CN118516248A - Bifidobacterium animalis subspecies BX-186 for relieving adverse effects of semeglutide - Google Patents
Bifidobacterium animalis subspecies BX-186 for relieving adverse effects of semeglutide Download PDFInfo
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention belongs to the technical field of biology, and particularly relates to an animal bifidobacterium lactis BX-186 strain for relieving adverse effects of semaglutin. The classification name of the bifidobacterium animalis subspecies BX-186 provided by the invention is as follows: bifidobacterium animalis subsp. Bifidobacterium animalis lactis, deposit unit: china general microbiological culture Collection center, accession number: CGMCC No.27837, preservation time: 2023, 7 and 7. The animal bifidobacterium lactosub-species BX-186 provided by the invention can influence the metabolic activity and physiological functions of intestinal microorganisms by directly interacting with intestinal flora, restore the balance of the intestinal flora, relieve gastrointestinal discomfort symptoms caused by the semeglutide, such as nausea, vomiting, diarrhea and the like, reduce the weight and the glycosylated hemoglobin HbA1c content in blood, and has wide application prospect.
Description
Technical Field
The invention belongs to the technical field of biology, and particularly relates to an animal bifidobacterium lactis BX-186 strain for relieving adverse effects of semaglutin.
Background
The semaglutin is a human glucagon-like peptide-1 (GLP-1) analogue produced by using saccharomyces cerevisiae cells through a gene recombination technology, and inhibits the release of glucagon which can raise blood sugar. The research shows that the medicine can regulate blood sugar, promote human body's sensitivity to insulin, raise satiety after meal, slow gastric emptying and inhibit appetite, so as to reduce body weight. Moreover, since the us FDA officially approved semaglutinin for the treatment of simple obesity in month 2021, researches show that semaglutinin can reduce the weight of non-diabetic simple fat friends by about 15% and has good safety once 2.4mg per week, so that semaglutinin plays an important role in reducing the weight. However, semaglutin has some side effects on the body, mainly including gastrointestinal reactions: such as nausea and vomiting, some of which are accompanied by diarrhea and constipation.
Bifidobacterium is a gram positive, motionless, rod-shaped bacterial genus with one end sometimes bifurcated and strictly anaerobic, and widely exists in the digestive tract, vagina, oral cavity and other habitats of humans and animals, and animal experiments find that a plurality of strains in Bifidobacterium (such as Bifidobacterium longum, bifidobacterium infantis, bifidobacterium animalis and the like) can improve host glucose tolerance.
The Chinese patent CN116376740A discloses a bifidobacterium longum with blood sugar reducing effect and application thereof, wherein the bifidobacterium longum is named WH2270, and the microorganism classification is named bifidobacterium longum subspecies Bifidobacterium longum subsp Longum; the microorganism strain is preserved in the Guangdong province center for 10 months and 18 days in 2022, the preservation address is No. 100 in martyr of Guangzhou City, and the preservation number is GDMCC No:62900 the bifidobacterium longum subspecies of the invention can improve the abundance of beneficial bacteria in intestinal tracts, can improve the content of short chain fatty acids in intestinal tracts, has excellent hypoglycemic effect, is separated from healthy infant feces, has no toxic genes, has no toxic or side effects in animal evaluation, is sensitive to various antibiotics, and has certain advantages compared with the traditional medicines for treating glycolipid metabolic disorders at present.
The Chinese another invention patent CN115804454A discloses a probiotic composition, a nutritional composition and application thereof, wherein the probiotic composition contains bifidobacterium lactis, bifidobacterium bifidum, bifidobacterium animalis, bifidobacterium longum, lactobacillus rhamnosus, lactobacillus casei, lactobacillus paracasei, lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus acidophilus and streptococcus thermophilus, and the probiotic composition promotes metabolism of probiotics in human intestinal tracts by effectively compounding prebiotics such as compound polysaccharide and specific kinds of proteins and the like of various probiotics, can help inhibit weight gain and even reduce weight, regulate blood sugar and blood fat, and has the effects of resisting oxidation and aging and improving skin condition.
