CN107050065A - The new opplication of Bifidoquater live bacterial composition - Google Patents
The new opplication of Bifidoquater live bacterial composition Download PDFInfo
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- CN107050065A CN107050065A CN201710205213.1A CN201710205213A CN107050065A CN 107050065 A CN107050065 A CN 107050065A CN 201710205213 A CN201710205213 A CN 201710205213A CN 107050065 A CN107050065 A CN 107050065A
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- BNYHRGTXRPWASY-UHFFFAOYSA-N nonylsulfonylurea Chemical compound CCCCCCCCCS(=O)(=O)NC(N)=O BNYHRGTXRPWASY-UHFFFAOYSA-N 0.000 description 1
- 229940125395 oral insulin Drugs 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 208000033808 peripheral neuropathy Diseases 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 208000011117 substance-related disease Diseases 0.000 description 1
- YROXIXLRRCOBKF-UHFFFAOYSA-N sulfonylurea Chemical class OC(=N)N=S(=O)=O YROXIXLRRCOBKF-UHFFFAOYSA-N 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- GXPHKUHSUJUWKP-UHFFFAOYSA-N troglitazone Chemical compound C1CC=2C(C)=C(O)C(C)=C(C)C=2OC1(C)COC(C=C1)=CC=C1CC1SC(=O)NC1=O GXPHKUHSUJUWKP-UHFFFAOYSA-N 0.000 description 1
- 229960001641 troglitazone Drugs 0.000 description 1
- 241001148471 unidentified anaerobic bacterium Species 0.000 description 1
- 238000002562 urinalysis Methods 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 150000003952 β-lactams Chemical class 0.000 description 1
Classifications
-
- 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
- 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
- A61K35/742—Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
-
- 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
-
- 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
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
The invention discloses the new opplication of Bifidoquater live bacterial composition, belong to pharmaceutical technology field.The invention discloses application of the Bifidoquater live bacterial composition in auxiliary hyperglycemic medicine or health food or food is prepared, Bifidoquater live bacterial composition reduces glycosylated albumin, the application prepared during auxiliary reduces glycosylated hemoglobin medicine or health food or food in preparation auxiliary, and Bifidoquater live bacterial composition is preparing the application suitable for type 2 diabetes patient, the auxiliary hyperglycemic medicine of merging insulin patients or health food or food.Present invention finds a kind of new application of Bifidoquater live bacterial composition, extend the application of Bifidoquater live bacterial composition, the clinical application range of Bifidobacterium tetragenous viable bacteria composition is extended to new diabetes endocrine section office by digesting section office, said composition belongs to probiotics micro-ecological formulation simultaneously, composition is harmless, and body is had no side effect.
Description
Technical field
The present invention relates to the new opplication of Bifidoquater live bacterial composition, belong to pharmaceutical technology field.
Background technology
Counted according to IDF (IDF), diabetic's total population quantity is 98,400,000, neuropathy is
70%, the wherein incidence of disease of diabetes is 60%, i.e., the total number of people of national diabetic's constipation is 41,000,000 populations, wherein
The total number of persons of diabetic's constipation is 22,000,000 in urban population.Clinical treatment Rezulin hypoglycemic medicine is mostly sulphonyl
Ureas Drugs Promoting Insulin Secretion, biguanides, alpha-glucosidase restrainer, Study of Thiazolidinedione derivatives as Insulin Sensitizer, two peptidyls
The inhibitor of peptase -4, glucagon-like peptide-1 analogs etc., these medicines can produce some side effects, such as hypoglycemia, digestion
Road reaction (abdominal distension, diarrhoea), allergy, dysfunction of liver, fash etc..
Diabetes be it is a kind of because internal insulin is absolute or relative deficiency caused by sugar, protein, fat, water and electrolysis
A series of metabolic syndromes such as matter.Diabetes patient is with intestinal bacilli illness and inflammatory reaction so as to produce constipation.Gut flora
Imbalance causes G- ratios in host to raise, intestinal permeability increase or bacterial translocation from gut, and body is by producing and absorbing
More toxin activate the low chronic inflammatory reaction of pancreas islet, inflammation can be caused by number of ways beta Cell of islet structure by
Damage and dysfunction, promote β Apoptosis, cause hypoinsulinism；Inflammation can also cause endothelial cell 26S Proteasome Structure and Function
It is abnormal, cause insulin to occur transit barrier in human tissue cell, it is impossible to bring into normal play and act on and cause insulin resistance.
There is document report Lactobacillus casei that there is hypoglycemic effect at present, probiotics reported in the literature can reach drop blood
Sugared efficacy effect need to take in 108Individual -109Individual viable bacteria, even more high.
Chinese invention patent CN 01108353.0 discloses a kind of " Bifidobacterium tetragenous viable bacteria piece ", by baby's bifid bar
Bacterium, lactobacillus acidophilus, four kinds of strain compositions of enterococcus faecalis and Bacillus cereus.
The content of each bacterium powder is respectively in every gram of tablet：Bifidobacterium infantis 5.0 × 106It is individual；Lactobacillus acidophilus be 2.5 ×
106It is individual；Enterococcus faecalis 2.5 × 106It is individual；Bacillus cereus 2.5 × 105It is individual.
