CN105998140B - 红景天含片 - Google Patents
红景天含片 Download PDFInfo
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- CN105998140B CN105998140B CN201610415390.8A CN201610415390A CN105998140B CN 105998140 B CN105998140 B CN 105998140B CN 201610415390 A CN201610415390 A CN 201610415390A CN 105998140 B CN105998140 B CN 105998140B
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- rhodiola root
- lozenge
- oxygen
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- mouse
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/41—Crassulaceae (Stonecrop family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
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Abstract
本发明涉及一种红景天含片,以红景天、刺五加、当归等制备得到,用于疏通经络、补气补血、促进气血运行,改善机体缺氧程度,具有良好的提升缺氧耐受力的功能。
Description
技术领域
本发明涉及中药领域,涉及中药组合物,具体涉及一种红景天含片。
背景技术
大气中的氧含量是20.9%。一般来说,凡是氧含量低于20.9%的环境,都是缺氧环境。即便是轻度缺氧的环境,长期在其中生活、工作,也会给身体带来不同程度的损失。例如:炎热季节长期在空调房间、寒冷季节长期在通风不畅的房间、产妇在密不透风的房间以及空气污染、环境问题造成的的缺氧环境,都会出现面色苍白、食欲不振、头痛、头晕、记忆力降低等等慢性环境性缺氧症状,如不采取补充给氧或缓解缺氧症状的产品加以改善,都会给健康带来不利影响,久而久之造成心、脑、肾、肝等器官病变。另外一类缺氧环境是由于高原、高空的空气稀薄造成的。尽管在高原、高空大气中,氧气的含量仍是20.9%,但是随着海拔高度增加,大气压力降低,即空气密度降低,随之大气中的氧分压也相应降低,氧气的绝对量也相应减少。导致吸入气体和肺泡气体中的氧分压降低,从而导致动脉血氧的饱和度降低而产生缺氧症状。
在缺氧环境中,人体摄入的氧气不足,血液中的氧分压过低,血红素处于不饱和状态,各部分组织的细胞就都会由于供氧不足出现一定的变化,表现出相对应的缺氧症状。轻度的环境性缺氧患者,在及时转入供氧正常环境或及时获得补充给氧后,可以很快恢复正常。如果缺氧时间较长,可能造成脑水肿等病理变化,有不同程度的头痛、恶心、呕吐、幻觉、表情淡漠或兴奋等延续症状。严重的患者,可能造成大脑皮质、基底节等永久性病变,发生瘫痪、记忆丧失或意识丧失。
