CN107411095A - 一种含有紫苏牡丹籽油的复方制剂 - Google Patents
一种含有紫苏牡丹籽油的复方制剂 Download PDFInfo
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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)
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- A—HUMAN NECESSITIES
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Abstract
本发明提供了一种含有紫苏牡丹籽油的复方制剂,该复方制剂,比单独的紫苏油、牡丹籽油、红松子油、葡萄籽油的降血脂血压的能力大很多,同时安全可靠,无任何毒副作用,同时添加维生素C,增强了对DPPH自由基的清除能力,综合提高了该制剂的抗氧化能力。
Description
技术领域
本发明属于保健药品食品领域,具体涉及一种含有紫苏牡丹籽油的复方制剂。
背景技术
从全世界范围来看,心脑血管疾病(CVD)对人类的危害日益严重,致死、致残率均超过50%,复发率也极高。研究表明,造成该类疾病的主要原因就是高血脂症。高血脂症是脑卒中、心肌梗死、猝死的危险因素。对于控制血脂异常,各类降血脂药物如他汀类已有良好的药效,但其对肝脏和肌肉的毒副作用限制了它的应用。
发明内容
为解决上述问题,本发明的目的是提出一种含有紫苏牡丹籽油的复方制剂。
一种含有紫苏牡丹籽油的复方制剂,使用含有如下按重量份数计的原料制成:紫苏油250-350份,牡丹籽油100-200份,红松子油50-90份,葡萄籽油50-90份,维生素C 0.25-50份。
优选的,所述含有紫苏牡丹籽油的复方制剂,使用含有如下按重量份数计的原料制成:紫苏油250-300份,牡丹籽油100-150份,红松子油50-80份,葡萄籽油50-80份,维生素C 0.25-30份。
优选的,所述含有紫苏牡丹籽油的复方制剂,使用含有如下按重量份数计的原料制成:紫苏油275-300份,牡丹籽油130-150份,红松子油65-80份,葡萄籽油65-80份,维生素C 0.25-10份。
所述的复方制剂的制备方法如下:
将:将采用超临界CO2流体萃取后的紫苏油,牡丹籽油,红松子油,葡萄籽油先直接进行混合,然后再与维生素C均匀混合即可得到所述的含有紫苏牡丹籽油的复方制剂,然后再按照软胶囊的生产工艺,制成软胶囊的形式。
上述的含有紫苏牡丹籽油的复方制剂,可以是液态,粉末,或进一步加工成颗粒冲剂,片剂,口服液等形式,在制备用于治疗降低血脂,降血压,溶解血栓的药物中的用途以及用于保健品中也属于本发明的保护范围。
紫苏籽油英文学名Perilla Seed Oil,从唇形科药用植物紫苏(Perillafrutesccns)的成熟的种籽获得,是一种高不饱和度的天然油脂,所含主要成份为α-亚麻酸,含量高达67%左右,是目前所发现的所有天然植物油中这种脂肪酸含量最高的。ɑ-亚麻酸是人体必需的脂肪酸,在人体中可转化为生命活性因子DHA和EPA(植物脑黄金),不含胆固醇,对人体具有医药功效。食用紫苏籽油的主要作用有:护肝养颜、抗血栓、降血脂血压、改善记忆、保护视力、缓解过敏反应、延缓衰老等。
牡丹籽油在2011年3月22日被卫生部批准为新资源食品,标志着牡丹籽油正式进入食品行列。牡丹籽油中含有不饱和脂肪酸高达92%以上,其中α-亚麻酸占42%,油酸占22%,亚油酸占28%,还有维生素A、维生素E,尼克酸、胡萝卜素、植物甾醇,多酚类物质等多种营养成分,既可内服也可外用,具有活血化瘀、消炎杀菌、降血压、降血脂、减肥等作用,外用可以美容养颜,消除色素沉积,减少皱纹,使肌肤细腻光洁,对皮肤病(包括青春痘、脚气、手脚蜕皮、上火起泡、湿疹、红肿、痒疼等)有奇效。国内最新研究成果还认为牡丹籽油具有防晒、防辐射、促进肝细胞再生、护发等新作用。
