CN104274705A - 解酒护肝咀嚼片及其制备方法 - Google Patents
解酒护肝咀嚼片及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种解酒护肝咀嚼片及其制备方法,所述解酒护肝咀嚼片包括:中药提取物、填充剂、粘合剂、崩解剂、润滑剂、所述中药提取物包括:白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根;其制备方法为先将中药组分加水煎煮,煎液滤过,滤液减压浓缩,所得浓缩液中加入乙醇水溶液,搅匀,静置,滤取上清液,经微滤膜过滤后减压浓缩,所得稠膏与填充剂、粘合剂、崩解剂、润滑剂混匀,制粒、干燥、压片制成,即可。本发明的解酒护肝咀嚼片具有良好的防醉、解酒、护肝功效,能迅速降低酒后血液中乙醇的浓度,降低酒精对肝细胞的损伤。
Description
技术领域
本发明属于中药技术领域,具体涉及一种解酒护肝咀嚼片及其制备方法。
背景技术
我国的饮食文化源远流长,其中酒文化属其中之一,且经久不衰,凡婚、丧、庆典,甚至会友,商谈均离不开酒,真所谓“有宴必有酒,无酒不称席”之说。但酒对人体的利、弊各有所说,关键在于“量”,少量则无害,量大则弊多,尤其是经常酗酒者,己成为社会、家庭、个人的一种祸害。根据有关报导:目前,因酒源性疾病如:脑痴呆、心血管疾病、肝硬化等等,已较之10年前增加了28倍,由此而造成的死亡人数也上升了30.6倍。医学界也普遍感到酒精性肝病的发病率在迅速上升,男性酒精中毒的患病率较女性高3~4倍,酒精性肝病的发病率男比女约2:1。为了减少酒源性疾病的发生,避免对肝脏的损伤,应积极提倡不酗酒。但由于我国酒文化的渊远历史,人们不可能与酒绝交,故研究具有护肝、保肝且能解酒的保健食品,对保护人体健康是非常必要的。
近年来,已有不少解酒的医药保健食品、饮料和药物的报导和产品的上市,如专利申请201210272537.4采用葛根、党参、枳椇子、大枣配制的“解酒护肝制剂”;专利申请201410207430.0以石斛、白茶、赶黄草、相思藤、枸杞叶、叶下珠、柚子皮、葛根、奶蓟草、紫花苦菜、洋甘菊、菱角叶、栀子花、香蜂草、留兰香配制的“一种石斛解酒护肝茶”。但不同配方的解酒制品的效果是有很大差别的。而且,目前市场上虽有各式解酒醒酒之产品,但功效甚微,效果也欠佳。但多数产品存在适应症较多,治疗范围广,疗效不明确,针对性不强等缺点。而且许多产品只对预防醉酒有效,醉酒后服用则效果不佳;或只注重保肝护肝,对饮酒后较高的血醇浓度无迅速而明显的改善作用。
发明内容
本发明的目的是克服现有技术的不足而提供一种解酒护肝咀嚼片及其制备方法,该解酒护肝咀嚼片具有良好的防醉、解酒、护肝功效,能迅速降低酒后血液中乙醇的浓度,降低酒精对肝细胞的损伤。
解酒护肝咀嚼片,以重量份计包括:中药提取物3~8份,填充剂3~12份,粘合剂0.5~1.5份,崩解剂0.7~1.8份,润滑剂0.2~0.7份;所述中药提取物以重量份计包括:白葛花3~9份,旋覆花4~8份,金银花2~7份,木槿花4~9份,当归3~7份,款冬花2~8份,腹皮1~6份,木香2~8份,石斛4~10份,刺五加1~7份,枳椇子3~10份,葛根2~9份。
白葛花:具有解酒醒脾、止血的功效。主治:伤酒烦热口渴;头痛头晕;脘腹胀满;呕逆吐酸;不思饮食;吐血;肠风下血。
旋覆花:具有消痰行水、降气止呕的功效。主治:咳喘痰粘;哆嗦噫气;胸痞胁痛。
金银花:具有清热解毒的功效。主治:温病发热;热毒血痢;痈肿疔疮;喉痹及多种感染性疾病。
