CN104257913A - 治疗奶牛乳房炎的中药浓缩液及由该浓缩液制备的涂膜剂 - Google Patents

治疗奶牛乳房炎的中药浓缩液及由该浓缩液制备的涂膜剂 Download PDF

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CN104257913A
CN104257913A CN201410504750.2A CN201410504750A CN104257913A CN 104257913 A CN104257913 A CN 104257913A CN 201410504750 A CN201410504750 A CN 201410504750A CN 104257913 A CN104257913 A CN 104257913A
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周庆民
徐馨
冯万宇
侯美如
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HEILONGJIANG INSTITUTE OF VETERINARY SCIENCE
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Abstract

本发明公开了一种用于治疗奶牛乳房炎的中药浓缩液及由该浓缩液制备的涂膜剂。优点一是中草药经过对有效成分提取，药物纯，无其它成分，无其它副作用；药效足，疗效好。二是成膜剂的加入，改变了传统乳房中草药膏药的剂型，既保留了传统中草药膏药给药方法的独特优点，又使药物使用简单、方便。三是药液中加入皮肤护理剂，使用药部位乳房皮肤得到保护，减少其不良反应。

Description

治疗奶牛乳房炎的中药浓缩液及由该浓缩液制备的涂膜剂
技术领域
本发明涉及一种用于治疗奶牛乳房炎的中药浓缩液，本发明还涉及一种由该中药浓缩液制备的涂膜剂。
背景技术
乳房炎是奶牛生产中最常见的一种疾病，是由多种因素导致的乳腺组织的一种抵抗性炎症反应，以病原微生物侵入乳腺引起的乳房炎占大部分，其主要病理变化是乳腺组织的泌乳障碍和乳腺组织的病变，危害大，损失严重。西药在乳房炎治疗上具有诸多缺点，如有的抗生素疗效不佳，抗生素的残留影响消费者的健康，频繁的使用抗生素容易使细菌耐药，导致再次治疗更加困难。而中草药作为纯天然药物，含有各种生物有效成分，不易产生耐药性，体内代谢较快，高效低毒，无残留；它不仅具有抗菌、抗病毒作用，还具有调节机体机能的作用，通过活血化淤，化淤散结，散结消肿，舒肝解郁，清热解毒，通经下乳，加上按摩、热敷可以促进血液循环，增强机体抵抗力，抑制病原微生物繁殖，从而促进炎症消散和组织修复。
临床上用于治疗奶牛乳房炎的中药制剂多为散剂、煎剂、注射剂。散剂和煎剂通过拌料或开水灌服，给药方便，但用量大，成本高，药物在瘤胃内有一定损失，且因肝脏的首过效应会影响疗效；中药注射剂作用迅速，但制备工艺繁琐且不易稳定，给药操作严格，乳池内灌注时易造成乳腺损伤。外用药膏是提取药物有效成分，浓缩后制成膏剂，采用涂抹方式给药，药物直接到达病所，药物经乳房皮肤吸收首先进入乳腺组织，并维持较高、恒定的血药浓度，延长作用时间，充分发挥药效，可以不经过肝脏的“首过效应”和胃肠道的破坏，不受胃肠道酶、消化液、PH值的影响，达到一定的血药浓度，提高生物利用度，减少给药次数，降低药物毒性和副作用，提高疗效。
用中草药制成膏药涂抹乳房治疗奶牛乳腺炎，尤其是对发热、肿胀、肿块等症状明显的乳房炎有着它药物与其不可比拟的优势，治疗效果非常明显。传统膏药的制作过程十分烦琐复杂，炼制时毒烟燎绕，容易发生事故，且火侯难以把握，炼出的膏药不老就嫩，坏膏弃膏的情况经常发生，而且含有重金属和铅等毒素，对机体不利，且容易过敏发痒，起泡或皮疹，副作用大；另外传统膏药制作时将药物经过高温油炸后，致使药物中的有效成份被破坏或丧失，其疗效则会大打折扣；其含有一定量的油脂，有助于药物之间的结合，及与皮肤的黏贴，但对涂抹处处理困难。
发明内容
本发明要解决的技术问题在于提供一种用于治疗奶牛乳房炎的中药浓缩液，本发明要解决的技术问题在于提供一种由该浓缩液制备的涂膜剂。
本发明用于治疗奶牛乳房炎的中药浓缩液由以下组分及重量份配比的中药经过浸泡、煮沸、过滤、浓缩、离心分离制备而成：
由上述浓缩液制备的涂膜剂其原料组成及重量份配比是：
中药浓缩剂 52～57份  成膜剂 30～40份    增塑剂 2～5份
皮肤护理剂 3～6份    表面活性剂 1～3份  透皮剂 5～8份
上述的成膜剂由重量比为2∶1的医药级聚乙烯醇1750和聚乙烯醇1799制成。
上述的皮肤护理剂由重量比为1∶9的水溶性羊毛脂和凡士林制成。
上述的透皮剂由重量比为2∶9的丙二醇和氮酮制成。
上述的表面活性剂为吐温-80。
上述的增塑剂为甘油。
以下是本发明产品的制备方法：
(1)中药浓缩剂：将上述的中草药按重量份混合一起，加8倍水浸泡30min，武火煎煮沸腾后再用文火煎30min，四层纱布过滤，再加4倍水煎煮30min，过滤，合并两次滤液，武火浓缩至药液量为加水总量的1/12，经3000转/min 20min离心，用蒸馏水调至含生药浓度1mg/ml，高压灭菌后冷藏保存备用。
(2)成膜剂：将聚乙烯醇1750和聚乙烯醇1799分别加入6倍的蒸馏水浸泡24小时，96℃水浴加热2.5小时，并不断搅拌至全部溶解，过滤去除杂物，晾凉。再将聚乙烯醇1750水溶液和聚乙烯醇1799水溶液按2∶1的比例混合，制备成本发明的成膜剂。
