CN110946913B - Probiotic composition for relieving constipation and hemorrhoids - Google Patents

Probiotic composition for relieving constipation and hemorrhoids Download PDF

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CN110946913B
CN110946913B CN201911301091.1A CN201911301091A CN110946913B CN 110946913 B CN110946913 B CN 110946913B CN 201911301091 A CN201911301091 A CN 201911301091A CN 110946913 B CN110946913 B CN 110946913B
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component
powder
lactobacillus
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CN110946913A (en
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赵林森
贾晓蒙
路江浩
孙新凯
梁丛丛
张欢欢
赵星
霍文敏
赵永娇
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Hebei Yiran Biotechnology Co.,Ltd.
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Hebei Inatural Biotechnology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7032—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/733—Fructosans, e.g. inulin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745—Bifidobacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

The invention relates to a probiotic composition for assisting in relieving constipation and hemorrhoid symptoms, which comprises a component A and a component B, wherein the component A and the component B are uniformly mixed; the component A comprises the following components in parts by weight: 3-4 parts of lactobacillus plantarum LP45 powder, 1.5-2.5 parts of lactobacillus acidophilus La28 powder, 0.5-1.5 parts of lactobacillus rhamnosus LR519 powder and 0.05-0.15 part of bifidobacterium bifidum TMC3115 powder; the component B comprises the following components in parts by weight: 38-44 parts of lactitol, 36-40 parts of fructo-oligosaccharide, 4-10 parts of inulin, 4-6 parts of orange fruit powder and 0.15-0.25 part of vitamin C. The probiotic composition disclosed by the invention can quickly supplement probiotics to the intestinal tract of a human body, provide nutrient substances for the probiotics in the intestinal tract, promote the quick propagation of the probiotics in the intestinal tract, adjust the environment of intestinal flora, improve constipation, improve body immunity, soften stool hardness, shorten single defecation time and effectively relieve pain caused by hemorrhoids.

Description

Probiotic composition for relieving constipation and hemorrhoids
Technical Field
The invention relates to a probiotic composition, in particular to a probiotic composition for assisting in relieving constipation and hemorrhoid symptoms.
Background
The hemorrhoids are one or more soft vein masses formed by expansion and buckling of venous plexus under the mucosa layer at the end of the rectum and the anal canal skin layer of a human body, are mainly characterized by hematochezia, pain, swelling and the like in clinical manifestations, and are the most common and frequent anorectal diseases in clinic. The disease can occur at any stage of the life of a human, and the incidence rate is gradually increased along with the increase of the age. It has been found that hemorrhoids are encountered in approximately 50% to 66% of people, with approximately 40% of patients with pathological hemorrhoids having no obvious symptoms.
The chronic hemorrhoids not only cause great pain to the patients, but also seriously cause the malfunction of the anus. Reflective dysfunction of the urogenital system can be caused by pain in the hip and waist caused by hemorrhoids. Moreover, once an anal abscess is formed and bleeding is caused by anal infection, bacteria, toxins and the like are liable to invade blood to cause septicemia and toxemia. Frequent prolapse of the hemorrhoids can cause relaxation of the sphincter muscles, and irritation of the surrounding skin by the exuded mucus can lead to itching and eczema. Gynecological diseases can also be caused by the mass propagation of pathogenic bacteria caused by haemorrhoid hemorrhage and inflammation.
The occurrence and the final conclusion of the hemorrhoids are determined by the structure of the human anus and intestine. Indirect reasons are dietary habits such as pungency, alcohol consumption and lack of dietary fiber; bad behavior habits such as: standing for a long time; and long-term unhealthy defecation habits, such as too long toilet time and the like. In summary, long-term unhealthy defecation is an important cause of hemorrhoids.
Disclosure of Invention
Technical problem to be solved
In order to solve the problems in the prior art, the invention provides a probiotic composition for assisting in relieving constipation and hemorrhoid symptoms, which is taken to regulate intestines and stomach of a human body, improve defecation difficulty, prevent hemorrhoid or relieve pain of a hemorrhoid patient in defecation.
