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目的对金雀异黄素的药学研究进展及临床应用进行综述,为金雀异黄素的研究尤其是新剂型的开发提供参考及理论依据。方法通过查阅关于金雀异黄素的药学研究进展及临床应用方面的中、外文学31篇,综述总结金雀异黄素的提取分离、合成工艺及含量测定,归纳其药剂学、体内过程和临床应用等方面的研究。结果与结论金雀异黄素又称染料木素,主要来源于豆类食物。其化学结构为5,7,4′-三羟基异黄酮,与内源性雌激素雌二醇相似。常用醇溶剂进行固相提取及硅胶柱法、正相硅胶柱色谱及重结晶法和水解法等方法进行提取分离。也有进行人工合成的研究报道。金雀异黄素的含量测定方法主要为高效液相色谱法和紫外分光光度法。近年来,高效液相-串联质谱、毛细管电泳、气相色谱等新方法越来越多地应用于金雀异黄素的含量测定。在金雀异黄素的药剂学研究体内过程的研究方面也取得了很多成果。在临床上,国内已批准多种主含金雀异黄素的异黄酮产品作为保健品用于人群,目前上市的经卫生部批准的多种功能性保健品有金转停胶囊、安睡美胶囊、血脂康胶囊、骨宝昕肾片、染料木素胶囊、天雌素大豆异黄酮营养片、“雌の源”金医保异黄酮片、天能中年宝片等20多个品种。
OBJECTIVE: To summarize the progress and clinical application of genistein in pharmacy and to provide a reference and theoretical basis for the genistein research, especially the development of new dosage forms. Methods By reviewing the progresses and clinical applications of genistein in the clinical application of 31 Chinese and foreign literature, summarize the genistein extraction and separation, synthesis process and content determination, summarized its pharmacology, in vivo process and Clinical application and other aspects of research. Results and Conclusions Genistein also known as genistein, mainly from legumes. Its chemical structure is 5,7,4’-trihydroxy isoflavone, similar to the endogenous estrogen estradiol. Commonly used alcohol solvent for solid phase extraction and silica gel column, normal phase silica gel column chromatography and recrystallization and hydrolysis methods such as extraction and separation. There are also reports of synthetic studies. Genistein content determination methods are mainly high performance liquid chromatography and ultraviolet spectrophotometry. In recent years, high performance liquid chromatography-tandem mass spectrometry, capillary electrophoresis, gas chromatography and other new methods are increasingly used in genistein content determination. There have also been many achievements in the genotoxicity research of genistein in the study of in vivo processes. Clinically, a number of main isoflavone-containing isoflavone products have been approved for use as health products in the domestic market. Currently, a number of functional health-care products approved by the Ministry of Health have been approved for the transfer of gold capsules, , Xuezhikang capsule, bone Bao Xin tablets, genistein capsules, estrogen soy isoflavone nutrition tablets, “female source ” gold medicinal isoflavone tablets, days to middle-aged treasure tablets more than 20 varieties.