CN109700832A - Pharmaceutical composition comprising bacillus licheniformis and American-cockroach-extract - Google Patents
Pharmaceutical composition comprising bacillus licheniformis and American-cockroach-extract Download PDFInfo
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Abstract
The present invention provides the pharmaceutical composition of a kind of American-cockroach-extract and bacillus licheniformis, which is treating and preventing the purposes in chemotherapy cause intestinal mucosa inflammation.
Description
Technical field
The present invention relates to the medicine groups for treating related disease in preparation comprising bacillus licheniformis and American-cockroach-extract
The application in object is closed, especially in treatment bacterium to the application in esoenteritis caused by chemotherapy (CIM).
Background technique
Oncotherapy is chemotherapy as a kind of more effective mode, is widely used within nearly 50 years, however this
Although mode can effective treating cancer, the anticancer drug that chemotherapy uses is during killing tumour cell, to just
Normal cell is also resulted in compared with macrolesion, and then damages the normal tissue and organ of human body, is caused different degrees of adverse reaction, is caused
Many complication such as Nausea and vomiting, bone marrow suppression, alopecia, cardiac toxic, oral cavity and gastrointestinal tract mucosa inflammation etc..Wherein chemotherapy causes
Intestinal mucosa inflammation is a kind of common adverse reactions caused by chemotherapy, and esoenteritis often results in ulcer formation, bleeding, diarrhea, pain
Etc. symptoms, reduce patients ' life quality, increase Infection probability and the death rate, also affect chemotherapy process.Therefore improve chemotherapy to cause
Intestinal mucosa inflammation adverse reaction has high clinical application to the quality of life for improving patient and the prognosis for improving tumor patient
Value and social benefit.
In recent years result of study shows: esoenteritis caused by chemotherapeutics is related under endothelial cell, extracellular matrix, mucous membrane
It interacts between confluent monolayer cells and between immunocyte, interact the complex process of regulation.Chemotherapy is solved at present causes intestinal mucosa
Scorching method focuses mostly on greatly inhibits intestinal mucosa caused by chemicals scorching with relative medicine, draws as 5-aminosalicylic acid improves 5-FU
The intestinal mucosa risen is scorching, and minocycline is expressed by reducing the mRNA of TNF-α and IL-1 β, inhibits the PARP-1's of 5-FU induction
Activity reduces apoptotic index, and has no effect on normal cell Proliferation, and then improves esoenteritis caused by chemotherapy, takes off
Melanin prevention administration has dosage to improve esoenteritis caused by chemotherapy the small intestine structural form that methotrexate (MTX) induces, and (China faces
Bed pharmacology and acology 2014, May；19 (5): 573-578).Therefore esoenteritis caused by treatment chemotherapeutics is a multiple
Miscellaneous process, conventional esoenteritis differs widely with treatment.
American cockroach is Insecta Pterigota Blattaria Blattidae Periplaneta insect, is commonly called as " cockroach ".American cockroach
Effective component has antitumor, raising immunity, protection liver reparation, anti-inflammatory and antalgic and other effects.Existing commercially available most of product
It is essentially all that form is formed by ethanol extract or the water extract exploitation of American cockroach.Such as Kangfuxin Liquid, it is loaded in China
People's republic's the Sanitation Ministry medicine standard Chinese patent drug the 19th and WS3-B-3674-2000 (Z) " Kangfuxin Liquid ", are by America
Preparation made of big Lian extract, has the effect of promoting blood circulation, nourishing yin and promoting granulation, is used for stagnation of blood stasis, bleeding of having a stomachache, stomach, ten
Two Duodenalulcers and deficiency of Yin tuberculosis, phthisical adjuvant treatment is achieved good results, quick because of its good effect, and wide
It is general to be applied to clinic.
Bacillus licheniformis (Bacillus licheniformis) is a kind of one of most common active bacteria formulation strain, is
One kind of bacillus, individual cells, 0.6~0.8 × 1.5~3 microns, cellular morphology and arrange in the shape of a rod, Dan Sheng, can produce
Raw nearly middle raw ellipticity gemma, sporangiocyst slightly expand.Bacillus licheniformis can promote body to generate antibacterial material, kill and cause a disease
Bacterium can generate antibacterial material and unique biological deoxidation mechanism, and capable of inhibiting pathogenic bacteria, (Escherichia coli produce gas pod
Film clostridium) growth and breeding, effectively recuperating gastrointestinal tract function disorder.Bacillus licheniformis can generate multiple active enzymes, such as egg
White enzyme, amylase, lipase, pectase, dextranase, cellulase etc., while a variety of enzymatic factors can also be generated, enhancing disappears
Change the activity of enzyme, promote digestive functions, increase appetite, stimulate enterocinesia, improves bowel movement function；In addition, can be in stomach
The beneficial microorganisms growth and breeding such as physiological anaerobic bacteria such as Bifidobacterium, lactic acid bacteria, peptostreptococcus create favorable conditions,
Promote its growth and breeding, and the beneficial bacteriums such as Bifidobacterium, lactobacillus acidophilus, enterococcus faecalis generate a large amount of second in reproductive process remittance
Acid, lactic acid, are acidified enteron aisle, can neutralize stool alkalinity, soften stool, promote defecation.
