CN105232526B - Purposes of the drug containing catechin in preparing antibacterial medicines - Google Patents
Purposes of the drug containing catechin in preparing antibacterial medicines Download PDFInfo
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- CN105232526B CN105232526B CN201510670008.3A CN201510670008A CN105232526B CN 105232526 B CN105232526 B CN 105232526B CN 201510670008 A CN201510670008 A CN 201510670008A CN 105232526 B CN105232526 B CN 105232526B
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
The present invention provides including catechin shown in formula (1) or the drug including its polymorphs body, the purposes in preparing antibacterial medicines.Experimental study shows, the antimicrobial spectrum of catechin is wider, exact inhibition is played to a variety of pathogenic microorganisms including staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomonas aeruginosa, hemolytic streptococcus etc., there is preferable selectivity simultaneously, it is non-stimulated for normal flora and vagina mucosa, it is with a wide range of applications for preparing antibacterial medicines.
Description
Technical field
The invention belongs to field of medicaments, particularly, the drug being related to including catechin, in preparing antibacterial medicines
Purposes.
Background technology
The natural warm and humid profit of female sex organ, easy cooperating microorganisms.Under normal circumstances, by human body from thermotectonics and change
Protective action can be played by learning environment, to from lesion.On the one hand, external genital both sides labia majora closes up coverage vagina naturally
Mouthful, make inoculating microbe be difficult to enter；Vagina front and rear wall is set to be close to, introitus due to the effect of pelvic floor muscles in intravaginal
It is closed, extraneous pollution can be prevented to a certain extent.On the other hand, under the influence of estrogen, vaginal epithelial cell is continuous
Metabolism, hyperplasia thicken, and increase and resist power to pathogen；Meanwhile under the action of bacterium vaginae, vaginal epithelial cell
In the glycogen that is rich in can be analyzed to lactic acid, to maintain the normal acidic environment of vagina, make the disease for being adapted to breed in mild alkaline conditions
Substance is suppressed.Therefore, though the intravaginal of healthy women does not usually cause inflammation with the presence of some bacteriums.
Under normal circumstances, for intravaginal with bacterium vaginae dominance, also a small amount of anaerobic bacteria, mycoplasma and candida albicans are above-mentioned
Flora forms certain ecological balance.But when body immunity is low, endocrine hormone changes or foeign element such as
Tissue damage, sexual intercourse, when destroying the ecological balance of vagina, these permanent floras may cause vagina infection, and come from
It may also avail oneself of the opportunity to get in extraneous pathogenic microorganism.In addition, with factors such as age growth, childbirths, vagina can be gradual
Relaxation can also increase the risk of inoculating microbe intrusion.
When such gynecological disease occurs, other than by self immune system, it should usually coordinate drug therapy, example
Antibiotic, external application antibacterial medicines etc. can such as be taken orally.It is infected since such infection is different from intracorporeal organ, disease locus is in
Body surface, therefore external used medicine curative effect is more direct.The vagina antibacterial medicines of the prior art, it is other to be divided into two major classes, wherein one
Class is the antibacterial medicines using antibiotic as active ingredient, and such drug effect is very fast, but tolerance easily occurs, and to microorganism
Inhibit do not have selectivity, therefore need the long period to rebuild vaginal flora after drug withdrawal, easily occurs again in the process
Subinfection；Another kind of antibacterial medicines using Chinese medicine composition as active ingredient, it is advantageous that it is smaller to skin irritatin, there is no micro-
Biological tolerance phenomenon, but defect is that some drugs uncertain therapeutic efficacy cuts and works slower.
Catechin is also known as cachou extract, tea tannin.For the derivative of flavanols, molecular formula C15H14O6, solid in colourless crystallization shape
Body can be dissolved in water；Its aqueous solution is heated or in the presence of a mineral acid, is easy to aggregate into amorphous tannin.In the prior art, it grinds
Study carefully and show that catechin has the effects that anti-oxidant, regulating lipid metabolism, therefore has been used for as slimming medicine and Kangshuaining mixture
Object, in addition there are report catechin with blood pressure lowering, hypoglycemic and other effects.Do not have in the prior art and sees there are catechin monomers
Compound has the report of bacteriostasis, more has no the report for being prepared into vagina antibacterial medicines.
