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Development of Fast and Selective Analytical Methods of Pharmaceuticals and Herbal Medicines by High-Performance Liquid Chromatography and Capillary Electrophoresis

机译:高效液相色谱和毛细管电泳的药物和草药快速和选择性分析方法的开发

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Pharmaceuticals are essential for the medical treatment of various diseases. From the herbal medicines (crude drugs), synthetic medicines to biopharmaceuticals, to assure its efficacy and safety, the production procedures and the quality control methods of pharmaceuticals are important. These are strictly regulated by Good Manufacturing Practice (GMP) and various guidelines. The key is to develop the “Specifications and testing methods” of the pharmaceutical scientifically and rationally according to the production process. There are many testing items such as identity tests, purity tests, assay, etc. in “Specifications and testing methods”. Among them, assay and purity test are core testing items. Optical purity evaluation is required for the single enantiomer pharmaceutical. Chromatographic methods and its detection methods are useful for the purpose. High-performance liquid chromatography (HPLC), thin layer chromatography (TLC) and gas chromatography (GC) are commonly used because the target analyses are almost a mixture. In this review, results of the development of the quality evaluation methods of relatively low molecular pharmaceuticals and herbal medicines by HPLC and capillary electrophoresis (CE) we have been investigated are summarized.
机译:药品对各种疾病的医疗至关重要。从草药(粗药),合成药物到生物制药,保证其功效和安全,制作程序和药物的质量控制方法很重要。这些严格受到良好制造业实践(GMP)和各种准则的监管。关键是根据生产过程科学和合理地制定药物的“规范和测试方法”。在“规格和测试方法”中,有许多测试项目如身份测试,纯度测试,测定等。其中,测定和纯度测试是核心测试项目。单对映体药物需要光学纯度评估。色谱法及其检测方法对于目的是有用的。通常使用高效液相色谱(HPLC),薄层色谱(TLC)和气相色谱(GC),因为靶分析几乎是混合物。在本次综述中,总结了通过HPLC和毛细管电泳(Ce)的相对低分子药物和草药的开发结果的结果。

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