CN104257620B - A kind of chitosan gel rubber dripping pill antibacterial for gynaecology and preparation method thereof - Google Patents
A kind of chitosan gel rubber dripping pill antibacterial for gynaecology and preparation method thereof Download PDFInfo
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- CN104257620B CN104257620B CN201410551578.6A CN201410551578A CN104257620B CN 104257620 B CN104257620 B CN 104257620B CN 201410551578 A CN201410551578 A CN 201410551578A CN 104257620 B CN104257620 B CN 104257620B
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Abstract
The present invention relates to a kind of chitosan gel rubber dripping pill antibacterial for gynaecology and preparation method thereof.The gel dripping pill includes following ingredients：The recombination chitosan of different molecular weight and deacetylation, gelling agent, acidulant, sodium chloride, purified water and dripping pill matrix.Recombination chitosan is mixed in suspension with certain density sodium-chloride water solution, appropriate gelling agent is then added, pH is adjusted with acidulant, the recombination chitosan gel that will be obtained is added in matrix melt, mix, be added to dripping pelletization in pill dripping machine, obtain chitosan gel rubber dripping pill.Chitosan gel rubber dripping pill roundness of the invention is good, drug-eluting is rapid, bioavilability is high, antibacterial ability to gram positive bacteria and negative bacterium reaches more than 99%, for the treatment of gynaecology's monilial vaginitis, bacterial vaginitis, trichomonas vaginitis or cervicitis etc., curative effect is good, safe, good biocompatibility, the invention further relates to its preparation method and medical applications.
Description
Technical field
The present invention relates to a kind of chitosan gel rubber dripping pill antibacterial for gynaecology and preparation method thereof.
Background technology
Shitosan (Chitosan), is widely present in the crust of Crustaceans shrimp, the crust of crab and insect, chemistry
Entitled poly- (Isosorbide-5-Nitrae) -2- amino -2- deoxidation-β-D- glucose, be chitosan moiety or it is all deacetylated after one kind for obtaining
Natural biological polymer, is the only macromolecule alkaline polysaccharide of nature presence, with good biocompatibility, nontoxic secondary work
With, easily absorbed, broad spectrum antibacterial the features such as, obtained in fields such as food industry, chemical industry, the synthesis of medical macromolecular materials
Extensive development and application.Research shows that the shitosan of low-molecular-weight is preferable to the fungistatic effect of gram positive bacteria, and for leather
Blue negative bacterium, the bacteriostasis of shitosan increase with the rising of molecular mass.
At present, more patent of invention or application for a patent for invention is related to the gynaecology that shitosan is principal component to resist（Suppression）Bacterium gel,
Such as CN101757071A discloses a kind of direct killing vagina mucosa and the Irreversible vagina antibiosis of uterine neck pathogenic microorganisms coagulate
Glue preparation, component is shitosan, dried scallop fine powder, wormwood fine powder, gellan gum, gelatin etc.；CN 102247616A disclose one kind
With shitosan as principal component, the gel preparation of the gynaecology with Carbomer and polyethylene glycol as thickener；CN102626524A is disclosed
One kind with shitosan as principal component, chitosan gynaecologic antibacterial gel with poloxamer as thickener；CN104027300A is public
A kind of antibacterial chitosan gel rubber agent and preparation method thereof is opened, has been main with polymer chitosan and low molecular chitosan compound
Matrix, auxiliary material etc. is repaired with the use of Trimethoprim, gelling agent, histocyte.
Chitosan gel rubber preparation disclosed above with the addition of other drugs, such as while with shitosan as principal component
Chlorhexidine acetate, Chinese medical extract or Nano Silver etc., cause biocompatibility to be deteriorated.Additionally, gel preparation easily receives season or temperature
The change of degree and reduce its stability, be lost in many and have peculiar smell, directly affect the adhesion and therapeutic effect of gel.
Pill using dropping preparation method by solid or liquid drug with it is ma trix melting be prepared into after solid dispersions be added dropwise to
The pill of condensation is shunk in the immiscible condensate liquid of matrix, is had wide range of applications, be available for oral, external application, local administration and
Mucosa delivery.Compared with gel preparation, pill has local drug concentration and bioavilability is high, good stability, effect are held
Long, easy to use the advantages of.
