CN105534916A - 一种恩诺沙星可溶性制剂及其制备方法 - Google Patents
一种恩诺沙星可溶性制剂及其制备方法 Download PDFInfo
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- DLFVBJFMPXGRIB-UHFFFAOYSA-N Acetamide Chemical compound CC(N)=O DLFVBJFMPXGRIB-UHFFFAOYSA-N 0.000 claims abstract description 86
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
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Abstract
本发明公开了一种恩诺沙星可溶性制剂及其制备方法，由恩诺沙星、小苏打、乙酰胺、水、载体组成，通过以小苏打、乙酰胺作为恩诺沙星的助溶剂，增加恩诺沙星可溶性制剂饮水使用时恩诺沙星在水中的溶解性。该发明提供的恩诺沙星可溶性制剂可溶于水，且制备方法简单，易于工业化。
Description
技术领域
本发明属于兽药制剂领域，具体涉及一种恩诺沙星可溶性制剂及其制备方法。
背景技术
恩诺沙星(Enrofloxacin)，又名恩氟奎林羧酸，属于氟奎诺酮类(Fluoroquinolones)之化学合成抑菌剂，为微黄色或淡黄色结晶性粉末，味苦，不溶于水。
本品为合成的第三代喹诺酮类抗菌药物，又名乙基环丙沙星，1996年10月4日获FDA批准，为畜禽和水产专用喹诺酮类抗菌药物。能与细菌DNA回旋酶亚基A结合，从而抑制了酶的切割与连接功能，阻止了细菌DNA的复制，而呈现抗菌作用。具有广谱抗菌活性、具有很强的渗透性，本品对革兰氏阴性菌有很强的杀灭作用，对革兰氏阳性菌也有良好的抗菌作用，口服吸收好，血药浓度高且稳定，能广泛分布于组织中，其代谢产物为环丙沙星，仍有强大抗菌作用。几乎对水生动物所有病原菌的抗菌活性均较强。对由耐药性致病菌引起的严重感染有效，与其它抗菌素无交叉耐药性。
恩诺沙星难溶于水，影响其使用后的吸收和方便性，给其应用带来限制。
发明内容
为克服现有技术不足，本发明提供了一种恩诺沙星可溶性制剂。
为实现上述目的，本发明的技术方案是这样实现的：
一种恩诺沙星可溶性制剂，其特征在于，由恩诺沙星、小苏打、乙酰胺、水、载体组成。
进一步，所述载体包括山梨醇、可溶性淀粉、无水糖、乳糖或其组合物。
进一步，所述的恩诺沙星重量百分比为1～10%、小苏打重量百分比为5-20%、乙酰胺重量百分比为2-20%、水重量百分比5-20%、余量为载体。
本发明的另一目的是提供一种恩诺沙星可溶性制剂的制备方法，其特征在于，包括以下步骤：a.准确称取处方量所需的乙酰胺，加入处方量所需水中，加热溶解乙酰胺，得乙酰胺水溶液;b.准确称取处方量所需的恩拉霉素、小苏打混合均匀；c.准确称量处方所需载体，分级与步骤b所得混合物中，混合均匀；d.将步骤a所得乙酰胺水溶液加入步骤c所制备的混合物中，边搅拌边加入乙酰胺水溶液，混合均匀，过筛，烘干，再次过筛即可。
进一步，所述载体包括山梨醇、可溶性淀粉、无水糖、乳糖或其组合物。
进一步，所述的恩诺沙星重量百分比为1～10%、小苏打重量百分比为5-20%、乙酰胺重量百分比为2-20%、水重量百分比5-20%、余量为载体。
本发明有益效果
本发明以乙酰胺和小苏打作为恩诺沙星的助溶剂，增加恩诺沙星可溶性制剂饮水使用时恩诺沙星在水中的溶解性。该发明提供的恩诺沙星可溶性制剂可溶于水，且制备方法简单，易于工业化。
具体实施方式
实施例1：
处方如下：
恩诺沙星1%、小苏打5%、乙酰胺2%、水5%、可溶性淀粉补齐。
制备方法如下：
a.准确称取处方量所需的乙酰胺，加入处方量所需水中，加热溶解乙酰胺，得乙酰胺水溶液;b.准确称取处方量所需的恩拉霉素、小苏打混合均匀；c.准确称量处方所需载体，分级与步骤b所得混合物中，混合均匀；d.将步骤a所得乙酰胺水溶液加入步骤c所制备的混合物中，边搅拌边加入乙酰胺水溶液，混合均匀，过筛，烘干，再次过筛即可。
