CN105435191B - 一种防治奶牛产后急性腹泻的中药组合物及其制备工艺 - Google Patents
一种防治奶牛产后急性腹泻的中药组合物及其制备工艺 Download PDFInfo
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Abstract
本发明公开了一种防治奶牛产后急性腹泻的中药组合物，各原料药按重量份计由以下组分组成：炙黄芪15‑25份、党参25‑35份、土白术25‑35份、厚朴25‑35份、陈皮25‑35份、广木香20‑30份、半夏15‑25份、藿香25‑35份、生姜15‑25份、香附25‑35份、泽泻20‑30份、益智仁30‑40份、焦山楂40‑50份。本发明的药物组合物不仅可有效提高受试奶牛的痊愈率，缩短治疗疗程，降低复发率，还可以提高患病奶牛的日平均产奶量，是治疗奶牛产后腹泻的有效中药制剂。
Description
技术领域
本发明涉及一种防治奶牛产后腹泻的中药组合物，属于兽药技术。
背景技术
奶牛产后腹泻是指奶牛产后胃肠功能失调，排粪次数增多，粪便稀软或粪稀如水的一种病症。该病约占产犊母牛的20％左右，是奶牛产后身体机能恢复的重要因素，严重影响奶牛产后泌乳性能，同时成母牛产后60天内各种原因造成的腹泻也是造成牧场奶牛死淘主要因素之一，给牧场主带来了巨大的经济损失。
目前，奶牛产后腹泻治疗主要以抗菌消炎、兴奋胃肠、补充能量、调整代谢为主要治疗原则，采用抗菌消炎类、电解质、营养调节剂、微生态制剂、止泻剂等进行治疗。但奶牛产后腹泻不同于痢疾、肠炎等引起的腹泻，主要与奶牛产后元气大衰，脾气虚损，运化失常，湿邪内生而致腹泻，其主要病机特点是气虚脾弱。临床治疗往往难以取得相应的治疗效果，同时，不合理抗菌素使用也会造成耐药菌菌株产生，影响公众卫生安全。其次，在奶牛产后腹泻治疗上，往往采取急于止泻治疗方案，这样往往会造成毒物蓄积在体内，导致更为严重的后果。因此，寻求有效治疗方案是奶牛产后健康管理的重要研究课题之一。
发明内容
本发明要解决的技术问题是克服现有的难题，提供了能够有效防治奶牛产后腹泻的中药组合物。
本发明另一目的是提供一种上述药物组合物的三种制备方法。
为了解决上述技术问题，本发明提供了如下的技术方案：
一种防治奶牛产后急性腹泻的中药组合物，各原料药按重量份计由以下组分组成：炙黄芪15-25份、党参25-35份、土白术25-35份、厚朴25-35份、陈皮25-35份、广木香20-30份、半夏15-25份、藿香25-35份、生姜15-25份、香附25-35份、泽泻20-30份、益智仁30-40份、焦山楂40-50份。
作为优选方案，上述的防治奶牛产后急性腹泻的中药组合物，各原料药按重量份计由以下组分组成：炙黄芪20份、党参30份、土白术30份、厚朴30份、陈皮30份、广木香25份、半夏20份、藿香30份、生姜20份、香附30份、泽泻25份、益智仁35份、焦山楂45份。
进一步优选的，炙黄芪、党参、土白术、厚朴、陈皮、广木香、半夏、藿香、生姜、香附、泽泻、益智仁、焦山楂的总质量占制成制剂总质量的20％-100％。
上述的防治奶牛产后腹泻的中药组合物的制备工艺，向原料药组分中加入添加药物可接受的赋形剂，制作成不同的剂型。
赋形剂，包括固体载体、抗结剂、防霉剂以及矫味剂等，均属于赋形剂。本发明选择优选如下种类。
固体载体包括蔗糖、淀粉、糊精、纤维素衍生物等。
抗结剂包括二氧化硅、硬脂酸钙、单硬脂酸甘油酯以及磷酸三钙等。
防霉剂包括双乙酸钠、山梨酸钾、丙酸钙以及碳酸氢钠等。
矫味剂包括甘氨酸、香兰素、谷氨酸钠、5’-鸟苷酸二钠以及其他食用香料等。
将各原料药组分按配比混合，净制，烘干，粉碎过筛，搅拌均匀，分装，即得到用于防治奶牛产后腹泻的中药组合物散剂。
优选的，所述烘干的温度为65℃；所述过筛的目数为100-200目。