(II) technical scheme
In order to achieve the purpose, the invention adopts the main technical scheme that:
in one aspect, the invention provides a probiotic composition for assisting in relieving constipation and hemorrhoid symptoms, which comprises a component A and a component B, wherein the component A and the component B are uniformly mixed;
wherein the component A comprises the following components in parts by weight: 3-4 parts of lactobacillus plantarum LP45 powder, 1.5-2.5 parts of lactobacillus acidophilus La28 powder, 0.5-1.5 parts of lactobacillus rhamnosus LR519 powder and 0.05-0.15 part of bifidobacterium bifidum TMC3115 powder;
wherein the component B comprises the following components in parts by weight: 38-44 parts of lactitol, 36-40 parts of fructo-oligosaccharide, 4-10 parts of inulin, 4-6 parts of orange fruit powder and 0.15-0.25 part of vitamin C.
According to the preferred embodiment of the invention, the colony count of the lactobacillus plantarum LP45 powder per unit mass is 3.8 multiplied by 1011cfu/g~4.2×1011cfu/g。
According to a preferred embodiment of the invention, the Bifidobacterium bifidum TMC3115 powder has a colony count per unit mass of 0.8 × 1011cfu/g~1.2×1011cfu/g。
According to the preferred embodiment of the invention, the colony count of the Lactobacillus rhamnosus LR519 bacterial powder is 1.8 multiplied by 1011cfu/g ~2.2×1011cfu/g。
According to a preferred embodiment of the present invention, Lactobacillus plantarum (A)Lactobacillus plantarum) LP45 with preservation number of CGMCC No. 8072; lactobacillus acidophilus (Lactobacillus acidophilus) La28 with the preservation number of CGMCC No. 11506; bifidobacterium bifidum (Bifidobacterium bifidum) TMC3115 with preservation number of CGMCC No. 8462; lactobacillus rhamnosus (A), (B), (C)Lactobacillus rhamnosus) LR519, accession number CGMCC No. 15969.
According to a preferred embodiment of the invention, the component A comprises the following components in parts by weight: 3.5 parts of lactobacillus plantarum LP45 bacterial powder, 2 parts of lactobacillus acidophilus La28 bacterial powder, 1 part of lactobacillus rhamnosus LR519 bacterial powder and 0.1 part of bifidobacterium bifidum TMC3115 bacterial powder; the component B comprises the following components in parts by weight: 41.2 parts of lactitol, 38 parts of fructo-oligosaccharide, 9 parts of inulin, 5 parts of orange fruit powder and 0.2 part of vitamin C are weighed.
On the other hand, the invention provides a preparation method of the probiotic composition for assisting in relieving constipation and hemorrhoid symptoms, which comprises the steps of manually premixing the component A and the component B accounting for 5-10% of the components in any embodiment, adding the rest of the component B after premixing, uniformly mixing in a mixing tank, feeding the mixture into a hopper of a racking machine by adopting vacuum, and racking the mixture into 2 g/strip by the racking machine.
According to the administration method of the probiotic composition, the probiotic composition is taken 2-3 times a day, 1-2 strips each time, and is infused with warm water below 40 ℃ for taking.
(III) advantageous effects
The invention has the beneficial effects that:
the probiotic composition provided by the invention can rapidly supplement probiotics to the intestinal tract of a human body, provide nutrient substances for the probiotics in the intestinal tract, promote the rapid propagation of the probiotics in the intestinal tract, adjust the environment of intestinal flora, improve the constipation problem, improve the body immunity, soften the stool hardness, shorten the single defecation time, and effectively relieve the pain (such as itching or pain) caused by hemorrhoids.
Drawings
Fig. 1 shows the results of a trial test of the probiotic composition of the invention on patients with hemorrhoids.
Detailed Description
For the purpose of better explaining the present invention and to facilitate understanding, the present invention will be described in detail below with reference to specific embodiments.
