CN104547294B - 裸花紫珠在解酒保肝产品中的应用及其产品 - Google Patents
裸花紫珠在解酒保肝产品中的应用及其产品 Download PDFInfo
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Abstract
本发明公开了裸花紫珠在解酒保肝方面的应用，另外本发明提供了一种解酒保肝产品，该产品的主要原料药为裸花紫珠，还可与葛根、山楂、枳椇子中的一种或几种原料药进行组合制备而成。
Description
本申请是对专利号为201210105982.1的发明专利的分案申请。原申请的申请日为2012年4月12日，申请号为201210105982.1，发明创造名称为裸花紫珠在解酒保肝产品中的应用及其产品。
技术领域
本发明涉及医药保健食品技术领域，具体涉及裸花紫珠在解酒保肝产品中的应用及其产品。
背景技术
酒作为人们生活中重要组成部分，人们往往通过饮酒来加强沟通与交流，然而饮酒者常常饮酒过量，不仅对个人健康造成危害，轻者不思饮食、头疼、呕吐，重者引起酒精中毒，引发胃、肝疾病；而且酒后驾车、斗殴等事件也造成不好的社会影响。裸花紫珠(CallicarpanudifloraHook.exArn.)为马鞭草科(Verbenaceae)紫珠属植物，主产于我国海南，是一种海南地道药材，具有收敛、止血、镇痛、消炎等功效，申请人新发现其在解酒保肝方面的新用途，目前市面也有不少中药制成的解酒产品，但尚未见裸花紫珠在解酒保肝方面的应用。
发明内容
本发明的目的裸花紫珠在解酒保肝产品中的应用，本发明的另一个目的是提供该中药及其制备方法。
本发明的目的通过以下技术方案实现：
本发明提供裸花紫珠在解酒保肝方面的新用途，本发明以裸花紫珠为原料药，以裸花紫珠原粉和/或其提取物制成解酒保肝产品。
本发明所述的裸花紫珠在解酒保肝产品中的应用，为更好的达到疗效，所述的原料药还可以与其他中药组合，所述的原料药还含有葛根、山楂、枳椇子，裸花紫珠、葛根、山楂、枳椇子的质量百分比范围为：裸花紫珠50～100％，葛根0～50％，山楂0-50％，枳椇子0-50％；裸花紫珠、葛根、山楂、枳椇子的质量百分比范围优选为：裸花紫珠65～100％，葛根0～35％，山楂0-35％，枳椇子0-35％；裸花紫珠、葛根、山楂、枳椇子的质量百分比范围进一步优选为：裸花紫珠75％，葛根10％，山楂5％，枳椇子10％。
由于原料药可以是新鲜药材，也可以是干药材，在本发明中上述的原料药在计算质量百分比范围时，都以折干计算。
本发明提供的解酒保肝产品，包括但不限于以下四种制备方法制备而成。
方法一：
当原料药有新鲜的和干燥的或全为干燥的时，
(1)分别取每味新鲜或干燥的原料药，加入原料药量的1-20倍的水或稀醇溶剂提取，提取液滤过，得滤液；
(2)将滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将各味原料药所得浸膏合并，再与药学上可接受的辅料制备成制剂。
方法二：
当原料药有新鲜的和干燥的时，
(1)取新鲜的原料药，加入原料药量的1-20倍的水或稀醇溶剂提取，提取液滤过，得滤液A；取干燥的原料药，加入原料药量的1-20倍的水或稀醇溶剂提取，提取液滤过，得滤液B；(2)将滤液A与B或AB合并的滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将所得浸膏与药学上可接受的辅料制备成制剂。
方法三：
当原料药都是新鲜药材时，
(1)分别取每味新鲜状态的原料药，可经压榨得到压榨液及压榨渣，压榨液滤过，得滤液C，剩余的压榨渣加入压榨渣量的1-20倍的水或稀醇溶剂，提取液滤过，得滤液D；
