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CN109260152A - 一种盐酸洛美沙星滴耳液 - Google Patents

一种盐酸洛美沙星滴耳液 Download PDF

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CN109260152A
CN109260152A CN201811344857.XA CN201811344857A CN109260152A CN 109260152 A CN109260152 A CN 109260152A CN 201811344857 A CN201811344857 A CN 201811344857A CN 109260152 A CN109260152 A CN 109260152A
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lomefloxacin hydrochloride
rilanit special
glycerol
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余亚明
秦怀生
郭风
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Yuzhou Hospital Of Traditional Chinese Medicine
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Abstract

一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星2.5‑3.5g、甘油40‑80g、氢化蓖麻油12‑18g、聚乙二醇15‑25g、乙二胺四乙酸二钠0.6‑1.4g。本发明提供的盐酸洛美沙星滴耳液，以氢化蓖麻油和聚乙二醇作为助溶剂，以甘油作为促渗剂，以乙二胺四乙酸二钠作为缓冲剂，可使盐酸洛美沙星滴耳液自聚集形成胶束溶液，既减少了滴耳液的刺激性，减少患者不适感，又延长了在耳部的滞留时间，提高了生物利用率，取得更好的治疗效果。

Description

一种盐酸洛美沙星滴耳液
技术领域
本发明涉及一种滴耳液，具体涉及一种盐酸洛美沙星滴耳液。
背景技术
慢性化脓性中耳炎是耳鼻喉科常见多发疾病，根据病例及临床表现，本病分为单纯型、骨疡型和胆脂瘤型，其中以单纯型最为常见，对于单纯型慢性化脓性中耳炎一般采用保守疗法以控制感染、通畅引流。申请人曾以口服头孢拉定胶囊以及使用盐酸洛美沙星滴耳液联合用药，取得了良好的疗效。但是使用的盐酸洛美沙星滴耳液以乙醇作为助溶剂，对耳室粘膜具有较强的刺激性作用，多有患者反馈滴加盐酸洛美沙星后发生疼痛难忍的症状，而且药液粘度低，流失严重，生物利用率差。
发明内容
本发明的目的就在于为解决现有技术的不足而提供一种盐酸洛美沙星滴耳液。
本发明的目的是以下述技术方案实现的：
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星2.5-3.5g、甘油40-80g、氢化蓖麻油12-18g、聚乙二醇15-25g、乙二胺四乙酸二钠0.6-1.4g。
优选的，每1000mL滴耳液中含有：盐酸洛美沙星3g、甘油60g、氢化蓖麻油15g、聚乙二醇20g、乙二胺四乙酸二钠1g。
所述氢化蓖麻油为peg40氢化蓖麻油。
所述聚乙二醇为聚乙二醇400。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至40-50℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
本发明提供的盐酸洛美沙星滴耳液，以氢化蓖麻油和聚乙二醇作为助溶剂，以甘油作为促渗剂，以乙二胺四乙酸二钠作为缓冲剂，可使盐酸洛美沙星滴耳液自聚集形成胶束溶液，既减少了滴耳液的刺激性，减少患者不适感，又延长了在耳部的滞留时间，提高了生物利用率，取得更好的治疗效果。
具体实施方式
实施例1
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星2.5-3.5g、甘油40-80g、氢化蓖麻油12-18g、聚乙二醇15-25g、乙二胺四乙酸二钠0.6-1.4g；氢化蓖麻油优选为peg40氢化蓖麻油，聚乙二醇优选为聚乙二醇400。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至40-50℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例2
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星3g、甘油60g、peg40氢化蓖麻油15g、聚乙二醇400 20g、乙二胺四乙酸二钠1g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至45℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例3
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星3.5g、甘油70g、peg40氢化蓖麻油15g、聚乙二醇400 23g、乙二胺四乙酸二钠0.8g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至48℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例4
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星2.8g、甘油50g、peg40氢化蓖麻油13g、聚乙二醇400 25g、乙二胺四乙酸二钠1.0g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至42℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例5
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星3.2g、甘油45g、peg40氢化蓖麻油18g、聚乙二醇400 17g、乙二胺四乙酸二钠1.2g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至40℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例6
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星3g、甘油80g、peg40氢化蓖麻油13g、聚乙二醇400 19g、乙二胺四乙酸二钠1.4g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至45℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例7
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星3g、甘油65g、peg40氢化蓖麻油15g、聚乙二醇400 24g、乙二胺四乙酸二钠1g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至45℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例8
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星2.6g、甘油40g、peg40氢化蓖麻油13g、聚乙二醇400 19g、乙二胺四乙酸二钠0.7g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至45℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
实施例9
一种盐酸洛美沙星滴耳液，每1000mL滴耳液中含有：盐酸洛美沙星3g、甘油60g、peg40氢化蓖麻油16g、聚乙二醇400 19g、乙二胺四乙酸二钠1.3g。
如上所述的盐酸洛美沙星滴耳液的制备方法，包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至45℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经0.45um无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
试验例
1、稳定性考察
取实施例2制备得到的盐酸洛美沙星滴耳液，分别放置于5℃25℃、35℃环境下对其外观、pH值、含量进行观察，结果均无明显变化。
、药效试验
取100例被诊断为慢性化脓性中耳炎的患者，随机分为治疗组和对照组。治疗组50例，男25例，女25例；平均年龄（42.6±17.3）岁，平均病程（9.85±5.27）个月。对照组50例，男24例，女26例；平均年龄（46.1±15.5）岁，平均病程（10.34±5.46）个月；两组性别、年龄、病程经统计学处理不具有显著性差异。
诊断标准：根据《实用耳鼻咽喉科学》和《中医耳鼻咽喉科学》拟定：1、间歇性或持续性耳内流脓，脓液为粘液性或黏脓性，无臭味，色白或黄个，量多或少；2、局部检查见鼓膜紧张部有大小不一的中央性穿孔，鼓室粘膜充血、水肿；听觉损伤一般为传导性耳聋；X线或CT显示乳突气房减少，密度增加。
两组病例局部治疗相同。先以3% 双氧水清洗耳道，去除脓液，患耳朝上滴入药水，治疗组滴入本发明实施例2制备得到的滴耳液，每次6-10滴，对照组滴入市售的盐酸洛美沙星滴耳液，每次6-10滴；治疗期间两组均口服头孢拉定胶囊，每次0.5g，4次/d，疗程2周。统计疗效（疗效标准：治愈：耳内流脓停止，检查中耳腔干洁，黏膜无充血或水肿。显效：耳内流脓显著减少，检查见中耳腔无脓液但潮湿，或有少许分泌物，黏膜轻度水肿或充血。无效：耳内流脓无改变或增多或稍显减少，查见中耳腔内仍有较多分泌物，粘膜充血、水肿），同时观察患者有无副作用（耳痛），结果见表1。