红松子是可榨油松子中品质最好的一种。松子油中含有大量的天然维生素和不饱和脂肪酸。天然维生素主要有A、B1、B2、E等,维生素E的含量最大,不饱和脂肪酸占有效成份总量的94%以上,在松子油中,含皮诺林酸152.60mg,亚油酸574.40mg。皮诺敛酸只存在于松子油中,能够降低胆固醇(TC)、甘油三酯(TG),升高高密度脂蛋白(HDL)。同时,目前最新研究表明,它还具有抗炎、解热、镇痛,对抗各种真菌、病毒感染等作用。
葡萄籽油含有丰富的不饱和脂肪酸,主要是油酸和亚油酸,其中亚油酸的含量高达72%-76%。亚油酸是人体必需脂肪酸,易于被人体吸收,长期食用葡萄籽油可降低人体血清胆固醇,有效调节人的植物神经功能。葡萄籽油富含维生素E,具有较强的抗氧化性,不易引起由于光照、热辐射和与空气接触而产生的氧化酸败现象。
维生素C又称L-抗坏血酸,是人体所必需的营养素。缺乏维生素C会造成坏血病。在生物体内,维生素C是一种抗氧化剂,保护身体免于自由基的威胁,同时也是一种辅酶。天然存在的抗坏血酸有L型和D型2种,后者无生物活性。维生素C是呈无色无臭的片状晶体,易溶于水,不溶于有机溶剂。在酸性环境中稳定,遇空气中氧、热、光、碱性物质,可促进其氧化破坏。VC的主要功能有:降低癌症发病、维持机体免疫功能、预防动脉硬化、抗氧化、抗自由基、抑制酪氨酸酶的形成等。
本发明的有益效果为:
本发明提供一种含有紫苏牡丹籽油的复方制剂,比单独的紫苏油、牡丹籽油、松子油、葡萄籽油的降血脂血压的能力大很多,同时安全可靠,无任何毒副作用,同时添加维生素C,增强了对DPPH自由基的清除能力,综合提高了该制剂的抗氧化能力,在经过本发明的制得的制剂,其主要吸收成分牡丹籽油和VC的生物利用相比起单独的使用的情况大幅度提高。
具体实施方式
下面结合具体的实施例对本发明做进一步说明:
下述实施例中所用的实验方法如无特殊说明,均为常规方法;所用的材料,试剂如无特殊说明,均是商业途径得到。
下述实施例中所用的原料中:
每克紫苏油含ɑ-亚麻酸60.12-65.41%,每克牡丹籽油含ɑ-亚麻酸40-50%,每克红松子油含亚油酸42-51%,皮诺林酸11-14%,每克葡萄籽油含亚油酸72-76%。因此该复合制剂对于高血脂、高血压患者降压降脂效果显著,并且无任何毒副作用。
实施例1
本实施例提供的含有紫苏牡丹籽油的复方制剂,使用含有如下按重量份数计的原料制成:紫苏油300份,牡丹籽油200份,红松子油、葡萄籽油各80份,VC 10份。制备方法如下:将300重量份的紫苏油、200重量份的牡丹籽油、各80重量份的红松子油和葡萄籽油、10重量份的VC混合均匀,即得到所述的含有紫苏牡丹籽油的复方制剂,然后按软件囊的生产工艺,制成规格为500mg/粒的软胶囊。
实施例2
本实施例提供的含有紫苏牡丹籽油的复方制剂,使用含有如下按重量份数计的原料制成:紫苏油275份,牡丹籽油150份,红松子油、葡萄籽油各90份,VC 30份。制备方法如下:将280重量份的紫苏油、150重量份的牡丹籽油、各90重量份的红松子油和葡萄籽油、30重量份的VC混合均匀,即得到所述的含有紫苏牡丹籽油的复方制剂,然后按软件囊的生产工艺,制成规格为500mg/粒的软胶囊。
实施例3
本实施例提供的含有紫苏牡丹籽油的复方制剂,使用含有如下按重量份数计的原料制成:紫苏油250份,牡丹籽油100份,红松子油、葡萄籽油各50份,VC 50份。制备方法如下:将250重量份的紫苏油、100重量份的牡丹籽油、各50重量份的红松子油和葡萄籽油、50重量份的VC混合均匀,即得到所述的含有紫苏牡丹籽油的复方制剂,然后按软件囊的生产工艺,制成规格为500mg/粒的软胶囊。
实施例4
