用紫外定量指纹图谱寻找六味地黄丸标准制剂的研究  

Searching of Liuwei Dihuang pill standard preparation by quantitative UV fingerprints

作　　者：陈新新[1] 孙国祥[1] 刘中博[1] 刘迎春[1] 马迪迪[1] 于云鹏[1] 谷徙芝 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]湖南九芝堂股份有限公司,长沙410205

出　　处：《中南药学》2014年第5期385-388,456,共5页Central South Pharmacy

基　　金：国家自然科学重大研究计划(No.90612002);国家基础科学人才培养基金资助(No.J1103606)

摘　　要：目的 用紫外定量指纹图谱寻找六味地黄丸（Liuwei Dihuang pill,LWDHP）标准制剂。方法 用流动注射分析（FIA）法采集107批LWDHP在190～400 nm的在线UVFP,采用紫外指纹定量法（QUFM）评价各批次的质量,并基于Sm、Pm和α评价LWDHP年质量均一性。采用正态分布检验,给出107批LWDHP质量的数据分布和标准指纹图谱置信区间。结果 有47批质量极好（1级）,28批质量很好（2级）,28批质量好（3级）,3批质量良好（4级）和1批质量中（5级）。Sm均匀度K值〈0.5,Pm均匀度K值〈20,α均匀度K值〈0.05,质量等级均匀度K值〈3,107批LWDHP年质量均一性很好。标准指纹图谱Sm、Pm和α的置信区间分别为0.996 6～1、99.0～101.5和0～0.014,在此范围内的有S17、S23、S24、S30、S37、S54、S61、S63、S81、S82、S89、S95、S99和S100共14批样品可作为标准制剂。结论 可用紫外定量指纹图谱寻找中药的标准制剂。Objective To search Liuwei Dihuang pill standard preparation （LWDHP-SP） by quantitative UV fingerprints. Method The flowing injection analysis was performed on 107 batches of LWDHPs to record the online UVFP of 190 -- 400 nm, in which quantified UVFP method （QUFM） was used to evaluate the quality of LWDHPs. The annual quality consistency was calculated based on Sm, Pm and a. The normal test was performed on Sin, Pm and a to obtain their data distribution and the confidence interval of the standard fingerprints. Results The 107 batches of LWDHPs were identified; the quality of 47 batches of LWDHPs was best （grade 1）;that of 28 batches was better （grade 2）; that of 28 batches was good （grade 3） ; that of 3 batches was fine （grade 4） and 1 was moderate （grade 5）. K of am, Pro, a and grade were less than 0.5, 20, 0.05 and 3, respectively. The annual quality uniformity of that 107 batches of LWDHPs was good. The confidence interval of the standard fingerprints Sin, Pm and a were 0.996 6 - 1, 99.0 - 101.5 and 0 - 0.014. S17, S23, S24, S30, S37, S54, S61, S63, S81, S82, S89, S95, S99 and S100 met the requirements of standard preparation. Conclusion The standard preparation of tradition Chinese medicine can be established by quantitative UVFPs.

关 键 词：六味地黄丸 标准制剂 紫外定量指纹图谱 紫外指纹定量法 

分 类 号：O657.7[理学—分析化学]