Four kinds of bacterium are deposited in the common Bio-Centers of China Microbiological preservation administration committee, address：Chaoyang District, Beijing City
The institute 3 of North Star West Road 1, preservation date：On June 20th, 2000, deposit number：The newborn bar of bifidobacterium infantis 0460.1, acidophilus
Bacterium 0460.2, enterococcus faecalis 0460.3, bacillus cereus 0460.4.
Described in the patent：The normal physiological bacterium of human body intestinal canal can be supplemented by being somebody's turn to do " Bifidobacterium tetragenous viable bacteria piece ", extensive
Microecological balance in complex.Clinical research shows, is somebody's turn to do " Bifidobacterium tetragenous viable bacteria piece " to adult acute's diarrhoea, chronic abdomen
Rush down, constipation of being grown up, infantile acute diarrhea etc. have good curative effect.
But patent is that pertinent literature does not refer to blood glucose and glycosylated hemoglobin and sugar of the said composition to diabetic
Changing albumin has reduction effect.
The content of the invention
The invention provides a kind of new opplication of Bifidoquater live bacterial composition, particularly a kind of Bifidoquater live bacterial combination
Thing is preparing the medicine or health food or food of auxiliary hyperglycemic, assistant hypoglycemic hemoglobin and assistant hypoglycemic albumin
In application.
Application of the Bifidoquater live bacterial composition in auxiliary hyperglycemic medicine or health food or food is prepared, it is described double
Discrimination tetragenous viable bacteria composition includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus.
Bifidoquater live bacterial composition is being prepared suitable for the auxiliary hyperglycemic medicine of type 2 diabetes patient or health care food
Application in product or food, the Bifidoquater live bacterial composition include bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and
Bacillus cereus.
Bifidoquater live bacterial composition is preparing the auxiliary hyperglycemic medicine for being applied to merge insulin patients or health care food
Application in product or food, the Bifidoquater live bacterial composition include bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and
Bacillus cereus.
Bifidoquater live bacterial composition answering in auxiliary reduction glycosylated albumin medicine or health food or food is prepared
With the Bifidoquater live bacterial composition includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus.
Bifidoquater live bacterial composition is in auxiliary reduction glycosylated hemoglobin medicine or health food or food is prepared
Using the Bifidoquater live bacterial composition includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and waxy gemma bar
Bacterium.
Preferably, in application described above, every gram of Bifidoquater live bacterial composition comprising bifidobacterium infantis 1.0 ×
106Individual -1.0 × 108Individual, lactobacillus acidophilus is 1.0 × 106Individual -1.0 × 108It is individual, enterococcus faecalis 1.0 × 106Individual -1.0 × 108
It is individual, bacillus cereus 1.0 × 105Individual -1.0 × 107It is individual.
It is highly preferred that in application described above, every gram of Bifidoquater live bacterial composition includes bifidobacterium infantis 5.0
×106It is individual；Lactobacillus acidophilus is 2.5 × 106It is individual；Enterococcus faecalis 2.5 × 106It is individual；Bacillus cereus 2.5 × 105It is individual.
The culture presevation number of bifidobacterium infantis of the present invention is bifidobacterium infantis 0460.1；The lactobacillus acidophilus
Culture presevation number be lactobacillus acidophilus 0460.2；The culture presevation number of the enterococcus faecalis is enterococcus faecalis 0460.3；It is described
The culture presevation number of bacillus cereus is bacillus cereus 0460.4.
In application described above, the formulation of the Bifidoquater live bacterial composition is tablet, capsule, granule, powder,
Any one in liquid preparation.
It is described present invention also offers a kind of assistant hypoglycemic medicine or health food containing Bifidoquater live bacterial composition
Bifidoquater live bacterial composition includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus；The auxiliary
The formulation of hypoglycemic medicine or health food is any one in tablet, capsule, granule, powder, liquid preparation.
Preferably, in application described above, every gram of Bifidoquater live bacterial composition includes bifidobacterium infantis
1.0×106Individual -1.0 × 108Individual, lactobacillus acidophilus is 1.0 × 106Individual -1.0 × 108It is individual, enterococcus faecalis 1.0 × 106Individual -1.0
×108It is individual, bacillus cereus 1.0 × 105Individual -1.0 × 107It is individual.
It is highly preferred that in application described above, every gram of Bifidoquater live bacterial composition includes bifidobacterium infantis 5.0
×106It is individual；Lactobacillus acidophilus is 2.5 × 106It is individual；Enterococcus faecalis 2.5 × 106It is individual；Bacillus cereus 2.5 × 105It is individual.
Present invention also offers a kind of assistant hypoglycemic food containing Bifidoquater live bacterial composition, the bifidoquater is lived
Bacteria composition includes bifidobacterium infantis, and lactobacillus acidophilus is, enterococcus faecalis and bacillus cereus.
Preferably, the described every gram Bifidoquater live bacterial composition includes bifidobacterium infantis 1.0 × 106Individual -1.0 ×
108Individual, lactobacillus acidophilus is 1.0 × 106Individual -1.0 × 108It is individual, enterococcus faecalis 1.0 × 106Individual -1.0 × 108It is individual, waxy gemma
Bacillus 1.0 × 105Individual -1.0 × 107It is individual.
It is highly preferred that every gram of Bifidoquater live bacterial composition includes bifidobacterium infantis 5.0 × 106It is individual；Acidophilus breast
Bacillus is 2.5 × 106It is individual；Enterococcus faecalis 2.5 × 106It is individual；Bacillus cereus 2.5 × 105It is individual.