Probiotics have been allowed for clinical treatment of many diseases and are generally defined as a group of active microorganisms that regulate and improve the intestinal flora when ingested in sufficient amounts from the diet, yielding clear benefits for human health. However, the strain is not disclosed in the prior art, so that side effects caused by the semaglutin can be relieved, and the probiotics have the effect of regulating intestinal flora, so that the relieving effect of the probiotics on adverse reactions of the semaglutin is a possible break.
Disclosure of Invention
Aiming at the problems existing in the prior art, the invention provides the bifidobacterium animalis subspecies BX-186 for relieving the adverse effects of the semeglutide, and can reduce the weight and the HbA1c content of glycosylated hemoglobin in blood.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
An animal bifidobacterium lactis subspecies BX-186 for alleviating the adverse effects of semaglutin, wherein the animal bifidobacterium lactis subspecies BX-186 are classified and named as follows: bifidobacterium animalis subsp. Bifidobacterium animalis lactis, deposit unit: china general microbiological culture Collection center, accession number: CGMCC No.27837, preservation time: 2023, 7, deposit address: the institute of microbiology, national academy of sciences, china, the area North Star, west way 1, 3, beijing, chaoyang.
The invention also provides a product for preventing, alleviating and/or treating adverse effects of semaglutin, the product comprising bifidobacterium animalis subspecies BX-186 and/or fermentation metabolites of bifidobacterium animalis subspecies BX-186.
Preferably, the adverse effect is a gastrointestinal discomfort symptom including diarrhea, vomiting, and nausea.
The invention also provides a product for reducing the glycosylated hemoglobin content in blood, which comprises bifidobacterium animalis subspecies BX-186 and/or fermentation metabolites of bifidobacterium animalis subspecies BX-186.
The invention also provides a weight-reducing product comprising bifidobacterium animalis subspecies BX-186 and/or a fermentation metabolite of bifidobacterium animalis subspecies BX-186.
Preferably, the daily intake of bifidobacterium subspecies BX-186 is not less than 1.0X10 6 CFU/d.
Preferably, the product is a food, a pharmaceutical or a health product.
Preferably, the food product comprises a dairy product, a soy product or a fruit and vegetable product.
Preferably, the dairy product comprises fermented milk, sour milk beverage, sour cream or cheese.
Preferably, the soy product comprises soy milk, fermented bean curd, fermented soya beans or soy sauce.
Preferably, the fruit and vegetable product comprises cucumber, carrot, beet, celery or cabbage product.
Preferably, the pharmaceutical product comprises pharmaceutical excipients.
Preferably, the pharmaceutical excipients include at least one of fillers, binders, wetting agents, disintegrants, lubricants and flavoring agents which are generally used in pharmacy.
Preferably, the pharmaceutical product is in the form of a tablet, powder, capsule or granule.
The invention also provides application of the bifidobacterium animalis subspecies BX-186 in preparing any one of the following products (1) - (3):
(1) A product for preventing, alleviating and/or treating adverse effects of semaglutin, which adverse effects are gastrointestinal distress symptoms including diarrhea, vomiting and nausea;
(2) A weight-loss product;
(3) A product for reducing the glycosylated hemoglobin content in blood.
Compared with the prior art, the invention has the following beneficial effects:
The bifidobacterium animalis subspecies BX-186 provided by the invention can influence the metabolic activity and physiological functions of intestinal microorganisms by directly interacting with intestinal flora, restore the balance of the intestinal flora, relieve gastrointestinal discomfort symptoms (including nausea, vomiting, diarrhea and the like) caused by the semeglutide, reduce the weight and the glycosylated hemoglobin HbA1c content in blood, and have wide application prospects.