(2)将滤液C或D或CD合并的滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将各味原料药所得浸膏合并，再与药学上可接受的辅料制备成制剂。
方法四：
当原料药都是新鲜药材时，
(1)取新鲜状态的原料药，可经压榨得到压榨液及压榨渣，压榨液滤过，得滤液E，剩余的压榨渣加入压榨渣量的1-20倍的水或稀醇溶剂，提取液滤过，得滤液F；
(2)将滤液E或F或EF合并的滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将所得浸膏与药学上可接受的辅料制备成制剂。
上述四种方法的步骤(2)所得浸膏可进一步精制，再与药学上可接受的辅料制备成制剂。
方法五：
当原料药都是干燥药材时，
(1)取干燥的原料药，粉碎，过筛；
(2)与药学上可接受的辅料制备成制剂。
本发明所述的裸花紫珠在解酒保肝产品中的应用，其特征在于所述产品可供给药形式为：口服剂、喷雾剂、粉针剂、注射剂、滴剂。为携带方便，优选为口服片剂、胶囊剂、喷雾剂、糖浆或滴剂。
为了更好的理解本发明，将通过以下动物实验说明本发明的技术效果。
实验一：小鼠平衡失调实验
将经过预选3min内不从转棒上坠落的健康昆明种小鼠随机分为实验组(实施例1-7所得样品)、模型组、对照组，每组20只。实验组按生药3g/kg体重给药，模型组和对照组给20ml/kg蒸馏水，30min后实验组、模型组用50％乙醇以10ml/kg灌胃，对照组给等体积蒸馏水，分别在给乙醇后15min、45min、75min、120min时将动物放入15转/min转棒式疲劳仪内，记录3min内没有从转棒上掉落小鼠数，数据见下表：
表1 乙醇致小鼠平衡失调试验结果(n＝20)
结果：乙醇灌胃后不同时间段，模型组小鼠明显平衡失调，与对照组相比，转棒上未掉落动物数明显减少，本发明实验组在饮酒后120min转棒上未掉落小鼠数与模型组相比均有显著性差异，表明本发明实验组可明显对抗酒精造成的平衡失调现象。
实验二：乙醇致小鼠睡眠时间的影响
健康昆明种小鼠随机分为实验组(实施例1-7所得样品)、模型组，每组10只。实验组分别给予受试物按3g生药/kg体重给药，模型组给20ml/kg蒸馏水，30min后实验组、模型组用50％乙醇以10ml/kg灌胃，以小鼠翻正反射消失作为睡眠指标，记录各组小鼠翻正反射消失的时间及恢复时间，计算出耐受时间(从灌胃乙醇至翻正反射消失的时间)和维持时间(从翻正反射消失到恢复时间)，数据见下表：
表2乙醇致小鼠睡眠时间的影响(n＝10)
*P<0.05，**P<0.01，与模型组比较。
结果：本发明实验组均能使50％乙醇使模型组小鼠睡眠耐受时间增长，睡眠维持时间缩短，与模型组相比具有显著性差异，表明本发明产品能缩短醉酒引起的睡眠时间，具有醒酒作用。
实验三：乙醇致小鼠急性中毒作用实验
健康昆明种小鼠随机分为实验组(实施例1-7所得样品)、模型组、空白组，每组10只。实验组分别给予受试物按3g生药/kg体重给药，空白组和模型组灌胃生理盐水20ml/kg，30min后，实验组和模型组用50％乙醇灌胃20ml/kg，空白组给等体积蒸馏水，观察5天内各组动物存活率。
表3 乙醇致小鼠急性中毒作用试验
结果：各实验组的小鼠死亡率均低于模型组，卡方检验显示，各实验组与模型组比较具有显著性差异，表明本发明中药能明显降低乙醇急性中毒小鼠死亡率，对乙醇致急性中毒具有预防作用。
实验四：对小鼠急性酒精性肝损伤的影响
健康昆明种小鼠随机分为实验组(实施例1-7所得样品)、模型组、空白组，每组10只。除空白组外，各组小鼠均灌胃50％乙醇，5ml/kg，连续给予20天，造模期间各组小鼠以标准饲料喂养，自由饮水，空白组给予等量生理盐水。从造模第15天起，实验组分别给予受试物按3g生药/kg体重给药，空白组和模型组灌胃生理盐水20ml/kg，连续给药10天，实验结束后，眼眶取血，测定血清ALT、AST。