(3)皮肤护理剂：将羊毛脂与凡士林按1∶9的比例混合，加4倍的蒸馏水，混匀。
(4)透皮剂：将氮酮和丙二醇按2∶9的比例混合，加2倍的蒸馏水，混匀。
(5)增塑剂：将甘油加1倍水稀释，混匀。
(6)表面活性剂：将吐温-80加3倍水稀释，混匀。
(7)将上述六种溶液按重量份配比混合，充分搅拌，混匀即可。
本发明的优点有三个方面，第一是中草药经过对有效成分提取，药物纯，无其它成分，无其它副作用；药效足，疗效好。第二是成膜剂的加入，改变了传统乳房中草药膏药的剂型，既保留了传统中草药膏药给药方法的独特优点，又使药物使用简单、方便。第三是药液中加入皮肤护理剂，使用药部位乳房皮肤得到保护，减少其不良反应。
具体实施例
实施例1
本发明用于治疗奶牛乳房炎的中药浓缩液由以下组分及重量份配比的中药制备而成：
实施例2
本发明用于治疗奶牛乳房炎的中药浓缩液由以下组分及重量份配比的中药制备而成：
实施例3
本发明产品乳房中药涂膜剂是由以下的有效药物组分及重量份配比制备而成的：
中药浓缩剂 52份  成膜剂 38份     增塑剂 4份
皮肤护理剂 5份   表面活性剂 3份  透皮剂 8份
实施例4
本发明产品乳房中药涂膜剂是由以下的有效药物组分及重量份配比制备而成的：
中药浓缩剂 55份  成膜剂 34份     增塑剂 3份
皮肤护理剂 4份   表面活性剂 3份  透皮剂 5份
实施例5
本发明产品乳房中药涂膜剂是由以下的有效药物组分及重量份配比制备而成的：
中药浓缩剂 57份  成膜剂 35份     增塑剂 2份
皮肤护理剂 3份   表面活性剂 2份  透皮剂 7份
实施例6
本发明产品的使用方法：在奶牛乳房肿胀部位喷洒或涂抹即可。
实施例7
本发明产品的质量检测及效果评价：
以下试验使用实施例3、4、5均能达到同样效果。
1、性状
本品为黑色、半透明黏稠状液体。
2、成膜时间试验
将药液涂抹在奶牛乳房上，观察其成膜时间、成膜状态。结果在6min时乳房涂抹部即可形成一层软膜。将膜慢慢揭开，形成的膜弹性较强、完整、成片、无孔洞。
3、稳定性试验
取制备好的乳房中药涂膜剂分装于250ml的玻璃瓶中，分别于室温避光和冰箱(0℃～5℃)储存，每隔7d定期观察。结果12个月内无沉淀、无分层、无变色现象。
4、皮肤刺激性试验
(1)一次涂抹试验：取健康成年兔16只，平均体重为2.6±0.3kg，雌雄不限，分两组，每组8只，剃光背部两侧毛约12cm2，取乳房中药涂膜剂和常水各15ml，分别均匀涂在背部两侧的剃毛处，于给药1、2、4、6、12、24、48、72h时(每一个时间段一只兔)揭下，观察皮肤变化。结果涂抹部均无红疹、水疱等皮肤异常反应。
(2)连续涂抹试验：取另外健康成年兔6只，平均体重为2.3±0.1kg，雌雄不限，分两组，每组3只，剃光家兔背部两侧毛约12cm2，取乳房中药涂膜剂和常水各15ml，分别均匀涂在家兔背部两侧的剃毛处，48h时揭下，隔2天一次，共3次，观察皮肤反应。结果涂抹部均无红疹、水疱等皮肤异常反应。
5、去膜试验
将乳房涂抹处形成的膜，从一边慢慢揭起，可揭下完整的膜，乳房皮肤涂抹处没有任何痕迹。
6、卫生学检验
(1)培养检验：将乳房中药涂膜剂分别加入普通肉汤培养基和琼脂培养基上，放置37℃恒温箱24h后观察培养基的变化。结果普通肉汤培养基内和琼脂培养基上都无细菌生长。
(2)常规保存检验：将乳房中药涂膜剂分装于250ml的玻璃瓶中密封，在常温下避光放置，每隔1个月观察一次。结果24个月内溶液中无任何细菌、真菌等微生物生成，溶液不变质。
7、杀菌效力检验
(1)抑菌试验：将从奶牛乳房炎病料中分离的金黄色葡萄球菌、无乳链球菌、停乳链球菌和大肠杆菌接种于各自适宜的培养基琼脂平板上，每种细菌同时接种2个培养基，然后分I、II两组，每组各有4种不同的培养基，I组加入薄层乳房中药涂膜剂，II组不加乳房中药涂膜剂，放置37℃恒温箱，培养24h后观察细菌的生长情况。
结果见表1。
表1 抑菌试验
结果加入薄层乳房中药涂膜剂的组，各培养基上无细菌生长；不加乳房中药涂膜剂的组，各培养基上有细菌生长。
(2)杀菌试验：将从奶牛乳房炎病料中分离的金黄色葡萄球菌、无乳链球菌、停乳链球菌和大肠杆菌接种于适宜的培养基琼脂平板上，每种细菌同时接种2个培养基，放置37℃恒温箱培养24h后分I、II两组，每组各有4种不同的培养基，I组加入薄层乳房中药涂膜剂，II组不加乳房中药涂膜剂，再放置37℃恒温箱继续培养，24h后观察细菌生长情况。
结果见表2。
表2 杀菌试验
结果加入乳房中药涂膜剂后，细菌停止生长，镜检：细菌死亡；不加乳房中药涂膜剂的培养基上，细菌继续生长，镜检无细菌死亡。
8、临床应用效果试验
(1)试验奶牛黑龙江省天和牧业公司，品种为中国荷斯坦奶牛。选择3～5岁、产犊3～5个月的乳房炎奶牛38头，常规饲养，专人管理，饲料精粗搭配，舍饲与放牧相结合。
(2)试验药品奶牛乳房中药涂膜剂，本所研制生产，批号：20130622。
(3)试验方法在饲养、环境、人员管理、挤奶等相同的情况下，将试验奶牛随机平均分为2组，每组19头，I组为对照组，不用任何药物治疗；II组为治疗组，乳房中药涂膜剂涂抹乳房肿胀部位，24h后揭下，再重新涂抹，连续5次。观察乳房炎发生情况。
(4)结果见表3。
表3 奶牛乳房中药涂膜剂临床应用效果试验
I组奶牛未经治疗，治愈率为零，发病率仍为100％，；II组奶牛经乳房中药涂膜剂治疗，治愈率为89.47％，乳腺炎发病率下降为10.53％。II组比I组效果显著。