实施例2：
处方如下：
恩诺沙星10%、小苏打20%、乙酰胺20%、水20%、无水糖补齐。
制备方法如下：
a.准确称取处方量所需的乙酰胺，加入处方量所需水中，加热溶解乙酰胺，得乙酰胺水溶液;b.准确称取处方量所需的恩拉霉素、小苏打混合均匀；c.准确称量处方所需载体，分级与步骤b所得混合物中，混合均匀；d.将步骤a所得乙酰胺水溶液加入步骤c所制备的混合物中，边搅拌边加入乙酰胺水溶液，混合均匀，过筛，烘干，再次过筛即可。
实施例3：
处方如下：
恩诺沙星2.5%、小苏打10%、乙酰胺10%、水10%、山梨醇补齐。
制备方法如下：
a.准确称取处方量所需的乙酰胺，加入处方量所需水中，加热溶解乙酰胺，得乙酰胺水溶液;b.准确称取处方量所需的恩拉霉素、小苏打混合均匀；c.准确称量处方所需载体，分级与步骤b所得混合物中，混合均匀；d.将步骤a所得乙酰胺水溶液加入步骤c所制备的混合物中，边搅拌边加入乙酰胺水溶液，混合均匀，过筛，烘干，再次过筛即可。
实施例4：
处方如下：
恩诺沙星5%、小苏打15%、乙酰胺5%、水15%、山梨醇与乳糖的混合物（山梨醇:乳糖=3:7）补齐。
制备方法如下：
a.准确称取处方量所需的乙酰胺，加入处方量所需水中，加热溶解乙酰胺，得乙酰胺水溶液;b.准确称取处方量所需的恩拉霉素、小苏打混合均匀；c.准确称量处方所需载体，分级与步骤b所得混合物中，混合均匀；d.将步骤a所得乙酰胺水溶液加入步骤c所制备的混合物中，边搅拌边加入乙酰胺水溶液，混合均匀，过筛，烘干，再次过筛即可。
以下通过具体试验例对本发明做进一步的说明和解释。
试验例1：恩诺沙星可溶性制剂水溶性试验
将上述实施例1～4所述的恩诺沙星可溶性制剂，按恩诺沙星制剂最大使用量75mg每1000ml水(以恩诺沙星计)的2～5倍配制时，水溶液澄清透明，进行任意比例稀释，均无异常出现，并且对配制的水温无限制，说明本发明实施例具有良好的溶解性，溶解度较高。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (6)
1.一种恩诺沙星可溶性制剂，其特征在于，由恩诺沙星、小苏打、乙酰胺、水、载体组成。
2.根据权利要求1所述的恩诺沙星可溶性制剂，其特征在于，所述载体包括山梨醇、可溶性淀粉、无水糖、乳糖或其组合物。
3.根据权利要求1～2任一项所述的恩诺沙星可溶性制剂，其特征在于，所述的恩诺沙星重量百分比为1～10%、小苏打重量百分比为5-20%、乙酰胺重量百分比为2-20%、水重量百分比5-20%、余量为载体。
4.一种恩诺沙星可溶性制剂的制备方法，其特征在于，包括以下步骤：a.准确称取处方量所需的乙酰胺，加入处方量所需水中，加热溶解乙酰胺，得乙酰胺水溶液;b.准确称取处方量所需的恩拉霉素、小苏打混合均匀；c.准确称量处方所需载体，分级与步骤b所得混合物中，混合均匀；d.将步骤a所得乙酰胺水溶液加入步骤c所制备的混合物中，边搅拌边加入乙酰胺水溶液，混合均匀，过筛，烘干，再次过筛即可。
5.根据权利要求4所述的恩诺沙星可溶性制剂的制备方法，其特征在于，所述载体包括山梨醇、可溶性淀粉、无水糖、乳糖或其组合物。
6.根据权利要求4～5任一项所述的恩诺沙星可溶性制剂的制备方法，其特征在于，所述的恩诺沙星重量百分比为1～10%、小苏打重量百分比为5-20%、乙酰胺重量百分比为2-20%、水重量百分比5-20%、余量为载体。
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| CN102038643A (zh) * | 2010-12-10 | 2011-05-04 | 青岛康地恩药业有限公司 | 恩诺沙星可溶性粉及其制备方法和应用 |
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| CN102038643A (zh) * | 2010-12-10 | 2011-05-04 | 青岛康地恩药业有限公司 | 恩诺沙星可溶性粉及其制备方法和应用 |
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