Invention content
The present invention is directed to be directed in the prior art, Antimicrobial drug choice is poor, therapeutic domain is relatively narrow, medicine exists
The technological deficiency of side effect etc. provides the effective, technical solution without obvious adverse reaction antibacterials, specially：
The present invention provides a kind of antibacterial drugs, including catechin, as shown in formula (I):
Further, the antibacterial medicines are the drug for inhibiting internal pathogen；
Further, the antibacterial medicines are the drug for inhibiting intravaginal pathogen；
Further, the antibacterial medicines are the drug for reducing intravaginal pathogen quantity；
Further, antibacterial action of the present invention includes to staphylococcus aureus, Escherichia coli, Candida albicans
The effect of multiple pathogenic microorganisms including bacterium, Pseudomonas aeruginosa, hemolytic streptococcus etc..
On the other hand, for catechin structural instability, the technological deficiency that property changes, influences drug effect, this hair easily occurs
It is bright to additionally provide a kind of catechin microcrystal, it is capable of providing stable antibacterial drug.The Microcrystal catechin uses Cu-K α spokes
It penetrates, it is as shown in table 1 with the X-ray powder diffraction spectral signature that 2 θ angles indicate：
1 catechin X-ray powder diffraction spectral signature of table
| 2 θ values | D values | FWHM | I/I0% |
| 15.120 | 5.8584 | 0.118 | 58 |
| 23.740 | 3.7448 | 0.212 | 100 |
On the one hand, content of the catechin in its pharmaceutical composition is 0.1-95 weight %；It is furthermore preferred that catechin is at it
Content is 0.1-75 weight % in pharmaceutical composition；It is furthermore preferred that catechin content in its pharmaceutical composition is 0.1-50 weights
Measure %；It is furthermore preferred that catechin content in its pharmaceutical composition is 0.1-25 weight %；It is furthermore preferred that catechin is in its medicine
Content is 0.1-15 weight % in compositions；It is furthermore preferred that catechin content in its pharmaceutical composition is 0.1-10 weights
Measure %.
The present invention is made by being combined catechin with one or more pharmaceutically acceptable excipient and/or carrier
Any dosage form used suitable for human or animal.Catechin can be administered in a unit containing its pharmaceutical composition, give
Medicine approach can be enteron aisle or non-bowel, such as oral, intravenous injection, intramuscular injection, hypodermic injection.Form of administration can be liquid
Dosage form, solid dosage forms or semisolid dosage form.Liquid dosage form can be solution (including true solution and colloidal solution), emulsion (packet
Include o/w types, w/o types and emulsion), suspension, injection (including liquid drugs injection, powder-injection and infusion) etc.；Solid dosage forms can be
Tablet (including ordinary tablet, enteric coatel tablets, lozenge, dispersible tablet, chewable tablets, effervescent tablet, oral disnitegration tablet), capsule (including ebonite
Capsule, soft capsule, capsulae enterosolubilis), granule, powder, pellet, dripping pill, the agent of gas (powder) mist, spray etc..
Catechin can be made ordinary preparation, be also made be sustained release preparation, controlled release preparation, targeting preparation and various particles to
Medicine system.