将各原料药组分按配比混合，净制除杂后，煎煮三次，每次加入8-10倍药材重量的纯化水，每次1小时，过滤，合并滤液，浓缩，喷雾干燥，粉碎，加入适量抗结剂、抗引湿剂，混匀即得到用于防治奶牛产后腹泻的中药组合物浸膏剂。
将各原料药组分按配比混合，净制除杂后，煎煮三次，每次加入8-10倍药材重量的纯化水，每次1小时，过滤，合并滤液，浓缩，加辅料，制成颗粒，干燥，整粒，即得用于防治奶牛产后腹泻的中药组合物颗粒剂。
在浸膏剂和颗粒剂制备中，浓缩时，浓缩为50-55℃下相对密度至1.31-1.35的稠膏。
所述辅料为蔗糖。
本发明有益效果：
本发明中药组合物奶牛产后腹泻之气虚脾弱的病机特点，根据中兽医理、法、方、药理论，选用多种中药组方。方中黄芪、党参、白术益气补虚健脾；厚朴、陈皮理气宽中、消除胀满；藿香、半夏、生姜醒脾和胃，降逆止呕；木香、香附疏肝调中、理气止痛；泽泻利水渗湿；益智仁温补固摄，暖脾止泻；焦山楂消食健胃，行气散瘀。诸药合用，共奏补虚健脾，利水渗湿，行气止痛之功效，故能有效改善产后母牛气虚脾弱的病生理状态，有效防治奶牛产后腹泻。本发明的药物组合物不仅可有效提高受试奶牛的痊愈率，缩短治疗疗程，降低复发率，还可以提高患病奶牛的日平均产奶量，是治疗奶牛产后腹泻的有效中药制剂。
为了进一步说明本发明的实质以及本发明中药物组合物对奶牛产后腹泻有益效果，申请人对本申请药物组合物进行了临床治疗试验研究，试验所用受试药物为浸膏散剂为例说明本发明药物组合物的优异效果。
本发明中药组合物治疗奶牛产后腹泻临床疗效评价试验研究。
1)试验药品
本发明中药组合物。
2)试验动物
本研究于2014年8月2015年7月份在兰州市郊奶牛场(2500头荷斯坦奶牛)进行试验研究，饲养管理是根据奶牛不同阶段的营养需求，按照NRC(2001)的营养要求，统一基础日粮标准(表1)，每日饲喂三次，自由采食，运动场自由饮水、运动，并实施规范的DHI测定工作。所选试验动物年龄3～8岁，体况评分在2.5～4.0之间，2～5胎次。
3)临床诊断标准
奶牛产后腹泻的临床诊断标准，包括诊断标准、纳入标准、排除标准以及剔除标准。
诊断标准：1)粪便性状有改变，呈粥状或水样腹泻，粪便评分在0.5～1.5之间(见表1)，色黄白、黄绿或灰白，或有恶臭；2)排便次数显著增多；3)伴腹胀、腹痛等症。具备1)和2)项下症状，即确诊为奶牛腹泻。
表1奶牛粪便评分量表
不同阶段的奶牛粪便推荐值：干奶牛3.5分；干奶后期3.0分；新产牛2.5分；高产牛3.0分；产奶后期牛3.5分。
纳入标准：入选奶牛为产后1～21天，无眼观的明显脱水现象。
排除标准：纳入产犊母牛患有其他并发症，如子宫炎、真胃移位及瘤胃鼓气等，或者已被施予其它治疗措施均不纳入本试验研究。
剔除标准：试验期间，如果受试产犊母牛接受与本试验研究无关的抗炎或抗菌素治疗措施，或能完成既定的给药方案均应剔除于最终结果分析。
4)试验设计
4.1随机分组将符合本研究诊断标准和纳入标准的腹泻母牛按照其耳标随机分为4组，其中对照组(60头)，试验1组(制备例4，60头)、试验2组(制备例2，60头)和试验3组(制备例5，60头)。
4.2治疗方案本发明中药组合物组(试验1组、试验2组和试验3组)，均经口灌服本发明中药组合物100g/头，一天一次，用药1～3天。对照组，采用牧场综合疗法：，一天一次，连用三天。
4.3观察项目及方法
在试验期间，观察受试腹泻母牛精神状态、采食饮水情况、粪便性状以及排便次数等临诊症状特点，并认真记录患病奶牛的耳号、发病时间、营养状况、精神状态、体温、呼吸、脉搏、粪便性状及排便次数及痊愈时间等，并根据奶牛粪便评分量表(见表1)，对治疗前后受试奶牛粪便进行打分。
5)疗效标准