Summary of the invention
The purpose of the present invention is to provide a kind of American-cockroach-extracts and bacillus licheniformis pharmaceutical composition, more into one
Step provides a kind of application of pharmaceutical composition in treatment and preventionization chemotherapy cause intestinal mucosa is scorching.
Wherein the pharmaceutical composition can be in a conventional manner by two kinds of active American-cockroach-extracts and lichens
Bacillus is prepared into single dosage form, the i.e. usually described compound preparation form of those skilled in the art；The medicine
The form that compositions can also be combined using American-cockroach-extract and bacillus licheniformis separate formulation, i.e. American cockroach
Extract is as single formulation, and bacillus licheniformis is as single formulation form, then by being prepared into combination preparation packaging
The mode that mode or independent preparation are successively implemented respectively.
If desired, can also be provided in kit as combination preparation.In some embodiments, kit/combination
Preparation includes one or more containers that American-cockroach-extract is housed, and one or more separately equipped with lichens described herein
The container of bacillus preparation.American-cockroach-extract and bacillus licheniformis can be mixed before administration, or can respectively to
Subject's application.When they, which are separated, applies to subject, they can be in same time, different in different time and interval
Period be administered as independent preparation, their application can be separated from each other, and can also have overlapping.Also contain in kit
Including for treat or the drug-induced esoenteritis combination preparation of Prophylactic chemotherapy in application note；Wherein in kit,
American-cockroach-extract can be Kangfuxin Liquid, and bacillus licheniformis is Bacillus licheniformis powder.The application note can describe
Are as follows: 1 times of clinical dosage of Kangfuxin Liquid is combined lichens clinic 1-10 multiple dose, preferably 3 times of -10 multiple dose.
In one embodiment of the invention, described pharmaceutical composition includes American-cockroach-extract and bacillus licheniformis
The mass parts ratio of bacterium powder, the American-cockroach-extract and bacillus licheniformis bacterium powder is 1:5-100；Preferably, the beauty
The mass parts ratio of the big Lian extract in continent and bacillus licheniformis bacterium powder is 1:15-50, another mode American cockroach is extracted
Object is 1:1-10, more preferably 1:3-10 according to clinical dosage ratio with bacillus licheniformis bacterium powder.
Pharmaceutical composition American cockroach raw material of the invention can be the dry polypide of American cockroach dry powder, American cockroach or
American cockroach young adult.The American-cockroach-extract be preferably American cockroach mention ethyl alcohol take object can according to this field routine
Technology obtains.American-cockroach-extract meets in country execution standard WS3-B-3674-2000 (Z) to " American cockroach Perip
The limit standard of the extract of the dry polypide of leneta ameri Cana ".It is calculated according to dry product, not containing total amino acid
It obtains and is less than 7.0%, such as commercially available rehabilitation is new.Alternatively, it is also possible to use American-cockroach-extract preparation method institute common at present
The total amino acid content in American cockroach ethanol extract is stated in terms of alanine not less than American cockroach ethanol extract dry weight
7wt%, more preferable 8wt%, most preferably 10wt%.Concentration of alcohol can choose 80~90%v/v, such as 80%v/v, 81%v/
V, 82%v/v, 83%v/v, 84%v/v, 85%v/v, 86%v/v, 87%v/v, 88%v/v, 89%v/v, 90%v/v.
American cockroach ethanol extract of the present invention can be prepared by the following: dry with Blattidae American cockroach
Adult or young adult are raw material, in room temperature or heating, under normal pressure or decompression state, are extracted with the ethanol solution of 20%-100%
(60 DEG C) three times；Filtration, merges 3 filtrates, is concentrated under reduced pressure, recycling ethyl alcohol to no alcohol taste.Add appropriate purified water degreasing, separation is simultaneously
Precipitating, oil reservoir are discarded, aqueous solution filtration is concentrated under reduced pressure, obtains American cockroach ethanol extract.Can also other extracting methods obtain
Obtain American-cockroach-extract, it is not limited to this.
