Composition with effect of regulating gastrointestinal functions and application of composition in oral preparation

Abstract

The invention relates to the technical field of medicines, in particular to a composition with a function of regulating intestines and stomach and application of an oral preparation of the composition in medicines. The functional components of the composition with the function of regulating the intestines and the stomach are prepared from the following raw materials in parts by weight: 25 to 60 parts of fructus crataegi, 4 to 12 parts of folium mori, 1 to 6 parts of fructus phyllanthi, 0.1 to 1.2 parts of flos chrysanthemi, 0.5 to 5 parts of radix puerariae, 3 to 12 parts of rhizoma dioscoreae, 1 to 8 parts of poria cocos, 0.1 to 1 part of radix ginseng, 0.05 to 0.9 part of colla corii asini, 0.1 to 1 part of mangosteen and 40 to 100 parts of collagen peptide. The oral pharmaceutical preparation prepared from the composition disclosed by the invention has the efficacy of regulating gastrointestinal functions, is safe and convenient, and has a wide market prospect.

Description

[0001] This application is based on the parent application CN202211153996.0. The parent application CN202211153996.0 has the following invention title: A composition with cosmetic effects and its use in oral preparations. The application date is September 21, 2022. Technical Field

[0002] The present invention relates to the technical field of medicines, and in particular to a composition having the effect of regulating gastrointestinal function and an oral preparation thereof, and application thereof in medicines. Background Art

[0003] As people increasingly appreciate the efficacy and use of plant and animal nutritional supplements, numerous products using these ingredients have been launched. However, these products often suffer from limited functionality and poor results. Therefore, developing oral beauty solutions with multiple functions has become a hot topic in market research and development. Summary of the Invention

[0004] The present invention aims to provide a composition containing hawthorn, mulberry leaf, emblica fruit, chrysanthemum, kudzu root, yam, poria, ginseng, mangosteen, collagen peptide and donkey-hide gelatin, which can work synergistically and produce significant effect of regulating gastrointestinal function.

[0005] In order to achieve the above-mentioned object of the present invention, the present invention provides the following technical solutions:

[0006] The composition is composed of the following raw materials in parts by weight: 25-60 parts of hawthorn, 4-12 parts of mulberry leaves, 1-6 parts of emblica fruit, 0.1-1.2 parts of chrysanthemum, 0.5-5 parts of kudzu root, 3-12 parts of yam, 1-8 parts of poria, 0.1-1 part of ginseng, 0.05-0.9 parts of donkey-hide gelatin, 0.1-1 parts of mangosteen, and 40-100 parts of collagen peptide.

[0007] Furthermore, the composition is composed of the following raw materials in parts by weight: 35-55 parts of hawthorn, 6-10 parts of mulberry leaves, 2-4 parts of emblica, 0.3-1 parts of chrysanthemum, 1-3 parts of kudzu root, 4-9 parts of yam, 2-6 parts of poria, 0.2-0.8 parts of ginseng, 0.1-0.7 parts of donkey-hide gelatin, 0.3-0.9 parts of mangosteen, and 50-90 parts of collagen peptide.

[0008] Furthermore, the composition is composed of the following raw materials in parts by weight: 40 parts of hawthorn, 9 parts of mulberry leaves, 3 parts of emblica, 0.5 parts of chrysanthemum, 2.5 parts of kudzu root, 7 parts of yam, 4 parts of poria, 0.5 parts of ginseng, 0.4 parts of donkey-hide gelatin, 0.5 parts of mangosteen, and 70 parts of collagen peptide.

[0009] The collagen peptide is deep-sea fish collagen peptide or freshwater fish collagen peptide.

[0010] The chrysanthemum is selected from the group consisting of chrysanthemums of Hangbai, Huangshan tribute chrysanthemum, Boju and Chuju; preferably, the chrysanthemum is chrysanthemum of Hangbai.

