CN104257620A - Chitosan gel dropping pill for gynaecologic bacteriostasis and preparation method thereof - Google Patents
Chitosan gel dropping pill for gynaecologic bacteriostasis and preparation method thereof Download PDFInfo
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- CN104257620A CN104257620A CN201410551578.6A CN201410551578A CN104257620A CN 104257620 A CN104257620 A CN 104257620A CN 201410551578 A CN201410551578 A CN 201410551578A CN 104257620 A CN104257620 A CN 104257620A
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- chitosan
- chitosan gel
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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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention relates to a chitosan gel dropping pill for gynaecologic bacteriostasis and a preparation method thereof. The gel dropping pill comprises the following constituents: compound chitosan with different molecular weights and deacetylation degrees, gelatinizer, acidifier, sodium chloride, purified water and dropping pill matrix. The method comprises the steps of mixing the compound chitosan and aqueous solution of sodium chloride with certain concentration, so as to form suspension, then feeding a proper amount of gelatinizer to the suspension, adjusting the pH value of the suspension through the acidifier, feeding compound chitosan gel obtained into matrix melt, uniformly mixing the compound chitosan gel and the matrix melt, and feeding the compound chitosan gel and the matrix melt into a pill dropping machine to prepare dropping pills, so as to obtain the chitosan gel dropping pill. The chitosan gel dropping pill is good in roundness, rapid in drug dissolution and high in bioavailability, the antibacterial ability of the chitosan gel dropping pill for gram-positive bacteria and gram-negative bacteria reaches greater than 99 percent, and the chitosan gel dropping pill is applied to the curing of monilial vaginitis, bacterial vaginitis, trichomonas vaginitis or cervicitis in gynecology, has good curative effect, high safety and good biocompatibility. The invention also relates to a preparation method and the medical application of the chitosan gel dropping pill.
Description
Technical field
The present invention relates to a kind of chitosan gel rubber drop pill antibacterial for gynecological and preparation method thereof.
Background technology
Chitosan (Chitosan), extensively be present in Crustaceans shrimp, the carapace of Eriocheir sinensis and the carapace of insecticide, chemistry by name poly-(1,4)-2-amino-2-deoxidation-β-D-glucose, a kind of natural biological polymer being chitosan moiety or obtaining after all taking off acetyl, it is the only macromolecule alkaline polysaccharide that nature exists, there is good biocompatibility, have no side effect, easily absorbed, the feature such as broad spectrum antibacterial, obtain development and application widely in the field such as synthesis of food industry, chemical industry, medical macromolecular materials.Research shows, low-molecular-weight chitosan is better to the fungistatic effect of gram positive bacteria, and for gram-negative bacteria, the bacteriostasis of chitosan increases along with the rising of molecular mass.
At present, more patent of invention or application for a patent for invention relate to anti-(pressing down) bacterium gel of gynecological that chitosan is main constituent, such as CN101757071A discloses a kind of Irreversible vagina antibiosis gel preparation directly killing vaginal mucosa and cervix uteri pathogenic microorganism, and component is chitosan, fine powder of Chlamys nobilis, fine powder of Folium Artemisiae Argyi, gellan gum, gelatin etc.; It is main constituent with chitosan that CN 102247616A discloses a kind of, the gel preparation of the gynecological being thickening agent with carbomer and Polyethylene Glycol; It is main constituent with chitosan that CN102626524A discloses a kind of, take poloxamer as the chitosan gynaecologic antibacterial gel of thickening agent; CN104027300A discloses a kind of antibacterial chitosan gel rubber agent and preparation method thereof, with polymer chitosan and low molecular chitosan complex for main matrix, repairs adjuvant etc. with the use of Trimethoprim, gellant, histiocyte.
Above-mentioned disclosed chitosan gel rubber preparation, while being main constituent with chitosan, with the addition of other drug, as chlorhexidine acetate, Chinese medicine extract or nanometer silver etc., causes biocompatibility to be deteriorated.In addition, gel preparation is subject to the change of season or temperature and reduces its stability, runs off many and has abnormal flavour, directly affecting adhesion and the therapeutic effect of gel.
Drop pill adopt dropping preparation method by solid or liquid drug with ma trix melting be prepared into solid dispersion after be added dropwise to the pill shrinking condensation in the condensed fluid immiscible with substrate, have wide range of applications, oral, external, topical and mucosa delivery can be supplied.Compared with gel preparation, drop pill has local drug concentration and bioavailability is high, good stability, persistent, the advantage such as easy to use.
Summary of the invention
The object of the present invention is to provide a kind of chitosan gel rubber drop pill antibacterial for gynecological, to gram positive bacteria as Candida albicans, staphylococcus aureus, streptococcus etc. and gram-negative bacteria such as escherichia coli, bacillus pyocyaneus, Salmonella etc. have good bacteriostasis.