Bacillus licheniformis of the present invention is preferably preserved in China General Microbiological culture presevation administrative center, preservation
Number is the bacterium of CGMCC NO.0183.The bacterial strain is in 201010578718.0 (Authorization Notice No. of Chinese invention patent number
CN102120972B it) and in Chinese invention patent number 92113318.9 (Authorization Notice No. CN1044324C) has been reported that, for number
63516 bacterial strain.It will be appreciated by those skilled in the art that the present disclosure applies equally to other bacillus licheniformis.
Wherein be not particularly limited in pharmaceutical composition, if necessary can according at present clinically be used alone two kinds of drugs
Routine clinical dosage selects, and American-cockroach-extract dosage is 0.05g-1g/ days, and preferably 0.1g-0.3g/ days, more preferably
It is 0.1g/ days, bacillus licheniformis bacterium powder dosage is 0.25g-15g/ days, preferably 0.25g-4.5g/ days, more preferably 4.5
Grams g/ days, wherein Bacillus licheniformis powder viable count be preferably 1-10 hundred million/gram, more preferably 2.5-5 hundred million/gram.
In some embodiments, pharmaceutical composition (including combination preparation form, single formulation form preparation, packing box
In preparation) can be configured to for taking orally, being injected intravenously, part, nasal cavity, subcutaneous administration mode.Dosage form also can be with
Using the conventional formulations way of realization such as tablet, capsule, oral solution, patch, preferably peroral dosage form.It is optional in pharmaceutical composition
Drug routine carrier, the conventional various pharmacology carriers of the drug, such as acceptable carrier of various pharmacology, as diluent,
Lubricant, adhesive and disintegrating agent and preservative, colorant, corrigent, plasticizer, film coating agent etc..Diluent
Example includes but is not limited to lactose, mannitol, calcium monohydrogen phosphate, starch, pregelatinized starch, microcrystalline cellulose, silica anhydride
(lightsilicicanhydride), synthetic aluminium silicate, aluminic acid metasilicic acid magnesium, microcrystalline cellulose 101, xylitol etc..Lubricant
Example include but is not limited to magnesium stearate, calcium stearate, talcum, sodium stearyl fumarate etc..The example of adhesive include but
It is not limited to hydroxypropyl cellulose, methylcellulose, sodium carboxymethylcellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone
Deng.The example of disintegrating agent includes but is not limited to carboxymethyl cellulose, calcium carboxymethylcellulose, croscarmellose sodium, carboxylic
Methyl starch sodium, low-substituted hydroxypropyl cellulose etc..The example of preservative includes but is not limited to oxybenzoic acid ester, the tertiary fourth of trichlorine
Alcohol, benzyl alcohol, benzyl carbinol, dehydroacetic acid, sorbic acid etc..The preferred embodiment of colorant includes but is not limited to water-insoluble precipitating color
Expect (lakepigment), natural pigment (such as beta carotene, chlorophyll, red ferric oxide), yellow ferric oxide, red ferric oxide, black oxygen
Change iron etc..The preferred embodiment of corrigent include but is not limited to saccharin sodium, dipotassium glycyrrhizinate, radix asparagi sweet extract, Steviosin (stevia),
Mint flavored powdered flavor etc..The example of plasticizer includes but is not limited to fatty acid glyceride, triethyl citrate, propylene glycol, gathers
Ethylene glycol etc..The example of film coating agent includes but is not limited to hydroxypropyl methyl cellulose, hydroxypropyl cellulose etc..
American-cockroach-extract and bacillus licheniformis pharmaceutical composition provided by the present invention is drawn in treatment chemotherapeutics
In the esoenteritis risen, compared to the significant effect of one-component American-cockroach-extract or bacillus licheniformis, and this result
Good verifying has been obtained in mouse test.
Specific embodiment
American-cockroach-extract of the invention Kangfuxin Liquid as main component is limited from the new medicine company share in Zhejiang capital
(specification is 10ml dose product, national drug standard Z15020805) of company's production, Bacillus licheniformis powder derives from Zhejiang capital
(specification 0.25g, viable count 2.5 is hundred million) for new medicine company limited liability company production.
Clinical dosage: being generally understood as the amount of the active material in the drug listed at present in conventional adult's consumption per day,
If American-cockroach-extract Kangfuxin Liquid specification is 10ml, 3*10ml is taken day, wherein American-cockroach-extract is about 1%
For quality than volume solubility, bacillus licheniformis daily dose is generally 0.25g*2*3, and viable count about 2.5 hundred million/gram.
Embodiment 1
The preparation method of American-cockroach-extract ethanol extract and bacillus licheniformis composition
1, it is formulated: referring to the following table 1.