[0011] The present invention provides a method for preparing the above-mentioned composition, which specifically comprises the following steps:

[0012] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice, filter, and combine the filtrates;

[0013] (2) Add the formulated amount of collagen peptide and donkey-hide gelatin to the combined filtrate, add water again and adjust the volume to 1300-1700 mL;

[0014] (3) Sterilize and repackage the fixed volume solution in bottles.

[0015] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0016] The ratio of the mass of the collagen peptide added in step (2) to the volume of water added to the fixed volume is (40-100): 1.5 g / L.

[0017] The present invention provides an oral preparation comprising the above composition.

[0018] The oral preparation further comprises pharmaceutically acceptable additives; the pharmaceutically acceptable additives comprise 0.1-2 parts of a sour agent and 20-70 parts of a sweetener; preferably, the pharmaceutically acceptable additives comprise 0.5-1.5 parts of a sour agent and 30-60 parts of a sweetener; more preferably, the pharmaceutically acceptable additives comprise 1 part of a sour agent and 45 parts of a sweetener.

[0019] The sweetener is selected from one or more of xylitol, sorbitol, mannitol, lactitol, maltitol, isomalt, erythritol, steviol glycoside, licorice, chia seeds, mogroside, and thaumatin; preferably, the sweetener is selected from one or more of xylitol, sorbitol, erythritol, and steviol glycoside.

[0020] The acidulant is selected from one or more of citric acid, ascorbic acid, gluconic acid, malic acid, tartaric acid, lactic acid, and fumaric acid; preferably, the sweetener is selected from one or more of xylitol, sorbitol, erythritol, and stevioside; preferably, the acidulant is selected from one or more of ascorbic acid, gluconic acid, and malic acid.

[0021] According to a preferred embodiment of the present invention, the oral preparation is a powder, granules, oral liquid, capsule or tablet.

[0022] According to a preferred embodiment of the present invention, when the oral preparation is an oral liquid, the steps include:

[0023] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice, filter, and combine the filtrates;

[0024] (2) Add the formulated amount of collagen peptide, sweetener, acidulant, and donkey-hide gelatin to the combined filtrate, and add water again to adjust the volume to 1300-1700 mL;

[0025] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0026] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0027] The ratio of the mass of the collagen peptide added in step (2) to the volume of water added to the fixed volume is (40-100): 1.5 g / L.

[0028] According to an embodiment of the present invention, when the oral preparation is a powder, the preparation method thereof comprises the following steps:

[0029] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, the filtrate is combined, concentrated, dried, and crushed to obtain a solid powder of the extract;

[0030] (2) The solid powder of the extract is mixed evenly with the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin, and then packaged to obtain a powder.

[0031] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0032] According to a preferred embodiment of the present invention, when the oral preparation is a granule, the steps include:

[0033] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0034] (2) Add the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulate and obtain granules.

[0035] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0036] According to an embodiment of the present invention, when the oral preparation is a tablet, the preparation method thereof comprises the following steps:

[0037] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0038] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then pressing the extract into tablets to obtain tablets.

[0039] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0040] According to an embodiment of the present invention, when the oral preparation is a capsule, the preparation method thereof comprises the following steps:

[0041] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0042] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then filling the extract into capsules to prepare capsules.

[0043] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0044] The present invention provides use of the above-mentioned composition and oral preparation thereof in preparing medicines having the effect of regulating gastrointestinal function.

[0045] The composition of the present invention can be used as a main raw material in the preparation of oral pharmaceutical preparations with the effect of regulating gastrointestinal function.

