WO2014134833A1 - Edible composition, preparation method therefor, and food product comprising the composition - Google Patents

Edible composition, preparation method therefor, and food product comprising the composition Download PDF

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Publication number
WO2014134833A1
WO2014134833A1 PCT/CN2013/072371 CN2013072371W WO2014134833A1 WO 2014134833 A1 WO2014134833 A1 WO 2014134833A1 CN 2013072371 W CN2013072371 W CN 2013072371W WO 2014134833 A1 WO2014134833 A1 WO 2014134833A1
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Prior art keywords
weight
parts
edible composition
propolis
inulin
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PCT/CN2013/072371
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French (fr)
Chinese (zh)
Inventor
黄璐
杨爽
汪小刚
张海峰
张思佳
朱江阳
熊周权
康辉
杨焕明
Original Assignee
武汉华大药业有限公司
深圳华大基因科技有限公司
华大基因(老挝)有限公司
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Priority to PCT/CN2013/072371 priority Critical patent/WO2014134833A1/en
Priority to CN201380073961.9A priority patent/CN105101817B/en
Publication of WO2014134833A1 publication Critical patent/WO2014134833A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/47Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L21/00Marmalades, jams, jellies or the like; Products from apiculture; Preparation or treatment thereof
    • A23L21/20Products from apiculture, e.g. royal jelly or pollen; Substitutes therefor
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/275Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of animal origin, e.g. chitin
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115Fatty acids or derivatives thereof; Fats or oils
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21Addition of substantially indigestible substances, e.g. dietary fibres
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L5/00Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/733Fructosans, e.g. inulin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • A61K35/64Insects, e.g. bees, wasps or fleas
    • A61K35/644Beeswax; Propolis; Royal jelly; Honey
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • Chinese patent CN101999652A discloses a health food South American vine soft capsule (referred to herein as South American vine soft capsule) having a blood fat lowering function, from red yeast extract, Pu'er cooked tea extract, and inca fruit oil. Composed of beeswax, the South American vine soft capsule has a single function and has no effect on high blood sugar.
  • the above method may further comprise adding any pharmaceutically acceptable pharmaceutical excipient to the above edible composition, and forming it into a pharmaceutically acceptable dosage form by a conventional process.
  • any pharmaceutically acceptable pharmaceutical excipient for example, hard capsules, soft capsules, tablets, or granules can be more conveniently consumed, thereby achieving a good auxiliary blood sugar lowering and lowering blood fat.
  • the present invention provides another method of preparing the above edible composition, comprising: mixing a predetermined proportion of inulin, indo-fruit powder, propolis, chitosan oligosaccharide, and The resulting mixture is pulverized to a particle diameter of from 1 to 100 ⁇ m to obtain a mixed fine powder constituting the edible composition. Therefore, the above method can be effectively used for preparing an edible composition, thereby facilitating the effect of the composition to lower blood sugar, lower blood fat, regulate intestinal tract, slimming beauty, and improve immunity.
  • Micronized silica gel 1 part by weight
  • Micronized silica gel 0.5 parts by weight
  • the area and chroma of the chloasma in 40 subjects decreased.
  • the area of chloasma before the test was (2331.49 ⁇ 1256.58) mm 2
  • the area of chloasma after the 30-day test was (1921.89 ⁇ 923.50) mm 2
  • the hue of chloas were (1.75 ⁇ 0.47) and (1.48 ⁇ , respectively). 0.35)
  • the results before and after the test were significantly different (P ⁇ 0.01). It can be seen from the above that the composition of the present invention has an obvious cosmetic freckle effect on the human body, and no adverse reaction is observed during the administration.

Abstract

An edible composition, a preparation method therefor, and a food product comprising the composition. The edible composition comprises inulin, lipactive, propolic, and oligochitosan. The edible composition provides blood sugar-lowering and blood lipid-lowering effects.

Description

可食用组合物及其制备方法和包含该组合物的食品  Edible composition, preparation method thereof and food product containing the same
技术领域 Technical field
本发明属于保健食品领域, 具体涉及可食用组合物及其制备方法和包含该组合物的食 The invention belongs to the field of health foods, and particularly relates to edible compositions, preparation methods thereof and foods containing the same
ΠΠ
ΡΠ。 Hey.
背景技术 Background technique
高血糖、 高血脂目前已经成为人类共同面临的最严重的公共健康问题之一, 在中老年 人中体现的尤其明显。  Hyperglycemia and hyperlipidemia have become one of the most serious public health problems facing humanity, especially among middle-aged and elderly people.
降血糖、 降血脂类产品的市场目前仍然以药品为主, 消费者主要的购买途径是医院。 随着中国老百姓自我诊断水平的不断提高, 针对糖尿病、 高血脂等患者的治疗调理已经不 再使用单纯的化学药物的方法, 这是由于大量的不良反应报道使人们认识到, 临床上很多 化学药物的单独或组合应用, 在发挥高效治疗作用的同时具有不可避免的毒副作用, 而且 停药后病情容易复发。 由此导致降血糖、 降血脂保健品市场正在持续升温。 目前已经有大 量的依靠天然植物发挥辅助降血糖、 降血脂作用的保健品被研制出来以及被 SFDA批准上 市。 然而, 遗憾的是, 很多辅助降血糖、 辅助降血脂的保健食品由于辅助作用有限, 疗效 并不令人满意。 例如, 中国专利 CN101999652A公开了一种具有降血脂功能的保健食品南 美油藤软胶囊 (在本文中被称为南美油藤软胶囊) , 由红曲提取物、 普洱熟茶提取物、 印 加果油和蜂蜡组成, 该南美油藤软胶囊功能单一, 对高血糖没有效果。  The market for blood sugar lowering and blood lipid lowering products is still dominated by medicines, and the main purchase route for consumers is hospitals. With the continuous improvement of the self-diagnosis level of Chinese people, the treatment of diabetes, hyperlipidemia and other patients has no longer used simple chemical drugs. This is because a large number of adverse reactions have made people realize that many chemical drugs are clinically The single or combined application has an inevitable toxic side effect while exerting an effective therapeutic effect, and the disease is prone to recurrence after stopping the drug. As a result, the market for hypoglycemic and hypolipidemic health products is continuing to heat up. At present, a large number of health products that rely on natural plants to assist in lowering blood sugar and lowering blood fat have been developed and approved by the SFDA. However, unfortunately, many health foods that help lower blood sugar and help reduce blood fat are not satisfactory because of their limited auxiliary effects. For example, Chinese patent CN101999652A discloses a health food South American vine soft capsule (referred to herein as South American vine soft capsule) having a blood fat lowering function, from red yeast extract, Pu'er cooked tea extract, and inca fruit oil. Composed of beeswax, the South American vine soft capsule has a single function and has no effect on high blood sugar.
因此目前的保健食品仍有待改进。 发明内容  Therefore, the current health food products still need to be improved. Summary of the invention
本发明旨在至少在一定程度上解决上述技术问题之一或至少提供一种有用的商业选择。 为此, 本发明的一个目的在于提供一种纯天然、 无毒副作用, 具有辅助降血糖、 降血脂的 组合物。  The present invention is directed to solving at least some of the above technical problems or at least providing a useful commercial choice. To this end, it is an object of the present invention to provide a composition which is naturally natural, has no toxic side effects, and which has an auxiliary blood sugar lowering and blood fat lowering.
由此, 在本发明的一个方面,本发明提出了一种可食用组合物, 根据本发明的实施例, 该可食用组合物包含: 3〜15重量份的菊粉; 2〜10重量份的印加果油; 5〜15重量份的蜂胶; 以及 2〜15重量份的壳寡糖, 任选地, 所述蜂胶的乙醇提取物中总黄酮含量为至少 15重 量0 /0Thus, in one aspect of the invention, the invention provides an edible composition comprising, according to an embodiment of the invention, 3 to 15 parts by weight of inulin; 2 to 10 parts by weight lipactive; 5~15 parts by weight of propolis; total flavonoids and 2~15 parts by weight of chitosan oligosaccharide, optionally, the ethanol extract of propolis content by weight of at least 15 0/0.
本发明人在前期系列研究的基础上, 对辅助降血糖、 降血脂的物质联用的潜力进行了 大量的有益探索, 并取得了意想不到的效果。 为此, 发明人经过艰苦的创造性劳动和优化 工作, 惊奇的发现: 由菊粉、 印加果、 蜂胶、 壳寡糖为原料的组合物, 在辅助降血糖、 辅 助降血脂方面的作用明显。 此外, 本发明的申请人通过实验, 还意外的发现: 该组合物还 具有调节肠道菌群、 减肥、 美容祛斑的保健功效。 并且本发明的发明人发现, 该组合物具 有显著的协同作用。 On the basis of the previous series of studies, the present inventors conducted a large number of beneficial explorations on the potential of the combination of substances for lowering blood sugar and lowering blood fat, and achieved unexpected effects. To this end, after intensive creative labor and optimization work, the inventors were surprised to find that the composition of inulin, inca fruit, propolis and chitooligosaccharide as raw materials has obvious effects in assisting blood sugar lowering and assisting blood fat lowering. In addition, the applicant of the present invention has unexpectedly discovered through experiments that the composition is still It has the health benefits of regulating intestinal flora, weight loss, and beauty freckle. And the inventors of the present invention found that the composition has a remarkable synergistic effect.
根据本发明的实施例, 优选的可食用组合物包含: 5〜12重量份的菊粉; 4〜8重量份的 印加果油; 6〜10重量份的蜂胶; 以及 5〜10重量份的壳寡糖。 由此, 可以进一步提高可食用 组合物在辅助降血糖、 辅助降血脂方面的作用。  According to an embodiment of the present invention, a preferred edible composition comprises: 5 to 12 parts by weight of inulin; 4 to 8 parts by weight of inca fruit oil; 6 to 10 parts by weight of propolis; and 5 to 10 parts by weight of shell Oligosaccharides. Thereby, the action of the edible composition in assisting blood sugar lowering and assisting blood fat lowering can be further enhanced.
根据本发明的实施例, 最优选的可食用组合物包含: 8重量份的菊粉; 6重量份的印加 果油; 8重量份的蜂胶; 以及 8重量份的壳寡糖。 由此, 可以进一步提高可食用组合物在辅 助降血糖、 辅助降血脂方面的作用。  According to an embodiment of the present invention, the most preferred edible composition comprises: 8 parts by weight of inulin; 6 parts by weight of ingrown oil; 8 parts by weight of propolis; and 8 parts by weight of chitooligosaccharide. Thereby, the effect of the edible composition in assisting blood sugar lowering and assisting blood fat lowering can be further enhanced.
其中, 菊粉是迄今为止人类发现的最优质、 纯天然、 可溶性的果聚糖混合物, 主要分 布在菊科植物中, 其中菊苣中含量最高。 国外以菊苣根为原料, 去除蛋白质和矿物质 后, 经喷雾干燥等步骤获得菊粉。 国内以菊芋 (洋姜) 根状茎为原料, 去除蛋白, 胶 质, 粗纤维和矿物质, 经水提取、 离子交换、 膜过滤、 喷雾干燥等生产工艺得到菊粉。 菊粉于 2009年被卫生部批准为新资源食品。菊粉具有低热量、水溶性等特性及增强双歧杆 菌增殖、 降低血糖血脂、 恢复胃肠功能、 增强钙质吸收等诸多功效。  Among them, inulin is the highest quality, pure natural, soluble fructan mixture found by humans, mainly distributed in Compositae, of which chicory is the highest. After using chicory root as a raw material to remove protein and minerals, the inulin is obtained by spray drying. In China, the rhizome of Jerusalem artichoke (Jerusalem) is used as raw material to remove protein, gum, crude fiber and minerals. The inulin is obtained by water extraction, ion exchange, membrane filtration and spray drying. Inulin was approved by the Ministry of Health as a new resource food in 2009. Inulin has the characteristics of low calorie, water solubility and the like, and enhances the proliferation of bifidobacteria, lowers blood sugar and blood lipids, restores gastrointestinal function, and enhances calcium absorption.