The content of the invention
It is an object of the invention to provide a kind of chitosan gel rubber dripping pill antibacterial for gynaecology, to gram positive bacteria as in vain
Color candida albicans, staphylococcus aureus, streptococcus etc. and gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa, salmonella etc.
There is good bacteriostasis.
A kind of chitosan gel rubber dripping pill antibacterial for gynaecology, it includes each component of following mass percent：
The recombination chitosan of high molecular weight chitosan and low-molecular weight chitoglycan：8~10%；
Sodium chloride：0.1~1mol/l；
Gelling agent：0.05~1%；
Acidulant：Regulation pH to 5.5 ~ 6.5；
Dripping pill matrix：60%~95%；
Purified water：In right amount
Described gel dripping pill, the molecular weight of the shitosan of HMW is more than 9 × 104U, deacetylation 85~95%,
The molecular weight of the shitosan of low-molecular-weight is less than 1.5 × 103U, deacetylation 98~100%；Wherein both ratios for 1.8 ~
2.2：3.8 ~ 4.2, the mass fraction of recombination chitosan is 8~10%.
Described gel dripping pill, HMW used and low-molecular weight chitoglycan also include chitosan derivatives, such as carboxylic
Methyl chitosan, methyl chitosan silver, chitosan quaternary ammonium salt, chitosan hydrochloride, chitosan lactate, chitosan acetate,
Sulfated chitosan or Chitosan poly oligosaccharide.
Described gel dripping pill, gelling agent used is selected from gelatin, carragheen, gellan gum, xanthans or sodium alginate
One or more composition, its mass fraction be 0.05 ~ 5%.
Described gel dripping pill, acidulant used is acetic acid, propionic acid or acetate propionate, and the recombination chitosan of gained coagulates
The pH of glue is between 5.5 ~ 6.5.
Described gel dripping pill, is 0.1 ~ 1mol/l with the concentration of the sodium chloride solution that recombination chitosan is made suspension.
Described gel dripping pill, dripping pill matrix used is Macrogol 4000, Macrogol 6000, stearic acid, polyoxy
Combination of two or more thing in ethene monostearate, poloxamer, glycerin gelatine, accounts for the 60 ~ 95% of gross weight.
The preparation method of described gel dripping pill is：By the content and component, by answering for HMW and low-molecular-weight
Close shitosan（1.8~2.2：3.8~4.2）With certain density sodium-chloride water solution（0.1~1mol/l）Mixing is in suspension, so
After add appropriate gelling agent, add acidulant to adjust pH to 5.5 ~ 6.5, obtain recombination chitosan gel.Recombination chitosan is coagulated
Glue is added in matrix melt, is stirred and evenly mixed, and is added to dripping pelletization in pill dripping machine, wipes the coolant on dripping pill surface, is dried,
Obtain chitosan gel rubber dripping pill.
It is characteristic of the invention that being main antipathogenic composition with the shitosan of different molecular weight, the shitosan of HMW can press down
Gram-negative bacteria processed, and inhibition of the shitosan of low-molecular-weight then to gram positive bacteria is notable, therefore, this chitosan gel rubber
The antimicrobial spectrum of dripping pill is extensive.The certain sodium chloride solution of addition, makes its fungistatic effect more notable, and using acidulant adjust pH to
5.5 ~ 6.5, to play its bacteriostasis property to greatest extent.Additionally, pill of the invention can significantly improve the biology of shitosan
Availability, compared with existing chitosan gel rubber preparation, with local drug concentration is high, has a broad antifungal spectrum, good stability, effect hold
Long, easy to use the advantages of.Preparation method of the invention is simple and easy to apply, operates controllable, suitable industrialized production.
