CN107308439A - 一种复方杨树花口服液及其制备方法 - Google Patents
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Abstract
本发明公开了一种复方杨树花口服液及其制备方法,属于兽药制剂技术领域。该口服液每100ml口服液组成为:杨树花提取液50‑70ml、黄芩提取液10‑20ml、苦荞茶提取液10‑20ml、亚硫酸氢钠5‑10g、大蒜素5‑10g、EDTA‑2Na 1‑5g、甘氨酸1‑3g、抗菌肽1‑5g、余量无菌水。本发明制备的复方杨树花口服液能防止细菌产生耐药性,与常见抗生素类有很好的药物协同效应,具有非常强的表面活性,对病原微生物细胞膜能迅速穿透失水死亡。对急性胃肠道细菌性疾病有特效,对多种病毒、真菌、球虫也有一定的杀灭作用。
Description
技术领域
本发明涉及一种兽用药物制剂技术领域,具体地说是一种复方杨树花口服液及其制备方法。
背景技术
近年来,随着养殖业的发展和规模扩大,畜禽疾病日益多样化、复杂化,大量的化学药物在畜禽生产中使用,药物的滥用使病原微生物耐受性增加,不仅加大了治疗疾病的难度,还严重威胁着人类的健康。
家禽细菌性肠炎是家禽常发的一种普遍型疾病,是由致病性大肠杆菌、沙门氏菌、李氏杆菌等细菌,病原主要是革兰氏阴性菌,其中少部分革兰氏阳性菌引起,大多数为单一感染,少数为两种或数种细菌混合感染,病禽主要变现为腹泻、拉黄色、黄绿、灰白等颜色粪便,有的呈水样,有的带饲料残渣或完全不消化的饲料,粪便经常污染肛门周围,严重甚至出现栓塞,堵塞肛门,病禽脱水严重、死亡率高。
杨树花(别名梧树芒,杨树吊),为杨柳科植物毛白杨Populus Carr.、加拿大杨Populus canadensis Moench或同属数种植物的干燥雄花序。春季花开时采收,除去杂质,晒干。性味苦,寒。归肝、胆、大肠经。功能为清热解毒,化湿止泻。主治湿热下痢,幼畜泄泻。现代医学研究表明可直接抑杀病原体,对各种痢疾杆菌、大肠杆菌、肺炎双球菌、乙型链球菌、金黄色葡萄球菌和伤寒杆菌等均有一定的抑菌作用。提高机体的抵抗力,对抗免疫抑制剂,调节机体的免疫功能,有效缓解畜禽发病期间的各种应激反应,使动物胃肠肌及括约肌张力提高。传统中药杨树花口服液对细菌、病毒引起的畜禽消化道疾病如痢疾、肠炎等有显著的疗效。但随着养殖规模和养殖量不断增长,畜禽消化道疾病经常表现为混合感染,病毒、细菌耐药性逐渐增强等新特征,使用单方杨树花口服液用药治疗时间延长、效果也并不理想,给家禽养殖者带来较大的损失。
发明内容
为了克服现有技术中的不足之处,本发明提供一种复方杨树花口服液及制备方法。本发明制备的复方杨树花口服液能防止细菌产生耐药性,与常见抗生素类有很好的药物协同效应,具有非常强的表面活性,对病原微生物细胞膜能迅速穿透失水死亡。对急性胃肠道细菌性疾病有特效,对多种病毒、真菌、球虫也有一定的杀灭作用。
本发明采用以下技术方案:
一种复方杨树花口服液,每100ml口服液组成为:杨树花提取液50-70ml、黄芩提取液 10-20ml、苦荞茶提取液10-20ml、亚硫酸氢钠5-10g、大蒜素5-10g、EDTA-2Na 1-5g、甘氨酸1-3g、抗菌肽1-5g、余量无菌水。
所述的复方杨树花口服液,每100ml口服液组成为:杨树花提取液60ml、黄芩提取液 15ml、苦荞茶提取物15ml、亚硫酸氢钠7g、大蒜素7g、EDTA-2Na 3g、甘氨酸2g、抗菌肽3g、余量无菌水。
上述的复方杨树花口服液的制备方法,它包括以下步骤:
