CN116712489A - 一种具有护肝作用的药物组合物及其制备方法 - Google Patents
一种具有护肝作用的药物组合物及其制备方法 Download PDFInfo
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- CN116712489A CN116712489A CN202310718231.5A CN202310718231A CN116712489A CN 116712489 A CN116712489 A CN 116712489A CN 202310718231 A CN202310718231 A CN 202310718231A CN 116712489 A CN116712489 A CN 116712489A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明提供了一种具有护肝作用的药物组合物及其制备方法,属于保健食品技术领域。本发明的药物组合物由枸杞子10~20份、桑椹10~20份、陈皮2~10份、甜味剂0~8份、酸味剂0~6份混合制备得到。本发明提供的药物组合物可显著降低小鼠血中谷草转氨酶、谷丙转氨酶活性;降低小鼠肝组织丙二醛、甘油三酯和还原性谷胱甘肽的含量,具有良好的护肝作用。
Description
技术领域
本发明涉及保健食品技术领域,尤其涉及一种具有护肝作用的药物组合物及其制备方法。
背景技术
随着污染加剧、加班熬夜、化学物质的使用,饮酒人群增多及药物滥用的现象增加,肝功能减退的人数也逐年上升,表现为食欲减退、乏力、精神不振等。若不及时干预将会影响正常的生活、工作与学习。因此重视肝功能减退的有效预防,阻止进一步损伤肝脏,是保健食品相关领域的研究热点。以中药研发为基础的护肝类保健产品有着不加重肝脏负担、易于被大众接受、副作用少等优势。
食疗食养在我国具有悠久的历史,在日常饮食中添加某些药材以滋补身体、预防疾病已成为一种典型的舌尖文化。国家相关部门发布既是食品又是药品的药材名单后,许多药食同源的中药材既以食品的身份深入百姓生活,也以药材的形式出现在保肝护肝的防治中。
枸杞子,为茄科多年生灌木宁夏枸杞(Lyciumbarbarum L.)的干燥成熟果实。始载于《神农本草经》,被列为上品,谓之“久服坚筋骨,轻身不老,耐寒暑”。枸杞子味甘、性平,归肝、肾经,具有益精明目、滋补肝肾、养阴润肺、补虚益精等功效。药理学研究显示,枸杞子在保肝、提高免疫力、清除自由基、抗氧化、抗肿瘤、神经保护等方面均有很好的效果。
桑椹为桑科植物桑(Morus alba L.)的成熟果实。桑椹的药用历史悠久,早在《本草纲目》中就有记载,桑椹味甘,性微寒,能生津,有滋阴补血、安魂镇神之效。其化学成分不仅含有丰富的氨基酸、维生素、矿物质等营养成分还含有白藜芦醇、黄酮、多糖等活性成多糖等活性成分。现代营养医学研究表明,桑葚具有抗氧化、抗炎症、抗肿瘤、调节免疫、保护肝脏、抗肥胖、保护神经等作用。
陈皮为芸香科柑桔属植物橘(Citrus reticulata Blanco)及其栽培变种的干燥成熟果皮。陈皮是一种历史悠久、药食同源的中国传统道地药材,在我国许多经典的中医著作中如《备急千金要方》、《药性论》、《本草纲目》等皆有记载。其所含的化学成分较多,其中以黄酮类为主,研究表明,陈皮中黄酮类成分有保肝护肝、强心、调节胃肠道平滑肌运动等作用。
目前以桑椹、陈皮两味药食同源中药材与枸杞子配伍作为原料,并具有护肝作用的保健食品少有报道,本发明将三者结合所得产品口感适宜、质量可控、营养丰富、具有保肝护肝的功效。
发明内容
本发明的目的在于提供一种具有护肝作用的药物组合物。
为了实现上述发明目的,本发明提供以下技术方案:
本发明提供了,一种具有护肝作用的药物组合物,其特征在于,所述药物组合物由如下重量份的原料制备得到:枸杞子10~20份、桑椹10~20份、陈皮2~10份。
本发明还提供了,一种具有护肝作用的药物组合物的制备方法,其特征在于,包括如下所述步骤:
取枸杞子、桑椹、陈皮加水浸提,合并液体部分浓缩,得到药物组合物。
优选的,所述枸杞子、桑椹、陈皮的总重量与水的重量比为1:5~15。
优选的,所述浸提的温度为76~96℃,浸提的次数为1~3次,每次浸提的时间为0.5~2.0h。
优选的,所述浓缩的温度为55~65℃,压强为0.06~0.08MPa。
优选的,所述药物组合物的可溶性固形物的含量为40~70%。
优选的,可将所述药物组合物制成片剂、颗粒剂、胶囊剂、饼干、硬糖、凝胶软糖或固体饮料。
本发明提供的药物组合物可显著降低小鼠血中谷草转氨酶、谷丙转氨酶活性;降低小鼠肝组织丙二醛、甘油三酯和还原性谷胱甘肽的含量。具有良好的护肝作用。
附图说明
图1为实施例7小鼠血清谷草转氨酶含量;
图2为实施例7小鼠血清谷丙转氨酶含量;
图3为实施例7小鼠肝组织丙二醛含量;
图4为实施例7小鼠肝组织甘油三酯含量;
图5为实施例7小鼠肝组织还原性谷胱甘肽含量。
具体实施方式
下面结合实施例对本发明提供的技术方案进行详细的说明,但是不能把它们理解为对本发明保护范围的限定。
实施例1
药物组合物固体饮料的制备:
(1)药物组合物的制备:的枸杞子150g、桑椹150g、陈皮50g,加入10倍中药总重量的纯净水,96℃水浴浸提2次,每次2.0h,合并液体部分,60℃,0.08MPa压强下,浓缩至可溶性固形物的含量为50%,得到药物组合物70g。
(2)固体饮料的制备
取步骤(1)制备的药物组合物30g,加入糊精20g、微晶纤维素30g、柠檬酸0.3g、安赛蜜0.5g制软材,过14目筛制颗粒,60℃干燥1.0h,整粒。
实施例2
凝胶软糖的制备
(1)药物组合物的制备:取枸杞子150g、桑椹150g、陈皮60g,加入8倍中药总重量的纯净水,90℃水浴浸提2次,每次2.0h,合并液体部分,60℃,0.08MPa压强下,浓缩至可溶性固形物的含量为50%,得到药物组合物80g。
(2)凝胶剂的制备:在卡拉胶中加40倍重量份的水,95℃溶胶0.5h;在琼脂中加20倍重量份的水,95℃溶胶1.0h;溶胶后混合成为凝胶剂;
(3)凝胶软糖的制备:取步骤(1)制备的药物组合物35g,加入凝胶剂30g、柠檬酸3g、甜菊糖苷5g,混合均匀后在90℃下均质30min,注模,脱模后干燥4.0h,制得凝胶软糖。
实施例3
硬糖的制备
(1)药物组合物的制备:取枸杞子80g、桑椹80g、陈皮24g,加入8倍中药总重量的纯净水,76℃水浴浸提2次,每次1.5h,合并液体部分,55℃,0.08MPa压强下,浓缩至可溶性固形物的含量为30%,得到药物组合物80g。
(2)硬糖的制备:将麦芽酮糖醇50g与纯水25g在120℃下熬糖,熬至糖液呈细丝状不易折断;取步骤(1)制备的药物组合物20g,与糖液、酸味剂0.5g、香精1g混合均匀后进一步高温熬糖,待无大气泡产生后注模,冷却后脱模、包装,制成硬糖。
实施例4
片剂的制备
(1)药物组合物的制备:取枸杞子180g、桑椹180g、陈皮50g,加入12倍中药总重量的纯净水,90℃水浴浸提3次,每次1.0h,合并液体部分,65℃,0.07MPa压强下,浓缩至可溶性固形物的含量为60%,得到药物组合物100g。
(2)片剂的制备:取步骤(1)制备的药物组合物60g,加入糊精40g、微晶纤维素50g、柠檬酸0.5g、阿斯巴甜1g,制作软材,过14目筛制颗粒,于60℃干燥1.0h,整粒,再加入硬脂酸镁0.8份混匀,使用单冲压片机进行压片,制成片剂。
实施例5
口服液的制备
(1)药物组合物的制备:取枸杞子60g、桑椹60g、陈皮40g,加入8倍中药总重量的纯净水,80℃水浴浸提3次,每次2.0h,合并液体部分,用200目筛网过滤,65℃,0.06MPa压强下,浓缩至可溶性固形物的含量为15%,得到药物组合物70g。
(2)口服液的制备:在20g药物组合物中加入甜菊糖苷0.2份、防腐剂苯甲酸钠0.3份,在100℃、<0.1Mpa的参数下,杀菌釜蒸气式灭菌10min,制得口服液。
实施例6
最大耐受量实验
