Composition for improving menstrual discomfort and application of composition in oral preparation

Abstract

The invention relates to the technical field of medicines, in particular to a composition for improving menstrual discomfort and application of an oral preparation of the composition in medicines. The composition for improving the menstrual period is 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 medicine oral preparation prepared from the composition disclosed by the invention has the effect of improving menstrual discomfort, 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 for improving menstrual discomfort and application of an oral preparation thereof in medicines. Background Art

[0003] Everyone loves beauty, and the pursuit of external beauty is a modern human need. Healthy skin is clear, radiant, elastic, and free of wrinkles, spots, and acne. Relying solely on external cosmetics and makeup merely covers up and disguises the skin. Targeted internal conditioning, treating the symptoms, can address the root cause and achieve twice the result with half the effort. Many factors can contribute to skin problems, including irregular work and rest, stress, an unbalanced diet, illness, immune system disorders, and aging. Furthermore, women with dysmenorrhea often experience imbalances in their Qi and blood, leading to facial pigmentation, dull complexion, and lack of elasticity. Poor digestion and malnutrition can also contribute to dry, opaque skin.

[0004] 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

[0005] 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. The composition works synergistically and can significantly improve menstrual discomfort, such as dysmenorrhea, chest pain, cold limbs, oligomenorrhea, blood clots and other problems.

[0006] In order to achieve the above-mentioned object of the present invention, the present invention provides the following technical solutions:

[0007] 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.

[0008] 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.

[0009] 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.

[0010] The collagen peptide is deep-sea fish collagen peptide or freshwater fish collagen peptide.

[0011] 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.

[0012] The preparation method of the composition for improving menstruation comprises the following steps:

[0013] (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;

[0014] (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;

[0015] (3) Sterilize and repackage the fixed volume solution in bottles.

[0016] 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.

[0017] 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.

[0018] The present invention provides an oral preparation comprising the above composition.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] According to a preferred embodiment of the present invention, the oral preparation is a powder, granules, oral liquid, capsule or tablet.

[0023] According to a preferred embodiment of the present invention, the oral preparation is a powder, granules, oral liquid, capsule or tablet.

[0024] According to an embodiment of the present invention, when the oral preparation is an oral liquid, the preparation method thereof comprises the following steps:

[0025] (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;

[0026] (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;

[0027] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0028] 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.

[0029] 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.

[0030] According to an embodiment of the present invention, when the oral preparation is a powder, the preparation method thereof comprises the following steps:

[0031] (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;

[0032] (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.

[0033] 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.

[0034] According to a preferred embodiment of the present invention, when the oral preparation is a granule, the steps include:

[0035] (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.

[0036] (2) Add the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulate and obtain granules.

[0037] 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.

[0038] According to an embodiment of the present invention, when the oral preparation is a tablet, the preparation method thereof comprises the following steps:

[0039] (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.

[0040] (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.

[0041] 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.

[0042] According to an embodiment of the present invention, when the oral preparation is a capsule, the preparation method thereof comprises the following steps:

[0043] (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.

[0044] (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.

[0045] 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.

[0046] The present invention provides use of the above-mentioned composition and oral preparation thereof in preparing medicines for improving menstrual discomfort.

[0047] The composition of the present invention can be used as a main raw material in the preparation of oral pharmaceutical preparations for improving menstrual discomfort.

[0048] The improvement of menstrual discomfort refers to improving one or more menstrual discomfort symptoms including dysmenorrhea, chest pain, cold limbs, oligomenorrhea, and blood clots in menstrual blood.

[0049] The beneficial effects of the present invention are:

[0050] The present invention creatively combines traditional medicinal and edible foods with collagen peptides. The components act synergistically, and after two months of continuous use, it can alleviate one or more of the following menstrual discomforts: dysmenorrhea, chest pain, cold extremities, oligomenorrhea, and blood clots. The product is easy to carry and can be used long-term, outperforming 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 prospect. DETAILED DESCRIPTION

[0051] 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.

[0052] 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.

[0053] Example 1

[0054] A composition for improving menstrual discomfort, comprising the following components:

[0055] 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.

[0056] Preparation method:

[0057] (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;

[0058] (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;

[0059] (3) Sterilize and repackage the fixed volume solution in bottles.

[0060] Example 2

[0061] A composition for improving menstrual discomfort, comprising the following components:

[0062] 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.

[0063] The preparation method is the same as that of Example 1.

[0064] Example 3

[0065] A composition for improving menstrual discomfort, comprising the following components:

[0066] 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.

[0067] The preparation method is the same as that of Example 1.

[0068] Example 4

[0069] A composition for improving menstrual discomfort, comprising the following components:

[0070] 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.

[0071] The preparation method is the same as that of Example 1.

[0072] Example 5

[0073] A composition for improving menstrual discomfort, comprising the following components:

[0074] 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.

[0075] The preparation method is the same as that of Example 1.

[0076] Example 6

[0077] A composition for improving menstrual discomfort, comprising the following components:

[0078] 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.

[0079] The preparation method is the same as that of Example 1.

