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WO2019100843A1 - 一种浒苔多糖复合降血脂保健品及其制备方法 - Google Patents

一种浒苔多糖复合降血脂保健品及其制备方法 Download PDF

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Publication number
WO2019100843A1
WO2019100843A1 PCT/CN2018/107271 CN2018107271W WO2019100843A1 WO 2019100843 A1 WO2019100843 A1 WO 2019100843A1 CN 2018107271 W CN2018107271 W CN 2018107271W WO 2019100843 A1 WO2019100843 A1 WO 2019100843A1
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parts
extract
polysaccharide
health care
care product
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PCT/CN2018/107271
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English (en)
French (fr)
Inventor
陈灿坤
陈友宁
陈友宏
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福建海兴保健食品有限公司
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Publication of WO2019100843A1 publication Critical patent/WO2019100843A1/zh

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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
    • A61K36/02—Algae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/062—Ascomycota
    • 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)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A61K36/424—Gynostemma
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488—Pueraria (kudzu)
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734—Crataegus (hawthorn)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate

Definitions

  • the invention belongs to the field of health care products, in particular to a canola polysaccharide compound hypolipidemic health care product and a preparation method thereof.
  • Cardio-cerebral vascular disease is a general term for cardiovascular and cerebrovascular diseases. It refers to diseases such as heart disease, cerebral thrombosis, and cerebral hemorrhage caused by hyperlipidemia, blood viscous, atherosclerosis, and hypertension. The number of people who die of cardiovascular and cerebrovascular diseases every year in the world is as high as 15 million, ranking first in all causes of death.
  • Hyperlipidemia is the culprit that induces repeated increases in blood pressure.
  • the blood is thick and the blood flow is blocked.
  • the blood can only rely on the power of the blood flow, and the blood vessels can be squeezed to pass, and the pressure on the blood vessels is continuously increased, forming high blood pressure. Severe blood lipids block, directly lead to cerebral thrombosis. When the pressure of blood flow is too large, it will explode blood vessels such as cerebral hemorrhage, stroke and other fatal crises.
  • Enteromorpha prolifera also known as “marine green algae” or “green algae” is an algae plant of the genus Brassica, which is a natural wild green in the intertidal tidal flat. Algae, with strong natural reproduction ability and huge yield, has high development and utilization value. Polysaccharide is the main active ingredient of canola, and studies have shown that canola polysaccharide has hypolipidemic effect.
  • hawthorn, lotus leaves, tea, etc. contain active ingredients that lower blood fat and anti-oxidation effects.
  • canola polysaccharides are compounded into compound brassica polysaccharide, which is expected to reduce the amount of polysaccharides and reduce the cost of raw materials.
  • Brassica polysaccharide prepared from Brassica oleracea polysaccharide, hawthorn extract, lotus leaf extract and tea polyphenols
  • the rats fed with high-fat diet were used as living bodies, and the compound Brassica polysaccharide was intragastrically injected into the living body.
  • TC total cholesterol
  • TG triglyceride
  • HDL-C high-density lipoprotein cholesterol
  • the product was also informed by the staff of the Shandong Institution Center for Disease Control and Prevention that the difference between the rat and the human body is large, and the clinical practice is responsible for the patient's life, and in view of the formulation of the product, the canola polysaccharide It is cold, the lotus leaf and the tea are cool, only the genus Hawthorn is warm, the effect of the gentle neutralization of the hawthorn is very limited, making the compound canola polysaccharide significantly too cool, which is highly irritating to the subject's digestive system. The side effects are obvious, so it cannot be used for normal human trials.
