阅读说明：本技术 一种护肝的组合物及其制备方法和应用 (Liver-protecting composition and preparation method and application thereof ) 是由 肖伟 张海弢 李曼曼 付娟 杨晓筱 范业文 柏伟荣 于 2019-03-22 设计创作，主要内容包括：本发明提出了一种护肝的组合物,其特征在于,以重量比计,所述组合物包括：葛根1～6份、红景天1～4份、灵芝1～4份、人参1～4份。葛根、红景天、灵芝、人参配伍合理,相互起协同作用,四药合用,相互作用,共同起到清湿热、解酒毒、疏肝胆、行积滞之功效,对化学性肝损伤具有较好的缓解作用,从而起到保护肝脏的作用。(The invention provides a liver-protecting composition, which is characterized by comprising the following components in parts by weight: 1-6 parts of kudzu root, 1-4 parts of rhodiola rosea, 1-4 parts of lucid ganoderma and 1-4 parts of ginseng. The kudzu vine root, the rhodiola rosea, the lucid ganoderma and the ginseng are reasonably compatible and mutually play a synergistic effect, and the four medicines are combined and mutually acted to jointly play the effects of clearing damp-heat, relieving alcoholism, soothing liver and gallbladder and removing stagnation, so that the traditional Chinese medicine has a better relieving effect on chemical liver injury and plays a role in protecting the liver.)

1. A liver-protecting composition, which is characterized by comprising the following components in percentage by weight: 1-6 parts of kudzu root, 1-4 parts of rhodiola rosea, 1-4 parts of lucid ganoderma and 1-4 parts of ginseng.

2. The composition as claimed in claim 1, wherein said composition comprises: 2-6 parts of kudzu root, 2-4 parts of rhodiola rosea, 2-4 parts of lucid ganoderma and 2-4 parts of ginseng.

3. The composition as claimed in claim 1, wherein said composition comprises: 2-4 parts of rhodiola rosea, 2-3 parts of lucid ganoderma and 2-3 parts of ginseng.

4. The composition as claimed in claim 1, wherein said composition comprises: 3 parts of kudzu root, 2 parts of rhodiola root, 2 parts of lucid ganoderma and 2 parts of ginseng.

5. A process for the preparation of a composition according to any one of claims 1 to 4, comprising the steps of:

(A) adding 8-14 times of water into the medicinal materials, decocting and extracting for 1-3 times, each time for 0.5-2.0 hours, filtering, and combining extracting solutions to obtain a filtrate;

(B) concentrating the obtained filtrate under reduced pressure at 60 +/-5-80 +/-5 ℃, concentrating until the relative density is 1.10-1.30, drying under reduced pressure at 60 +/-5-80 +/-5 ℃ to obtain dry extract, crushing the dry extract and sieving.

6. Use of the composition of any one of claims 1 to 4 for the preparation of a liver-protecting pharmaceutical, food or nutraceutical product.

7. A pharmaceutical, food or health product prepared from the composition of any one of claims 1 to 4 and pharmaceutically acceptable adjuvants or additives.

8. The drug, food or health product of claim 7, wherein the drug, food or health product is selected from the group consisting of a hard capsule, a tablet, a granule, a pill and an oral liquid.

9. A preparation method of hard capsules for protecting liver is characterized by comprising the following steps: taking 3 parts of kudzuvine root, 2 parts of rhodiola rosea, 2 parts of lucid ganoderma and 2 parts of ginseng, adding 10 times of water for decoction and extraction for 2 times, each time for 1.5 hours, filtering, combining the two extracting solutions, concentrating under reduced pressure at 70 +/-5 ℃, concentrating to the relative density of 1.20-1.25, drying under reduced pressure at 70 +/-5 ℃ to obtain dry extract, crushing the dry extract by a universal crusher, sieving by a 100-mesh sieve, adding an appropriate amount of auxiliary materials, uniformly mixing, granulating, drying, finishing granules and filling.

10. A process for the preparation of a hard gelatin capsule as claimed in claim 9 wherein the granulation is carried out using a 20 mesh sieve; the drying is carried out at 65 +/-5 ℃ and normal pressure, and the moisture in the granules is controlled to be below 5.0%.

Technical Field

The invention relates to the field of medicines, foods or health-care foods, in particular to a liver-protecting composition and a preparation method and application thereof.