Specific embodiment
With reference to specific embodiment, the present invention is further illustrated：
Embodiment 1
A kind of formula such as table 1 of the chitosan gel rubber dripping pill antibacterial for gynaecology：
Sodium chloride is dissolved in purified water, sodium chloride solution is prepared into, then by the shitosan and low molecule of HMW
The shitosan of amount is added into sodium chloride solution, is made uniform shitosan sodium chloride suspension, then adds gellan gum, is added
Proper amount of acetic acid adjusts pH to 5.5 ~ 6.5, obtains recombination chitosan gel.Recombination chitosan gel is added the polyethylene glycol of melting
6000 and stearic mixed melting thing in, stir and evenly mix, be added to dripping pelletization in pill dripping machine, wipe the cooling on dripping pill surface
Liquid, dries, and obtains chitosan gel rubber dripping pill.
Embodiment 2
A kind of formula such as table 2 of the chitosan gel rubber dripping pill antibacterial for gynaecology：
Sodium chloride is dissolved in purified water, sodium chloride solution is prepared into, then by the shitosan and low molecule of HMW
The shitosan of amount is added into sodium chloride solution, is made uniform shitosan sodium chloride suspension, then adds carragheen, is added
Proper amount of acetic acid adjusts pH to 5.5 ~ 6.5, obtains recombination chitosan gel.By recombination chitosan gel add Macrogol 4000 and
In the mixed melting thing of poloxamer, stir and evenly mix, be added to dripping pelletization in pill dripping machine, wipe the coolant on dripping pill surface,
Dry, obtain chitosan gel rubber dripping pill.
Embodiment 3
A kind of formula such as table 3 of the chitosan gel rubber dripping pill antibacterial for gynaecology：
Sodium chloride is dissolved in purified water, sodium chloride solution is prepared into, then by the shitosan and low molecule of HMW
The shitosan of amount is added into sodium chloride solution, is made uniform shitosan sodium chloride suspension, then adds gelatin, is added suitable
Amount vinegar acid for adjusting pH obtains recombination chitosan gel to 5.5 ~ 6.5.Recombination chitosan gel is added into polyoxyethylene monostearate
In the mixed melting thing of ester and poloxamer, stir and evenly mix, be added to dripping pelletization in pill dripping machine, wipe the cooling on dripping pill surface
Liquid, dries, and obtains chitosan gel rubber dripping pill.
Embodiment 4
A kind of formula such as table 4 of the chitosan gel rubber dripping pill antibacterial for gynaecology：
Sodium chloride is dissolved in purified water, sodium chloride solution is prepared into, then by the shitosan and low molecule of HMW
The shitosan of amount is added into sodium chloride solution, is made uniform shitosan sodium chloride suspension, then adds gellan gum, is added
Proper amount of acetic acid adjusts pH to 5.5 ~ 6.5, obtains recombination chitosan gel.Recombination chitosan gel is added the polyoxyethylene of melting
In the mixed melting thing of monostearate and glycerin gelatine, stir and evenly mix, be added to dripping pelletization in pill dripping machine, wipe dripping pill table
The coolant in face, dries, and obtains chitosan gel rubber dripping pill.
Bacterium is determined using dilution plate counting method and reduces percentage（That is bacteriostasis rate）, evaluate the chitosan gel rubber dripping pill body
The outer inhibition to bacterium.
The chitosan gel rubber dripping pill as obtained in above-mentioned embodiment, fungistatic effect is good, to gram positive bacteria and Grain-negative
The antibacterial ability of bacterium reaches more than 99%, for gynaecology's monilial vaginitis, bacterial vaginitis, trichomonas vaginitis or
The treatment of cervicitis etc., has the advantages that curative effect is good, safe, good biocompatibility.
Claims (8)
1. a kind of chitosan gel rubber dripping pill antibacterial for gynaecology, it is characterised in that by each component of following mass percent
Composition：
The recombination chitosan 8~10% of high molecular weight chitosan and low-molecular weight chitoglycan；
Sodium chloride：1mol/l；
Gelling agent：0.05~5%
Acidulant, adjusts pH to 5.5~6.5；
Dripping pill matrix：60%~95%；
The molecular weight of the shitosan of the HMW is more than 9 × 104U, deacetylation 85~95%, the shell of low-molecular-weight gather
The molecular weight of sugar is less than 1.5 × 103U, deacetylation 98~100%；Wherein both ratios are 1.8~2.2：3.8~4.2,
The mass fraction of recombination chitosan is 8~10%；
The preparation method of the chitosan gel rubber dripping pill is：It is by the recombination chitosan of HMW and low-molecular-weight and concentration
The sodium-chloride water solution mixing of 1mol/l is in suspension, is subsequently adding gelling agent mixing, and acidulant adjusts pH to 5.5~6.5, obtains
To recombination chitosan gel；By in recombination chitosan gel addition matrix melt, stir and evenly mix, be added to dripping in pill dripping machine
Pelletization, obtains chitosan gel rubber dripping pill.