表4 本发明组合物对小鼠急性酒精性肝损伤血清中ALT、AST含量的影响
*P<0.05，**P<0.01，与空白组比较。▲P<0.05，▲▲P<0.01，与模型组比较。
结果：各实验组能显著降低血清中ALT、AST的含量，与模型组比较具有显著性差异，表明本发明中药对肝脏具有一定的保护作用。
本发明的有益效果：裸花紫珠为主料的解酒保肝产品，饮酒者在饮酒前半小时至1小时或者酒后1小时内服用，可有效提高肝脏抗氧化能力，使乙醇脱氢酶和醛脱氢酶的活性增强，加快乙醇及其代谢产物的消除速率，减轻代谢中间产物乙醛对人体的损害，缩短酒后不适时间，具有保肝降酶作用。
发明人另选了葛根、枳椇子、山楂及其它常用的解酒药物，其中裸花紫珠与葛根、枳椇子、山楂合用，起到的协同增效的作用显著，比起裸花紫珠单用更好。
具体实施方式
实施例1注射液
处方
裸花紫珠375g 葛根 125g 氯化钠 7g 吐温-80 5g 注射用水加至1000ml。
制法：
裸花紫珠、葛根加4kg水煎煮2次，每次1小时，滤过，滤液浓缩至相对密度为1.10～1.15，加乙醇至含醇量达55％，搅拌，冷藏，滤过，滤液回收乙醇，浓缩至500ml，再加乙醇至含醇量达85％，室温放置30小时，滤过，滤液回收乙醇至无醇味，与蒸馏液合并，滤过，加氯化钠，吐温-80，搅拌溶解，加注射用水至1000ml，用G3垂熔玻璃漏斗滤过，灭菌，即得。
实施例2滴丸
处方
裸花紫珠(鲜) 1.75kg 葛根(鲜) 0.25kg 山楂 25g 枳椇子 50g
聚乙二醇900g
制法：
取裸花紫珠和葛根两药材加6kg的55％乙醇提取2次，每次1小时，滤过，得滤液a，取山楂和枳椇子两药材加6kg的55％乙醇提取2次，每次1小时，滤过，得滤液b，滤液a和b合并，浓缩至相对密度为1.25～1.30，干燥、粉碎成细粉，加入聚乙二醇，加热至熔化，制成滴丸，即得。
实施例3喷雾剂
处方
裸花紫珠(鲜) 1.75kg 山楂 75g 枳椇子 75g
制法：
取裸花紫珠加5kg的水提取2次，每次1小时，滤过，滤液浓缩至相对密度为1.05～1.10的清膏c，取山楂加0.6kg的水提取2次，每次1小时，滤过，滤液浓缩至相对密度为1.05～1.10的清膏d，取枳椇子加0.7kg的水提取2次，每次1小时，滤过，滤液浓缩至相对密度为1.05～1.10的清膏e，清膏c、d、e合并，加1％的壳聚糖醋酸溶液(清膏重的4.5％～5.0％)，室温放置24小时，滤过，浓缩至500ml，加尼泊金，溶解，滤过，加蒸馏水至1000ml，分装于喷雾器中，即得。
实施例4粉针剂
处方
裸花紫珠 350g 葛根 75g 山楂 25g 枳椇子 50g
制法：
以上裸花紫珠4味药材加4.5kg55％乙醇提取2次，每次1小时，滤过，滤液回收乙醇，浓缩至相对密度为1.10～1.15，过聚苯乙烯类大孔吸附树脂柱，弃去流出液，6倍柱体积的水洗涤柱体，弃去洗涤液，80％乙醇洗脱，收集洗脱液，回收乙醇，减压浓缩至相对密度为1.20～1.25，冷冻干燥，即得。
实施例5糖浆剂
处方
裸花紫珠(鲜) 1.8kg 枳椇子(鲜) 1kg 蔗糖650g 山犁酸钾 2.0g
制法：
取裸花紫珠、枳椇子两味药材加5kg水煎煮2次，滤过，浓缩至相对密度为1.15～1.25，蔗糖加水煮沸，溶解后滤过，浓缩成糖浆，与浓缩液合并，混匀，煮沸，放冷，加入山犁酸钾溶解，混匀，用冷开水稀释至1000ml，即得。
实施例6胶囊
处方
裸花紫珠 350g 葛根 75g 枳椇子 75g 淀粉 500g 乳糖 400g 微粉硅胶10g 硬脂酸镁3g
制法：