印加果 (P/ feweriii vo/ b fc L.Jnca Peanut, sacha inchi) 为大戟科藤本植物, 又称印加 花生、 南美油藤、 星油藤、 美藤果。 多年生油料植物, 原产南美洲亚马逊河流域雨林, 最 初由印加人变野生为家种, 在南美洲印加地区已被当地土著应用了上千年的历史。 当年种 植, 当年可挂果, 种子富含油脂、 蛋白质、 氨基酸, 还有维生素 A, 维生素 E和一些其它 微量元素, 印加果油含有极其丰富的不饱和脂肪酸(ω-3、 ω-6、 ω-9), 以及维生素 Α、 Ε和 蛋白质, 且三种不饱和脂肪酸含量高达 92 %以上。 富含多不饱和脂肪酸的印加果及油食用 是安全的, 可凉拌、或炒熟了直接食用。现代医学证明, 印加果在防治心血管硬化性疾病, 调节胆固醇、 血脂含量, 降低血小板聚集率、 抑制肿瘤生长及血栓和动脉粥样硬化斑块形 成, 调节人体机能等方面有显著功效。 动物实验显示, 印加果油对小鼠的 LD50>54g/kg, 急 性经口毒性属于无毒级, 亦未显示致突变性 (黄超培,等. 癌变 ·畸变 ·突 变, 2012, 24(2): 148-150)。 大鼠口服印加果 60天, 血清学水平上无毒性, 且能够降低大鼠血 清总胆固醇 (TC) 和降低血清甘油三酯 (TG) 的含量, 增加高密度脂蛋白 (HDL-C ) 的水 平 ( Arilmi Gorriti, et al. Rev Peru Med Exp Salud Publica, 2010, 27(3): 352-60)。  Inca (P/lessiii vo/ b fc L.Jnca Peanut, sacha inchi) is a large vine, also known as Inca peanut, South American vine, Star vine, and Meito fruit. The perennial oil plant, native to the Amazonian rainforest of South America, was originally transformed from the Incas to the wild, and has been used by local indigenous people for thousands of years in the Inca region of South America. When planted in the same year, the fruit can be hung. The seeds are rich in oil, protein, amino acids, vitamin A, vitamin E and some other trace elements. Inca oil contains extremely rich unsaturated fatty acids (ω-3, ω-6, ω- 9), as well as vitamins, strontium and protein, and the content of three unsaturated fatty acids is over 92%. Inca fruit and oil rich in polyunsaturated fatty acids are safe to eat, and can be eaten directly after salad or frying. Modern medicine has proved that Inca fruit has significant effects in preventing and treating cardiovascular sclerosing diseases, regulating cholesterol and blood lipid levels, reducing platelet aggregation rate, inhibiting tumor growth, thrombosis and atherosclerotic plaque formation, and regulating human body function. Animal experiments show that the LD50>54g/kg of Inca fruit oil in mice, the acute oral toxicity is non-toxic, and it has not shown mutagenicity (Huang Chaopei, et al. Cancer, Distortion, Mutation, 2012, 24(2): 148-150). Oral administration of Inca fruit for 60 days is non-toxic at the serological level, and can reduce serum total cholesterol (TC) and serum triglyceride (TG) levels, and increase the level of high-density lipoprotein (HDL-C). (Arilmi Gorriti, et al. Rev Peru Med Exp Salud Publica, 2010, 27(3): 352-60).
蜂胶是蜜蜂从植物芽孢或树干上采集的树脂 (树胶), 混入其上腭腺、 蜡腺的分泌物加 工而成的一种具有芳香气味的胶状物质,是蜜蜂用其作为净化环境、防病治病的唯一物质。 研究证明, 蜂胶含有丰富而独特的生物活性物质, 如黄酮类化合物、 酸、 醇、 酚、 醛、 酯、 醚类以及烯、 萜、 类化合物和多种氨基酸、 脂肪酸、 酶类、 维生素、 多种微量 元素等。 蜂胶作为保健食品主要有免疫调节的功效, 还有辅助抗氧化、 调节血脂、 血 压、 血糖、 辅助保护胃粘膜等多种保健功能, 对人体有着广泛的医疗、 保健作用, 现 已成为各国科学研究的热点。 Propolis is a kind of resinous substance with aroma smell, which is a resin (gum) collected by plant bees from plant spores or tree trunks. It is used to purify the environment and prevent it. The only substance that cures the disease. Studies have shown that propolis contains rich and unique biologically active substances such as flavonoids, acids, alcohols, phenols, aldehydes, esters, ethers and alkenes, terpenoids, compounds and various amino acids, fatty acids, enzymes, vitamins, and more. Trace elements and so on. Propolis as a health food mainly has the effect of immune regulation, as well as auxiliary antioxidant, blood lipid regulation, blood Pressure, blood sugar, and auxiliary protection of gastric mucosa and other health care functions have a wide range of medical and health care effects on the human body, and have become a hot spot in scientific research in various countries.
壳寡糖是壳聚糖降解以后聚合度 2-10 的产物,其水溶性比壳聚糖好,容易被吸收利用, 壳寡糖在人体内吸收率近 100%, 且生物活性比壳聚糖更强。 它能够抑制肿瘤细胞生长, 强 化肝功能, 增强免疫力, 防止胃溃疡, 降低血压、 血糖、 血脂、 吸收胆固醇及抗菌作用等。  Chitosan oligosaccharide is a product of polymerization degree 2-10 after degradation of chitosan. Its water solubility is better than that of chitosan, and it is easily absorbed and utilized. The absorption rate of chitosan oligosaccharide in human body is nearly 100%, and the biological activity is more than chitosan. Stronger. It inhibits tumor cell growth, strengthens liver function, enhances immunity, prevents stomach ulcers, lowers blood pressure, blood sugar, blood lipids, cholesterol absorption and antibacterial effects.
本发明所述的印加果, 是印加果的果实经采收后, 先脱壳成果仁, 晒干, 再将果仁按 照传统方法加工粉碎成印加果粉;  The Inca fruit of the present invention is that after the fruit of the Inca fruit is harvested, the shell is firstly shelled, dried, and the nuts are processed and pulverized into the printed fruit powder according to a conventional method;
本发明所述的印加果油, 是印加果的果实经采收后, 先脱壳成果仁, 晒干, 再将果仁 经低温物理冷搾、 过滤除杂后成印加果油。  The indica fruit oil according to the present invention is obtained after harvesting the fruit of the Inca fruit, first peeling the shell and drying the fruit, and then cold-pressing the nut by low temperature, filtering and removing the impurities to form the printed fruit oil.
本发明所述的蜂胶是优质提纯蜂胶粉, 其蜂胶乙醇提取物中总黄酮含量应≥15%。 根据本发明的实施例, 可以将上述可食用组合物中加入任何在药学上可接受的药用辅 料, 并且可以通过常规工艺, 将其制成药剂学上所说的剂型, 例如硬胶囊、 软胶囊、 片剂、 或颗粒剂。 本发明优选的剂型为软胶囊, 由此可以更加方便食用, 进而达到很好的辅助降 血糖、 降血脂的作用。  The propolis according to the invention is a high-quality purified propolis powder, and the total flavonoid content in the propolis ethanol extract should be ≥15%. According to an embodiment of the present invention, any pharmaceutically acceptable pharmaceutical excipient may be added to the above edible composition, and it may be formulated into a pharmaceutically acceptable dosage form by a conventional process, such as hard capsules, soft. Capsules, tablets, or granules. The preferred dosage form of the present invention is a soft capsule, which can be more conveniently consumed, thereby achieving a good auxiliary effect of lowering blood sugar and lowering blood fat.
在本发明的第二个方面, 本发明提出了另一种可食用组合物。 根据本发明的实施例, 该组合物包括: 3〜15 重量份的菊粉; 5〜25 重量份的印加果粉; 5〜15 重量份的蜂胶; 以及 2〜15重量份的壳寡糖, 任选地, 所述蜂胶的乙醇提取物中总黄酮含量为至少 15重量%。 由此, 该可食用组合物具有良好的降血糖、 降血脂、 调节肠道、 减肥美容、 提高免疫力等 作用, 更加符合保健品的要求和发展趋势。  In a second aspect of the invention, the invention proposes another edible composition. According to an embodiment of the present invention, the composition comprises: 3 to 15 parts by weight of inulin; 5 to 25 parts by weight of Inca fruit powder; 5 to 15 parts by weight of propolis; and 2 to 15 parts by weight of chitooligosaccharide, Optionally, the total flavonoid content of the propolis extract in ethanol is at least 15% by weight. Thus, the edible composition has good effects of lowering blood sugar, lowering blood fat, regulating intestinal tract, slimming beauty, and improving immunity, and is more in line with the requirements and development trends of health care products.
根据本发明的实施例, 优选的可食用组合物包含: 5〜12重量份的菊粉; 10〜20重量份 的印加果粉; 6〜10重量份的蜂胶; 以及 5〜10重量份的壳寡糖。 由此, 该可食用组合物能够 更好的发挥降血糖、 降血脂、 调节肠道、 减肥美容、 提高免疫力等作用, 更加符合保健品 的要求和发展趋势。  According to an embodiment of the present invention, a preferred edible composition comprises: 5 to 12 parts by weight of inulin; 10 to 20 parts by weight of Inca fruit powder; 6 to 10 parts by weight of propolis; and 5 to 10 parts by weight of shell oligomer sugar. Therefore, the edible composition can better exert the effects of lowering blood sugar, lowering blood fat, regulating intestinal tract, slimming beauty, and improving immunity, and is more in line with the requirements and development trends of health care products.
根据本发明的实施例, 优选的可食用组合物包含: 8 重量份的菊粉; 15 重量份的印加 果粉; 8重量份的蜂胶; 以及 8重量份的壳寡糖。 由此, 将组合物中的各成分的用量更加精 确化, 由此, 能够更好的发挥降血糖、 降血脂、 调节肠道、 减肥美容、 提高免疫力等功效。  According to an embodiment of the present invention, a preferred edible composition comprises: 8 parts by weight of inulin; 15 parts by weight of indosin; 8 parts by weight of propolis; and 8 parts by weight of chitooligosaccharide. Thereby, the amount of each component in the composition is further refined, whereby the effects of lowering blood sugar, lowering blood fat, regulating the intestine, slimming beauty, and improving immunity can be exhibited.
在本发明的第三个方面, 本发明提出了一种制备上述的可食用组合物的方法, 该方法 包括: 将预定比例的菊粉、 蜂胶、 以及壳寡糖混合, 并将所得到的混合物进行粉碎至粒径 为 1-100微米之间, 以便得到混合细粉; 将混合细粉与印加果油混合, 以便得到可食用组合 物。 根据本发明的实施例, 在将混合细粉与印加果油混合之前, 预先将印加果油与大豆油 混合均匀后, 与混合细粉混合, 以便得到可食用组合物。 由此, 利用该方法可以有效的制 备可食用组合物。 从而发挥该组合物的降血糖、 降血脂、 调节肠道、 减肥美容、 提高免疫 力等功效。 In a third aspect of the invention, the invention provides a method of preparing the above edible composition, the method comprising: mixing a predetermined proportion of inulin, propolis, and chitooligosaccharide, and mixing the resulting mixture The pulverization is carried out to a particle diameter of from 1 to 100 μm to obtain a mixed fine powder; the mixed fine powder is mixed with the imic fruit oil to obtain an edible composition. According to an embodiment of the present invention, before the mixed fine powder is mixed with the imic fruit oil, the ingrown fruit oil is mixed with the soybean oil in advance, and then mixed with the mixed fine powder to obtain an edible composition. Thus, the edible composition can be efficiently prepared by this method. Thereby exerting the composition to lower blood sugar, lower blood fat, regulate intestinal tract, slimming beauty, and improve immunity Force and other effects.
根据本发明的实施例, 上述方法还可以进一步包括将上述可食用组合物中加入任何在 药学上可接受的药用辅料, 并且可以通过常规工艺, 将其制成药剂学上所说的剂型, 例如 硬胶囊、 软胶囊、 片剂、 或颗粒剂由此可以更加方便食用, 进而达到很好的辅助降血糖、 降血脂的作用。  According to an embodiment of the present invention, the above method may further comprise adding any pharmaceutically acceptable pharmaceutical excipient to the above edible composition, and forming it into a pharmaceutically acceptable dosage form by a conventional process. For example, hard capsules, soft capsules, tablets, or granules can be more conveniently consumed, thereby achieving a good auxiliary blood sugar lowering and lowering blood fat.
在本发明的第四个方面, 本发明提出了另一种制备上述的可食用组合物的方法, 其特 征在于, 包括: 将预定比例的菊粉、 印加果粉、 蜂胶、 壳寡糖混合, 并将所得到的混合物 进行粉碎至粒径为 1-100微米之间, 以便得到混合细粉, 所述混合细粉构成所述可食用组合 物。 由此, 利用上述方法可以有效的用于制备一种可以食用组合物, 由此, 利于该组合物 更好的发挥降血糖、 降血脂、 调节肠道、 减肥美容、 提高免疫力等功效。  In a fourth aspect of the present invention, the present invention provides another method of preparing the above edible composition, comprising: mixing a predetermined proportion of inulin, indo-fruit powder, propolis, chitosan oligosaccharide, and The resulting mixture is pulverized to a particle diameter of from 1 to 100 μm to obtain a mixed fine powder constituting the edible composition. Therefore, the above method can be effectively used for preparing an edible composition, thereby facilitating the effect of the composition to lower blood sugar, lower blood fat, regulate intestinal tract, slimming beauty, and improve immunity.
根据本发明的实施例, 上述方法还可以进一步地包括将该可食用组合物进行加工制备 成各种便于食用的剂型, 可以是药学上所说的胶囊、 软胶囊、 片剂、 或颗粒剂等, 制成保 健食品或功能食品、 营养食品、 滋补品等。 由此可以更加方便食用, 进而达到很好的辅助 降血糖、 降血脂的作用。  According to an embodiment of the present invention, the above method may further comprise processing the edible composition into various edible dosage forms, which may be pharmaceutically acceptable capsules, soft capsules, tablets, or granules, etc. , made into health foods or functional foods, nutritious foods, tonics, etc. This makes it easier to eat, and thus achieves a good auxiliary effect of lowering blood sugar and lowering blood fat.