缺氧不仅在大气中氧分压过低情况下发生,也可在循环、血液、呼吸等系统疾病时由于氧供给和利用障碍而出现。人体生命活动中所有消耗的能量主要来自生物氧化过程,所以氧是生命活动不可缺少的物质。缺氧是一种非常常见的病理过程,可以直接引起机体死亡。缺氧可以由于外界环境中氧分压的降低,以及氧的摄取、携带或运输障碍,或由于组织细胞受损引起,缺氧会使组织和器官不能得到足够的氧的供给或者不能充分利用氧来进行代谢活动,使得代谢、功能和形态结构发生变化。人们在日常生活中对具有提高缺氧耐受力功能的保健食品的补充认识不足,以及不合理的饮食结构,很难从饮食中摄取足够量的提高缺氧耐受力的物质以提高机体抗缺氧的能力状态。开发本产品针对此类人群的需要,选取具有提高缺氧耐受力功能的原料,开发方便易服的保健食品,可减弱体内缺氧对机体的伤害程度、改善机体疲劳状态,提升生活质量。因此开发本产品对于适宜人群的养生保健将起到重要的作用,同时具有较强的科学价值。
同时,中药多为天然药物,药性温和,不良反应少,在协调机体整体平衡、抗缺氧、增强机体抗病能力等方面具有独特的药效。我公司立项开发红景天含片,本产品以益肺健脾、活血通脉、滋补强壮、扶正固本,达到提高缺氧耐受力作用,从而达到预防疾病的保健功能。
近年来对提高缺氧耐受力的防治已经能够引起人们的足够重视,西药由于长期服用其毒副作用较大,不良反应严重,不受人们的青睐。而以“药食同源”为原料制成的保健食品不仅可以起到预防的作用,而且还能达到提高缺氧耐受力的目的。目前市场上此类保健食品不多,所以还不能满足日益膨胀的市场需求,为此我公司开发了红景天含片,本产品以功效确切的原料组方,各原料安全可靠,并且作为片剂携带、服用方便,对于处于缺氧环境者及亚
红景天提取物:为景天科植物大花红景天Rhodiola crenulata(Hook.f.etThoms.)H.Ohba的干燥根及根茎,性甘、苦、平,归肺、心经。具有扶正固本、益气活血、清肺止咳、通脉平喘之功,用于气虚血瘀等症。红景天的应用已有悠久的历史,《神农本草经》记载“上品、无毒、多服久服不伤人,有轻身益气之功效”。藏《四部医典》记载其“性平、味涩、善润肺,能补肾、理气养血,主治周身乏困、胸闷、恶心、体虚等症。”明李时珍《本草纲目》中记载“景天、上品,甘、涩、寒、无毒,具有祛邪恶气、补诸不足之功效”。红景天的化学成分主要有多糖类、皂甙类、黄酮类等。现代研究证明,红景天具有增强免疫、抗缺氧、抗氧化、抗寒冷等药理作用。
刺五加提取物:为五加科植物刺五加Acanthopanaz senticosus(Rupr.EtMazim.)Hamns.的干燥根,为名贵中药,其性温、味辛、微苦,归脾、肾、心经。具有益气健脾、补肾安神之功,主要用于腰膝酸软、体虚乏力、食欲不振、腰膝酸痛、失眠多梦等症。刺五加首载于《神农本草经》,列为上品,《实用补养中药一书》中记载:“属于补气药,具有补虚扶弱的功效,可来预防或治疗体质虚弱之症候,滋补强壮,延年益寿”。刺五加中含有刺五加苷、多种糖类、氨基酸、脂肪酸、维生素类、芝麻脂素、甾醇等成分。近年来,国内学者对刺五加进行了药效药理研究,其具有抗疲劳、抗衰老、抗肿瘤、抗辐射、免疫增强等生物活性。
当归提取物:为伞科植物当归的干燥根,味甘、辛,性温,归肝、心、脾经。功能补血和血、调经止痛、润肠通便。用于血虚萎黄、眩晕心悸、月经不调、虚寒腹痛、跌打损伤等症。祖国医学认为,当归味甘而重,故专能补血,其气轻而辛,故又能行血,补中有动,行中有补,为血中之要药。因而,它既能补血,又能活血,既可通经,又能活络。当归是中医中的最常用药多用于煲汤,特别对贫血患者是最好的,还能显著促进机体造血功能,升高红细胞、白细胞和血红蛋白含量。当归中主要成分有苯酞类、香豆素类、黄酮类、有机酸类等化合物,具有改善血液循环、改善冠脉循环、抗血栓形成、降血糖、抗癌、抗炎镇痛、保肝利胆、调经活血、抗衰老等作用。
发明内容
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
红景天 1.5-6g
刺五加 3-27g
当归 2-12g。
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
红景天提取物 150g
