CN104257811B - 一种保肝的食品、保健品或药物组合物 - Google Patents
一种保肝的食品、保健品或药物组合物 Download PDFInfo
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- CN104257811B CN104257811B CN201410473048.4A CN201410473048A CN104257811B CN 104257811 B CN104257811 B CN 104257811B CN 201410473048 A CN201410473048 A CN 201410473048A CN 104257811 B CN104257811 B CN 104257811B
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- A61K2236/30—Extraction of the material
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Abstract
本发明提供了一种保肝的食品、保健品或药物组合物，其原料含有如下重量配比的组分：栀子0.5～1.5份、蒲公英1～2份、山楂0.5～1份、荷叶1份、决明子0.5～1份。研究表明，本发明组合物能明显改善化学性肝损伤的各项指标，具有良好的保肝降酶作用，且本发明组合物配伍精当，发挥了协同作用，药效活性明显优于各单味原料。
Description
技术领域
本发明涉及一种保肝的食品、保健品或药物组合物。
背景技术
肝脏是身体内以代谢功能为主的一个器官，并在身体里面起着去氧化，储存肝糖，分泌性蛋白质的合成等等的作用，是人体的重要器官。随着生活水平的提高和环境污染的加剧，人体肝脏的损伤几率呈上升趋势。
化学性肝损伤的发生与日常接触化学毒物、酒精及一些药物有关，这些因素易造成肝脏功能受损。大自然和人类工业生产过程中均存在一些对肝脏有毒性的物质，称为“亲肝毒物”，这些毒物在人群中普遍易感，潜伏期短，病变的过程与感染的剂量直接相关，可引起肝脏不同程度的肝细胞坏死、脂肪变性、肝硬化和肝癌。
目前，已经报道具有抗肝损伤的药物已有数十种，如虫草、大黄、三七、黄芪、苦参、丹参、枸杞子、五味子、灵芝、马齿苋、绞股蓝、川芎等，其中，不乏药食同源的中药材。因此，从中药中寻找可用于预防肝损伤的药物，也就成为了研究的热点。
发明内容
本发明的目的在于提供一种保肝的食品、保健品或药物组合物。
具体地，本发明提供了一种保肝的食品、保健品或药物组合物，其原料含有如下重量配比的组分：
栀子0.5～1.5份、蒲公英1～2份、山楂0.5～1份、荷叶1份、决明子0.5～1份。
进一步地，其原料含有如下重量配比的组分：
栀子1份、蒲公英1.5份、山楂1份、荷叶1份、决明子0.5份。
进一步地，其原料由如下重量配比的组分组成：
栀子0.5～1.5份、蒲公英1～2份、山楂0.5～1份、荷叶1份、决明子0.5～1份。
优选地，其原料由如下重量配比的组分组成：
栀子1份、蒲公英1.5份、山楂1份、荷叶1份、决明子0.5份。
上述各原料均为药食同源材料，即可作为药物或保健品使用，亦可作为食品使用。
其中，它是由原料的药粉、水提物或/和乙醇提取物为活性成分，加上药学上常用的辅料或辅助性成分制备而成的经口给药剂型。
例如，所述剂型选自口服液、饮料、颗粒剂、散剂、丸剂、片剂或胶囊剂。