在本发明的第五个方面, 本发明提出了一种食品, 根据本发明的实施例, 该食品包括 前面所述的可食用组合物。 根据本发明的实施例, 该食品的形式并不受特别限制, 只要可 以用于食用即可。 根据本发明的具体示例, 该食品可以呈胶囊剂、 片剂、 冲剂或颗粒剂的 形式。 由此, 便于人食用, 从而提高可食用组合物更有效地改善胃肠道功能和增强人体免 疫力的调节作用。 可以理解, 前面关于可食用组合物特征和优点的描述, 均适用于该食品, 在此不再赘述。  In a fifth aspect of the invention, the invention provides a food product comprising an edible composition as hereinbefore described in accordance with an embodiment of the invention. According to an embodiment of the present invention, the form of the food is not particularly limited as long as it can be used for eating. According to a specific example of the invention, the food product may be in the form of a capsule, a tablet, a granule or a granule. Thereby, it is convenient for human consumption, thereby improving the regulating effect of the edible composition to more effectively improve the function of the gastrointestinal tract and enhance the immunity of the human body. It will be understood that the foregoing description of the features and advantages of the edible compositions applies to the food product and will not be described again.
由此, 本发明所提供的食品可以作为保健食品, 其可以通过常规工艺, 制成药剂学 上所说的胶囊剂、 片剂、 或冲剂。  Thus, the food provided by the present invention can be used as a health food, which can be made into a pharmaceutically acceptable capsule, tablet, or granule by a conventional process.
另外, 本发明所述的由菊粉、 印加果、 蜂胶、 壳寡糖为原料组成的组合物, 本身这四 种物质都具有调节血糖和血脂、 增强免疫的作用, 菊粉、 印加果、 蜂胶、 壳寡糖按上述的 比例合理使用, 显著的起到了各物质彼此间具有的协同增效的作用, 具有极好的降血糖、 降血脂作用。 此外, 还具有调节肠道、 减肥美容祛斑、 提高免疫力等保健功效, 适用于肥 胖型高血糖、 高血脂患者的食用。  In addition, the composition consisting of inulin, inca, propolis and chitosan oligosaccharide as described above has the functions of regulating blood sugar and blood lipids and enhancing immunity, inulin, inca and propolis. The chitosan oligosaccharide is reasonably used according to the above ratio, and remarkablely plays a synergistic effect between the substances, and has an excellent effect of lowering blood sugar and lowering blood fat. In addition, it also has the health effects of regulating intestinal tract, slimming beauty and freckle, improving immunity, and is suitable for consumption of patients with hypertrophic hyperglycemia and hyperlipemia.
另外, 根据本发明的实施例, 由于印加果中含丰富的不饱和脂肪酸, 印加果粉不宜加 热干燥, 故我们在其保健食品的固体形态制剂制备工艺中, 不进行制粒, 而是先将原料经 超细粉碎设备加工粉碎, 再直接与其他辅料混合后压片。 辅料选择淀粉、 糊精、 微晶纤维 素、 微粉硅胶、 硬脂酸镁等, 其中微粉硅胶、 硬脂酸镁用作助流剂。  In addition, according to the embodiment of the present invention, since the Inca fruit is rich in unsaturated fatty acids, the Inca fruit powder is not suitable for heating and drying, so in the preparation process of the solid form preparation of the health food, we do not perform granulation, but firstly It is processed and crushed by ultra-fine pulverizing equipment, and then directly mixed with other auxiliary materials and then pressed. The auxiliary material is selected from the group consisting of starch, dextrin, microcrystalline cellulose, micro-silica gel, magnesium stearate, etc., wherein the micro-powder silica gel and magnesium stearate are used as a glidant.
在本发明的第六个方面, 本发明提出了一种制备食品的方法, 该方法可以包括: 提供 上述的可食用组合物, 其中, 印加果粉、 菊粉、 蜂胶和壳寡糖呈颗粒状; 以及将可食用组 合物进行成型处理, 以便获得该食品。 由此利用该方法可以有效制备得到该食品。 In a sixth aspect of the invention, the invention provides a method of preparing a food product, the method comprising: providing The edible composition described above, wherein the inca fruit powder, the inulin, the propolis, and the chitosan oligosaccharide are in the form of granules; and the edible composition is subjected to a molding treatment to obtain the food. Thus, the food can be efficiently prepared by the method.
根据本发明的一个实施例, 上述颗粒的粒径并不受特别限制, 根据本发明的具体实施 例, 上述粒径可以为 1〜100微米, 由此可以提高制备得到食品的质量, 以便更好的发挥该 食品的调节肠道、 减肥美容祛斑、 提高免疫力等保健功效, 并且利用该方法制备的食品还 可以适用于肥胖型高血糖、 高血脂患者的食用。  According to an embodiment of the present invention, the particle diameter of the above particles is not particularly limited. According to a specific embodiment of the present invention, the particle diameter may be 1 to 100 μm, thereby improving the quality of the prepared food, so as to be better. The food can be used to regulate the intestinal tract, slimming beauty and freckle, improve immunity and other health effects, and the food prepared by the method can also be applied to obese hyperglycemic and hyperlipidemia patients.
根据本发明的一个实施例, 上述成型进一步包括: 将可食用组合物制成胶囊剂、片剂、 冲剂或颗粒剂的形式。 由此更加便于食用, 以便进一步提高该食品的调节肠道、 减肥美容 祛斑、 提高免疫力等保健功效。 根据本发明的具体实施例, 制备上述食品的剂型时可以添 加药学上可以接受的辅料, 例如可以选择淀粉、 糊精、 微晶纤维素、 微粉硅胶、 硬脂酸镁 等, 其中微粉硅胶、 硬脂酸镁用作助流剂。 由此可以更加利于上述剂型食品的制备。  According to an embodiment of the present invention, the above molding further comprises: forming the edible composition into the form of a capsule, a tablet, a granule or a granule. Therefore, it is more convenient to eat, so as to further improve the health effects of regulating the intestinal tract, reducing the beauty and freckle, and improving immunity. According to a specific embodiment of the present invention, a pharmaceutically acceptable auxiliary material may be added when preparing the dosage form of the above food product, for example, starch, dextrin, microcrystalline cellulose, micro-powder silica gel, magnesium stearate, etc. may be selected, wherein the micro-powder silica gel, hard Magnesium citrate is used as a glidant. Thereby, the preparation of the above-mentioned dosage form food can be more advantageous.
根据本发明的实施例, 可以将上述保健食品制备成固体制剂, 具体方法如下: 称取原 料菊粉 3〜15重量份、 印加果粉 5〜25重量份、 蜂胶 5〜15重量份、 壳寡糖 2〜15重量份, 采 用超细粉碎设备加工粉碎, 使得所粉碎的菊粉、 印加果粉、 蜂胶粉、 壳寡糖粉的颗粒粒径 达到 10-150微米之间。 将上述细粉混合均匀, 加入药剂学上常用的辅料, 根据需要, 制备 成最终的片剂、 颗粒剂、 胶囊的保健食品等制剂形态。  According to an embodiment of the present invention, the above-mentioned health food can be prepared into a solid preparation, and the specific method is as follows: 3 to 15 parts by weight of the raw material inulin, 5 to 25 parts by weight of the inoculated fruit powder, 5 to 15 parts by weight of propolis, chitosan oligosaccharide 2 to 15 parts by weight, processed and pulverized by an ultrafine pulverizing apparatus, so that the pulverized inulin, the inulin powder, the propolis powder, and the chitosan oligosaccharide powder have a particle size of 10 to 150 μm. The above fine powder is uniformly mixed, and an auxiliary material which is commonly used in pharmacy is added, and if necessary, it is prepared into a final form of a tablet, a granule, a health food such as a capsule, and the like.
根据本发明的实施例, 还可以将上述保健食品制备成软胶囊(以下简称印加软胶囊), 具体方法如下:  According to an embodiment of the present invention, the above-mentioned health food can also be prepared into a soft capsule (hereinafter referred to as Inka soft capsule), and the specific method is as follows:
1、 称取原料菊粉 3〜15重量份、 蜂胶 5〜15重量份、 壳寡糖 2〜15重量份, 采用超细粉 碎设备加工粉碎, 使得所粉碎的菊粉、 蜂胶粉、 壳寡糖粉的颗粒粒径达到 1-100微米之间, 均质 (均质是食品或化工行业生产中经常要运用的一项技术, 食品加工中的均质就是 指物料的料液在挤压, 强冲击与失压膨胀的三重作用下使物料细化, 从而使物料能更 均匀的相互混合, 均质主要通过均质机来进行) 得混合细粉, 备用;  1. Weigh 3 to 15 parts by weight of raw material inulin, 5 to 15 parts by weight of propolis, 2 to 15 parts by weight of chitosan oligosaccharide, and pulverize with ultrafine pulverizing equipment to make pulverized inulin, propolis powder and chitooligosaccharide The particle size of the powder reaches between 1 and 100 microns, and homogenization (homogeneity is a technique often used in the production of food or chemical industry. The homogenization in food processing means that the material of the material is squeezed, strong Under the triple action of impact and pressure loss expansion, the material is refined, so that the materials can be more evenly mixed with each other, and the homogenization is mainly carried out by a homogenizer) to obtain a fine powder and reserve;
2、 称取印加果油 2〜10重量份, 大豆油 2〜10重量份, 置于配料罐中, 匀速搅拌, 并加 入上述步骤 (1 ) 得到的细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完后抽 真空脱尽气泡, 制成内容物料, 待用;  2. Weigh 2~10 parts by weight of Inca fruit oil, 2~10 parts by weight of soybean oil, put in the batching tank, stir at a constant speed, add the fine powder obtained in the above step (1), stir for 30 minutes, mix the liquid Grinding and grinding three times, after the grinding, vacuuming and removing the air bubbles, making the content material, ready for use;
3、 将内容物料液置于软胶囊压丸机中, 按照现有软胶囊生产技术填充压制成软胶囊。 产品名称: 印加软胶囊  3. The content material liquid is placed in a soft capsule press machine, and filled into soft capsules according to the existing soft capsule production technology. Product Name: Inca Soft Capsules
保健功能: 辅助降血糖、 辅助降血脂  Health care function: assist in lowering blood sugar, assisting blood fat reduction
适宜人群: 血糖偏高者、 血脂偏高者; 不适宜人群: 少年儿童  Suitable for people: those with high blood sugar and high blood lipids; unsuitable people: children
食用方法及食用量: 每日 2次, 每次 2-3粒, 温开水送食  How to eat and the amount of food: 2 times a day, 2-3 capsules each time, warm water to feed
产品规格: l .Og/粒; 保质期: 24个月; 贮藏方法: 密封, 置阴凉干燥处 注意事项: 本品不能代替药物; 蜂产品过敏者慎用 Product specifications: l .Og / grain; Shelf life: 24 months; Storage method: sealed, placed in a cool dry place Note: This product is not a substitute for drugs;
本发明所述的组合物经急性毒性试验证明安全无毒, 符合保健食品的要求和发展趋势。 在本发明的第六个方面, 本发明提出了上述可食用组合物在制备制剂中的用途。 根据 本发明的具体实施例, 利用上述可食用组合物可以制备任意便于食用的制剂, 例如可以制 成药剂学上所说的剂型, 例如硬胶囊、 软胶囊、 片剂、 或颗粒剂。 根据本发明的具体实施 例, 上述制剂可以用于降血糖、 降血脂、 美容祛斑、 治疗便秘和肥胖。 由此, 可以通过利 用上述可食用组合物制备剂型用于发挥其降血糖、 降血脂、 美容祛斑、 治疗便秘和肥胖等 功效。  The composition of the present invention proves to be safe and non-toxic by the acute toxicity test, and meets the requirements and development trends of health foods. In a sixth aspect of the invention, the invention provides the use of the above edible composition in the preparation of a formulation. According to a specific embodiment of the present invention, any edible composition can be prepared by using the above edible composition, for example, a pharmaceutically acceptable dosage form such as a hard capsule, a soft capsule, a tablet, or a granule can be prepared. According to a specific embodiment of the present invention, the above preparation can be used for blood sugar lowering, blood fat lowering, beauty ecchymosis, treatment of constipation and obesity. Thus, it is possible to prepare a dosage form by using the above edible composition for exerting effects such as blood sugar lowering, blood fat lowering, beauty freckle, constipation and obesity.
本发明所述的组合物, 能非常显著的降低小鼠实验性糖尿病的高血糖, 相对于单一的 印加果、 蜂胶以及蜂胶 +壳寡糖的组合, 本发明的组合物比在降低实验小鼠血糖方面的作用 效果更佳, 本发明组合物中的菊粉、 印加果油、 蜂胶、 壳寡糖具有协同作用。  The composition of the present invention can significantly reduce the hyperglycemia of experimental diabetic diabetes in mice, and the composition of the present invention is lower than the experimental mice in comparison with a single combination of inca, propolis and propolis + chitooligosaccharide The effect of blood sugar is more effective, and the inulin, inca fruit oil, propolis, and chitosan oligosaccharide in the composition of the present invention have a synergistic effect.
