Preparation for promoting gastrointestinal digestion and preparation method and application thereof

Abstract

The invention discloses a preparation for promoting gastrointestinal tract digestion and a preparation method and application thereof. The preparation comprises the following components in parts by weight: 20-40 parts of hawthorn, 30-50 parts of fried malt, 60-80 parts of Chinese yam, 3-18 parts of pericarpium citri reticulatae, 10-30 parts of radix fici simplicissimae, 10-30 parts of hericium erinaceus, 3-18 parts of liquorice, 20-40 parts of bifidobacterium animalis subsp. Lactis, 20-40 parts of casei casei, 20-40 parts of plant lactobacillus and 3-18 parts of lactobacillus acidophilus. In the preparation, the traditional Chinese medicine formula has the effects of strengthening the spleen and stomach, promoting digestion and relieving stagnation, the probiotics regulate intestinal flora balance and promote digestion and absorption of the body, the traditional Chinese medicine formula and the probiotics synergistically play a role in promoting digestion, improving gastrointestinal motility and promoting secretion of gastric juice and pepsase, and the preparation has a positive effect on maintaining gastrointestinal health.

Description

Technical Field

[0001] The present invention relates to the technical field of functional foods, and in particular to a preparation for promoting gastrointestinal digestion, and a preparation method and application thereof. Background Art

[0002] Functional dyspepsia (FD) is a common functional gastrointestinal disease in clinical practice, which is manifested by symptoms of indigestion in the stomach and duodenum, mainly postprandial fullness, early satiety, upper abdominal pain and burning sensation in the upper abdomen, without organic, systemic and metabolic diseases. Functional dyspepsia is also a common disease in children, accounting for more than 40% of pediatric internal medicine outpatient clinics. FD can affect the growth, nutritional status, physical and intellectual development of children, and even affect their normal life in severe cases. Traditional Chinese medicine classifies FD as a disease of "fullness, stomachache, abdominal distension", etc. Through the application of Chinese medicine for regulating qi, strengthening the spleen, and digestion, it can effectively improve symptoms such as fullness, stomachache, abdominal distension, and loss of appetite.

[0003] Modern research shows that patients with indigestion are usually accompanied by problems such as intestinal flora imbalance and slow intestinal motility. Probiotics can regulate the balance of intestinal flora and improve intestinal function, which can improve the symptoms of indigestion. Probiotics are mainly found in the digestive tract of humans and animals. They can regulate the balance of intestinal flora, enhance the barrier function of intestinal mucosa, produce antibacterial substances, promote nutrient absorption, maintain intestinal health, and have a beneficial effect on human health. When consumed in appropriate doses, probiotics can have a positive effect on human health by improving the balance of microorganisms in the gastrointestinal tract. The metabolites of probiotics can affect the pH of the intestine, thereby affecting the digestion and absorption of nutrients by the host. For example, Lactobacillus can produce a variety of vitamins and amino acids to help the human body absorb trace elements such as calcium and iron; Bifidobacterium can produce digestive enzymes to promote the conversion of fats, proteins, and carbohydrates into soluble substances and improve the body's digestion and absorption functions. The applications of probiotics in functional foods mainly include promoting digestive system function (promoting digestion and absorption), enhancing immune system function (enhancing the body's immune response ability), reducing carcinogenic risks (inhibiting the growth of harmful bacteria and thus reducing the production of carcinogens), etc.

[0004] Traditional Chinese medicine has the characteristics and advantages of stable action, overall conditioning, and root cause treatment, which are similar to modern microecological theories and ideas. Studies have found that probiotics can promote the metabolism of polysaccharides and glycosides in traditional Chinese medicine in the intestine, and the metabolized polysaccharides or glycosides can also play a prebiotic role and promote the growth of probiotics. Polyphenols in traditional Chinese medicine also have the effect of promoting the growth of probiotics such as lactobacillus and bifidobacterium in the intestine. The compound preparation of traditional Chinese medicine and probiotics has the effect of maintaining the stability of intestinal flora, and the comprehensive application effect is better than that of traditional Chinese medicine or probiotics alone. However, different proportions of traditional Chinese medicine and probiotics have different effects on intestinal digestion and absorption functions. Therefore, it is of great significance to explore traditional Chinese medicine and probiotics with good digestive function in improving functional dyspepsia and maintaining gastrointestinal health.

[0005] Dry granulation is a production process that directly makes granules by compacting and crushing powder raw materials through rollers. It can improve the physical properties of raw powders and solve the problems of uneven powder particle size, uneven density, poor fluidity, and easy stratification. However, the yield rate of dry granulation and the particle size of the obtained granules are affected by both the components in the formula and the granulation conditions; on the other hand, the scientific nature of the entire formula and the efficacy of each component must also be considered comprehensively. Therefore, it is very important to balance the quality performance and efficacy of the preparations obtained after dry granulation. Summary of the invention

[0006] In order to overcome the above-mentioned defects and shortcomings in the prior art, the present invention provides a preparation for promoting gastrointestinal digestion and a preparation method and application thereof.

[0007] The first object of the present invention is to provide a composition.

[0008] The second object of the present invention is to provide the use of the above composition in preparing a preparation for promoting gastrointestinal digestion.