Bifidobacterium tetragenous viable bacteria composition of the present invention comprising bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis,
Bacillus cereus.
The content of each bacterium powder is respectively in every gram of composition：Bifidobacterium infantis 5.0 × 106It is individual；Lactobacillus acidophilus is 2.5
×106It is individual；Enterococcus faecalis 2.5 × 106It is individual；Bacillus cereus 2.5 × 105It is individual.
Wherein, four kinds of bacterium are deposited in the common Bio-Centers of China Microbiological preservation administration committee, address：Beijing is exposed to the sun
The institute 3 of area North Star West Road 1, preservation date：On June 20th, 2000, deposit number：Bifidobacterium infantis 0460.1, acidophilus breast
Bacillus 0460.2, enterococcus faecalis 0460.3, bacillus cereus 0460.4.
The bifidobacterium infantis, culture presevation number is bifidobacterium infantis 0460.1；Preservation place is positioned at Beijing
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of Chaoyang District North Star West Road 1, preservation date is 2000
June 20；
The lactobacillus acidophilus, culture presevation number is lactobacillus acidophilus 0460.2；Preservation place is positioned at Beijing Chaoyang
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of area North Star West Road 1, preservation date is in June, 2000
20 days；
The enterococcus faecalis, culture presevation number is enterococcus faecalis 0460.3；Preservation place is positioned at Chaoyang District, Beijing City north
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of occasion West Road 1, preservation date is on June 20th, 2000；
The bacillus cereus, culture presevation number is bacillus cereus 0460.4；Preservation place is positioned at Beijing
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of Chaoyang District North Star West Road 1, preservation date is 2000
June 20.
Hypoglycemic medicine conventional at present have sulfonylurea Drugs Promoting Insulin Secretion, non-sulfonylurea Drugs Promoting Insulin Secretion,
Biguanides, alpha-glucosidase restrainer, Study of Thiazolidinedione derivatives as Insulin Sensitizer, the inhibitor of peptidyl peptidase -4, pancreas hyperglycaemia
Plain analog of sample peptide -1 etc..Diabetic takes these medicines and occurs that hypoglycemia, digestive tract reaction, allergic reaction etc. are bad
Reaction symptom.
Bifidobacterium tetragenous viable bacteria composition play auxiliary hyperglycemic mechanism be：Enterococcus faecalis and bacillus cereus category
In aerobic bacteria, bifidobacterium infantis and lactobacillus acidophilus belong to anaerobic bacteria, and Bifidobacterium tetragenous viable bacteria composition enters human body intestines
Behind road, the oxygen in enterococcus faecalis and bacillus cereus consumption enteron aisle, is that bifidobacterium infantis and lactobacillus acidophilus provide and detested
Oxygen environment and the growth for promoting bifidobacterium infantis and lactobacillus acidophilus, bifidobacterium infantis are so that enteron aisle group reaches equilibrium-like
State, fast quick-recovery gut flora balance, gut flora balance reduces intestinal permeability, body inflammatory reduction, IGT
It is eased, so as to reach the function of reduction blood sugar level, glycosylated hemoglobin and glycosylated albumin level.
Beneficial effect of the present invention：
Bifidoquater live bacterial composition of the present invention is mainly used in Gastroenterology dept. in clinical practice at present, and product adaptation disease is used for
The treatment diarrhoea related to intestinal bacilli illness, constipation, functional dyspepsia FD.Present invention finds Bifidoquater live bacterial combination
A kind of new application of thing, endocrine section office are gradually extended to by the application containing four plants of bacteria compositions of Bifidobacterium from digestion section office
Application, there is the effect of auxiliary reduction, Ke Yiyong to the blood glucose and glycosylated hemoglobin and glycosylated albumin of diabetic
It is applied to the auxiliary hyperglycemic medicine or health food or food for the treatment of type 2 diabetes patient, merging insulin patients in preparation
Product.Bifidoquater live bacterial composition of the present invention is used to prepare auxiliary hyperglycemic medicine, and composition is harmless, and body is had no side effect.
The present invention is prepared using bifidobacterium infantis, lactobacillus acidophilus, four kinds of bacterium powders of enterococcus faecalis and bacillus cereus
Into composition, wherein bifidobacterium infantis 1.0 × 106Individual -1.0 × 108Individual, lactobacillus acidophilus is 1.0 × 106Individual -1.0 × 108
It is individual, enterococcus faecalis 1.0 × 106Individual -1.0 × 108It is individual, bacillus cereus 1.0 × 105Individual -1.0 × 107Individual, the present invention is not only
It was found that composition prepared by bifidobacterium infantis, lactobacillus acidophilus, four kinds of bacterium powders of enterococcus faecalis and bacillus cereus can reach
Blood glucose, glycosylated hemoglobin and glycosylated albumin effect are reduced, and also found the four kinds of bacterium of the above for only needing low amount level
Composition is with regard to that can reach reduction blood glucose, glycosylated hemoglobin and glycosylated albumin effect.
Brief description of the drawings
Fig. 1 is the change of glycosylated albumin before and after two groups of treatments.
Embodiment
To illustrate Bifidoquater live bacterial composition of the present invention to blood glucose, drop glycosylated hemoglobin and the effect for dropping glycosylated albumin
Really, the present invention will be further described by zoopery and clinical trial for the present embodiment, but the present invention is not limited by embodiment
System.