木槿花:具有清热利湿、凉血解毒的功效。主治:肠风泻血;赤白下痢;痔疮出血;肺热咳嗽;咳血;白带;疮疖痈肿;烫伤。
当归:具有补血、活血、调经止痛、润燥滑肠的功效。主治:血虚诸证;月经不调;经闭;痛经;癥瘕结聚;崩漏;虚寒腹痛;痿痹;肌肤麻木;肠燥便难;赤痢后重;痈疽疮疡;跌扑损伤。
款冬花:具有润肺下气、化痰止咳的功效。主治:新久咳嗽;气喘;劳嗽咳血。
腹皮:具有下气宽中、行水消肿的功效。主治:胸腹胀闷;水肿;脚气;小便不利。
木香:具有健脾和胃、行气止痛、驱早的功效。主治:胃脘;胞腹胀痛;哎吐腹泻;痢疾;食积;早积。
石斛:具有生津益胃、滋阴清热、润肺益肾、明目强腰的功效。主治:热病伤津;口干烦渴;胃阴不足;胃痛干呕;肺燥干咳;虚热不退;阴伤目暗;腰膝软弱。
刺五加:具有补肾强腰、益气安神、活血通络的功效。主治:肾虚体弱;腰膝酸软;小儿行迟;脾虚乏力;气虚浮肿;食欲不振;失眠多梦;健忘;胸痹疼痛;风寒湿痹;跌打肿痛。
枳椇子为鼠李科植物枳椇Hovenia dulcis Thunb,带有肉质柄的果实或种子。性甘、平、无毒。具有补中益气、解酒毒、利二便、平肝熄风之功效。治酒醉、烦渴、利二便。枳椇子含有特效护肝因子,可以保护肝细胞免受酒精及化学因素的损害。有实验证明:枳椇子在消化道中能对乙醇吸收产生抑制作用,可有效地减缓和阻碍乙醇进入人体的速度和浓度,从而减少乙醇对肝脏等脏器的损害。因此,枳椇子有明显的延缓和减少乙醇吸收的作用,能有效地降低乙醇在体内的蓄积浓度,有良好的防醉和解酒之功效。
葛根为豆科植物葛Pueraria lobata(Willd.)Ohwi.的根,具有解酒、止渴之功效,用于解酒醒脾、酒毒伤胃、饮食不思、胸膈饱胀等。葛根有提高肝脏乙醇脱氢酶(ADH)的活性作用,有利于乙醇在体内的分解代谢,从而可以解酒毒。葛根中还含有调节中枢神经细胞的天然活性成分,可作用于大脑皮层,调节被酒精麻醉的大脑神经元,使之恢复正常兴奋状态,有助于大脑的快速清醒。
白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根共同产生协同作用、增强作用,使本发明解酒护肝的效果更为明显。
作为上述发明的进一步改进,所述填充剂为甘露醇。
作为上述发明的进一步改进,所述粘合剂为预胶化淀粉。
作为上述发明的进一步改进,所述崩解剂为交联羧甲基纤维素钠。
作为上述发明的进一步改进,所述润滑剂为十二烷基硬脂酸钠。
上述解酒护肝咀嚼片的制备方法,包括以下步骤:
步骤1,取白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根,加水煎煮,煎液滤过,滤液减压浓缩,至80℃下的相对密度为1.22~1.24,放冷,得浓缩液;
步骤2,在步骤1所得浓缩液中加入乙醇水溶液,搅匀,静置8~16小时,滤取上清液,经微滤膜过滤后减压浓缩,至80℃下的相对密度为1.25~1.39的稠膏;
步骤3,取填充剂、粘合剂、崩解剂、润滑剂,与步骤2所得稠膏混匀,制粒,干燥,压片制成,即可。
作为上述发明的进一步改进,步骤1中加水煎煮过程,加入的水量是白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根总重量的5~8倍。
作为上述发明的进一步改进,步骤2中乙醇水溶液的浓度为60~90wt.%。
作为上述发明的进一步改进,步骤2中加入乙醇水溶液的量是白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根总重量的3~6倍。