Background

Chemical liver injury is liver injury caused by chemical hepatotoxic substances, wherein alcohol is one of the important sources of main hepatotoxic substances and is a problem which cannot be ignored in the current society, and the incidence rate of the chemical liver injury is on the trend of rising year by year along with the development of economy in China and the improvement of living standard of people, thereby seriously affecting the physical health of the Chinese people.

At present, products with a protective function on chemical liver injury in domestic markets do not have a recognized leading brand, so that the development of liver-protecting products containing traditional Chinese medicines has wide market prospects.

Disclosure of Invention

In view of the above, the present invention is directed to a liver-protecting composition, a pharmaceutical product, a food or a health food composition, and a method for preparing the same. Specifically, the invention provides a liver-protecting composition which can be directly ground into powder, or can be an extract prepared by a conventional method or other forms, and the composition is characterized by comprising the following components in parts by weight: 1-6 parts of kudzu root, 1-4 parts of rhodiola rosea, 1-4 parts of lucid ganoderma and 1-4 parts of ginseng.

Further, the composition comprises by weight: 2-6 parts of kudzu root, 2-4 parts of rhodiola rosea, 2-4 parts of lucid ganoderma and 2-4 parts of ginseng; or the like, or, alternatively,

further, the composition comprises: 2-4 parts of rhodiola rosea, 2-3 parts of lucid ganoderma and 2-3 parts of ginseng.

Preferably, the composition comprises: 3 parts of kudzu root, 2 parts of rhodiola root, 2 parts of lucid ganoderma and 2 parts of ginseng.

The invention also provides a preparation method of any one of the compositions, which is characterized by comprising the following steps:

(A) adding 8-14 times of water into the medicinal materials, decocting and extracting for 1-3 times, each time for 0.5-2.0 hours, filtering, and combining extracting solutions to obtain a filtrate;

(B) concentrating the obtained filtrate under reduced pressure at 60 + -5-80 + -5 deg.C until the relative density is 1.10-1.30, drying under reduced pressure at 60 + -5-80 + -5 deg.C to obtain dry extract, pulverizing the dry extract, and sieving to obtain the final product

The invention also provides a composition prepared by the preparation method. It is noted that the Chinese herbs used in the composition of the present invention can be directly ground into powder, extract, or other forms.

The invention also provides application of any one of the compositions in preparation of liver-protecting medicines, foods or health-care foods. The liver protecting effect preferably has auxiliary protecting effect on chemical liver injury.

The invention also provides a medicine, food or health-care product, which is characterized in that the medicine, food or health-care product is prepared from any one of the compositions and auxiliary materials or additives acceptable on the medicine, food or health-care product.

Specifically, the adjuvant may be corn starch, lactose, microcrystalline cellulose, dextrin, maltodextrin, dry starch, croscarmellose sodium, low substituted hydroxypropylcellulose, magnesium stearate, silicon dioxide, etc.

Specifically, the above medicine, food or health product can be selected from hard capsule, tablet, granule, pill or oral liquid, etc.

The invention also provides a preparation method of the hard capsule for protecting liver, which is characterized by comprising the following steps: taking 3 parts of kudzuvine root, 2 parts of rhodiola rosea, 2 parts of lucid ganoderma and 2 parts of ginseng, adding 10 times of water for decoction and extraction for 2 times, each time for 1.5 hours, filtering, combining the two extracting solutions, concentrating under reduced pressure at 70 +/-5 ℃, concentrating to the relative density of 1.20-1.25, drying under reduced pressure at 70 +/-5 ℃ to obtain dry extract, crushing the dry extract by a universal crusher, sieving by a 100-mesh sieve, adding an appropriate amount of auxiliary materials, uniformly mixing, granulating, drying, finishing granules and filling.

Preferably, the granulation is performed using a 20 mesh screen. The drying is carried out at 65 +/-5 ℃ and normal pressure, and the moisture in the granules is controlled to be below 5.0%.

The invention also provides a preparation method of the liver-protecting tablet, which is characterized by comprising the following steps: taking 3 parts by weight of kudzu root, 2 parts by weight of rhodiola rosea, 2 parts by weight of lucid ganoderma and 2 parts by weight of ginseng, adding 10 times of water for decoction and extraction for 2 times, each time lasting for 1.5 hours, filtering, combining the two extracting solutions, concentrating under reduced pressure at 70 +/-5 ℃, concentrating until the relative density is 1.20-1.25, drying under reduced pressure at 70 +/-5 ℃ to obtain dry extract, crushing the dry extract, sieving by a 100-mesh sieve, adding a proper amount of auxiliary materials, uniformly mixing, granulating, tabletting and coating to obtain the compound preparation.