Table 1
Wherein American cockroach ethanol extract is obtained according to the method for Chinese patent CN101957345A embodiment 1.Wherein
Total amino acid content is calculated as the 9.0wt% of American cockroach ethanol extract dry weight with alanine.Bacillus licheniformis bacterium powder obtains
It is obtained according to the method for CN1044324C embodiment 1.
2, preparation process
According to dosage shown in table 1, Bacillus licheniformis powder, microcrystalline cellulose 101 and xylitol are weighed, places it in stream
Change bed, sprays into American cockroach ethanol extract, until continuing drying 20 minutes after all spraying into, obtaining America by granulator
Big Lian-Bacillus licheniformis powder particle.Then, the particle and mint flavored powdered flavor, magnesium stearate, silica are mixed
It closes, is filled in corresponding No. 1 capsule shells.
The preparation method formula of embodiment 2 American-cockroach-extract ethanol extract and bacillus licheniformis composition: ginseng
See the following table 2.
Table 2
Wherein American cockroach ethanol extract is obtained according to the method for Chinese patent CN101957345A embodiment 1.Wherein
Total amino acid content is calculated as the 9.0wt% of American cockroach ethanol extract dry weight with alanine.Bacillus licheniformis bacterium powder obtains
It is obtained according to the method for CN1044324C embodiment 1.
2, preparation process
According to dosage shown in table 1, Bacillus licheniformis powder, microcrystalline cellulose 101 and pregelatinized starch are weighed, is set
In fluidized bed, American cockroach ethanol extract is sprayed into, until continuing drying 20 minutes after all spraying into, obtaining by granulator
American cockroach-Bacillus licheniformis powder particle.Then, by the particle and mint flavored powdered flavor, hydroxypropyl cellulose, dioxy
SiClx mixed pressuring plate.
3 Kangfuxin Liquid of embodiment and bacillus licheniformis combination therapy
Zoopery
1. experiment purpose: replicating the mouse small intestine mucositis model of induced by irinotecan, then investigate bacillus licheniformis
And its improvement result of small intestinal mucosa inflammation is induced with Kangfuxin Liquid combination chemotherapeutic toxicity, and then health is combined to bacillus licheniformis
The drug effect of multiple new liquid carries out preliminary evaluation.
2. experimental material
2.1 irinotecan hydrochloride trihydrate
2.1.1 character and physicochemical property: solid powder, purity 99.1%, molecular weight 677, (1.2g hydrochloric acid Irinotecan three
Hydrate and 1g Irinotecan are suitable.) (actual purchase 4g)
2.1.2 preservation condition: shading deposits in 4 DEG C.
2.1.3 unit is provided: commercially available.
2.1.4 safeguard procedures: conventional (mask, gloves, work clothes).
2.2 experimental animal
2.2.1ICR mouse.
2.2.2 animal rank: SPF grades.
2.2.3 gender and quantity: male, totally 200.
2.2.4 the weight of animals: 28-30g.
2.2.5 experimental animal source: Shanghai western Poole-Bi Kai experimental animal Co., Ltd, production licence number: SCXK
(Shanghai) 2013-0016.
2.2.6 animal feeding condition and management: SPF grades of environment animals rooms, experimental animal use credit number: SYXK (Shanghai)
2015-0005。
3, experimental method
3.1 experimental group
200 male ICR mouses adapt to screen body after feeding 2 weeks and focus on 28-30g weight mouse 140, and it is small for inducing
Mouse small intestinal mucosa inflammation model.Blank group (non-modeling), model group, Loperamide positive controls (6mg/ are randomly divided by weight
Kg), bacillus licheniformis 6.9*108CFU/kg (clinical 3 times of equivalents), bacillus licheniformis 2.3*109CFU/kg (clinic 10
Times equivalent), Kangfuxin Liquid (clinical 1 times of equivalent), bacillus licheniformis 6.9*108CFU/kg+ Kangfuxin Liquid is (1 times clinical
Equivalent), bacillus licheniformis 2.3*109CFU/kg+ Kangfuxin Liquid (clinical 1 times of equivalent), every group of 14 ICR mouse.Face
Bed dose clinical equivalent is according to bacillus licheniformis viable capsule and Kangfuxin Liquid clinical human's dosage according to art technology
Personnel routinely convert by the mode of converting.
3.2 modelings and administration
For Kangfuxin Liquid according to clinical equivalent dosage, bacillus licheniformis is matched with 10% glucose saline postpones stomach-filling immediately,
One kind is first administered, is administered after half an hour second.