[0046] The beneficial effects of the present invention are:

[0047] This invention creatively combines traditional medicinal and edible foods with collagen peptides. The synergistic effect of the components can address issues such as poor digestion, loss of appetite, spleen and stomach weakness, and indigestion caused by busy work schedules, irregular meal times, and frequent fast food consumption. The effect is significantly better than similar oral liquids. Furthermore, the flavors of the components are consistent, and the addition of appropriate additives enhances the taste, making it easily accepted by consumers and promising a broad market. DETAILED DESCRIPTION

[0048] The present invention is further described below by way of specific implementation methods, but the scope of application of the present invention is not limited to the following embodiments. Substitutions and / or combinations of the technical features of the present invention within the content, spirit, and / or scope of the present invention will be obvious to those skilled in the art and are encompassed by the present invention.

[0049] The hawthorn, mulberry leaf, emblica fruit, chrysanthemum, kudzu root, yam, poria, ginseng, mangosteen, and additives used in the present invention are commonly available commercially. The collagen peptide is derived from deep-sea fish or freshwater fish, and the donkey-hide gelatin is purchased from Dong'e, Shandong. The amount of water added for decoction and the volume determination in the preparation method of the present invention are conventional techniques, and the liquid concentration is within the conventional range for oral preparations.

[0050] Example 1

[0051] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0052] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g.

[0053] Preparation method:

[0054] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen and boil twice, filter, and combine the filtrates;

[0055] (2) Add the formulated amount of collagen peptide and donkey-hide gelatin to the combined filtrate, add water again and adjust the volume to 1500 mL;

[0056] (3) Sterilize and repackage the fixed volume solution in bottles.

[0057] Example 2

[0058] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0059] Hawthorn 50g, mulberry leaves 7.5g, emblica 2.5g, chrysanthemum 0.8g, kudzu root 1.6g, yam 6g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.2g, mangosteen 0.7g, collagen peptide 80g.

[0060] The preparation method is the same as that of Example 1.

[0061] Example 3

[0062] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0063] Hawthorn 35g, mulberry leaf 10g, emblica fruit 2g, chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g.

[0064] The preparation method is the same as that of Example 1.

[0065] Example 4

[0066] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0067] Hawthorn 35g, mulberry leaves 10g, emblica 2g, Huangshan tribute chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g.

[0068] The preparation method is the same as that of Example 1.

[0069] Example 5

[0070] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0071] Hawthorn 55g, mulberry leaf 6g, emblica fruit 4g, chrysanthemum 1g, kudzu root 1g, yam 4g, poria 6g, ginseng 0.2g, donkey-hide gelatin 0.7g, mangosteen 0.3g, collagen peptide 50g.

[0072] The preparation method is the same as that of Example 1.

[0073] Example 6

[0074] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0075] Hawthorn 25g, mulberry leaves 12g, emblica fruit 1g, chrysanthemum 0.1g, kudzu root 5g, yam 3g, poria 8g, ginseng 0.1g, donkey-hide gelatin 0.9g, mangosteen 0.1g, collagen peptide 40g.

[0076] The preparation method is the same as that of Example 1.

[0077] Example 7

[0078] A composition having the effect of regulating gastrointestinal function, the components and the preparation method thereof are as follows:

[0079] Hawthorn 60g, mulberry leaves 4g, emblica 6g, chrysanthemum 1.2g, kudzu root 0.5g, yam 12g, poria 1g, ginseng 1g, donkey-hide gelatin 0.05g, mangosteen 1g, collagen peptide 100g.

[0080] The preparation method is the same as that of Example 1.

[0081] Example 8

[0082] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0083] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0084] Preparation method:

[0085] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen and boil twice, filter, and combine the filtrates;

[0086] (2) Add the formulated amount of collagen peptide, sweetener, acidulant, and donkey-hide gelatin to the combined filtrate, and add water again to make the volume 1500 mL;

[0087] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0088] Example 9

[0089] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0090] Hawthorn 50g, mulberry leaves 7.5g, emblica 2.5g, chrysanthemum 0.8g, kudzu root 1.6g, yam 6g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.2g, mangosteen 0.7g, collagen peptide 80g, erythritol 51g, L-malic acid 1.2g.

[0091] The preparation method is the same as Example 8.

