CN116326780A - A compound probiotic preparation for alleviating irritable bowel syndrome and its preparation process - Google Patents

Abstract

The invention belongs to the field of microorganisms and the technical field of food and medicine processing, in particular to a composite probiotic preparation for relieving irritable bowel syndrome and a preparation process thereof, wherein the composite probiotic preparation comprises a component A and a component B, and the component A comprises a probiotic composition consisting of 4 strains, and specifically comprises lactobacillus acidophilus CUL60, lactobacillus acidophilus CUL21, bifidobacterium animalis subspecies CUL34 and bifidobacterium bifidum CUL20; the component B comprises sugar alcohol, prebiotics, fruit powder, essence, vitamin C and common pharmaceutical formulation additive auxiliary materials. The invention provides a probiotic composition comprising 4 strains, which can promote the rapid propagation of probiotics in intestinal tracts, promote intestinal peristalsis, improve the symptoms of constipation-type irritable bowel syndrome and relieve the pain of patients; compared with the prior art, the method does not depend on raw materials with low water content, and reduces the cost; an important index for controlling the quality of the probiotic product, namely the water activity, is also provided, so that the stability of the probiotic product is effectively improved.

Description

A compound probiotic preparation for alleviating irritable bowel syndrome and its preparation process

technical field

The invention relates to the field of microorganisms and the technical field of food and medicine processing, in particular to a compound probiotic preparation for alleviating irritable bowel syndrome and a preparation process thereof.

Background technique

Irritable bowel syndrome (IBS) is a chronic functional bowel disease caused by brain-gut interaction dysfunction, with recurrent abdominal pain and abnormal defecation as the main clinical features. The pathogenesis of IBS symptoms is far from clear, and most hypotheses focus on one or more of the following: altered intestinal luminal environment, immune activation, neuromuscular dysfunction of the gut, and dysregulation of the brain-gut axis.

Irritable bowel syndrome (IBS) is a chronic functional bowel disease caused by brain-gut interaction dysfunction, with recurrent abdominal pain and abnormal defecation as the main clinical features. The pathogenesis of IBS symptoms is far from clear, and most hypotheses focus on one or more of the following: altered intestinal luminal environment, immune activation, neuromuscular dysfunction of the gut, and dysregulation of the brain-gut axis.

In the current clinical practice, Western medicine is mostly used for treatment, and cisapride is one of them. This medicine is used for the treatment of constipation-predominant irritable bowel syndrome. Although it can improve the patient's symptoms to a certain extent, it is prone to various adverse reactions when taken for a long time. Such as allergies, dizziness and so on.

Probiotics are a class of active microorganisms that are beneficial to the host. They are a general term for active beneficial microorganisms that colonize the human intestinal tract and reproductive system and can produce definite health effects to improve the host's micro-ecological balance and exert beneficial effects. Probiotics can eliminate harmful bacteria in the gut by producing bacteriocins, changing pH by producing lactic acid, and producing hydrogen peroxide. More and more studies have proved that probiotics can regulate the balance of intestinal microorganisms, improve the abundance of flora, and inhibit the growth of harmful bacteria. Moreover, more than 30 kinds of probiotic strains have been included in the "List of Strains Available for Food", and the list is still being added.

The existing patent "CN113943682A" discloses Bifidobacterium longum subspecies longum and its fermented food and probiotic preparations for alleviating constipation. The Bifidobacterium longum subsp. The time of the first black stool and the propulsion rate of the small intestine can regulate the content of gastrointestinal active peptides in the serum, which can act on the related proteins or receptors of the colon tissue to relieve constipation. The existing patent "CN114717132A" announced a strain of Bifidobacterium lactis with preservation number CCTCCNO: M2021905, which can regulate the gastrointestinal function of mice and prevent and relieve constipation symptoms. Intestinal beneficial bacteria include Lactobacillus and Bifidobacterium, and the combination of multiple strains is better. But above-mentioned 2 patents all use single bacterial strain, and effect is limited. Moreover, the effects of probiotics on mice were investigated, and the effects on humans were not further explored.

The existing patent "CN111616368A" discloses a composition for relieving constipation and a preparation method thereof. The invention controls the moisture content of the raw material to be lower than 5%, which increases the purchasing cost of the raw material. Moreover, it has been found in actual work that the moisture content of probiotic products is more important to the stability of live bacteria, but the water activity (Water Activity, abbreviated as aw) is more important to the shelf-life stability of probiotics.

Therefore, we propose a compound probiotic preparation for alleviating irritable bowel syndrome and its preparation process to solve the above problems.

Contents of the invention

Aiming at the deficiencies of the prior art, the present invention provides a compound probiotic preparation for relieving irritable bowel syndrome and its preparation process, which solves the problem of irritable bowel syndrome in the prior art, the effect of using a single strain is not obvious, and the control Raw material moisture leads to increased procurement costs, and the problem of uncontrolled key indicators - water activity in the process of probiotic preparations.

