CN114794475A - 一种具有护肝功能的口崩片及其制备方法 - Google Patents
一种具有护肝功能的口崩片及其制备方法 Download PDFInfo
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- CN114794475A CN114794475A CN202210470199.9A CN202210470199A CN114794475A CN 114794475 A CN114794475 A CN 114794475A CN 202210470199 A CN202210470199 A CN 202210470199A CN 114794475 A CN114794475 A CN 114794475A
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- american ginseng
- orally disintegrating
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Abstract
本发明属于保健食品技术领域,具体涉及一种具有护肝功能的口崩片及其制备方法;本发明提供的口崩片由60~90重量份填充剂、2~4重量份泡腾剂、20~30重量份润滑剂、30~40重量份崩解剂、15~20重量份枫糖、10~15重量份西洋参提取物粉、10~15重量份壳寡糖、10~15重量份甘露寡糖、10~15重量份低聚果糖组成;经制备西洋参提取物粉、制粒和压片,即可制得本发明的口崩片;本发明的口崩片配比合理,具有很好的营养价值和护肝效果,尤其对长期饮酒的人,具有很好的护肝保健作用。
Description
本申请是申请日为2018年07月10日、申请号为201810750189.4、发明名称为《一种具有护肝功能的口崩片及其制备方法》的分案申请。
技术领域
本发明属于保健食品技术领域,具体涉及一种具有护肝功能的口崩片及其制备方法。
背景技术
现代医学研究证明,西洋参具有强壮中枢神经,安定身心并恢复疲劳,有镇静及解酒作用。
壳寡糖具有很强吸附性,能吸附体内有害重金属和其它毒素并排出体外,减少毒素对肝脏的损伤,它还能修复受损肝细胞,并促使产生肝炎病毒抗体,预防肝炎;壳寡糖带有正电荷的特性,可螯合脂肪,增加酶活性,阻止胆固醇和中性脂肪上升,预防脂肪肝,它还能最大限度激活肝脏脂代谢功能,具有活化和修复肝细胞的功能,同时可以与带负电荷的脂类与胆汁酸结合排除体外,阻止人体对脂肪的吸收,降低血脂,预防脂肪肝。
甘露寡糖在激活免疫应答上有一定作用,还可显著提高抗体反应能力,从而加强疫苗的保护效能;甘露寡糖除具有辅剂和抗原特性之外,还有能刺激肝脏分泌甘露糖结合蛋白,从而影响免疫系统的作用,这种结合蛋白可结合细菌被囊,从而启动免疫系统产生应答反应。
在保健品中的应用低聚果糖具有类似膳食纤维素的功能,由于低聚果糖能达到促进钙、镁、铁等矿物质和微量元素吸收的效果,并可以促进体内自然合成B类复合维生素,具有支持大脑、神经系统活动,促进消化及能量生成的作用,故可在补钙、铁、锌等食品、保健品以及提高人体免疫力的滋补食品中添加低聚果糖,这样既可以提高产品的功效,还可以降低产品的火气。
枫糖含钙量是蜂蜜的10倍而含钠量仅有其1/10,科学家在纯枫糖中发现共有34项新化合物,其中5种苯酚以前从未在自然界中发现过。