Preferably, in above technical scheme, the drug is externally applied drug；The drug include but not limited to mucous membrane to
Pharmaceutically dosage form；It is further preferred that the dosage form is vagina mucosa form of administration, vagina mucosa administration has in terms of systemic therapy
Many advantages, for example hydrolysis of the protease to drug can be reduced to avoid first pass effect, penetrating agent is lived selected from non-ionic surface
Property agent, including cholate, glyceride, organic acid, polidocanol, lecithin, palmitoyl chloride carnitine etc.；It is furthermore preferred that institute
It includes powder, creme, ointment, gelling agent, emulsion, lotion, suppository, effervescent tablet or liniment etc. to state dosage form.According to its dosage form, originally
The pharmaceutical composition of invention can apply various pharmaceutical field customary adjuvants, including one kind in excipient, transdermal agent and antipruritic
Or it is a variety of.The excipient is this field customary adjuvant, preferably liquid paraffin, glycerol monostearate vinegar, stearic acid, poly-
It is one or more in vinyl alcohol, carbomer and carboxymethyl cellulose.The transdermal agent is this field customary adjuvant, to promote
It is absorbed into skin, preferably lauryl sodium sulfate and/or azone.The antipruritic is this field customary adjuvant, preferably
It is peppermint oil and/or borneol.In addition to above-mentioned auxiliary material, the pharmaceutical composition of the invention also pharmaceutical activity containing antibacterial action
Ingredient is used as compound preparation.
Test result is as follows for specific pharmacological evaluation：
(1) bacteriostasis of catechin
1) In Vitro Bacteriostasis effect experiment of the catechin to Candida albicans：Bacteriostatic experiment, body are carried out using agar method
The experimental results showed that, as time goes by, catechin has significantly inhibiting effect, catechin aqueous solution to Candida albicans outside
5min is acted on, the average bacteriostasis rate to Candida albicans is up to the inhibiting rate of Candida albicans after being 91.24%, 20min
99% or more, given the test agent has stronger bacteriostasis to Candida albicans.
2) In Vitro Bacteriostasis effect experiment of the catechin to Escherichia coli：Bacteriostatic experiment is carried out using agar method, in vitro
The experimental results showed that as time goes by, catechin has significantly inhibiting effect, the effect of catechin aqueous solution to Escherichia coli
10min, the average bacteriostasis rate to Escherichia coli is 91.24%, and given the test agent has stronger bacteriostasis to Escherichia coli.
3) In Vitro Bacteriostasis effect experiment of the catechin to staphylococcus aureus：Antibacterial reality is carried out using agar method
It tests, Vitro Experimental Results show as time goes by, and catechin has significantly inhibiting effect, youngster to staphylococcus aureus
Theine aqueous solution acts on 2min, reaches 98% or more to the average bacteriostasis rate of staphylococcus aureus, given the test agent is to golden yellow
Color staphylococcus has stronger bacteriostasis.
4) In Vitro Bacteriostasis effect experiment of the catechin to Pseudomonas aeruginosa：Bacteriostatic experiment is carried out using agar method, in vitro
The experimental results showed that as time goes by, catechin has significantly inhibiting effect, the effect of catechin aqueous solution to Pseudomonas aeruginosa
10min reaches 90% or more to the average bacteriostasis rate of Pseudomonas aeruginosa, and given the test agent has stronger bacteriostasis to Pseudomonas aeruginosa.
5) In Vitro Bacteriostasis effect experiment of the catechin to hemolytic streptococcus：Bacteriostatic experiment is carried out using agar method,
Vitro Experimental Results show that as time goes by catechin has significantly inhibiting effect, catechin water to hemolytic streptococcus
Solution effects 5min reaches 90% or more to the average bacteriostasis rate of hemolytic streptococcus, and given the test agent is to hemolytic streptococcus
There is stronger bacteriostasis.
(2) influence of the catechin for internal normal flora
Bacteriostatic experiment is carried out using agar method, Vitro Experimental Results show as time goes by, to find catechin water
Solution effects 20min or more, the average bacteriostasis rate to Bacillus acidi lactici is only 3.27%, and given the test agent does not have Bacillus acidi lactici
Bacteriostasis.
(3) resistance assay of catechin
It is tested using total number of bacterial colonies and initial contaminating bacteria detection method, Vitro Experimental Results show catechin
Total number of bacterial colonies, coliform, staphylococcus aureus, Pseudomonas aeruginosa, hemolytic streptococcus, the fungus colony of aqueous solution are total
Number meets regulation.
(4) catechin tests the effect of vagina mucosa
Using Tests For Irritating Effects, mucosal irritation experiment is carried out to animal subject, is compareed with blank group and shows contamination
Zu Ge groups are showed no congested, oedema, as a result show catechin to the nonirritant effect of vagina mucosa.