Description of biological preservation
The classification of bifidobacterium animalis subspecies BX-186 for alleviating the adverse effects of semaglutin is named as follows: bifidobacterium animalis subsp. Bifidobacterium animalis lactis; preservation unit: china general microbiological culture Collection center, which is called CGMCC for short; preservation number: CGMCC No.27837; preservation time: 2023, 7; preservation address: the institute of microbiology, national academy of sciences, of China, the area North Star, west way 1, 3, of the Korean area of Beijing; the detection result of the strain is survival.
Drawings
FIG. 1 shows the HbA1c content of glycosylated hemoglobin in blood of 4 groups of subjects.
Detailed Description
The invention is further described below in conjunction with specific embodiments, and advantages and features of the invention will be apparent from the description. These examples are merely exemplary and are not intended to limit the scope of the invention in any way. The methods, ingredients and amounts referred to in the examples below, unless otherwise indicated, are conventional methods known to those skilled in the art. The raw materials used in the invention are all common commercial products, wherein bifidobacterium animalis subspecies Bb-12 are purchased from Corylus Hansen; soytone, available from Angel Yeast Co., ltd; yeast peptone, available from Angel Yeast Co., ltd; semaglutin, available from Shanghai Sail Biotech.
Example 1
The bifidobacterium animalis subspecies BX-186 bacterial powder is prepared according to the conventional bacterial powder preparation process, and the preparation process comprises the following steps:
1. Activating strains: inoculating the bifidobacterium animalis subspecies BX-186 strain frozen at-80 ℃ into corresponding liquid culture media after sterilization at 121 ℃ for 15min, and performing anaerobic culture at 37 ℃ for 18-24h, thus performing subculture for 1-2 times to obtain activated strains; the bifidobacterium animalis subspecies BX-186 is cultivated by adopting a lactobacillus optimized culture medium.
2. Preparing bacterial liquid: inoculating each strain activated in the step (1) into a lactobacillus optimized culture medium, and stopping anaerobic culture at 37 ℃ until the pH value is 4.5-4.8 to obtain seed liquid.
The composition of the optimized lactobacillus culture medium is as follows: 23.5Kg of sucrose, 12.0Kg of lactose, 15.0Kg of soytone, 5.0Kg of yeast powder, 12Kg of yeast peptone, 21.0Kg of Na 2HPO3, 2.0Kg of citric acid, 0.3Kg of MgSO 4·7H2O 0.6Kg,MnSO4·5H2 O, 1.0Kg of Tween-80, 0.3Kg of L-cysteine hydrochloride and distilled water to 1000L.
3. Inoculating and fermenting: inoculating the seed solution in the step (2) into the lactobacillus optimized culture medium prepared in the step (2) according to 1 per mill, and fermenting for 18 hours under controlled fermentation conditions.
The fermentation conditions are controlled as follows: culturing at 30deg.C in the early stage of fermentation, and naturally fermenting until pH is 5.0; then adjusting the fermentation temperature to 37 ℃ for constant temperature culture, controlling the pH value to be 6.0, and keeping anaerobic fermentation. The pH was maintained at 6.0 during this step by adding a neutralizing agent, which is NaOH.
The anaerobic fermentation condition is maintained in the following manner: by introducing nitrogen once every two hours.
4. Terminating fermentation: when the acid production of the thalli is stopped, the fermentation is stopped, the high-density fermentation liquor of the strain is obtained, and the viable count of the fermentation liquor reaches more than 2 multiplied by 10 10 CFU/mL. Wherein, whether acid production is stopped is judged by no more decrease in pH and stop of the addition of the neutralizing agent.
5. And (3) freeze drying: a. and (3) concentration of thalli: concentrating the high-density fermentation broth by 12000g centrifugation;
b. and (3) adding a protective agent: adding 5 times of protective agent solution in the bacterial concentrate; the composition of the protectant solution is as follows: 15Kg of skim milk, 12Kg of lactose, 1Kg of vitamin C, 1Kg of sodium glutamate and 1000L of distilled water;
c. And (3) drying: freeze-drying the bacterial suspension added with the protective agent to obtain freeze-dried bacterial powder, mixing bacterial powder of each strain according to a proportion (colony forming unit number proportion), and controlling the total number of viable bacteria in the mixed bacterial powder to be more than 2.0X10 11 CFU/g.