刺五加提取物 150g
当归提取物 400g。
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
本发明涉及一种红景天组合物,其特征在于,制成药物、保健品、食品。
本发明涉及一种红景天组合物,其特征在于,制成片剂、胶囊剂、散剂、汤剂等剂型。
本发明涉及一种红景天组合物,其特征在于,本产品采用常规的片剂生产工艺:过筛→称量→混合→制软材→制粒→干燥→整粒→总混→压片→内包装→外包装→检验→入库。
本发明涉及一种红景天组合物,其特征在于用于疏通经络、补气补血、促进气血运行,改善机体缺氧程度。
本产品的研发基础源于祖国传统中医药理论和现代药理研究。中医理论认为,通过疏通经络、补气补血、促进气血运行,会有助于改善机体缺氧程度。因此,本配方主选红景天提取物、刺五加提取物、当归提取物为主要原料,其中:红景天味甘、苦,性平,归肺、心经,具有扶正固本、健脾益气、补肺养阴、活血通脉之功;刺五加性温、味辛而微苦,归脾、肾、心经,具有益气健脾、固本强壮、补肾安神之功;当归提取物味甘、辛,性温,归肝、心、脾经,具有补气补血、活血化瘀之功。众药合用,共奏补气补血、益肺健脾、活血通脉、扶正固本之功,可有效降低心肌耗氧量,使冠脉、脑血管流量增加;提高机体组织氧的利用率,提高机体的带氧和供氧能力,降低含氧量、耗氧速度,并通过清除自由基或减少自由基对血管内皮的损失实现抗缺氧损伤的保护作用,最终通过多种成分多靶点多种作用机理达到良好的提高缺氧耐受力的保健功能。
工艺技术路线设计依据和技术参数的确定
1辅料的选择
1.1甘露醇
甘露醇无吸湿性,便于颗粒的干燥,常用作片剂等的填充剂;甘露醇味甜、微凉,可使片剂溶解时吸热,使口腔清凉有舒适感,被广泛用于咀嚼片的矫味剂,故我们选择甘露醇为填充剂和矫味剂。
1.2柠檬酸、甜菊糖甙、甜橙香精:作为本品的矫味剂。
1.3硬脂酸镁
本品加入硬脂酸镁作为润滑剂,可增加颗粒流动性,使片剂的剂量准确,片面光洁美观, 减少冲模的磨损,保证片重差异合格。
以上辅料用量均符合制剂学要求。
2工艺路线设计依据
本产品采用常规的片剂生产工艺:过筛→称量→混合→制软材→制粒→干燥→整粒→总混→压片→内包装→外包装→检验→入库。此生产工艺路线设计严格按照保健食品良好生产规范执行。工艺流程及说明以及试验数据见生产工艺部分。
组分和制剂的选择
本产品符合现代制剂要求,优选红景天提取物、刺五加提取物、当归提取物之间的组合,可掩盖不适气味和不良异味,而且性质稳定。
具体实施例
实施例1
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
实施例1
红景天 1.5-6g
刺五加 3-27g
当归 2-12g。
实施例2
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
红景天提取物 150g
刺五加提取物 150g
当归提取物 400g。
实施例3
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
实施例4
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
实施例5
本发明涉及一种红景天组合物,其特征在于,由如下组分组成:
实施例6本发明的口感的效果
含片指含于口腔内缓慢溶解的压制片。此类产品优势在于口感好、服用方便、任何环境下均可食用;提取物溶化性好,含在口腔中缓慢的含化,使有效成分能较长时间停留在口腔,持续发挥药效,并易于通过口腔粘膜吸收完全。本产品中红景天提取物、刺五加提取物、当归提取物的口感均较好,具有良好的抗缺氧的保健功能,适合制成含片。含片服用比一般片剂更为方便,尤其适合吞咽动作不灵活的人。由于方便消费者服用,依从性良好,也更容易获得消费者认可,从而也能为消费者提供更多种的选择。含片携带方便,分剂量准确,含量均匀;生产、保存、运输方便,适合工业化生产。
