本文關(guān)鍵詞： 頭孢呋辛鈉 貯存條件 充氮 色級(jí)　出處：《蘇州大學(xué)》2014年碩士論文　論文類(lèi)型：學(xué)位論文

【摘要】：【目的】 頭孢呋辛鈉溶液顏色不穩(wěn)定，本研究探討無(wú)菌頭孢呋辛鈉原料藥貯存條件和充氮對(duì)色級(jí)的影響。 【方法】 取完全相同生產(chǎn)工藝生產(chǎn)的194批無(wú)菌頭孢呋辛鈉原料藥，每批分裝出16瓶模擬小包裝，每瓶30g，其中8瓶模擬生產(chǎn)過(guò)程充入高純液氮，8瓶不充氮，將4瓶充氮的和4瓶不充氮的放在冷處保存，另外4瓶充氮的和4瓶不充氮的放在陰涼處保存，分別在貯存第3、6、12個(gè)月（±3天）各取冷處充氮1瓶、冷處不充氮1瓶、陰涼處充氮1瓶、陰涼處不充氮1瓶，按《中國(guó)藥典》溶液顏色檢查法的第一法觀察顏色變化。為了便于統(tǒng)計(jì)，將色級(jí)YG1規(guī)定為0.5，色級(jí)=YG1規(guī)定為1.0，色級(jí)YG2規(guī)定為1.5，色級(jí)=YG2規(guī)定為2.0，，依次類(lèi)推。比較冷庫(kù)和陰涼庫(kù)貯存、充氮與不充氮情況下色級(jí)的差異。 【結(jié)果】 （1）在不充氮條件下，陰涼庫(kù)貯存12個(gè)月已有19.1%批次的達(dá)到最高色級(jí)YG6，而冷庫(kù)只有7.2%批次的達(dá)到最高色級(jí)=YG5。 （2）在充氮條件下，陰涼庫(kù)貯存12個(gè)月已有8.8%批次的達(dá)到最高色級(jí)=YG5，而冷庫(kù)只有2.6%批次的達(dá)到最高色級(jí)YG5。 【結(jié)論】 （1）無(wú)菌頭孢呋辛鈉原料冷處貯存時(shí)色級(jí)穩(wěn)定性明顯好于陰涼貯存； （2）無(wú)菌頭孢呋辛鈉原料充氮時(shí)色級(jí)穩(wěn)定性明顯好于不充氮。
[Abstract]:[purpose] The color of cefuroxime sodium solution was unstable. The effects of storage conditions and nitrogen filling on color grade of aseptic cefuroxime sodium were studied. [methods] 194 batches of aseptic cefuroxime sodium were obtained from the same production process. Each batch was packed with 16 bottles of simulated small packaging, each bottle of 30g, 8 bottles of simulated production process filled with high-purity liquid nitrogen. 8 bottles without nitrogen, 4 bottles of nitrogen filled and 4 bottles of non-nitrogen filled in cold storage, the other 4 bottles of nitrogen-filled and 4 bottles of non-nitrogen-filled storage in the shade, respectively in storage no. 3. For 12 months (鹵3 days), 1 bottle of nitrogen was taken from the cold place, 1 bottle was not filled with nitrogen in the cold place, 1 bottle was filled with nitrogen in the shade place, and 1 bottle was not filled with nitrogen in the cool place. The color change was observed according to the first method of the solution color examination method of Chinese Pharmacopoeia. For the sake of statistics, the color grade YG1 was 0.5, the color grade YG1 was 1.0 and the color grade YG2 was 1.5. The color grade YG2 was 2.0, and so on. The difference of color grade between cold storage and cool storage was compared with that without nitrogen filling. [results] 1) under the condition of no nitrogen filling, 19.1% batches have reached the highest color grade YG6 for 12 months, while only 7.2% batches of cold storage have reached the highest color grade YG5. 2) under the condition of nitrogen filling, 8.8% batches of shady storage have reached the highest color grade YG5 for 12 months, while only 2.6% batches of cold storage have reached the highest color grade YG5. [conclusion] 1) the color stability of aseptic cefuroxime sodium in cold storage was better than that in shady storage. 2) the color stability of aseptic cefuroxime sodium was better than that of no nitrogen filling.
【學(xué)位授予單位】：蘇州大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類(lèi)號(hào)】：TQ460.4;R978.1

【參考文獻(xiàn)】

相關(guān)期刊論文 前6條

1 陳壯生;劉麗平;;注射用頭孢呋辛鈉粉針澄清度和顏色探討[J];廣東藥學(xué)院學(xué)報(bào);2010年05期

2 陳宗志;金珍鑾;繆存來(lái);;不同廠家注射用頭孢呋辛鈉在輸液中穩(wěn)定性的比較研究[J];海峽藥學(xué);2008年05期

3 劉哲封;;頭孢呋辛酯及頭孢呋辛鈉合成工藝進(jìn)展[J];河北化工;2012年07期

4 陳兆坤;胡昌勤;沈永嘉;;頭孢呋辛鈉有色雜質(zhì)的HPTLC分析[J];海南醫(yī)學(xué)院學(xué)報(bào);2007年04期

5 劉川;趙穎穎;尹秋響;謝闖;王靜康;;頭孢呋辛鈉在水溶液中的降解動(dòng)力學(xué)[J];化學(xué)工業(yè)與工程;2013年01期

6 劉華;蔡秋琴;戴國(guó)興;趙洪娥;楊晉超;;頭孢呋辛鈉穩(wěn)定性研究[J];河北化工;2013年03期

本文編號(hào)：1459004