The viable count of the bifidobacterium animalis subspecies BX-186 bacteria powder prepared in the embodiment reaches 2000 hundred million/g-5000 hundred million/g.
Comparative example 1
The preparation process of the bifidobacterium animalis subspecies Bb-12 bacterial powder is the same as that of the embodiment 1, and the viable count of the bifidobacterium animalis subspecies Bb-12 bacterial powder is 2000 hundred million/g-5000 hundred million/g.
Experimental example
1. Experimental objects
120 Adult volunteers, including 60 men and 60 women, were enrolled, each with BMI either greater than or equal to 27kg/m 2 or greater than or equal to 30kg/m 2. All subjects were first run in for 20 weeks of semaglutin, and only subjects tolerating a 2.4mg dose at week 20 could run the randomization experiment. For intolerance to 2.4mg of semaglutin and for some personal reasons, 20 were excluded and eventually 100 subjects participated in the experiment.
2. Experimental method
2.1 Grouping
100 Volunteers were randomly divided into 4 groups of 25 persons each. The 4 groups are as follows: probiotic group: bifidobacterium animalis subspecies BX-186 flour + semeglutide; comparison group: bifidobacterium animalis subspecies Bb-12 bacteria powder and semaglutin; control group: semaglutin; placebo group: placebo (physiological saline).
2.2 Methods of administration
The intake dose of the bifidobacterium animalis subspecies BX-186 bacterial powder and the bifidobacterium animalis subspecies Bb-12 bacterial powder is 300 hundred million CFU/d per person, the injection dose of the semeglutide is 32.4mg/d per person, and the injection dose of the placebo is 32.4mg/d per person.
2.3 Index detection
Each group was subjected to a questionnaire assessment of body weight, adverse gastrointestinal reactions (nausea, diarrhea, vomiting) and blood samples from the subjects were collected for the measurement of glycosylated hemoglobin after baseline (baseline) and 6 months of intervention to assess the modulating effect of bifidobacterium animalis subspecies BX-186 on adverse reactions in the subjects caused by semaglutinin.
3. Experimental results
3.1 Subject weight analysis
The body weight of the subjects was assessed during the baseline period and after 6 months of intervention. The results are shown in table 1, with the probiotic, control and control groups, the body weight of the subjects was significantly reduced after 6 months of intervention compared to the placebo group, and the magnitude of the probiotic reduction was higher than the other groups. Indicating that the intervention of bifidobacterium animalis subspecies lactis BX-186 can reduce the weight more effectively.
Weight index of Table 14 group of subjects
3.2 Analysis of nausea Condition in a subject
Subjects were subjected to a nausea condition questionnaire analysis at baseline and 6 months after the intervention treatment. The results are shown in table 2, with the probiotic group, after 6 months of intervention, the nausea of the subjects was significantly improved compared to the control and control groups, and not significantly different from the placebo group. Indicating that the intervention of bifidobacterium animalis subspecies lactis BX-186 can relieve nausea symptoms caused by injection of semaglutin.
Table 24 nausea index status for group of subjects
3.3 Analysis of diarrhea status in subjects
Subjects were subjected to a diarrhea condition questionnaire analysis at baseline and 6 months after the intervention treatment. The results are shown in table 3, with the probiotic group, after 6 months of intervention, the diarrhea status of the subjects was significantly improved compared to the control and control groups, and no significant differences from the placebo group. Indicating that the intervention of bifidobacterium animalis subspecies lactis BX-186 can relieve diarrhea symptoms caused by injection of semaglutin.
