CN116270866A - 一种抗病毒口服液的制备方法 - Google Patents
一种抗病毒口服液的制备方法 Download PDFInfo
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Abstract
本发明提供了一种兽用抗病毒口服液及其制备方法,所述抗病毒口服液处方包含白芍、山药、栀子、黄芩、连翘、玄参、地黄、板蓝根,将所述处方量药材加入增溶剂进行提取,经静置、滤过、浓缩、再滤过、灌装、灭菌制得。本发明具有抗菌、抗病毒、保肝健脾、提高机体免疫力作用,对畜禽的瘟热症状有独特的疗效,本组方中添加增溶剂,不仅能解决长时间静置后出现沉淀现象,而且还能提高药材有效成分的溶出率,最大限度地提高中药的有效成分。
Description
技术领域
本发明涉及一种抗病毒口服液及其制备方法,属于兽药领域。
背景技术
口服液是将汤剂进一步精制、浓缩、灌封、灭菌而得到的,最早是以保健品的一种形式出现于市场,随着对中药制剂研究的深入,具有治疗效果的口服液在市场中大量涌现。现有技术中的抗病毒口服液用于禽新城疫、法氏囊等病毒以及病毒性呼吸道疾病等,有着用药方便的优势,市场需求规模巨大,但中药治疗效果不显著,且长时间静置后出现沉淀物,是口服液的一个短板;另外,中药的有效成分提高提取率的问题,仍未完全解决。
发明内容
本发明的目的是克服现有工艺的不足,提供一种兽用抗病毒口服液,以纯天然中药为组分,组方合理,具有抗菌、抗病毒、保肝健脾、提高机体免疫力,对畜禽的瘟热症状有独特的疗效,对由病毒或者细菌引起的畜禽各类疫病均有显著疗效,可用于禽新城疫、法氏囊等病毒以及病毒性呼吸道疾病等,本组方中添加增溶剂,不仅能解决长时间静置后出现沉淀现象,而且还能提高药材有效成分的溶出率,最大限度地提高中药的有效成分。
本发明提供了一种抗病毒口服液的制备方法,其中,所述方法包括以下步骤:步骤(1)取白芍、山药、栀子、黄芩、连翘、玄参、地黄、板蓝根洗净、晾干切制成3-5cm长段,在药材中加入药材量8倍的水、水量0.5w/v%的增溶剂、水量1w/v%的保护剂,在真空度0.06MPa-0.075MPa,温度65℃-75℃减压提取两次,每次1.5h-2h,合并提取液得到基础药液,所述的增溶剂为泊洛沙姆407,所述保护剂为PEG-400;步骤(2)把所述步骤(1)得到的所述基础药液经过静置1.5h-2h,用1.5-2微米孔径滤膜滤过,滤液浓缩至950ml-980ml,再经0.5-1微米孔径滤膜滤过得到浓缩液;以及步骤(3)将所述步骤(2)所得浓缩液加纯化水定容至1000ml,经灌装、灭菌得到所述抗病毒口服液。泊洛沙姆是优良增溶剂,且无毒、无刺激性特性,为新型高效的非离子型聚氧乙烯-聚氧丙烯共聚物,其中聚氧乙烯占80%,而聚氧乙烯比例在30%以上的共聚物,不论分子量大小,在水中均易溶解,增加药物的溶解度,提高药物的有效成分。
同时,山药具有补脾养胃,益肺生津,补肾泄精,主治脾胃虚弱,食欲不振,脾虚泄泻,虚劳咳喘,滑精,带下,尿频数。白芍具有平肝止痛,养血敛阴,主治肝阴不足,虚热,泻痢腹痛,四肢拘挛。选择白芍、山药入方,以起到保肝健脾、提高机体免疫力作用,有益于治疗效果的提升。
作为本发明的一种实施方式,所述步骤(1)中所述减压提取每次1.5h;所述步骤(2)中所述基础药液静置2h,所述基础药液经过静置后的滤膜孔径为1.5微米;所述滤液浓缩后的滤膜孔径为0.5微米。
作为本发明的一种实施方式,所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:白芍150g-250g、山药150g-250g、栀子250g、黄芩225g、连翘200g、玄参75g、地黄75g、板蓝根200g。
作为本发明的一种实施方式,所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:白芍150g、山药150g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。
作为本发明的一种实施方式,所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:白芍200g、山药200g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。