以上物质不但可以平时作为保健品食用,也可以作为药材使用,共同食用或使用时,更能够相互促进。口崩片作为一种新的剂型,具有吸收快,生物利用度高,肠道残留少,副作用低和可以避免肝脏的首过效应等显著优点。因此,研发一种含有上述材料的具有护肝功能的口崩片及其制备方法成为一项迫切而重要的工作。
发明内容
本发明的目的在于克服现有技术存在的缺点,提供一种具有护肝功能的口崩片。
为实现上述目的,本发明以下技术方案:
一种具有护肝功能的口崩片由60~90重量份填充剂、2~4重量份泡腾剂、20~30重量份润滑剂、30~40重量份崩解剂、15~20重量份枫糖、10~15重量份西洋参提取物粉、10~15重量份壳寡糖、10~15重量份甘露寡糖、10~15重量份低聚果糖组成;
所述具有护肝功能的口崩片的制备方法,由如下步骤组成:
1)、西洋参提取物粉的制备:取鲜西洋参,洗净晾干,粉碎成药粉,加水,常温下浸泡1~2小时;加热煮沸并保持微沸状态30min,滤出药液;向滤渣中加水至与第一次熬煮的水量相同,重新煮沸并保持微沸状态30min,滤出药液;将两次滤出的药液合并,沉淀、过滤、离心,取上层清液,即为西洋参提取液;采用喷雾干燥法将西洋参提取液干燥成粉,即得西洋参提取物粉;
2)、酸性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得酸性干颗粒;该步骤中泡腾剂为有机酸;
3)、碱性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得碱性干颗粒;该步骤中泡腾剂为碳酸氢钠;
4)、混合压片步骤:将酸性干颗粒和碱性干颗粒混合均匀,用压片机压制成片剂,即的具有护肝功能的口崩片;
所述步骤2)和步骤3)中,各组分研磨至80目以下的颗粒,湿法制粒的粒度为20目以下,干燥后干颗粒的粒度为10~60目;
所述填充剂为甘露醇、乳糖、微晶纤维、蔗糖、玉米淀粉中的一种或几种;
所述泡腾剂为碳酸氢钠和有机酸,按重量计,碳酸氢钠和有机酸的比例为1:1;所述有机酸为柠檬酸和酒石酸的任意一种或两者的混合物,有机酸当为者的混合物时,所述柠檬酸和酒石酸的比例为1:1;
所述润滑剂为硬脂酸镁、滑石粉和微粉硅胶中的一种或几种;
所述解剂为羧甲基淀粉钠、低取代羟丙基纤维素和交联聚乙烯比咯烷酮、交联羧甲基纤维素钠中的一种或几种。
所述重量份为本领域公知μg、㎎、g、kg等重量单位,或为其倍数,如1/100、1/10、10倍、100倍等。
本发明提供的口崩片具有护肝功效的药理:
1、壳寡糖的物理吸附作用可以减少减缓人体对酒精的吸收,西洋参通过生理调节可以缓解醉酒后症状,甘露寡糖可有效清除羟自由基(·OH),适量添加甘露寡糖有益于提高肝脏组织的抗氧化能力,保护肝脏免受各种氧化应激和损伤,三种原料通过不同的途径,起到解酒护肝的作用;
2、醉酒的人多数会呕吐,损伤肠胃,导致一定的营养流失,本发明提供的口崩片中含有的低聚果糖可以提供为人体提供营养物质,同时也可以改善肠道益生菌促进营养吸收,和富含营养的枫糖配合,为醉酒后的人群提供营养;
3、甘露寡糖具有一定的免疫原性,能刺激机体免疫应答,此外还能促进有益菌增殖,改善肠道微环境,提高机体免疫力;西洋参中的活性成分可以很好地补气养血,促进血清蛋白合成、骨髓蛋白合成、器官蛋白合成等,对机体的免疫力起到提高的作用,对烟酒过多引起的虚烦躁火、纳呆(食欲差)倦怠等很好的缓解作用,因此由于长期饮酒导致机体的免疫力下降的人群长期服用本发明的口崩片,可以起到提高免疫力、保健的作用。
本发明的另一目的是提供一种具有护肝功能的口崩片的制备方法,由以下步骤组成:
1)、西洋参提取物粉的制备:取鲜西洋参,洗净晾干,粉碎成药粉,加水,常温下浸泡1~2小时;加热煮沸并保持微沸状态30min,滤出药液;向滤渣中加水至与第一次熬煮的水量相同,重新煮沸并保持微沸状态30min,滤出药液;将两次滤出的药液合并,沉淀、过滤、离心,取上层清液,即为西洋参提取液;采用喷雾干燥法将西洋参提取液干燥成粉,即得西洋参提取物粉;
2)、酸性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得酸性干颗粒;该步骤中泡腾剂为有机酸;
3)、碱性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得碱性干颗粒;该步骤中泡腾剂为碳酸氢钠;
4)、混合压片步骤:将酸性干颗粒和碱性干颗粒混合均匀,用压片机压制成片剂,即得具有护肝功能的口崩片;
所述步骤2)和步骤3)中,各组分研磨至80目以下的颗粒,湿法制粒的粒度为20目以下,干燥后干颗粒的粒度为10~60目。
借由上述方案,本发明至少具有以下优点:
1、本发明提供的口崩片含有枫糖、西洋参提取物粉、壳寡糖、低聚果糖、甘露寡糖:壳寡糖的物理吸附性可以减少人体对酒精的吸收,西洋参在安神镇静方面可缓解醉酒症状,壳寡糖和甘露寡糖可减少酒精对肝脏的损伤,低聚果糖能促进人体对矿物质和微量元素的吸收,配合枫糖中多种营养物质,既能为长期饮酒的人群提供微量元素和矿物质,又能改良口崩片的口感,因此本发明配比合理,具有很好的营养价值和护肝效果,尤其对长期饮酒的人,具有很好的护肝保健作用;
2、本发明采用口崩片的剂型,在服用时可以直接将药物放入口中,药物遇到唾液发生崩解,随着人体自主或不自主的吞咽动作进入消化系统吸收后起效,使得服药更为轻松、安全,尤其适用于醉酒后神志不清、吞咽困难的人;
3、本发明选取的原料中西洋参、甘露寡糖与低聚果糖长期服用能提高人体免疫力;西洋参、壳聚糖能激活肝脏脂代谢功能,修复受损肝细胞,预防脂肪肝。
4、本发明提供的口崩片经小鼠实验验证,证明本发明的口崩片中有效成分对护肝有显著效果。
具体实施方式
下面通过实施例对本发明做进一步详细描述,但是本发明并不局限于下述实施方式。
实施例1:
本实施例提供的具有护肝功能的口崩片各组分及其重量份如下:60重量份填充剂、2重量份泡腾剂、20重量份润滑剂、30重量份崩解剂、15重量份枫糖、10重量份西洋参提取物粉、10重量份壳寡糖、10重量份甘露寡糖、10重量份低聚果糖组成;
其中,填充剂为甘露醇、乳糖、微晶纤维、蔗糖、玉米淀粉;
其中,泡腾剂为碳酸氢钠和有机酸,按重量计,碳酸氢钠和有机酸的比例为1:1;
其中,有机酸为柠檬酸和酒石酸,柠檬酸和酒石酸的比例为1:1;
其中,润滑剂为硬脂酸镁、滑石粉和微粉硅胶;
其中,崩解剂为羧甲基淀粉钠、低取代羟丙基纤维素和交联聚乙烯比咯烷酮、交联羧甲基纤维素钠。
本实施例中具有护肝功能的口崩片,制备方法如下:
1)、西洋参提取物粉的制备:取鲜西洋参,洗净晾干,粉碎成药粉,加水,常温下浸泡1小时;加热煮沸并保持微沸状态30min,滤出药液;向滤渣中加水至与第一次熬煮的水量相同,重新煮沸并保持微沸状态30min,滤出药液;将两次滤出的药液合并,沉淀、过滤、离心,取上层清液,即为西洋参提取液;采用喷雾干燥法将西洋参提取液干燥成粉,即得西洋参提取物粉;
2)、酸性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得酸性干颗粒;该步骤中泡腾剂为有机酸;