The present invention specifically adopts the following technical solutions in order to achieve the above object:

A compound probiotic preparation for relieving irritable bowel syndrome comprises component A and component B.

Further, the component A includes a probiotic composition composed of 4 strains, and the probiotic composition composed of 4 strains is specifically: Lactobacillus acidophilus CUL60 (Lactobacillus acidophilus CUL60), and the preservation number of the strain is NCIMB 30157; Lactobacillus acidophilus CUL21 (Lactobacillus acidophilusCUL21), the strain preservation number is NCIMB 30156; Bifidobacterium animalis subsp. LactisCUL34 (Bifidobacterium animalis subsp. LactisCUL34), the strain preservation number is NCIMB 30172; , The strain deposit number is NCIMB 30153.

Further, the probiotic composition composed of the four strains is named Lab4 probiotics, wherein the Lactobacillus acidophilus CUL60 and the Lactobacillus acidophilus CUL21 are symbiotic fermentation bacteria, and the Bifidobacterium animalis subspecies CUL34 and Bifidobacterium bifidum CUL20 are symbiotic fermentation bacteria.

Preferably, the total number of colonies per unit mass of the Lab4 probiotics is 1.0-4.5×10 ¹¹ cfu/g.

Preferably, the recommended daily dosage of the Lab4 probiotics is 20-60 billion cfu.

Further, the component B includes sugar alcohols, prebiotics, fruit powder, essence, vitamin C and common pharmaceutical dosage form additives.

Preferably, the prebiotics include resistant dextrin, polydextrose, inulin, xylooligosaccharides, fructooligosaccharides, isomaltooligosaccharides, galactooligosaccharides, soybean oligosaccharides.

Preferably, the sugar alcohol comprises erythritol, xylitol, sorbitol, mannitol, lactitol, maltitol, and isomalt.

Preferably, the fruit powder comprises apple juice powder, mango juice powder, passion fruit juice powder, orange juice powder, pineapple juice powder, lychee juice powder, banana juice powder, mangosteen juice powder, pineapple juice powder, cantaloupe juice powder, kumquat Juice powder, grape juice powder, kiwi fruit juice powder, sour plum juice powder, watermelon juice powder, peach juice powder, lemon juice powder, pomelo juice powder, red grape juice powder, sweet orange juice powder, pomegranate juice powder, blackcurrant Juice Powder, Blueberry Juice Powder, Cranberry Juice Powder, Raspberry Juice Powder, Strawberry Juice Powder, Acerola Juice Powder, Acai Berry Juice Powder, Red Guava Juice Powder, Green Plum Juice Powder, Roselle Juice Powder, Ume Juice powder, cherry juice powder, pear juice powder, mulberry juice powder.

Preferably, the pharmaceutical dosage forms include tablets, powders, granules, hard capsules and pills.

Preferably, the excipients include one or more combinations of fillers, binders, wetting agents, diluents, disintegrants, lubricants, and flavoring agents commonly used in pharmacy.

The preparation process of the above-mentioned compound probiotic preparation for alleviating irritable bowel syndrome mainly includes the preparation process of compound probiotic preparation powder, hard capsule and tablet.

Further, the preparation process of the compound probiotic preparation powder comprises the following steps:

S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH;

S2, mixing component A and component B uniformly to obtain a mixture;

S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.2;

S4. The dried mixture is transported to the hopper of the packing machine by means of vacuum feeding, and the packing machine packs it into required product specifications.

Further, the preparation process of the composite probiotic preparation hard capsule comprises the following steps:

S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH;

S2, mixing component A and component B uniformly to obtain a mixture;

S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.2;

S4. Fill the dried mixture into pellets and pack them into corresponding packaging materials.

Further, the preparation process of the synthetic probiotic preparation tablet comprises the following steps:

S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH;

S2, mixing component A and component B uniformly to obtain a mixture;

S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.2;

S4. Compress the dried mixture into tablets and pack it into corresponding packaging materials.

Further, the water activity of the compound probiotic preparation powder, hard capsule, and tablet is required to be lower than 0.1, and the humidity in the workshop is controlled to be lower than 20% RH.

Compared with the prior art, the present invention provides a compound probiotic preparation for alleviating irritable bowel syndrome and its preparation process, which has the following beneficial effects:

The present invention provides a probiotic composition including 4 strains. The combination of multiple strains can quickly replenish Lactobacillus and Bifidobacteria in the intestine, and provide rich prebiotics to promote the rapid reproduction of probiotics in the intestine. Promote intestinal peristalsis, improve the symptoms of constipation-predominant irritable bowel syndrome, and relieve the pain of patients.

Compared with the prior art, the present invention does not rely on low-moisture raw materials and reduces costs.

