CN114366770A - 一种七清败毒颗粒的制备方法 - Google Patents

一种七清败毒颗粒的制备方法 Download PDF

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CN114366770A
CN114366770A CN202011098282.5A CN202011098282A CN114366770A CN 114366770 A CN114366770 A CN 114366770A CN 202011098282 A CN202011098282 A CN 202011098282A CN 114366770 A CN114366770 A CN 114366770A
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李新
逯荷香
李阳
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Luoyang Ruihua Animal Health Products Co ltd
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Abstract

一种七清败毒颗粒的制备方法，该药组合物主要由原料黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g、包合剂β‑糊精10‑30g、矫味剂阿斯巴甜0.5‑1g、包衣材料HPMC10‑20g辅料：蔗糖400‑600g。本发明以包合剂：β‑糊精，能够包合苦味成分，除了可以降低和消除药物的异味感，还能起到减少药物毒副作用及刺激性、提高药物溶解度的作用。同时加入矫味剂阿斯巴甜是药物的口感更加良好。加入包衣材料HPMC可以使颗粒更加的稳定，不仅可以防止颗粒的吸潮也能掩盖颗粒的苦味。使颗粒更加稳定、溶解性更好、口感更佳、提高生物利用度。便于畜禽使用。

Description

一种七清败毒颗粒的制备方法
技术领域
本发明属于兽用药物技术领域，一种七清败毒颗粒的制备方法。
背景技术
七清败毒颗粒由黄芩、虎杖、白头翁、苦参、板蓝根、绵马贯众、大青叶七味中药材经提取加工制成的颗粒，具有清热解毒，燥湿止泻。湿热泄泻，雏鸡白痢之功效。但七清败毒颗粒，味苦，适口性差，溶解速度慢而且容易吸潮。因而加入包合剂β-糊精可以使七清败毒颗粒的溶解速度更快、溶解性更好，也可以消除药物的异味感，同时加入矫味剂可以使颗粒的口感更佳，加入包衣材料HPMC可以使颗粒在高热高湿环境，更加稳定不宜吸潮方便存储和使用，是目前兽药市场所需求的。
发明内容
本发明目的在于提供一种以β-糊精为包合剂、阿斯巴甜为矫味剂、HPMC为包衣材料的七清败毒颗粒的制备方法。
本发明的目的是通过下述技术方案实现的：
一种七清败毒颗粒，本发明的原料：黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g
辅料：β-糊精10-30g、阿斯巴甜0.5-1g、HPMC10-20g、蔗糖 400-600g。
优选的，由以下重量的原料和辅料制备而成；
原料：黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g
辅料：β-糊精20g、阿斯巴甜1g、HPMC20g、蔗糖600g。
如上所述的七清败毒颗粒的制备方法，包括以下步骤：
(1)七清败毒颗粒浸膏的制备：取原料加水提取，滤液浓缩相对密度为1.30-1.35的浸膏备用；
(2)七清败毒颗粒的制备：取β-糊精、阿斯巴甜、HPMC与粉碎后的蔗糖混合均匀，然后加入全部浸膏做软材料、采用喷雾干燥法制粒，即得七清败毒颗粒。
步骤(1)具体为：取原料加8-10倍量的水浸泡，2小时，然后进行煎煮，第一次2小时，过滤；取第一次煎煮后的滤渣加6倍量的水，煎煮1小时，过滤，合并滤液，80℃以下减压浓缩至相对密度为 1.30-1.35(55℃)的浸膏。
本发明以β-糊精作为包合剂可以使颗粒的溶解速度更快、溶解性更好，也可以消除药物的异味感，同时加入矫味剂可以使颗粒的口感更佳，加入包衣材料HPMC可以使颗粒在高热高湿环境，更加稳定不宜吸潮方便存储和使用，目前兽药市场所需求的。
具体实施方式
实施例1
一种七清败毒颗粒，由以下重量的原料和辅料制备而成；
原料：黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g
辅料：β-糊精10g、阿斯巴甜0.5g、HPMC10g、蔗糖500g。
如上所述的七清败毒颗粒的制备方法，包括以下步骤；
(1)七清败毒浸膏的制备：取原料药材加8-10倍量的水浸泡，2 小时，然后进行煎煮，第一次2小时，过滤；取第一次煎煮后的滤渣加 6倍量的水，煎煮1小时，过滤，合并滤液，80℃以下减压浓缩至相对密度为1.30-1.35(55℃)的浸膏，备用；