Bifidobacterium tetragenous viable bacteria composition of the present invention comprising bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis,
Bacillus cereus.
Every gram of Bifidoquater live bacterial composition includes bifidobacterium infantis 5.0 × 106It is individual；Lactobacillus acidophilus is 2.5
×106It is individual；Enterococcus faecalis 2.5 × 106It is individual；Bacillus cereus 2.5 × 105It is individual.
Wherein, four kinds of bacterium are deposited in the common Bio-Centers of China Microbiological preservation administration committee, address：Beijing is exposed to the sun
The institute 3 of area North Star West Road 1, preservation date：On June 20th, 2000, deposit number：Bifidobacterium infantis 0460.1, acidophilus breast
Bacillus 0460.2, enterococcus faecalis 0460.3, bacillus cereus 0460.4.
The bifidobacterium infantis, culture presevation number is bifidobacterium infantis 0460.1；Preservation place is positioned at Beijing
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of Chaoyang District North Star West Road 1, preservation date is 2000
June 20；
The lactobacillus acidophilus, culture presevation number is lactobacillus acidophilus 0460.2；Preservation place is positioned at Beijing Chaoyang
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of area North Star West Road 1, preservation date is in June, 2000
20 days；
The enterococcus faecalis, culture presevation number is enterococcus faecalis 0460.3；Preservation place is positioned at Chaoyang District, Beijing City north
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of occasion West Road 1, preservation date is on June 20th, 2000；
The bacillus cereus, culture presevation number is bacillus cereus 0460.4；Preservation place is positioned at Beijing
Institute of Microorganism, Academia Sinica's common micro-organisms center of the institute 3 of Chaoyang District North Star West Road 1, preservation date is 2000
June 20.
Bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and waxy bud are included in Bifidobacterium tetragenous viable bacteria composition
Spore bacillus, and the one or more of auxiliary materials for meeting States Pharmacopoeia specifications, Bifidobacterium tetragenous viable bacteria group can also be added in composition
Active component in compound is bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and Bacillus cereus, four kinds of viable bacterias of the above
Active component can be made tablet, granule, capsule, and which kind of formulation is any formulation such as powder, concrete composition be prepared into not
Influence can be produced on auxiliary hyperglycemic effect, gavage mouse for convenience in the present embodiment zoopery will be with above-mentioned four kinds of bacterium
Mixing bacterium powder be prepared into solution and carry out following zoopery, and carry out by taking Bifidobacterium tetragenous viable bacteria piece as an example following clinic
Experiment proves that Bifidoquater live bacterial composition can play a part of auxiliary hyperglycemic.
The preparation method of Bifidobacterium tetragenous viable bacteria composition is as follows：
(1) powder preparation method：The fermented culture of four kinds of bacterial strains, it is lyophilized be prepared into bacterium powder, four kinds of bacterium powders cross 60 eye mesh screens；
Auxiliary material carries out sieving processing after weighing by a certain percentage；The auxiliary material for processing of sieving first is added in batch mixed machine and carries out criticizing mixed, then
Add mixing bacterium powder.Blowing after four kinds of freeze-dried powders are mixed with auxiliary material in mixing machine, is obtained into after being packed using packing machine
Product.
(2) preparation method of granule：The fermented culture of four kinds of bacterial strains, it is lyophilized be prepared into bacterium powder, four kinds of bacterium powders cross 60 mesh
Screen cloth；Auxiliary material carries out sieving processing after weighing by a certain percentage；Auxiliary material after sieving and bacterium powder are added and made in comminutor
Grain.Finished product is obtained after being packed after the completion of granulation using packing machine.
(3) preparation method of capsule：The fermented culture of four kinds of bacterial strains, it is lyophilized be prepared into bacterium powder, four kinds of bacterium powders cross 60 mesh
Screen cloth；Auxiliary material carries out sieving processing after weighing by a certain percentage；The auxiliary material for processing of sieving first is added in batch mixed machine and carries out criticizing mixed,
Then mixing bacterium powder is added.Blowing after four kinds of freeze-dried powders are mixed with auxiliary material in mixing machine, after being mixed using capsule filling machine
Supplementary material put into capsule, obtain finished product after packaging.
(4) preparation method of tablet：The fermented culture of four kinds of bacterial strains, it is lyophilized be prepared into bacterium powder, four kinds of bacterium powders cross 60 mesh sieves
Net；Auxiliary material carries out sieving processing after weighing by a certain percentage；The auxiliary material for processing of sieving first is added in batch mixed machine and carries out criticizing mixed, so
Mixing bacterium powder is added afterwards.Blowing after four kinds of freeze-dried powders are mixed with auxiliary material in mixing machine, carries out obtaining after tabletting using tablet press machine
Finished product.
