头孢喹肟注射液溶于乙醚吗?

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硫酸头孢喹肟注射液
&nbsp&nbsp 本品为硫酸头孢喹肟与油酸乙酯等配制而成的混悬注射液。含头孢喹肟(C23H24N6O5S2)应为标示量的90.0%~105.0%。 【性状】&nbsp本品为类白色至浅褐色混悬液体;久置分层。 【鉴别】 (1)含量测定项下记录的色谱图中,供试品主峰的保留时间应与对照品峰的保留时间一致。 (2)取摇匀后的供试品2&nbspml,加水5&nbspml,稀盐酸1&nbspml,混匀,置超声浴中超声10分钟,弃去有机层,溶液显硫酸盐的鉴别反应(附录15页)。 【检查】有关物质&nbsp&nbsp照含量测定项下的方法。 取摇匀后的供试品1.0&nbspml,加入流动相25.0&nbspml,置超声浴中超声5分钟,弃去有机层,取水层滤过,取续滤液10μl,注入液相色谱仪,记录色谱图,2,3-环己基吡啶与头孢喹肟相对保留时间为0.20。按峰面积归一化法计算,2,3-环己基吡啶应不得过3.0%,其他单一杂质应不得过0.50%,杂质总量应不得过4.0%。 水分&nbsp&nbsp取本品,照水分测定法检查,含水分不得过0.2%。 细菌内毒素&nbsp&nbsp取摇匀后的供试品2&nbspml与细菌内毒素检查用水3&nbspml混匀,分成2等份,振摇30秒,离心15分钟(2000g),吸取水层1&nbspml,加1&nbspmol/L氢氧化钠溶液0.06&nbspml调节pH值至6.5~7.5。用细菌内毒素检查用水按1:10稀释后,照细菌内毒素检查法(附录73页)检查,每1&nbspmg头孢喹肟中含细菌内毒素的量应小于0.1&nbspEU。 无菌&nbsp&nbsp取供试品8瓶,混合均匀,加入含6%吐温-80的蛋白胨缓冲液(1g/L)400ml,混匀,加入800×106单位青霉素酶(每1ml供试品溶液,加2×106单位青霉素酶),充分振摇,将供试品倒置,在37℃放置4小时;取供试品溶液,依法检查(附录79页,直接接种法),应符合规定。 分散性&nbsp&nbsp取本品1瓶,振摇30秒,将供试品转移置玻璃容器中,不得观察到结块或沉淀物。 沉降&nbsp&nbsp取本品1瓶,振摇30秒,取供试品10&nbspml置刻度试管中(内径1.0~1.5&nbspcm),10分钟内不得沉淀。 粒度&nbsp&nbsp取摇匀后的供试品,置显微镜下检查,颗粒直径在5μm以下应不得少于80%,10μm以下不得少于90%,20μm以下不得少于95%,50μm以下不得少于100%。 装量&nbsp&nbsp按最低装量检查法检查,应符合规定。 【含量测定】&nbsp照高效液相色谱法测定。 色谱条件与系统适用性试验&nbsp&nbsp用十八烷基硅烷键合硅胶为填充剂;取一水合高氯酸钠3.45g溶于1000&nbspml水中,加磷酸12&nbspml和乙腈90&nbspml,用三乙胺调节pH至3.6为流动相;检测波长为270&nbspnm。取头孢噻肟约25&nbspmg,溶于100.0&nbspml流动相中,另取头孢喹肟约25&nbspmg,置25&nbspml量瓶中,精密加入上述头孢噻肟溶液1&nbspml,用流动相稀释至刻度。精密量取10μl注入液相色谱仪,记录色谱图;计算头孢喹肟与头孢噻肟的分离度,应大于1.0。 对照品溶液的制备&nbsp&nbsp精密称取硫酸头孢喹肟对照品适量(约相当于头孢喹肟25&nbspmg),置250&nbspml量瓶中,用流动相溶解并稀释至刻度,摇匀,即得。 供试品溶液的制备&nbsp精密量取摇匀后的供试品适量(约相当于头孢喹肟50&nbspmg),精密加入流动相100&nbspml,置超声浴中超声5分钟,弃去油层,滤过;精密量取续滤液5&nbspml,置25&nbspml量瓶,加流动相稀释至刻度,摇匀,即得。 测定法&nbsp&nbsp精密量取对照品溶液和供试品溶液各10μl,分别注入液相色谱仪,记录色谱图。按外标法以峰面积计算,即得。 【作用与用途】抗生素类药。主要用于治疗大肠杆菌引起的奶牛乳房炎,多杀性巴氏杆菌或胸膜肺炎放线杆菌引起的猪呼吸道疾病 【用法与用量】肌内注射&nbsp&nbsp一次量&nbsp&nbsp每1&nbspkg体重&nbsp牛1&nbspmg 一日1次&nbsp&nbsp连用2日&nbsp猪2~3&nbspmg  一日1次 连用3日 【休药期】牛&nbsp5日;猪&nbsp2日;弃奶期&nbsp1日。 【规格】&nbsp50ml:1.25g 【贮藏】遮光,25℃以下保存。 【有效期】&nbsp2年。 【生产企业】英特威国际有限公司(Intervet&nbspInternational&nbspGmbH) 注:蛋白胨缓冲液(1g/L) 蛋白胨(酪蛋白胨或肉蛋白胨)&nbsp&nbsp&nbsp1g KH2PO4&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp3.6g Na2HPO4?2H2O&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp7.2g NaCl&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp4.3g 最终pH为7.0±0.2。溶液应无色澄清&nbsp&nbsp
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硫酸头孢喹肟说明书
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长效头孢喹肟微球的研制及其在猪体内的药动学研究
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头孢噻肟钠
头孢噻肟钠
头孢噻肟钠
Cefotaxime sodium salt
≥99.5%(HPLC)
C16H16N5NaO7S2
分子量477.45
Beilstein号
EC号 264-915-9
MDL号 MFCD
PubChem编号
上海 (10)天津 (5)
上海 (8)天津 (3)
上海 (>10)天津 (预计交期:3-5个工作日)
¥1,850.00
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¥6,998.00
¥2,799.20
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储存温度2-8°C
61 ° (C=1, H2O)
头孢噻肟钠 ;Cefotaxim sodium salt
Cg,Cg,Cmg,Cmg in glass bottle
警示性声明
个人防护设备
dust mask type N95 (US),Eyeshields,Faceshields,Gloves
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