In conclusion the invention has the advantages that：Catechin has wide antimicrobial spectrum, can be to including gold
A variety of pathogenic microorganisms including staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomonas aeruginosa, hemolytic streptococcus etc.
Play exact inhibition；And catechin has embodied the inhibiting effect of microorganism certain selectivity, does not destroy human body
Interior normal flora reduces the probability of superinfection；On the other hand, the present invention also demonstrates catechin to the non-stimulated work of vagina mucosa
With, further demonstrate catechin particularly suitable for effect vagina antibacterial medicines.
Specific implementation mode
In order to make the objectives, technical solutions and advantages of the present invention clearer, With reference to embodiment, to this
Invention is further described.It should be understood that these descriptions are merely illustrative, and it is not intended to limit the scope of the present invention.This
Outside, in the following description, descriptions of well-known structures and technologies are omitted, so as not to unnecessarily obscure the concept of the present invention.
In addition to being defined, technical and scientific term used in following embodiment has and fields technology people of the present invention
The identical meanings that member is commonly understood by.
Embodiment 1：Catechin tests Candida albicans fungistatic effect
-, equipment
Test strain：To Candida albicans (ATCC 10231), China General Microbiological Culture Collection Center provides, and the 4th
Generation.
Test specimen：Catechin aqueous solution (concentration 5g/L)
Phosphate buffer (PBS 0.03moL/L, pH7.2)
Culture medium：Sabouraud's agar.
Two, method
Test basis：GB15979-2002.
Testing conditions：20 DEG C of test ambient temperature, number of repetition 3 times.
Three, experimental result
Fungistatic effect is as shown in the table：
1 catechin of table is to Candida albicans fungistatic effect experimental result
Note：Positive controls bacterium number is 5.35 × 104cfu/mL (4.8 × 104~5.8 × 104cfu/mL).
Four, conclusion
According to GB15979-2002《Disposable Sanitary Accessory sanitary standard》, catechin aqueous solution acts on 5min, right
The average bacteriostasis rate of Candida albicans is 91.24%, and given the test agent has stronger bacteriostasis to Candida albicans.
Embodiment 2：Catechin tests Escherichia coli fungistatic effect
(-) equipment
Test strain：Escherichia coli (8099), preventive medicine academy of sciences Disinfection examination center provide, the 4th generation
Test specimen：Catechin aqueous solution (concentration 3g/L)
Phosphate buffer (PBS 0.03moL/L, pH7.2)
Culture medium：Nutrient agar.
(2) method
Test basis：GB15979-2002
Testing conditions：20 DEG C of test ambient temperature, number of repetition 3 times
(3) experimental result
Fungistatic effect is as shown in the table：
2 catechin of table is to Escherichia coli fungistatic effect experimental result
Note：Positive controls bacterium number is 4.11 × 104cfu/mL (3.76 × 104~4.38 × 104cfu/mL).
Four, conclusion
According to GB15979-2002《Disposable Sanitary Accessory sanitary standard》, catechin aqueous solution acts on 10min, right
The average bacteriostasis rate of Escherichia coli is 90.27%, and given the test agent has stronger bacteriostasis to Escherichia coli.
Embodiment 3：Catechin tests staphylococcus aureus fungistatic effect
One, equipment
Test strain：Staphylococcus aureus (ATCC 6538), China General Microbiological Culture Collection Center provide, and the 4th
Generation.
Test specimen：Catechin aqueous solution (concentration 8g/L)
Phosphate buffer (PBS 0.03moL/L, pH7.2)
Culture medium：Nutrient agar.
Two, method
Test basis：GB15979-2002
Testing conditions：20 DEG C of test ambient temperature, number of repetition 3 times
Three, experimental result
Fungistatic effect is as shown in the table：
3 catechin of table is to staphylococcus aureus fungistatic effect experimental result
Note：Positive controls bacterium number is 3.67 × 104cfu/mL (3.24 × 104~4.08 × 104cfu/mL).