1 animal experiment is designed and method
The animal experiment of table 1 is designed and method
2 human experimentation master-plans and method
Abbreviation involved by following case study on implementation is explained as follows：
AKP (Alkaline Phosphatase) alkaline phosphatase；ALT (Alanine Aminotransterase) third ammonia
Sour aminopherase；AST (Aspartate Aminotransferase) aspartate amino transferase；Cr
(Creatinine) creatinine；CRF (Case Report Form) Case report no table；FAS (Full Analysis Set) complete analysis
Data set；HB (Hemoglobin) hemoglobin；PLT (Platelet) blood platelet；PPS (Per-Protocol Set) side of meeting
Case data set；RBC (Red Blood Cell) red blood cell；SS (Satety Set) data of safety collection；WBC(White Blood
Cell) leucocyte；TBIL (Total bilirubin) total bilirubin；GGT (γ-glutamyl transpeptadase) paddy ammonia
Acyl transpeptidase；BUN (Urea nitrogen) urea nitrogen；BFI (Bowel Function Index) gut function index；PAC-SYM
(Patient Assessment of Constipation symptom) constipation patient Self-reporting inventory；CSBMs
(Complete Spontaneous Bowel Movements) spontaneous defecation situation completely；SBMs(Spontaneous Bowel
Movements) spontaneous defecation situation；PGIC (Patient-reported Global Impression of Change) patient
To the Global Impression of change.
2.1 experimental design
Using random, double blinding, placebo parallel control, multiple center clinical study.
2.2 case quantity and packet
Total case load is chosen to be 240；6 centers.Patient is to suffer from type ii diabetes and the patient with constipation symptom.
2.3 random device
Using layering district's groups random device.
(1) by SAS9.4 statistical package PROC PLAN processes, using the method that district's groups are random, each adapt to is produced
Disease subject receives to handle the random arrangement of (investigational agent and comparison medicine), has both listed random coded table.
(2) case load is distributed：Subject's medicine numbering that each center is distributed is random, and this experiment is in totally 6
The heart, each center by setting rule, i.e., headed by group leader's unit, the lead-in busbar of each center of participant Chinese phonetic alphabet by name
Sequence, is produced with SAS software kits《Centre code table of random number》, obtain the random coded at each center.Each center is in distribution medicine
Provided successively by number during thing.
3 case selection standards
3.1 include case standard
Any one of following person of being unsatisfactory for, not may participate in this experiment：
(1) meet diabetes diagnostic criterion, belong to diabetes B person, the course of disease >=1 year；
(2) glycosylated hemoglobin (HbA1c) >=7% when screening, and≤12%；
(3) chronic constipation diagnostic criteria, the course of disease >=6 month are met；
(4) 18~70 one full year of life (including 18 and 70 one full year of life), men and women does not limit；
(5) Written informed consent is voluntarily signed.
3.2 exclusion standard
Possess following any one person, experiment is not may participate in：
(1) type i diabetes, other specific types diabetic such as gestational diabetes；Or diabetes glucose control is not
Stable (fasting blood-glucose>11.1mmol/L)；
(2) there are diabetic ketoacidosis or hyperosmolar nonketotic diabetic coma history person；
(3) organic constipation, such as intestines problem, E＆M disease (except diabetes)；The nervous system disease,
Constipation caused by muscle disease etc.；
(4) it is drug induced constipation, such as antidepressants, calcium antagonist, diuretics, sympathetic transmitter releasers, antiacid containing aluminium or calcium
Constipation caused by medicine, calcium agent, chalybeate, antidiarrheal agent etc.；
(5) enterogastric diseases, such as colitis, mesenteric lymphadenitis, there is intestinal surgery history person；
(6) medicine that clinical effectiveness may be influenceed to evaluate or method were used in nearly 2 weeks, such as：Antibiotic (beta-lactam
Class, aminoglycoside, macrolides etc.)；Tiny ecosystem active bacteria formulation (hay bacillus bigeminy viable bacteria capsulae enterosolubilis, Bifidobacterium
Lactobacillus live triple piece, clostridium butyricum enterococcus live triple piece etc.)；Osmotic laxative treatments (magnesium sulfate, lactulose etc.)；Anthraquinone
Class (rheum officinale class, aloe, folium sennae etc.)；Promote gastroenteritic power medicine (metoclopramide, Domperidone, Cisapride) etc.；
(7) there are miocardial infarction or headstroke history in past 6 months, or there is serious angiocardiopathy and risk person, bag
Include unstable angina, heart failure or have arrhythmia cordis of threat to life etc.；
(8) Liver and kidney function exception person (i.e. ALT or AST are more than 1.5 times of Upper Limit of Normal Value；Creatinine is more than normal value), or just
In the person that receives dialysis treatment；
(9) serious high blood pressure disease is suffered from, remain unchanged systolic pressure >=160mmHg, diastolic pressure ＞ 90mmHg after medicine control
Or have low blood pressure (tranquillization seat blood pressure) ＜ 90/50mmHg) patient；
(10) mental patient, Alcoholic Dependent Patients or there is drug abuse history person；
(11) fertility person is prepared in 3 months during women breast-feeding their children, gravid woman and medication or after medication stopping；
(12) allergic constitution or previously to multi-medicament allergy sufferers, or to the patient of experiment drug ingedient allergy used；
(13) experiment participated in other clinical investigators in first 3 months；
(14) researcher thinks that other patients of this research should not be participated in.
4 research medicines and treatment method
4.1 experiment medications
(1) investigational agent：Bifidobacterium tetragenous viable bacteria piece, Chinese medicines quasi-word S20060010.Main component：Bifidobacterium infantis,
Lactobacillus acidophilus, enterococcus faecalis, Bacillus cereus, specification：0.5g/ pieces, storage：2~8 DEG C are kept in dark place and transport, effectively
Phase：18 months.