本实施例提供的含有紫苏牡丹籽油的复方制剂,使用含有如下按重量份数计的原料制成:紫苏油350份,牡丹籽油130份,红松子油、葡萄籽油各65份,VC 0.25份。制备方法如下:将350重量份的紫苏油、130重量份的牡丹籽油、各65重量份的红松子油和葡萄籽油、0.25重量份的VC混合均匀,即得到所述的含有紫苏牡丹籽油的复方制剂,然后按软件囊的生产工艺,制成规格为500mg/粒的软胶囊。
对本制剂的效果进行测试实验
现将实施例1-4中的含有紫苏牡丹籽油的复方制剂的功效测试。
测试方法如下:
选取12位高血脂并且高血压的成人患者,每人每天服用4粒规格为500mg/粒的软胶囊,服用时间为每天早饭和晚饭前半小时各2粒(空腹服用),第一次服用前一天的早晨和服用一个月(30d)后第二天早晨空腹抽静脉血检查,分析测定TG、TC、HDL、LDL,同时在第一次服用前一天的早晨和服用三个月(90d)后的第二天早晨测量血压。具体实验分组为:第1到第3位患者服用实施例1所述规格为500mg/粒的软胶囊;第4到第6位患者服用实施例2所述规格为500mg/粒的软胶囊;第7到第9位患者服用实施例3所述规格为500mg/粒的软胶囊;第10到第12位患者服用实施例4所述规格为500mg/粒的软胶囊。实验结果如下表所示:
其中,TC的正常参考值为0-5.17mmol/L,TG的正常参考值为0-1.71mmol/L,HDL的含量正常参考值为0.78-2.20mmol/L,血液中LDL的含量正常参考值为2.10-3.10mmol/L;血压的正常参考值为80-120mmHg。测试结果如表一:
表一
从上表可以看出服用一个月后的12位患者的TC、TG、LDL值均降低至正常范围内,HDL值上升;服用3个月后的12患者血压均明显降低,因此说明本发明提供的含有紫苏牡丹籽油的复方制剂具有明显降低血脂和降低血压的功效。
对本制剂中牡丹籽油和VC生物利用度实验测定。
本次测定了实施例1-4中维生素C或者牡丹籽油的生物利用度,每个样品取10个样本测定,具体测定方法如下说明:
1、以纯化维生素C 40mg/kg的的剂量灌胃给药至小鼠,测定静脉中VC的浓度,设该数值的生物利用度为100%作为对照,实施例1-4以相同剂量VC(40mg/kg)对应的制剂灌胃给药至小鼠,相同条件下测定该实制剂的相对生物利用度。实施例1-4给小鼠的制剂量依次为267mg/kg,160mg/kg,80mg/kg,16g/kg。
2、以牡丹籽油40mg/kg的剂量灌胃给药至小鼠,测定静脉中牡丹籽油的浓度,设该数值的生物利用度为100%作为对照,实施例1-4以相同剂量牡丹籽油(40mg/kg)对应的制剂灌胃给药至小鼠,相同条件下测定该制剂的相对生物利用度。实施例1-4给小鼠的制剂量依次为200mg/kg ,267mg/kg,222mg/kg,400mg/kg。
最终得到的制剂生物利用度如表二:
表二中数据为平均值。
表二
由上述表格的实验结果表明,实施例1为VC浓度最低的复方制剂,实施例4为VC浓度最高的复方制剂,与实施例4相比,实施例1的VC生物利用度显示出显著性的差异,同时和单一的VC比较,生物利用度也显示出显著性差异。实施例1中的牡丹籽油浓度最低,实施例4中的牡丹籽油浓度最高,两者相比,实施例4的牡丹籽油生物利用度显示出显著性差异,同时和单一的牡丹籽油相比,生物利用度也显著性提高。由此可见本制剂相对于单一牡丹籽油,添加了紫苏油后能提高牡丹籽油的生物利用度。
下面对本制剂的抗氧化能力进行如下对比测定:
实验分为五组,分别加入本复合制剂,紫苏油,牡丹籽油,红松子油,葡萄籽油10mg,用体积分数为95%的乙醇作为溶剂,定容至10ml,配制成1mg/ml混合溶液。取2ml 0.1mmol/LDPPH乙醇溶液加入2ml的混合溶液,充分振荡,室温条件下避光0.5h,以95%乙醇液调零,在波长517nm处测定吸光度,记为A1,以DPPH乙醇溶液作空白对照,记为A2,以相同质量浓度的VC水溶液作阳性对照,平行测定3次,取平均值,自由基清除率按下式进行计算:
DPPH自由基清除率(%)=[(A2-A1)/A2]*100
式中:A2:t=0时空白样的吸光度
A1:t=0.5h的吸光度