[0009] The third object of the present invention is to provide a preparation.

[0010] The fourth object of the present invention is to provide a method for preparing the above-mentioned preparation.

[0011] Therefore, the present invention claims the following:

[0012] A composition comprises, by weight, 20 to 40 parts of hawthorn, 30 to 50 parts of roasted malt, 60 to 80 parts of yam, 3 to 18 parts of tangerine peel, 10 to 30 parts of five-fingered peach, 10 to 30 parts of hericium erinaceus, 3 to 18 parts of liquorice, 20 to 40 parts of Bifidobacterium animalis subsp. lactis V9, 20 to 40 parts of Lactobacillus Casei Zhang, 20 to 40 parts of Lactobacillus plantarum P-8 and 3 to 18 parts of Lactobacillus acidophilus LA-06.

[0013] Preferably, by weight, the traditional Chinese medicine composition comprises 30 parts of hawthorn, 40 parts of roasted malt, 70 parts of yam, 10 parts of tangerine peel, 20 parts of five-fingered peach, 20 parts of Hericium erinaceus, 10 parts of licorice, 30 parts of Bifidobacteriumanimalis subsp.lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8 and 10 parts of Lactobacillus acidophilus LA-06.

[0014] In the composition of the present invention, hawthorn is sour and sweet, and malt is sweet and flat, both enter the spleen and stomach meridians, and the two medicines are used together, which is good at tonifying the middle and strengthening the stomach, digesting food and removing accumulation; Chinese yam is sweet and flat, can tonify the qi of the spleen, lung and kidney, and is good at treating spleen deficiency, less food, fatigue and weakness; Tangerine peel is bitter and pungent, warm in nature, pungent and bitter, good at regulating qi and strengthening the spleen, and harmonizing the middle and guiding stagnation; Five-fingered hair peach and Hericium erinaceus can both tonify the qi of the spleen and stomach, and have the effect of strengthening the spleen and nourishing the stomach; Licorice is sweet and flat and can be supplemented, enters the middle jiao, can strengthen the spleen and harmonize the stomach, not only has the effect of strengthening the overall spleen and stomach, but also can reconcile various medicines. The compatibility of various medicines can invigorate the spleen and stomach, make it regular, and the qi movement is not stagnant, which can reach the effect of invigorating the spleen and harmonizing the stomach, digesting food and removing stagnation. Animal Bifidobacterium lactis subspecies, Lactobacillus casei, Plant Lactobacillus and Lactobacillus acidophilus are all common probiotics, which have the functions of regulating the balance of intestinal flora, promoting digestion and absorption of the body, and maintaining intestinal health. The use of Chinese herbal formula supplemented with probiotics can comprehensively exert the functions of Chinese medicine and probiotics, achieve the purpose of synergistic enhancement, and enhance the effect of promoting digestive function.

[0015] In the composition of the present invention, the viable counts of Bifidobacterium animalis subsp. lactis V9, 20 to 40 parts of Lactobacillus Casei Zhang, Lactobacillus plantarum P-8 and Lactobacillus acidophilus LA-06 are all 10 8 ~10 10 CFU / g.

[0016] Preferably, the roasted malt is plain roasted malt, which enhances the effect of digestion and promoting qi circulation.

[0017] Preferably, the yam is fried yam with bran, which enhances the effect of strengthening the spleen and replenishing qi.

[0018] Use of any of the above compositions in the preparation of a preparation for promoting gastrointestinal digestion.

[0019] Preferably, the promoting gastrointestinal digestion is promoting the secretion of gastric juice and / or pepsin.

[0020] Preferably, the promoting gastrointestinal digestion is to increase the activity of pepsin.

[0021] Preferably, the promoting gastrointestinal digestion is promoting gastric emptying and / or intestinal motility.

[0022] As an practicable manner, the preparation includes but is not limited to medicines and health foods, the medicines also include pharmaceutically acceptable excipients, and the health foods also include food-acceptable additives.

[0023] A preparation comprising any one of the above-mentioned compositions.

[0024] The preparation method of the above-mentioned preparation comprises the following steps:

[0025] S1. Hawthorn, fried malt, yam, tangerine peel, five-fingered peach, Hericium erinaceus and licorice were crushed to obtain a Chinese medicine powder;

[0026] S2. Bifidobacterium animalis subsp. lactis V9, Lactobacillus Casei Zhang, Lactobacillus plantarum P-8 and Lactobacillus acidophilus LA-06 are fully mixed with the above-mentioned broken wall powder according to a ratio, the pressure is set to 115-125 bar, and a preparation with a moisture mass fraction of 6.5-7.5% is prepared by dry granulation.

[0027] Preferably, in step S1, hawthorn, roasted malt, yam, tangerine peel, quinoa chinensis, hericium erinaceus and licorice are first crushed into powders of 60-120 meshes before the wall-breaking and crushing.

[0028] Preferably, in step S1, the particle size D of the Chinese medicine wall-broken powder is 90 15~75μm.

