CN107296828A - 一种复方黄芪多糖口服液及其制备方法 - Google Patents
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Abstract
本发明公开了一种黄芪多糖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：黄芪多糖20‑30g、恩诺沙星可溶性粉5‑10g、甘氨酸1‑5g、苦荞茶提取液1‑10ml、金银花提取液1‑10ml、EDTA‑2Na 1‑5g、余量无菌水。本发明将黄芪多糖与恩诺沙星、苦荞茶提取液、金银花提取液配伍使用，发挥不同作用机制的互补和协同作用，尤其甘氨酸的加入更增加了这两种作用，从而起到更强的抗菌、抗病毒、提高免疫力的效果。
Description
技术领域
本发明属于兽药制剂技术领域，具体的涉及一种复方黄芪多糖口服液及其制备方法
背景技术
目前，家畜、家禽养殖逐步走向大型化、规模化。而这种养殖模式，如果一旦发生疫病，很快就会极速蔓延，导致家畜、家禽大面积的发病，给养殖户造成巨大的经济损失。尤其是病毒性疾病已经成为目前危害家禽养殖的头号杀手。新城疫、禽流感、肾型传支已经成为目前危害养殖最为常见的病毒病。由于病毒病造成的养殖损失巨大，肉禽高死亡、饲料报酬增高，蛋禽高死亡、产蛋下降，种禽产蛋下降在临床上屡见不鲜。病毒病是一类顽固性疾病，其治疗效果并不理想。平时主要靠疫苗接种预防和治疗。但有些病毒病由于各种原因，至今仍然没有较为理想的疫苗。病毒性疾病一旦发病后的治疗效果都不是很理想。
黄芪多糖是豆科植物蒙古黄芪或膜荚黄芪的干燥根经提取、浓缩、纯化而成的水溶性杂多糖。黄芪多糖能强化机体的体液免疫功能，产生大量的免疫球蛋白和补体，并有清热解毒，调节机体代谢机能紊乱之功效，能提高动物体的免疫力，增强其抗病能力。主要用于抗病毒治疗，对鸡新城疫病、法氏囊病、喉气管炎以及猪圆环病毒病、蓝耳病、传染性胃肠炎等均具有突出的防治功效。但随着养殖规模和养殖量不断增长，畜禽病毒性疾病经常表现为混合感染，呈现出病毒、细菌耐药性逐渐增强等新特征，使用单方黄芪多糖口服液用药治疗效果并不理想。
发明内容
针对现有技术的不足，本发明提供了一种复方黄芪多糖口服液及其制备方法。本发明的口服液治疗病毒病效果显著，对非典型性新城疫、传支等病毒病有直接的治疗作用；此外还具有免疫补位作用，在疫苗接种时同时使用，能有效避免免疫间隙带来的损失。
本发明采用以下技术方案：
一种黄芪多糖口服液，每100ml口服液组成为：黄芪多糖20-30g、恩诺沙星可溶性粉5-10g、甘氨酸1-5g、苦荞茶提取液1-10ml、金银花提取液1-10ml、EDTA-2Na 1-5g、余量无菌水。
优选的，所述的黄芪多糖口服液，每100ml口服液组成为：黄芪多糖25g、恩诺沙星可溶性粉8g、甘氨酸3g、苦荞茶提取液5ml、金银花提取液5ml、EDTA-2Na 3g、余量无菌水。
上述的黄芪多糖口服液的制备方法，它包括以下步骤：
1)将苦荞茶和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分钟即得苦荞茶提取液，备用；
2)将金银花采用和步骤1)中相同的方法获得金银花提取液，备用；
3)将处方量的黄芪多糖和恩诺沙星可溶性粉溶于适量水中，搅拌溶解完全，得混合溶液；
4)将处方量苦荞茶提取液和金银花提取液加入上述混合液中搅拌完全，然后向其中加入处方量甘氨酸、EDTA-2Na，搅拌溶解完全，加无菌水至全量，搅拌10-20min；
5)将步骤4)所得溶液过滤，灌封，灭菌，即得本发明的复方黄芪多糖口服液。