本发明所述的组合物, 能非常显著的降低血液中的血清总胆固醇、 甘油三酯的含量, 增加高密度脂蛋白的水平, 而且降血脂的作用优于印加果油及南美油藤软胶囊。  The composition of the invention can significantly reduce the serum total cholesterol and triglyceride content in the blood, increase the level of high density lipoprotein, and the effect of lowering blood fat is better than the Inca fruit oil and the South American vine soft capsule. .
根据本发明的实施例, 人体试食实验也证实了本发明具有明显的辅助降血糖、 降血脂 的作用, 以及改善胃肠道功能, 润肠通便、 防治便秘的作用, 以及美容祛斑、 减肥方面的 保健功能。 故本发明的组合物特别适用于肥胖型高血糖、 高血脂患者的食用。  According to an embodiment of the present invention, the human body experiment also proves that the invention has obvious effects of assisting blood sugar lowering, lowering blood fat, improving gastrointestinal function, laxative, preventing constipation, and reducing freckles and weight loss. Aspects of health care functions. Therefore, the composition of the present invention is particularly suitable for consumption by obese hyperglycemic and hyperlipidemia patients.
本发明的有益效果在于:  The beneficial effects of the invention are:
1、 本发明所述的组合物, 所有原料取于自然、 源于天然, 且不含任何化学制剂, 无毒 副作用、 安全可靠; 原料来源广泛易得, 组方配伍科学合理, 疗效确切, 具有协同增效作 用; 且制备工艺简单, 贮运和应用安全, 生产成本低廉, 易被消费者接受。  1. The composition of the present invention, all raw materials are taken from nature, originated from nature, and do not contain any chemical preparations, have no toxic and side effects, are safe and reliable; the sources of raw materials are widely available, and the compatibility of the prescriptions is scientific and reasonable, and the curative effect is exact. Synergistic effect; and the preparation process is simple, the storage and transportation and application are safe, the production cost is low, and it is easy to be accepted by consumers.
2、 本发明组方经过动物功能试验和人群食用试验都证明无任何毒副作用, 有显著的降 血糖、 降血脂、 调节肠道、减肥美容、 提高免疫力等作用, 符合保健品的要求和发展趋势。 本发明的组合物能非常显著的降低血液中的血清总胆固醇、 甘油三酯的含量, 增加高密度 脂蛋白的水平; 在调节血糖方面, 可使病人病人空腹血糖显著下降。此组合物适于高血糖、 高血脂、 肥胖人群以及老年人群等, 通过日常服用, 从治本的角度出发, 通过改善脂质代 谢、 改善血流、 提高人体免疫力等, 最终达到保护健康的目的。  2. The composition of the invention has proved that it has no toxic and side effects after animal function test and human consumption test, and has significant effects of lowering blood sugar, lowering blood fat, regulating intestinal tract, slimming beauty, improving immunity, etc., in line with the requirements and development of health care products. trend. The composition of the present invention can significantly reduce the serum total cholesterol and triglyceride levels in the blood, and increase the level of high-density lipoprotein; in regulating blood sugar, the patient's fasting blood glucose can be significantly decreased. This composition is suitable for hyperglycemia, hyperlipidemia, obesity, and the elderly. By daily taking, from the perspective of curing, it can improve the lipid metabolism, improve blood flow, improve human immunity, and ultimately achieve health protection. .
3、 本发明经过超细粉碎设备加工粉碎, 使得菊粉、 蜂胶、 壳寡糖原料达到微粉化, 更 有利于人体吸收; 而且由于菊粉具有的低热量、 水溶性等特性以及增强双歧杆菌增殖、 降 低血糖血脂、 恢复胃肠功能、 增强钙质吸收等诸多功效, 故本发明的组合物特别适用于肥 胖型高血糖、 高血脂患者的食用。  3. The invention is processed and pulverized by ultra-fine pulverizing equipment, so that the inulin, propolis and chitosan oligosaccharide raw materials are micronized, which is more beneficial to human body absorption; and because of the low calorie and water solubility characteristics of the inulin, and the enhancement of Bifidobacterium The composition of the present invention is particularly suitable for consumption by obese hyperglycemic and hyperlipidemia patients, such as proliferating, lowering blood sugar and blood lipids, restoring gastrointestinal function, enhancing calcium absorption and the like.
4、 本发明通过对纯天然原料的合理组配, 实现了便捷的、 显著的降血糖、 降血脂等保 健功效, 药效明显、 安全性好, 质量稳定, 产品可长期保存, 为人们日常保健提供了新的 选择。 4. The invention realizes convenient and remarkable blood sugar lowering and blood fat lowering health effects through reasonable combination of pure natural raw materials, obvious drug effect, good safety, stable quality, long-term preservation of products, and daily health care for people. Provided new Choose.
具体实施方式  detailed description
下面实施例是对本发明的进一步说明,而不是限制本发明的保护范围。需要说明的是, 除非明确指出, 下面实施例中所采用的原材料均为市售可得的。  The following examples are intended to further illustrate the invention and are not intended to limit the scope of the invention. It should be noted that the raw materials used in the following examples are commercially available unless explicitly stated.
表 1 本发明所述实施例 1-12的食品配方 (原料的重量单位: 重量份)  Table 1 Food Formulations of Examples 1 to 12 of the Invention (Unit of Weight of Raw Materials: Parts by Weight)
Figure imgf000008_0001
Figure imgf000008_0001
本发明所述的保健食品各组分按上表用量, 通过常规工艺, 可以制成药剂学上所说的 软胶囊剂、 片剂、 胶囊或颗粒剂。 具体的制备方法见各实施例。 菊粉  The components of the health food according to the present invention can be prepared into pharmaceutically acceptable soft capsules, tablets, capsules or granules according to the above-mentioned dosages by conventional techniques. The specific preparation methods are shown in the respective examples. Inulin
印加果油  Inca fruit oil
蜂胶  Propolis
壳寡糖  Chitooligosaccharide
大豆油 加工粉碎, 使得所粉碎的菊粉、 蜂胶粉、 壳寡糖粉的颗粒粒径为 50微米的细粉, 均质成混 合细粉, 备用; 称取印加果油 6重量份, 大豆油 4重量份, 置于配料罐中, 匀速搅拌, 并 加入上述步骤 (1 ) 得到的细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完后 抽真空脱尽气泡, 制成内容物料, 待用; 最后将内容物料液置于软胶囊压丸机中, 按照现 有软胶囊生产技术填充压制成软胶囊。 Soybean oil Processing and pulverizing, so that the fine powder of the pulverized inulin, propolis powder and chitosan oligosaccharide powder having a particle size of 50 μm is homogenized into a mixed fine powder, and ready for use; 6 parts by weight of the indica oil is weighed, and 4 parts of the soybean oil is weighed. Serve in a batching tank, stir at a constant speed, and add the fine powder obtained in the above step (1), stir for 30 minutes, mix the liquid after mixing, grind and grind three times, and then vacuum to remove the bubbles. Material, ready to use; Finally, the content material liquid is placed in a soft capsule press machine, and filled into soft capsules according to the existing soft capsule production technology.
实施例 2: 组合物软胶囊  Example 2: Soft capsule of composition
菊粉 3重量份  Inulin 3 parts by weight
印加果油 2重量份  Inca fruit oil 2 parts by weight
蜂胶 5重量份  Propolis 5 parts by weight
壳寡糖 5重量份  Chitooligosaccharide 5 parts by weight
大豆油 10重量份  Soybean oil 10 parts by weight
制备方法: 称取菊粉 3重量份、 蜂胶 5重量份、 壳寡糖 5重量份, 采用超细粉碎设备 加工粉碎, 使得所粉碎的菊粉、 蜂胶粉、 壳寡糖粉的颗粒粒径为 10微米的细粉, 均质成混 合细粉, 备用; 称取印加果油 2重量份, 大豆油 10重量份, 置于配料罐中, 匀速搅拌, 并 加入上述步骤 (1 ) 得到的细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完后 抽真空脱尽气泡, 制成内容物料, 待用; 最后将内容物料液置于软胶囊压丸机中, 按照现 有软胶囊生产技术填充压制成软胶囊。  Preparation method: weighing 3 parts by weight of inulin, 5 parts by weight of propolis, and 5 parts by weight of chitosan oligosaccharide, and pulverizing by using ultrafine pulverizing equipment, so that the particle size of the pulverized inulin, propolis powder and chitosan oligosaccharide powder is 10 micron fine powder, homogenized into mixed fine powder, spare; weigh 2 parts by weight of inca fruit oil, 10 parts by weight of soybean oil, put in the batching tank, stir at a constant speed, and add the fine powder obtained in the above step (1) After stirring for 30 minutes, the mixture of materials and liquid is ground and grinded three times. After the grinding, the vacuum is removed to remove the bubbles, and the content is prepared for use. Finally, the content liquid is placed in the soft capsule press machine, according to the existing Soft capsule production technology is filled into soft capsules.
实施例 3: 组合物软胶囊  Example 3: Soft capsule of composition
菊粉 15重量份  Inulin 15 parts by weight
印加果油 10重量份  Inca fruit oil 10 parts by weight
蜂胶 15重量份  Propolis 15 parts by weight
壳寡糖 15重量份  Chitooligosaccharide 15 parts by weight
大豆油 2重量份  Soybean oil 2 parts by weight
制备方法: 称取菊粉 15重量份、 蜂胶 15重量份、 壳寡糖 15重量份, 采用超细粉碎设 备加工粉碎, 使得所粉碎的菊粉、 蜂胶粉、 壳寡糖粉的颗粒粒径为 50微米的细粉, 均质成 混合细粉, 备用; 称取印加果油 10重量份, 大豆油 2重量份, 置于配料罐中, 匀速搅拌, 并加入上述步骤 (1 ) 得到的细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完 后抽真空脱尽气泡, 制成内容物料, 待用; 最后将内容物料液置于软胶囊压丸机中, 按照 现有软胶囊生产技术填充压制成软胶囊。  Preparation method: 15 parts by weight of inulin, 15 parts by weight of propolis, 15 parts by weight of chitosan oligosaccharide, and processed and pulverized by ultrafine pulverizing equipment, so that the particle size of the pulverized inulin, propolis powder and chitosan oligosaccharide powder is 50 micron fine powder, homogenized into mixed fine powder, spare; weigh 10 parts by weight of indica oil, 2 parts by weight of soybean oil, put in the batching tank, stir at a constant speed, and add the fine powder obtained in the above step (1) After stirring for 30 minutes, the mixture of materials and liquid is ground and grinded three times. After the grinding, the vacuum is removed to remove the bubbles, and the content is prepared for use. Finally, the content liquid is placed in the soft capsule press machine, according to the existing Soft capsule production technology is filled into soft capsules.
实施例 4: 组合物软胶囊  Example 4: Soft capsule of composition
菊粉 5重量份  Inulin 5 parts by weight
印加果油 4重量份 蜂胶 6重量份 Ingredients 4 parts by weight Propolis 6 parts by weight
壳寡糖 5重量份  Chitooligosaccharide 5 parts by weight
大豆油 8重量份  Soybean oil 8 parts by weight
制备方法: 称取菊粉 5重量份、 蜂胶 6重量份、 壳寡糖 5重量份, 采用超细粉碎设备 加工粉碎, 使得所粉碎的菊粉、 蜂胶粉、 壳寡糖粉的颗粒粒径为 20微米的细粉, 均质成混 合细粉, 备用; 称取印加果油 4重量份, 大豆油 8重量份, 置于配料罐中, 匀速搅拌, 并 加入上述步骤 (1 ) 得到的细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完后 抽真空脱尽气泡, 制成内容物料, 待用; 最后将内容物料液置于软胶囊压丸机中, 按照现 有软胶囊生产技术填充压制成软胶囊。  Preparation method: 5 parts by weight of inulin, 6 parts by weight of propolis, and 5 parts by weight of chitooligosaccharide are weighed and processed by ultrafine pulverizing equipment, so that the particle size of the pulverized inulin, propolis powder and chitosan oligosaccharide powder is 20 micron fine powder, homogenized into mixed fine powder, spare; weigh 4 parts by weight of inca fruit oil, 8 parts by weight of soybean oil, put in the batching tank, stir at a constant speed, and add the fine powder obtained in the above step (1) After stirring for 30 minutes, the mixture of materials and liquid is ground and grinded three times. After the grinding, the vacuum is removed to remove the bubbles, and the content is prepared for use. Finally, the content liquid is placed in the soft capsule press machine, according to the existing Soft capsule production technology is filled into soft capsules.
