CN104398538A - Composite probiotics preparation for mitigating chemotherapy side effect - Google Patents
Composite probiotics preparation for mitigating chemotherapy side effect Download PDFInfo
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- CN104398538A CN104398538A CN201410585415.XA CN201410585415A CN104398538A CN 104398538 A CN104398538 A CN 104398538A CN 201410585415 A CN201410585415 A CN 201410585415A CN 104398538 A CN104398538 A CN 104398538A
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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
- A61K35/745—Bifidobacteria
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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
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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
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Abstract
A disclosed composite probiotics preparation for mitigating chemotherapy side effect is characterized in that the composite probiotics preparation is prepared by mixing the following probiotics according to certain live bacterium quantity: bifidobacterium breve, lactobacillus acidophilus, lactobacillus casei and streptococcus thermophilus with the ratio of 1:1-3: 1-3: 1-3, and the total live bacterium quantity of the mixed composite probiotics preparation is 20-80 billion. The composite probiotics preparation is capable of effectively mitigating patient side effect generated by chemotherapy.
Description
Technical field
The present invention relates to a kind of composite probiotics preparations, particularly a kind of composite probiotics preparations for alleviating chemotherapy side effect.
Background technology
As the effective means for the treatment of tumor, chemotherapy is widely used clinically.But some chemotherapeutics (as 5-Fu) often also can injure normal cell while killing tumor cell, especially speed of growth intestinal mucosa cells, hematopoietic stem cell etc. faster, and make patient bear serious side effect.General clinical manifestation is severe diarrhea, intestinal mucosal injury, and body is become thin, lassitude and immunity degradation etc.Now there are some researches show, bacillus bifidus can protect intestinal mucosal barrier effectively, suppresses intestinal mucosal permeability to increase.Lactobacillus can regulate Cellular Immunity, recovers intestinal microbial population, alleviates the probability that patient suffers from diarrhoea.Streptococcus can stop intestinal from the field planting etc. of harmful bacteria.These three kinds of bacterium obtain application to a certain degree all in the medical field, but the domestic composite probiotics preparations that there is no for alleviating chemotherapy side effect at present.
Summary of the invention
The present invention is the above-mentioned deficiency in order to solve existing for prior art, proposes a kind of composite probiotics preparations that effectively can alleviate the side effect that patient produces because of chemotherapy.
Technical solution of the present invention is: a kind of composite probiotics preparations for alleviating chemotherapy side effect, is characterized in that: described composite probiotics preparations is mixed according to certain number of viable by following probiotic bacteria:
Bifidobacterium breve: bacillus acidophilus: lactobacillus casei: streptococcus thermophilus=1:1-3:1-3:1-3, and total number of viable of mixed composite probiotics preparations is 200-800 hundred million.
Compared with the existing technology, tool has the following advantages in the present invention:
This kind for alleviating the composite probiotics preparations of chemotherapy side effect, its all bacterial strain all derives from human body, through through screening, domestication and prescription checking, safety is high, and have good ecological mutual aid, safety is high, and clinical practice is secure.It has remarkable result in the aid nutrition adjustment alleviating the alteration of intestinal flora caused by chemotherapy, enteritis, obviously can improve the microbial state treatment of intestinal microbial population, reduces endotoxin, strengthens the barrier function of intestinal.Therefore this composite probiotics preparations is as enteral Tiny ecosystem nutritional preparation, and for the product development of the enteral nutrition preparation of chemotherapy patients, its use is very extensive.Its viable count consumption is large, belongs to medical food, without dose limitation, have no side effect, easy to use, can be used as the nutrition treatment that nutrition assembly and other nutrients one are used from clinical patient, allow patient just can complete auxiliary treatment in the process of diet at ordinary times, greatly can alleviate patient suffering.
Detailed description of the invention
The specific embodiment of the present invention will be described below.
Described composite probiotics preparations is mixed according to certain number of viable by following probiotic bacteria: by bifidobacterium breve (
bifidobacterium breve), bacillus acidophilus (
lactobacillus acidophilus), lactobacillus casei (
lactobacillus casei), streptococcus thermophilus (
streptococcus thermophilus) be the ratio mixing of 1:1-3:1-3:1-3 according to number of viable, and to ensure that total number of viable of mixed composite probiotics preparations is 200-800 hundred million.