本发明的有益效果是：本发明将黄芪多糖与恩诺沙星、苦荞茶提取液、金银花提取液配伍使用，发挥不同作用机制的互补和协同作用，尤其甘氨酸的加入更增加了这两种作用，从而起到更强的抗菌、抗病毒、提高免疫力的效果，与单一使用的抗病毒效果相比，差异显著，可用于抗病毒治疗，如鸡新城疫病、法氏囊病、喉气管炎以及猪圆环病毒病、蓝耳病、传染性胃肠炎等。配方中少量的金银花提取液和苦荞茶提取液在与黄芪多糖起到协同抗菌作用的同时还作为抗氧化剂，与金属离子络合剂EDTA-2Na共同作用，保证了口服液的长期稳定性。
具体实施方式
下面结合具体的实施例对本发明做进一步的详细说明。
实施例1
一种黄芪多糖口服液，每100ml口服液组成为：黄芪多糖20g、恩诺沙星可溶性粉5g、甘氨酸1g、苦荞茶提取液1ml、金银花提取液1ml、EDTA-2Na 1g、余量无菌水。
上述的黄芪多糖口服液的制备方法，它包括以下步骤：
1)将苦荞茶和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分钟即得苦荞茶提取液，备用；
2)将金银花采用和步骤1)中相同的方法获得金银花提取液，备用；
3)将处方量的黄芪多糖和恩诺沙星可溶性粉溶于适量水中，搅拌溶解完全，得混合溶液；
4)将处方量苦荞茶提取液和金银花提取液加入上述混合液中搅拌完全，然后向其中加入处方量甘氨酸、EDTA-2Na，搅拌溶解完全，加无菌水至全量，搅拌10-20min；
5)将步骤4)所得溶液过滤，灌封，灭菌，即得本发明的复方黄芪多糖口服液。
实施例2
一种黄芪多糖口服液，每100ml口服液组成为：黄芪多糖30g、恩诺沙星可溶性粉10g、甘氨酸5g、苦荞茶提取液10ml、金银花提取液10ml、EDTA-2Na 5g、余量无菌水。
制备方法同实施例1。
实施例3
一种黄芪多糖口服液，每100ml口服液组成为：黄芪多糖25g、恩诺沙星可溶性粉8g、甘氨酸3g、苦荞茶提取液5ml、金银花提取液5ml、EDTA-2Na 3g、余量无菌水。
制备方法同实施例1。
对比例1
单一黄芪多糖口服液的制备
每100ml口服液组成为：黄芪多糖25g、甘氨酸3g、苦荞茶提取液5ml、金银花提取液5ml、EDTA-2Na 3g、余量无菌水。
对比例2
单一恩诺沙星口服液的制备
每100ml口服液组成为：恩诺沙星可溶性粉8g、甘氨酸3g、苦荞茶提取液5ml、金银花提取液5ml、EDTA-2Na 3g、余量无菌水。
对比例3
无甘氨酸的口服液的制备
每100ml口服液组成为：黄芪多糖25g、恩诺沙星可溶性粉8g、苦荞茶提取液5ml、金银花提取液5ml、EDTA-2Na 3g、余量无菌水。
对比例4
无苦荞茶、金银花的口服液的制备
每100ml口服液组成为：黄芪多糖25g、恩诺沙星可溶性粉8g、EDTA-2Na 3g、余量无菌水。
本发明的复方黄芪多糖口服液在临床治疗鸡新城疫的应用效果试验
试验材料与方法：山东临沂某种鸡场自然发病病例1600例，平均分为8组。其中1-3组分别服用本发明实例1-3的产品，4-7组分别服用本发明对比例1-4的产品，第8组为空白对照组，不服用任何药物治疗。用法与用量：除空白对照组外，试验组将复方黄芪多糖口服液每100ml兑水250Kg，自由饮水给药。连续给药5天，统计死亡率。
疾病诊断：临床表现为精神沉郁，食欲减退或不吃，鸡只表现呼吸困难，张口呼吸。口中可见粘液增加，呈灰白色，鸡只甩头时常见粘液流出。嗦囊空虚，内含液体呈波动感。常见下痢，有的呈绿色下痢便。
试验结果：具体见表1。
表1临床应用试验结果统计
| 组别 | 数量 | 死亡数 | 死亡率％ |
| 实施例1 | 200 | 15 | 7.5 |
| 实施例2 | 200 | 10 | 5.0 |
| 实施例3 | 200 | 12 | 6.0 |
| 对比例1 | 200 | 45 | 22.5 |
