CN104055731B - 一种抗球虫药物氟腺嘌呤溶液及其制备方法 - Google Patents
一种抗球虫药物氟腺嘌呤溶液及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种抗球虫药物氟腺嘌呤溶液制剂,包括下列百分比组成:氟腺嘌呤4‑10%,乳化剂0.5‑10%,溶解剂40‑90%,溶剂0.5‑50%,去离子水1‑50%,氟腺嘌呤为W/V,其他溶媒则为V/V,W的单位为克(g),V的单位为毫升(mL)。本发明还公开了此种抗球虫药物氟腺嘌呤溶液的制备方法。本发明的氟腺嘌呤制剂在与水混合后不析出、沉淀,在兽医临床上使用方便,节省了大量的人力、物力。该制备方法简单,稳定性好,易于存储运输,具有较好的应用推广前景。
Description
【所属技术领域】
本发明涉及兽药领域,确切的说是一种抗球虫药物氟腺嘌呤的制剂及其制备方法。
【背景技术】
球虫病是一种原虫类的寄生虫疾病,它主要寄生虫与动物的体内,特别是家禽(鸡)非常普遍,对动物的机体造成较大的损害。鸡球虫病是由艾美耳属一种或多种球虫寄生于鸡的肠上皮细胞内所引起的寄生性原虫病,具有发病率高,危害大等特点。在世界各地普遍发生。发病率可达80~100%,死亡率20~30%,严重时高达80%,全世界因鸡球虫病所造成的损失每年约20亿英镑。在养鸡生产中,几乎所有雏鸡饲料中都必须加入抗球虫药物,我国每年投入预防本病的药物费用平均每羽鸡0.3~0.5元,每年用于防治鸡球虫病的药费达数亿元人民币,占鸡病全部防治费用的近1/3。
氟腺嘌呤是上个世纪有美国Merck公司开发的抗球虫药物,其主要结构与其他抗球虫药物不同,与其他抗球虫药无交叉耐药性。经研究证实,氟腺嘌呤具有广谱抗球虫活性,对鸡的多种艾美耳球虫,如柔嫩艾美耳球虫、脆弱艾美耳球虫、毒害艾美耳球虫、巨型艾美耳球虫、堆型艾美耳球虫、布氏艾美耳球虫均有较强的抑制和杀灭作用。由于在国内没有在临床上大规模的应用,其对鸡球虫病具有良好的防治效果,是一种高效、广谱的抗球虫药。
氟腺嘌呤化学名称:6-氨基-9-(2-氯-6-氟苄基)-9H-嘌呤,分子结构如下:
分子式:C12H9ClFN5
分子量:277.68
由于氟腺嘌呤在上个世纪发明的药物,因为其具有良好的抗球虫作用,另外还有促进增重作用,主要用于添加到饲料中,用来治疗和预防鸡的球虫病。氟腺嘌呤不溶于水,到目前为止一直没有其溶液制剂的报道。随着养殖业的集约化、规模化的发展,拌料给药已经存在一定的局限性,造成了大量的人力、物力的浪费。
【发明内容】
为了解决上述的技术问题,本发明提供了一种氟腺嘌呤溶液制剂,能与水混合而不析出、沉淀;成分稳定,使用方便;该溶液制剂制备的方法简单、易行,具有较高的应用推广价值。
一种抗球虫药物氟腺嘌呤溶液制剂,其特征在于包括由下列百分比组成:氟腺嘌呤4-10%,乳化剂0.5-10%,溶解剂40-90%,溶剂0.5-50%,去离子水1-50%,氟腺嘌呤为W/V,其他溶媒则为V/V,W的单位为克(g),V的单位为毫升(mL)。
所述的乳化剂包括吐温系列(吐温20、吐温40、吐温60、吐温80等)、司盘系列(司盘20、司盘60、司盘80)、曲拉通系列(曲拉通X-35、曲拉通X-100、 曲拉通X-114)、曲拉通(OP乳化)、蓖麻油聚氧乙烯醚(蓖麻油聚氧乙烯醚-40、蓖麻油聚氧乙烯醚-80)、氢化蓖麻油聚氧乙烯醚、聚氧乙烯氢化蓖麻油中的至少一种。
所述的溶解剂包括乙酸、冰乙酸、乳酸中的至少一种。
所述的溶剂包括乙醇、无水乙醇、丙醇、丙二醇、聚乙二醇系列(聚乙二醇200、聚乙二醇400、聚乙二醇600、聚乙二醇800)、异丙醇、正丁醇中的至少一种。