(2)七清败毒颗粒的制备：取β-糊精、阿斯巴甜、HPMC与粉碎后的蔗糖混合均匀，然后加入全部浸膏做软材料、采用喷雾干燥法制粒，即得七清败毒颗粒。
实施例2
一种七清败毒颗粒，由以下重量的原料和辅料制备而成；
原料：黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g
辅料：β-糊精30g、阿斯巴甜0.8g、HPMC15g、蔗糖400g。
如上所述的七清败毒颗粒的制备方法，包括以下步骤；
(3)七清败毒浸膏的制备：取原料药材加8-10倍量的水浸泡，2 小时，然后进行煎煮，第一次2小时，过滤；取第一次煎煮后的滤渣加6倍量的水，煎煮1小时，过滤，合并滤液，80℃以下减压浓缩至相对密度为1.30-1.35(55℃)的浸膏，备用；
(4)七清败毒颗粒的制备：取β-糊精、阿斯巴甜、HPMC与粉碎后的蔗糖混合均匀，然后加入全部浸膏做软材料、采用喷雾干燥法制粒，即得七清败毒颗粒。
实施例3
一种七清败毒颗粒，由以下重量的原料和辅料制备而成；
原料：黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g
辅料：β-糊精20g、阿斯巴甜1g、HPMC20g、蔗糖600g。
如上所述的七清败毒颗粒的制备方法，包括以下步骤；
(5)七清败毒浸膏的制备：取原料药材加8-10倍量的水浸泡，2 小时，然后进行煎煮，第一次2小时，过滤；取第一次煎煮后的滤渣加 6倍量的水，煎煮1小时，过滤，合并滤液，80℃以下减压浓缩至相对密度为1.30-1.35(55℃)的浸膏，备用；
(6)七清败毒颗粒的制备：取β-糊精、阿斯巴甜、HPMC与粉碎后的蔗糖混合均匀，然后加入全部浸膏做软材料、采用喷雾干燥法制粒，即得七清败毒颗粒。
表1实施例4市售样品与实施例1-3样品稳定性考察
通过考察样品的性状来评价样品在高温(30℃)高湿(65％)条件下的的稳定性，如不变色不结块即为正常变色或者结块则不正常。
表1
Figure BDA0002724476230000041
由表1分析样品中加入一定量的HPMC在高温高湿条件下放置存放 24个月后不会产生结块现象，说明产品中添加一定量的HPMC可保证产品的稳定性。
表2：实施例5市售样品与实施例1-3样品溶水性考察
表2
Figure BDA0002724476230000042
由表2分析采用本方法的颗粒溶解性比市售颗粒的溶化性好，而且加入一定量的包合剂溶化性越好。
临床试验一
(1)试验动物
天津市某鸡场有一批20日龄肉鸡，发现精神萎顿、羽毛蓬乱，采食量均下降，体温升高，寒颤，扎堆，闭眼嗜睡等，同时伴有下痢，排含气泡的稀便，之后渐渐变为灰白色。个别雏鸡还出现关节肿大，行走不便。
刨检发现，心包积液，肝脏肿大，肾脏充血、出血，胆囊增大，盲肠肿胀。
(2)试验药品：本发明实施例3所配制药品。
(3)试验设计及方法
随机选择该鸡场病鸡300只。
试验组1为常规用药组，选用市售七清败毒颗粒，混饮：每1L水，禽2.5g，连续用药3天。
试验组2为本发明实施例3药物组，混饮，每1L水，禽2.5g，连续用药3天。
(4)疗效判定标准
治愈率：试验结束后精神、食欲、临床症状完全恢复正常的病鸡占该组总鸡数的比例。
有效率：试验结束后精神、食欲、临床症状明显好转的的病鸡占该组总鸡数的比例。
无效率：试验期间出现死亡，用药后不见好转的病鸡占该组总鸡数的比例。
表1本发明药物对禽消化道疾病防治试验分组
Figure BDA0002724476230000051
(5)试验结果
本发明药物对家禽的治愈效果。
表2临床试验结果
Figure BDA0002724476230000052
实验组2鸡群在服用本发明实施例3药物后，鸡群精神状态明显好转，采食量明显增加。
临床试验二
(1)试验动物
广东某鸡场有一批35日龄鸡，发现鸡精精神萎顿、羽毛蓬乱，呈昏睡状，闭眼嗜睡等症状，食欲下降，扎堆打盹，剖检可见肝脏肿大、个别肝脏有灰白色坏死点，胃肠道浆膜面和黏膜面有大小不等的白色坏死灶。
(2)试验药品：本发明实施例3所配制药品。
(3)试验设计及方法
随机选择该鸡场病鸡260只。
试验组1为常规用药组，选用市售七清败毒颗粒，混饮，每1L水， 2.5g，连用3天；
试验组2为本发明实施例3所配制药品。本发明药物组，混饮，每1L水，2.5g，连用3天。
(4)疗效判定标准
治愈率：试验结束后精神、食欲、临床症状完全恢复正常的病鸡占该组总鸡数的比例。
有效率：试验结束后精神、食欲、临床症状明显好转的的病鸡占该组总鸡数的比例。
无效率：试验期间出现死亡，用药后不见好转的病鸡占该组总鸡数的比例。
表1本发明药物对禽消化道疾病防治试验分组
Figure BDA0002724476230000061
(5)试验结果
本发明药物对家禽的治愈效果。
表2临床试验结果
Figure BDA0002724476230000071
实验组2鸡群在服用本发明实施例3药物后，鸡群精神状态明显好转，采食量明显增加。