| 对比例2 | 200 | 76 | 38 |
| 对比例3 | 200 | 56 | 28 |
| 对比例4 | 200 | 20 | 10 |
| 空白对照 | 200 | 128 | 64.0 |
从上述表1中的结果可以看出，与空白对照组相比，本发明实施例1-3制备的复方黄芪多糖口服液对新城疫的治疗效果较好，死亡率低。将对比例1、对比例2、本发明的口服液和空白对照相比，单一的黄芪多糖口服液和单一恩诺沙星口服液对鸡新城疫的治疗效果较差，死亡率要明显高于本发明的产品；将对比例3与本发明的实施例1-3的产品相比可以发现，对于本发明口服液来说配方中有无甘氨酸作为增效剂，差异非常显著，甘氨酸可以显著增强黄芪多糖和恩诺沙星的抗菌杀菌效果；而将对比例4与本发明的产品应用例比较可知，苦荞茶提取液和金银花提取液对本发明的抗病毒效果虽然也有作用，但作用并不显著。这是由于本发明配方中的金银花和苦荞茶虽然也含有中药杀菌抗菌成分，但整体剂量使用较小，杀菌作用也较小，但二者共同使用时其抗氧化作用显著，与金属离子络合剂共用，提高了本发明口服液的稳定性。
本发明还对所制备的复方黄芪多糖口服液的稳定性进行了考察。
温度加速试验：本实验研究了复方黄芪多糖口服液在40℃温度加速实验(6个月)。将复方黄芪多糖(3个批次)按市场包装，放在盛饱和氯化钠溶液的密闭干燥器中(相对湿度约为75％)，再将干燥器置于隔水式电热恒温培养箱中维持40℃温度。在温度加速试验6个月的试验期内每个月取样考察外观、色泽、澄明度、pH值及不溶性微粒等。结果表明：从第3个月起pH开始增加，共增加了0.3；但含量下降并不明显，范围在0.1％-2％之间，从第5个月开始，含量下降幅度较大，达2.5％-3.2％，接近前四个月的和，但总的下降范围在允许的范围之内；其余指标没有明显的变化，未见色泽、澄明度的变化，也没有发现不溶性微粒。
长期稳定性试验：本试验研究了复方黄芪多糖口服液的长期稳定性试验(18个月)。将黄芪多糖制剂(3个批次)按市场包装，置于阴凉、干燥、避光处保存，每隔一个月取样考察外观色泽、澄明度、pH值和不溶性微粒等。结果表明：复方黄芪多糖口服液比较稳定，在室温(大约16℃-25℃范围)、避光、阴凉干燥的环境下，其含量下降很少，在试验期的18个月下降范围在3％-4％。黄芪多糖含量没有明显的变化，外观色泽没有可见的变化，溶液澄清透明，没有不溶性微粒出现。
Claims (3)
1.一种黄芪多糖口服液，其特征在于，每100ml口服液组成为：黄芪多糖20-30g、恩诺沙星可溶性粉5-10g、甘氨酸1-5g、苦荞茶提取液1-10ml、金银花提取液1-10ml、EDTA-2Na 1-5g、余量无菌水。
2.根据权利要求1所述的黄芪多糖口服液，其特征在于，每100ml口服液组成为：黄芪多糖25g、恩诺沙星可溶性粉8g、甘氨酸3g、苦荞茶提取液5ml、金银花提取液5ml、EDTA-2Na3g、余量无菌水。
3.一种权利要求1或2所述的黄芪多糖口服液的制备方法，其特征在于，它包括以下步骤：
1)将苦荞茶和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分钟即得苦荞茶提取液，备用；
2)将金银花采用和步骤1)中相同的方法获得金银花提取液，备用；
3)将处方量的黄芪多糖和恩诺沙星可溶性粉溶于适量水中，搅拌溶解完全，得混合溶液；
4)将处方量苦荞茶提取液和金银花提取液加入上述混合液中搅拌完全，然后向其中加入处方量甘氨酸、EDTA-2Na，搅拌溶解完全，加无菌水至全量，搅拌10-20min；
5)将步骤4)所得溶液过滤，灌封，灭菌，即得本发明的复方黄芪多糖口服液。
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