本发明所述药学上可接受的辅料，是指除活性成分以外包含在剂型中的物质，包括但不仅限于填充剂(稀释剂)、润滑剂(助流剂或抗粘着剂)、分散剂、湿润剂、粘合剂、调节剂、增溶剂、抗氧剂、抑菌剂、乳化剂、崩解剂等。粘合剂包含糖浆、阿拉伯胶、明胶、山梨醇、黄芪胶、纤维素及其衍生物(如微晶纤维素、羧甲基纤维素钠、乙基纤维素或羟丙甲基纤维素等)、明胶浆、糖浆、淀粉浆或聚乙烯吡咯烷酮等；填充剂包含乳糖、糖粉、糊精、淀粉及其衍生物、纤维素及其衍生物、无机钙盐(如硫酸钙、磷酸钙、磷酸氢钙、沉降碳酸钙等)、山梨醇或甘氨酸等；润滑剂包含微粉硅胶、硬脂酸镁、滑石粉、氢氧化铝、硼酸、氢化植物油、聚乙二醇等；崩解剂包含淀粉及其衍生物(如羧甲基淀粉钠、淀粉乙醇酸钠、预胶化淀粉、改良淀粉、羟丙基淀粉、玉米淀粉等)、聚乙烯吡咯烷酮或微晶纤维素等；湿润剂包含十二烷基硫酸钠、水或醇等；抗氧剂包含亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、二丁基苯酸等；抑菌剂包含0.5％苯酚、0.3％甲酚、0.5％三氯叔丁醇等；调节剂包含盐酸、枸橼酸、氢氧化钾(钠)、枸橼酸钠及缓冲剂(包括磷酸二氢钠和磷酸氢二钠)等；乳化剂包含聚山梨酯-80、脂肪酸山梨坦、普流罗尼克F-68，卵磷酯、豆磷脂等；增溶剂包含吐温-80、胆汁、甘油等。
所述药学上可接受的辅助性成分，它具有一定生理活性，但该成分的加入不会改变上述化合物或衍生物在疾病治疗过程中的主导地位，而仅仅发挥辅助功效，这些辅助功效仅仅是对该成分已知活性的利用，是医药领域惯用的辅助治疗方式。若将上述辅助性成分与本发明化合物配合使用，仍然应属于本发明保护的范围。
本发明还提供了上述食品、保健品或药物组合物的制备方法，其特征在于：
(1)按配比称取原料；
(2)将原料加水提取，合并水提液，制备剂型即可。
进一步地，步骤(2)中，所述提取方法选自煎煮、浸渍或超声。
水提物或以药粉入药，均是中药传统使用方式，水提后，由于水的溶解范围广，能够将大部分有效成分溶出，使药物更容易被人体吸收，起效更快，例如汤剂等给药形式；以原粉入药，药粉的表面积较大，也有利于药材中有效成分在体内的吸收，但药材未经提取，有效成分仍需在体内溶出再吸收，其起效相对水提物较慢，但也同时削弱了药材中有害成分对人体造成的毒副反应，适合于长期服用，如将原粉制备成丸剂等给药形式。目前在制药过程中，乙醇作为溶剂对药物进行提取，也是最为常见的提取方式之一，乙醇为半极性溶剂，溶解性能界于极性与非极性溶剂之间，可以溶解水溶性的某些成分，也能溶解非极性溶剂溶解的一些成分，通常用乙醇提取代替水煎，从而避免大量无效成分的溶出，提高有效成分的浓度和提取效率，不过乙醇的价格较水贵，在现代制药工业大生产中，为了节省生产成本，通常还是以水煎为主。在本发明已知组合物水提物具有生理活性的情况下，为了适应各种生产和使用时的需求，可以任选水提、原粉、醇提或它们的组合方法来制备具体的剂型。
本发明还提供了上述食品、保健品或药物组合物在制备保肝降酶、抗肝损伤的食品、保健品或药品中的用途。
进一步地，所述酶为谷草转氨酶或/和谷丙转氨酶；所述肝损伤为化学性肝损伤。
研究表明，本发明组合物能明显改善化学性肝损伤的各项指标，具有良好的保肝降酶作用，且本发明组合物配伍精当，发挥了协同作用，药效活性明显优于各单味原料。
显然，根据本发明的上述内容，按照本领域的普通技术知识和手段，在不脱离本发明上述基本技术思想前提下，还可以做出其他多种形式的修改、替换或变更。
以下通过具体实施例的形式，对本发明的上述内容再做进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实施例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
实施例1 本发明组合物的制备
取栀子10g、蒲公英15g、山楂10g、荷叶10g、决明子5g，加水煎煮3次，合并水煎液，过滤，浓缩，加入适量调味剂，制备成饮料。
实施例2 本发明组合物的制备
取栀子10g、蒲公英15g、山楂10g、荷叶10g、决明子5g，加水在60℃温浸3次，合并浸出液，过滤，浓缩，加入适量填充剂，制备成口含片。
实施例3 本发明组合物的制备
取栀子10g、蒲公英15g、山楂10g、荷叶10g、决明子5g，加水在60℃超声提取3次，合并提取液，过滤，浓缩，加入适量填充剂，制备成颗粒剂。以下通过试验例具体说明本发明的有益效果。