作为上述发明的进一步改进,步骤2中微滤膜的平均孔径范围是0.5μm~1μm。
本发明的解酒护肝咀嚼片具有良好的防醉、解酒、护肝功效,能迅速降低酒后血液中乙醇的浓度,降低酒精对肝细胞的损伤。
具体实施方式
实施例1
解酒护肝咀嚼片,以重量份计包括:中药提取物3份,填充剂3份,粘合剂0.5份,崩解剂0.7份,润滑剂0.2份;所述中药提取物以重量份计包括:白葛花3份,旋覆花4份,金银花2份,木槿花4份,当归3份,款冬花2份,腹皮1份,木香2份,石斛4份,刺五加1份,枳椇子3份,葛根2份。
上述解酒护肝咀嚼片的制备方法,包括以下步骤:
步骤1,取白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根,加水煎煮,加入的水量是中药组分总重量的5倍,煎液滤过,滤液减压浓缩,至80℃下的相对密度为1.22,放冷,得浓缩液;
步骤2,在步骤1所得浓缩液中加入浓度为60wt.%的乙醇水溶液,加入的乙醇水溶液的量是中药组分总重量的3倍,搅匀,静置8小时,滤取上清液,经微滤膜过滤后减压浓缩,微滤膜的平均孔径范围是0.5μm,至80℃下的相对密度为1.25的稠膏;
步骤3,取填充剂、粘合剂、崩解剂、润滑剂,与步骤2所得稠膏混匀,制粒,干燥,压片制成,即可。
实施例2
解酒护肝咀嚼片,以重量份计包括:中药提取物5份,填充剂6份,粘合剂0.8份,崩解剂1.2份,润滑剂0.3份;所述中药提取物以重量份计包括:白葛花4份,旋覆花6份,金银花3份,木槿花5份,当归4份,款冬花6份,腹皮2份,木香5份,石斛7份,刺五加3份,枳椇子6份,葛根7份。
上述解酒护肝咀嚼片的制备方法,包括以下步骤:
步骤1,取白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根,加水煎煮,加入的水量是中药组分总重量的6倍,煎液滤过,滤液减压浓缩,至80℃下的相对密度为1.24,放冷,得浓缩液;
步骤2,在步骤1所得浓缩液中加入浓度为70wt.%的乙醇水溶液,加入的乙醇水溶液的量是中药组分总重量的4倍,搅匀,静置12小时,滤取上清液,经微滤膜过滤后减压浓缩,微滤膜的平均孔径范围是0.8μm,至80℃下的相对密度为1.28的稠膏;
步骤3,取填充剂、粘合剂、崩解剂、润滑剂,与步骤2所得稠膏混匀,制粒,干燥,压片制成,即可。
实施例3
解酒护肝咀嚼片,以重量份计包括:中药提取物6份,填充剂8份,粘合剂1.2份,崩解剂1.5份,润滑剂0.5份;所述中药提取物以重量份计包括:白葛花6份,旋覆花7份,金银花5份,木槿花8份,当归4份,款冬花3份,腹皮2份,木香8份,石斛9份,刺五加3份,枳椇子4份,葛根8份。
上述解酒护肝咀嚼片的制备方法,包括以下步骤:
步骤1,取白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根,加水煎煮,加入的水量是中药组分总重量的7倍,煎液滤过,滤液减压浓缩,至80℃下的相对密度为1.24,放冷,得浓缩液;
步骤2,在步骤1所得浓缩液中加入浓度为60wt.%的乙醇水溶液,加入的乙醇水溶液的量是中药组分总重量的6倍,搅匀,静置16小时,滤取上清液,经微滤膜过滤后减压浓缩,微滤膜的平均孔径范围是1μm,至80℃下的相对密度为1.39的稠膏;
步骤3,取填充剂、粘合剂、崩解剂、润滑剂,与步骤2所得稠膏混匀,制粒,干燥,压片制成,即可。
实施例4
