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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。
The quality of traditional Chinese medicine preparations is stable. In particular, the injection of herbal extracts can reduce the unfavorable factors of the unstable quality of medicinal materials, and the standardization and standardization of the extraction process will be the key. Chromatographic method selection and method validation should be based on the specific circumstances of the research object, with the aim of providing reproducible and suitable column chromatography or planar chromatography that can be used to construct the fingerprint features, and pay attention to diversification and practical application of methods. The fingerprint obtained from the quantification operation is used to express the overall similarity of the batch product, which is different from the concept and requirements of the determination of the specific component. Therefore, the method validation of the hard content determination should not be carried out; the test phase for establishing the fingerprint should have a clear concept. At the same time, combining national circumstances allows a gradual and gradual process from shallow to deep, from fine to fine, and from low to high under the premise of science and standardization, in order to facilitate the promotion and deepening of the research and implementation of quality control of traditional Chinese medicine with fingerprints.