  • the animal test uses a short-feeding rat with high-fat diet.
  • the subject is actually only a short-term hyperlipidemia, and the blood lipid index is liable to decrease.
  • the blood lipid index is not so easy.
  • One of the objects of the present invention is to provide a cantharidin polysaccharide complex hypolipidemic health product.
  • the invention relates to a canola polysaccharide compound hypolipidemic health care product, wherein the health care product is a capsule or a tablet or a granule granule, and the health care product is composed of the following raw materials: 50-70 parts of canola polysaccharide extract, 10-15 parts of pueraria root extract, gynostemma 5-10 parts of the extract, 5-10 parts of the hawthorn extract, and 10-15 parts of the red yeast enzyme, and the parts of each raw material are parts by weight.
  • Another object of the present invention is to provide a method for preparing the above-mentioned health care product.
  • the invention discloses a preparation method of a canola polysaccharide compound hypolipidemic health care product, comprising the following steps:
  • the present inventors organically combined five kinds of drugs, such as canola polysaccharide extract, puerarin extract, Gynostemma pentaphyllum extract, hawthorn extract, and red yeast enzyme, to comprehensively take care of each other, to expand the scope of treatment, to meet the needs of the disease, and at the same time, to supervise the drug.
  • the strength and toxicity of the body can eliminate the unfavorable factors that may be caused to the human body.
  • Pueraria lobata extract, hawthorn extract and red yeast enzyme are all warm, effectively neutralizing the coldness of the extract of Brassica polysaccharide, effectively reducing the stimulation of the digestive system and enhancing intestinal absorption.
  • the polysaccharide has a large molecular weight and is not easily absorbed by the intestinal tract of hyperlipidemia patients.
  • the red yeast enzyme (fermented active bacteria) is used to increase the absorption rate of the polysaccharide, and the complementary advantage is increased.
  • the content of potassium in the polysaccharide of canola is as high as 3.9%, which can promote the excretion of sodium and has a good protective effect on blood vessels.
  • the polysaccharide of canola is also a treasure trove rich in magnesium. Studies have shown that magnesium intake can prevent cardiovascular diseases and protect the endothelial layer of arteries and blood vessels.
  • Pueraria indications dilatation of blood vessels; Pueraria lobata total flavonoids and puerarin can improve myocardial oxygen metabolism, while dilating vascular microcirculation, reducing vascular resistance, increasing blood flow; flavonoids can increase brain and coronary
  • the blood flow of blood vessels, puerarin can reduce the coronary vascular resistance, increase the coronary flow, and puerarin also has obvious hypoglycemic effect.
  • Gynostemma extract can prevent the deposition of lipids on the blood vessel wall, improve immune function, and inhibit adverse reactions caused by glucocorticoids.
  • the present inventors further limited the contents of the polysaccharides of Brassica oleracea, Radix Puerariae, Gynostemma pentaphyllum, Hawthorn, and Monascus, not only to achieve an optimal level of hypolipidemic effect, but also to avoid the occurrence of side effects, and diseases.
  • the human body test of the Prevention and Control Center proves that the canola polysaccharide compound hypolipidemic health care product of the present application can be used as an auxiliary hypolipidemic drug.
  • the invention relates to a canola polysaccharide compound hypolipidemic health care product, wherein the health care product is a capsule or a tablet or a granule granule, and the health care product is composed of the following raw materials: 50-70 parts of canola polysaccharide extract, 10-15 parts of pueraria root extract, gynostemma 5-10 parts of the extract, 5-10 parts of the hawthorn extract, and 10-15 parts of the red yeast enzyme, and the parts of each raw material are parts by weight.