[0029] The preparation is formulated with specific components, and has the functions of promoting digestion, improving gastrointestinal motility, and promoting the secretion of gastric juice and pepsin. In addition, auxiliary materials (oligofructose, lactitol, erythritol, etc.) can be added as prebiotics to improve its solubility and taste, and better acceptance.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] The invention discloses a preparation for promoting gastrointestinal digestion, a preparation method and an application thereof. In the preparation, a Chinese medicine formula strengthens the spleen and stomach, and digests food and relieves stagnation; probiotics regulate the balance of intestinal flora and promote digestion and absorption of the body; the Chinese medicine formula and the probiotics synergistically play a digestive promotion function, improve gastrointestinal motility and promote the secretion of gastric juice and pepsin, increase the activity of pepsin and promote gastric emptying and intestinal peristalsis, and have a positive effect on maintaining gastrointestinal health.

[0032] The preparation of the present invention is compatible with a specific formula of broken wall powder of traditional Chinese medicine and probiotics, so that the probiotics promote the metabolism of traditional Chinese medicine, and the metabolites of traditional Chinese medicine provide nutrients for the probiotics to play the role of prebiotics, participate in the regulation of intestinal flora, and promote the colonization and growth of probiotics to achieve a mutually promoting effect.

[0033] The preparation method of the invention adopts a dry granulation process after mixing the broken wall powder of traditional Chinese medicine with the probiotic powder, so that the finished product yield is good, the retention rate of live bacteria is high, and the stability of live bacteria during the storage period is good. DETAILED DESCRIPTION

[0034] The present invention is further described below with reference to specific examples, but the examples do not limit the present invention in any form. Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in the art.

[0035] Unless otherwise specified, the reagents and materials used in the following examples are commercially available.

[0036] The viable counts of Bifidobacterium animalis subsp. lactis V9, Lactobacillus Casei Zhang, Lactobacillus plantarum P-8 and Lactobacillus acidophilus LA-06 used in the Examples and Comparative Examples were all 10 8 ~10 10 CFU / g.

[0037] Example 1

[0038] This embodiment provides a formulation of granules, comprising the following components calculated by weight:

[0039] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried tangerine peels, 20 parts of five-fingered peaches, 20 parts of hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06.

[0040] This example was prepared by the following method:

[0041] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D 90 <45μm broken wall powder;

[0042] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8 and Lactobacillus acidophilus LA-06 with the above-mentioned broken cell wall powder according to a proportion;

[0043] (3) The mass fraction of moisture in the material was controlled at 6.5%, and dry granulation was adopted. The pressure was set to 120 bar, and the granules were made by rolling and sieving.

[0044] Example 2

[0045] This embodiment provides a formulation of granules, comprising the following components calculated by weight:

[0046] 40 parts of hawthorns, 30 parts of roasted malt, 80 parts of yam, 3 parts of dried tangerine peel, 30 parts of five-fingered peach, 10 parts of hericium erinaceus, 18 parts of liquorice; 20 parts of Bifidobacterium animalis subsp. lactis V9, 40 parts of Lactobacillus Casei Zhang, 20 parts of Lactobacillus plantarum P-8, and 18 parts of Lactobacillus acidophilus LA-06.

[0047] This example was prepared by the following method:

[0048] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 60 mesh according to the proportion, and then crush it into D 90 <75μm broken wall powder;

[0049] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken wall powder according to a proportion;

[0050] (3) The mass fraction of moisture in the material was controlled to be 7.0%, and dry granulation was adopted. The pressure was set to 115 bar, and the granules were made by rolling and sieving.

[0051] Example 3

[0052] This embodiment provides a formulation of granules, comprising the following components calculated by weight:

[0053] 20 parts of hawthorns, 50 parts of roasted malt, 60 parts of yam, 18 parts of dried orange peels, 10 parts of five-fingered peaches, 30 parts of hericium erinaceus, 3 parts of liquorice; 40 parts of Bifidobacterium animalis subsp. lactis V9, 20 parts of Lactobacillus Casei Zhang, 40 parts of Lactobacillus plantarum P-8, and 3 parts of Lactobacillus acidophilus LA-06.

[0054] This example was prepared by the following method:

[0055] (1) Crush hawthorn, roasted malt, Chinese yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 80 mesh according to the proportion, and then crush it into D 90 <15μm broken wall powder;

[0056] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken cell wall powder according to a proportion;

[0057] (3) The mass fraction of moisture in the material was controlled at 7.5%, and dry granulation was adopted. The pressure was set to 125 bar, and the material was rolled and sieved to prepare granules.

[0058] Example 4

[0059] This embodiment provides a formulation of granules, comprising the following components calculated by weight:

[0060] 35 parts of hawthorns, 35 parts of roasted malt, 75 parts of yam, 5 parts of dried orange peels, 25 parts of five-fingered peaches, 15 parts of hericium erinaceus, 15 parts of liquorice; 25 parts of Bifidobacterium animalis subsp. lactis V9, 35 parts of Lactobacillus Casei Zhang, 25 parts of Lactobacillus plantarum P-8 and 15 parts of Lactobacillus acidophilus LA-06.