选用ICR小鼠(20±2g)40只,SPF级,雌雄各半,适应性喂养3天,分为空白雄性、空白雌性、给药雌性、给药雄性四组,禁食不禁水16h后,以最大溶解度(1g/mL)和最大灌胃量(0.4mL/10g)灌胃实施例2制备的药物组合物一次,连续14天观察小鼠的摄食量、毛发、体重、活动均正常,未见死亡。表明护肝作用的保健食品最大耐受量为40.0g/kg。
实施例7
护肝作用的功效实验
使用实施例2制备的药物组合物为枸杞桑椹方剂,以最大耐受量的1/40、1/20、1/10,设置枸杞桑椹方剂提取物的低(1.0g/kg)、中(2.0g/kg)、高(4.0g/kg)三个剂量组。
选用ICR雄性小鼠50只,适应性喂养3天,随机分为正常组、模型组、枸杞桑椹方剂提取物低剂量组(1.0g/kg)、中剂量组(2.0g/kg)、高剂量组(4.0g/kg),每组10只。
除正常组给予等量纯化水外,其他各组小鼠经口灌胃给予50%(v/v)乙醇溶液诱导小鼠肝损伤,灌胃体积为0.1mL/10g,两次灌胃间隔3h,连续造模30天,得到肝损伤小鼠。给予各剂量组小鼠灌胃枸杞桑椹方剂提取物,正常组和模型组小鼠灌胃等量纯化水,连续灌胃30天,每周记录小鼠体重。各组小鼠禁食不禁水12h后,称取体重,麻醉后眼球取血,迅速解剖留取肝脏组织。
实验结果分析:护肝保健食品检验结果如图1~5所示。
图1结果表明,在小鼠血清谷草转氨酶活性测定中,与正常组相比,模型组小鼠血中谷草转氨酶活性显著升高(P<0.001);与模型组相比,枸杞桑椹方剂提取物低、中、高剂量组小鼠血中谷草转氨酶活性显著降低(P<0.01,P<0.001)。
图2结果表明,在小鼠血清谷丙转氨酶活性测定中,与正常组相比,模型组小鼠血中谷丙转氨酶活性显著升高(P<0.001);与模型组相比,枸杞桑椹方剂提取物低、中、高剂量组小鼠血中谷丙转氨酶活性显著降低(P<0.01,P<0.001)。
图3结果表明,小鼠肝组织丙二醛含量测定中,与正常组相比,模型组小鼠肝组织丙二醛含量显著升高(P<0.001);与模型组相比,枸杞桑椹方剂提取物低、中、高剂量组小鼠肝组织丙二醛含量降低(P<0.01,P<0.001)。
图4结果表明,小鼠肝组织甘油三酯含量测定中,与正常组相比,模型组小鼠肝组织甘油三酯含量显著升高(P<0.001);与模型组相比,枸杞桑椹方剂提取物低、中、高剂量组小鼠肝组织甘油三酯含量降低(P<0.05,P<0.01,P<0.001)。
图5结果表明,小鼠肝组织还原性谷胱甘肽含量测定中,与正常组相比,模型组小鼠肝组织还原性谷胱甘肽含量显著升高(P<0.001);与模型组相比,枸杞桑椹方剂提取物低、中、高剂量组小鼠肝组织还原性谷胱甘肽含量降低(P<0.05,P<0.001)。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (7)
1.一种具有护肝作用的药物组合物,其特征在于,所述药物组合物由如下重量份的原料制备得到:枸杞子10~20份、桑椹10~20份、陈皮2~10份。
2.一种权利要求1所述药物组合物的制备方法,其特征在于,包括如下所述步骤:
取枸杞子、桑椹、陈皮加水浸提,合并液体部分浓缩,得到药物组合物。
3.如权利要求2所述药物组合物的制备方法,其特征在于,所述枸杞子、桑椹、陈皮的总重量与水的重量比为1:5~15。
4.如权利要求3所述药物组合物的制备方法,其特征在于,所述浸提的温度为76~96℃,浸提的次数为1~3次,每次浸提的时间为0.5~2.0h。
5.如权利要求4所述药物组合物的制备方法,其特征在于,所述浓缩的温度为55~65℃,压强为0.06~0.08MPa。
6.如权利要求5所述药物组合物的制备方法,其特征在于,所述药物组合物的可溶性固形物的含量为40~70%。
7.如权利要求2~6任一项所述药物组合物的制备方法,其特征在于,将所述药物组合物制成片剂、颗粒剂、胶囊剂、饼干、硬糖、凝胶软糖或固体饮料。
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