Four, conclusion
According to GB15979-2002《Disposable Sanitary Accessory sanitary standard》, catechin aqueous solution acts on 2min, right
The average bacteriostasis rate of staphylococcus aureus is 98.66%, and given the test agent has stronger bacteriostasis to staphylococcus aureus.
Embodiment 4：Catechin tests Bacillus acidi lactici fungistatic effect
One, equipment
Test strain：Zhan's formula Bacillus acidi lactici (ATCC 25258), American Type Culture Collecti provide, the 4th generation.
Test specimen：Catechin aqueous solution (concentration 10g/L)
Phosphate buffer (PBS 0.03moL/L, pH7.2)
Culture medium：MRS culture mediums.
Two, method
Test basis：GB 4789.35-2010
Testing conditions：20 DEG C of test ambient temperature, number of repetition 3 times
Three, experimental result
Fungistatic effect is as shown in the table：
4 catechin of table is to Bacillus acidi lactici fungistatic effect experimental result
Note：Positive controls bacterium number is 4.25 × 104cfu/mL (3.88 × 104~4.51 × 104cfu/mL).
Four, conclusion
According to GB 4789.35-2010《Lactic acid bacteria test stone》The method of inspection of defined executes inspection, finds catechu
Plain aqueous solution acts on 20min, and the average bacteriostasis rate to Bacillus acidi lactici is only 3.27%, and given the test agent does not have Bacillus acidi lactici true
The bacteriostasis cut.
Embodiment 5：Catechin aqueous solution resisting microbial contamination performance detection
One, equipment
Laboratory sample：Catechin aqueous solution (concentration 5g/L)
Two, method
Test basis：GB15979-2002
Testing conditions：20 DEG C of environment temperature, relative humidity 40-50%.
Three, experimental result
Fungistatic effect is as shown in the table：
5 microbial contamination testing result of table
Four, conclusion
Total number of bacterial colonies, coliform, staphylococcus aureus, Pseudomonas aeruginosa, the hemolytic chain of catechin aqueous solution
Coccus, fungus colony sum meet GB15979-2002《Disposable Sanitary Accessory sanitary standard》Regulation.
Embodiment 6：Catechin aqueous solution vaginal mucosa irritation is tested
One, test objective
Detect stimulation and intensity of the tested material to experimental animal vaginal mucosa.
Two, experiment condition
1, experimental animal：Regular grade female large ear rabbit 6,2.5~3.0kg of weight is tested dynamic by Beijing Shahe's tonneau
Object cultivates factory and provides, quality certification number SCXK (capital) 2010-00040238286, is adapted to 3 days in examining room outside animal house, health status
Well.
2, experimental animal feeding environment：Regular grade Animal Lab., quality certification number：Dynamic facility is No. 004 accurate in fact in Tianjin.Temperature
20~25 DEG C, relative humidity 40~70%.Feed is provided by Beijing HFK Bio-Technology Co., Ltd., and Feed Manufacturing is permitted
It can the number of card SCXK (capital) 2009-0008.
Three, tested material
Catechin aqueous solution (a concentration of 10g/L), weighs sample 10g, adds water to 1L, tested.
Four, test method
1, test basis：《Disinfection technology standard》2.3.5 Tests For Irritating Effects in (version in 2002).
2, experiment packet：Experimental animal is divided into contamination group, blank control group, every group three.
3, operation sequence：Inspection Check experimental animal introituses have no secretion, hyperemia, oedema and other damages before experiment.It will
Length is that the blunt nosed hose of 8cm or so is connected with the syringe of 2ml.Syringe and hose fill spare by test solution.Animal faces upward
It is fixed, expose perineum and introitus, by hose with vagina (4~5cm) is gently inserted into after being moistened by test solution, syringe is used in combination
It is slowly injected into 2ml given the test agent, withdrawal conduit completes contamination.Control animals physiological saline makees same processing.24 after contamination
Hour, animal is put to death using aeroembolism method, cuts open the belly and takes out complete vagina, longitudinally split, visually observe whether hyperemia, oedema etc..