The present invention proposes an important indicator for controlling the quality of probiotic products—water activity, which effectively increases the stability of the finished product of probiotics.

Description of drawings

Fig. 1 is a table of raw material components and preparation process conditions of the compound probiotic preparation powder of the present invention.

Implementation

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

Example

A compound probiotic preparation powder, the number of components of raw materials is as follows: 10-20 parts of Lab4 probiotics, 400-800 parts of erythritol, 50-30 parts of fructooligosaccharide, 10-50 parts of passion fruit juice powder, Maltodextrin 10-20 parts.

The preparation process is:

S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH;

S2. Manually premix Lab4 probiotics and maltodextrin, and then put 1/2 erythritol, fructooligosaccharide, manual premix, passion fruit juice powder, and the remaining 1/2 erythritol into the mixing tank Mix sugar alcohol evenly;

S3, drying the mixture with a vacuum dryer, controlling the water activity after drying to be lower than 0.2;

S4. The dried mixture is transported into the hopper of the packing machine by means of vacuum feeding, and then packed into 2g/bar by the packing machine.

Example

A compound probiotic preparation hard capsule, the number of components of raw materials is as follows: 10-20 parts of Lab4 probiotics, 50-100 parts of fructo-oligosaccharides, 50-100 parts of xylo-oligosaccharides, 400-900 parts of maltodextrin, 3-10 parts of silicon dioxide, 3-10 parts of magnesium stearate.

The preparation process is:

S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH;

S2, mixing all raw materials evenly to obtain a mixture;

S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.2;

S4. Compress the dried mixture into tablets and pack it into corresponding packaging materials.

Example

A probiotic composition tablet, the number of components of raw materials is as follows: 10-20 parts of Lab4 probiotics, 50-100 parts of fructooligosaccharide, 300-800 parts of sorbitol, 50-150 parts of xylitol, lactose 30-100 parts, 1-20 parts of apple essence, 3-10 parts of magnesium stearate.

The preparation process is:

S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH;

S2, mixing all raw materials evenly to obtain a mixture;

S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.1;

S4. Compress the dried mixture into tablets and pack it into corresponding packaging materials.

clinical experiments:

A double-blind placebo-controlled experiment was used to study the significant improvement effect of Lab4 probiotics on constipation-predominant irritable bowel syndrome.

Method: Inclusion criteria:

The diagnostic criteria for irritable bowel syndrome are the same as Rome IV: 1. The course of the disease is more than 6 months, and in the past 3 months, abdominal pain has been repeated, at least one day a week, accompanied by 2 or more of the following abnormal changes Symptoms: (1) with recurrent abdominal pain; (2) with changes in defecation frequency; (3) with changes in stool properties. 2. Absence of morphological changes and biochemical abnormalities that could explain symptoms. On average, at least 1 day a week in the past 3 months, accompanied by 2 or more of the following items: (1) related to defecation; (2) accompanied by changes in defecation frequency; (3) accompanied by stool properties (appearance) Change. It is required that the symptoms have appeared for at least 6 months before the diagnosis, and the above diagnostic criteria have been met in the past 3 months.

Difficult defecation, dry stool, feeling of incompleteness after defecation.

Those with clear consciousness and normal cognition.

The patient gave informed consent and signed the informed consent form.

Experimental method: 52 people meeting the inclusion criteria were divided into 2 groups, 26 people in each group: one group took 25 billion cfu of Lab4 probiotics per day. The second group took Placebo (placebo). IBS symptoms were assessed every two weeks during the study and again two weeks after discontinuation of probiotic supplementation (at week 10).

IBS symptoms measured included:

1) Number of days with pain;

2) The degree of abdominal pain;

3) abdominal distension;

4) Quality of life;

5) Satisfaction with bowel habits.

Experimental results:

Volunteers taking Lab4 probiotics showed a significant improvement in total IBS symptoms compared to placebo (*P<0.05);

Use of the Lab4 probiotic group significantly reduced days of abdominal pain and improved bloating;

Use of the Lab4 probiotic group significantly reduced days of abdominal pain and improved bloating.

Conclusions: Lab4 probiotics significantly reduced overall symptoms and improved quality of life in diagnosed IBS-C patients; continuous probiotic supplementation was necessary to maintain this improvement.

Specifically, compared with the prior art, the compound probiotic preparation provided by the present invention includes 4 strains of probiotics; the combination of multiple strains can quickly replenish Lactobacillus and Bifidobacteria in the intestine, and provide rich prebiotics to promote the development of probiotics. Rapid reproduction of bacteria in the intestinal tract; promote intestinal peristalsis, improve the symptoms of constipation-type irritable bowel syndrome, and relieve the pain of patients; on the other hand, it can not rely on low-moisture raw materials to reduce costs; finally, the present invention An important index to control the quality of probiotic products - water activity, to increase the stability of probiotic finished products.