以上裸花紫珠三味药材粉碎，过筛，与淀粉，乳糖混合，乙醇制软材，制粒，干燥，整粒，加入微粉硅胶、硬脂酸镁，混合均匀，填充、即得。
实施例7片剂
处方
裸花紫珠500g 淀粉150g 乳糖150g 微粉硅胶3g 硬脂酸镁2g
制法：
裸花紫珠加水3kg煎煮2次，每次2小时，滤过，滤液浓缩至相对密度为1.30～1.35稠膏，与淀粉，乳糖混合，乙醇制软材，制粒，干燥，整粒，加入微粉硅胶、硬脂酸镁，混合均匀，压片，即得。
Claims (12)
1.裸花紫珠在制备解酒保肝产品中的应用，其特征在于以裸花紫珠为原料药，用裸花紫珠水提取物制成解酒保肝产品。
2.根据权利要求1所述的裸花紫珠在制备解酒保肝产品中的应用，其特征在于所述的原料药还可以含有葛根、山楂、枳椇子中的一种或多种，裸花紫珠、葛根、山楂、枳椇子的质量百分比范围为：
3.根据权利要求2所述的裸花紫珠在制备解酒保肝产品中的应用，其特征在于所述的原料药还可以含有葛根、山楂、枳椇子中的一种或多种，裸花紫珠、葛根、山楂、枳椇子的质量百分比范围为：
4.根据权利要求2所述的裸花紫珠在制备解酒保肝产品中的应用，其特征在于所述裸花紫珠、葛根、山楂、枳椇子的质量百分比为：
5.根据权利要求2所述的裸花紫珠在制备解酒保肝产品中的应用，其特征在于所述的裸花紫珠、葛根、山楂、枳椇子的质量百分比为：
6.根据权利要求2所述的裸花紫珠在制备解酒保肝产品中的应用，其特征在于所述裸花紫珠、葛根、山楂、枳椇子的质量百分比为：
7.根据权利要求3所述的裸花紫珠在制备解酒保肝产品中的应用，其特征在于所述的裸花紫珠、葛根、山楂、枳椇子的质量百分比为：
8.权利要求2～7任一所述的解酒保肝产品，其特征在于产品的制备方法包括如下步骤：
(1)分别取每味新鲜或干燥的原料药，加入原料药量的1-20倍的水提取，提取液滤过，得滤液；
(2)将滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将各味原料药所得浸膏合并，再与药学上可接受的辅料制备成制剂。
9.权利要求2～7任一所述的解酒保肝产品，其特征在于产品的制备方法包括如下步骤：
(1)取新鲜的原料药，加入原料药量的1-20倍的水提取，提取液滤过，得滤液A；取干燥的原料药，加入原料药量的1-20倍的水或提取，提取液滤过，得滤液B；
(2)将滤液A与B或AB合并的滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将所得浸膏与药学上可接受的辅料制备成制剂。
10.权利要求2～7任一所述的解酒保肝产品，其特征在于产品的制备方法包括如下步骤：
(1)分别取每味新鲜状态的原料药，可经压榨得到压榨液及压榨渣，压榨液滤过，得滤液C，剩余的压榨渣加入压榨渣量的1-20倍的水，提取液滤过，得滤液D；
(2)将滤液C或D或CD合并的滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将各味原料药所得浸膏合并，再与药学上可接受的辅料制备成制剂。
11.权利要求2～7任一所述的解酒保肝产品，其特征在于产品的制备方法包括如下步骤：
(1)取新鲜状态的原料药，可经压榨得到压榨液及压榨渣，压榨液滤过，得滤液E，剩余的压榨渣加入压榨渣量的1-20倍的水，提取液滤过，得滤液F；
(2)将滤液E或F或EF合并的滤液浓缩成相对密度为1.05～1.35的浸膏；
(3)将所得浸膏与药学上可接受的辅料制备成制剂。
12.根据权利要求1～7任一所述的裸花紫珠在制备解酒保肝产品中的应用，其特征在于所述产品可供给药形式为：口服剂、喷雾剂、注射剂。
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