试验例1 处方配比筛选
1.1实验材料
1.1.1实验药品
供试品：栀子、蒲公英、山楂、荷叶、决明子，购自四川百信药业，质量符合《中华人民共和国药典》2010年版一部要求；阳性对照品：肝喜乐胶囊，01001102，山西德元堂药业有限公司生产；阴性对照品：纯化水，质量符合《中华人民共和国药典》2010年版二部要求。
为确定最佳配比剂量，设定不同剂量配比组进行初步筛选，分别为：
配比组1(栀子：蒲公英：山楂：荷叶：决明子＝1：1.5：1：1：0.5)；
配比组2(栀子：蒲公英：山楂：荷叶：决明子＝1：1：1：1：1)；
配比组3(栀子：蒲公英：山楂：荷叶：决明子＝0.5：2：1：1：0.5)；
配比组4(栀子：蒲公英：山楂：荷叶：决明子＝1.5：1：0.5：1：1)。
分别加水煎煮浓缩为80g原生药/100ml浸膏备用。
1.1.2实验试剂
苦味酸，中性红，纯化水，门冬氨酸氨基转移酶(AST)IFCC法检测试剂盒(速率法):规格：R1：60ml/支，R2：45ml/支，四川省迈克科技有限责任公司。碱性磷酸酶(ALP)AMP法检测试剂盒(速率法):规格：R1：60ml/支，R2：45ml/支，四川省迈克科技有限责任公司。
1.1.3实验仪器
余姚金诺TU10001B型电子天平(d＝0.1g)；德国Sartorius BS124S型电子天平；TMS-1024i型全自动生化分析仪。
1.1.4实验动物
KM小鼠，普通级，体重18.0-22.0g，雌雄各半。来源：成都达硕生物科技有限公司。生产许可证号：SCXK(川)2008-24。
1.2.实验方法
1.2.1分组
KM小鼠70只，雌雄各半，体重18.0-22.0g，按体重随机分为空白对照组、模型对照组、肝喜乐组、配比组1、配比组2、配比组3、配比组4，共7组，每组10只。
1.2.2给药
给药途径：选择与各受试物临床一致给药途径，灌胃给药。
剂量：空白、模型对照组(等体积纯化水)、肝喜乐组(12mg·kg-1)、配比组1(8g·kg-1)、配比组2(8g·kg-1)、配比组3(8g·kg-1)、配比组4(8g·kg-1)各中药组剂量均以生药量计。
给药体积：10ml/kg。
给药频率及周期：1次/日，共10日。
1.2.3造模
于末次给药1h后，小鼠按0.1ml/lOg腹腔注射0.08％CCl4花生油溶液进行造模。
1.2.4对脏器指数、肝功能的影响
小鼠造模后，禁食过夜不禁水，24h后全部小鼠称重后，摘眼球取血，离心，分离出血清，测定ALT、AST。采血后，迅速解剖，取出肝脏，称重，计算脏器指数。
1.3.实验结果
1.3.1对脏器指数的影响
表1 抗四氯化碳致小鼠急性肝损伤试验肝脏脏器指数检测结果
注:模型组与空白组比较△△△P<0.001；给药组与模型组比较**P<0.01
试验结果见表2，脏器指数检查结果显示，与空白组比较，模型组小鼠肝脏脏器指数极显著性升高，表明急性肝损伤模型造模成功。与模型组比较，除阳性药肝喜乐外，其余各组未见统计学差异(P<0.01)。
1.3.2对肝功能的影响
表2 抗四氯化碳致小鼠急性肝损伤试验肝功检测结果
注:模型组与空白组比较△△△P<0.001，给药组与模型组比较*P<0.05**P<0.01
试验结果见表2。肝功能检测结果显示，与空白组比较，模型组小鼠ALT和AST均极显著性升高，表明急性肝损伤模型造模成功。与模型组比较，各给药组均能明显获显著降低小鼠ALT(P<0.05，P<0.01)，但仅阳性药、配比组1能明显降低小鼠AST(P<0.05)。
综上实验，配比组1能有效改善肝损伤的各项指标，具有显著的保肝作用，故配比组1(栀子：蒲公英：山楂：荷叶：决明子＝1：1.5：1：1：0.5)为最佳剂量配比。
试验例2 本发明组合物与单味药的功效比较
2.1实验材料
2.1.1实验药品