[0061] This example was prepared by the following method:

[0062] (1) Crush hawthorn, roasted malt, Chinese yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 60 mesh according to the proportion, and then crush it into D90 <75μm broken wall powder;

[0063] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken cell wall powder according to a proportion;

[0064] (3) The mass fraction of moisture in the material was controlled at 6.8%, and dry granulation was adopted. The pressure was set to 118 bar, and the granules were made by rolling and sieving.

[0065] Example 5

[0066] This embodiment provides a formulation of granules, comprising the following components calculated by weight:

[0067] 25 parts of hawthorns, 45 parts of roasted malt, 65 parts of yam, 15 parts of dried tangerine peels, 15 parts of five-fingered peaches, 25 parts of hericium erinaceus, 5 parts of liquorice; 35 parts of Bifidobacterium animalis subsp. lactis V9, 25 parts of Lactobacillus Casei Zhang, 35 parts of Lactobacillus plantarum P-8, and 5 parts of Lactobacillus acidophilus LA-06.

[0068] This example was prepared by the following method:

[0069] (1) Crush hawthorn, roasted malt, Chinese yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 80 mesh according to the proportion, and then crush it into D 90 <15μm broken wall powder;

[0070] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken cell wall powder according to a proportion;

[0071] (3) The mass fraction of moisture in the material was controlled at 7.3%, and dry granulation was adopted. The pressure was set to 123 bar, and the granules were made by rolling and sieving.

[0072] Comparative Example 1

[0073] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0074] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried orange peels, 20 parts of five-fingered peaches, 20 parts of hericium erinaceus, and 10 parts of liquorice.

[0075] This comparative example was prepared by the following method:

[0076] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D 90 <45μm broken wall powder;

[0077] (2) fully mixing the above-mentioned broken wall powder;

[0078] (3) The mass fraction of moisture in the material was controlled to be 10.0%, and dry granulation was adopted. The pressure was set to 120 bar, and the granules were made by rolling and sieving.

[0079] Comparative Example 2

[0080] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0081] 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06;

[0082] In order to ensure the feasibility of the preparation molding process and provide nutrition for the probiotics, 30 parts of oligofructose, 30 parts of lactitol, 70 parts of erythritol and 70 parts of maltodextrin were added.

[0083] This comparative example was prepared by the following method:

[0084] The components were fully mixed according to the proportions, the mass fraction of moisture in the materials was controlled to be 6.5%, dry granulation was adopted, the pressure was set to 60 bar, rolling and sieving were performed to prepare granules.

[0085] Comparative Example 3

[0086] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0087] 30 parts of hawthorn, 40 parts of roasted malt, 70 parts of Poria, 10 parts of white hyacinth bean, 20 parts of five-fingered peach, 20 parts of Hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06.

[0088] This comparative example was prepared by the following method:

[0089] (1) Grind hawthorn, roasted malt, Poria cocos, white lentil, five-fingered peach, Hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then grind into D 90 <45μm broken wall powder;

[0090] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken wall powder according to a proportion;

[0091] (3) The mass fraction of moisture in the material was controlled at 6.5%, and dry granulation was adopted. The pressure was set to 120 bar, and the granules were made by rolling and sieving.

[0092] Comparative Example 4

[0093] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0094] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried orange peels, 20 parts of pseudoginseng, 20 parts of hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8 and 10 parts of Lactobacillus acidophilus LA-06.

[0095] This comparative example was prepared by the following method:

[0096] (1) Crush hawthorn, roasted malt, Chinese yam, dried orange peel, Pseudostellaria heterophylla, Hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush into D90 <45μm broken wall powder;

[0097] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken cell wall powder according to a proportion;

[0098] (3) The mass fraction of moisture in the material was controlled at 6.5%, and dry granulation was adopted. The pressure was set to 120 bar, and the granules were made by rolling and sieving.

[0099] Comparative Example 5

[0100] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0101] 50 parts of hawthorns, 60 parts of roasted malt, 50 parts of yam, 20 parts of dried orange peels, 40 parts of five-fingered peaches, 5 parts of hericium erinaceus, 2 parts of liquorice; 50 parts of Bifidobacterium animalis subsp. lactis V9, 50 parts of Lactobacillus Casei Zhang, 50 parts of Lactobacillus plantarum P-8, and 20 parts of Lactobacillus acidophilus LA-06.

[0102] This comparative example was prepared by the following method:

[0103] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D 90 <45μm broken wall powder;

[0104] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken cell wall powder according to a proportion;

[0105] (3) The mass fraction of moisture in the material was controlled to be 7.0%, and dry granulation was adopted. The pressure was set to 125 bar, and the granules were made by rolling and sieving.

[0106] Comparative Example 6

[0107] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0108] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried tangerine peels, 20 parts of five-fingered peaches, 20 parts of hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06.

[0109] This comparative example was prepared by the following method:

[0110] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D 90 <45μm broken wall powder;

[0111] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken wall powder according to a proportion;

[0112] (3) The mass fraction of moisture in the material was controlled at 6.5%, and dry granulation was adopted. The pressure was set to 130 bar, and the granules were made by rolling and sieving.

[0113] Comparative Example 7

[0114] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0115] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried tangerine peels, 20 parts of five-fingered peaches, 20 parts of hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06.

