin difference in medicinally effective components for Longdan Xiegan pills（LDXGP） by quantified fingerprint method（QFM）.Methods The chromatographic fingerprints of LDXGPs（self-made and market samples） and each crude drug were obtained with the gradient elution solvent system composed of 1% acetic acid solution and acetonitrile containing 1% acetic acid.The detection wavelength was 265 nm.The fingerprints were evaluated by attribution ratio pi,transgression ratio qi,macro qualitative similarity Sm,and macro quantitative similarity Pm to disclose the results of attribution ratio and determine the process recovery of the medicinally effective components for LDXGPs.Results The self-made sample（S1） was used as the referential fingerprint.In terms of components absorbed ultraviolet light,S3（Radix Scutellariae） was assessed to be the most important crude drug containing much more effective component,followed by S2（Radix Gentianae）,the second most important crude drug.The 12 batches of market LDXGPs were evaluated by systematic quantified fingerprint method taking S1 as the reference model and the qualities were all poor.The relative error of Sm was chosen to analyze the possible reason for the origin difference in medicinally effective components.The solution to improving the quality of preparations was also listed.Conclusion The quantified fingerprint method is effective for identifying fingerprint attribution ratio and the origin difference in medicinally effective components for LDXGP,which may play a guiding role in production.
出处
《中南药学》
CAS
2009年第11期858-862,共5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
龙胆泻肝丸
指纹定量法
系统指纹定量法
Sm相对误差
LDXGP
quantified fingerprint method
systematic quantified fingerprint method
the relative error of Sm