实施例 5: 组合物软胶囊  Example 5: Softgel of composition
菊粉 12重量份  Inulin 12 parts by weight
印加果油 8重量份  Inca fruit oil 8 parts by weight
蜂胶 10重量份  Propolis 10 parts by weight
壳寡糖 10重量份  Chitooligosaccharide 10 parts by weight
大豆油 4重量份  Soybean oil 4 parts by weight
制备方法: 称取菊粉 12重量份、 蜂胶 10重量份、 壳寡糖 10重量份, 采用超细粉碎设 备加工粉碎, 使得所粉碎的菊粉、 蜂胶粉、 壳寡糖粉的颗粒粒径为 8微米的细粉, 均质成 混合细粉, 备用; 称取印加果油 8重量份, 大豆油 4重量份, 置于配料罐中, 匀速搅拌, 并加入上述步骤 (1 ) 得到的细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完 后抽真空脱尽气泡, 制成内容物料, 待用; 最后将内容物料液置于软胶囊压丸机中, 按照 现有软胶囊生产技术填充压制成软胶囊。  Preparation method: Weigh 12 parts by weight of inulin, 10 parts by weight of propolis, and 10 parts by weight of chitosan oligosaccharide, and pulverize by using ultrafine pulverizing equipment, so that the particle size of the pulverized inulin, propolis powder and chitosan oligosaccharide powder is 8 micron fine powder, homogenized into mixed fine powder, spare; weigh 8 parts by weight of inca fruit oil, 4 parts by weight of soybean oil, put in the batching tank, stir at a constant speed, and add the fine powder obtained in the above step (1) After stirring for 30 minutes, the mixture of materials and liquid is ground and grinded three times. After the grinding, the vacuum is removed to remove the bubbles, and the content is prepared for use. Finally, the content liquid is placed in the soft capsule press machine, according to the existing Soft capsule production technology is filled into soft capsules.
实施例 6: 组合物软胶囊  Example 6: Soft capsule of composition
菊粉 10重量份  Inulin 10 parts by weight
印加果油 8重量份  Inca fruit oil 8 parts by weight
蜂胶 9重量份  Propolis 9 parts by weight
壳寡糖 5重量份  Chitooligosaccharide 5 parts by weight
大豆油 6重量份  Soybean oil 6 parts by weight
制备方法: 称取菊粉 10重量份、 蜂胶 9重量份、 壳寡糖 5重量份, 采用超细粉碎设备 加工粉碎, 使得所粉碎的菊粉、 蜂胶粉、 壳寡糖粉的颗粒粒径为 50微米的细粉, 均质成混 合细粉, 备用; 称取印加果油 8重量份, 大豆油 6重量份, 置于配料罐中, 匀速搅拌, 并 加入上述步骤 (1 ) 得到的细粉, 搅拌 30分钟, 料液混合后置胶体磨碾磨三次, 研磨完后 抽真空脱尽气泡, 制成内容物料, 待用; 最后将内容物料液置于软胶囊压丸机中, 按照现 例 7: 组合物片剂 印加果粉 20重量份 Preparation method: Weigh 10 parts by weight of inulin, 9 parts by weight of propolis, and 5 parts by weight of chitosan oligosaccharide, and pulverize by using ultrafine pulverizing equipment, so that the particle size of the pulverized inulin, propolis powder and chitosan oligosaccharide powder is 50 micron fine powder, homogenized into mixed fine powder, spare; weigh 8 parts by weight of inca fruit oil, 6 parts by weight of soybean oil, put in the batching tank, stir at a constant speed, and add the fine powder obtained in the above step (1) Stir for 30 minutes, mix the liquid mixture and grind it for three times. After the grinding, vacuum the air to remove the air bubbles to make the content material, and use it. Finally, place the content material in the soft capsule pressure pill machine. Example 7: Composition tablet printing plus fruit powder 20 parts by weight
蜂胶 10重量份  Propolis 10 parts by weight
8重量份  8 parts by weight
淀粉 30重量份  Starch 30 parts by weight
微晶纤维素 10重量份  Microcrystalline cellulose 10 parts by weight
硬脂酸镁 1重量份  Magnesium stearate 1 part by weight
制备方法: 称取原料菊粉 6重量份、 印加果粉 20重量份、 蜂胶 10重量份、 壳寡糖 8 重量份, 采用超细粉碎设备加工粉碎, 使得所粉碎的菊粉、 印加果粉、 蜂胶粉、 壳寡糖粉 的颗粒粒径为 60微米的混合细粉。 将上述细粉混合均匀, 加入淀粉、 微晶纤维素、 硬脂酸 按照现有片剂压片生产技术压制成片剂。  Preparation method: weighing 6 parts by weight of raw material inulin, 20 parts by weight of ino fruit powder, 10 parts by weight of propolis, and 8 parts by weight of chitosan oligosaccharide, and pulverizing by using ultrafine pulverizing equipment to make pulverized inulin, inca fruit powder and propolis powder The chitosan oligosaccharide powder has a particle size of 60 μm mixed fine powder. The above fine powder is uniformly mixed, and starch, microcrystalline cellulose, and stearic acid are added and compressed into tablets according to the existing tablet tablet production technique.
实施例 8: 组合物胶  Example 8: Composition Glue
菊粉 8重量份  Inulin 8 parts by weight
印加果粉 15重量份  Inca fruit powder 15 parts by weight
蜂胶 8重量份  Propolis 8 parts by weight
8重量份  8 parts by weight
30重量份 30 parts by weight
Figure imgf000011_0001
1重量份
Figure imgf000011_0001
1 part by weight
制备方法: 称取原料菊粉 8重量份、 印加果粉 15重量份、 蜂胶 8重量份、 壳寡糖 8重 量份, 采用超细粉碎设备加工粉碎, 使得所粉碎的菊粉、 印加果粉、 蜂胶粉、 壳寡糖粉的 颗粒粒径为 30微米的混合细粉。 将上述细粉混合均匀, 加入淀粉、 微粉硅胶, 按照现有胶 囊生产技术灌装成胶囊。  Preparation method: Weigh 8 parts by weight of raw material inulin, 15 parts by weight of Inca fruit powder, 8 parts by weight of propolis, and 8 parts by weight of chitosan oligosaccharide, and pulverize by using ultrafine pulverizing equipment to make pulverized inulin, Inca fruit powder and propolis powder The chitosan oligosaccharide powder has a particle size of 30 μm mixed fine powder. The above fine powder is uniformly mixed, starch and microsilica gel are added, and the capsule is filled according to the existing capsule production technology.
实施例 9: 组合物颗粒剂  Example 9: Composition granules
菊粉 3重 t份  Inulin 3 heavy t
印加果粉 t份  Inca fruit powder t
蜂胶 t份  Propolis
2重 t份  2 heavy t
25重量份 25 parts by weight
Figure imgf000011_0002
0.5重量份
Figure imgf000011_0002
0.5 parts by weight
制备方法: 称取原料菊粉 3重量份、 印加果粉 5重量份、 蜂胶 5重量份、 壳寡糖 2重 量份, 采用超细粉碎设备加工粉碎, 使得所粉碎的菊粉、 印加果粉、 蜂胶粉、 壳寡糖粉的 颗粒粒径为 80微米的混合细粉。 将上述细粉混合均匀, 加入糊精、 微粉硅胶, 按照现有颗 粒剂生产技术装袋成颗粒剂。 Preparation method: weigh 3 parts by weight of raw material inulin, 5 parts by weight of Inca fruit powder, 5 parts by weight of propolis, 2 weight of chitooligosaccharide The parts are processed and pulverized by an ultrafine pulverizing apparatus, so that the pulverized inulin, the inulin powder, the propolis powder, and the chitosan oligosaccharide powder have a particle size of 80 μm. The above fine powder is uniformly mixed, dextrin and microsilica gel are added, and the granules are bagged according to the existing granule production technology.
实施例 10: 组合物颗粒剂  Example 10: Composition granules
15重量份  15 parts by weight
印加果粉 10重量份  Inca fruit powder 10 parts by weight
蜂胶 15重量份  Propolis 15 parts by weight
15重量份  15 parts by weight
50重量份  50 parts by weight
20重量份 20 parts by weight
Figure imgf000012_0001
1重量份
Figure imgf000012_0001
1 part by weight
制备方法: 称取原料菊粉 15重量份、 印加果粉 10重量份、 蜂胶 15重量份、 壳寡糖 15 重量份, 采用超细粉碎设备加工粉碎, 使得所粉碎的菊粉、 印加果粉、 蜂胶粉、 壳寡糖粉 的颗粒粒径为 100微米的混合细粉。 将上述细粉混合均匀, 加入淀粉、 微晶纤维素、 微粉 硅胶, 按照现有颗粒剂生产技术装袋成颗粒剂 (印加颗粒剂) 。  Preparation method: Weigh 15 parts by weight of raw material inulin, 10 parts by weight of Inca fruit powder, 15 parts by weight of propolis, 15 parts by weight of chitosan oligosaccharide, and pulverize by using ultrafine pulverizing equipment to make pulverized inulin, Inca fruit powder and propolis powder The chitosan oligosaccharide powder has a particle size of 100 μm mixed fine powder. The above fine powder is uniformly mixed, and starch, microcrystalline cellulose, and micronized silica gel are added, and the granules (indo granules) are bagged according to the existing granule production technology.
实施例 11 : 组合物片剂  Example 11: Composition Tablet
菊粉 12重量份  Inulin 12 parts by weight
印加果粉 20重量份  Inca fruit powder 20 parts by weight
蜂胶 10重量份  Propolis 10 parts by weight
10重量份  10 parts by weight
糊精 50重量份  Dextrin 50 parts by weight
微晶纤维素 15重量份  Microcrystalline cellulose 15 parts by weight
微粉硅胶 1重量份  Micronized silica gel 1 part by weight
制备方法: 称取原料菊粉 12重量份、 印加果粉 20重量份、 蜂胶 10重量份、 壳寡糖 10 重量份, 采用超细粉碎设备加工粉碎, 使得所粉碎的菊粉、 印加果粉、 蜂胶粉、 壳寡糖粉 的颗粒粒径为 1 微米的混合细粉。 将上述细粉混合均匀, 加入糊精、 微晶纤维素、 微粉硅 胶, 按照现有片剂压片生产技术压制成片剂。  Preparation method: Weigh 12 parts by weight of raw material inulin, 20 parts by weight of Inca fruit powder, 10 parts by weight of propolis, and 10 parts by weight of chitosan oligosaccharide, and pulverize by using ultrafine pulverizing equipment to make pulverized inulin, Inca fruit powder and propolis powder The chitosan oligosaccharide powder has a particle size of 1 micron mixed fine powder. The above fine powder was uniformly mixed, and dextrin, microcrystalline cellulose, and micronized silica gel were added, and the tablets were compressed according to the existing tablet tablet production technology.
实施例 12: 组合物胶囊  Example 12: Composition capsule
菊粉 5重量份  Inulin 5 parts by weight
印加果粉 10重量份  Inca fruit powder 10 parts by weight
蜂胶 6重量份  Propolis 6 parts by weight
5重量份 淀粉 30重量份 5 parts by weight 30 parts by weight of starch
微粉硅胶 0.5重量份  Micronized silica gel 0.5 parts by weight
制备方法: 称取原料菊粉 5重量份、 印加果粉 10重量份、 蜂胶 6重量份、 壳寡糖 5重 量份, 采用超细粉碎设备加工粉碎, 使得所粉碎的菊粉、 印加果粉、 蜂胶粉、 壳寡糖粉的 颗粒粒径为 50微米的混合细粉。 将上述细粉混合均匀, 加入淀粉、 微粉硅胶, 按照现有胶 囊生产技术灌装成胶囊。  Preparation method: weigh 5 parts by weight of raw material inulin, 10 parts by weight of ino fruit powder, 6 parts by weight of propolis, and 5 parts by weight of chitosan oligosaccharide, which are processed and crushed by ultrafine pulverizing equipment to make pulverized inulin, inca fruit powder and propolis powder The chitosan oligosaccharide powder has a particle size of 50 μm mixed fine powder. The above fine powder is uniformly mixed, starch and microsilica gel are added, and the capsule is filled according to the existing capsule production technology.
实施例 13: 降血糖动物实验  Example 13: Blood glucose lowering animal experiment
将实施例 1 所得软胶囊按照卫生部 《保健食品检验与评价技术规范 (2003年) 》 的辅 助降血糖功能动物实验评价办法进行评价。  The soft capsule obtained in Example 1 was evaluated in accordance with the experimental evaluation method of the auxiliary hypoglycemic functional animal of the Ministry of Health's "Technical Specification for Health Food Inspection and Evaluation (2003)".
1、 试验方法: 取雄性 SD 大鼠 60只, 按照标准方法制备小剂量链佐菌素致糖尿病大 鼠模型, 三日后根据大鼠血糖值随机分为 6组, 每组 10只。 各组连续灌胃给药 8天, 每日 1次, 空白组给予等量蒸馏水, 最后一次给药后两小时取血, 测定血糖值。  1. Test method: 60 male Sprague-Dawley rats were used to prepare a small-dose streptavidin-induced diabetic rat model according to the standard method. Three days later, the blood glucose levels of the rats were randomly divided into 6 groups, 10 in each group. Each group was administered by continuous intragastric administration for 8 days, once a day. The blank group was given the same amount of distilled water, and blood was taken two hours after the last administration, and the blood glucose level was measured.
