复方两面针含片定量指纹图谱和体外全成分溶出方法测定研究  

Quantified fingerprints and the overall components dissolution method of compound Liangmianzhen tablets

作　　者：孙林艳[1] 孙国祥[1] 张晶[1] 张艳华 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]广西花红药业股份有限公司,广西柳州545000

出　　处：《中南药学》2017年第4期403-408,共6页Central South Pharmacy

基　　金：国家自然科学基金资助项目(No.90612002;No.81573586)

摘　　要：目的建立复方两面针含片(compound Liangmianzhen tablets,LMZT)的HPLC定量指纹图谱(HPLC-FP)和相对特征指纹图谱(HPLC-RCFP)以及全组分溶出紫外指纹图谱(DUV-FP),综合评价LMZT质量。方法采用HPLC建立LMZT 220 nm指纹图谱,以没食子酸(GA)为参照物峰,确立21个共有指纹峰并采用系统指纹定量法(SQFM)评价;以GA为单标,建立RCFP,并采用单标定量指纹法评价(Q1FM);采用流动注射法(FIA)测定溶出试验的供试品并用紫外指纹定量法(QUVFM)评价。结果 HPLC-FP的评价结果是S2质量等级为1,S3质量等级为2,S4、S9、S10、S12、S13和S15~S20质量等级为3,S1、S5~S7、S11和S14质量等级为4,S8质量等级为5。HPLC-RCFP的评价结果与HPLC-FP宏定量相似度P_m结果相差很小,质量等级相同。DUV-FP的评价结果显示所有样品在45 min时的溶出度不低于70%,均符合要求。结论 SQFM能定性定量评价中药制剂质量,Q1FM能突出评价单标含量差异,QUVFM能用于监测全组分溶出动力学的测定,实现整体药效物质基础监控和评价中药复方制剂整体组分体外溶出的监测。这为中药一致性评价提供了一种新方法实例。Objective To develop HPLC fingerprints （HPLC-FP）, HPLC relative characteristic fingerprints （HPLC-RCFP） and overall components dissolution UV fingerprints （DUV-FP） to evaluate the quality of compound Liangmianzhen tablets （LMZT） comprehensively. Methods HPLC-FP of LMZT was established at 220 nm which had 21 common peaks with GA as the reference peak and HPLC-RCFP was established based on the single maker compound, GA. Data analysis were performed using independently developed software by systematic quantitative fingerprint method （SQFM） and quantified 1 marker fingerprint method （Q1FM）, respectively. The samples for overall components dissolution were analyzed using flow injection analyses （FIA）, which were used to develop DUV-FP evaluated by quantitative UV fingerprint method （QUVFM）. Results In terms of HPLC-FP, 20 batches of LMZT were all qualified, in which S2 was grade 1, S3 was grade 2, S4, S9, S10, S12, S13 and S15 -- S20 were grade 3, S1, S5 -- S7, Sll and S14 were grade 4, S8 was grade 5. There were little difference between the results of HPLC-RCFP and HPLC-FP, and demonstrated HPLC-RCFP can also be used to evaluate the quality of LMZTs. The results of DUV-FP showed that the accumulation dissolution of all samples were not less than 70% at 45 min, which were all qualified. Conclusion SQFM can evaluate the quality both qualitatively and quantitatively for holistic componengs in traditional Chinese medicine （TCM）; Q1FM can obviously demonstrate the difference of the content of the single maker; QUVFM can be used to determine overall componengs dissolution, in which we can evaluate the quality consistency from the entire components and monitor the holistic substances in compound TCM for a good clinical. This provide a novel example for evaluating the quality consistency of TCM.

关 键 词：复方两面针含片 系统指纹定量法 单标定量指纹法 整体溶出度 紫外定量指纹法 

分 类 号：R284[医药卫生—中药学] O234[医药卫生—中医学]