1)将杨树花和50℃的温水按照料液比为1g:20ml混合浸泡30-45min后大火煎煮至沸腾,换慢火继续煎煮30分钟,抽滤后得一次提取液和滤渣;向滤渣中加入5倍于其重量的冷水,以大火煎至沸腾后换小火煎煮30分钟,抽滤后得二次提取液;将上述一次提取液和二次提取液混合加热至沸腾后15分钟即得杨树花提取液;
2)采用与步骤1)中相同的处理方法获得黄芩提取液和苦荞茶提取液,然后与步骤1) 所得杨树花提取液混合得到混合药液;
3)将混合药液的pH用稀盐酸调节为3.8,然后加入亚硫酸氢钠、EDTA-2Na、甘氨酸搅拌溶解完全,煮沸30分钟后冷却至室温;
4)将步骤3)处理所得的混合药液用氢氧化钠调节pH至7.0,然后将大蒜素、抗菌肽加入其中搅拌溶解完全,然后将混合液离心5分钟,取上清液;
5)将步骤4)所得上清液采用0.65微米微孔滤膜进一步超滤后,加无菌水至全量灌装,灭菌即得复方杨树花口服液。
所述步骤4)中离心机转速为7000r/min。
本发明的有益效果是:本发明将杨树花、黄芩、苦荞茶提取物联合使用,提高了杨树花的生物利用度,增强疗效,三者联合作用抗菌效果优异,临床上主治猪的大肠杆菌病的预防和治疗,代替部分抗生素的应用,减少临床上的药物残留,绿色环保,无毒副作用。同时本发明的成分中还含有甘氨酸和大蒜素,这几种物质的加入又增加了这种协同作用,使该产品对多种原因(如霉菌、病毒、各种肠道致病菌等)引起的肠炎腹泻的治疗具有良好的治疗效果。此外,本发明的口服液也可阶段性添加使用起到很好的肠道保健作用,粪便成形、消化细腻、显著降低料肉比、明显改善肉体品质。
具体实施方式
下面结合具体实施例对本发明作进一步的详细说明。
实施例1
一种复方杨树花口服液,每100ml口服液组成为:杨树花提取液70ml、黄芩提取液20ml、苦荞茶提取液20ml、亚硫酸氢钠10g、大蒜素10g、EDTA-2Na 5g、甘氨酸3g、抗菌肽5g、余量无菌水。
上述的复方杨树花口服液的制备方法,它包括以下步骤:
1)将杨树花和50℃的温水按照料液比为1g:20ml混合浸泡30-45min后大火煎煮至沸腾,换慢火继续煎煮30分钟,抽滤后得一次提取液和滤渣;向滤渣中加入5倍于其重量的冷水,以大火煎至沸腾后换小火煎煮30分钟,抽滤后得二次提取液;将上述一次提取液和二次提取液混合加热至沸腾后15分钟即得杨树花提取液;
2)采用与步骤1)中相同的处理方法获得黄芩提取液和苦荞茶提取液,然后与步骤1) 所得杨树花提取液混合得到混合药液;
3)将混合药液的pH用稀盐酸调节为3.8,然后加入亚硫酸氢钠、EDTA-2Na、甘氨酸搅拌溶解完全,煮沸30分钟后冷却至室温;
4)将步骤3)处理所得的混合药液用氢氧化钠调节pH至7.0,然后将大蒜素、抗菌肽加入其中搅拌溶解完全,然后将混合液离心5分钟,取上清液;所述离心机转速为7000r/min;
5)将步骤4)所得上清液采用0.65微米微孔滤膜进一步超滤后,灌装,灭菌即得复方杨树花口服液。
实施例2
一种复方杨树花口服液,每100ml口服液组成为:杨树花提取液50ml、黄芩提取液10ml、苦荞茶提取液10ml、亚硫酸氢钠5g、大蒜素5g、EDTA-2Na 1g、甘氨酸1g、抗菌肽1g、余量无菌水。
上述的复方杨树花口服液的制备方法,它包括以下步骤:
1)将杨树花和50℃的温水按照料液比为1g:20ml混合浸泡30-45min后大火煎煮至沸腾,换慢火继续煎煮30分钟,抽滤后得一次提取液和滤渣;向滤渣中加入5倍于其重量的冷水,以大火煎至沸腾后换小火煎煮30分钟,抽滤后得二次提取液;将上述一次提取液和二次提取液混合加热至沸腾后15分钟即得杨树花提取液;
2)采用与步骤1)中相同的处理方法获得黄芩提取液和苦荞茶提取液,然后与步骤1) 所得杨树花提取液混合得到混合药液;