作为本发明的一种实施方式,所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:山药250g、白芍250g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。本发明还提供了所述的方法制备的抗病毒口服液。
本发明的抗病毒口服液性状稳定,高温下保存3个月无变化,pH下降小,且有效含量更高,有效成分稳定性更好。
本发明还提供了所述的抗病毒口服液在制备抗病毒药物中的应用。
作为本发明的一种实施方式,所述应用为制备治疗抗温热毒症的药物中的应用。
具体实施方式
下面结合具体实施例来进一步描述本发明,本发明的优点和特点将会随着描述更为清楚。但这些实施例仅是范例性的,并不对本发明的范围构成任何限制。本领域技术人员应该理解的是,在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换,但这些修改和替换均落入本发明的保护范围内。
本发明中所用的化学试剂均为分析纯,购自国药集团。本发明所述的实验方法,若无特殊说明,均为常规方法;所述的生物材料,若无特殊说明,均可从商业途径获得。
制备实施例1
1.1原料和用量
以制备1000ml口服液所采用的药材原料由以下重量的组分组成:白芍150g、山药150g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。
1.2制备方法
步骤1、取上述各药材洗净、晾干切制成3-5cm长段后,加入药材量的8倍水、水量0.5%的增溶剂、水量1%的保护剂,真空度0.06MPa-0.075MPa,温度65℃-75℃减压提取两次,每次1.5h,合并提取液得到基础药液;
步骤2:把步骤1得到的基础液经过静置2h,用1.5微米孔径滤膜滤过,滤液浓缩至950ml-980ml,再经0.5微米孔径滤膜滤过得到浓缩液;
步骤3:将步骤2所得浓缩液加纯化水定容至1000ml,经灌装、灭菌得到一种抗病毒口服液。
所述的增溶剂为泊洛沙姆407。
所述的保护剂为PEG-400。
制备实施例2
2.1原料和用量
以制备1000ml口服液所采用的药材原料由以下重量的组分组成:白芍200g、山药200g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。
2.2制备方法
步骤1、取上述各药材洗净、晾干切制成3-5cm长段后,加入药材量的8倍水、水量0.5%的增溶剂、水量1%的保护剂,真空度0.06MPa-0.075MPa,温度65℃-75℃减压提取两次,每次1.5h,合并提取液得到基础药液;
步骤2:把步骤1得到的基础液经过静置2h,用1.5微米孔径滤膜滤过,滤液浓缩至950ml-980ml,再经0.5微米孔径滤膜滤过得到浓缩液;
步骤3:将步骤2所得浓缩液加纯化水定容至1000ml,经灌装、灭菌得到一种抗病毒口服液。
所述的增溶剂为泊洛沙姆407。
所述的保护剂为PEG-400。
制备实施例3
3.1原料和用量
以制备1000ml口服液所采用的药材原料由以下重量的组分组成山药250g、白芍250g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。
3.2制备方法
步骤1、取上述各药材洗净、晾干切制成3-5cm长段后,加入药材量的8倍水、水量0.5%的增溶剂、水量1%的保护剂,真空度0.06MPa-0.075MPa,温度65℃-75℃减压提取两次,每次1.5h,合并提取液得到基础药液;
步骤2:把步骤1得到的基础液经过静置2h,用1微米孔径滤膜滤过,滤液浓缩至950ml-980ml,再经0.45微米孔径滤膜滤过得到浓缩;
步骤3:将步骤2所得浓缩液加纯化水定容至1000ml,经灌装、灭菌得到一种抗病毒口服液。
所述的增溶剂为泊洛沙姆407。
所述的保护剂为PEG-400。
制备实施例4
4.1原料和用量
以制备1000ml口服液所采用的药材原料由以下重量的组分组成:白芍200g、山药200g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。
4.2制备方法