供试品：栀子、蒲公英、山楂、荷叶、决明子，购自四川百信药业，质量符合《中华人民共和国药典》2010年版一部要求；阳性对照品：肝喜乐胶囊，01001102，山西德元堂药业有限公司生产；阴性对照品：纯化水，质量符合《中华人民共和国药典》2010年版二部要求。试验时复方高、中、低剂量加水煎煮浓缩为160、80、40g原生药/100ml浸膏备用，各单味药物制备为80g原生药/100ml浸膏备用。
2.1.2实验试剂
苦味酸，中性红，纯化水，门冬氨酸氨基转移酶(AST)IFCC法检测试剂盒(速率法):规格：R1：60ml/支，R2：45ml/支，四川省迈克科技有限责任公司。碱性磷酸酶(ALP)AMP法检测试剂盒(速率法):规格：R1：60ml/支，R2：45ml/支，四川省迈克科技有限责任公司。组织标本固定液(FAA液)：分别量取95％乙醇5895ml、甲醛800ml、冰乙酸400ml和纯化水905ml倒入塑料桶，混匀即可。脱水试剂：取95％乙醇用纯化水稀释配成70％、80％和90％乙醇溶液。透明试剂：二甲苯(AR级)，规格：500ml/瓶，成都科龙化工试剂厂生产。苏木素染液:称取苏木素1.2g，加入450ml纯化水混匀，再先后加入碘酸钠0.24g、硫酸铝钾30g，待其完全溶解，最后加入甘油150ml，搅拌混匀，即得。伊红染液：量取95％乙醇505ml和纯化水95ml，混匀，加入伊红3g，搅匀使溶解，即得。盐酸－乙醇分化液：取95％乙醇438ml和纯化水156ml，混匀，再缓慢加入浓盐酸6ml，搅拌混匀，即得。封片试剂：中性树胶，规格：100g/瓶，中国上海标本模型厂生产。盖玻片清洗液：取纯化水500ml，加入重铬酸钾50g，搅拌、溶解、混匀，再向其中缓慢加入浓硫酸50ml，搅拌混匀即可。
2.1.3实验仪器
余姚金诺TU10001B型电子天平(d＝0.1g)；德国Sartorius BS124S型电子天平；TMS-1024i型全自动生化分析仪；常州中威TSJ-Ⅲ电脑自动组织脱水机；常州中威BMJ-Ⅲ型包埋机；常州中威PHY-Ⅲ病理组织漂烘仪；徕卡RM2126轮转式切片机；北京永光明202-O型台式干燥箱；日本奥林巴斯BX41-32P02显微镜；常州中威BMJ-Ⅲ型冷冻台。
2.1.4实验动物
KM小鼠，普通级，体重18.0-22.0g，雌雄各半。来源：成都达硕生物科技有限公司。生产许可证号：SCXK(川)2008-24。
2.2.实验方法
2.2.1分组
KM小鼠110只，雌雄各半，体重18.0-22.0g，按体重随机分为空白对照组、模型对照组、肝喜乐组、复方高剂量组、复方中剂量组、复方低剂量组、栀子组、蒲公英组、山楂组、荷叶组、决明子组，共11组，每组10只。本发明复方选用实施例1～3的处方配比。
2.2.2给药
给药途径：选择与各受试物临床一致给药途径，灌胃给药。
剂量：空白对照组(等体积纯化水)、模型对照组(等体积纯化水)、肝喜乐组(12mg·kg-1)、复方高剂量组(16g·kg-1)、复方中剂量组(8g·kg-1)、复方低剂量组(4g·kg-1)、栀子组(8g·kg-1)、蒲公英组(8g·kg-1)、山楂组(8g·kg-1)、荷叶组(8g·kg-1)、决明子组(8g·kg-1)。
给药体积：10ml/kg。
给药频率及周期：1次/日，共10日。
2.2.3造模
末次给药1h后，小鼠按0.1ml/l0g腹腔注射0.08％CCl4花生油溶液进行造模。
2.2.4对脏器指数、肝功能的影响及病理检查
小鼠造模后，禁食过夜不禁水，24h后全部小鼠称重后，摘眼球取血，离心，分离出血清，测定ALT、AST。采血后，迅速解剖，取出肝脏，称重，计算脏器指数。肝脏固定3天后，进行组织样本取材。将切取好的组织块分类放入脱水盒内,并装入对应的蜡块标签。进行脱水、透明及浸蜡，常规石蜡包埋，组织切片，厚0.4μm，每个蜡块切取一张切片，H.E.染色，中性树胶封片。光学显微镜检查肝组织有无肝细胞变性坏死、肝小叶炎细胞浸润、胆小管扩张淤胆、肝血窦增宽充血、汇管区纤维增生、胆管及血管增生、胆管上皮变性坏死及汇管区炎细胞浸润等指标，并对以上病变程度进行分级评分，评分标准见表3。BI-2000医学图像分析系统进行图像采集。数据统计时首先进行正态性检验，符合正态则采用excel中F检验进行方差齐性检验，然后选择t检验进行统计，不符合正态性检验则采用非参数检验进行统计。