3)、碱性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得碱性干颗粒;该步骤中泡腾剂为碳酸氢钠;
4)、混合压片步骤:将酸性干颗粒和碱性干颗粒混合均匀,用压片机压制成片剂,即的具有护肝功能的口崩片。
实施例2:
本实施例提供的具有护肝功能的口崩片各组分及其重量份如下:90重量份填充剂、4重量份泡腾剂、30重量份润滑剂、40重量份崩解剂、20重量份枫糖、15重量份西洋参提取物粉、15重量份壳寡糖、15重量份甘露寡糖、15重量份低聚果糖组成;
其中,填充剂为甘露醇、乳糖;
其中,泡腾剂为碳酸氢钠和柠檬酸,按重量计,碳酸氢钠和柠檬酸的比例为1:1;
其中,润滑剂为硬脂酸镁、滑石粉;
其中,崩解剂为羧甲基淀粉钠、低取代羟丙基纤维素。
本实施例中具有护肝功能的口崩片具体制备步骤与实施例1中的步骤相同。
实施例3:
本实施例提供的具有护肝功能的口崩片各组分及其重量份如下:80重量份填充剂、3重量份泡腾剂、25重量份润滑剂、35重量份崩解剂、16重量份枫糖、12重量份西洋参提取物粉、12重量份壳寡糖、13重量份甘露寡糖、13重量份低聚果糖组成。
填充剂为微晶纤维、蔗糖、玉米淀粉;
泡腾剂为碳酸氢钠和酒石酸,按重量计,碳酸氢钠和酒石酸的比例为1:1;
润滑剂为硬脂酸镁、微粉硅胶;
崩解剂为交联聚乙烯比咯烷酮、交联羧甲基纤维素钠;
本实施例中具有护肝功能的口崩片具体制备步骤与实施例1中的步骤相同。
实施例4:护肝功能实验
1)实验原理
机体反复多次过量摄入乙醇后,乙醇可通过诱导CYP4502E1,引起氧化应激、脂质过氧化、代谢/营养的紊乱以及线粒体结构和功能的改变等一系列反应,导致肝细胞的功能损伤。
2)实验动物
雄性小鼠(18-22克),四组,每组10只。
3)实验方法
3.1剂量和分组
分别以人体推荐量的10倍、5倍、1倍为剂量组,另设一个对照组。(人体推荐剂量以壳寡糖计0.5g)
3.2受试样品的给予
经口灌胃给予受试样品,连续给予30天。
3.3实验步骤
将口崩片溶解于水,每日经口灌胃给予受试样品,对照组给予纯净水。将动物每周称重两次,以调整受试样品剂量。剂量组和对照组于实验结束前14天每天经口灌胃给予30%的乙醇,小鼠灌胃量10ml/kg BW(乙醇密度0.8g/ml,折合乙醇的剂量为2400mg/kgBW),样品灌胃后间隔4小时再给予乙醇。实验结束前禁食4h,经腹腔注射60mg/kg BW的戊巴比妥钠溶液麻醉后,腹主动脉采血,并取肝组织,进行各项指标的检测及病理组织学检查。
3.4肝脏病理组织学变化、诊断标准和结果判定
3.4.1实验材料
取小鼠肝脏左叶用10%福尔马林固定,从肝左叶中部做横切面取材,常规制片,HE染色。
3.4.2镜检
用5倍物镜连续观察整张组织切片,主要观察肝细胞变性(脂肪变性、水样变性、胞浆凝聚、气球样变)、肝细胞坏死和炎症改变等,并同时给予记录。
肝细胞气球样变:
肝细胞脂肪变性:
胞浆凝聚:
水样变性:
炎症改变:
肝细胞坏死:
3.5.3肝脏病变计分方法
将每只动物肝细胞各种病理变化得分相加,肝细胞坏死评分2倍计入,以总分进行统计分析。每只动物肝脏病变得分=肝细胞变性得分(气球样变得分+脂肪变性得分+胞浆凝聚得分+水样变性得分)×1+肝细胞炎症改变得分×1+肝细胞坏死得分×2
3.5.4病理结果判定
受试样品任何一个剂量组与模型对照组之间,肝细胞病变程度明显减轻,可判断动物实验病理结果阳性。
3.6亚急性酒精性肝损伤结果判定
表1各组小白鼠亚急性酒精性肝损伤判定结果