步骤1、取上述各药材洗净、晾干切制成3-5cm长段后,加入药材量的8倍水,真空度0.06MPa-0.075MPa,温度65℃-75℃减压提取两次,每次1.5h,合并提取液得到基础药液;
步骤2:把步骤1得到的基础液经过静置2h,用1微米孔径滤膜滤过,滤液浓缩至950ml-980ml,再经0.45微米孔径滤膜滤过得到浓缩液;
步骤3:将步骤2所得浓缩液加纯化水定容至1000ml,经灌装、灭菌得到一种抗病毒口服液。
实施例5
将实施例1-4所得样品依次命名为样品1、样品2、样品3和样品4,另外购买市售类似功效的清瘟解毒口服液做为对照品1。在40℃±2℃的条件下,在实验的第0个月、1个月、2个月、3个月、6个月分别取样一次,通过观察制剂的性状、PH、密度,测定栀子苷、黄芩苷的含量作为参照,研究本发明所述抗病毒口服液的稳定性。
为进一步检验按照本发明所提供方法制备的抗病毒口服液的药效,发明人按照《中华人民共和国兽药典》(中国农业出版社)二部中所记载的检验标准,对现有工艺和本发明所提供的方法所制备的药液进行了检验比对,具体检验比对结果如下表:
表1保存0个月
编号 | 性状 | PH | 密度 | 栀子苷含量 | 黄芩苷含量 |
样品1 | 棕黑色 | 5.8 | 1.05 | 2.90 | 2.84 |
样品2 | 棕黑色 | 5.8 | 1.05 | 2.91 | 2.87 |
样品3 | 棕黑色 | 5.8 | 1.05 | 2.90 | 2.85 |
样品4 | 棕黑色 | 5.6 | 1.04 | 2.62 | 2.55 |
对照品1 | 棕黑色 | 5.5 | 1.04 | 2.61 | 2.56 |
表2保存1个月
编号 | 性状 | PH | 密度 | 栀子苷含量 | 黄芩苷含量 |
样品1 | 棕黑色 | 5.7 | 1.05 | 2.88 | 2.79 |
样品2 | 棕黑色 | 5.6 | 1.05 | 2.89 | 2.83 |
样品3 | 棕黑色 | 5.7 | 1.05 | 2.87 | 2.80 |
样品4 | 浑浊 | / | / | / | / |
对照品1 | 浑浊 | / | / | / | / |
表3保存2个月
编号 | 性状 | PH | 密度 | 栀子苷含量 | 黄芩苷含量 |
样品1 | 棕黑色 | 5.5 | 1.05 | 2.65 | 2.65 |
样品2 | 棕黑色 | 5.6 | 1.05 | 2.79 | 2.71 |
样品3 | 棕黑色 | 5.4 | 1.05 | 2.69 | 2.67 |
样品4 | 浑浊 | / | / | / | / |
对照品1 | 浑浊 | / | / | / | / |
表4保存3个月
编号 | 性状 | PH | 密度 | 栀子苷含量 | 黄芩苷含量 |
样品1 | 棕黑色 | 5.0 | 1.05 | 2.50 | 2.48 |
样品2 | 棕黑色 | 5.3 | 1.05 | 2.55 | 2.58 |
样品3 | 棕黑色 | 5.0 | 1.05 | 2.51 | 2.50 |
样品4 | 浑浊 | / | / | / | / |
对照品1 | 浑浊 | / | / | / | / |
表5保存6个月
编号 | 性状 | PH | 密度 | 栀子苷含量 | 黄芩苷含量 |
样品1 | 浑浊 | / | / | / | / |
样品2 | 浑浊 | / | / | / | / |
样品3 | 浑浊 | / | / | / | / |
样品4 | 浑浊 | / | / | / | / |
对照品1 | 浑浊 | / | / | / | / |
对表1-5结果进行分析,本发明所提供方法所制备的抗病毒口服液与市售类似产品相比,本发明性状稳定,高温下保存3个月无变化,pH下降小,且有效含量更高,有效成分的稳定性更好。而不添加增溶剂、保护剂提取制备的样品4以及商业对照品1稳定性和活性成分的有效含量均不及本发明的抗病毒口服液。
实施例6本发明抗病毒口服液临床治疗实验
试验动物:试验鸡由白鹤一养殖公司提供,均犯温热毒症。将同批次试验鸡600只,随机分成6组,试验1-5组分别用样品1-4、对照品1同等剂量给药,第6组作为空白组,空白组仅正常饲喂不给药。
临床效果判定:
判断标准
治愈:状态好,摄食能力强;无效:症状未减轻。
表6实验结果
编号 | 治愈率(%) | 无效率(%) |
第1组(实施例1) | 90 | 10 |