The invention provides a probiotic composition for assisting in relieving constipation and hemorrhoid symptoms, which comprises a component A and a component B, wherein the component A and the component B are uniformly mixed; the component A comprises the following components in parts by weight: 3-4 parts of lactobacillus plantarum LP45 powder, 1.5-2.5 parts of lactobacillus acidophilus La28 powder, 0.5-1.5 parts of lactobacillus rhamnosus LR519 powder and 0.05-0.15 part of bifidobacterium bifidum TMC3115 powder; the component B comprises the following components in parts by weight: 38-44 parts of lactitol, 36-40 parts of fructo-oligosaccharide, 4-10 parts of inulin, 4-6 parts of orange fruit powder and 0.15-0.25 part of vitamin C.
Wherein the colony count of the lactobacillus plantarum LP45 bacterial powder per unit mass is 3.8 multiplied by 1011cfu/g~4.2×1011cfu/g, the colony number per unit mass of the bifidobacterium bifidum TMC3115 bacterial powder is 0.8 multiplied by 1011cfu/g~1.2×1011cfu/g, the colony number per unit mass of the Lactobacillus rhamnosus LR519 bacterial powder is 1.8 multiplied by 1011cfu/g ~2.2×1011cfu/g。
Wherein, Lactobacillus plantarum (A)Lactobacillus plantarum) LP45 with preservation number of CGMCC No. 8072; lactobacillus acidophilus (Lactobacillus acidophilus) La28 with the preservation number of CGMCC No. 11506; bifidobacterium bifidum (b)Bifidobacteriumbifidum) TMC3115 with preservation number of CGMCC No. 8462; lactobacillus rhamnosus (A), (B), (C)Lactobacillus rhamnosus) LR519, accession number CGMCC No. 15969.
Preferably, the component a of the probiotic composition comprises, by weight: 3.5 parts of lactobacillus plantarum LP45 bacterial powder, 2 parts of lactobacillus acidophilus La28 bacterial powder, 1 part of lactobacillus rhamnosus LR519 bacterial powder and 0.1 part of bifidobacterium bifidum TMC3115 bacterial powder; the component B comprises the following components in parts by weight: 41.2 parts of lactitol, 38 parts of fructo-oligosaccharide, 9 parts of inulin, 5 parts of orange fruit powder and 0.2 part of vitamin C are weighed.
The preparation method comprises the following steps: the component A and the component B accounting for 5-10% of the total weight of the components are manually premixed, after the mixing is finished, the rest of the component B is added, the components are uniformly mixed in a mixing tank, the materials are loaded into a hopper of a racking machine in vacuum, and the materials are packed into 2 g/strip by the racking machine.
The taking method comprises the following steps: it is administered 2-3 times a day, 1-2 strips each time, and is administered after soaking in warm water below 40 deg.C.
The component A contains Lactobacillus plantarum LP45 powder, Lactobacillus acidophilus La28 powder, Lactobacillus rhamnosus LR519 powder and Bifidobacterium bifidum TMC3115 powder. The efficacy and the characteristics are respectively as follows: LP45 and TMC3115 can supplement the amount of lactobacillus and bifidobacterium in human intestinal tract, inhibit pathogenic bacteria such as staphylococcus aureus, and exert the effect similar to prebiotics, promote the proliferation of lactobacillus and bifidobacterium in human intestinal tract, regulate human intestinal flora, and improve constipation. Compared with the common lactobacillus, the lactobacillus rhamnosus LR519 has higher antioxidant activity, can effectively remove the number of free radicals in the organism and relieve the oxidative stress reaction of the organism, thereby preventing healthy cells of the organism from being invaded by the free radicals. The lactobacillus acidophilus La28 has good adsorption effect on harmful substances in intestinal tract and can regulate immunity of human body.
The component B contains lactitol, fructo-oligosaccharide, inulin, orange fruit powder and vitamin C. The efficacy and the characteristics are respectively as follows:
the metabolism of lactitol is irrelevant to insulin, the blood sugar concentration is not increased, the lactitol can be eaten by diabetic patients, and the novel sweetener has the characteristics of low calorie, no sugar and the like and is suitable for the diabetic patients. Lactitol has a protective effect on teeth. Lactitol is not digested and absorbed by the intestines and stomach, and does not cause the increase of insulin. It has been shown that lactitol inhibits sucrose absorption and provides nutrients to the intestinal flora to rapidly proliferate beneficial flora in the intestine. When a human ingests 10g lactitol daily, fecal pH was significantly decreased after 7 days (P =0.02), propionic and butyric acid concentrations were significantly increased (P =0.001), bifidobacteria were significantly increased (P =0.017), and there were few symptoms of gastrointestinal distress.