[0116] This comparative example was prepared by the following method:

[0117] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D90 <45μm broken wall powder;

[0118] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, and Lactobacillus acidophilus LA-06 with the above-mentioned broken cell wall powder;

[0119] (3) The mass fraction of moisture in the material was controlled at 6.5%, and dry granulation was adopted. The pressure was set to 110 bar, and the granules were made by rolling and sieving.

[0120] Comparative Example 8

[0121] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0122] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried tangerine peels, 20 parts of five-fingered peaches, 20 parts of hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06.

[0123] This comparative example was prepared by the following method:

[0124] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D 90 <45μm broken wall powder;

[0125] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken wall powder according to a proportion;

[0126] (3) The mass fraction of moisture in the material was controlled at 5.5%, and dry granulation was adopted. The pressure was set to 140 bar, and the granules were made by rolling and sieving.

[0127] Comparative Example 9

[0128] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0129] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried tangerine peels, 20 parts of five-fingered peaches, 20 parts of hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06.

[0130] This comparative example was prepared by the following method:

[0131] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D 90 <45μm broken wall powder;

[0132] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken wall powder according to a proportion;

[0133] (3) The mass fraction of moisture in the material was controlled to be 10.0%, and dry granulation was adopted. The pressure was set to 100 bar, and the material was rolled and sieved to prepare granules.

[0134] Comparative Example 10

[0135] This comparative example provides a formulation of granules, comprising the following components calculated by weight:

[0136] 30 parts of hawthorns, 40 parts of roasted malt, 70 parts of yam, 10 parts of dried tangerine peels, 20 parts of five-fingered peaches, 20 parts of hericium erinaceus, 10 parts of liquorice; 30 parts of Bifidobacterium animalis subsp. lactis V9, 30 parts of Lactobacillus Casei Zhang, 30 parts of Lactobacillus plantarum P-8, and 10 parts of Lactobacillus acidophilus LA-06.

[0137] This comparative example was prepared by the following method:

[0138] (1) Crush hawthorn, roasted malt, yam, tangerine peel, five-fingered peach, hericium erinaceus, and licorice into fine powder of about 120 mesh according to the proportion, and then crush it into D90 <45μm broken wall powder;

[0139] (2) thoroughly mixing Bifidobacterium animalis subspecies lactis V9, Lactobacillus casei Zhang, Lactobacillus plantarum P-8, Lactobacillus acidophilus LA-06 and the above-mentioned broken wall powder according to a proportion;

[0140] (3) The mass fraction of moisture in the material was controlled at 10.5%, and dry granulation was adopted. The pressure was set to 100 bar, and the granules were made by rolling and sieving.

[0141] Test Example 1

[0142] 1. Experimental Methods

[0143] The granules prepared in the above Examples 1 to 5 and Comparative Examples 1 to 10 were compared and analyzed in terms of the finished product yield during the preparation process, the live bacteria retention rate in the finished granules, and the live bacteria stability during the storage of the granules under the same conditions.

[0144] Finished product yield: Tested according to "Chinese Pharmacopoeia 2020 Edition 0982 Particle Size and Particle Size Distribution Determination Method Second Double Screening Method".

[0145] Live bacteria retention rate: After testing the total number of live bacteria in accordance with GB 4789.35 National Food Safety Standard Food Microbiology Inspection Lactic Acid Bacteria Inspection, divide it by the theoretical number of live bacteria in the formula to get the live bacteria retention rate.

[0146] Stability study: store the product at about 4°C according to the storage conditions of finished products, and take samples to test the live bacteria retention rate in 6, 12 and 18 months.

[0147] 2. Experimental Results

[0148] The results are shown in Table 1. According to the results in Table 1, the materials have good compressibility when the moisture content is 6.0% to 8.0%, poor compressibility when the moisture content is lower than 6.0%, and easy to stick to the roller when the moisture content is higher than 10.0%. At the same time, the moisture content has an effect on the activity (survival amount) of probiotics during the storage period. The survival rate and stability of live bacteria are good when the moisture content of the particles is 6.5% to 7.5%; when the pressing pressure is lower than 115 bar, the yield of the finished particles is low. When the pressure is too high, as high as 125 bar or more, it affects the activity (survival amount) of probiotics and reduces the number of live bacteria.

[0149] Table 1 Investigation of yield and stability of samples with different formulations and processes

[0150]

[0151] Test Example 2: Experiment on promoting digestive function

[0152] 1. Experimental Methods

[0153] Animals: SPF Wistar rats, half male and half female, weighing 180 g to 220 g.

[0154] Grouping: The experimental animals were divided into a blank control group, Example 1 and Comparative Examples 1 to 5, with 10 animals in each group.

[0155] Sample: Take the granules of Example 1 and the granules of Comparative Examples 1 to 5, and pack them into 3g / bag, and take 1 bag at a time, twice a day. The oral dose for rats is 0.54g granules / (kg·d), and prepare them into suspension with distilled water.