3)将混合药液的pH用稀盐酸调节为3.8,然后加入亚硫酸氢钠、EDTA-2Na、甘氨酸搅拌溶解完全,煮沸30分钟后冷却至室温;
4)将步骤3)处理所得的混合药液用氢氧化钠调节pH至7.0,然后将大蒜素、抗菌肽加入其中搅拌溶解完全,然后将混合液离心5分钟,取上清液;所述离心机转速为7000r/min;
5)将步骤4)所得上清液采用0.65微米微孔滤膜进一步超滤后,加无菌水至全量,灌装,灭菌即得复方杨树花口服液。
实施例3
一种复方杨树花口服液,每100ml口服液组成为:杨树花提取液60ml、黄芩提取液15ml、苦荞茶提取物15ml、亚硫酸氢钠7g、大蒜素7g、EDTA-2Na 3g、甘氨酸2g、抗菌肽3g、余量无菌水。
上述的复方杨树花口服液的制备方法,它包括以下步骤:
1)将杨树花和50℃的温水按照料液比为1g:20ml混合浸泡30-45min后大火煎煮至沸腾,换慢火继续煎煮30分钟,抽滤后得一次提取液和滤渣;向滤渣中加入5倍于其重量的冷水,以大火煎至沸腾后换小火煎煮30分钟,抽滤后得二次提取液;将上述一次提取液和二次提取液混合加热至沸腾后15分钟即得杨树花提取液;
2)采用与步骤1)中相同的处理方法获得黄芩提取液和苦荞茶提取液,然后与步骤1) 所得杨树花提取液混合得到混合药液;
3)将混合药液的pH用稀盐酸调节为3.8,然后加入亚硫酸氢钠、EDTA-2Na、甘氨酸搅拌溶解完全,煮沸30分钟后冷却至室温;
4)将步骤3)处理所得的混合药液用氢氧化钠调节pH至7.0,然后将大蒜素、抗菌肽加入其中搅拌溶解完全,然后将混合液离心5分钟,取上清液;所述离心机转速为7000r/min;
5)将步骤4)所得上清液采用0.65微米微孔滤膜进一步超滤后,加无菌水至全量,灌装,灭菌即得复方杨树花口服液。
对比例1
制备单一杨树花口服液
复方杨树花口服液,每100ml口服液组成为:杨树花提取液60ml、亚硫酸氢钠7g、EDTA-2Na 3g、抗菌肽3g、余量无菌水。
对比例2
制备含黄芩提取液的杨树花口服液
复方杨树花口服液,每100ml口服液组成为:杨树花提取液60ml、黄芩提取液15ml、亚硫酸氢钠7g、EDTA-2Na 3g、抗菌肽3g、余量无菌水。
对比例3
制备含苦荞茶提取液的杨树花口服液
复方杨树花口服液,每100ml口服液组成为:杨树花提取液60ml、黄芩提取液15ml、苦荞茶提取物15ml、亚硫酸氢钠7g、EDTA-2Na 3g、抗菌肽3g、余量无菌水。
对比例4
制备含甘氨酸的杨树花口服液
复方杨树花口服液,每100ml口服液组成为:杨树花提取液60ml、黄芩提取液15ml、苦荞茶提取物15ml、亚硫酸氢钠7g、EDTA-2Na 3g、甘氨酸2g、抗菌肽3g、余量无菌水。对比例5
制备含大蒜素的杨树花口服液
复方杨树花口服液,每100ml口服液组成为:杨树花提取液60ml、黄芩提取液15ml、苦荞茶提取物15ml、亚硫酸氢钠7g、EDTA-2Na 3g、大蒜素7g、抗菌肽3g、余量无菌水。临床药效学试验
试验药品:实施例1-3制备的口服液和对比例1-5制备的口服液。
试验动物:山东临沂郊区某猪场2周龄仔猪,病猪出现以下症状:厌食、呕吐、腹泻、脱水和酸碱平衡紊乱,粪便呈黄色、灰色或黑色,水样或糊状,腥臭,持续2-4天,诊断为病毒性腹泻。
试验方法:随机选择该猪场体重为5±1Kg的仔猪400头,平均分为8组,试验一组服用本发明实例1的产品,试验二组服用本发明实例2的产品,试验三组服用本发明实例3 的产品,试验四组服用本发明对比例1的产品,试验五组服用本发明对比例2的产品,试验六组服用本发明对比例3的产品,试验七组服用本发明对比例4的产品,试验八组服用本发明对比例5的产品,所有试验组一次用药,具体方法为药物与水混合勾兑喂食,勾兑比例为每1ml药物用水40g,每组药物用量为按体重每5ml/kg,一日一次,连续给药3天,每天观察病猪临床变化,并进行记录。
