CN110917127A - 一种制备恩诺沙星注射液的方法 - Google Patents
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Abstract
本发明公开了一种制备恩诺沙星注射液的方法，属于兽用药技术领域。本发明注射液包括以下组分：恩诺沙星、亚硫酸氢钠、丙二醇、乙醇、EDTA、氢氧化钠和注射用水。本发明注射液的制备方法为：将亚硫酸氢钠、EDTA、氢氧化钠分别用部分注射用水溶解，然后取丙二醇，加热，加入亚硫酸氢钠、EDTA的水溶液，搅拌，加入氢氧化钠溶液，搅拌，再加入恩诺沙星，搅拌，最后加入乙醇、余量的注射用水搅拌，再加活性炭吸附后过滤即得。本发明恩诺沙星注射液，不仅解决了恩诺沙星注射液稳定性差，低温环境下容易析出结晶的技术问题，有利于药效的充分发挥，配方成本低，而且本发明恩诺沙星注射液的制备方法简单，生产成本低，适合生产应用。
Description
技术领域
本发明涉及兽用药技术领域，特别涉及一种制备恩诺沙星注射液的方法。
背景技术
恩诺沙星属氟喹诺酮类动物专用的广谱杀菌药。它对大肠杆菌、沙门氏菌、克雷伯氏杆菌、布鲁氏菌、巴氏杆菌、胸膜肺炎放线杆菌、丹毒杆菌、变形杆菌、黏质沙雷氏菌、化脓性棒状杆菌、败血波特氏菌、金黄色葡萄球菌、支原体、衣原体等均有良好作用，对铜绿假单胞菌和链球菌的作用较弱，对厌氧菌作用微弱。对敏感菌有明显的抗菌后效应。恩诺沙星的抗菌机制是作用于细菌细胞的DNA旋转酶，干扰细菌DNA的复制、转录和修复重组，使细菌不能正常生长繁殖而死亡。
恩诺沙星肌内注射吸收迅速，在动物体内分布广泛，能很好进入组织，体液除了脑脊液外，几乎所有组织的药物浓度均高于血浆。恩诺沙星主要通过肾脏（肾小管分泌和肾小球滤过）排泄，15%-50%以原形从尿中排出，在动物体内的代谢主要是脱去7-哌嗪环的乙基生成环丙沙星，其次为氧化及葡萄糖醛酸结合。由于恩诺沙星苦味强烈，作为口服制剂使用时，动物的耐受剂量比较低，所以在临床使用时一般采用注射液的形式给药。但恩诺沙星注射液存在稳定性差，低温环境下容易析出结晶的问题，严重影响疗效和安全性。
发明内容
为了解决现有技术中恩诺沙星注射液稳定性差，低温环境下容易析出结晶的技术问题，本发明的目的在于提供一种恩诺沙星注射液及其制备方法，本发明恩诺沙星注射液在低温环境下稳定性较好，有利于药效的充分发挥，配方及生产成本低，制备方法简单，适合生产应用。
本发明公开一种恩诺沙星注射液，每10ml该注射液的组成如下：恩诺沙星0.45-0.55g、亚硫酸氢钠0.015-0.025g、丙二醇3.5-4.5ml、乙醇1.5-2.5ml、EDTA0.0005-0.0015g、氢氧化钠0.060-0.070g、余量为注射用水。
优选的，所述的恩诺沙星注射液，每10ml该注射液的组成如下：恩诺沙星0.5g、亚硫酸氢钠0.02g、丙二醇4ml、乙醇2ml、EDTA0.001g、氢氧化钠0.065g、余量为注射用水。
本发明还公开一种恩诺沙星注射液的制备方法，包括以下步骤：
（1）将亚硫酸氢钠、EDTA、氢氧化钠分别用部分注射用水溶解，备用；
（2）取丙二醇，加热约50℃，加入步骤（1）中制得的亚硫酸氢钠、EDTA的水溶液，搅拌15分钟，加入氢氧化钠溶液，搅拌15分钟，加入恩诺沙星，搅拌20分钟，加入乙醇、余量的注射用水搅拌15分钟，再加活性炭吸附15分钟后过滤即得。
优选的，所述步骤（2）后还包括将所述步骤（2）得到的恩诺沙星注射液进行灌封和灭菌。
本发明恩诺沙星注射液，不仅解决了恩诺沙星注射液稳定性差，低温环境下容易析出结晶的技术问题，有利于药效的充分发挥，配方成本低，而且本发明恩诺沙星注射液的制备方法简单，生产成本低，适合生产应用。
具体实施方式
下面将结合本发明中的实施例，对本发明的技术方案进行清楚、完整的描述。
实施例1
一种恩诺沙星注射液，每10ml该注射液的组成如下：恩诺沙星0.5g、亚硫酸氢钠0.02g、丙二醇4ml、乙醇2ml、EDTA0.001g、氢氧化钠0.065g、余量为注射用水。
上述恩诺沙星注射液的制备方法，包括以下步骤：
（1）将0.02g亚硫酸氢钠、0.001gEDTA、0.065g氢氧化钠分别用部分注射用水溶解，备用；
（2）取4ml丙二醇，加热约50℃，加入步骤（1）中制得的亚硫酸氢钠、EDTA的水溶液，搅拌15分钟，加入氢氧化钠溶液，搅拌15分钟，加入0.5g恩诺沙星，搅拌20分钟，加入2ml乙醇、余量的注射用水搅拌15分钟，再加活性炭吸附15分钟后过滤即得。