According to the traditional Chinese medicine compatibility principle, in the composition, the kudzuvine root has the effects of expelling pathogenic factors from muscles and skin, allaying fever, promoting the production of body fluid to quench thirst, clearing and activating the channels and collaterals and relieving alcoholism; the rhodiola rosea has the effects of tonifying qi and activating blood; the lucid ganoderma tonifies qi and enhances the immunity of the organism; ginseng has effects of invigorating primordial qi, restoring pulse, relieving depletion, invigorating spleen, benefiting lung, promoting fluid production, and nourishing blood; the medicines in the formula are combined and mutually synergistic, the ginseng and the lucid ganoderma in the formula can strengthen the body resistance and consolidate the constitution, the radix puerariae can inhibit the warm and dry property of the ginseng by the sweet and cool functions, and the rhodiola rosea with the effects of tonifying qi and activating blood is matched to achieve the aim of auxiliary protection of chemical liver injury by strengthening the body resistance and consolidating the constitution and tonifying qi and activating blood. The kudzu vine root, the rhodiola rosea, the lucid ganoderma and the ginseng are reasonably compatible and mutually play a synergistic effect, and the four medicines are combined and mutually acted to jointly play the effects of clearing damp-heat, relieving alcoholism, soothing liver and gallbladder and removing stagnation, so that the traditional Chinese medicine has a better relieving effect on chemical liver injury and plays a role in protecting the liver. Modern pharmacological experiments show that the composition provided by the invention can obviously improve the levels of GSH, MDA and TG in mouse liver tissues, and has a good protection effect on chemical liver injury.

The preparation method of the composition provided by the invention is to extract the kudzu root, the lucid ganoderma, the rhodiola rosea and the ginseng together, the extraction process is simple to operate, the energy consumption is low, the cost is low, and compared with the respective extraction of the raw materials, the extraction process is complex and the effective compatibility cannot be achieved to play the drug effect; the drying method of the composition preparation is reduced pressure drying, and the drying process is simple; in addition, the composition has good particle fluidity after preparation, meets the product requirements, is suitable for continuous filling production, has no influence on the weight increase of mice as proved by animal function experiments, and has the function of remarkable liver injury protection.

Detailed Description

The present invention will now be described in more detail with reference to specific embodiments thereof so that the aspects and advantages of the invention may be better understood. However, the contents of the specific embodiments described below are for illustrative purposes only and are not limiting of the present invention.

It should be noted that, if the specific conditions are not specified, the procedures are carried out according to the conventional conditions or the conditions recommended by the manufacturer, and the raw materials or auxiliary materials used, and the reagents or equipment used are not specified by the manufacturer, and are conventional products commercially available. All percentages, ratios, proportions, or parts are by weight unless otherwise specified.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In addition, any methods and materials similar or equivalent to those described herein can be used in the practice of the present invention.

The components used in the invention, such as kudzu root, lucid ganoderma, rhodiola rosea and ginseng, are all commercially available traditional Chinese medicinal materials, and the auxiliary materials are all commercially available medicinal auxiliary materials.

And (3) raw and auxiliary material inspection and requirement:

kudzu root: is the dry root of Ohwi of Pueraria lobata (Willd.) Ohwi of Leguminosae, and should meet the related regulations under the Pueraria lobata of the pharmacopoeia of the people's republic of China 2015 edition.

Ganoderma lucidum: is a dried fruiting body of Ganoderma lucidum (Leys. ex Fr) Karst. or Ganoderma sinense Garoderma sinense Zhao, Xu et Zhang of Polyporaceae, and meets the relevant regulations under the Ganoderma lucidum item of the pharmacopoeia of the people's republic of China 2015 edition.

Rhodiola root: is the dry root or rhizome of Rhodiola crenulata Rhodiola crenulate (hook.f. et Thoms.) H.Ohba, and meets the related regulation of Rhodiola rosea in the 2015 edition of pharmacopoeia of the people's republic of China.

Ginseng: is the dried root or rhizome of Araliaceae plant ginseng Panax ginseng C.A.Mey. and should meet the related regulations under the ginseng item of the first edition of pharmacopoeia of the people's republic of China 2015 edition.

The auxiliary materials such as corn starch, lactose and the like meet the requirements of the four parts of the pharmacopoeia of the people's republic of China in 2015 edition.