疗效判断标准:
治愈:病猪症状消失,肛门干燥,无红肿,粪便恢复正常,精神转好,食欲增长;
有效:猪病症状减轻、粪便由水样转为糊状,精神、食欲明显好转;
无效:症状未见消失,试验期间腹泻虚脱严重或致死。
临床药效试验结果:具体见表1。
表1临床药效学试验结果
由上述表1可以看出本发明的复方杨树花口服液对猪仔腹泻的治疗效果非常显著,总有效率可以达到99%以上。而与对比例1-5相比,本发明的口服液效果要更好。将对比例1-4 的口服液与对比例1的单一杨树花口服液相比,单独增加黄芪、甘氨酸、苦荞茶等几种物质对猪仔腹泻的治疗效果也有提高,但效果并不明显。这是由于本发明制备的口服液中多种组分共同作用,尤其是加入抗氧化剂亚硫酸氢钠、金属离子络合剂EDTA-2Na增加了口服液中有效成分的稳定性,药物有效成分增多,药效高。同时还添加了适量的黄芪提取液、苦荞茶提取液,多种中药的有效成分与甘氨酸、大蒜素、抗菌肽组分协同作用,可以有效的治疗禽畜病毒性腹泻、肠炎。本发明的口服液抗菌效果更好,药效迅猛,药力持久,能迅速杀灭病毒、细菌及变异的菌毒株;提高机体的抵抗力,调节机体的免疫功能,有效缓解畜禽发病期间的各种应激反应,提高动物胃肠肌及括约肌张力,抑制分泌机能,表现出收敛止泄作用。从而有效地预防和治疗畜禽的痢疾或肠炎,优化了治疗效果。使用本发明复方杨树花口服液的同时还可与抗病毒药物同用,进一步提高动物抵抗病毒的能力。服用后2~3天即可痊愈,治疗效果明显,使用后不易复发。
Claims (4)
1.一种复方杨树花口服液,其特征在于,每100ml口服液组成为:杨树花提取液50-70ml、黄芩提取液10-20ml、苦荞茶提取液10-20ml、亚硫酸氢钠5-10g、大蒜素5-10g、EDTA-2Na1-5g、甘氨酸1-3g、抗菌肽1-5g、余量无菌水。
2.根据权利要求1所述的复方杨树花口服液,其特征在于,每100ml口服液组成为:杨树花提取液60ml、黄芩提取液15ml、苦荞茶提取物15ml、亚硫酸氢钠7g、大蒜素7g、EDTA-2Na3g、甘氨酸2g、抗菌肽3g、余量无菌水。
3.一种权利要求1或2所述的复方杨树花口服液的制备方法,其特征在于,它包括以下步骤:
1)将杨树花和50℃的温水按照料液比为1g:20ml混合浸泡30-45min后大火煎煮至沸腾,换慢火继续煎煮30分钟,抽滤后得一次提取液和滤渣;向滤渣中加入5倍于其重量的冷水,以大火煎至沸腾后换小火煎煮30分钟,抽滤后得二次提取液;将上述一次提取液和二次提取液混合加热至沸腾后15分钟即得杨树花提取液;
2)采用与步骤1)中相同的处理方法获得黄芩提取液和苦荞茶提取液,然后与步骤1)所得杨树花提取液混合得到混合药液;
3)将混合药液的pH用稀盐酸调节为3.8,然后加入亚硫酸氢钠、EDTA-2Na、甘氨酸搅拌溶解完全,煮沸30分钟后冷却至室温;
4)将步骤3)处理所得的混合药液用氢氧化钠调节pH至7.0,然后将大蒜素、抗菌肽加入其中搅拌溶解完全,然后将混合液离心5分钟,取上清液;
5)将步骤4)所得上清液采用0.65微米微孔滤膜进一步超滤后,加无菌水至全量,灌装,灭菌即得复方杨树花口服液。
4.根据权利要求3所述的复方杨树花口服液的制备方法,其特征在于,所述步骤4)中离心机转速为7000r/min。
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