Claims (4)

1.一种七清败毒颗粒，其特征在于由以下重量份的原料和辅料制备而成：
原料：黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g
辅料：β-糊精10-30g、阿斯巴甜0.5-1g、HPMC10-20g、蔗糖400-600g。
2.如权利要求1所述的七清败毒颗粒，其特征在于由以下重量份的原料和辅料制备而成；
原料：黄芩100g、虎杖100g、白头翁80g、苦参80g、板蓝根100g、绵马贯众60g、大青叶40g
辅料：β-糊精20g、阿斯巴甜1g、HPMC20g、蔗糖600g。
3.如权利要求1-2所述的七清败毒颗粒，其特征在于包括以下步骤：
(1)七清败毒颗粒浸膏的制备：取原料，加水煎煮2次，第一次2小时，第二次1小时，煎液滤过，滤液合并，80℃以下减压浓缩至相对密度为1.30-1.35(55℃)，的浸膏，备用；
(2)七清败毒颗粒的制备：取β-糊精、阿斯巴甜、HPMC与粉碎后的蔗糖粉混合均匀，然后加入全部浸膏做软材料、采用喷雾干燥法制粒，即得七清败毒颗粒。
4.如权利要求3所述的七清败毒颗粒的制备方法，其特征在于(1)取原料加8-10倍量的水浸泡2小时，然后进行煎煮，第一次2小时，过滤；取第一次煎煮后的滤渣加6倍量的水，煎煮1小时，过滤，合并滤液，80℃以下减压浓缩至相对密度为1.30-1.35(55℃)的浸膏。
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