  • the invention discloses a preparation method of a canola polysaccharide compound hypolipidemic health care product, comprising the following steps:
  • the above-mentioned one of the canola polysaccharide compound hypolipidemic health-care products and the canola polysaccharide extract in the preparation method are all prepared according to the canola polysaccharide extraction method disclosed in the application No. 201310028640.9.
  • the mixed materials of the canola polysaccharide compound hypolipidemic health supplement obtained in the three examples of the present application were subjected to animal tests, and the rats in the blank control group, the model control group and the gavage test sample group were respectively tested for TC, TG, LDL-C.
  • the specific results are listed below (see Table 3, the blood collection subjects in the blank control group in Table 3 are: ordinary rats fed normal diet; the blood collection subjects in the model control group are: feeding high-fat diet un-administered test samples Rats; the subjects of Examples 1-3 are: rats fed a high-fat diet and high-dose gavage test samples):
  • the data in Table 3 above is part of the data intercepted by the inventors in numerous trials.
  • the TC, TG, and LDL-C values of the rats in the gavage test sample group of Examples 1-3 were significantly decreased relative to the model control group, and the HDL-C value was relative to the model.
  • the control group had a significant increase. Therefore, the mixed raw material of the canola polysaccharide compound hypolipidemic health care product of the invention has the auxiliary hypolipidemic effect.
  • the present inventors sent the mixed material of the canola polysaccharide compound hypolipidemic health care product obtained in the above Example 1 to the Fujian Institution Center for Disease Control and Prevention for animal testing (registered inspection acceptance number: ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13 13
  • the TC, TG, LDL-C values of the model control group were higher than the blank control group, the difference was statistically significant (P ⁇ 0.05); the high dose group (ie, the gavage test) The TC and TG values of the rats in the sample group were lower than those in the model control group (P ⁇ 0.05). There was no significant difference between the LDL-C values and the model control group (P>0.05). According to the judgment standard in the "Evaluation Method of Auxiliary Blood Lipid Function" (National Food and Drug Administration [2012] No. 107), it is considered that the mixed raw material of the canola polysaccharide compound hypolipidemic health supplement has the effect of reducing blood fat.
  • the present inventors furtherly obtain the same candied polysaccharide polysaccharide hypolipidemic health care product prepared by the method for preparing the mossy polysaccharide compound hypolipidemic health-care product according to the present invention, and send it to Shandong province.
  • the Center for Disease Control and Prevention conducted a human test (sample number: GZ03920140305).
  • the test results were as follows: 102 patients with hyperlipidemia, 51 patients in the test group, and 51 patients in the control group. During the test, the diet and living habits remained unchanged.
  • the test group took the test samples and the control group used the blank control for 60 days.
  • test structure indicated that the test substance had an auxiliary hypolipidemic function.
  • blood, urine, stool routine and serum total protein, albumin, aspartate aminotransferase, alanine aminotransferase, urea nitrogen, creatinine, uric acid, blood sugar and other safety indicators were examined. Subjects were in the normal range, indicating that the subject had no adverse effects on the health of the tester. General conditions (including mental, sleep, diet, weight, bowel movements, blood pressure, heart rate, etc.) were normal during the test, and no allergies and other adverse reactions were observed.
  • the canola polysaccharide composite hypolipidemic health product of the present invention and the canola polysaccharide extract in the preparation method are also limited to the method of extracting the canola polysaccharide disclosed in the patent No. 201310028640.9.

