三波长高效液相色谱指纹图谱、紫外指纹图谱及燃烧热联合鉴定银翘解毒丸质量

Identification of quality of Yinqiao Jiedu Wan by combining 3 wavelength HPLC fingerprints,UV fingerprints and combustion heat

目的建立银翘解毒丸(Yinqiao Jiedu Wan,YQJDW)三波长HPLC指纹图谱(HPLC-FP)联合紫外指纹图谱(UVFP)及燃烧热值谱(CH),从整体角度监控其全部化学物质组成的含量分布情况。方法采用DAD检测器记录YQJDW在203、246和300nm的HPLC指纹图谱,用六级系统指纹定量法(level-6systematic qualified fingerprint method,L6-SQFM)综合评价药品质量等级;测定YQJDW(190～400nm)紫外吸收光谱建立UVFPs突出反映中药中具有不饱和化学键及共轭体系物质的整体信息;用ZDHW6000型微机全自动量热仪测定YQJDW热含量相似度,从整体上表征该制剂中全部化学成分整体质量。最后对三者进行平均整合。结果综合评价结果表明S2～S9质量(1或2级)极好或好;WS1质量(4级)较好;S1和DS1质量(5级)中等;其余质量(6级)一般。结论把HPLC-FP、UVFP和燃烧热3种技术综合联用可覆盖中药化学物质总体信息全貌,具有准确、便捷、快速、重现、有效和可控的特点,是中药质量控制和评价的一种创新模式。从能量角度提供评价中药质量参数是中药质量控制研究和代谢研究的一种新思路和新方法。

Objective To monitor the content distribution of chemical components in Yinqiao Jiedu Wan （YQJDW） by combining the 3 wavelength HPLC fingerprints （HPLC-FPs） with both UV fingerprints （UVFPs） and combustion heat （CH） to control the quality of YQJDWs. Methods HPI.C FPs of YQJDWs were recorded by DAD detector under 203, 246 and 300 nm, and the quality grades were evaluated by level-6 systematically qualified fingerprint method （L6-SQFM）. The ultraviolet absorption spectrum （190--400 nm） was determined to establish the UVFPs, which dis- tinguishly displayed the integrity of the unsaturated-bond and conjugated-bond chemicals in traditional Chinese medicine （TCM）. The heat content similarity （HCS） was obtained by ZDHW6000 computer automatic calorimeter to stand for the entire quality of all the chemical constituents in the prescription. The 3 wavelength HPLC FPs （TW HPLC-FPs）, their average method （AM）, UVFPs and HCSs were finally integrated to monitor the chemical constituents in YQJD Ws. Results The quality of S2--S9 was very good （grade 1 or 2 ） ; that of WS1 was good （grade 4） ; that of S1 and DS1 was acceptable （grade 5） ; and that of the others was passable （grade 6）. Conclusion Combination of HPLC FP, UVFP and HCS offers simple, quick, efficient, accurate, reproducible and profitable way to cover all the chemical constituents in TCM, which helps to innovate the quality control and evaluation scope of TCM.