(2) comparison medicine：Bifidobacterium tetragenous viable bacteria piece simulant, with Bifidobacterium tetragenous viable bacteria piece outward appearance, color etc. is complete
Entirely unanimously but without drug ingedient.Main component：Pharmaceutic adjuvant, storage：2~8 DEG C are kept in dark place and transport, the term of validity：18
Month.
Above-mentioned Bifidobacterium tetragenous viable bacteria piece medicine is produced by the long-range Biology Pharmacy Co., Ltd in Hangzhou.
4.2 dosage regimen
(1) test group (abbreviation A groups)：Primary Care+Bifidobacterium tetragenous viable bacteria piece, orally, 3 times a day, 3 tablets once,
Warm water delivery service is used after the meal, need to separately be taken with Primary Care medicine, is spaced 15 minutes.Continuously take 8 weeks.
(2) control group (abbreviation B groups)：Primary Care+Bifidobacterium tetragenous viable bacteria piece simulant, orally, 3 times a day, often
It secondary 3, after the meal with warm water delivery service, need to separately take, be spaced 15 minutes with Primary Care medicine.Continuously take 8 weeks.
4.3 research cycle
Treatment phase 4 weeks, follow-up period 8 weeks.
4.4 Primary Care
Using diabetes conventional therapy, oral drugs or insulin injection control blood glucose, and can be taken according to actual conditions
Individualized treatment scheme, (including carries out Diabetes Mellitus Knowledge education, psychology and dredges while carrying out health education and adjustment life style
Lead, diet control, moderate exercise etc..Diet should be noted that breakfast, lunch and dinner at regular time and quantity, eat the high food of fat content less, many food coarse food grains and
The more vegetables of containing cellulose, drink more water, move and set up good bowl evacuation habit).As far as possible control fasting blood-glucose≤
7mmol/L, 2h-plasma glucose≤10mmol/L should not change Primary Care scheme and dosage under study for action.
5 therapeutic evaluatioies
5.1 curative effect index evaluations
Glycosylated albumin and glycosylated hemoglobin
5.2 safety evaluatio
(1) general physical examination project：Vital sign (heart rate, breathing, body temperature, blood pressure) and physical examination (including general physical checkup,
Abdomen examination and anal orifice and rectal intestine refer to inspection, should be specifically noted that whether there is abdominal tenderness during abdomen examination, abdominal mass etc.)；
(2) lab index：Blood routine (RBC, HB, WBC, PLT), liver function (ALT, AST, AKP, TBIL, GGT), kidney
Function (Cr, BUN), routine urinalysis, glycosylated albumin, glycosylated hemoglobin, electrocardiogram；
(3) adverse events：Adverse events, serious adverse events and adverse reaction rate.
6 the standard of curative effect evaluation
6.1 curative effect indexs
Glycosylated albumin and glycosylated hemoglobin：Comparative test group and control group, organize the numerical value difference between interior, group.
6.2 secondary efficacy indexs
The change of glycosylated albumin；(changing value using glycosylated hemoglobin at 12 weeks is adopted as curative effect index for subgroup analysis
Exploration BMI is carried out with the method for chromatographic analysis with 25kg/m2, diabetic duration 8 years, baseline fasting plasma glucose 8mmol/L to be divided
Layer analysis)；The stability analysis of hypoglycemic effect：Stability=2 week of hypoglycemic, 4 weeks, the standard deviation of 8 Wednesdays time blood glucose inspection value.
6.3 safety evaluation standard
Nothing：Safety, without any adverse reaction；
Slightly：Compare safety, if any adverse reaction, be not required to do any processing, medication can be continued；
Moderate：There is safety issue, there is moderate adverse reaction, administration can be continued after processing；
Severe：Because of serious adverse reaction termination test.
7 results of animal
7.1 different experiments group fasting blood-glucose situations of change
The change of the different experiments group fasting blood-glucose of table 2 is compared (mean ± standard deviation, mmol/L)
From Table 2, it can be seen that contain the bacteria suspension of four kinds of bacterium powders to mouse stomach, it is real with the extension of gavage time
Test group mouse fasting blood sugar on a declining curve, during by the 5th week, in experimental group normal dose group mouse fasting blood sugar from
14.36 ± 0.12mmmol/L is reduced to 6.67 ± 0.09mmmol/L；In experimental group high dose group mouse fasting blood sugar from
14.26 ± 0.05mmmol/L is reduced to 6.73 ± 0.09mmmol/L；In experimental group low dose group mouse fasting blood sugar from
14.30 ± 0.14mmmol/L is reduced to 6.63 ± 0.05mmmol/L.Thus illustrate, bifidobacterium infantis, lactobacillus acidophilus, excrement
Four kinds of bacterium powder compositions of enterococcus and bacillus cereus have the function of reduction diabetic mice fasting blood-glucose.
The change of 7.2 different experiments group glycosylated hemoglobins is compared
The change of the different experiments group glycosylated hemoglobin of table 3 is compared (mean ± standard deviation, %)
From table 3 it is observed that contain the bacteria suspension of four kinds of bacterium powders to mouse stomach, it is real with the extension of gavage time
Test group mouse glycosylated hemoglobin value on a declining curve, during by the 5th week, normal dose group mouse HbAle egg in experimental group
White value is reduced to 3.86 ± 0.05 from 5.33 ± 0.09；In experimental group high dose group mouse glycosylated hemoglobin value from 5.26 ±
0.05 is reduced to 3.83 ± 0.05；In experimental group low dose group glycosylated hemoglobin value be reduced to 4.03 from 5.23 ± 0.05 ±
0.05.Thus illustrate, bifidobacterium infantis, lactobacillus acidophilus, four kinds of bacterium powder composition tools of enterococcus faecalis and bacillus cereus
There is the function of reduction diabetic mice glycosylated hemoglobin.