实施例7本发明的效果
以下实验例中的受试样品为本发明实施例5制备的具有提高缺氧耐受力功能的保健食品,常规用量为每日2次,每次1片,每片为1.0g。每100g含:红景天苷476mg。
具体实验内容如下:
1材料和方法
1.1样品:红景天含片,规格:1.0g/片×60片/瓶,样品性状为片剂,样品人体推荐剂量为2.0g/人/日。
1.2实验动物:试验动物及分组:选用SPF级CI/F1代健康雄性小鼠120只,由上海西普尔-必凯实验动物有限公司提供,实验动物生产许可证号:SCXK(沪)2013-0016。合格证编号:2008001644688。体重19.1~20.9g。
小鼠检疫3天后,按体重随机分为三个大组,其中I组小鼠40只,分为4个剂量组,每组10只,进行常压耐缺氧实验;II组小鼠40只,分为4个剂量组,每组10只,进行亚硝酸钠中毒存活实验;III组小鼠40只,分为4个剂量组,每组10只,进行急性脑缺血性缺氧实验。
试验动物在温度为20~25℃、相对湿度为40%~70%的本中心屏障系统中饲养。实验动物使用许可证号:SYXK(苏)2012-0041。辐照灭菌饲料由苏州双狮实验动物饲料科技有限公司提供,批准文号:苏饲审(2009)05032。
1.3剂量选择与受试物给予方式:根据红景天含片每人每日推荐摄入量为2.0g(按60kg体重计),设低、中、高三个剂量组即0.17g/kg·bw、0.33g/kg·bw、1.00g/kg·bw,分别相当于人体推荐摄入量5倍、10倍、30倍,另设0g/kg·bw对照组以无菌水代替受试物。受试样品用无菌水配制,低、中、高剂量配制浓度分别为17mg/mL、33mg/mL、100mg/mL,按0.1mL/10g·bw灌胃。经口每日一次给予小鼠相应浓度的受试样品,连续灌胃一个月后测各项指标。
1.4主要仪器与试剂
T1000型电子天平、JA-2003型电子天平、250mL磨口瓶、秒表、凡士林、钠石灰、亚硝酸钠。
1.5试验方法
1.5.1常压耐缺氧实验
连续灌胃一个月,末次给样1h后,取I组小鼠,将小鼠分别放入盛有5g钠石灰的250mL磨口瓶内(每瓶1只),用凡士林封瓶口,盖严,使之不漏气,立即计时,直至呼吸停止,记录小鼠因缺氧而死亡的时间。
受试样品组与0g/kg·bw组比较,存活时间延长,并具有统计学意义,则判定该实验结果阳性。
1.5.2亚硝酸钠中毒存活实验
连续灌胃一个月,末次给样1h后,取II组小鼠,按230mg/kg·bw剂量腹腔注射亚硝酸钠(注射量为0.1mL/10g·bw),立即计时,记录小鼠存活时间。
受试样品组与0g/kg·bw组比较,存活时间延长,并具有统计学意义,则可判定该实验结果阳性。
1.5.3急性脑缺血性缺氧实验
连续灌胃一个月,末次给样1h后,取III组小鼠,自颈部逐只断头,立即按秒表记录小鼠断头后至张口喘气停止时间。
受试样品组与0g/kg·bw组比较,喘气时间延长,并具有统计学意义,则可判定该实验结果阳性。
1.6试验数据统计:用SPSS10.0软件对各实验原始数据进行方差齐性检验,满足方差齐要求的数据资料用单因素方差分析方法中多个实验组与一个对照组间均数的两两比较方法进行统计处理;对非正态分布或方差不齐的数据资料进行适当的变量转换,待满足正态或方差齐要求后,用转换所得的数据进行统计处理。对非正态分布的数据用秩和检验进行统计处理。
1.7结果判定
常压耐缺氧实验、亚硝酸钠中毒存活实验、急性脑缺血性缺氧实验三项实验中任二项实验结果阳性,可判定该受试样品具有提高缺氧耐受力功能的作用。
2结果
实验过程中动物饮水摄食正常,外观无异常。
