CN106176598A - 一种盐酸头孢噻呋混悬注射液及其制备方法 - Google Patents
一种盐酸头孢噻呋混悬注射液及其制备方法 Download PDFInfo
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- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
- A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
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Abstract
一种盐酸头孢噻呋混悬注射液，每100mL注射液中含有：盐酸头孢噻呋4‑6g、硬脂酸铝1‑5g、BHT 0.01‑0.2g、天蚕素抗菌肽0.01‑0.03g、其余为注射级大豆油。本发明提供的盐酸头孢噻呋混悬注射液，提高药物的溶解度和溶出效率，沉降速度慢，分散性好，提高药物制剂的稳定性；载药量高，降低给药体积，增加生物安全性；与粘膜组织有很好的粘附性，实现靶向给药；而且添加天蚕素抗菌肽以后可显著增强盐酸头孢噻呋混悬注射液的药效。
Description
技术领域
本发明属于兽药加工技术领域，具体涉及一种盐酸头孢噻呋混悬注射液及其制备方法。
背景技术
头孢噻呋是第三代动物专用的头孢菌素类抗生素，在水中不溶，在丙酮中微溶，在乙醇中几乎不溶，常将其制成钠盐或盐酸盐供注射用，具广谱杀菌作用，对革兰氏阳性. 革兰氏阴性包括产内酰胺酶菌株均有效，敏感菌有巴斯德氏菌、放线杆菌、沙门氏菌、链球菌、葡萄球菌等，其抗菌活性比氨苄西林强，对链球菌的活性也比喹诺酮类抗菌药强。
注射剂作为一种常用的给药剂型，与其他剂型相比，注射剂起效快，剂量准确，作用可靠，不受胃肠道诸因素影响，可产生定位、靶向及长效作用，适用于不能口服给药的个体及不能口服的药物；但盐酸头孢噻呋的非水溶性给注射应用带来很大的限制。
发明内容
本发明的目的就在于提供一种盐酸头孢噻呋混悬注射液及其制备方法。
本发明的目的是以下述方式实现的：
一种盐酸头孢噻呋混悬注射液，每100mL注射液中含有：盐酸头孢噻呋4-6g、硬脂酸铝1-5g、BHT 0.01-0.2g、天蚕素抗菌肽0.01-0.03g、其余为注射级大豆油。
如上所述的盐酸头孢噻呋混悬注射液的制备方法，包括以下步骤：将硬脂酸铝加入大豆油中溶解，然后加入BHT，搅拌溶解，冷却后加入盐酸头孢噻呋，搅拌混匀，然后加入天蚕素抗菌肽搅拌混匀，补注射级大豆油至全量搅拌混匀，均质，分装包装即得。
本发明提供的盐酸头孢噻呋混悬注射液，提高药物的溶解度和溶出效率，沉降速度慢，分散性好，提高药物制剂的稳定性；载药量高，降低给药体积，增加生物安全性；与粘膜组织有很好的粘附性，实现靶向给药；而且添加天蚕素抗菌肽以后可显著增强盐酸头孢噻呋混悬注射液的药效。
具体实施方式
实施例1
一种盐酸头孢噻呋混悬注射液，每100mL注射液中含有：盐酸头孢噻呋4-6g、硬脂酸铝1-5g、BHT（二丁基羟基甲苯）0.01-0.2g、天蚕素抗菌肽0.01-0.03g、其余为注射级大豆油。
如上所述的盐酸头孢噻呋混悬注射液的制备方法，包括以下步骤：将硬脂酸铝加入大豆油中加热溶解，散去泡沫，油温控制在约120℃左右，形成淡黄色粘稠状澄明液体后加入BHT，搅拌溶解，冷却后加入盐酸头孢噻呋，搅拌混匀，然后加入天蚕素抗菌肽搅拌混匀，补注射级大豆油至全量搅拌混匀，均质，压力为30Mpa，检测半成品合格，分装、扎盖、贴签、包装即得。整个生产过程中无菌操作，所有容器、管道、设备、包装材料等均必须洁净干燥，设备、管道应用油淌洗后使用，避免与水接触，硬脂酸铝胶的制备是本品制备的关键环节，制得的硬脂酸铝应为淡黄色粘稠状澄明液体。
使用大豆油，对原料稳定性影响小，乳化分散效果最好，一方面保证药物的稳定，另一方面起到良好的缓释作用，达到长效效果；使用硬脂酸铝作为稳定剂和助悬剂，使产品的沉降速度慢，重分散性更好，使用BHT（二丁基羟基甲苯）可起到良好的抗氧化和防腐的作用，加入天蚕素抗菌肽可增强机体免疫力，提高盐酸头孢噻呋的药效。
本发明采用乳化包合技术，缓释、长效的作用增强，乳化均质以后，药物粒径达到微米级，有效成分释出量和释出速度大为提高，生物利用度高，组织刺激性低。
实施例2
一种盐酸头孢噻呋混悬注射液，每100mL注射液中含有：盐酸头孢噻呋5g、硬脂酸铝3g、BHT 0.1g、天蚕素抗菌肽0.02g、其余为注射级大豆油。其余同实施例1。
本发明实施例3-16盐酸头孢噻呋混悬注射液配方见表1-2，其他同实施例2。
药效实验
取200头仔猪，分为3组，第一组肌内注射本发明实施例2制备得到的盐酸头孢噻呋混悬注射液，第二组肌内注射国内某公司盐酸头孢噻呋混悬注射液，第三组肌内注射国外某品牌盐酸头孢噻呋混悬注射液，分别在3日龄、7日龄、21日龄时每头注射0.2ml、0.3ml、0.5ml；第28日统计每组仔猪腹泻率、断奶仔猪成活率、仔猪呼吸道疾病发生率。
从表3可知，本发明制备得到的盐酸头孢噻呋混悬注射液相对现有技术中盐酸头孢噻呋混悬注射液，其仔猪腹泻率和仔猪呼吸道疾病发生率明显下降，断奶仔猪成活率明显提高，具有更好的疗效。
以上所述的仅是本发明的优选实施方式，应当指出，对于本领域的技术人员来说，在不脱离本发明整体构思前提下，还可以作出若干改变和改进，这些也应该视为本发明的保护范围。
Claims (2)
1.一种盐酸头孢噻呋混悬注射液，其特征在于每100mL注射液中含有：盐酸头孢噻呋4-6g、硬脂酸铝1-5g、BHT 0.01-0.2g、天蚕素抗菌肽0.01-0.03g、其余为注射级大豆油。
2.如权利要求1所述的盐酸头孢噻呋混悬注射液的制备方法，其特征在于包括以下步骤：将硬脂酸铝加入大豆油中溶解，然后加入BHT，搅拌溶解，冷却后加入盐酸头孢噻呋，搅拌混匀，然后加入天蚕素抗菌肽搅拌混匀，补注射级大豆油至全量搅拌混匀，均质，分装包装即得。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111228211A (zh) * | 2020-01-14 | 2020-06-05 | 开封嘉骏生物科技有限公司 | 一种盐酸头孢噻呋注射剂的生产配方及其生产工艺 |
| CN114224835A (zh) * | 2021-12-28 | 2022-03-25 | 福建傲农生物制药有限公司 | 一种复方盐酸头孢噻呋注射液及其制备方法和应用 |
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