According to research, the ratio of beneficial bacteria to the total number of bacteria in the intestinal tract has a natural trend of decreasing year by year as people age, and the content of fructo-oligosaccharide in food taken by adults in daily life is low, so that bifidobacteria have insufficient food, the quantity of bifidobacteria is gradually reduced, and diseases are frequently induced. The fructo-oligosaccharide is a natural active substance, has sweetness 0.3-0.6 times of that of sucrose, and has effects of regulating intestinal flora, proliferating Bacillus bifidus, and regulating immunity. The fructo-oligosaccharide has stability superior to that of sucrose under acidic condition, and can reach large intestine even if being washed by gastric acid and bile of human body, thereby providing nutrient substances for Bacillus bifidus in large intestine and rapidly propagating Bacillus bifidus. In addition, fructo-oligosaccharide can inhibit growth and reproduction of exogenous pathogenic bacteria and intrinsic putrefying bacteria in intestine, reduce accumulation of putrefying substances in intestine, promote intestinal peristalsis and cleaning, relax bowels, reduce long-term retention of harmful toxin, prevent constipation or diarrhea, and improve metabolism of digestive system.
Inulin (natural fructan) and Fructooligosaccharides (FOS) have a relationship. Fructooligosaccharides are shorter in sugar chain and inulin is longer; therefore, the fermentation speed of the inulin is slower, and the gas production speed is also slower. Inulin is one tenth of sucrose in sweetness, contains no calories, is not digested by the human body itself, and is utilized by our intestinal bacteria after it enters the large intestine. Inulin has a good selectivity, and is essentially only utilized by "probiotics", and thus belongs to one of the well-known prebiotics. Inulin can also lower blood sugar, prevent constipation and treat obesity, and dietary fiber can reduce food retention time in stomach and intestine, increase feces amount, and effectively treat constipation. The inulin which is taken in a proper amount can help to improve hyperlipemia, relieve constipation and help to lose weight, but the inulin belongs to a diffuse fiber, and the symptom of part of irritable bowel syndrome patients can be aggravated if the amount of the inulin is too large. Therefore, inulin supplementation with some anti-flatulence probiotics (lactobacillus plantarum) may alleviate irritable bowel syndrome.
The orange powder is prepared from fresh orange as raw material by spray drying at normal temperature or low temperature. The orange powder is used as a flavoring agent to provide orange juice flavor and sweetness. The orange is sweet, slightly sour, fresh and cool in taste and rich in vitamin C. The orange powder contains water soluble fiber and water insoluble fiber in balance, the water soluble fiber has functions of lowering cholesterol index in blood and controlling blood sugar level, and the water insoluble fiber can promote digestion and promote metabolism. Vitamin C can improve immunity of organism, is helpful for iron absorption, assists functions of protein transamination, transsulfuration and the like in liver, converts plant and animal protein amino acid absorbed by intestinal tract to important raw materials such as various enzymes, coenzyme, neurotransmitter, hormone, glutathione and the like required by human body, and ensures that the body updates and repairs nutrient raw materials required by metabolism. The vitamin C can promote normal synthesis of collagen, prevent cell connection disorder, and relieve pain caused by hemorrhoid. In addition, vitamin C, also known as l-ascorbic acid, is acidic, and Lactobacillus plantarum is also most suitable for survival in a weakly acidic (pH 6.5) environment. Vitamin C is an important free radical scavenger, and is converted into semi-dehydroascorbic acid and dehydroascorbic acid by supplying electrons step by step so as to achieve the purpose of scavenging oxygen free radicals. The vitamin C and the lactobacillus rhamnosus LR519 synergistically play a role in clearing free radicals in vivo.
The following are specific examples of the present invention.