2、 试验对象:  2. Test object:
空白组: 给予蒸馏水;  Blank group: Give distilled water;
对照 1组: 给予二甲双胍 300mg/kg;  Control group 1: Metformin 300 mg/kg;
对照 2组: 给予印加果油 300mg/kg;  Control group 2: Indica oil 300mg/kg;
对照 3组: 给予蜂胶软胶囊 (国食健字 G20060790, 北京同仁堂健康药业股份有限公 司, 保健功能: 辅助降血糖, 主要原料: 蜂胶) 300mg/kg;  Control group 3: Propolis soft capsules were given (Guo Shi Jian Zi G20060790, Beijing Tongrentang Health Pharmaceutical Co., Ltd., health function: auxiliary blood sugar lowering, main raw material: propolis) 300mg/kg;
对照 4组: 给予蜂胶壳寡糖胶囊 (国食健字 G20120038, 山东科尔生物医药科技开发 有限公司, 保健功能: 辅助降血糖, 主要原料: 蜂胶乙醇提取物、 壳寡糖) 300mg/kg; 本实施例的组合物组: 给予印加软胶囊 300mg/kg。  Control group 4: Giving propolis shell oligosaccharide capsules (Guo Shi Jian Zi G20120038, Shandong Keer Biomedical Technology Development Co., Ltd., health care function: auxiliary blood sugar lowering, main raw materials: propolis ethanol extract, chitosan oligosaccharide) 300mg/kg; Composition group of the present example: Inka soft capsules were administered at 300 mg/kg.
3、 实验结果: 不同实验组降血糖的结果如表 2所示。  3. Experimental results: The results of hypoglycemia in different experimental groups are shown in Table 2.
表 2 不同实验组降血糖效果比较  Table 2 Comparison of hypoglycemic effects in different experimental groups
空腹血糖 (mmol/L)  Fasting blood glucose (mmol/L)
动物数 (只)  Number of animals (only)
给药前 给药后 空白组 10 15.3±1.8 14.2±1.3 对照 1组 10 15.4±2.0 9.4±1.4* 对照 2组 10 15.4±1.8 12.8±2.3Δ 对照 3组 10 15.3±2.0 11.5±1.8Δ 对照 4组 10 15.4±2.1 10.7±1.9Δ 本发明组合物组 10 15.4±1.9 9.6±1.6* Blank group after administration before administration 15.3±1.8 14.2±1.3 Control group 1 10 15.4±2.0 9.4±1.4* Control group 2 10 15.4±1.8 12.8±2.3 Δ control group 3 10 15.3±2.0 11.5±1.8 Δ control 4 Group 10 15.4 ± 2.1 10.7 ± 1.9 Δ composition group 10 of the invention 15.4 ± 1.9 9.6 ± 1.6 *
( 1 ) 与空白组比较 *Ρ<0.01 ; (2) 与空白组比较 ΔΡ<0.05 从表 2的动物试验结果表明, 对照 1组、 对照 2组、 对照 3组、 对照 4组以及本发明 所述的组合物组对小鼠实验性糖尿病的高血糖均具有下降作用, 本发明所述的组合物、 以 及二甲双胍对小鼠实验性糖尿病的高血糖具有极其显著的下降作用, 显示该组合物具有降 血糖的功能, 相对于单一的印加果、 蜂胶以及蜂胶 +壳寡糖的组合, 本发明的组合物比在降 低实验小鼠血糖方面的作用效果更佳, 说明本发明组合物中的菊粉、 印加果油、 蜂胶、 壳 寡糖具有协同作用, 本发明具有明显的技术优势, 具有显著的辅助治疗作用。 (1) Compared with the blank group *Ρ<0.01; (2) Compared with the blank group Δ Ρ<0.05 From the animal test results of Table 2, the control group 1 , the control 2 group, the control 3 group, the control 4 group, and the composition group of the present invention have a decreasing effect on hyperglycemia of experimental diabetic diabetes in mice, and the present invention The compositions described, as well as metformin, have an extremely significant decrease in hyperglycemia in experimental diabetic mice, indicating that the composition has a hypoglycemic function relative to a single combination of inca, propolis, and propolis + chitooligosaccharide. The composition of the present invention has a better effect than lowering the blood sugar of the experimental mouse, indicating that the inulin, the ingrown fruit oil, the propolis, and the chitosan oligosaccharide in the composition of the present invention have synergistic effects, and the present invention has obvious technical advantages. Has a significant adjuvant treatment.
实施例 14: 降血脂动物实验  Example 14: Blood lipid lowering animal experiment
将实施例 1制备得到的软胶囊按照卫生部《保健食品检验与评价技术规范(2003年)》 的辅助降血脂功能动物实验评价办法进行评价。  The soft capsule prepared in Example 1 was evaluated according to the experimental evaluation method of the auxiliary hypolipidemic functional animal of the Ministry of Health's "Technical Specification for Health Food Inspection and Evaluation (2003)".
1、 试验材料及方法:  1. Test materials and methods:
Wistar雄性大鼠 60只, 体重 200±20g, 由武汉大学实验动物中心提供。 诱发大鼠高血 脂症病理模型配方(高脂伺料) : 基础伺料中加入 1 %胆固醇, 10%蛋黄, 10%猪油, 烘干 成块。 本发明所述的实验样品软胶囊由武汉华大药业有限公司提供, 按本发明的实施例 1 制备得到 (以下简称印加软胶囊) 。  Sixty Wistar male rats weighing 200±20 g were provided by Experimental Animal Center of Wuhan University. Induced rat hyperlipidemia pathological model formula (high fat feeding): 1% cholesterol, 10% egg yolk, 10% lard, and dried into a block. The experimental sample soft capsule of the present invention is provided by Wuhan Huada Pharmaceutical Co., Ltd., and is prepared according to Example 1 of the present invention (hereinafter referred to as Inca Soft Capsule).
高脂血症模型大鼠的制备方法: 将 Wistar雄性大鼠随机分为 6组 (每组 10只), 即高血 脂大鼠 (高血脂症模型对照组) , 伺喂高脂伺料(高脂伺料配方为基础伺料 93.8%、 胆固醇 1.0%、 猪油 5.0%、 胆盐 0.2%) , 不给于受试物;  Preparation of hyperlipidemia model rats: Wistar male rats were randomly divided into 6 groups (10 in each group), namely hyperlipidemic rats (hyperlipidemia model control group), and served with high-fat diet (high The fat-feeding formula is based on 93.8%, cholesterol 1.0%, lard 5.0%, bile salt 0.2%), and is not given to the test substance;
给药方法:  Method of administration:
各组大鼠均喂以高脂伺料, 在此基础上, 对照 1组: 给予印加果油 200mg/kg;  Rats in each group were fed with high-fat diet. On the basis of this, control group 1 was given 200 mg/kg of Inca fruit oil;
印加软胶囊的低、 中、 高三个剂量组、 以及对照 2组的南美油藤软胶囊组 (其软胶囊 按中国专利 CN 101999652A公开的实施例 1制备得到),均连续 20天灌胃该胶囊的内容物, 每日 1次, 剂量为: 实验样品低剂量组给予印加软胶囊 100mg/kg, 实验样品中剂量组给予 印加软胶囊 200mg/kg, 实验样品高剂量组给予印加软胶囊 400mg/kg, 对照 2组给予南美油 藤软胶囊 200mg/kg。  The low-, medium-, and high-dose groups of Inca soft capsules and the control group 2 of the South American vine soft capsule group (the soft capsules are prepared according to Example 1 disclosed in Chinese Patent No. CN 101999652A), and the capsules are administered for 20 consecutive days. The contents, once a day, the dosage is: the low dose group of the experimental sample is given 100mg/kg of Inka soft capsule, the middle dose of the experimental sample is 200mg/kg of Inca soft capsule, and the high dose group of the experimental sample is given 400mg/kg of Inka soft capsule. The control group 2 was given 200 mg/kg of South American vine soft capsule.
高血脂症模型对照组则不给予受试物, 而是按 50mg/kg (按中剂量组剂量)体重灌胃生 理盐水。 所有动物均在相同环境下伺养 20天。 末次给予各受试物的 4h后, 取血测定血清 总胆固醇 (TC mmol/L, 氯化铁显色法)、 血清三酰甘油 (TG mmol/L, 乙酰丙酮法)、 高密度脂 蛋白胆固醇 (; HDL-C mmol/L, 磷钨酸法)。  In the hyperlipidemia model control group, the test substance was not administered, but the physiological saline was administered at a dose of 50 mg/kg (in the middle dose group). All animals were kept in the same environment for 20 days. After 4 hours of the last administration of each test substance, blood was taken for determination of serum total cholesterol (TC mmol/L, ferric chloride chromogenic method), serum triacylglycerol (TG mmol/L, acetylacetone method), high-density lipoprotein cholesterol. (; HDL-C mmol/L, phosphotungstic acid method).
2、 实验结果  2, the experimental results
各组大鼠血清总 TG、 TC和 HDL-C的含量见表 3。  The contents of serum total TG, TC and HDL-C in each group of rats are shown in Table 3.
结果表明: 高血脂症模型对照组的 TC、 TG值明显高于各受试物剂量组, 统计学上有 非常显著的差异, 说明大鼠病理模型造型成功。 与高血脂症模型对照组相比, 印加果油组 的大鼠血清中的 TG、 TC水平显著降低 (P<0.05), 但是 HDL-C的水平升高不显著 (P>0.05)。 与高血脂症模型对照组相比,南美油藤软胶囊组、印加软胶囊低剂量组对大鼠血清中的 TG、 TC水平显著降低 (P<0.05), HDL-C的水平显著升高 (P<0.05); 印加软胶囊中剂量组、 以及印 加软胶囊高剂量组对大鼠血清中的 TG、 TC有极其显著的降低 (P<0.01), 对 HDL-C有极其 显著的升高 (P<0.01)。 在喂以高脂伺料的基础上, 同时加喂受试物, 大鼠的 TG、 TC值均低 于高血脂症模型对照组, 说明各受试物对高血脂症有防治作用, 本发明所制备得到的印加 软胶囊可起到良好的降脂血的作用; 印加软胶囊能明显升高 HDL-C水平, 说明其有抗动脉 粥样硬化 (AS)的作用。本发明所述的印加软胶囊对调节血脂的作用优于印加果油及南美油藤 软胶囊, 本发明具有明显的技术优势, 对高脂血症具有显著的辅助治疗作用。 The results showed that the TC and TG values of the hyperlipidemia model control group were significantly higher than those of the test substance dose group, and there were statistically significant differences, indicating that the pathological model of the rat was successful. Compared with the hyperlipidemia model control group, the Inca fruit oil group The levels of TG and TC in the serum of rats were significantly decreased (P<0.05), but the level of HDL-C was not significantly increased (P>0.05). Compared with the hyperlipidemia model control group, the TG and TC levels in the serum of the South American Youteng Soft Capsule Group and the Inka Soft Capsule group were significantly lower (P<0.05), and the HDL-C level was significantly increased (P<0.05). P<0.05); Inka soft capsule middle dose group and Inca soft capsule high dose group had extremely significant decrease in serum TG and TC (P<0.01), and extremely significant increase in HDL-C ( P < 0.01). On the basis of feeding high-fat diet, and feeding the test substance at the same time, the TG and TC values of the rats were lower than that of the hyperlipidemia model control group, indicating that each test substance has a preventive and therapeutic effect on hyperlipidemia, and the present invention The prepared Inca soft capsule can play a good role in lowering blood fat; Inca soft capsule can significantly increase HDL-C level, indicating that it has anti-atherosclerosis (AS) effect. The Inca soft capsule of the invention has better effect on regulating blood lipid than the Inca fruit oil and the South American oil vine soft capsule. The invention has obvious technical advantages and has significant auxiliary therapeutic effect on hyperlipidemia.
表 3 不同实验组降 TC、 TG、 HDL-C的效果比较  Table 3 Comparison of effects of TC, TG and HDL-C in different experimental groups
血脂指标 (mmol/L)  Blood lipid index (mmol/L)
动物数 (只)  Number of animals (only)
TC TG HDL-C 高脂血症模型组 10 1.74±0.37 3.84±0.28 0.57±0.15 对照 1组 10 1.21±0.22* 3.31±0.45* 0.64±0.21 对照 2组 10 1.09±0.18* 3.20±0.39* 1.20±0.24* 本发明低剂量组 10 1.12±0.21* 3.25±0.40* 1.15±0.19* 本发明中剂量组 10 0.92±0.15Δ 2.77±0.29Δ 1.37±0.28Δ 本发明高剂量组 10 0.72±0.09Δ 2.03±0.20Δ 1.52±0.16Δ TC TG HDL-C hyperlipidemia model group 10 1.74±0.37 3.84±0.28 0.57±0.15 Control group 1 10 1.21±0.22* 3.31±0.45* 0.64±0.21 Control group 2 10 1.09±0.18* 3.20±0.39* 1.20± 0.24 * low dose group of the present invention 10 1.12 ± 0.21 * 3.25 ± 0.40 * 1.15 ± 0.19 * according to the present invention, dose 10 0.92 ± 0.15 Δ 2.77 ± 0.29 Δ 1.37 ± 0.28 Δ high dose group of the present invention 10 0.72 ± 0.09 Δ 2.03 ± 0.20 Δ 1.52 ± 0.16 Δ
( 1 ) 与高血脂症模型对照组比较 *Ρ<0.05; (2) 与高血脂症模型对照组比较 ΔΡ<0.01 实施例 15: 降血糖、 降血脂人体试食实验 (1) Compared with hyperlipidemia model control group *Ρ<0.05; (2) Compared with hyperlipidemia model control group Δ Ρ<0.01 Example 15: hypoglycemic, hypolipidemic human test experiment
依据卫生部 《保健食品检验与评价技术规范 (2003年) 》 , 进行降血糖、 降血脂人体 试食实验。  According to the “Technical Specifications for Health Food Inspection and Evaluation (2003)” of the Ministry of Health, a human blood test for blood sugar lowering and blood fat reduction was conducted.
