CN107823186A - 一种恩诺沙星肠溶粉配方及制备方法 - Google Patents
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Abstract
本发明公开了一种恩诺沙星肠溶粉配方及制备方法,原料重量份为:恩诺沙星50~75份,硬脂酸5~10份,淀粉10~25份,滑石粉0.5~3份,丙烯酸树脂4~15份。一种恩诺沙星肠溶粉制备方法,包括第一层包被、制粒及第二层包被、烘干。本发明采用分子态微囊化工艺,使本品在水中和口腔内不溶解,有效的解决了苦味、异味对猪采食量造成的影响,同时通过肠溶释技术,在肠道中快速释放、吸收,迅速到达峰浓度,达到有效血液浓度,临床疗效确实。
Description
技术领域
本发明涉及一种兽药制备工艺,特别是涉及一种恩诺沙星肠溶粉配方及制备方法。
背景技术
恩诺沙星(Enrofloxacin)为第三代喹诺酮类抗菌药物,又名乙基环丙氟哌酸、乙基环丙沙星、恩氟沙星等,其外观为微黄色或淡橙黄色结晶性粉末;无臭,味苦;遇光后颜色逐渐变为橙红色。在氯仿中易溶,在水中极微溶解,在空气中易吸潮结块。恩诺沙星抗菌谱广,杀菌活性强,能杀灭呼吸道、消化道以及生殖道病原菌,对革兰氏阴性菌、阳性菌、支原体、衣原体等具有良好的杀灭作用,且与其他抗菌药物无交叉耐药性。恩诺沙星具有较高的生物利用度,单胃动物静注、内服和肌注给药吸收迅速和较完全,组织穿透能力强,能穿过血乳屏障,到达胎儿。
但恩诺沙星具有苦味,直接饲喂易导致拒食,采食量下降,而且对胃具有强烈的化学刺激作用,易引起胃痉挛,导致动物出现呕吐,导致恩诺沙星难以通过口服直接给药。肌肉注射恩诺沙星注射液,但注射工作量大,对猪的应激也较大。此外恩诺沙星遇光易分解,易吸潮结块,导致其药效降低,同时也为生产加工带来麻烦。
发明内容
本发明的目的是为克服上述不足,提供一种无味、使用方便、效果好的恩诺沙星肠溶粉配方及制备方法。
本发明解决其技术问题所采用的技术方案:一种恩诺沙星肠溶粉配方,原料重量份为:恩诺沙星50~75份,硬脂酸5~10份,淀粉10~25份,滑石粉0.5~3份,丙烯酸树脂4~15份。
一种恩诺沙星肠溶粉制备方法,包括以下步骤:
1、第一层包被:按照原料重量份,称取恩诺沙星,溶于1~1.2mol/L的氢氧化钠溶液中,于45~55℃加入熔融状态的硬脂酸,室温下搅拌均匀,制成恩诺沙星硬脂酸混合体;
2、制粒及第二层包被:将恩诺沙星硬脂酸混合体加入淀粉、滑石粉,进行制粒和滚圆,在滚圆过程中,在颗粒表面喷涂丙烯酸树脂,得到近似球形的微囊颗粒;
3、烘干:将恩诺沙星微囊颗粒本成品烘干,得到最终成品。
所述微囊颗粒的直径为50~200μm。
本发明采用分子态微囊化工艺,使本品在水中和口腔内不溶解,有效的解决了苦味、异味对猪采食量造成的影响,同时通过肠溶释技术,在肠道中快速释放、吸收,迅速到达峰浓度,达到有效血液浓度,临床疗效确实。
本发明通过肠溶控释技术,使得恩诺沙星水溶性物质载体在胃内缓慢崩解,在肠道中控制释放,肠道全程释放,缓慢吸收,临床疗效确实。药物和载体以分子态融合在一起,避免在储存及使用过程中出现氧化、降解、挥发、结块等现象,很大程度上提高了药物稳定性。形态规则、大小均匀的球形颗粒,流动性好,方便与饲料混合均匀,药物能够更好的被利用。分子态微囊避免混饲药物间发生不良反应,安全性高。
本发明通过改进技术配方,并对恩诺沙星进行二层包被,避免恩诺沙星见光分解,减少药效损失,完全掩盖普通恩诺沙星苦味,减少猪只拒食,不刺激胃,避免采食动物胃痉挛和反胃,方便生产。同时在使用过程中能充分发挥恩诺沙星强有力的杀菌作用。