Embodiment 1
By the bifidobacterium breve of 5,000,000,000 number of viable (
bifidobacterium breve), the bacillus acidophilus of 5,000,000,000 number of viable (
lactobacillus acidophilus), the lactobacillus casei of 5,000,000,000 number of viable (
lactobacillus casei) and 5,000,000,000 number of viable streptococcus thermophilus (
streptococcus thermophilus) mix, total number of viable of the final composite probiotics preparations obtained is 20,000,000,000.
Embodiment 2
By the bifidobacterium breve of 10,000,000,000 number of viable (
bifidobacterium breve), the bacillus acidophilus of 20,000,000,000 number of viable (
lactobacillus acidophilus), the lactobacillus casei of 20,000,000,000 number of viable (
lactobacillus casei) and 20,000,000,000 number of viable streptococcus thermophilus (
streptococcus thermophilus) mix, total number of viable of the final composite probiotics preparations obtained is 70,000,000,000.
Embodiment 3
By the bifidobacterium breve of 8,000,000,000 number of viable (
bifidobacterium breve), the bacillus acidophilus of 24,000,000,000 number of viable (
lactobacillus acidophilus), the lactobacillus casei of 24,000,000,000 number of viable (
lactobacillus casei) and 24,000,000,000 number of viable streptococcus thermophilus (
streptococcus thermophilus) mix, total number of viable of the final composite probiotics preparations obtained is 80,000,000,000.
Here is microbiology test for compound formulation described in the application and zoopery.Wherein Experiment on Microbiology comprises the metabolite detection, Resistance detection, plasmids detection etc. of strain, and animal experiment comprises model test and anxious poison test.
To the research of chemotherapy animal model effect
Get above-mentioned bifidobacterium breve (
bifidobacterium breve), bacillus acidophilus (
lactobacillus acidophilus), lactobacillus casei (
lactobacillus casei), streptococcus thermophilus (
streptococcus thermophilus) cultivate respectively, use normal saline to become plastc ring after collecting thalline.Select SPF level SD rat to be divided into 4 groups at random, be respectively normal group, 5-Fu+ normal saline group, 5-Fu+ low dosage probiotic group, 5-Fu+ high dose probiotic group.Rat according to dosage 30mg/kg lumbar injection 5-Fu every day, normal group is not injected.Low dose group every rat gavage every day probiotic bacteria 1 × 10
8cFU, high dose group is 1 × 10
9cFU, normal group and 5-Fu group gavage equal-volume normal saline.5 days altogether chemotherapy time, probiotic bacteria intervention 8 days altogether, rat was put to death in the 8th day.The change of application PCR-DGGE technical measurement intestinal microbial population, calculates species abundance index (S), and Shannon-Wiener index (H '), species evenness index (E).Result shows, high dose group and low dose group on intestinal microbial population abundance index, Shannon-Wiener index (H ') and species evenness index with normal group all without significant difference (see table 1), but be significantly different from 5-Fu group.Meanwhile, high dose group and low dose group all have with 5-Fu group in plasma endotoxin content (see table 2), mucous membrane of small intestine thickness, height of naps and Crypt depth (see table 3) and body weight change (see table 4) pole significant difference (
p<0.01), but simultaneously with normal group also there were significant differences (
p<0.01).Pathological section shows, and compared with 5-Fu group, high dose group and its spleen lymphocyte showed increased of low dose group, tissue hyperemia and fibrosis phenomenon obviously alleviate.But gap is still had compared with normal group.Test in all indexs at this between high dose group and low dose group and all do not occur notable difference.
Probiotics strain Characteristics Detection
Adopt test kit to detect 4 probiotics respectively and whether produce nitrate reductase, BASM fluid medium detects whether produce amino decarboxylase, use blood plate to detect whether produce hemolysin.Quick paper disk method is used to detect the drug resistance of each probiotic bacteria respectively.Use plasmid extraction kit extracts the plasmid of 4 strain bacterium respectively and whether electrophoresis detection contains plasmid.4 probiotics Resistance detection the results are shown in Table 5, and sensitivity criterion uses CLSI sensitivity testing to antibacterials standard.Amino acid decarboxylases detects and shows, only have streptococcus thermophilus and bacillus acidophilus for positive, all the other are negative.Meanwhile, detect at nitrate reductase, hemolysin detect and in plasmids detection, survey bacterial strain and be feminine gender (see table 6).