本试验研究以用药后腹泻应用本发明中药组合物按治疗方案经1-3日治疗后，以治疗后5天内粪便评分恢复至2.5～3.5之间，全身症状消失，且在恢复后2天内无复发，判为有效。如果再治疗5天内粪便评分仍低于2.0，排便次数和精神状态无好转甚至恶化，判为无效。以用药后，受试奶牛产奶量恢复作为第二疗效评价标准。
6)数据统计
利用(Version 17.0)进行数据分析。平均胎次、体况评分、产奶量、粪便评分、发病时间以及平均产奶量等进行方差分析和LSD多重比较。卡方检验评价两组受试奶牛的治愈率和复发率。所有统计检验均采用双侧检验，P<0.05认为检验的差异有统计学意义。不同试验组计量资料采用“mean±std””进行统计描述。
7)结果
7.1描述性分析结果
试验分析结果表明，对照组和本发明中药组合物组的所纳入患病母牛在平均年龄、平均胎次、体况评分、粪便评分和发病时间之间无显著差异(P>0.05)，表明两组别基线资料具有可比性(见表2)。
表2两组所纳入胎衣不下牛的基线资料
注：发病时间为奶牛腹泻发生距离分娩日的天数
7.2本发明中药组合物治疗奶牛产后腹泻的临床疗效
本发明中药组合物治疗奶牛产后腹泻的临床效果见表1。与对照组比较，本发明中药组合物治疗奶牛产后腹泻的痊愈率极显著提高(P<0.01)，痊愈时间显著缩短(P<0.05)，腹泻的复发率极显著降低(P<0.01)，而本发明中药组合物各组间无明显差别(P>0.05)。同时，与对照比较，本发明中药组合物各组别受试奶牛的日平均产奶量显著提升(p<0.05)，同时患病奶牛应用本发明中药组合物治疗后，其日平均产奶奶量可恢复至发病前的水平。
表3本发明中药组合物治疗奶牛产后腹泻临床疗效试验结果
注：同一阶段同列数据肩标有相同字母者差异不显著(P>0.05)，标注不同小写字母者差异显著(P<0.05)；同一组别同列标注不同大写字母者差异显著(P<0.01)。
8)结论
结果表明，本发明中药组合物不仅可有效提高痊愈率，缩短治疗疗程，降低复发率，还可以提高患病奶牛的日平均产奶量，是治疗奶牛产后腹泻的有效中药制剂。
具体实施方式
以下对本发明的优选实施例进行说明，应当理解，此处所描述的优选实施例仅用于说明和解释本发明，并不用于限定本发明。
实施例1：
一种用于治疗奶牛产后腹泻的中药组合物的制备方法，包括以下步骤：按处方比例，称取炙黄芪20份、党参30份、土白术30份、厚朴30份、陈皮30份、广木香25份、半夏20份、藿香30份、生姜20份、香附30份、泽泻25份、益智仁35份、焦山楂45份，净制，65℃烘干，碎过100～200目筛，搅拌均匀，分装，即得用于治疗奶牛产后腹泻的中药组合物散剂。
实施例2：
一种用于治疗奶牛产后腹泻的中药组合物的制备方法，包括以下步骤：按处方比例，称取炙黄芪20份、党参30份、土白术30份、厚朴30份、陈皮30份、广木香25份、半夏20份、藿香30份、生姜20份、香附30份、泽泻25份、益智仁35份、焦山楂45份，净制除杂后，煎煮三次，每次加入8～10倍药材重量的纯化水，每次1小时，虑过，合并滤液，浓缩至相对密度为1.31～1.35(50～55℃)的稠膏，喷雾干燥，粉碎，加入适量的抗结剂、抗引湿剂等，混匀即得用于治疗奶牛产后腹泻的中药组合物浸膏剂。
实施例3：
一种用于治疗奶牛产后腹泻的中药组合物的制备方法，包括以下步骤：按处方比例，称取炙黄芪20份、党参30份、土白术30份、厚朴30份、陈皮30份、广木香25份、半夏20份、藿香30份、生姜20份、香附30份、泽泻25份、益智仁35份、焦山楂45份，净制后，每次加入8～10倍药材重量的纯化水，每次1小时，虑过，合并滤液，浓缩至相对密度为1.31～1.35(50～55℃)的稠膏，加适量辅料，如蔗糖粉、淀粉、糊精等，制成颗粒，干燥，整粒，即得用于治疗奶牛产后腹泻的中药组合物颗粒剂。
实施例4：