第2组(实施例2) | 92 | 8 |
第3组(实施例3) | 91 | 9 |
第4组(实施例4) | 70 | 30 |
第5组(对照品1) | 68 | 32 |
第6组(空白组) | 1 | 99 |
对表6结果进行分析,本发明方法所制备的抗病毒口服与市售类似产品相比,本发明效果更佳;实施例4制备的抗病毒口服液采用常规方法制备,没有添加增溶剂和保护剂提取,其治疗效果也比较本发明制备的抗病毒口服差。
以上所述实施案例仅表达了本申请的具体实施方式,其描述较为具体和详细,但并不能因此而理解为对本申请保持范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本申请技术方案构思的前提下,还可以做出若干变形和改造,这些都属于本申请的保护范围。
Claims (6)
1.一种抗病毒口服液的制备方法,其中,所述方法包括以下步骤:
步骤(1)取白芍、山药、栀子、黄芩、连翘、玄参、地黄、板蓝根洗净、晾干切制成3-5cm长段,在药材中加入药材量8倍的水、水量0.5w/v%的增溶剂、水量1w/v%的保护剂,在真空度0.06MPa-0.075MPa,温度65℃-75℃减压提取两次,每次1.5h-2h,合并提取液得到基础药液,所述的增溶剂为泊洛沙姆407,所述保护剂为PEG-400;
步骤(2)把所述步骤(1)得到的所述基础药液经过静置1.5-2h,用1.5-2微米孔径滤膜滤过,滤液浓缩至950ml-980ml,再经0.5-1微米孔径滤膜滤过得到浓缩液;以及
步骤(3)将所述步骤(2)所得浓缩液加纯化水定容至1000ml,经灌装、灭菌得到所述抗病毒口服液。
2.根据权利要求1所述的方法,其中,所述步骤(1)中所述减压提取每次1.5h;
所述步骤(2)中所述基础药液静置2h,所述基础药液经过静置后的滤膜孔径为1.5微米;所述滤液浓缩后的滤膜孔径为0.5微米。
3.根据权利要求1所述的方法,其中,所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:白芍150g-250g、山药150g-250g、栀子250g、黄芩225g、连翘200g、玄参75g、地黄75g、板蓝根200g。
4.根据权利要求1所述的方法,其中,所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:白芍150g、山药150g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g;或
所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:白芍200g、山药200g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g;或
所述步骤(1)中所述药材用量为每制备1000ml口服液所用的所述药材为:山药250g、白芍250g、栀子250g、黄芩225g、连翘200g、板蓝根200g、玄参75g、地黄75g。
5.根据权利要求1~4所述的方法制备的抗病毒口服液。
6.根据权利要求5所述的抗病毒口服液在制备抗病毒药物中的应用;优选地,所述应用为制备治疗抗温热毒症的药物中的应用。
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CN103919914A (zh) * | 2014-04-15 | 2014-07-16 | 河南牧翔动物药业有限公司 | 一种兽用清瘟解毒口服液的制备方法 |
CN106110119A (zh) * | 2016-07-18 | 2016-11-16 | 安徽奥力欣生物科技有限公司 | 一种兽用清瘟解毒口服液及其制备方法 |
CN108096416A (zh) * | 2017-12-08 | 2018-06-01 | 重庆金宇恒科技有限公司 | 一种禽用抗支气管炎病毒的组合物、冻干粉及制备方法 |
CN108096523A (zh) * | 2017-12-08 | 2018-06-01 | 重庆昇顺科技有限公司 | 一种禽用抗肝炎病毒的组合物、制备方法及应用 |
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