Probiotic bacteria acute toxicity test
After 4 probiotics are cultivated respectively, collected by centrifugation thalline also uses normal saline to make plastc ring.Select male SD rat 20, be divided into 2 groups at random, often organize 10, the wherein disposable gavage heavy dose 5 of experimental group
×10
9cFU/ml probiotic bacteria suspension 1ml, matched group gavage equal-volume normal saline, then Continuous Observation 7 days, animal was put to death in the 8th day.Record its body weight change every day, average food-intake, dead quantity, the secretion situation of the mental status and excretion and secretions.Animal after gavage the 8th day, after lumbar injection chloral hydrate anesthesia, in the blood sampling of abdominal cavity cardinal vein, uses Mda test kit to detect MDA concentration in serum.Liver is taken out in bacterium operation, uses glutathion detection kit to detect liver glutathione content.Aseptic operation gets equivalent liver, the heart, kidney, spleen tissue respectively.After refiner is smashed, get 100 μ L tissue fluids and be coated with LIM culture medium, BS culture medium and Lbs culture medium 37 DEG C of Anaerobic culturel 48h respectively, bacterial detection transposition.Result shows, after heavy dose gavages probiotic bacteria, compared with matched group, rat body weight obviously increases, and does not occur death, and each internal organs do not find obvious pathological changes through anatomic observation, and the rat mental status is without exception, without bacterial translocation, without diarrhoea situation.Serum MAD and liver gsh content be equal no significant difference compared with matched group.Concrete outcome is in table 7.
Table 1 Bacteria from Gl Tract of Rats bio-diversity is analyzed
Note: compare with normal group, a:
p<0.05
Table 2 four groups of rat plasma endotoxin contents compare
| Group | Endotoxin content (EU/mL) |
| Normal group | 0.08±0.01 b |
| 5-Fu group | 0.85±0.21 a |
| Low dose group | 0.41±0.20 ab |
| High dose group | 0.34±0.14 ab |
Note: with normal group ratio, a:
p<0.01; Compared with 5-Fu group, b:
p<0.01
Table 3 four groups of Intestinal Mucosa pathological change contrasts
Note: compared with normal group, a:
p<0.01 and 5-Fu group is compared, b:
p<0.01
Before and after table 4 four groups of rat experiments, body weight change compares
Note: with normal group ratio, a:
p<0.01; With 5-Fu group ratio, b:
p<0.01
Table 5 probiotic bacteria drug sensitive test result
| Bacillus acidophilus | Bifidobacterium breve | Streptococcus thermophilus | Lactobacillus casei | |
| Rifampicin | I | S | S | S |
| Ampicillin | I | I | S | S |
| Nalidixan | R | R | R | R |
| Bactrim | R | I | S | R |
| Tetracycline | I | R | I | R |
| Cefalotin | I | R | S | I |
| Ciprofloxacin | R | I | I | R |
| Gentamycin | R | I | I | R |
| Cephazolin | S | R | S | I |
| Fluorine piperazine | S | S | S | S |
| Ofloxacin-double-crane pharm | R | I | I | R |
| Amoxicillin | S | S | S | S |
Note: antibacterial circle diameter: >20mm is responsive (S), and 15mm ~ 19mm is intermediary (I), <14mm is drug resistance (R)
Table 6 probiotic bacteria produces harmful substance testing result
| Bifidobacterium breve | Bacillus acidophilus | Lactobacillus casei | Streptococcus thermophilus | |
| Amino decarboxylase | － | + | － | + |
| Nitrate reductase | － | － | － | － |
| Hemolysin | － | － | － | － |
| Plasmid | － | － | － | － |
Note :+be the testing result positive ,-be that testing result is negative
Table 7 Organism of Rats Indexs measure result
| Matched group | Experimental group | PValue | |
| GSH(mg/gprot) | 2.38±0.54 | 2.05±0.55 | >0.05 |
| MAD(nmol/ml) | 6.57±0.59 | 6.64±0.65 | >0.05 |
| △ body weight (g) | 37.3±6.27 | 45.1±6.56 | <0.05 |
Note: △ body weight is that when putting to death, body weight deducts the 1st day body weight.