[0092] Example 10

[0093] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0094] Hawthorn 35g, mulberry leaf 10g, emblica fruit 2g, Huangshan tribute chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g, erythritol 60g, L-malic acid 0.5g.

[0095] The preparation method is the same as Example 8.

[0096] Example 11

[0097] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0098] Hawthorn 25g, mulberry leaf 12g, emblica fruit 1g, chrysanthemum 0.1g, kudzu root 5g, yam 3g, poria 8g, ginseng 0.1g, donkey-hide gelatin 0.9g, mangosteen 0.1g, collagen peptide 40g, erythritol 20g, L-malic acid 2g.

[0099] The preparation method is the same as Example 8.

[0100] Example 12

[0101] A powder with the effect of regulating gastrointestinal function, comprising the following components:

[0102] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0103] Preparation method:

[0104] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen and boil twice, filter and combine the filtrates, concentrate, dry, and grind to obtain a solid powder of the extract;

[0105] (2) The solid powder of the extract is mixed evenly with the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin, and then packaged to obtain a powder.

[0106] Example 13

[0107] A tablet with the effect of regulating gastrointestinal function, comprising the following components:

[0108] Hawthorn 50g, mulberry leaves 7.5g, emblica 2.5g, chrysanthemum 0.8g, kudzu root 1.6g, yam 6g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.2g, mangosteen 0.7g, collagen peptide 80g, erythritol 51g, L-malic acid 1.2g.

[0109] Preparation method:

[0110] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0111] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then pressing the extract into tablets to obtain tablets.

[0112] Example 14

[0113] A capsule having the effect of regulating gastrointestinal function, comprising the following components:

[0114] Hawthorn 35g, mulberry leaf 10g, emblica fruit 2g, Huangshi tribute chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g, erythritol 60g, L-malic acid 0.5g.

[0115] Preparation method:

[0116] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0117] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then filling the extract into capsules to prepare capsules.

[0118] Example 15

[0119] A granule with the effect of regulating gastrointestinal function, comprising the following components:

[0120] Hawthorn 25g, mulberry leaf 12g, emblica fruit 1g, chrysanthemum 0.1g, kudzu root 5g, yam 3g, poria 8g, ginseng 0.1g, donkey-hide gelatin 0.9g, mangosteen 0.1g, collagen peptide 40g, erythritol 20g, L-malic acid 2g.

[0121] Preparation method:

[0122] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0123] (2) Add the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulate and obtain granules.

[0124] Example 16

[0125] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0126] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, maltitol 45g, citric acid 1g.

[0127] The preparation method is the same as Example 8.

[0128] Example 17

[0129] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0130] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 20g, L-malic acid 2g.

[0131] The preparation method is the same as Example 8.

[0132] Example 18

[0133] A powder with the effect of regulating gastrointestinal function, comprising the following components:

[0134] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, xylitol 70g, ascorbic acid 0.1g.

[0135] The preparation method is the same as Example 12.

[0136] Example 19

[0137] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0138] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, mannitol 45g, lactitol 5g, tartaric acid 1g, lactic acid 0.5g.

[0139] The preparation method is the same as Example 8.

[0140] Comparative Example 1

[0141] AXXZIA AG fifth-generation anti-sugar oral liquid, product number: 100020357100.

[0142] Comparative Example 2

[0143] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0144] Hawthorn 15g, mulberry leaf 15g, emblica fruit 7g, chrysanthemum 1.5g, kudzu root 6g, yam 14g, poria 9g, ginseng 1.2g, donkey-hide gelatin 1g, mangosteen 1.3g, collagen peptide 110g.

[0145] The preparation method is the same as that of Example 1.

[0146] Comparative Example 3

[0147] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0148] 2.5g of Pueraria root, 7g of Chinese yam, 4g of Poria cocos, 0.5g of ginseng, 0.4g of donkey-hide gelatin, 0.5g of mangosteen, and 70g of collagen peptide.