通过上表中的实验结果可以看出,各实验组的小白鼠肝细胞基本未发生病变,而对照组的小白鼠肝细胞明显发生病变,由此可以得出以下结论:本实施例的口崩片具有护肝的功效,长期服用能预防亚急性酒精性肝损伤。
本发明的实施方式不限于此,在本发明上述基本技术思想前提下,按照本领域的普通技术知识和惯用手段对本发明内容所做出其它多种形式的修改、替换或变更,均落在本发明权利保护范围之内。
Claims (2)
1.一种具有护肝功能的口崩片,其特征在于,由60~90重量份填充剂、2~4重量份泡腾剂、20~30重量份润滑剂、30~40重量份崩解剂、15~20重量份枫糖、10~15重量份西洋参提取物粉、10~15重量份壳寡糖、10~15重量份甘露寡糖、10~15重量份低聚果糖组成;
所述具有护肝功能的口崩片的制备方法,由如下步骤组成:
1)、西洋参提取物粉的制备:取鲜西洋参,洗净晾干,粉碎成药粉,加水,常温下浸泡1~2小时;加热煮沸并保持微沸状态30min,滤出药液;向滤渣中加水至与第一次熬煮的水量相同,重新煮沸并保持微沸状态30min,滤出药液;将两次滤出的药液合并,沉淀、过滤、离心,取上层清液,即为西洋参提取液;采用喷雾干燥法将西洋参提取液干燥成粉,即得西洋参提取物粉;
2)、酸性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得酸性干颗粒;该步骤中泡腾剂为有机酸;
3)、碱性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得碱性干颗粒;该步骤中泡腾剂为碳酸氢钠;
4)、混合压片步骤:将酸性干颗粒和碱性干颗粒混合均匀,用压片机压制成片剂,即的具有护肝功能的口崩片;
所述步骤2)和步骤3)中,各组分研磨至80目以下的颗粒,湿法制粒的粒度为20目以下,干燥后干颗粒的粒度为10~60目;
所述填充剂为甘露醇、乳糖、微晶纤维、蔗糖、玉米淀粉中的一种或几种;
所述泡腾剂为碳酸氢钠和有机酸,按重量计,碳酸氢钠和有机酸的比例为1:1;所述有机酸为柠檬酸和酒石酸的任意一种或两者的混合物,有机酸当为者的混合物时,所述柠檬酸和酒石酸的比例为1:1;
所述润滑剂为硬脂酸镁、滑石粉和微粉硅胶中的一种或几种;
所述解剂为羧甲基淀粉钠、低取代羟丙基纤维素和交联聚乙烯比咯烷酮、交联羧甲基纤维素钠中的一种或几种。
2.权利要求1所述具有护肝功能的口崩片的制备方法,其特征在于,由如下步骤组成:
1)、西洋参提取物粉的制备:取鲜西洋参,洗净晾干,粉碎成药粉,加水,常温下浸泡1~2小时;加热煮沸并保持微沸状态30min,滤出药液;向滤渣中加水至与第一次熬煮的水量相同,重新煮沸并保持微沸状态30min,滤出药液;将两次滤出的药液合并,沉淀、过滤、离心,取上层清液,即为西洋参提取液;采用喷雾干燥法将西洋参提取液干燥成粉,即得西洋参提取物粉;
2)、酸性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得酸性干颗粒;该步骤中泡腾剂为有机酸;
3)、碱性颗粒的制备:按重量份的一半称取各组分,研磨,然后充分混合后湿法制粒,干燥得碱性干颗粒;该步骤中泡腾剂为碳酸氢钠;
4)、混合压片步骤:将酸性干颗粒和碱性干颗粒混合均匀,用压片机压制成片剂,即得具有护肝功能的口崩片;
所述步骤2)和步骤3)中,各组分研磨至80目以下的颗粒,湿法制粒的粒度为20目以下,干燥后干颗粒的粒度为10~60目。
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