本文選題：恩諾沙星注射液　切入點(diǎn)：制備　出處：《西北農(nóng)林科技大學(xué)學(xué)報(bào)(自然科學(xué)版)》2017年05期

【摘要】：【目的】用葡甲胺、聚乙二醇400作為助溶劑制備較低pH值的20%恩諾沙星注射液,并考察其穩(wěn)定性,為臨床應(yīng)用提供理論依據(jù)�！痉椒ā坑谜辉囼�(yàn)L9(33)篩選最佳溶劑條件,按制劑通則試制備20%恩諾沙星注射液,用HPLC法測(cè)定恩諾沙星含量,并通過(guò)溫度加速試驗(yàn)、光加速試驗(yàn)及長(zhǎng)期放置試驗(yàn)考察其穩(wěn)定性。【結(jié)果】確定恩諾沙星注射液的配制處方為:恩諾沙星100g,聚乙二醇400為100mL,葡甲胺100g,20%氫氧化鈉溶液適量(調(diào)節(jié)pH 9.5~10.5),注射用水加至500mL。穩(wěn)定性試驗(yàn)結(jié)果表明,20%恩諾沙星注射液試制品外觀均為淡黃色,澄清,pH值9.5~10.5,含量98.0%~102.0%,均符合2010年版獸藥典規(guī)定,產(chǎn)品質(zhì)量穩(wěn)定可控,有效期可暫定為2年�！窘Y(jié)論】20%恩諾沙星注射液處方設(shè)計(jì)合理,制備工藝可控,質(zhì)量穩(wěn)定可靠。
[Abstract]:[objective] to prepare 20% enrofloxacin injection with low pH value by using meglumine and polyethylene glycol 400 as cosolvent, and to investigate its stability and provide theoretical basis for clinical application.20% enrofloxacin injection was prepared according to the general rules of preparation. The content of enrofloxacin was determined by HPLC method.[results] the formulation of enrofloxacin injection was determined to be 100 g of enrofloxacin, 100 mL of polyethylene glycol, and 20% of sodium hydroxide solution of meglumine (adjust pH 9.510. 5%).The results of stability test showed that the appearance of 20% enrofloxacin injection was light yellow, the pH value was 9.5% and 10.5, and the content was 98.0% 102.0. The product quality was stable and controllable, and the product quality was stable and controllable according to the provisions of the 2010 Veterinary Pharmacopoeia.[conclusion] the formulation of 20% enrofloxacin injection is reasonable, the preparation process is controllable and the quality is stable and reliable.
【作者單位】： 河南牧業(yè)經(jīng)濟(jì)學(xué)院;河南普爾泰動(dòng)物藥業(yè)有限公司;西北農(nóng)林科技大學(xué)動(dòng)物醫(yī)學(xué)院;
【分類號(hào)】：S859.53

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本文編號(hào)：1695313