[0156] Methods: Except for the blank control group, rats in each group were given the test substance at a volume of 0.1mL / 10g·BW every day, and the blank control group was given an equal volume of purified water. After continuous administration for 15 days, the animals in each group were fasted but not watered for 24 hours, and the rats were anesthetized with ether. After pylorus ligation, they continued to fast and deprive of water. After 4 hours of anesthesia, laparotomy was performed, the cardia was ligated, and the stomach was taken out to measure the amount of gastric juice per unit time. 1mL of gastric juice was taken into a 50mL conical flask, and 0.05mol / L hydrochloric acid solution was added and shaken well, and two protein tubes were put into it. After plugging the bottle mouth, it was incubated in a constant temperature incubator at 37℃ for 24 hours. The length (mm) of the transparent part at both ends of the protein tube was taken out to measure the average value of the values ​​at the four ends, and the pepsin activity and pepsin excretion were calculated.

[0157] 2. Experimental Results

[0158] The results are shown in Table 2. As can be seen from Table 2, after administration of Example 1 of the present invention and Comparative Examples 1 to 5, the gastric juice volume and pepsin activity of the rats were higher than those of the blank control group, and the difference between Example 1 and the blank control group was statistically significant, indicating that the granules prepared in Example 1 have a significant effect of promoting gastric juice secretion and increasing pepsin activity.

[0159] The gastric juice volume and pepsin activity of the rats in Example 1 group were higher than those in Comparative Examples 1 to 5. Comparison between Comparative Example 1 and Example 1 shows that Example 1 combines the effects of Chinese medicine wall-broken powder and probiotics, and the two work in coordination to jointly enhance and promote the body's digestive function;

[0160] Comparison between Example 2 and Example 1 shows that Comparative Example 2 contains only probiotics, which mainly regulates the intestinal microecology, but has no significant effect on promoting gastric juice secretion and increasing pepsin activity;

[0161] Comparative Example 3 is compared with Example 1. The Chinese medicine formula removes yam and tangerine peel and replaces them with corresponding proportions of Poria cocos and white hyacinth bean. The effect of regulating qi and strengthening the spleen is not as good as the yam and tangerine peel of the original formula, so the effect of promoting gastric juice secretion is not as good as the yam and tangerine peel in Example 1.

[0162] Comparative Example 4 is compared with Example 1. In the Chinese medicine formula, the five-fingered ginseng is replaced with Pseudostellaria heterophylla. Pseudostellaria heterophylla has better yin-nourishing effect than the five-fingered ginseng, but the five-fingered ginseng is better in replenishing qi and strengthening the spleen.

[0163] Compared with Example 1, the proportions of most medicinal flavors and probiotics in the Chinese medicine formula increased, but the efficacy of promoting gastric juice secretion and increasing pepsin activity did not increase accordingly, indicating that the Chinese medicine formula of Example 1 has a better ratio effect.

[0164] According to the results of the rat gastric juice secretion and pepsin activity analysis test, the pharmacological effect of Example 1 of the present invention in promoting digestive function is better than that of Comparative Examples 1 to 5. After testing, the granules prepared in Examples 2 to 5 have similar pharmacological effects in promoting digestive function as the granules in Example 1.

[0165] Table 2 Results of gastric juice volume, pepsin activity and protease excretion in rats (x±s)

[0166]

[0167] Note: Compared with the blank control group, *P<0.05.

[0168] Test Example 3: Test to promote gastric emptying

[0169] 1. Experimental Methods

[0170] Animals: 84 Kunming mice, half male and half female, weighing 18 g to 22 g.

[0171] Grouping: After the experimental animals were weighed, they were randomly divided into a blank control group, Example 1, and Comparative Examples 1 to 5 according to body weight and gender balance, with 12 animals in each group.

[0172] Sample: Take the granules of Example 1 and the granules of Comparative Examples 1 to 5, and pack them into 3g / bag, and take 1 bag at a time, twice a day. The oral dose for mice is 1.07g granules / (kg·d), and prepare them into suspension with distilled water.

[0173] Methods: Except for the blank control group, the animals in each group were given oral administration once a day for 10 consecutive days. The blank control group was given an equal volume of purified water. The animals were fasted for 24 hours before the last administration. 30 minutes after the last administration, 0.05% phenol red solution (w / v) was administered by oral administration at 0.3 mL / animal. After 20 minutes, the animals were killed by cervical dislocation. The abdominal cavity was opened immediately, and the stomach was taken from the pyloric sphincter. It was put into 25 mL of 0.1 mol / L NaOH solution, chopped and stirred evenly, and allowed to stand at room temperature for 1 hour. 4 mL of supernatant was taken and added with 0.5 mL of 33% trichloroacetic acid solution (w / v) to remove the protein, and centrifuged at 1600 g for 30 minutes. 1 mL of 2 mol / L NaOH solution was added to the supernatant, and the absorbance value (A value) was measured at 560 nm, which was the residual amount of phenol red in the stomach; in addition, 4 normal mice were given 0.05% phenol red and immediately killed, and the stomach was taken and its absorbance was measured as the baseline absorbance of phenol red. The gastric emptying rate was calculated according to the following formula:

[0174] Gastric emptying rate (%) = (1-A 胃内酚红 / A 基准酚红 ×100%

[0175] 2. Experimental Results

[0176] The results are shown in Table 3. As can be seen from Table 3, the gastric emptying rates of mice in Example 1 and Comparative Examples 1 to 5 of the present invention after administration were higher than those in the blank control group, and the differences between Example 1, Comparative Example 1, Comparative Example 4 and Comparative Example 5 and the blank control group were statistically significant, indicating that the granules prepared in Example 1 and Comparative Examples 1, Comparative Examples 4 and Comparative Examples 5 all had a significant effect of promoting gastric emptying movement in experimental animals.