Claims (3)

1.一种用于治疗奶牛乳房炎的中药浓缩液，其特征在于：该中药浓缩液由以下组分及重量份配比的中药经过浸泡、煮沸、过滤、浓缩、离心分离制备而成： 
。
2.由权利要求1所述用于治疗奶牛乳房炎的中药浓缩液制备的涂膜剂，其特征在于：该涂膜剂的原料组成及重量份配比是： 
中药浓缩剂52～57份  成膜剂30～40份    增塑剂2～5份 
皮肤护理剂3～6份    表面活性剂1～3份  透皮剂5～8份 
上述的成膜剂由重量比为2∶1的医药级聚乙烯醇1750和聚乙烯醇1799制成。 
上述的皮肤护理剂由重量比为1∶9的水溶性羊毛脂和凡士林制成。 
上述的透皮剂由重量比为2∶9的丙二醇和氮酮制成。 
上述的表面活性剂为吐温-80。 
上述的增塑剂为甘油。 
3.一种如权利要求2所述涂膜剂的制备方法： 
(1)中药浓缩剂：将上述的中草药按重量份混合一起，加8倍水浸泡30min，武火煎煮沸腾后再用文火煎30min，四层纱布过滤，再加4倍水煎煮30min，过滤，合并两次滤液，武火浓缩至药液量为加水总量的1/12，经3000转/min20min离心，用蒸馏水调至含生药浓度1mg/ml，高压灭菌后冷藏保存备用。 
(2)成膜剂：将聚乙烯醇1750和聚乙烯醇1799分别加入6倍的蒸馏水浸泡24小时，96℃水浴加热2.5小时，并不断搅拌至全部溶解，过滤去除杂物，晾凉。再将聚乙烯醇1750水溶液和聚乙烯醇1799水溶液按2∶1的比例混合，制备成本发明的成膜剂。 
(3)皮肤护理剂：将羊毛脂与凡士林按1∶9的比例混合，加4倍的蒸馏水，混匀。 
(4)透皮剂：将氮酮和丙二醇按2∶9的比例混合，加2倍的蒸馏水，混匀。 
(5)增塑剂：将甘油加1倍水稀释，混匀。 
(6)表面活性剂：将吐温-80加3倍水稀释，混匀。 
(7)将上述六种溶液按重量份配比混合，充分搅拌，混匀即可。 
CN201410504750.2A 2014-09-17 2014-09-17 治疗奶牛乳房炎的中药浓缩液及由该浓缩液制备的涂膜剂 Pending CN104257913A (zh)

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