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Abstract

一种浒苔多糖复合降血脂保健品。该保健品为胶囊或片剂或颗粒冲剂，该保健品由以下原料组成：浒苔多糖提取物50-70份、葛根提取物10-15份、绞股蓝提取物5-10份、山楂提取物5-10份、红曲酵素10-15份，各原料份数均为重量份。还提供上述保健品的制备方法，将上述原料按照上述重量份混合，成型，干燥，包装，检验，得到成品。

Description

一种浒苔多糖复合降血脂保健品及其制备方法 技术领域
本发明属于保健品领域，尤其是一种浒苔多糖复合降血脂保健品及其制备方法。
背景技术
心脑血管疾病是心脏血管和脑血管疾病的统称，泛指由于高血脂症、血液粘稠、动脉粥样硬化、高血压所导致的心脏病、脑血栓、脑溢血等疾病。全世界每年死于心脑血管疾病的人数高达1500万人，居各种死因首位。
高血脂是诱发血压反复升高的元凶。血液粘稠，血流受阻，血液只能依靠血流的力量，挤压血管才能通过，给血管的压力不断增大，形成了高血压。血脂堵塞严重，直接引发脑血栓。当血流拥挤的压力过大时会挤爆血管出现如脑溢血、中风等致命危机。
浒苔(Enteromorpha prolifera，EP)，也称“海洋绿藻”或“绿藻”，为绿藻门石莼目石莼科浒苔属的藻类植物，其作为潮间带滩涂中的天然野生绿藻，自然繁殖能力强且产量巨大，具备很高的开发和利用价值。多糖为浒苔的主要活性成分，目前已有研究表明浒苔多糖具有降血脂功效。
另有研究表明，山楂、荷叶、茶叶等均含有降血脂及抗氧化作用的活性成分，将这些原料与浒苔多糖配制成复方浒苔多糖，有望能减少浒苔多糖用量、降低原料成本，同时有可能在降血脂方面发挥多靶点、多成分协同的作用。
2015年，陈婕和林文庭于《大连医科大学学报》上发表了一份名为“复方浒苔多糖降血脂及抗脂质过氧化作用研究”的科技文献，该科技文献中公布了一种复方浒苔多糖(由浒苔多糖、山楂提取物、荷叶提取物及茶多酚各25％配制而成)，以喂养高脂饲料的大鼠作为活体，将该复方浒苔多糖灌胃干预活体45d，测定发现：与未灌胃复方浒苔多糖的大鼠相比，灌胃了复方浒苔多糖的大鼠的血清中的总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)均有所下降；而高密度脂蛋白胆固醇(HDL-C)有所提高，其认为：该复合浒苔多糖具有降血脂的作用。
事实上，上文的作者-陈捷和林文庭均属于本发明人的合作开发人，本发明人早期也有将按照上述复方浒苔多糖配方制得的复方浒苔多糖产品送至福建省疾病防治中心进行了动物试验，测定结果为：与未灌胃复方浒苔多糖的大鼠相比，灌胃了复方浒苔多糖的大鼠的血清中的总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)均无明显变化；而高密度脂蛋白胆固醇(HDL-C)有所提高，但是，提高的幅度较小(详见下表1)。因此， 福建省疾病防治中心给出的结论是：根据《辅助降血脂功能评价方法》(国食药监保化[2012]107号)中的判断标准，认为该产品不具有辅助降血脂的作用。除此之外，该产品还被山东省疾病预防控制中心的工作人员告知：大鼠与人体两者基体差异大，进行临床是要对病人生命负责的，而鉴于该产品的配方中浒苔多糖属寒性，荷叶和茶叶均属凉性，只有山楂属温性，山楂的温性中和凉性的效果非常有限，使得该复方浒苔多糖明显过凉，其对受试者的消化系统刺激大，副作用明显，因此，其不能用于正常的人体试验。另外，事实上，即使经动物试验具有辅助降血脂作用的产品用于临床试验时也经常会不具有辅助降血脂的作用，原因在于：动物试验中采用的是经高脂饲料短期喂养的大鼠作为受试对象，该受试对象实际上只是短期的高血脂，血脂指标容易下降，而对于患有糖尿病或高血脂的自然人来说，其是长期的高血脂，血脂指标下降并不那么容易。
表1.现有的复方浒苔多糖产品对大鼠血脂(mmol/L，n＝10)的影响