The change of 7.3 different experiments group glycosylated albumins is compared
The change of the different experiments group glycosylated albumin of table 4 is compared (mean ± standard deviation, %)
As can be seen from Table 4, the bacteria suspension of four kinds of bacterium powders is contained to mouse stomach, it is real with the extension of gavage time
Test group mouse glycosylated albumin value on a declining curve, during by the 5th week, normal dose group mouse glycosylated albumin value in experimental group
9.17 ± 0.05 are reduced to from 11.27 ± 0.09；High dose group mouse glycosylated albumin value drops from 11.23 ± 0.05 in experimental group
It is low to 9.20 ± 0.05；Low dose group glycosylated albumin value is reduced to 9.23 ± 0.05 from 11.23 ± 0.05 in experimental group.Thus
Illustrate, bifidobacterium infantis, lactobacillus acidophilus, four kinds of bacterium powder compositions of enterococcus faecalis and bacillus cereus have reduction glycosuria
The function of sick mouse glycosylated albumin.
7.4 different experiments group insulin levels compare
The change of the different experiments group insulin of table 5 is compared (mean ± standard deviation, mIU/L)
As can be seen from Table 5, the bacteria suspension of four kinds of bacterium powders is contained to mouse stomach, it is real with the extension of gavage time
Test the plain level value of group mouse islets in rising trend, during by the 5th week, normal dose group mouse islets element level value in experimental group
3.37 ± 0.05 are increased to from 1.23 ± 0.05；High dose group mouse islets element level value value is from 1.23 ± 0.05 liters in experimental group
It is high to 3.47 ± 0.05；Low dose group mouse islets element level value is increased to 3.27 ± 0.05 from 1.27 ± 0.05 in experimental group.
Thus illustrate, bifidobacterium infantis, lactobacillus acidophilus, four kinds of bacterium powder compositions of enterococcus faecalis and bacillus cereus, which have, to be promoted
The function of diabetic mice insulin secretion, so as to reach the effect of reduction blood glucose in diabetic mice.
8 clinical test results
8.1 enter group and performance
6 two groups of patient baseline's data of table (mean ± standard deviation)
7 two groups of patient baseline's data of table
8.2 curative effect indexs-glycosylated hemoglobin and glycosylated albumin index
Table 8 treats the change (FAS) of front and rear glycosylated albumin
It can be drawn from the result of table 8, Bifidoquater live bacterial chip is taken during treating, experimental group is real compared with control group
Extension of the group with the time is tested, the amount versus baseline level of patient's glycosylated albumin is on a declining curve.Experimental group glycosylated albumin drops
Low amount is much larger than control group.Thus illustrate that Bifidoquater live bacterial chip can be with the level of diabetes patient's glycosylated albumin.
Table 9 treats the change (PPS) of front and rear glycosylated albumin
It can be drawn from the result of table 9, Bifidoquater live bacterial chip is taken during treating, experimental group is real compared with control group
Extension of the group with the time is tested, the amount versus baseline level of patient's glycosylated albumin is on a declining curve.Experimental group glycosylated albumin drops
Low amount is much larger than control group.Thus illustrate that Bifidoquater live bacterial chip can be with the level of diabetes patient's glycosylated albumin.
Consolidated statement 8 and the result of table 9 can be drawn, for the statistical result of the change FAS collection and PPS collection of glycosylated albumin
It is roughly the same, it can verify that Bifidoquater live bacterial chip has preferable effect to the level for reducing diabetic's glycosylated albumin
Really.
Table 10 treats the change (FAS) of front and rear glycosylated hemoglobin
It can be drawn from the result of table 10, Bifidoquater live bacterial chip is taken during treating, experimental group is real compared with control group
Extension of the group with the time is tested, the amount versus baseline level of patient's glycosylated hemoglobin is on a declining curve.Thus bifidoquater is illustrated
Live bacterial chip can reduce the level of diabetes patient's glycosylated hemoglobin.
Table 11 treats the change (PPS) of front and rear glycosylated hemoglobin
It can be drawn from the result of table 11, Bifidoquater live bacterial chip is taken during treating, experimental group is real compared with control group
Extension of the group with the time is tested, the amount versus baseline level of patient's glycosylated hemoglobin is on a declining curve.Thus bifidoquater is illustrated
Live bacterial chip can reduce the level of diabetes patient's glycosylated hemoglobin.
Consolidated statement 10 and the result of table 11 can be drawn, for the statistics of the change FAS collection and PPS collection of glycosylated hemoglobin
As a result it is roughly the same, it can verify that Bifidoquater live bacterial chip has to the level for reducing diabetic's glycosylated albumin preferable
Effect.