动物药效试验:
2017年4月,四川富顺县某养殖场,35-45日龄仔猪68头出现精神萎靡、呕吐、拉稀、水样腹泻,经细菌培养发现感染大肠杆菌、沙门氏菌。将68头仔猪分成3组,分别为恩诺沙星肠溶粉治疗组、市售某公司恩诺沙星可溶性粉治疗组、空白组。治疗组将药物1kg拌料1000kg,供猪只自由采食,连用2-3日。见效判断标准:拉稀、腹泻的次数及量明显减少,粪便由水状转为糊状,症状明显减轻、好转。治愈判断标准:拉稀、腹泻停止,猪只体况回复正常。
试验结果对比:恩诺沙星肠溶粉在适口性、治疗效果、疗效稳定性等方面明显优于普通市售某公司恩诺沙星可溶性粉。
具体实施方式
实施例1:
一种恩诺沙星肠溶粉配方,原料重量份为:恩诺沙星61份,硬脂酸8份,淀粉20份,滑石粉1份,丙烯酸树脂10份。
一种恩诺沙星肠溶粉制备方法,包括以下步骤:
1、第一层包被:按照原料重量份,称取恩诺沙星,溶于1~1.2mol/L的氢氧化钠溶液中,于45~55℃加入熔融状态的硬脂酸,室温下搅拌均匀,制成恩诺沙星硬脂酸混合体;
2、制粒及第二层包被:将恩诺沙星硬脂酸混合体加入淀粉、滑石粉,进行制粒和滚圆,在滚圆过程中,在颗粒表面喷涂丙烯酸树脂,得到近似球形的微囊颗粒;
3、烘干:将恩诺沙星微囊颗粒本成品烘干,得到最终成品。
所述微囊颗粒的直径为100μm。
实施例2:
一种恩诺沙星肠溶粉配方,原料重量份为:恩诺沙星50份,硬脂酸10份,淀粉25份,滑石粉2份,丙烯酸树脂13份。
一种恩诺沙星肠溶粉制备方法,包括以下步骤:
1、第一层包被:按照原料重量份,称取恩诺沙星,溶于1~1.2mol/L的氢氧化钠溶液中,于45~55℃加入熔融状态的硬脂酸,室温下搅拌均匀,制成恩诺沙星硬脂酸混合体;
2、制粒及第二层包被:将恩诺沙星硬脂酸混合体加入淀粉、滑石粉,进行制粒和滚圆,在滚圆过程中,在颗粒表面喷涂丙烯酸树脂,得到近似球形的微囊颗粒;
3、烘干:将恩诺沙星微囊颗粒本成品烘干,得到最终成品。
所述微囊颗粒的直径为50μm。
实施例3:
一种恩诺沙星肠溶粉配方,原料重量份为:恩诺沙星75份,硬脂酸5份,淀粉10份,滑石粉0.5份,丙烯酸树脂9.5份。
一种恩诺沙星肠溶粉制备方法,包括以下步骤:
1、第一层包被:按照原料重量份,称取恩诺沙星,溶于1~1.2mol/L的氢氧化钠溶液中,于45~55℃加入熔融状态的硬脂酸,室温下搅拌均匀,制成恩诺沙星硬脂酸混合体;
2、制粒及第二层包被:将恩诺沙星硬脂酸混合体加入淀粉、滑石粉,进行制粒和滚圆,在滚圆过程中,在颗粒表面喷涂丙烯酸树脂,得到近似球形的微囊颗粒;
3、烘干:将恩诺沙星微囊颗粒本成品烘干,得到最终成品。
所述微囊颗粒的直径为200μm。
Claims (3)
1.一种恩诺沙星肠溶粉配方,其特征在于:原料重量份为:恩诺沙星50~75份,硬脂酸5~10份,淀粉10~25份,滑石粉0.5~3份,丙烯酸树脂4~15份。
2.一种恩诺沙星肠溶粉制备方法,包括以下步骤:
(1)第一层包被:按照原料重量份,称取恩诺沙星,溶于1~1.2mol/L的氢氧化钠溶液中,于45~55℃加入熔融状态的硬脂酸,室温下搅拌均匀,制成恩诺沙星硬脂酸混合体;
(2)制粒及第二层包被:将恩诺沙星硬脂酸混合体加入淀粉、滑石粉,进行制粒和滚圆,在滚圆过程中,在颗粒表面喷涂丙烯酸树脂,得到近似球形的微囊颗粒;
(3)烘干:将恩诺沙星微囊颗粒本成品烘干,得到最终成品。
3.根据权利要求2所述的一种恩诺沙星肠溶粉制备方法,其特征在于:所述微囊颗粒的直径为50~200μm。
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