[0149] Preparation method:

[0150] (1) Add 600 mL of water to the formula amount of Poria cocos, Chinese yam, ginseng, Pueraria root, and mangosteen and boil twice, filter, and combine the filtrates;

[0151] (2) Add the formulated amount of collagen peptide and donkey-hide gelatin to the combined filtrate, add water again and adjust the volume to 1500 mL;

[0152] (3) Sterilize and repackage the fixed volume solution in bottles.

[0153] Comparative Example 4

[0154] A composition having the effect of regulating gastrointestinal function, comprising the following components:

[0155] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, mangosteen 0.5g, collagen peptide 70g.

[0156] Preparation method:

[0157] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, and mangosteen and boil twice, filter, and combine the filtrates;

[0158] (2) Add the formulated amount of collagen peptide to the combined filtrate, add water again and adjust the volume to 1500 mL;

[0159] (3) Sterilize and repackage the fixed volume solution in bottles.

[0160] Comparative Example 5

[0161] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0162] Hawthorn 15g, mulberry leaf 15g, emblica fruit 7g, chrysanthemum 1.5g, kudzu root 6g, yam 14g, poria 9g, ginseng 1.2g, donkey-hide gelatin 1g, mangosteen 1.3g, collagen peptide 110g, erythritol 75g, L-malic acid 4g.

[0163] The preparation method is the same as Example 8.

[0164] Comparative Example 6

[0165] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0166] Pueraria root 2.5g, Chinese yam 7g, Poria cocos 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0167] Preparation method:

[0168] (1) Add 600 mL of water to the formula amount of Poria cocos, Chinese yam, ginseng, Pueraria root, and mangosteen and boil twice, filter, and combine the filtrates;

[0169] (2) Add the formulated amount of collagen peptide, sweetener, acidulant, and donkey-hide gelatin to the combined filtrate, and add water again to make the volume 1500 mL;

[0170] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0171] Comparative Example 7

[0172] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0173] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0174] Preparation method:

[0175] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, and mangosteen and boil twice, filter, and combine the filtrates;

[0176] (2) Add the formulated amount of collagen peptide, sweetener, and acidulant to the combined filtrate, and add water again to make the volume up to 1500 mL;

[0177] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0178] Comparative Example 8

[0179] An oral liquid with the effect of regulating gastrointestinal function, comprising the following components:

[0180] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 17g, L-malic acid 3g.

[0181] The preparation method is the same as Example 8.

[0182] Comparative Example 9

[0183] Sanwang brand pseudoginseng, tangerine peel, yam, hawthorn, malt, poria oral liquid, national food and health code G20140164, Jiangxi Sanwang Health Products Co., Ltd., main ingredients: pseudoginseng, tangerine peel, yam, hawthorn, malt, poria, white sugar, purified water.

[0184] Experimental Example 1 Effect of the composition of the present invention on rats with spleen deficiency due to dietary disorder

[0185] 1. Materials

[0186] 1.1 Animals:

[0187] Thirty-six SD rats, SPF grade, weighing 200±20 g, were provided by Lunan Pharmaceutical Group Co., Ltd. and were adaptively raised for one week before the experiment.

[0188] 1.2 Medication

[0189] The compositions obtained in Examples 1 and 2 of the present invention and the oral solution of Comparative Example 9 were prepared using domperidone (produced by Xi'an Janssen Pharmaceutical Co., Ltd.).

[0190] 1.2.3 Dosage in rats

[0191] Compositions of Examples 1 and 2: 2 mL / 100 g; oral solution of Comparative Example 9: 2 mL / 100 g; positive control (domperidone): 2 mL / kg.

[0192] 2. Experimental Procedure

[0193] The method used in the spleen and stomach deficiency and cold model is consistent with factors such as irregular diet and excessive consumption of sweet and greasy foods in humans.