所述的抗球虫药物氟腺嘌呤溶液制剂,其特征在于:所述制剂包括以下方法和步骤制备:将氟腺嘌呤溶解于溶解剂中,加热搅拌,直至形成澄清透明的溶液,再加入乳化剂和溶剂,最后加入去离子水,搅拌形成澄清透明的溶液。
所述的加入乳化剂和溶剂的顺序可以不分先后。
【具体实施方式】
下述具体实施例对本发明进行了详细的说明,通过实施例可以进一步地了解本发明,但它们不是对本发明的限定。
实施例1
分别称取4克氟腺嘌呤,加入到20mL的冰乙酸中,加热搅拌,直至溶解后至澄清透明,加入吐温60体积为4mL,搅拌均匀,加入聚乙二醇200体积为20mL,搅拌均匀后,用去离子水定容到100mL,即制得氟腺嘌呤溶液制剂。
实施例2
分别称取6克氟腺嘌呤,加入到60mL的乳酸中,加热搅拌,直至溶解后至澄清透明,加入丙二醇体积为4mL,搅拌均匀,加入无水乙醇体积为10mL,搅拌均匀后,用去离子水定容到100mL,即制得氟腺嘌呤溶液制剂。
本发明氟腺嘌呤溶液制剂临床试验
试验鸡隔离饲养至10日龄,随机分为4个组,每组20只,再依次称重编号。除阴性和阳性组外,其余试验鸡只在人工感染球虫前一天拌料给药,按氟腺嘌呤溶液制剂按照40mg/kg剂量,托曲珠利溶液250mg/kg剂量分别饮水给药,鸡自由采食和饮水。
用药24h后,取实验室保存的孢子化卵囊经离心洗去重铬酸钾,稀释至适当浓度,镜检计数,除阴性对照组外,其余各组每只鸡嗉囊灌服艾美耳球虫孢子化卵囊5.0万个,感染后随时观察,每日记录鸡的精神、发病及血便情况。感染后第7天,取鸡粪用饱和盐水漂浮法镜检有无卵囊,于第8天称重剖杀、进行病变记分和卵囊计数,计算抗球虫指数(ACI)。
阳性对照组感染后第3天,鸡采食量开始下降,同时表现精神沉郁,第4天开始出现血便,第5天血便非常明显,共死亡2只,剖解死亡鸡见盲肠高度肿大,内充满血液、血凝块,肠粘膜出现大量点状出血。存活鸡羽毛松乱,双翅下垂,个别鸡缩颈闭眼。阴性对照组鸡食欲正常、无死亡、无血便、精神状态良好。各用药剂量组:氟腺嘌呤溶液制剂组鸡群精神状态良好,无血便,无死亡;托曲珠利精神沉郁、羽毛松乱、食欲下降、消瘦,第5天开始血便明显且病鸡肛门周围留有血样粪便,均有死亡鸡;具体结果见表1。
表1 氟腺嘌呤溶液制剂临床试验
由表可以看出氟腺嘌呤溶液制剂抗球虫效果非常好,卵囊排出量少,增重率无明显影响,盲肠病变记分为0分,较好的控制了血便,表明球虫的体内繁殖受到抑制或被杀灭。球虫对托曲珠利耐药,抗球虫效力低,抗球虫效果不理 想。
以上内容是结合具体的实施例对本发明所作的进一步详细说明,不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干简单推演或替换,都应当视为属于本发明的保护范围。
Claims (1)
1.一种抗球虫药物氟腺嘌呤溶液制剂,其特征在于,具体的制备过程为:称取4克氟腺嘌呤,加入到20mL的冰乙酸中,加热搅拌,直至溶解后至澄清透明,加入吐温60体积为4mL,搅拌均匀,加入聚乙二醇200体积为20mL,搅拌均匀后,用去离子水定容到100mL,即制得氟腺嘌呤溶液制剂。
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CN102274173A (zh) * | 2011-09-09 | 2011-12-14 | 广州华农大实验兽药有限公司 | 一种抗球虫新药阿德呋啉溶液及其制备方法 |
CN103099810A (zh) * | 2013-01-09 | 2013-05-15 | 广州华农大实验兽药有限公司 | 一种嘌呤类抗球虫用药物及其制备方法 |
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