Then vagina is put into 4% formalin and is fixed more than for 24 hours, choose the tissue film-making at the both ends and central 3 positions of vagina,
HE is dyed, and carries out histopathologic examination's (being shown in Table 6).
Five, experimental result
It visually observes each experimental animal vaginal mucosa and is showed no congested, oedema, histopathologic examination's stimulus index is
0.55。
Fungistatic effect is as shown in the table：
6 catechin of table is to vaginal mucosa stimulate the reaction scoring experimental result
Six, conclusion
Catechin is to the nonirritant effect of vagina mucosa.
Embodiment 7：The preparation of catechin lotion
Prescription：Catechin microcrystal 10g, sodium chloride 8.5g, PLURONICS F87 1g, distilled water add to 1000ml；
Preparation method：Catechin microcrystal 45g, PLURONICS F87 2g are taken, the two is dissolved in distilled water, is made all molten
Solution, adds sodium chloride to be redissolved, and adds distilled water to 1000ml, filtration, it is filling to obtain the final product.
Embodiment 8：The preparation of catechin creme
Prescription：1. catechin 20g, 2. hexadecanol 76.5g, 3. vaseline 180g, atoleine 40g, 5. dodecyl sulphur
Sour sodium 8.5g, 6. propylene glycol 45g, 7. nipalgin second vinegar 1g, 8. newly boiling aseptic double-distilled water is several.
Preparation method：First 5. 6. 7. distilled water will will be added to dissolve by heating to obtain solution 2. 3. 4. in melting to obtain solution A in water-bath
B, injection solution B obtains solution C after 1. being dissolved with appropriate distilled water, and it is cold to emulsification that solution A is gradually added into stirring in solution C
But.
The embodiments of the present invention have been described in detail above, but content is only the preferred embodiment of the present invention,
It is not intended to limit the invention.All all any modification, equivalent and improvement etc. done in the application range of the present invention, should all
It is included within protection scope of the present invention.
Claims (3)
1. catechin is preparing the purposes in inhibiting intravaginal pathogen external used medicine；It is characterized in that, the catechin such as formula
(I) shown in:
The catechin is Microcrystal catechin；The Microcrystal catechin is radiated using Cu-K α, the X- indicated with 2 θ angles
Ray Powder Diffraction pattern has peak at 15.12+/- 0.01 and 23.740+/- 0.01；The drug to Candida albicans and/or
Hemolytic streptococcus is inhibited.
2. purposes according to claim 1, which is characterized in that the dosage form of the drug is the agent of Via vagina mucosa delivery
Type.
3. purposes according to claim 1 or 2, which is characterized in that the dosage form of the drug be powder, creme, ointment,
Gelling agent, emulsion, lotion, suppository, effervescent tablet or liniment.
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| CN106109398A (en) * | 2016-06-14 | 2016-11-16 | 上海通用药业股份有限公司 | A kind of vagina gel containing tioconazole |
| CN106038477A (en) * | 2016-06-14 | 2016-10-26 | 上海通用药业股份有限公司 | Method for preparing vagina gel containing tioconazole |
| CN109010332A (en) * | 2018-08-06 | 2018-12-18 | 华茗国际健康产业（香港）有限公司 | A kind of inhibiting-bacteria preparation based on crystallite catechin |
| CN110089519B (en) * | 2019-05-08 | 2022-02-11 | 东北大学 | Microbial corrosion inhibitor and use method thereof |
| CN113081881A (en) * | 2020-04-10 | 2021-07-09 | 杭州睿道医药科技有限公司 | Antibacterial and antiviral wash-free hand sanitizer and preparation method thereof |
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| CN102875513A (en) * | 2012-05-17 | 2013-01-16 | 王孝仓 | Microcrystal catechin and preparation method thereof |
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| CN102875513A (en) * | 2012-05-17 | 2013-01-16 | 王孝仓 | Microcrystal catechin and preparation method thereof |
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| 儿茶素类对h-VRS的体外抗菌活性研究;刘强 等;《中国抗生素杂志》;20110731;第36卷(第7期);第557-560页 * |
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