Diarrhea index status of Table 34 group of subjects
3.4 Analysis of vomiting status in subjects
Subjects were subjected to a vomiting status questionnaire analysis at baseline and 6 months after intervention treatment. The results are shown in table 4, with the probiotic group, after 6 months of intervention, the vomiting status of the subjects was significantly improved compared to the control and control groups, and not significantly different from the placebo group. The intervention of bifidobacterium animalis subspecies BX-186 can effectively relieve the vomiting symptoms caused by the injection of the semaglutin.
Vomit index status of Table 44 group of subjects
3.5 HbA1c indicator analysis of glycosylated hemoglobin of subject
Blood samples from subjects were subjected to a volume analysis at baseline and 6 months after the intervention treatment. The results are shown in figure 1, with the HbA1c content in the blood of the subjects of the probiotic group, the control group and the control group significantly reduced compared to the placebo group, and the probiotic group most significantly reduced after 6 months of intervention. Indicating that the intervention of bifidobacterium animalis subspecies lactis BX-186 can effectively reduce HbA1c content in blood of a subject.
In conclusion, the intervention of the bifidobacterium animalis subspecies BX-186 can effectively relieve gastrointestinal discomfort symptoms (including nausea, vomiting and diarrhea) of a subject caused by the semaglutinin, and can achieve the effects of reducing the weight and the HbA1c content of glycosylated hemoglobin in blood.
Finally, it should be noted that the above description is only for illustrating the technical solution of the present invention, and not for limiting the scope of the present invention, and that the simple modification and equivalent substitution of the technical solution of the present invention can be made by those skilled in the art without departing from the spirit and scope of the technical solution of the present invention.
Claims (10)
1. An animal bifidobacterium lactis subspecies BX-186 for alleviating the adverse effects of semaglutin, which is characterized in that the classification of the animal bifidobacterium lactis subspecies BX-186 is named as: bifidobacterium animalis subsp. Bifidobacterium animalis lactis, deposit unit: china general microbiological culture Collection center, accession number: CGMCC No.27837, preservation time: 2023, 7 and 7.
2. A product for preventing, alleviating and/or treating adverse effects of semaglutin, characterized in that said product comprises bifidobacterium animalis subspecies BX-186 and/or a fermentation metabolite of said bifidobacterium animalis subspecies BX-186 according to claim 1.
3. The product of claim 2, wherein the adverse effect is a gastrointestinal distress symptom including diarrhea, vomiting, and nausea.
4. A product for reducing the glycosylated hemoglobin content of blood, characterized in that the product comprises bifidobacterium animalis subspecies BX-186 and/or a fermentation metabolite of bifidobacterium animalis subspecies BX-186 according to claim 1.
5. A weight-reducing product, characterized in that it comprises bifidobacterium animalis subspecies BX-186 and/or a fermentation metabolite of bifidobacterium animalis subspecies BX-186 according to claim 1.
6. The product according to any one of claims 2-5, wherein the product is a food, pharmaceutical or health product.
7. The product of claim 6, wherein the food product comprises a dairy product, a soy product, or a fruit and vegetable product, the dairy product comprising fermented milk, yogurt drink, sour cream, or cheese; the bean product comprises soybean milk, fermented bean curd, fermented soybean or soybean paste; the fruit and vegetable product comprises cucumber, carrot, beet, celery or cabbage product.
8. The product of claim 6, wherein the pharmaceutical product comprises a pharmaceutical excipient and the pharmaceutical product is in the form of a tablet, powder, capsule or granule.
9. The product of claim 8, wherein the pharmaceutical excipients comprise at least one of fillers, binders, wetting agents, disintegrants, lubricants and flavoring agents commonly used in pharmacy.
10. Use of bifidobacterium animalis subspecies BX-186 as claimed in claim 1 in the manufacture of any one of the following products (1) - (3), (1) products for preventing, alleviating and/or treating adverse effects of semaglutin, said adverse effects being gastrointestinal distress symptoms including diarrhea, vomiting and nausea; (2) a weight-loss product; (3) a product for reducing the glycosylated hemoglobin content in blood.
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