解酒护肝咀嚼片,以重量份计包括:中药提取物6份,填充剂10份,粘合剂1.4份,崩解剂1.2份,润滑剂0.6份;所述中药提取物以重量份计包括:白葛花7份,旋覆花5份,金银花3份,木槿花5份,当归6份,款冬花3份,腹皮2份,木香6份,石斛7份,刺五加6份,枳椇子8份,葛根6份。
上述解酒护肝咀嚼片的制备方法,包括以下步骤:
步骤1,取白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根,加水煎煮,加入的水量是中药组分总重量的5倍,煎液滤过,滤液减压浓缩,至80℃下的相对密度为1.22,放冷,得浓缩液;
步骤2,在步骤1所得浓缩液中加入浓度为60wt.%的乙醇水溶液,加入的乙醇水溶液的量是中药组分总重量的3倍,搅匀,静置8小时,滤取上清液,经微滤膜过滤后减压浓缩,微滤膜的平均孔径范围是0.5μm,至80℃下的相对密度为1.25的稠膏;
步骤3,取填充剂、粘合剂、崩解剂、润滑剂,与步骤2所得稠膏混匀,制粒,干燥,压片制成,即可。
实施例5
解酒护肝咀嚼片,以重量份计包括:中药提取物8份,填充剂12份,粘合剂1.5份,崩解剂1.8份,润滑剂0.7份;所述中药提取物以重量份计包括:白葛花9份,旋覆花8份,金银花7份,木槿花9份,当归7份,款冬花8份,腹皮6份,木香8份,石斛10份,刺五加7份,枳椇子10份,葛根9份。
上述解酒护肝咀嚼片的制备方法,包括以下步骤:
步骤1,取白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根,加水煎煮,加入的水量是中药组分总重量的5倍,煎液滤过,滤液减压浓缩,至80℃下的相对密度为1.22,放冷,得浓缩液;
步骤2,在步骤1所得浓缩液中加入浓度为60wt.%的乙醇水溶液,加入的乙醇水溶液的量是中药组分总重量的3倍,搅匀,静置8小时,滤取上清液,经微滤膜过滤后减压浓缩,微滤膜的平均孔径范围是0.5μm,至80℃下的相对密度为1.25的稠膏;
步骤3,取填充剂、粘合剂、崩解剂、润滑剂,与步骤2所得稠膏混匀,制粒,干燥,压片制成,即可。
实验例1对小鼠血清ALT、AST的影响
取健康小鼠60只,体重18~22g,雌雄各半,随机分为6组,实验组设高剂量、中剂量、低剂量组,其它设正常组、模型组和阳性(海王金樽)对照组,经过适应性饲养一周后进行实验。
实验中各组按设定的酒量或药量每天定时灌胃,至第44日给药结束后,所有动物禁饲一天,第45日给药一小时后,在小鼠眶动脉和眶静脉取血,取血清待检,同时,迅速剖取肝脏,按要求保存待检。
ALT、AST主要存在于肝细胞浆内,当肝细胞损伤时,细胞内转氨酶可进入血液中,从而引起血液中ALT、AST升高。给酒精小鼠比较有显著性差异(P<0.01)。预防实验结果表明:本发明解酒护肝咀嚼片可降低模型小鼠血清ALT、AST,预防效果优于阳性对照组,说明本发明解酒护肝咀嚼片能通过消化道吸收,起到保护肝细胞,抑制肝组织内ALT、AST的升高,并能稳定肝细胞膜,抑制ALT、AST释放入血液中,从而有效地防治酒精性肝损伤。结果如下:
剂量(mg/kg) | ALT | AST | |
空白组 | 0 | 5.11±6.36 | 38.62±13.13 |
模型组 | 0 | 42.22±32.34## | 67.56±9.49## |
阳性组 | 426 | 34.09±25.16 | 62.84±9.88 |
低剂量组 | 60 | 35.39±25.24 | 66.27±3.49 |
中剂量组 | 180 | 17.62±13.09 | 58.26±16.96 |