一种用于治疗奶牛产后腹泻的中药组合物的制备方法，包括以下步骤：按处方比例，称取炙黄芪15份、党参25份、土白术25份、厚朴25份、陈皮25份、广木香20份、半夏15份、藿香25份、生姜15份、香附25份、泽泻20份、益智仁30份、焦山楂40份，净制后，煎煮三次，每次加入8～10倍药材重量的纯化水，每次1小时，虑过，合并滤液，浓缩至相对密度为1.31～1.35(50～55℃)的稠膏，喷雾干燥，粉碎，加入适量的抗结剂、抗引湿剂等，混匀即得用于治疗奶牛产后腹泻的中药组合物浸膏剂。
实施例5：
一种用于治疗奶牛产后腹泻的中药组合物的制备方法，包括以下步骤：按处方比例，炙黄芪25份、党参35份、土白术35份、厚朴35份、陈皮35份、广木香30份、半夏25份、藿香35份、生姜25份、香附35份、泽泻35份、益智仁40份、焦山楂50份，净制后，煎煮三次，每次加入8～10倍药材重量的纯化水，每次1小时，虑过，合并滤液，浓缩至相对密度为1.31～1.35(50～55℃)的稠膏，喷雾干燥，粉碎，加入适量的抗结剂、抗引湿剂等，混匀即得用于治疗奶牛产后腹泻的中药组合物浸膏剂。
上所述仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
1.一种防治奶牛产后急性腹泻的中药组合物，其特征在于：各原料药按重量份计由以下组分组成：炙黄芪15-25份、党参25-35份、土白术25-35份、厚朴25-35份、陈皮25-35份、广木香20-30份、半夏15-25份、藿香25-35份、生姜15-25份、香附25-35份、泽泻20-30份、益智仁30-40份、焦山楂40-50份。
2.根据权利要求1所述的防治奶牛产后急性腹泻的中药组合物，其特征在于：各原料药按重量份计由以下组分组成：炙黄芪20份、党参30份、土白术30份、厚朴30份、陈皮30份、广木香25份、半夏20份、藿香30份、生姜20份、香附30份、泽泻25份、益智仁35份、焦山楂45份。
3.根据权利要求1或2所述的防治奶牛产后急性腹泻的中药组合物，其特征在于：炙黄芪、党参、土白术、厚朴、陈皮、广木香、半夏、藿香、生姜、香附、泽泻、益智仁、焦山楂的总质量占制成制剂总质量的20％-100％。
4.根据权利要求1或2所述的防治奶牛产后急性腹泻的中药组合物的制备工艺，其特征在于：向原料药组分中加入添加药物可接受的赋形剂，制作成不同的剂型。
5.根据权利要求4所述的防治奶牛产后急性腹泻的中药组合物的制备工艺，其特征在于：将各原料药组分按配比混合，净制，烘干，粉碎过筛，搅拌均匀，分装，即得到用于防治奶牛产后腹泻的中药组合物散剂。
6.根据权利要求5所述的防治奶牛产后急性腹泻的中药组合物的制备工艺，其特征在于：所述烘干的温度为65℃；所述过筛的目数为100-200目。
7.根据权利要求4所述的防治奶牛产后急性腹泻的中药组合物的制备工艺，其特征在于：将各原料药组分按配比混合，净制除杂后，煎煮三次，每次加入8-10倍药材重量的纯化水，每次1小时，过滤，合并滤液，浓缩，喷雾干燥，粉碎，加入适量抗结剂、抗引湿剂，混匀即得到用于防治奶牛产后腹泻的中药组合物浸膏剂。
8.根据权利要求4所述的防治奶牛产后急性腹泻的中药组合物的制备工艺，其特征在于：将各原料药组分按配比混合，净制除杂后，煎煮三次，每次加入8-10倍药材重量的纯化水，每次1小时，过滤，合并滤液，浓缩，加辅料，制成颗粒，干燥，整粒，即得用于防治奶牛产后腹泻的中药组合物颗粒剂。
9.根据权利要求7或8所述防治奶牛产后急性腹泻的中药组合物的制备工艺，其特征在于：浓缩时，浓缩为50-55℃下相对密度至1.31-1.35的稠膏。
10.权利要求8所述的防治奶牛产后急性腹泻的中药组合物的制备工艺，其特征在于：所述辅料为蔗糖。
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