2.1红景天含片对小鼠体重的影响
由表1可见,小鼠的初始体重0.17g/kg·bw、0.33g/kg·bw、1.00g/kg·bw组与0g/kg·bw组比较,差异无统计学意义。表明小鼠的初始体重在各组间较为均衡。
经口给予小鼠不同剂量的红景天含片1个月后,各剂量组体重增长值经方差齐性检验,满足方差齐性要求,用单因素方差分析方法中多个实验组与一个对照组间均数的两两比较方法进行统计处理。0.17g/kg·bw、0.33g/kg·bw、1.00g/kg·bw组与0g/kg·bw组比较,差异无统计学意义(P>0.05)。
表1红景天含片对小鼠体重的影响
续表
续表
2.2红景天含片对小鼠常压耐缺氧存活时间的影响
经口给予小鼠不同剂量的红景天含片一个月,进行常压耐缺氧实验,对所测定的常压耐缺氧实验中存活时间进行方差齐性检验,满足方差齐性要求,用单因素方差分析方法中多个实验组与一个对照组间均数的两两比较方法进行统计处理。由表2可见,小鼠常压耐缺氧实验中1.00g/kg·bw组存活时间长于0g/kg·bw组,差异有统计学意义(P<0.05)。
表2红景天含片对小鼠常压耐缺氧存活时间的影响
2.3红景天含片对小鼠亚硝酸钠中毒存活时间的影响
经口给予小鼠不同剂量的红景天含片一个月,进行亚硝酸钠中毒存活实验,对所测定的亚硝酸钠中毒存活时间进行方差齐性检验,满足方差齐性要求,用单因素方差分析方法中多个实验组与一个对照组间均数的两两比较方法进行统计处理。由表3可见,小鼠亚硝酸钠中毒存活实验中1.00g/kg·bw组存活时间长于0g/kg·bw组,差异有统计学意义(P<0.05)。
表3红景天含片对小鼠亚硝酸钠中毒存活时间的影响
2.4红景天含片对小鼠急性脑缺血性缺氧喘气时间的影响
经口给予小鼠不同剂量的红景天含片一个月,进行急性脑缺血性缺氧实验,将所测定的急性脑缺血性缺氧喘气时间进行方差齐性检验,满足方差齐性要求,用单因素方差分析方法中多个实验组与一个对照组间均数的两两比较方法进行统计处理。由表4可见,小鼠急性脑缺血性缺氧实验中0.17g/kg·bw、0.33g/kg·bw、1.00g/kg·bw组喘气时间与0g/kg·bw组比较,差异无统计学意义(P>0.05)。
表4红景天含片对小鼠急性脑缺血性缺氧喘气时间的影响
3小结
经口给予小鼠不同剂量的红景天含片一个月,进行常压耐缺氧实验、亚硝酸钠中毒存活实验、急性脑缺血性缺氧实验,结果显示:
3.1小鼠常压耐缺氧实验:1.00g/kg·bw组存活时间长于0g/kg·bw组,差异有统计学意义(P<0.05)。此项为阳性。
3.2小鼠亚硝酸钠中毒存活实验:1.00g/kg·bw组存活时间长于0g/kg·bw组,差异有统计学意义(P<0.05)。此项为阳性。
3.3小鼠急性脑缺血性缺氧实验:0.17g/kg·bw、0.33g/kg·bw、1.00g/kg·bw组喘气时间与0g/kg·bw/d组比较,差异无统计学意义(P>0.05)。此项为阴性。
根据《保健食品检验与评价技术规范》之提高缺氧耐受力功能试验的结果判定,在本实验条件下红景天含片具有提高缺氧耐受力功能的作用。
Claims (1)
1.一种甘露醇和柠檬酸在制备提高缺氧耐受力功能的红景天含片上的用途,其特征在于,
红景天含片由如下组分组成:
红景天提取物 1.47g
刺五加提取物 1.47g
当归提取物 3.92g
甘露醇 2.303g
柠檬酸 0.4606g
甜菊糖甙 0.098g
甜橙香精 0.0294g
硬脂酸镁 0.049g;
采用常规的片剂生产工艺:过筛→称量→混合→制软材→制粒→干燥→整粒→总混→压片→内包装→外包装→检验→入库。
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