Figure PCTCN2018107271-appb-000001
发明内容
本发明目的之一在于提供一种浒苔多糖复合降血脂保健品。
一种浒苔多糖复合降血脂保健品，该保健品为胶囊或片剂或颗粒冲剂，该保健品由以下原料组成：浒苔多糖提取物50-70份、葛根提取物10-15份、绞股蓝提取物5-10份、山楂提取物5-10份、红曲酵素10-15份，各原料份数均为重量份。
本发明目的之二在于提供上述该保健品的制备方法。
一种浒苔多糖复合降血脂保健品的制备方法，包括以下步骤：
(1)分别称取浒苔多糖提取物50-70份、葛根提取物10-15份、绞股蓝提取物5-10份、山楂提取物5-10份、红曲酵素10-15份，混合，得到混合原料；
(2)将混合原料进行成型，干燥，包装，检验，得到成品。
本发明人首次将浒苔多糖提取物、葛根提取物、绞股蓝提取物、山楂提取物、红曲酵素五种药物有机组合使用，全面兼顾，以扩大治疗范围，适应病情的需要，同时，监制药物的烈性和毒性，消除对人体可能造成的不利因素。其中的葛根提取物、山楂提取物和红曲酵素均属温性，有效中和了浒苔多糖提取物的寒性，有效降低对消化系统的刺激，增强肠道吸收。其中的浒苔多糖分子量大，不容易被高血脂患者肠道吸收，利用红曲酵素(发酵提取 的活性生物菌)来提高浒苔多糖的吸收率，增加了互补的优势。并且，浒苔多糖中所含钾元素含量高达3.99％，能促进钠的排泄，对血管也有很好的保护作用，同时，浒苔多糖还是富含镁元素的宝库。研究表明，摄入镁，能防治心血管疾病，保护动脉，血管的内皮层。再有，葛根功能主治：扩张血管；葛根中的葛根总黄酮和葛根素能改善心肌的氧代谢，同时能扩张血管微循环，降低血管阻力，使血流量增加；黄酮类物质能增加脑及冠状血管的血液流量，葛根素可使冠状血管阻力下降，冠状流量增加，同时葛根素还有明显的降血糖功效。绞股蓝提取物能够防止脂质在血管壁的沉积，提高免疫功能，抑制糖皮质激素引起的不良反应等。另外，本发明人还进一步将浒苔多糖、葛根、绞股蓝、山楂、红曲酵素的含量均进行了限定，不仅实现了将降血脂效果提高到最佳水平，还避免了副作用的产生，经疾病预防控制中心人体试验，证明本申请的浒苔多糖复合降血脂保健品可作为辅助降血脂药物使用。
具体实施方式
一种浒苔多糖复合降血脂保健品，该保健品为胶囊或片剂或颗粒冲剂，该保健品由以下原料组成：浒苔多糖提取物50-70份、葛根提取物10-15份、绞股蓝提取物5-10份、山楂提取物5-10份、红曲酵素10-15份，各原料份数均为重量份。
一种浒苔多糖复合降血脂保健品的制备方法，包括以下步骤：
(1)分别称取浒苔多糖提取物50-70份、葛根提取物10-15份、绞股蓝提取物5-10份、山楂提取物5-10份、红曲酵素10-15份，混合，得到混合原料；
(2)将混合原料进行成型，干燥，包装，检验，得到成品。
其中，上述的一种浒苔多糖复合降血脂保健品和制备方法中的浒苔多糖提取物均按照申请号201310028640.9专利公布的浒苔多糖提取方法来制备。
根据上述的一种浒苔多糖复合降血脂保健品的制备方法中步骤(1)得到的混合原料进行如下3个实施例，现将这3个实施例的试验条件具体列表如下(见表2)：
表2
Figure PCTCN2018107271-appb-000002
本申请的3个实施例得到的浒苔多糖复合降血脂保健品混合原料进行动物试验，分别测定空白对照组、模型对照组、灌胃受试样品组的大鼠TC、TG、LDL-C值，具体结果列表如下(见表3，表3中的空白对照组的采血对象为：喂养普通饲料的普通大鼠；模型对照组的采血对象为：喂养高脂饲料未灌胃受试样品的大鼠；实施例1-3的对象为：喂养高脂饲料并高 剂量灌胃受试样品的大鼠)：
表3
Figure PCTCN2018107271-appb-000003
上述表3中的数据为本发明人进行无数次试验中截取的部分数据。从表3可看出，实施例1-3的灌胃受试样品组的大鼠TC、TG、LDL-C值相对于模型对照组均有明显的下降，而HDL-C值相对于模型对照组均有明显的升高。因此，本发明的浒苔多糖复合降血脂保健品混合原料具有辅助降血脂作用。