[0194] 36 rats are divided into normal control group, spleen deficiency model group, positive control group, embodiment 1 group, embodiment 2 group, comparative example 9 group, every group of rats 6.Except normal control group, gavage refined lard (1mL / 100g) every day, give cabbage to feed simultaneously, continuous modeling 10 days.Normal control group rats, gavage every day give equal volume water, normal feed feeding.Each group is administered 1 time every day, continuous administration 14 days.Before modeling, after modeling, after administration 14 days, weigh each group of rats.

[0195] 3. Statistical processing

[0196] SPSS 19.0 statistical software was used for analysis, and the experimental data were expressed as mean ± standard deviation (x ± SD). One-way analysis of variance (ANOVA) was used for comparison among multiple groups, and P < 0.05 indicated statistical significance.

[0197] 4. Results

[0198] Table 1 Effect of the composition of the present invention on rats with spleen deficiency due to dietary disorder

[0199]

[0200] Note: Compared with the normal group, *P<0.05, **P<0.01;

[0201] Compared with the model group, #P<0.05, ##P<0.0.

[0202] The weights of the animals in each group were similar before and after modeling. After modeling, the weights of the modeling groups were significantly lower than those of the normal control group (P<0.01). Compared with the model group, the weights of the rats in the domperidone group, Example 1 group, and Example 2 group were significantly higher than those in the model group (P<0.01). There was a difference in the weight of the rats in the comparative example 9 group compared with the model group (P<0.05).

[0203] According to Traditional Chinese Medicine (TCM), improper diet, excessive hunger and satiety, and overeating of fatty and sweet foods can damage the spleen and stomach. Feeding rats refined lard and cabbage can damage their spleen and stomach, leading to weight loss. The present composition can significantly improve weight loss in rats caused by spleen and stomach disorders and regulate gastrointestinal function.

[0204] Experimental Example 2 Evaluation of the Gastrointestinal Function Regulating Effect of the Composition of the Present Invention

[0205] 1. Subject population

[0206] A total of 225 volunteers aged 25-40 were recruited. All subjects experienced varying degrees of symptoms, including spleen and stomach weakness, loss of appetite, indigestion, abdominal distension, and poor sleep. None of the subjects had any of the following: acute diarrhea; indigestion caused by severe organic disease; physical weakness that prevented testing; or short-term use of items related to the tested function that could affect the interpretation of the results.

[0207] 2. Experimental process

[0208] The volunteers were randomly divided into nine groups, each with 25 participants. Groups 1 to 4 were tested with the products of Examples 1 to 4, respectively; Group 5 was tested with the product of Example 6; and Groups 6 to 9 were tested with the products of Comparative Example 9 and Comparative Examples 2 to 4, respectively. Each participant took one 30 mL vial once daily after meals for 30 consecutive days. During this period, no medications or products with similar functions, such as those regulating gastrointestinal function or promoting digestion, were used. Lifestyle and dietary habits remained unchanged during the trial.

[0209] Test result judgment criteria:

[0210] (1) Significantly effective: symptoms disappear or are significantly alleviated;

[0211] (2) Effective: symptoms slightly alleviated;

[0212] (3) Ineffective: Symptoms remain unchanged or worsen.

[0213] 3. Results

[0214] Table 2 Evaluation table of the effect of regulating gastrointestinal function of subjects

[0215]

[0216] As can be seen from the results in the table, the content and composition changes of the formula components of embodiment 1-6, comparative example 9 and comparative example 2-4 can cause the change of regulating gastrointestinal effect. Within the scope of protection of the present invention, the gastrointestinal effect of embodiment 1 is the most remarkable, and the effective rate of embodiment 1 to embodiment 3 is higher, and the improvement rate is all higher than 80%. The chrysanthemum of embodiment 4 is selected from Huangshan Gongju, and the gastrointestinal regulating effect is just worse than that of chrysanthemum selected from chrysanthemum in embodiment 3 formula. When the formula quantity is not suitable (comparative example 2), or the prescription is incomplete (comparative example 3,4), regulating gastrointestinal effect is just obviously not as good as embodiment product. In addition, the product of patent of the present invention is all better than the commercially available product described in comparative example 9, shows that the composition of the present invention regulates gastrointestinal effect remarkably.