Example 1
The embodiment provides a probiotic composition for assisting in relieving constipation and hemorrhoid symptoms, which comprises a component A: 3.5 parts of Lactobacillus plantarum LP45 bacterial powder (4.0X 10)11cfu/g), 2 parts of lactobacillus acidophilus La28 powder, 1 part of lactobacillus rhamnosus LR519 powder (2.0 × 10)11cfu/g) and 0.1 part of bifidobacterium bifidum TMC3115 bacterial powder (1.0 multiplied by 10)11cfu/g) were mixed well.
And (B) component: weighing 41.2 parts of lactitol, 38 parts of fructo-oligosaccharide, 9 parts of inulin, 5 parts of orange fruit powder and 0.2 part of vitamin C, and uniformly mixing.
In component A, Lactobacillus plantarum (A)Lactobacillus plantarum) LP45 with preservation number of CGMCC No. 8072; lactobacillus acidophilus（Lactobacillus acidophilus）La28 with the preservation number of CGMCC No. 11506; bifidobacterium bifidum（Bifidobacteriumbifidum）TMC3115 with preservation number of CGMCC No. 8462; lactobacillus rhamnosus（Lactobacillus rhamnosus）LR519, accession number CGMCC No. 15969.
The preparation process comprises the following steps:
manually premixing all the component A and 5% of the component B, adding the rest component B after premixing, canning, mixing, uniformly mixing, feeding in vacuum to a hopper of a packaging machine, and subpackaging into 2 g/strip by the packaging machine.
Example 2 in example 2, on the basis of example 1, lactose alcohol in the component B is increased to 43 parts, fructo-oligosaccharide is increased to 40 parts, inulin is changed to 4 powder, orange powder is 5 parts, and 0.25 part of vitamin C is uniformly mixed. The inulin ratio is correspondingly reduced to adapt to Irritable Bowel Syndrome (IBS) patients.
Clinical medication practice studies and statistical data
The beneficial effects of the probiotic composition of the present invention are further illustrated by the clinical trials using the probiotic composition prepared in example 1.
Clinical data
1.1 subject screening
1.1.1. Selecting an object range:
(1) those who meet the first and second diagnostic criteria of internal hemorrhoid (hematochezia, which can stop after defecation, prolapse, which can be taken back after defecation); there is a history of hemorrhoids and occasionally recurrences.
(2) Age 18 to 60 years, sex randomized.
(3) Voluntarily participate in clinical trials.
1.1.2. Case exclusion criteria:
(1) those taking other probiotics;
(2) pregnancy and lactation;
(3) other pathological changes (such as injury, operation, inflammation, and tumor) in the rectal anal canal;
(4) patients who can not follow up on time;
(5) patients on antibiotics, glucocorticoids;
(6) severe dysfunction of the heart, lung, liver, and kidney, which researchers believe is not suitable for inclusion.
1.1.3. Case shedding criteria:
(1) serious adverse reactions occur, and the research and treatment are difficult to continue after judgment;
(2) other drugs are used at will because the patients do not cooperate;
(3) patients are allergic or intolerant to the test agents;
(4) abnormal exacerbation and difficulty in resuming study treatment due to other reasons judged by researchers;
(5) pregnancy during the test;
(6) the patient requests to withdraw from the trial;
(7) those who are lost of visit.
2.2.4. Rejection criteria
(1) The bacteria agent is not used;
(2) the related auxiliary inspection is not completed as required;
(3) misdiagnosis and mistaking;
2.2.5. termination criteria
(1) In the test process, the treatment of most of the microbial agents has no curative effect or serious safety problem, and has no clinical value;
(2) in the test process, a determined test scheme has major errors, or major deviation occurs in the implementation process, so that the effect of the microbial inoculum is difficult to evaluate.
Intervention method
Selecting the group meeting the group entry condition, and taking the subject half an hour in the morning and at night each day 3 times a day, one tablet (2 g/tablet) each time, and taking with 30-36 deg.C warm water for 14 days continuously. During the trial period, the subject is required to fill out a trial condition record table every day according to the self condition. The symptoms before and after the patient takes the test are used as a contrast to compare the symptoms of bleeding, prolapse, pain and pruritus of the patient and the improvement degree of defecation.