[0080] Example 7

[0081] A composition for improving menstrual discomfort, the components and preparation method thereof are as follows:

[0082] 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.

[0083] The preparation method is the same as that of Example 1.

[0084] Example 8

[0085] An oral liquid for improving menstrual discomfort, comprising the following components:

[0086] 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.

[0087] Preparation method:

[0088] (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;

[0089] (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;

[0090] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0091] Example 9

[0092] An oral liquid for improving menstrual discomfort, comprising the following components:

[0093] 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.

[0094] The preparation method is the same as Example 8.

[0095] Example 10

[0096] An oral liquid for improving menstrual discomfort, comprising the following components:

[0097] 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.

[0098] The preparation method is the same as Example 8.

[0099] Example 11

[0100] An oral liquid for improving menstrual discomfort, comprising the following components:

[0101] 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.

[0102] The preparation method is the same as Example 8.

[0103] Example 12

[0104] A powder for improving menstrual discomfort, comprising the following components:

[0105] 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.

[0106] Preparation method:

[0107] (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;

[0108] (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.

[0109] Example 13

[0110] A tablet for improving menstrual discomfort, comprising the following components:

[0111] 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.

[0112] Preparation method:

[0113] (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 filtrate and concentrate to obtain an extract.

[0114] (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.

[0115] Example 14

[0116] A capsule for improving menstrual discomfort, comprising the following components:

[0117] 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.

[0118] Preparation method:

[0119] (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 filtrate and concentrate to obtain an extract.

[0120] (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.

[0121] Example 15

[0122] A granule for improving menstrual discomfort, comprising the following components:

[0123] 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.

[0124] Preparation method:

[0125] (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 filtrate and concentrate to obtain an extract.

[0126] (2) Add the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulate and obtain granules.

[0127] Example 16

[0128] An oral liquid for improving menstrual discomfort, comprising the following components:

[0129] 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.

[0130] The preparation method is the same as Example 8.

[0131] Example 17

[0132] An oral liquid for improving menstrual discomfort, comprising the following components:

[0133] 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.

[0134] The preparation method is the same as Example 8.

[0135] Example 18

[0136] A powder for improving menstrual discomfort, comprising the following components:

[0137] 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.

[0138] The preparation method is the same as Example 12.

[0139] Example 19

[0140] An oral liquid for improving menstrual discomfort, comprising the following components:

[0141] 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.

[0142] The preparation method is the same as Example 8.

[0143] Comparative Example 1

[0144] AXXZIA AG fifth-generation anti-sugar oral liquid, product number: 100020357100.

[0145] Comparative Example 2

[0146] A composition for improving menstruation, comprising the following components:

[0147] 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.

[0148] The preparation method is the same as that of Example 1.

[0149] Comparative Example 3

[0150] A composition for improving menstruation, comprising the following components:

[0151] 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.

[0152] Preparation method:

[0153] (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;

[0154] (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;

[0155] (3) Sterilize and repackage the fixed volume solution in bottles.

[0156] Comparative Example 4

[0157] A composition for improving menstruation, comprising the following components:

[0158] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, mangosteen 0.5g, collagen peptide 70g.

[0159] Preparation method:

[0160] (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;

[0161] (2) Add the formulated amount of collagen peptide to the combined filtrate, add water again and adjust the volume to 1500 mL;

[0162] (3) Sterilize and repackage the fixed volume solution in bottles.

[0163] Comparative Example 5

[0164] An oral liquid for improving menstruation, comprising the following components:

[0165] 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.

[0166] The preparation method is the same as Example 8.

[0167] Comparative Example 6

[0168] An oral liquid for improving menstruation, comprising the following components:

[0169] 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.

[0170] Preparation method:

[0171] (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;

[0172] (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;

[0173] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0174] Comparative Example 7

[0175] An oral liquid for improving menstruation, comprising the following components:

[0176] Hawthorn 40g, mulberry leaf 9g, emblica 3g, chrysanthemum 0.5g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0177] Preparation method:

[0178] (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;

[0179] (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;

[0180] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0181] Comparative Example 8

[0182] An oral liquid for improving menstruation, comprising the following components:

[0183] 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.

[0184] The preparation method is the same as Example 8.

[0185] Comparative Example 9

[0186] Edible ginseng and donkey-hide gelatin paste, product number: 70538262915, main ingredients: purified water, ginseng, donkey-hide gelatin, black wolfberry, mulberry, pectin, vitamin C, citric acid.

[0187] Example 1 Study on the Effect of the Composition of the Present Invention on Primary Dysmenorrhea in Rats

[0188] 1. Materials

[0189] 1.1 Animals:

[0190] Thirty 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.

[0191] 1.2 Medication

[0192] The compositions obtained in Examples 1 and 2 of the present invention and the oral solution of Comparative Example 9.

[0193] 1.3 Dosage in rats

[0194] Compositions of Examples 1 and 2: 2 mL / 100 g / d; oral solution of Comparative Example 9: 2 mL / 100 g / d.