Finally, it should be noted that: the above is only a preferred embodiment of the present invention, and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, for those skilled in the art, it still The technical solutions recorded in the foregoing embodiments may be modified, or some technical features thereof may be equivalently replaced. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims (8)

1. A compound probiotic preparation for relieving irritable bowel syndrome, characterized in that: it includes component A and component B. 2. A compound probiotic preparation for alleviating irritable bowel syndrome according to claim 1, characterized in that: said component A comprises a probiotic composition composed of 4 strains, and the probiotic composition composed of 4 strains The bacterial composition is specifically composed of Lactobacillus acidophilus CUL60, Lactobacillus acidophilus CUL21, Bifidobacterium animalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20; Further, the probiotic composition composed of the four strains is named Lab4 probiotics, wherein the Lactobacillus acidophilus CUL60 and the Lactobacillus acidophilus CUL21 are symbiotic fermentation bacteria, and the Bifidobacterium animalis subspecies CUL34 and Bifidobacterium bifidum CUL20 are symbiotic fermentation bacteria; Preferably, the total number of colonies per unit mass of the Lab4 probiotics is 1.0-4.5×10 ¹¹ cfu/g; Preferably, the recommended daily dosage of the Lab4 probiotics is 20-60 billion cfu. 3. A compound probiotic preparation for relieving irritable bowel syndrome according to claim 1, characterized in that: said component B includes sugar alcohols, prebiotics, fruit powder, flavors, vitamin C and common pharmaceutical dosage forms added auxiliary materials ; Preferably, the prebiotics include resistant dextrin, polydextrose, inulin, xylooligosaccharides, fructooligosaccharides, isomaltooligosaccharides, galactooligosaccharides, soybean oligosaccharides; Preferably, the sugar alcohol comprises erythritol, xylitol, sorbitol, mannitol, lactitol, maltitol, isomalt; Preferably, the fruit powder comprises apple juice powder, mango juice powder, passion fruit juice powder, orange juice powder, pineapple juice powder, lychee juice powder, banana juice powder, mangosteen juice powder, pineapple juice powder, cantaloupe juice powder, kumquat Juice powder, grape juice powder, kiwi fruit juice powder, sour plum juice powder, watermelon juice powder, peach juice powder, lemon juice powder, pomelo juice powder, red grape juice powder, sweet orange juice powder, pomegranate juice powder, blackcurrant Juice Powder, Blueberry Juice Powder, Cranberry Juice Powder, Raspberry Juice Powder, Strawberry Juice Powder, Acerola Juice Powder, Acai Berry Juice Powder, Red Guava Juice Powder, Green Plum Juice Powder, Roselle Juice Powder, Ume Juice powder, cherry juice powder, pear juice powder, mulberry juice powder; Preferably, the pharmaceutical dosage form comprises tablet, powder, granule, hard capsule, pill; Preferably, the excipients include one or more combinations of fillers, binders, wetting agents, diluents, disintegrants, lubricants, and flavoring agents commonly used in pharmacy. 4. A preparation process for alleviating irritable bowel syndrome according to any one of claims 1-3, characterized in that: mainly comprising the preparation process of compound probiotic preparation powder, hard capsules and tablets . 5. a kind of preparation technology of compound probiotic preparation for alleviating irritable bowel syndrome according to claim 4 is characterized in that: the preparation technology of described compound probiotic preparation powder comprises the following steps: S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH; S2, mixing component A and component B uniformly to obtain a mixture; S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.2; S4. The dried mixture is transported to the hopper of the packing machine by means of vacuum feeding, and the packing machine packs it into required product specifications. 6. a kind of preparation technology of compound probiotic preparation for alleviating irritable bowel syndrome according to claim 4 is characterized in that: the preparation technology of described compound probiotic preparation hard capsule comprises the following steps: S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH; S2, mixing component A and component B uniformly to obtain a mixture; S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.2; S4. Fill the dried mixture into pellets and pack them into corresponding packaging materials. 7. a kind of preparation technology of compound probiotic preparation for alleviating irritable bowel syndrome according to claim 4 is characterized in that: the preparation technology of described compound probiotic preparation tablet comprises the following steps: S1. Control the temperature and humidity of the workshop: the temperature is 18-26 ° C, and the relative humidity is lower than 30% RH; S2, mixing component A and component B uniformly to obtain a mixture; S3. Carry out vacuum drying to the mixture, and control the water activity after drying to be lower than 0.2; S4. Compress the dried mixture into tablets and pack it into corresponding packaging materials. 8. a kind of preparation technology of compound probiotic preparation for alleviating irritable bowel syndrome according to claim 4, is characterized in that: the water activity requirement of described compound probiotic preparation powder, hard capsule, tablet is lower than 0.1, and control the workshop humidity below 20% RH.

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