4. inspection target:
(0 is normal for mouse weight, food ration, diarrhea of mouse scoring；1 laxativeness, it is wet just, perianal is sticked together without excrement；
2 mild diarrheas, wet just excrement is shapeless, and crissum, which has, to be sticked together；3 severe diarrheas, watery stool, perianal large area excrement are glutinous
), mouse death rate, leave and take stool in mice sample and small intestine (duodenum), colonic specimen samples (distal colon) (formaldehyde is fixed),
The drug effect of a total of 2 experimental evaluations combination prevention and treatment treatment, the results show that clinical 3 multiple doses of lichens and 10 times of agent in 1 test
Amount combination Kangfuxin Liquid group is than being applied alone lichens or being applied alone Kangfuxin Liquid effect good (table 3 or 4).
The clinical 3 multiple doses combination Kangfuxin Liquid comparison of 3 lichens of table
The clinical 10 multiple doses combination Kangfuxin Liquid comparison of 4 lichens of table
Claims (10)
1. a kind of pharmaceutical composition includes American-cockroach-extract and bacillus licheniformis and optional pharmaceutical carrier.
2. pharmaceutical composition as described in claim 1, it is characterised in that described pharmaceutical composition include American-cockroach-extract and
The mass parts ratio of bacillus licheniformis bacterium powder, the American-cockroach-extract and bacillus licheniformis bacterium powder is 1:5-100；It is excellent
The mass parts ratio of selection of land, the American-cockroach-extract and bacillus licheniformis bacterium powder is 1:15-50.
3. pharmaceutical composition as described in claim 1, it is characterised in that described pharmaceutical composition include American-cockroach-extract and
Bacillus licheniformis bacterium powder is 1:3-10 according to clinical dosage.
4. pharmaceutical composition as described in claim 1, it is characterised in that described pharmaceutical composition be include American-cockroach-extract
With the single formulation form of bacillus licheniformis.
5. pharmaceutical composition as described in claim 1, it is characterised in that described pharmaceutical composition be include American-cockroach-extract
The combination preparation of preparation and bacillus licheniformis preparation.
6. pharmaceutical composition as claimed in claim 3 is characterized in that the medicine composition provides in a kit form, described
Kit includes: 1) American-cockroach-extract pharmaceutical preparation form；2) bacillus licheniformis pharmaceutical preparation form；3) for treating
And/or the application note of the drug-induced esoenteritis combination preparation of Prophylactic chemotherapy.
7. pharmaceutical composition as described in claim 1, it is characterised in that American-cockroach-extract is American cockroach ethanol extract,
Total amino acid contained by described pharmaceutical composition must not be less than 7.0%.
8. pharmaceutical composition as claimed in claim 7, it is characterised in that American cockroach ethanol extract is prepared by the following:
Using the dry adult of Blattidae American cockroach or young adult as raw material, in room temperature or heating, under normal pressure or decompression state, with
The ethanol solution of 20%-100% extracts three times at 60 DEG C；Filtration, merges 3 filtrates, is concentrated under reduced pressure, recycling ethyl alcohol to no alcohol
Taste；Add appropriate purified water degreasing, separate and discard precipitating, oil reservoir, aqueous solution is filtered, is concentrated under reduced pressure, obtains American cockroach
Ethanol extract.
9. pharmaceutical composition as described in claim 1 is oral dosage form；Preferably, described pharmaceutical composition is tablet, glue
Capsule or oral solution.
10. pharmaceutical composition as described in claim 1 is in the drug that preparation treatment and/or Prophylactic chemotherapy cause intestinal mucosa inflammation
Application.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110376092A (en) * | 2019-08-28 | 2019-10-25 | 西南医科大学 | A kind of compound haw thorn Content of Chlorogenic Acid and content of hesperidin measurement and integrated evaluating method |
| JP2022551319A (en) * | 2019-10-11 | 2022-12-08 | リャンシャン ジァネンダ バイオマテリアル ブリーディングシーオー．，エルティーディー． | American cockroach extract, formulation, preparation method and use thereof |
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Cited By (3)
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| CN110376092A (en) * | 2019-08-28 | 2019-10-25 | 西南医科大学 | A kind of compound haw thorn Content of Chlorogenic Acid and content of hesperidin measurement and integrated evaluating method |
| JP2022551319A (en) * | 2019-10-11 | 2022-12-08 | リャンシャン ジァネンダ バイオマテリアル ブリーディングシーオー．，エルティーディー． | American cockroach extract, formulation, preparation method and use thereof |
| JP7391204B2 (en) | 2019-10-11 | 2023-12-04 | リャンシャン ジァネンダ バイオマテリアル ブリーディングシーオー．，エルティーディー． | Extracts of American cockroach, formulations, preparation methods and uses thereof |
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