[关键词]
[摘要]
目的建立茵栀黄注射液HPLC指纹图谱,以考察其一致性和稳定性,提高其质量控制水平。方法采用高效液相色谱法,针对23批(包括不同厂家、不同批号、不同加速条件)茵栀黄注射液建立HPLC指纹图谱;利用相似度评价软件对指纹图谱进行相似度分析,并以相似度、共有峰相对峰面积为指标,进行样品聚类分析。结果不同厂家的样品各自聚为一类,表明茵栀黄注射液各批次间产品质量具有稳定性;各厂家产品逐次聚为一类,表明各厂家产品具有差异性和相对一致性;同一批次不同稳定性加速试验样品与正常批次差异明显,表明指纹图谱检测具有灵敏性。结论建立的HPLC指纹图谱可用于茵栀黄注射液质量控制,对保证产品质量的一致性和稳定性具有重要价值。
[Key word]
[Abstract]
Objective To evaluate the consistency and stability of Yinzhihuang Injection with HPLC fingerprint and improve its quality standard.Methods HPLC was used to establish the fingerprints of 23batches of Yinzhihuang Injection,including samples from different manufacturers,batch number,andconditions of acceleration.Similarity calculation and hierarchical cluster analysis were used to evaluate theconsistency and stability of them with similarity and relative peak area of common peaks in fingerprints.Results Samples of same manufacturer were classified respectively,which showed the consistency of ev-ery batch;Samples from different manufacturers were classified successively,which showed the diversityand relative coherence:Samples treated with accelerated test were different from normaJ ones obviously,which showed the sensitive of fingerprints.ConclusionThe established HPLC fingerprint could be ap-plied to the quality control of Yinzhihuang Injection and show fairly importance in ensuring the consistencyand stability of it.
[中图分类号]
[基金项目]
国家自然科学基金资助项目(30701109)