得到恩诺沙星注射液后，对所述恩诺沙星注射液进行检测，检测合格后，采用本领域技术人员熟知的方式进行灌封和灭菌，得到恩诺沙星注射液产品。
试验例1 稳定性试验
取实施例1制备的恩诺沙星注射液，按照中国兽药典2010年版一部附录兽药稳定性试验指导原则进行加速试验，按照市售包装，在温度40±2℃、相对湿度为75±5%、光照度为4500±500LX的条件下放置6个月，在试验期间第1、2、3、6个月末分别取样一次，对注射液的外观性状、pH值和含量（按标示百分含量计）进行检测，结果见表1。
表1 恩诺沙星注射液稳定性试验结果
上述试验结果表明，经过6个月的加速试验后，本发明恩诺沙星注射液的外观性状、pH值和标示百分含量均无明显变化，说明本发明注射液稳定性好。
试验例2 抗冻性试验
取实施例1制备的恩诺沙星注射液，按市售包装，分别在0-5℃冷藏和-20±2℃冷冻条件下放置6个月，在试验期间第1、2、3、6个月末分别取样一次，对恩诺沙星注射液的外观性状和冷冻后解冻情况（于10±2℃解冻）进行检测，结果见表2。
表2 恩诺沙星注射液的抗冻性试验结果
上述试验结果显示，经过6个月冷藏试验后，本发明制备的恩诺沙星注射液的外观性状无明显变化。经过6个月的冷冻试验后，本发明制备的恩诺沙星注射液析出少量结晶，在10±2℃该结晶能够完全复溶，不会影响注射液的使用。以上试验结果表明本发明恩诺沙星注射液抗冻性好。
试验例3 临床疗效试验
恩诺沙星注射液主要用于家畜及小动物敏感菌所致的细菌性疾病和支原体感染,如大肠杆菌病、沙门氏菌病、巴氏杆菌病、放线杆菌性胸膜肺炎、乳腺炎、支原体肺炎等。
仔猪大肠杆菌病是由致病性大肠杆菌引起的一类仔猪肠道传染性疾病，是仔猪的一种常见病和多发病。现以大肠杆菌为例，选用本发明实施例1制备的恩诺沙星注射液及市售恩诺沙星注射液对仔猪大肠杆菌病进行临床疗效试验，试验设为试验1组、试验2组和对照组，试验1组给予本发明实施例1制备的恩诺沙星注射液，剂量0.1ml/kg，试验2组给予本发明实施例1制备的恩诺沙星注射液，剂量0.2ml/kg，对照组给予市售恩诺沙星注射液，按试验2组给予的恩诺沙星的剂量给药，1次/天，连续3天，给药方式为肌肉注射，结果见表3。
观察指标：观察用药后仔猪的精神状况及腹泻情况。
临床疗效判断标准：分治愈、显效和无效3级。
治愈：用药1-2天后，粪便变稠，继续用药至第3天，拉稀停止，粪便恢复正常；
显效：用药1-2天后，粪便变稠，拉稀次数减少，继续用药至第3天，拉稀未停止；
无效：用药3天后，腹泻仍然无明显好转。
治愈率=治愈头数/治疗头数×100%；
有效率=显效头数/治疗头数×100%。
表3 恩诺沙星注射液对仔猪大肠杆菌病的临床疗效试验结果
表3试验结果显示，本发明恩诺沙星注射液对仔猪大肠杆菌病具有优异的临床效果，试验1组和试验2组的治愈率分别高达83.33%和90.00%，有效率高达100%，显著高于市售恩诺沙星注射液的治愈率58.89%和有效率68.89%，表明本发明恩诺沙星注射液的临床疗效好。
本发明恩诺沙星注射液，不仅解决了恩诺沙星注射液稳定性差，低温环境下容易析出结晶的技术问题，有利于药效的充分发挥，配方成本低，而且本发明恩诺沙星注射液的制备方法简单，生产成本低，适合生产应用。本发明恩诺沙星注射液能够通过《中国兽药典》2010年版中恩诺沙星注射液质量标准的检测，是国标产品。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (2)
1.一种制备恩诺沙星注射液的方法，其特征在于：每10ml该注射液的组成如下：恩诺沙星0.45-0.55g、亚硫酸氢钠0.015-0.025g、丙二醇3.5-4.5ml、乙醇1.5-2.5ml、EDTA0.0005-0.0015g、氢氧化钠0.060-0.070g、余量为注射用水；
所述制备方法包括如下步骤：
（1）将亚硫酸氢钠、EDTA、氢氧化钠分别用部分注射用水溶解，备用；
（2）取丙二醇，加热约50℃，加入步骤（1）中制得的亚硫酸氢钠、EDTA的水溶液，搅拌15分钟，加入氢氧化钠溶液，搅拌15分钟，加入恩诺沙星，搅拌20分钟，加入乙醇、余量的注射用水搅拌15分钟，再加活性炭吸附15分钟后过滤即得。
2.如权利要求1所述的方法，其特征在于：每10ml该注射液的组成如下：恩诺沙星0.5g、亚硫酸氢钠0.02g、丙二醇4ml、乙醇2ml、EDTA0.001g、氢氧化钠0.065g、余量为注射用水。
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