Claims (5)

1.一种盐酸洛美沙星滴耳液，其特征在于每1000mL滴耳液中含有：盐酸洛美沙星2.5-3.5g、甘油40-80g、氢化蓖麻油12-18g、聚乙二醇15-25g、乙二胺四乙酸二钠0.6-1.4g。
2.如权利要求1所述的盐酸洛美沙星滴耳液，其特征在于每1000mL滴耳液中含有：盐酸洛美沙星3g、甘油60g、氢化蓖麻油15g、聚乙二醇20g、乙二胺四乙酸二钠1g。
3.如权利要求1-2任一项所述的盐酸洛美沙星滴耳液，其特征在于所述氢化蓖麻油为peg40氢化蓖麻油。
4.如权利要求1-2任一项所述的盐酸洛美沙星滴耳液，其特征在于所述聚乙二醇为聚乙二醇400。
5.如权利要求1-4任一项所述的盐酸洛美沙星滴耳液的制备方法，其特征在于包括以下步骤：将配方量的盐酸洛美沙星加入适量水中，加热至40-50℃，超声溶解；然后加入配方量的甘油、氢化蓖麻油、聚乙二醇和乙二胺四乙酸二钠，搅拌均匀，加水至1000mL，经无菌滤膜过滤，即得盐酸洛美沙星滴耳液。
CN201811344857.XA 2018-11-13 2018-11-13 一种盐酸洛美沙星滴耳液 Pending CN109260152A (zh)

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