發(fā)布時(shí)間：2018-06-27 14:09

  本文選題：呋布西林鈉 + 有關(guān)物質(zhì)��； 參考：《藥學(xué)學(xué)報(bào)》2015年12期

【摘要】：呋布西林鈉是目前僅在中國(guó)上市使用的半合成廣譜抗生素,對(duì)多種革蘭陽性菌及革蘭陰性菌均有良好抗菌活性。由于合成工藝相對(duì)復(fù)雜等因素,對(duì)呋布西林鈉的深入研發(fā)一直處于相對(duì)停滯狀態(tài),目前,現(xiàn)行有效的質(zhì)量標(biāo)準(zhǔn)僅為1989年版的衛(wèi)生部藥品標(biāo)準(zhǔn),其中采用容量法測(cè)定含量,且未對(duì)有關(guān)物質(zhì)進(jìn)行控制。據(jù)多篇文獻(xiàn)報(bào)道,呋布西林鈉中可能含有大量的呋布西林鈉同分異構(gòu)體,對(duì)其生物活性存在較大爭(zhēng)議。為更好的控制呋布西林鈉產(chǎn)品的質(zhì)量,本研究建立了適用于呋布西林鈉有關(guān)物質(zhì)檢查的HPLC分析方法。采用C18柱,柱溫35℃,以梯度洗脫的方式,在225 nm下對(duì)其有關(guān)物質(zhì)進(jìn)行測(cè)定。通過方法學(xué)驗(yàn)證,保證了該系統(tǒng)的可靠性和準(zhǔn)確性,并通過制備主要有關(guān)物質(zhì),對(duì)各有關(guān)物質(zhì)的結(jié)構(gòu)、生物活性和色譜行為進(jìn)行了確證,為合理制定質(zhì)控限度提供了充分的數(shù)據(jù)支撐。
[Abstract]:Furobuxicillin sodium is a semi-synthetic broad-spectrum antibiotic which is only used in China. It has good antibacterial activity against many Gram-positive bacteria and Gram-negative bacteria. Because of the relative complexity of the synthetic process, the deep research and development of furobuxicillin sodium has been relatively stagnant. At present, the current effective quality standard is only the medicine standard of the Ministry of Health in 1989, in which the content is determined by volumetric method. And the related substances are not controlled. According to many literatures, furobuxicillin sodium may contain a large number of isomers of furobuxicillin sodium, and its biological activity is controversial. In order to control the quality of furobuxicillin sodium, a HPLC method was established for the determination of furobuxicillin sodium related substances. The related substances were determined by gradient elution at 225 nm on C _ (18) column at 35 鈩，

本文編號(hào)：2074166