中药制剂质量稳定,尤其是注射剂以药材提取物投料可以减少药材投料质量不稳定的不利因素,而提取物生产工艺的规范化和标准化将是关键。色谱的方法选择、方法学验证应视研究对象的具体情况而定,以能提供可重现的、足以构成指纹特征的适宜的柱色谱或平面色谱为目的,注意方法的多样化和实用化;量化操作得到的指纹图谱用以表达批间产品整体相似度,与特定成分的含量测定概念和要求不同,因此不应生搬硬套含量测定的方法学验证;建立指纹图谱的试验阶段对此应有清晰的概念。同时结合国情允许在科学和规范的前提下,有一个由浅入深、由精到细、由低到高的循序渐进的过程,以利于指纹图谱控制中药质量研究和实施的推广和深化。

To meet the need of consistency of c hr omatographic fingerprint,the key measure for the production of injections fr om Chinese medicinal materials is to use standardized herbal extracts as startin g materials instead of raw medi cinal materi-als,and the production procedures must also be standardized.As for chro matographic fingerprint,the choic e of chro-matographic methods and the validation of its methodologies should aim a t guaranteeing the establishment of a repro-ducible and applicable column chrom atogram or planar chromatogram with unique features of characteristic f ingerpri nting and attention should be paid to the di versity of methods used and prevale n t applicability.The similarity of c hromato-graphic fingerprints obtained by quantified operation as a whole can mon itor the consistency of products batch by batch and producer by producer.It should b e clearly understood from the beg inning that the concepts of quantified o peration and quantified analysis of fin gerpr int are different from the concept of conventional quantitative analysis o f a target single constituent in assay.Referring to i mplementing fingerprintin g on quality assessment of herbal drugs widely and deeply,a gradual process fro m the lower level to higher one should be developed step by step.