[0177] The gastric emptying rate values ​​of the mice in the Example 1 group were higher than those in the Comparative Examples 1 to 5, and the differences between the Comparative Examples 2 and 3 and those in the Example 1 were statistically significant, indicating that the effect of the Example 1 in promoting gastric emptying movement in experimental animals was better than that in the Comparative Examples 1 to 5, especially compared with the Comparative Examples 2 and 3.

[0178] Comparing Comparative Example 1 with Example 1, Example 1 combines the effects of Chinese medicine wall-broken powder and probiotics, and has a more significant effect of enhancing the digestion and absorption function of the body;

[0179] Comparison between Example 2 and Example 1 shows that Comparative Example 2 contains only probiotics, which mainly regulates the intestinal microecology, but has no significant effect on promoting gastric emptying.

[0180] Comparative Example 3 is compared with Example 1. The Chinese medicine formula removes yam and tangerine peel and replaces them with corresponding proportions of Poria cocos and white hyacinth bean. The effect of regulating qi and strengthening the spleen is not as good as that of yam and tangerine peel in Example 1.

[0181] Comparative Example 4 is compared with Example 1. In the Chinese medicine formula, the five-fingered ginseng is replaced with Pseudostellaria heterophylla. Pseudostellaria heterophylla has better yin-nourishing effect than the five-fingered ginseng, but the five-fingered ginseng has better qi-tonifying effect.

[0182] Compared with Example 1, the proportions of most medicinal flavors and probiotics in the Chinese medicine formula increased, but the efficacy of promoting gastric emptying movement did not increase accordingly, indicating that the Chinese medicine formula of Example 1 has a better ratio effect.

[0183] From the results of the mouse gastric emptying promotion test, the pharmacological effect of Example 1 of the present invention in promoting gastric emptying is better than that of Comparative Examples 1 to 5. After testing, the granules prepared in Examples 2 to 5 have similar pharmacological effects as the granules in Example 1 in promoting gastric emptying.

[0184] Table 3 Results of mouse gastric emptying rate test (x±s)

[0185]

[0186]

[0187] Note: Compared with the blank control group, * P<0.05, ** P<0.01; Compared with Example 1, △△ P<0.01.

[0188] Test Example 4: Intestinal Propulsion Test

[0189] 1. Experimental Methods

[0190] Animals: 84 Kunming mice, half male and half female, weighing 18 g to 22 g.

[0191] Grouping: The experimental animals were weighed and randomly divided into a blank control group, Example 1, and Comparative Examples 1 to 5 according to body weight and gender balance, with 12 animals in each group.

[0192] Sample: Take the granules of Example 1 and the granules of Comparative Examples 1 to 5, and pack them into 3g / bag, and take 1 bag at a time, twice a day. The oral dose for mice is 1.07g granules / (kg·d), and prepare them into suspension with distilled water.

[0193] Methods: Except for the blank control group, the animals in each group were given oral administration once a day for 10 consecutive days. The blank control group was given an equal volume of purified water. The animals were fasted for 24 hours before the last administration. 30 minutes after the last administration, they were gavaged with activated carbon gum arabic suspension 0.2mL / 20g body weight. 15 minutes after gavage, the animals were killed by cervical dislocation, the abdominal cavity was immediately opened, the digestive tract from the pylorus to the end of the small intestine was completely removed, and it was laid flat on a glass plate without traction. The total length was measured and the distance from the front of the carbon end to the pylorus was recorded as the intestinal propulsion distance, and the small intestine propulsion rate was calculated.

[0194] Small intestine propulsion rate (%) = propulsion distance of charcoal powder in the small intestine / total length of small intestine × 100%.

[0195] 2. Experimental Results

[0196] The results are shown in Table 4. As can be seen from Table 4, the small intestinal propulsion rates of mice in Example 1 and Comparative Examples 1 to 5 of the present invention after administration were higher than those in the blank control group, and the differences between Example 1 and Comparative Example 5 and the blank control group were statistically significant, indicating that the granules prepared in Example 1 and Comparative Examples 1 to 5 all have the effect of promoting intestinal motility in experimental animals, and the effects of Example 1 and Comparative Example 5 are the most significant.

[0197] The small intestinal propulsion rate of the mice in Example 1 group was higher than that of Comparative Examples 1 to 5, and the differences between Comparative Examples 2 and 3 and Example 1 were statistically significant, indicating that Example 1 is better than Comparative Examples 1 to 5 in promoting intestinal motility in experimental animals, especially compared with Comparative Examples 2 and 3.

[0198] Comparison between Comparative Example 1 and Example 1 shows that Example 1 adds probiotics to the Chinese medicine wall-broken powder formula. Probiotics and Chinese medicine can synergize and enhance the digestion and absorption functions of the body by regulating the balance of intestinal flora.