Observation index
(1) The standard of curative effect is formulated according to the diagnosis standard of hemorrhoid diseases formulated by anorectal surgery in China, and is divided into three conditions of healing, effectiveness and ineffectiveness.
And (4) healing, namely completely or basically eliminating the symptoms of perianal pain, edema and the like of the patient.
Effectively, the perianal pain of the patient is obviously improved, and the edema is reduced.
The symptoms of perianal pain, edema and the like of the patient are not obviously improved.
(2) And (4) comparing the symptom scores of bleeding, prolapse, pain and pruritus before and after treatment of the patients.
Bleeding: the score of 0-3 is 0, the score of 0 indicates that the patient has no bleeding symptoms, the score of 1 indicates that the patient bleeds slightly and is stained with blood after defecation, the score of 2 indicates that the patient drips and carries blood when defecating, the blood stops automatically after defecation, and the score of 3 indicates that the patient bleeds in a jet shape and cannot stop automatically in a short time.
Removing: 0-3 points, wherein 0 point indicates that the patient does not prolapse, 1 point indicates that the patient automatically receives the excrement after having hemorrhoid prolapse, 2 points indicate that the patient needs to receive the excrement by hands after having hemorrhoid prolapse, and 3 points indicate that the patient continuously prolapse.
Pain: the score of 0-9 indicates that the patient has no pain, the score of 4 indicates that the patient has mild pain and can endure while defecation, and the score of 9 indicates that the patient has severe pain and can not normally relax the bowels.
Pruritus: the score of 0-9 indicates that the patient has no pruritus, the score of 4 indicates that the patient has mild pruritus and does not need intervention, and the score of 9 indicates that the patient has severe pruritus and seriously affects daily life.
Intake test results of probiotic compositions
(1) The number of people who finish trying to dress this time is 14 in total.
(2) The total score of symptom signs and the quantitative score of symptom signs before and after trial administration have significant difference (P is less than 0.05), the total score of symptom signs before treatment is 14.23 +/-1.638, and the score after treatment is 5.077 +/-1.016.
TABLE 1 comparison of the integral Total sign changes before and after treatment
Figure 181027DEST_PATH_IMAGE002
(3) As shown in fig. 1 and table 2, the results of the administration test of the probiotic composition of the formulation of example 1 of the present invention are shown. Fig. 1 is a table of quantitative integral changes of symptom signs before and after treatment, and table 2 is a table of quantitative integral changes of symptom signs before and after treatment.
Table 2 is a table of quantitative integral values of symptom and sign before and after treatment
Figure 645637DEST_PATH_IMAGE004
Note: except for the marked values, the remaining P < 0.05.
Table 3 is a statistical table of the effect of the administration test. Each symptom was evaluated by the symptom score method in the test protocol, and the higher the score, the more obvious the symptom, and 0 score indicates no symptom. The left bar represents the score of symptoms before taking the trial, and the right bar represents the score of symptoms after taking the trial.
TABLE 3 statistical table of curative effect of trial administration
Number of examples Recovery method Is effective Invalidation Total effective rate
14 8（57.14%） 5（35.71%） 1（7.14%） 92.86%
According to different disease conditions of test-eaten patients, the probiotic powder is respectively subjected to curative effect analysis, has good effect on treating and relieving mild and moderate hemorrhoids, has the cure rate of 57.14 percent, the effective rate of 35.71 percent and the total effective rate of 92.86 percent. (see Table 3)
3. Analysis of results
The trial number of people completed in this trial was 14, and 13 people all had effects except that the symptoms were not effectively improved after one person took the trial. Of the 13 patients, 6 were patients with degree I, 5 were patients with degree II, and the remaining 2 were patients with degree III.