实验结果表明:对DPPH自由基清除能力大小依次为VC(80.13%)>本制剂(75.45%)>牡丹籽油(60.72%)>葡萄籽油(58.48%)>红松子油(51.01%)>紫苏油(50.13%),清除率均超过50%,说明本复合制剂比单一的四种油的抗氧化活性增强。
下面对本制剂的无毒副作用进行如下实验:
受试制剂:该复合软胶囊0.5g/粒
配制方法:实验前用0.5%CMC作溶剂配制浓度为0.2g/ml的溶液,供灌胃使用。
动物:昆明种小鼠,8周龄。
实验方法:普通级小鼠20只,雌雄各半,体重19—21g,先禁食12h,每次给0.2g/ml的溶液5ml,1天3次,每次间隔6h,灌胃后开始观察小鼠的眼,毛,摄食,呼吸变化等情况,存活小鼠1周后处死并尸检。
结果:用该制剂后上述观察均无异常反应,也无一死亡,解剖后未发现异常,该胶囊为无毒药物,可供临床使用。
以上实施例,仅是对本发明的技术做更详细地说明,并不是对本发明的限制,在不脱离上述技术方案的总体思路下,未经创造性劳动或直接进行等同替换亦属于本发明的保护范围之内。
Claims (8)
1.一种含有紫苏牡丹籽油的复方制剂,其特征在于所述含有紫苏牡丹籽油的复方制剂包括以下成份:紫苏油、牡丹籽油、红松子油、葡萄籽油和维生素C。
2.如权利要求1所述的含有紫苏牡丹籽油的复方制剂,其特征在于:所述复方制剂由如下重量份数计的原料制成:紫苏油250-350份,牡丹籽油100-200份,红松子油50-90份,葡萄籽油50-90份,维生素C 0.25-50份。
3.如权利要求1所述的含有紫苏牡丹籽油的复方制剂,其特征在于:所述复方制剂由如下重量份数计的原料制成:紫苏油250-300份,牡丹籽油100-150份,红松子油50-80份,葡萄籽油50-80份,维生素C 0.25-30份。
4.如权利要求1所述的含有紫苏牡丹籽油的复方制剂,其特征在于:所述复方制剂由如下重量份数计的原料制成:紫苏油275-300份,牡丹籽油130-150份,红松子油65-80份,葡萄籽油65-80份,维生素C 0.25-10份。
5.如权利要求1—4任一项所述的含有紫苏牡丹籽油的复方制剂的制备方法,其特征在于包括以下步骤:将采用超临界CO2流体萃取后的紫苏油,牡丹籽油,红松子油,葡萄籽油先直接进行混合,然后再与维生素C均匀混合即可。
6.如权利要求5所述的一种含有紫苏牡丹籽油的复方制剂的制备方法,其特征在于:采用超临界CO2流体萃取后的各主要成分中,每克紫苏油含ɑ-亚麻酸60.12-65.41%,每克牡丹籽油含ɑ-亚麻酸40-50%,每克红松子油含亚油酸42-51%,皮诺林酸11-14%,每克葡萄籽油含亚油酸72-76%。
7.如权利要求5所述的含有紫苏牡丹籽油的复方制剂的制备方法,其特征在于该复方制剂可采用软胶囊的制备工艺制成软胶囊。
8.如权利要求1—4任一项所述的含有紫苏牡丹籽油的复方制剂的应用,其特征在于:该复方制剂用于保健品。
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CN103494199A (zh) * | 2013-10-11 | 2014-01-08 | 河南科技大学 | 一种具有降脂作用的牡丹籽油软胶囊及其制备方法 |
CN104886271A (zh) * | 2014-03-06 | 2015-09-09 | 洛阳春魁农业开发有限公司 | 一种含有紫苏籽油的牡丹籽调和油及其制备方法 |
CN104106806A (zh) * | 2014-06-30 | 2014-10-22 | 山东省农业可持续发展研究所 | 一种稳压降脂保健品 |
CN105918505A (zh) * | 2016-06-21 | 2016-09-07 | 厦门农特康生物科技有限公司 | 一种富含α-亚麻酸保护心血管的调和油 |
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