1、 样品:  1, sample:
本实施例的软胶囊由实施例 1制备得到 (以下简称印加软胶囊) 。  The soft capsule of this example was prepared in the same manner as in Example 1 (hereinafter referred to as Inca soft capsule).
2、 人体试食及试验方法:  2, human body test and test methods:
按自愿原则选择 60 例 II型糖尿病人,其中男性 42人,女性 18人,年龄范围 43-75 岁, 无严重心肝肾等并发症, 采取试食前中后对比设计。 受试者原用治疗药物种类、 饮食控制 及活动不变, 每日服印加软胶囊 2次, 每次 3粒, 于早、 晚饭前服用, 连续服用 30天。 监 测病人血压、大小便、体重的变化,并测定空腹和餐后 2小时的血糖(用葡萄糖氧化酶法); 测定血脂 (总胆固醇 TC、 甘油三酯 TG和高密度脂蛋白 HDL-C) 。  According to the voluntary principle, 60 patients with type II diabetes were selected, including 42 males and 18 females, aged 43-75 years old. There were no complications such as severe heart, liver and kidney. The subjects were treated with the same type of medication, diet control and activities. The capsules were given 2 times a day, 3 capsules each time, taken before breakfast and supper, and continued for 30 days. The changes in blood pressure, bowel movements, and body weight were monitored, and blood glucose was measured on a fasting and 2 hours postprandial (using glucose oxidase method); blood lipids (total cholesterol TC, triglyceride TG, and high density lipoprotein HDL-C) were measured.
3、 评判标准:  3. Judging criteria:
显效: 基本症状消失, 空腹或餐后 2小时的血糖较治疗前下降不超过 30.0%。 有效: 基本症状明显改善, 空腹和餐后 2小时的血糖较治疗前下降不超过 10.0%。 无效: 基本症状无明显改善, 空腹和餐后 2小时的血糖较治疗前下降小于 10.0%。 4、 人体试食结果: Significant effect: The basic symptoms disappeared, and the blood glucose at 2 hours after fasting or after meals decreased by no more than 30.0% compared with before treatment. Effective: The basic symptoms are significantly improved. The blood glucose at 2 hours after fasting and after meals does not decrease by more than 10.0% compared with before treatment. Invalid: The basic symptoms did not improve significantly. The blood glucose at 2 hours after fasting and after meals decreased by less than 10.0% compared with before treatment. 4, human body test results:
试食 30天本实施例的印加软胶囊后与试食前相比, 病人的血压、 大小便、 体重均无显 著性差异。 关于对试食前后的血糖的影响, 试食 30天后病人空腹血糖和餐后 2h血糖有明 显的降低, 较试食前有极显著性差异 (P<0.01 ) , 具体结果见表 4。 关于对试食前后的血脂 的影响, 试食 30天后病人的胆固醇、 甘油三脂较试食前均有明显的降低, 高密度脂蛋白较 试食前有明显的升高, 差异均有显著性 (P<0.05 ) , 具体结果见表 5。 由此可见, 本发明所 述的印加软胶囊具有明显的辅助降血糖、 降血脂的保健功能, 并对受试人群健康无损害作 用。  After 30 days of ingestion, there was no significant difference in blood pressure, urine and body weight between the Inca soft capsules of this example and before the test. Regarding the effect on blood glucose before and after the test, the fasting blood glucose and the 2h postprandial blood glucose were significantly lower after 30 days of the test, which was significantly different from that before the test (P<0.01). The specific results are shown in Table 4. Regarding the effect on blood lipids before and after the test, the cholesterol and triglyceride of the patients were significantly lower than those before the test, and the high-density lipoprotein was significantly higher than that before the test. The difference was significant (P <0.05), the specific results are shown in Table 5. Thus, the Inca soft capsule of the present invention has an obvious health-care function of assisting blood sugar lowering and lowering blood fat, and has no damage to the health of the tested population.
表 4 印加软胶囊对病人血糖的影响  Table 4 Effect of Inca Soft Capsule on Blood Glucose in Patients
组别 空腹血糖 (mmol/L) 餐后 2小时血糖(mmol/L)  Group Fasting blood glucose (mmol/L) 2 hours postprandial blood glucose (mmol/L)
试食前 8.85±2.69 10.95±3.80  Before the test, 8.85±2.69 10.95±3.80
试食 30天 5.64±1.07 6.22±1.35  Try food for 30 days 5.64±1.07 6.22±1.35
P值 0.0041 0.0078 表 5 印加软胶囊对病人血脂的影响  P value 0.0041 0.0078 Table 5 Effect of Inka soft capsule on blood lipids in patients
试食前(mmol/L) 试食 30天后 (mmol/L) P值  Before the test (mmol/L), after 30 days of test (mmol/L) P value
总胆固醇 TC 7.75±0.96 5.69±0.70 0.0325 甘油三酯 TG 2.62±0.67 1.58±0.51 0.0148 高密度脂蛋白 HDL-C 0.75±0.17 1.44±0.36 0.0429 实施例 16: 治疗便秘效果试验  Total cholesterol TC 7.75±0.96 5.69±0.70 0.0325 Triglyceride TG 2.62±0.67 1.58±0.51 0.0148 High-density lipoprotein HDL-C 0.75±0.17 1.44±0.36 0.0429 Example 16: Treatment of constipation effect test
依据卫生部 《保健食品检验与评价技术规范 (2003年) 》 , 本发明在进行深入的有效 性和安全性研究后, 采用实施例 10提供的印加颗粒剂 (以下简称印加颗粒剂) 对便秘患者 的治疗效果进行试验。  According to the Ministry of Health's "Technical Specification for Health Food Inspection and Evaluation (2003)", the present invention uses the Indo-granules (hereinafter referred to as Indo-granules) provided in Example 10 for constipation patients after conducting in-depth efficacy and safety studies. The therapeutic effect was tested.
试验对象:  Test subject:
抽取轻度便秘患者 42例, 年龄为 39-61岁; 中度便秘患者 43例, 年龄为 40-62岁; 重 度便秘患者 45例,年龄为 41-61 岁。其中轻度便秘是指 2-3 天排便 1次, 中度便秘是指 3-6 天排便 1次, 重度便秘是指 7天以上排便 1次或依靠泻药排便, 每天 1次或两天 1次。  Forty-two patients with mild constipation were enrolled, aged 39-61 years; 43 patients with moderate constipation, aged 40-62 years; 45 patients with severe constipation, aged 41-61 years. Among them, mild constipation refers to 1-2 days of bowel movements, moderate constipation refers to 3-6 days of bowel movements, and severe constipation refers to more than 7 days of bowel movements or relies on laxatives for defecation, once or twice a day. .
试验方法:  experiment method:
采用印加颗粒剂对便秘患者进行治疗。 轻度便秘患者服用印加颗粒剂 7天, 前三天每天服用 2袋, 之后四天每天 1袋, 温水 冲饮。 中度便秘患者服用印加颗粒剂 7天, 前三天每天服用 4袋, 之后四天每天 2袋, 温 水冲饮。 重度便秘患者服用印加颗粒剂 7天, 前三天每天服用 6袋, 之后四天每天 3袋, 温水冲饮。 Treatment of patients with constipation with Inca granules. Patients with mild constipation took Inka granules for 7 days, taking 2 bags a day for the first three days, and then taking 1 bag every day for four days. Patients with moderate constipation took Inka granules for 7 days, taking 4 bags a day for the first three days, and then 2 bags a day for four days, brewing in warm water. Patients with severe constipation took Inka granules for 7 days, taking 6 bags a day for the first three days, and then 3 bags a day for four days, brewing in warm water.
试验效果:  Test effect:
轻度便秘患者在服用印加颗粒剂的前 3天内, 每天排 2到 3次松软偏松散大便, 便秘 情况得到显著改善, 第 4-7 天减量服用后, 每天排 1到 2次松软大便。 中度便秘患者在服 用印加颗粒剂的前 3天内, 其中有 38例患者每天排 2到 3次松软偏松散大便, 7 例患者每 天排 1到 2次松软大便, 第 4-7 天减量服用后, 43例患者均每天排 1到 2次松软大便。 重 度便秘患者在服用印加颗粒剂的前 3天内, 其中有 25例患者每天排 2到 3次松软偏松散大 便, 16例患者每天排 1到 2次松软大便, 其余 4例患者 3天内排便 1次, 便秘情况也有所 改善, 第 4-7 天减量服用后, 43例患者均每天排 1到 2次大便, 2例患者 2天排便 1次。 不同程度的便秘患者均得到了有效治疗。  Patients with mild constipation had 2 to 3 loose loose stools every day for the first 3 days after taking Inga granules, and the constipation was significantly improved. After the 4-7 days, the soft stools were discharged 1 to 2 times a day. Among the patients with moderate constipation within the first 3 days of taking Inka granules, 38 patients had 2 to 3 loose loose stools per day, 7 patients had 1 to 2 soft stools per day, and 4-7 days decreased. After that, 43 patients had 1 or 2 soft stools per day. In the first 3 days after taking Inga granules, 25 patients had 2 to 3 loose loose stools per day, 16 patients had 1 to 2 soft stools per day, and the remaining 4 patients had 1 bowel movement within 3 days. The constipation situation also improved. After taking the dose on days 4-7, 43 patients had 1 or 2 bowel movements per day, and 2 patients had bowel movements once every 2 days. Patients with different degrees of constipation have been treated effectively.
从本发明所述的组合物保健食品对便秘患者的治疗效果试验来看, 该产品具有改善胃 肠道功能, 能起到润肠通便、 防治便秘的作用, 服用期间未见不良反应。  From the therapeutic effect test of the composition health food of the present invention for constipation patients, the product has the function of improving the function of the stomach and intestines, and can function as a laxative and constipation, and no adverse reactions are observed during the administration.
实施例 17 : 治疗肥胖效果试验  Example 17: Treatment of obesity effect test
1、 试验材料及方法  1. Test materials and methods
本实施例的印加软胶囊由实施例 1制备得到,规格 l .Og/粒,推荐食用方法为每日 2次, 每次 2粒。  The incorporation soft capsule of the present example was prepared in the same manner as in Example 1, and the specification was 1.0 g/granule. The recommended eating method was 2 times a day, 2 tablets each time.
受试对象:经体检符合试验要求,超重度在 20%以上的肥胖志愿者 52名,无其它疾病, 内脏功能正常。  Subjects: 52 obese volunteers who were over 20% overweight after physical examination, no other diseases, and normal visceral function.
方法: 采用自身对照设计, 受试者每天服用 4粒, 分 2次服用, 连续 30天。 试食期间 日常饮食及运动量与试验前保持一致。 各项指标于试食试验开始及结束时各测试 1次。  METHODS: Using a self-controlled design, subjects received 4 capsules per day for 2 consecutive days for 30 consecutive days. During the trial period, the daily diet and exercise volume were consistent with those before the test. The indicators were tested once at the beginning and end of the test.
2、 功效性观察  2, efficacy observation
①测量身高 (cm:)、 体重 (kg)并计算标准体重、 超重度:  1 Measure height (cm:), weight (kg) and calculate standard weight, overweight:
成人标准体重 (kg)= [身高 (cm)-100]x0.9  Adult standard weight (kg) = [height (cm)-100] x 0.9
超重度(%)= (实测体重 -标准体重) /标准体重 x l 00 %  Overweight (%) = (measured weight - standard weight) / standard weight x l 00 %
②体内脂肪总量 (kg)及脂肪百分率 (%)测定: 用电阻抗仪测定人体脂肪含量。  2 Total body fat (kg) and percentage of fat (%): The body fat content was measured by an electrical resistance meter.
③腰围、 臀围 (cm)测量: 用皮尺测量。  3 Waist circumference, hip circumference (cm) measurement: Measure with a measuring tape.
3、 观察结果  3. Observation results
3.1 体重、 体内脂肪总量及脂肪百分率测定  3.1 Determination of body weight, total body fat and percentage of fat
试食后受试者平均体重下降了 3.7kg,体脂总量平均下降 1.6kg,体脂百分率下降 1.0%, 与试食前相比有显著性差异 (P<0.05 ) , 结果见表 6。 After the test, the average weight of the subjects decreased by 3.7 kg, the total body fat decreased by 1.6 kg, and the percentage of body fat decreased by 1.0%. There was a significant difference (P<0.05) compared with before the test, and the results are shown in Table 6.