Claims (1)
1. for alleviating a composite probiotics preparations for chemotherapy side effect, it is characterized in that: described composite probiotics preparations is mixed according to certain number of viable by following probiotic bacteria:
Bifidobacterium breve: bacillus acidophilus: lactobacillus casei: streptococcus thermophilus=1:1-3:1-3:1-3, and total number of viable of mixed composite probiotics preparations is 200-800 hundred million.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105394773A (en) * | 2015-10-16 | 2016-03-16 | 大连医科大学 | Compound probiotics and dietary fiber preparation for relieving constipation |
| CN106389480A (en) * | 2016-08-24 | 2017-02-15 | 大连医科大学 | Complex probiotic preparation for reducing 5-hydroxytryptamine side effects after chemotherapy |
| CN107684567A (en) * | 2017-11-07 | 2018-02-13 | 大连医科大学 | It is a kind of to be used to improve composite probiotics preparations that are fat and reducing blood fat |
| CN113750129A (en) * | 2021-09-17 | 2021-12-07 | 无锡弘焕微生态科技有限公司 | Traditional Chinese medicine probiotic fermentation liquor preparation for relieving side effects of chemotherapy |
| CN114053311A (en) * | 2020-07-29 | 2022-02-18 | 景岳生物科技股份有限公司 | Probiotic composition for increasing effect of chemotherapeutic drug gemcitabine on pancreatic cancer and application thereof |
| CN118006513A (en) * | 2024-04-08 | 2024-05-10 | 佛山科学技术学院 | Microbial agent for stimulating intestinal development of animals in low-nutrition state and application thereof |
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| WO2003013558A1 (en) * | 2001-07-30 | 2003-02-20 | Claudio De Simone | Treatment of radiation-induced diarrhea with probiotics |
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| WO2003013558A1 (en) * | 2001-07-30 | 2003-02-20 | Claudio De Simone | Treatment of radiation-induced diarrhea with probiotics |
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| P DELIA ET AL: ""Use of probiotics for prevention of radiation-induced diarrhea"", 《WORLD JOURNAL OF GASTROENTEROLOGY》 * |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105394773A (en) * | 2015-10-16 | 2016-03-16 | 大连医科大学 | Compound probiotics and dietary fiber preparation for relieving constipation |
| CN105394773B (en) * | 2015-10-16 | 2018-12-28 | 大连医科大学 | For improving the compound probiotic and dietary fiber formulation of constipation |
| CN106389480A (en) * | 2016-08-24 | 2017-02-15 | 大连医科大学 | Complex probiotic preparation for reducing 5-hydroxytryptamine side effects after chemotherapy |
| CN107684567A (en) * | 2017-11-07 | 2018-02-13 | 大连医科大学 | It is a kind of to be used to improve composite probiotics preparations that are fat and reducing blood fat |
| CN114053311A (en) * | 2020-07-29 | 2022-02-18 | 景岳生物科技股份有限公司 | Probiotic composition for increasing effect of chemotherapeutic drug gemcitabine on pancreatic cancer and application thereof |
| CN114053311B (en) * | 2020-07-29 | 2024-04-12 | 景岳生物科技股份有限公司 | Probiotic composition for increasing effect of chemotherapeutic drug gemcitabine on pancreatic cancer inhibition and application thereof |
| US11969448B2 (en) | 2020-07-29 | 2024-04-30 | Genmont Biotech Inc. | Method for improving an effect of chemotherapeutic drug of gemcitabine on inhibiting pancreatic cancer and improving side effect of chemotherapeutic drug of Gemcitabine |
| CN113750129A (en) * | 2021-09-17 | 2021-12-07 | 无锡弘焕微生态科技有限公司 | Traditional Chinese medicine probiotic fermentation liquor preparation for relieving side effects of chemotherapy |
| CN118006513A (en) * | 2024-04-08 | 2024-05-10 | 佛山科学技术学院 | Microbial agent for stimulating intestinal development of animals in low-nutrition state and application thereof |
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