另，本发明人将上述实施例1得到的浒苔多糖复合降血脂保健品混合原料送至福建省疾病预防控制中心进行动物试验(注册检验受理编号：闽疾控中心卫检健13-0173，报告书编号：闽疾控中心卫检健13-0173-3)，检查结果如下(详见下表4)：采用混合型高脂血症动物模型，造模7天后，模型对照组血清胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)值高于空白对照组，差异均有统计学意义(P＜0.05)，判定模型成立。经口服灌胃给予受试样品30天后，模型对照组TC、TG、LDL-C值高于空白对照组，差异均有统计学意义(P＜0.05)；高剂量组(即灌胃受试样品组)大鼠TC、TG值低于模型对照组，差异均有统计学意义(P＜0.05)，LDL-C值与模型对照组比较，差异无统计学意义(P＞0.05)。根据《辅助降血脂功能评价方法》(国食药监保化[2012]107号)中的判断标准，认为该浒苔多糖复合降血脂保健品混合原料有辅助降血脂的作用。
表4.本发明的浒苔多糖复合降血脂保健品混合原料对大鼠血脂(mmol/L，n＝10)的影响
Figure PCTCN2018107271-appb-000004
本发明人再将根据本发明的浒苔多糖复合降血脂保健品制备方法制得的与上述浒苔多糖复合 降血脂保健品混合原料的配方相同的浒苔多糖复合降血脂保健品送至山东省疾病预防控制中心进行人体试验(样品编号：GZ03920140305)，试验结果如下：采用自身及组间对照法，102例高血脂症受试者，试食组51例，对照组51例。试食期间饮食及生活习惯不变，试食组服用试验样品，对照组采用空白对照，连续服用60天。试食后血清胆固醇(TC)较试食前下降了0.51±0.39mmol/L，差异有显著性(P＜0.01)；甘油三酯(TG)下降了0.28±0.19mmol/L，差异有显著性(P＜0.01)；低密度脂蛋白胆固醇(LDL-C)下降了0.19±0.18mmol/L，差异有显著性(P＜0.01)；TC、TG二项指标试食后试食组与对照组组间比较明显降低，差异有显著性(P＜0.01)，LDL-C试食后试食组与对照组组间比较明显降低，差异有显著性(P＜0.01)；试食组总有效率显著高于对照组(P＜0.01)、试验结构表明该受试物有辅助降血脂功能。试食后血、尿、便常规和血清总蛋白、白蛋白、谷草转氨酶、谷丙转氨酶、尿素氮、肌酐、尿酸、血糖等各项安全性指标检查。受试者均在正常范围，说明该受试者对试食者身体健康无不良影响。试食过程中一般状况(包括精神、睡眠、饮食、体重、大小便、血压、心率等)正常，未观察到过敏及其他不良反应。
当然，本发明的一种浒苔多糖复合降血脂保健品和制备方法中的浒苔多糖提取物也限于按照申请号201310028640.9专利公布的浒苔多糖提取方法来制备。

Claims (2)

  1. 一种浒苔多糖复合降血脂保健品，该保健品为胶囊或片剂或颗粒冲剂，其特征在于：该保健品由以下原料组成：浒苔多糖提取物50-70份、葛根提取物10-15份、绞股蓝提取物5-10份、山楂提取物5-10份、红曲酵素10-15份，各原料份数均为重量份。
  2. 一种权利要求1所述的一种浒苔多糖复合降血脂保健品的制备方法，其特征在于，包括以下步骤：
    (1)分别称取浒苔多糖提取物50-70份、葛根提取物10-15份、绞股蓝提取物5-10份、山楂提取物5-10份、红曲酵素10-15份，混合，得到混合原料；
    (2)将混合原料进行成型，干燥，包装，检验，得到成品。
PCT/CN2018/107271 2017-08-17 2018-09-25 一种浒苔多糖复合降血脂保健品及其制备方法 WO2019100843A1 (zh)

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