[0195] 2. Experimental Procedure

[0196] 2.1 Modeling

[0197] Thirty rats were divided into a normal control group, a dysmenorrhea model group, an Example 1 group, an Example 2 group, and a comparative example 9 group, with six rats in each group. Except for the normal control group, the rats in each of the remaining groups were subcutaneously injected with diethylstilbestrol injection for 10 consecutive days (0.8 mg / rat per day on the first and tenth days, and 0.4 mg / rat per day on the remaining eight days) to increase the sensitivity of the uterus to oxytocin. Furthermore, except for the rats in the blank control group, which were immersed in room temperature water for 5 minutes at 10 a.m. every day, the rats in each of the remaining groups were immersed in ice water for 5 minutes at 10 a.m. every day. Forty minutes after the last immersion on the tenth day, each rat was intraperitoneally injected with 2 U of oxytocin, and the rats' writhing reactions were then observed.

[0198] 2.2 Administration

[0199] Starting from the fourth day after model establishment, rats in each group were gavaged with the corresponding oral preparation. The normal control group and dysmenorrhea model group were gavaged with an equal amount of distilled water (2 mL / 100 g / d).

[0200] 2.3 Detection indicators

[0201] The number of writhing reactions of each rat within 30 minutes after intraperitoneal injection of oxytocin and the number of animals writhing in each group were observed and recorded, and the incidence rate and number of writhing reactions were calculated.

[0202] The incidence of writhing = the number of writhing animals in each group / the total number of experimental animals in each group × 100%

[0203] Number of writhing = number of writhing events in each group / total number of experimental animals in each group × 100%

[0204] 3 Statistical processing

[0205] 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.

[0206] 4 Results

[0207] Table 1 Effect of the composition of the present invention on rats with primary dysmenorrhea

[0208]

[0209] Note: Compared with the model group, #P<0.05, ##P<0.01.

[0210] As shown in Table 1, the oral formulations of Examples 1, 2, and Comparative Example 9 all reduced the incidence of writhing in rats. In particular, the composition of Example 1 was able to control the incidence of writhing to 16.7%. The oral formulations of Examples 1, 2, and 9 all reduced the number of writhing episodes, with statistically significant differences compared to the model group (Example 1 and Example 2, P < 0.01; Comparative Example 1, P < 0.05). These results demonstrate that the oral formulations of the present invention have significant analgesic effects and can alleviate dysmenorrhea.

[0211] Experimental Example 2 Evaluation of the Effect of the Composition of the Present Invention on Improving Menstruation

[0212] 1. Subject population

[0213] 135 volunteers with premenstrual syndrome were randomly divided into 9 groups, with 15 people in each group. All the volunteers had one or more menstrual problems such as dysmenorrhea, chest pain, cold limbs, scanty menstrual bleeding, and blood clots.

[0214] 2. Experimental process

[0215] The first group tried the product of Example 1, the second group tried the product of Example 2, the third group tried the product of Example 3, the fourth group tried the product of Example 4, the fifth group tried the product of Example 6, the sixth group tried the product of Comparative Example 9, the seventh group tried the product of Comparative Example 2, the eighth group tried the product of Comparative Example 3, and the ninth group tried the product of Comparative Example 4.

[0216] Each person took one 30ml vial once daily after meals for two consecutive months, suspending use during menstruation. No other conditioning products were used during this period. The statistical results are shown in Table 2.

[0217] 3. Results

[0218] Table 2 Evaluation table of subjects' improvement of menstrual period effect

[0219]

[0220] As can be seen from the results in the table, changes in the content and composition of the formula components of Examples 1-6, Comparative Example 9 and Comparative Examples 2-4 will cause changes in the effect of improving menstruation. The effect of improving menstruation in Example 1 is the most significant. The effects of improving menstruation in Comparative Examples 2 and 3 are second best. The chrysanthemum in Example 4 is selected from Huangshan Gongju, and the effect of improving menstruation is worse than that in the formula of Example 3 in which the chrysanthemum is selected from Hangbaiju. Moreover, from the data, the products of the embodiments of the present invention are more focused on improving dysmenorrhea and menstrual blood clots. In addition, the effectiveness of the embodiment products in improving menstruation is higher than 60%, and most of them are better than the product of Comparative Example 9. When the formula amount is not appropriate (Comparative Example 2) or the prescription is incomplete (Comparative Examples 3 and 4), the effect of improving menstruation is obviously not as good as the embodiment products, indicating that the composition of the present invention is significantly effective in improving menstruation.

[0221] Experimental Example 3 Taste Test of the Oral Preparation of the Composition of the Present Invention

[0222] 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.

[0223] 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:

[0224] result

[0225] Table 3 Oral preparation taste test results

[0226]

[0227] 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 for improving menstrual discomfort, 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 for improving menstrual discomfort.

9. The use according to claim 8, characterized in that The improvement of menstrual discomfort refers to improving one or more menstrual discomfort symptoms including dysmenorrhea, chest pain, cold limbs, oligomenorrhea, and blood clots in menstrual blood.

10. The use according to claim 9, characterized in that The improvement of menstrual discomfort is to improve at least one of the menstrual discomfort symptoms of dysmenorrhea and blood clots during menstruation.

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