8.3 secondary efficacy indexs
(1) change of glycosylated albumin：FAS analysis results show, test group and control group baseline period glycosylated albumin
Value is respectively：21.38 ± 5.74% and 21.93 ± 6.51%；4 weeks after treatment, respectively 20.08 ± 6.05% and 20.58 ±
7.30%；After treatment 8 weeks be respectively 19.07 ± 5.56% and 20.83 ± 8.74%, test group take medicine 8 weeks after variation tendency most
To be obvious；12 weeks after treatment, two groups are respectively 19.03 ± 5.19% and 19.36 ± 6.14%.Thus illustrate, Bifidobacterium four
Connection live bacterial chip has reduction effect to glycosylated hemoglobin, so that the effect with auxiliary reduction diabetes blood glucose.(see Fig. 1)
(2) subgroup is analyzed：As can be seen from Table 12 in baseline period BMI >=25kg/m2, diabetic duration is less than 8 years, empty
The subject of use of exogenous insulin when abdomen blood glucose is less than 8mmol/L and baseline, test group is saccharified at 12 weeks blood than control group
Downward trend of the Lactoferrin compared with baseline becomes apparent from, and thus illustrates, Bifidobacterium tetragenous viable bacteria piece has effects that auxiliary hyperglycemic.
Table 12 treats the change subgroup analysis of front and rear glycosylated hemoglobin
(3) stability analysis (stability=2 week of hypoglycemic, 4 weeks, the standard of 8 Wednesdays time blood glucose inspection value of hypoglycemic effect
Difference)：As a result show test group hypoglycemic stability (2.02 ± 2.77mmol/L) compared with control group (2.77 ± 5.51mmol/L)
As a result show that the data of control group are more discrete compared with test group.Thus illustrate, Bifidobacterium tetragenous viable bacteria piece has auxiliary hyperglycemic
Effect.
8.4 safety indexes
Changes of vital signs before and after treatment, including body temperature, heart rate, breathing, systolic pressure, diastolic pressure and laboratory examination refer to
Mark, including red blood cell, leucocyte, erythrocyte, blood platelet, urinary leukocyte, urine erythrocyte, Urine proteins, ALT, AST, ALP,
The indexs such as TBiL, GGT, BUN, Cr are normal.
Above clinical research shows that Bifidobacterium tetragenous viable bacteria piece of the present invention can aid in reducing blood sugar in diabetic patients,
Especially type 2 diabetes patient or/and merge insulin patients, Bifidobacterium tetragenous viable bacteria piece of the present invention can aid in reduction
Blood glucose, reduction drop glycosylated hemoglobin and reduction drop glycosylated albumin.
Although the present invention is disclosed as above with preferred embodiment, it is not limited to the present invention, any to be familiar with this
The people of technology, without departing from the spirit and scope of the present invention, can do various changes and modification, therefore the protection of the present invention
What scope should be defined by claims is defined.
Claims (10)
1. application of the Bifidoquater live bacterial composition in auxiliary hyperglycemic medicine or health food or food is prepared, the bifid
Tetragenous viable bacteria composition includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus.
2. Bifidoquater live bacterial composition is preparing auxiliary hyperglycemic medicine or health food suitable for type 2 diabetes patient
Or the application in food, the Bifidoquater live bacterial composition include bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and wax
Sample bacillus.
3. Bifidoquater live bacterial composition is applied to the auxiliary hyperglycemic medicine or health food of merging insulin patients preparing
Or the application in food, the Bifidoquater live bacterial composition include bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and wax
Sample bacillus.
4. application of the Bifidoquater live bacterial composition in auxiliary reduction glycosylated albumin medicine or health food or food is prepared,
The Bifidoquater live bacterial composition includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus.
5. Bifidoquater live bacterial composition answering in auxiliary reduction glycosylated hemoglobin medicine or health food or food is prepared
With the Bifidoquater live bacterial composition includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus.
6. according to any described applications of claim 1-5, it is characterised in that every gram of Bifidoquater live bacterial composition is included
Bifidobacterium infantis 1 × 106Individual -1 × 108Individual, lactobacillus acidophilus is 1 × 106Individual -1 × 108It is individual, enterococcus faecalis 1 × 106Individual -1
×108It is individual, bacillus cereus 1 × 105Individual -1 × 107It is individual.
7. according to any described applications of claim 1-5, it is characterised in that the culture presevation number of the bifidobacterium infantis is
Bifidobacterium infantis 0460.1；The culture presevation number of the lactobacillus acidophilus is lactobacillus acidophilus 0460.2；The enterococcus faecalis
Culture presevation number be enterococcus faecalis 0460.3；The culture presevation number of the bacillus cereus is bacillus cereus
0460.4。
8. according to any described applications of claim 1-5, it is characterised in that the formulation of the Bifidoquater live bacterial composition is
Any one in tablet, capsule, granule, powder, liquid preparation.
9. a kind of assistant hypoglycemic medicine or health food containing Bifidoquater live bacterial composition, the Bifidoquater live bacterial combination
Thing includes bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus；The assistant hypoglycemic medicine or health care food
The formulation of product is any one in tablet, capsule, granule, powder, liquid preparation.
10. a kind of assistant hypoglycemic food containing Bifidoquater live bacterial composition, the Bifidoquater live bacterial composition includes baby
Youngster Bifidobacterium, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus.
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Denomination of invention: New application of bifid tetralogy viable bacteria composition Effective date of registration: 20211101 Granted publication date: 20210330 Pledgee: Bank of Hangzhou Limited by Share Ltd. science and Technology Branch Pledgor: HANGZHOU GRAND BIOLOGIC PHARMACEUTICAL Inc. Registration number: Y2021330002099 |