[0199] Comparison between Example 2 and Example 1 shows that Comparative Example 2 contains only probiotics, lacks the effects of Chinese medicine in strengthening the spleen and stomach, and removing food stagnation, and mainly regulates the intestinal microecology, and has no significant effect in promoting intestinal motility and thus enhancing digestive function;

[0200] Comparison of Example 1 and Comparative Example 3 shows that the Chinese medicine formula removes yam and tangerine peel and replaces them with corresponding proportions of Poria cocos and white hyacinth bean. Although the effect of invigorating qi and strengthening spleen is still retained, the effect of regulating qi and strengthening spleen is not as good as that of yam and tangerine peel in Example 1. The experimental results show that the function of promoting intestinal motility in Comparative Example 3 is not as good as that of Example 1, which is confirmed by the theory of formula compatibility.

[0201] Comparative Example 4 is compared with Example 1. In the Chinese medicine formula, the five-fingered ginseng is replaced with Pseudostellaria heterophylla. Pseudostellaria heterophylla has better yin-nourishing effect than the five-fingered ginseng, but the five-fingered ginseng has better qi-tonifying effect.

[0202] Compared with Example 1, the proportions of most medicinal flavors and probiotics in the Chinese medicine formula increased, but the efficacy of promoting intestinal motility did not increase accordingly. This may be due to the bidirectional regulation of Chinese medicine. Its efficacy and dosage are positively correlated within a certain range, but beyond a certain dosage range, the effect may turn into a negative correlation. Therefore, the ratio of the Chinese medicine formula needs to be within the optimized range to exert the best efficacy.

[0203] From the results of the test on promoting intestinal motility in mice, the pharmacological effect of Example 1 of the present invention on promoting intestinal motility is better than that of Comparative Examples 1 to 5. After testing, the granules prepared in Examples 2 to 5 have similar pharmacological effects on promoting intestinal motility as the granules in Example 1.

[0204] Table 4 Results of mouse small intestinal propulsion rate test (x±s)

[0205] Group Dosage (g / kg) Number of animals Small intestinal propulsion rate (%) Blank control group — 12 <![CDATA[54.53±8.09 △△ ]]> Example 1 1.07 12 <![CDATA[68.23±7.33 ** ]]> Comparative Example 1 1.07 12 60.86±8.95 Comparative Example 2 1.07 12 <![CDATA[57.63±6.61 △ ]]> Comparative Example 3 1.07 12 <![CDATA[57.94±7.11 △ ]]> Comparative Example 4 1.07 12 63.35±7.96 Comparative Example 5 1.07 12 <![CDATA[65.17±9.10 * ]]>

[0206] Note: Compared with the blank control group, * P<0.05, ** P<0.01; Compared with Example 1, △ P<0.05, △△ P<0.01.

[0207] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. A composition, characterized in that The composition comprises, by weight, 20 to 40 parts of hawthorn, 30 to 50 parts of roasted malt, 60 to 80 parts of yam, 3 to 18 parts of tangerine peel, 10 to 30 parts of five-fingered peach, 10 to 30 parts of hericium erinaceus, 3 to 18 parts of liquorice, 20 to 40 parts of Bifidobacterium animalis subsp. lactis V9, 20 to 40 parts of Lactobacillus Casei Zhang, 20 to 40 parts of Lactobacillus plantarum P-8 and 3 to 18 parts of Lactobacillus acidophilus LA-06.

2. Use of the composition according to claim 1 in preparing a preparation for promoting gastrointestinal digestion.

3. The use according to claim 2, characterized in that: The promoting of gastrointestinal digestion is promoting the secretion of gastric juice and / or pepsin.

4. The use according to claim 2, characterized in that: The promoting of gastrointestinal digestion is to increase the activity of pepsin.

5. The use according to claim 2, characterized in that: The promoting of gastrointestinal digestion is promoting gastric emptying and / or intestinal motility.

6. The use according to claim 2, characterized in that: The preparation includes but is not limited to medicines and health foods. The medicines also include pharmaceutically acceptable excipients, and the health foods also include food-acceptable additives.

7. A preparation, characterized in that The preparation contains the composition according to claim 1.

8. The method for preparing the preparation according to claim 7, characterized in that: The following steps are involved: S1. Hawthorn, fried malt, yam, tangerine peel, five-fingered peach, Hericium erinaceus and licorice were crushed to obtain a Chinese medicine powder; S2. Bifidobacterium animalis subsp. lactis V9, Lactobacillus Casei Zhang, Lactobacillus plantarum P-8 and Lactobacillus acidophilus LA-06 are fully mixed with the above-mentioned broken wall powder according to a ratio, the pressure is set to 115-125 bar, and a preparation with a moisture mass fraction of 6.5-7.5% is prepared by dry granulation.

9. The preparation method according to claim 8, characterized in that: In step S1, hawthorn, roasted malt, yam, tangerine peel, quinoa striata, hericium erinaceus and liquorice are first crushed into powder of 60-120 meshes before the wall-breaking and crushing.

10. The preparation method according to claim 8, characterized in that: In step S1, the particle size D of the Chinese medicine wall-broken powder is 90 15~75μm.

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