2. chitosan gel rubber dripping pill according to claim 1, it is characterised in that：HMW and low-molecular-weight shell used
Glycan also includes chitosan derivatives.
3. chitosan gel rubber dripping pill according to claim 2, it is characterised in that：The chitosan derivatives are carboxymethyl shell
Glycan, methyl chitosan silver, chitosan quaternary ammonium salt, chitosan hydrochloride, chitosan lactate, chitosan acetate, shitosan
Sulfuric ester or Chitosan poly oligosaccharide.
4. the chitosan gel rubber dripping pill according to claim 1, it is characterised in that：Gelling agent is selected from gelatin, carragheen, ties cold
Combination of two or more thing in glue, xanthans or sodium alginate, its mass fraction is 0.05~5%.
5. chitosan gel rubber dripping pill according to claim 1, it is characterised in that：Acidulant used be propionic acid, acetic acid or
Propionic acid-acetic acid, the pH of the recombination chitosan gel of gained is between 5.5~6.5.
6. chitosan gel rubber dripping pill according to claim 1, it is characterised in that：Matrix used be Macrogol 4000,
Two kinds or more compositions in Macrogol 6000, stearic acid, polyoxyl 40 stearate, poloxamer, glycerin gelatine.
7. chitosan gel rubber dripping pill according to claim 1, it is characterised in that：The chitosan gel rubber dripping pill of gained is blue to leather
Positive bacteria and gram-negative bacteria have good bacteriostasis, and inhibiting rate is up to more than 99%.
8. chitosan gel rubber dripping pill according to claim 7, it is characterised in that：The gram positive bacteria is Candida albicans
Bacterium, staphylococcus aureus, streptococcus, the gram-negative bacteria are Escherichia coli, Pseudomonas aeruginosa, salmonella.
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547199B (en) * | 2015-01-12 | 2017-10-03 | 石河子大学 | A kind of vagina bactericidal composition and preparation method thereof |
| CN104971038A (en) * | 2015-07-01 | 2015-10-14 | 浙江红雨医药用品有限公司 | Chitosan vaginal pH sustained-release gel and preparation thereof |
| CN105919926B (en) * | 2016-06-29 | 2019-11-05 | 江苏开源康达医疗器械有限公司 | A kind of Carbomer cervical gel and preparation method thereof |
| CN108553426B (en) * | 2018-06-01 | 2020-04-03 | 广东药科大学 | Chitosan dropping pill and preparation method thereof |
| CN113842368A (en) * | 2021-10-28 | 2021-12-28 | 江苏万腾新材料科技有限公司 | A Chinese medicinal dripping pill with alopecia preventing and health promoting effects, and its preparation method |
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| US20040127389A1 (en) * | 2001-04-12 | 2004-07-01 | Torbjorn Mathisen | Effervescent solid composition of matter |
| CN103040728A (en) * | 2013-02-03 | 2013-04-17 | 福州乾正药业有限公司 | Chitosan gel for women as well as preparation method and medical application thereof |
| CN104027300A (en) * | 2014-07-07 | 2014-09-10 | 江苏瑞京科技发展有限公司 | Antibacterial chitosan gel and preparation method thereof |
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Patent Citations (3)
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| US20040127389A1 (en) * | 2001-04-12 | 2004-07-01 | Torbjorn Mathisen | Effervescent solid composition of matter |
| CN103040728A (en) * | 2013-02-03 | 2013-04-17 | 福州乾正药业有限公司 | Chitosan gel for women as well as preparation method and medical application thereof |
| CN104027300A (en) * | 2014-07-07 | 2014-09-10 | 江苏瑞京科技发展有限公司 | Antibacterial chitosan gel and preparation method thereof |
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