[0217] Experimental Example 3 Taste Test of the Oral Preparation of the Composition of the Present Invention

[0218] The products obtained in Examples 8, 9, 16, 17, Comparative Example 1, and 8 were subjected to a taste test. Specifically, 90 volunteers were randomly divided into 6 groups, with 15 people in each group. They were asked to taste the six groups of products selected above and evaluate and score the taste of the products, with a total score of 5 points.

[0219] 5 = good taste, acceptable; 4 = good taste, acceptable; 3 = average taste, relatively acceptable; 2 = poor taste, barely acceptable; 1 = very poor taste, unacceptable. This scale includes the ability to use 0.1 points, so there is a possibility of 50 level differences. The results are as follows:

[0220] result

[0221] Table 3 Oral preparation taste test results

[0222]

[0223] From the above scoring results, it can be seen that the taste of the products is acceptable to the public, and the taste of Example 8 is the best. Except for Comparative Example 8, the taste of most of the products is better than Comparative Example 1.

Claims

1. A composition having the effect of regulating gastrointestinal function, characterized in that: The effective ingredients of the composition are composed of the following raw materials in parts by weight: 25-60 parts of hawthorn, 4-12 parts of mulberry leaves, 1-6 parts of emblica, 0.1-1.2 parts of chrysanthemum, 0.5-5 parts of kudzu root, 3-12 parts of yam, 1-8 parts of poria, 0.1-1 parts of ginseng, 0.05-0.9 parts of donkey-hide gelatin, 0.1-1 parts of mangosteen, 40-100 parts of collagen peptide; or 35-55 parts of hawthorn, 6-10 parts of mulberry leaves, 2-4 parts of emblica, 0.3-1 parts of chrysanthemum, kudzu root 1-3 parts, 4-9 parts of yam, 2-6 parts of poria, 0.2-0.8 parts of ginseng, 0.1-0.7 parts of donkey-hide gelatin, 0.3-0.9 parts of mangosteen, 50-90 parts of collagen peptide; or 40 parts of hawthorn, 9 parts of mulberry leaves, 3 parts of emblica, 0.5 part of chrysanthemum, 2.5 parts of kudzu root, 7 parts of yam, 4 parts of poria, 0.5 part of ginseng, 0.4 parts of donkey-hide gelatin, 0.5 part of mangosteen, 70 parts of collagen peptide; the collagen peptide is deep-sea fish collagen peptide or freshwater fish collagen peptide.

2. The composition according to claim 1, wherein The chrysanthemum is selected from the group consisting of Hangbai chrysanthemum, Huangshan tribute chrysanthemum, Bozhou chrysanthemum and Chuzhou chrysanthemum.

3. An oral preparation, characterized in that The oral preparation comprises the composition according to claim 1 or 2.

4. The oral preparation according to claim 3, wherein The oral preparation further comprises pharmaceutically acceptable additives.

5. The oral preparation according to claim 4, wherein The pharmaceutically acceptable additives include 0.1-2 parts of a sour agent and 20-70 parts of a sweetener.

6. The oral preparation according to claim 5, wherein The sweetener is selected from one or more of xylitol, sorbitol, erythritol, and stevioside; the acidulant is selected from one or more of ascorbic acid, gluconic acid, and malic acid.

7. The oral preparation according to claim 3, wherein The oral preparation is powder, granule, oral liquid, capsule or tablet.

8. Use of the composition according to any one of claims 1 to 2 or the oral preparation according to any one of claims 3 to 7 in the preparation of a medicament having the effect of regulating gastrointestinal function.

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