The symptoms before and after the patient takes the test are taken as a contrast, and the quantitative scoring is carried out according to the symptoms of bleeding, prolapse, pain and pruritus of the patient and the defecation condition. The total symptom score before treatment was 14.23 + -1.638, and after treatment was 5.077 + -1.016, which was reduced by 64.32% (see table 2). The four main symptoms of bleeding, prolapse, pain and pruritus are all obviously reduced (see figure 1), wherein the bleeding symptom integral is reduced from 0.923 to 0.077, the pain symptom integral is reduced from 2.462 to 0.462, and the quantitative integral value has a significant difference (P is less than 0.05) (see attached table 2), which indicates that the composite bacterial powder can improve the symptoms of the hemorrhoids and relieve the pain of patients suffering from the hemorrhoids. In addition to the primary symptoms of hemorrhoids, the other four bowel movement symptoms, including stool consistency, bowel movement time, frequency, and the quantitative integral of the sensation of defecation, were significantly reduced. The composite probiotic powder can relieve the hemorrhoids and improve the defecation of the patient. After two weeks of trial administration, the hemorrhoid symptoms of 8 of 14 subjects completely disappeared, partial symptoms of 5 subjects were relieved, and 1 subject was not improved, i.e., 57.14% of the patients were healed, 35.71% of the patients were effective, and the total effective rate was 92.86% (see table 3). The composite probiotic powder can play a significant role in relieving and assisting in treating mild and moderate hemorrhoids.

Claims (3)

1. The probiotic composition is characterized by consisting of a component A and a component B, wherein the component A and the component B are uniformly mixed;
wherein the component A comprises the following components in parts by weight: 3-4 parts of lactobacillus plantarum (Lactobacillus plantarum) LP45 powder, 1.5-2.5 parts of Lactobacillus acidophilus (L. acidophilus)Lactobacillus acidophilus) La28 bacterial powder, 0.5-1.5 parts of lactobacillus rhamnosus (Lactobacillus rhamnosus: (L))Lactobacillus rhamnosus) LR519 fungus powder and 0.05-0.15 parts of Bifidobacterium bifidum (b.), (Bifidobacteriumbifidum) TMC3115 bacterial powder;
the lactobacillus plantarum LP45 has a preservation number of CGMCC No. 8072; lactobacillus acidophilus La28 with the preservation number of CGMCC No. 11506; bifidobacterium bifidum TMC3115 with preservation number CGMCC No. 8462; lactobacillus rhamnosus LR519 with preservation number of CGMCC No.15969;
the colony number of the lactobacillus plantarum LP45 bacterial powder per unit mass is 3.8 multiplied by 1011cfu/g~4.2×1011cfu/g; the colony count of Bifidobacterium bifidum TMC3115 is 0.8 × 1011cfu/g~1.2×1011cfu/g; the colony number of the Lactobacillus rhamnosus LR519 bacteria powder is 1.8 multiplied by 1011cfu/g ~2.2×1011cfu/g；
Wherein the component B comprises the following components in parts by weight: 38-44 parts of lactitol, 36-40 parts of fructo-oligosaccharide, 4-10 parts of inulin, 4-6 parts of orange fruit powder and 0.15-0.25 part of vitamin C.
2. The probiotic composition according to claim 1, characterized in that the component A consists of the following components in parts by weight: 3.5 parts of lactobacillus plantarum LP45 bacterial powder, 2 parts of lactobacillus acidophilus La28 bacterial powder, 1 part of lactobacillus rhamnosus LR519 bacterial powder and 0.1 part of bifidobacterium bifidum TMC3115 bacterial powder; the component B comprises the following components in parts by weight: 41.2 parts of lactitol, 38 parts of fructo-oligosaccharide, 9 parts of inulin, 5 parts of orange fruit powder and 0.2 part of vitamin C.
3. A preparation method of a probiotic composition for assisting in relieving constipation and hemorrhoid symptoms is characterized in that the component A and the component B with the content of 5-10% are manually premixed, after the premixing is finished, the rest component B is added, the components are uniformly mixed in a mixing tank, vacuum feeding is adopted to feed the components into a hopper of a racking machine, and the components are packed into 2 g/strip by the racking machine.
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CN112237287B (en) * 2020-11-26 2022-11-29 河北一然生物科技股份有限公司 Lactobacillus rhamnosus LR519 capable of relieving constipation and composition thereof
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