中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
2期
100-104
,共5页
一测多评%校正因子%银黄颗粒%质量控制
一測多評%校正因子%銀黃顆粒%質量控製
일측다평%교정인자%은황과립%질량공제
simultaneous quantitative assay by single marker(QAMS)%related correction factor%Yinhuang Granules%quality control
目的：建立以一个对照品同步测定银黄颗粒中6种咖啡酰奎宁酸含量的分析方法及其方法学的验证模式。方法：采用HPLC－DAD以药材中有效成分绿原酸、新绿原酸、隐绿原酸、异绿原酸A、异绿原酸B、异绿原酸C为指标，在一定的线性范围内，建立绿原酸与后5种成分间的相对校正因子（分别为1．21，0．96，0．84，0．90，0．78），并测定绿原酸的含量，用所建立的校正因子计算其他5个成分的含量；同时采用外标法测定银黄颗粒中6种咖啡酰奎宁酸类成分的含量，并比较计算值与实测值的差异，以验证一测多评法的准确性和可行性。结果：建立的校正因子重现性良好，15批银黄颗粒中采用校正因子计算的含量值与外标法实测值之间无显著差异（ RSD＜5％）。结论：在对照品缺乏的情况下，该方法可以作为一个新模式应用于银黄颗粒中咖啡酰奎宁酸类成分的多成分定量。
目的：建立以一箇對照品同步測定銀黃顆粒中6種咖啡酰奎寧痠含量的分析方法及其方法學的驗證模式。方法：採用HPLC－DAD以藥材中有效成分綠原痠、新綠原痠、隱綠原痠、異綠原痠A、異綠原痠B、異綠原痠C為指標，在一定的線性範圍內，建立綠原痠與後5種成分間的相對校正因子（分彆為1．21，0．96，0．84，0．90，0．78），併測定綠原痠的含量，用所建立的校正因子計算其他5箇成分的含量；同時採用外標法測定銀黃顆粒中6種咖啡酰奎寧痠類成分的含量，併比較計算值與實測值的差異，以驗證一測多評法的準確性和可行性。結果：建立的校正因子重現性良好，15批銀黃顆粒中採用校正因子計算的含量值與外標法實測值之間無顯著差異（ RSD＜5％）。結論：在對照品缺乏的情況下，該方法可以作為一箇新模式應用于銀黃顆粒中咖啡酰奎寧痠類成分的多成分定量。
목적：건립이일개대조품동보측정은황과립중6충가배선규저산함량적분석방법급기방법학적험증모식。방법：채용HPLC－DAD이약재중유효성분록원산、신록원산、은록원산、이록원산A、이록원산B、이록원산C위지표，재일정적선성범위내，건립록원산여후5충성분간적상대교정인자（분별위1．21，0．96，0．84，0．90，0．78），병측정록원산적함량，용소건립적교정인자계산기타5개성분적함량；동시채용외표법측정은황과립중6충가배선규저산류성분적함량，병비교계산치여실측치적차이，이험증일측다평법적준학성화가행성。결과：건립적교정인자중현성량호，15비은황과립중채용교정인자계산적함량치여외표법실측치지간무현저차이（ RSD＜5％）。결론：재대조품결핍적정황하，해방법가이작위일개신모식응용우은황과립중가배선규저산류성분적다성분정량。
Objective:To establish a new method of quality evaluation and validate its feasibility by simultaneous quantitative as-say by single marker of six caffeoylquinic acids in Yinhuang Granules.Methods:The new quality evaluation method quantitative analysis of multi-components by single marker ( QAMS) was established and validated with six caffeoylquinic acids in 4 varieties of Yinhuang with HPLC-DAD.Six caffeoylquinic acids:chlorogenic acid,neochlorogenic acid, cryptochlorogenic acid, isochloro-genic acid A, B, and C, were selected as indicators to evaluate the quality.In the linear range, related correction factors of the relationship with chlorogenic acid and the other five caffeoylquinic acids (1.21,0.96,0.84,0.90,0.78) were established and used for content determination of six caffeoylquinic acids in Yinhuang Granules.The method was evaluated by comparing quantita-tive results between external standard method and QAMS.Results:No significant differences were found in quantitative results of six caffeoylquinic acids in 15 batches of Yinhuang Granules determined by both external standard method and QAMS ( RSD <5%).Conclusion: The new method is feasible for evaluating the quality of Yinhuang Granules by QAMS without enough refer-ence substances.