表3 大鼠肝脏病理组织学检查评分表
2.3.实验结果
2.3.1对脏器指数的影响
表4 抗四氯化碳致小鼠急性肝损伤试验肝脏脏器指数检测结果
注:模型组与空白组比较△△△P<0.001；给药组与模型组比较**P<0.01
试验结果见表4。脏器指数检查结果显示，与空白组比较，模型组小鼠肝脏脏器指数极显著性升高，表明急性肝损伤模型造模成功。与模型组比较，除阳性药肝喜乐外，其余各组未见统计学差异(P<0.01)。
2.3.2对肝功能的影响
试验结果见表5。
表5 不同剂型青黛抗四氯化碳致小鼠急性肝损伤试验肝功检测结果
注:模型组与空白组比较△△△P<0.001，给药组与模型组比较*P<0.05**P<0.01
肝功能检测结果显示，与空白组比较，模型组小鼠ALT和AST均极显著性升高，表明急性肝损伤模型造模成功。与模型组比较，各给药组均能明显获显著降低小鼠ALT(P<0.05，P<0.01)，但仅阳性药、复方高、中剂量能明显降低小鼠AST(P<0.05)。
2.3.3病理检查结果
试验结果见表6。
表6 抗四氯化碳致小鼠急性肝损伤试验病理检查结果
注：①模型组与空白组比较△△△p<0.001；②给药组与模型组比较*p<0.05**p<0.01
病理检查结果显示：①取样时肉眼观察：空白对照组小鼠鼠肝脏外观轮廓、质地及颜色正常。模型组、各给药组小鼠肝脏外观均发现有明显肿胀，颜色呈淡黄色。②镜下观察结果描述：空白组：可见肝小叶完整，界板无破坏，小叶轮廓清楚，其中央静脉及汇管区仍保持正常分布，血管内皮完整清晰，肝细胞索排列整齐，核膜、核仁清楚，胞质丰富、淡染。模型组：可见肝小叶结构紊乱不清，肝细胞浊肿、空泡、嗜酸性变，坏死明显，呈带状或大片状分布，并伴有弥漫性炎细胞浸润，血管内皮中度变性、坏死脱落。肝喜乐组、复方高、中剂量组：病理改变性质同模型组基本一致，但程度较轻。其余各给药组：病理改变性质同模型组基本一致。
组织病理学检查综合肉眼与镜下所见，模型组肝脏病理损害显著，与空白对照组比较其肝脏病变程度综合评分极显著升高(P<0.001)，说明造模成功。复方高、中剂量组与模型组比较，肝脏病理损害的病变程度综合评分均有下降(P<0.05，P<0.01)，说明本发明组合物能减轻四氯化碳所致小鼠肝脏病理性损伤。
从上述结果可知，本发明组合物明显优于其中各味药单独使用，说明本发明组合物各组分具有协同增效的作用。
综上，本发明组合物能明显改善化学性肝损伤的各项指标，说明本发明组合物有保肝的作用。
Claims (7)
1.一种保肝的食品、保健品或药物组合物，其特征在于：
其原料由如下重量配比的组分组成：
栀子1份、蒲公英1.5份、山楂1份、荷叶1份、决明子0.5份。
2.根据权利要求1所述的食品、保健品或药物组合物，其特征在于：它是由原料的药粉、水提物或/和乙醇提取物为活性成分，加上药学上常用的辅料或辅助性成分制备而成的经口给药剂型。
3.根据权利要求2所述的食品、保健品或药物组合物，其特征在于：所述剂型选自口服液、饮料、颗粒剂、散剂、丸剂、片剂或胶囊剂。
4.权利要求1～3任意一项所述食品、保健品或药物组合物的制备方法，其特征在于：
(1)按配比称取原料；
(2)将原料加水提取，合并水提液，制备剂型即可。
5.根据权利要求4所述的制备方法，其特征在于：步骤(2)中，所述提取方法选自煎煮、浸渍或超声。
6.权利要求1～3任意一项所述食品、保健品或药物组合物在制备保肝降酶、抗肝损伤的食品、保健品或药品中的用途。
7.根据权利要求6所述的用途，其特征在于：所述酶为谷草转氨酶或/和谷丙转氨酶；所述肝损伤为化学性肝损伤。
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