高剂量组 | 540 | 12.04±8.25** | 52.25±18.90* |
与正常组比较,##p<0.01;与模型组比较,*p<0.05,**p<0.01。
从上表可知,使用本发明解酒护肝咀嚼片的实验组,其ALT、AST低于模型组、阳性对照组。也就是说,本发明解酒护肝咀嚼片可降低模型小鼠血清ALT、AST,预防效果优于阳性对照组。说明本发明解酒护肝制剂能通过消化道吸收,起到保护肝细胞,抑制肝组织内ALT、AST的升高,并能稳定肝细胞膜,抑制ALT、AST释放入血液中,从而有效地防治酒精性肝损伤。
实验例2毒理试验:
选昆明种健康小鼠20只,体重18~22g,雌雄各半,每鼠按0.4mL/10g灌服可溶最高浓度的本发明解酒护肝制剂,每4小时连续3次。观察给药后7天的反应、饮食、活动情况及动物死亡数,并计算小鼠的最大耐受量及最大耐受倍数。
结果:7天内各小鼠饮食、活动正常,毛色光泽,无一死亡。小鼠灌服本发明解酒护肝制剂的最大耐受量(MTD)为360g/kg,而小鼠对人的最大耐受倍数为840倍,表明人服用本发明解酒护肝制剂将十分安全。
Claims (10)
1.解酒护肝咀嚼片,其特征在于:以重量份计包括:中药提取物3~8份,填充剂3~12份,粘合剂0.5~1.5份,崩解剂0.7~1.8份,润滑剂0.2~0.7份;所述中药提取物以重量份计包括:白葛花3~9份,旋覆花4~8份,金银花2~7份,木槿花4~9份,当归3~7份,款冬花2~8份,腹皮1~6份,木香2~8份,石斛4~10份,刺五加1~7份,枳椇子3~10份,葛根2~9份。
2.根据权利要求1所述的解酒护肝咀嚼片,其特征在于:所述填充剂为甘露醇。
3.根据权利要求1所述的解酒护肝咀嚼片,其特征在于:所述粘合剂为预胶化淀粉。
4.根据权利要求1所述的解酒护肝咀嚼片,其特征在于:所述崩解剂为交联羧甲基纤维素钠。
5.根据权利要求1所述的解酒护肝咀嚼片,其特征在于:所述润滑剂为十二烷基硬脂酸钠。
6.权利要求1所述的解酒护肝咀嚼片的制备方法,其特征在于:包括以下步骤:
步骤1,取白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根,加水煎煮,煎液滤过,滤液减压浓缩,至80℃下的相对密度为1.22~1.24,放冷,得浓缩液;
步骤2,在步骤1所得浓缩液中加入乙醇水溶液,搅匀,静置8~16小时,滤取上清液,经微滤膜过滤后减压浓缩,至80℃下的相对密度为1.25~1.39的稠膏;
步骤3,取填充剂、粘合剂、崩解剂、润滑剂,与步骤2所得稠膏混匀,制粒,干燥,压片制成,即可。
7.根据权利要求6所述的解酒护肝咀嚼片的制备方法,其特征在于:步骤1中加水煎煮过程,加入的水量是白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根总重量的5~8倍。
8.根据权利要求6所述的解酒护肝咀嚼片的制备方法,其特征在于:步骤2中乙醇水溶液的浓度为60~90 wt.%。
9.根据权利要求6所述的解酒护肝咀嚼片的制备方法,其特征在于:步骤2中加入乙醇水溶液的量是白葛花、旋覆花、金银花、木槿花、当归、款冬花、腹皮、木香、石斛、刺五加、枳椇子、葛根总重量的3~6倍。
10.根据权利要求6所述的解酒护肝咀嚼片的制备方法,其特征在于:步骤2中微滤膜的平均孔径范围是0.5μm~1μm。
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