表 6 试食前后体重、 体脂测定结果 ( ±s, n=52) 测定项 试食前 试食后 差值 体重 (kg) 86.5±18.0 82.9±16.5* 3.7±1.4 体脂总量 (kg) 30.3±8.5 28.7±7.4* 1.6±1.2 体脂百分率 (%) 33.8±5.0 32.8±4.6* 1.0±0.8 注: 与试食前相比, *P<0.05  Table 6 Results of body weight and body fat measurement before and after the test (±s, n=52) The difference weight (kg) after the test was measured. 86.5±18.0 82.9±16.5* 3.7±1.4 Total body fat (kg) 30.3 ±8.5 28.7±7.4* 1.6±1.2 Body fat percentage (%) 33.8±5.0 32.8±4.6* 1.0±0.8 Note: Compared with before the test, *P<0.05
3.2腰围、 臀围的测量  3.2 Measurement of waist circumference and hip circumference
人体试食试验后, 受试者腰围平均减少 4.8 cm, 臀围平均减少 1.6 cm, 与试验前比较差 异有极显著性 (P<0.01) 结果见表 7。  After the human body test, the average waist circumference of the subjects decreased by 4.8 cm and the hip circumference decreased by 1.6 cm. The difference between the two groups was extremely significant (P<0.01). The results are shown in Table 7.
表 7 试食前后腰围、 臀围测量结果 ( ±s, n=52) 测定项 试食前 试食后 差值 腰围 (cm) 110.0±15.2 104.9±13.2** 5.1±2.2 臀围 ( cm) 113.4±11.8 112.0±10.2** 1.4±1.5 注: 与试食前相比, **P<0.01  Table 7 Measurement results of waist circumference and hip circumference before and after the test (±s, n=52) Measurement of the difference in waist circumference before the test (0.05) 110.0±15.2 104.9±13.2** 5.1±2.2 Hip circumference (cm) 113.4± 11.8 112.0±10.2** 1.4±1.5 Note: Compared with before the test, **P<0.01
本试食试验中, 受试者连续服用印加软胶囊 30天后, 体重、 体内脂肪总量、 体脂百分 率、腰围、臀围均显著下降。 由此可见, 本发明所述的组合物对人体具有明显的减肥作用, 且服用期间未见不良反应。  In this test, the subjects continued to take Inca soft capsules for 30 days, and the body weight, body fat, body fat percentage, waist circumference and hip circumference decreased significantly. Thus, the composition of the present invention has a significant weight loss effect on the human body, and no adverse reactions are observed during the administration.
实施例 18: 美容祛黄褐斑人体试食试验  Example 18: Beauty Tanning Chloasma Human Tasting Test
本实施例的软胶囊由实施例 1制备得到, 规格 l .Og/粒, 推荐食用方法为每日 2次, 每 次 2粒。 受试对象为经体检符合试验要求, 年龄在 35-52岁, 面部出现大小不等、 形状各异 的点面状黄褐色斑的女性患者, 共 40例, 无其它疾病, 内脏功能正常。 试验采用自身对照 设计, 受试者每天服用 4粒, 分 2次服用, 连续 30天。 受试者在试验期间停止服用其他药 物或保健品, 停止使用其它化妆品及保养品。观察黄褐斑颜色深浅、有无新的黄褐斑出现, 计算黄褐斑面积。  The soft capsule of the present example was prepared in the same manner as in Example 1, and the specification was 1.0 g/granule. The recommended method of consumption was 2 times a day, 2 tablets each time. The subjects were women who were 35-52 years old and had face-like yellow-brown spots of different sizes and shapes. There were 40 cases with no other diseases and normal visceral function. The trial was designed according to its own control. The subjects took 4 capsules a day and took them in 2 divided doses for 30 consecutive days. Subjects stopped taking other medicines or health supplements during the trial and stopped using other cosmetics and skin care products. Observe the color depth of the chloasma, the presence of new chloasma, and calculate the area of chloasma.
试食 30 天后, 40 例受试者黄褐斑面积及色度均有所下降。 试验前黄褐斑面积为 (2331.49±1256.58 ) mm2, 30天试食试验后黄褐斑面积为 ( 1921.89±923.50) mm2, 黄褐斑 色度分别为 (1.75±0.47)和 (1.48±0.35 ) , 试验前后的结果比较差异有显著性 (P<0.01)。 且 由此可见, 本发明所述的组合物对人体具有明显的美容祛斑作用, 且服用期间未见不良反 应。 在本说明书的描述中, 参考术语"一个实施例"、 "一些实施例"、 "示例"、 "具体示例"、 或"一些示例"等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含 于本发明的至少一个实施例或示例中。 在本说明书中, 对上述术语的示意性表述不一定指 的是相同的实施例或示例。 而且, 描述的具体特征、 结构、 材料或者特点可以在任何的一 个或多个实施例或示例中以合适的方式结合。 After 30 days of feeding, the area and chroma of the chloasma in 40 subjects decreased. The area of chloasma before the test was (2331.49±1256.58) mm 2 , and the area of chloasma after the 30-day test was (1921.89±923.50) mm 2 , and the hue of chloas were (1.75±0.47) and (1.48±, respectively). 0.35), the results before and after the test were significantly different (P<0.01). It can be seen from the above that the composition of the present invention has an obvious cosmetic freckle effect on the human body, and no adverse reaction is observed during the administration. In the description of the present specification, reference is made to the terms "one embodiment", "some embodiments", "example", "specific examples", The description of "some examples" and the like means that the specific features, structures, materials or characteristics described in connection with the embodiments or examples are included in at least one embodiment or example of the invention. In the present specification, the schematic representation of the above terms does not necessarily mean the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples.
尽管上面已经示出和描述了本发明的实施例,可以理解的是,上述实施例是示例性的, 不能理解为对本发明的限制, 本领域的普通技术人员在不脱离本发明的原理和宗旨的情况 下在本发明的范围内可以对上述实施例进行变化、 修改、 替换和变型。  Although the embodiments of the present invention have been shown and described, it is understood that the foregoing embodiments are illustrative and not restrictive Variations, modifications, alterations and variations of the above-described embodiments are possible within the scope of the invention.

Claims

权利要求书 claims
1、 一种可食用组合物, 其特征在于, 包括: 1. An edible composition, characterized in that it includes:
3-15重量份的菊粉; 3-15 parts by weight of inulin;
2〜10重量份的印加果油; 2 to 10 parts by weight of Sacha Inchi oil;
5〜15重量份的蜂胶; 以及 5 to 15 parts by weight of propolis; and
2- 15重量份的壳寡糖。 2-15 parts by weight of chitosan oligosaccharide.
2、根据权利要求 1所述的可食用组合物, 其特征在于, 所述蜂胶的乙醇提取物中总黄 酮含量为至少 15重量%。 2. The edible composition according to claim 1, wherein the total flavonoid content in the ethanol extract of propolis is at least 15% by weight.
3、 根据权利要求 1 所述的可食用组合物, 其特征在于, 包括: 3. The edible composition according to claim 1, comprising:
5-12重量份的菊粉; 5-12 parts by weight of inulin;
4〜8重量份的印加果油; 4 to 8 parts by weight of Sacha Inchi oil;
6〜10重量份的蜂胶; 以及 6 to 10 parts by weight of propolis; and
5〜10重量份的壳寡糖。 5 to 10 parts by weight of chitosan oligosaccharide.
4、 根据权利要求 1 所述的可食用组合物, 其特征在于, 包括: 4. The edible composition according to claim 1, comprising:
8重量份的菊粉; 8 parts by weight of inulin;
6重量份的印加果油; 6 parts by weight of sacha inchi oil;
8重量份的蜂胶; 以及 8 parts by weight of propolis; and
8重量份的壳寡糖。 8 parts by weight of chitosan oligosaccharide.
5、 一种可食用组合物, 其特征在于, 包括: 5. An edible composition, characterized in that it includes:
3- 15重量份的菊粉; 3-15 parts by weight of inulin;
5-25重量份的印加果粉; 5-25 parts by weight of inca inca fruit powder;
5〜15重量份的蜂胶; 以及 5 to 15 parts by weight of propolis; and
2-15重量份的壳寡糖。 2-15 parts by weight of chitosan oligosaccharide.
6、根据权利要求 5所述的可食用组合物, 其特征在于, 所述蜂胶的乙醇提取物中总黄 酮含量为至少 15重量%。 6. The edible composition according to claim 5, characterized in that the total flavonoid content in the ethanol extract of propolis is at least 15% by weight.
7、 根据权利要求 5所述的可食用组合物, 其特征在于, 包括: 7. The edible composition according to claim 5, characterized in that it includes:
5-12重量份的菊粉; 5-12 parts by weight of inulin;
10-20重量份的印加果粉; 10-20 parts by weight of inca inca fruit powder;
6〜10重量份的蜂胶; 以及 6 to 10 parts by weight of propolis; and
5〜10重量份的壳寡糖。 5 to 10 parts by weight of chitosan oligosaccharide.
8、 根据权利要求 5所述的可食用组合物, 其特征在于, 包括: 8重量份的蜂胶; 以及 8. The edible composition according to claim 5, comprising: 8 parts by weight of propolis; and
8重量份的壳寡糖。 8 parts by weight of chitosan oligosaccharide.
9、 根据权利要求 1-8任意一项所述的可食用组合物, 其特征在于, 所述可食用组合物 呈胶囊剂、 片剂、 冲剂或颗粒剂的形式。 9. The edible composition according to any one of claims 1 to 8, characterized in that the edible composition is in the form of capsules, tablets, granules or granules.
10、 一种制备权利要求 1-4任意一项所述的可食用组合物的方法, 其特征在于, 包括: 将预定比例的菊粉、 蜂胶、 以及壳寡糖混合, 并将所得到的混合物进行粉碎至粒径为 10. A method for preparing the edible composition according to any one of claims 1 to 4, characterized in that it includes: mixing inulin, propolis, and chitosan oligosaccharide in a predetermined proportion, and mixing the resulting mixture Grind until the particle size is
1-100微米之间, 以便得到混合细粉; 以及 Between 1-100 microns in order to obtain a mixed fine powder; and
将所述混合细粉与印加果油混合, 以便得到所述可食用组合物。 The mixed fine powder is mixed with inca inchi oil to obtain the edible composition.
11、 根据权利要求 10所述的方法, 其特征在于, 进一步包括: 11. The method according to claim 10, further comprising:
在将所述混合细粉与印加果油混合之前, 预先将所述印加果油与大豆油混合。 Before mixing the mixed fine powder with inca inchi oil, the inca inchi oil and soybean oil are mixed in advance.
12、 一种制备权利要求 5-8任意一项所述的可食用组合物的方法, 其特征在于, 包括: 将预定比例的菊粉、 印加果粉、 蜂胶、 壳寡糖混合, 并将所得到的混合物进行粉碎至 粒径为 1-100微米之间, 以便得到混合细粉, 所述混合细粉构成所述可食用组合物。 12. A method for preparing the edible composition according to any one of claims 5 to 8, characterized by comprising: mixing a predetermined proportion of inulin, sacha inchi powder, propolis, and chitosan oligosaccharide, and mixing the resulting The mixture is pulverized to a particle size of 1-100 microns to obtain a mixed fine powder, and the mixed fine powder constitutes the edible composition.
13、 一种食品, 其特征在于, 包含权利要求 1-8任意一项所述的可食用组合物, 所述食 品呈胶囊剂、 片剂、 冲剂或颗粒剂的形式。 13. A food, characterized in that it contains the edible composition according to any one of claims 1 to 8, and the food is in the form of capsules, tablets, granules or granules.
14、 一种制备食品的方法, 其特征在于, 包括: 14. A method of preparing food, characterized in that it includes:
提供权利要求 1-9任意一项所述的可食用组合物, 其中, 所述印加果粉、 菊粉、 蜂胶和 壳寡糖呈颗粒状; 以及 The edible composition according to any one of claims 1 to 9 is provided, wherein the inca inchi powder, inulin, propolis and chitosan oligosaccharide are in granular form; and
将所述可食用组合物进行成型处理, 以便获得所述食品。 The edible composition is subjected to a shaping process in order to obtain the food product.
15、 根据权利要求 14所述的方法, 其特征在于, 所述颗粒的粒径为 1-100微米。 15. The method according to claim 14, characterized in that the particle size of the particles is 1-100 microns.
16、 根据权利要求 14所述的方法, 其特征在于, 所述成型处理进一步包括: 将所述可 食用组合物制成胶囊剂、 片剂、 冲剂或颗粒剂的形式。 16. The method according to claim 14, wherein the shaping process further includes: making the edible composition into the form of capsules, tablets, granules or granules.
17、权利要求 1-8任意一项所述的可食用组合物在制备制剂中的用途, 所述制剂用于降 血糖、 降血脂、 美容祛斑、 治疗便秘和肥胖的至少之一。 17. Use of the edible composition according to any one of claims 1 to 8 in preparing a preparation for at least one of lowering blood sugar, lowering blood lipids, beautifying and removing freckles, treating constipation and obesity.
PCT/CN2013/072371 2013-03-08 2013-03-08 Edible composition, preparation method therefor, and food product comprising the composition WO2014134833A1 (en)

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