For the chitosan gel rubber drop pill that gynecological is antibacterial, it comprises 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;
Gellant: 0.05 ~ 1%;
Acidulant: regulate pH to 5.5 ~ 6.5;
Basic compose: 60% ~ 95%;
Purified water: appropriate
Described gel drop pill, the molecular weight of the chitosan of high molecular is for being greater than 9 × 10
4u, deacetylation 85 ~ 95%, the molecular weight of low-molecular-weight chitosan is lower than 1.5 × 10
3u, deacetylation 98 ~ 100%; Wherein both ratios are 1.8 ~ 2.2:3.8 ~ 4.2, and the mass fraction of recombination chitosan is 8 ~ 10%.
Described gel drop pill, high molecular used and low-molecular weight chitoglycan also comprise chitosan derivatives, as carboxymethyl chitosan, methyl chitosan silver, chitosan quaternary ammonium salt, chitosan hydrochlorate, chitosan lactate, chitosan acetate, sulfated chitosan or Chitosan oligosaccharide.
Described gel drop pill, gellant used is selected from one or more compositionss in gelatin, carrageenan, gellan gum, xanthan gum or sodium alginate, and its mass fraction is 0.05 ~ 5%.
Described gel drop pill, acidulant used is acetic acid, propanoic acid or acetate propionate, and the pH of the recombination chitosan gel of gained is between 5.5 ~ 6.5.
Described gel drop pill, the concentration making the sodium chloride solution of suspension with recombination chitosan is 0.1 ~ 1mol/l.
Described gel drop pill, Basic compose used is two or more compositionss in Macrogol 4000, polyethylene glycol 6000, stearic acid, polyoxyethylene monostearate, poloxamer, glycerin gelatine, accounts for 60 ~ 95% of gross weight.
The preparation method of described gel drop pill is: by described content and component, high molecular and low-molecular-weight recombination chitosan (1.8 ~ 2.2:3.8 ~ 4.2) are mixed in suspension with certain density sodium-chloride water solution (0.1 ~ 1mol/l), then appropriate gellant is added, add acidulant and regulate pH to 5.5 ~ 6.5, obtain recombination chitosan gel.Recombination chitosan gel is added in matrix melt, stirring and evenly mixing, join dripping in pill dripping machine and become ball, wipe the liquid coolant on drop pill surface, dry, obtain chitosan gel rubber drop pill.
Feature of the present invention is main antipathogenic composition with the chitosan of different molecular weight, the chitosan of high molecular can suppress gram-negative bacteria, low-molecular-weight chitosan is then remarkable to the inhibition of gram positive bacteria, and therefore, the antimicrobial spectrum of this chitosan gel rubber drop pill is extensive.Add certain sodium chloride solution, make its fungistatic effect more remarkable, and use acidulant to regulate pH to 5.5 ~ 6.5, to play its bacteriostasis property to greatest extent.In addition, drop pill of the present invention can significantly improve the bioavailability of chitosan, compared with existing chitosan gel rubber preparation, have that local drug concentration is high, has a broad antifungal spectrum, good stability, persistent, the advantage such as easy to use.Preparation method of the present invention is simple, operates controlled, is applicable to suitability for industrialized production.
Detailed description of the invention
Below in conjunction with specific embodiment, further illustrate the present invention:
Embodiment 1
A kind of formula of the chitosan gel rubber drop pill antibacterial for gynecological is as table 1:
Sodium chloride is dissolved in purified water, be prepared into sodium chloride solution, then the chitosan of high molecular and low-molecular-weight chitosan are added in sodium chloride solution, make uniform chitosan sodium chloride suspension, then gellan gum is added, add proper amount of acetic acid and regulate pH to 5.5 ~ 6.5, obtain recombination chitosan gel.In polyethylene glycol 6000 recombination chitosan gel being added melting and stearic mixed melting thing, stirring and evenly mixing, joins dripping in pill dripping machine and becomes ball, wipe the liquid coolant on drop pill surface, dry, obtains chitosan gel rubber drop pill.
Embodiment 2
A kind of formula of the chitosan gel rubber drop pill antibacterial for gynecological is as table 2:
Sodium chloride is dissolved in purified water, be prepared into sodium chloride solution, then the chitosan of high molecular and low-molecular-weight chitosan are added in sodium chloride solution, make uniform chitosan sodium chloride suspension, then carrageenan is added, add proper amount of acetic acid and regulate pH to 5.5 ~ 6.5, obtain recombination chitosan gel.Recombination chitosan gel is added in the mixed melting thing of Macrogol 4000 and poloxamer, stirring and evenly mixing, join dripping in pill dripping machine and become ball, wipe the liquid coolant on drop pill surface, dry, obtain chitosan gel rubber drop pill.
Embodiment 3
A kind of formula of the chitosan gel rubber drop pill antibacterial for gynecological is as table 3:
Sodium chloride is dissolved in purified water, be prepared into sodium chloride solution, then the chitosan of high molecular and low-molecular-weight chitosan are added in sodium chloride solution, make uniform chitosan sodium chloride suspension, then gelatin is added, add proper amount of acetic acid and regulate pH to 5.5 ~ 6.5, obtain recombination chitosan gel.Recombination chitosan gel is added in the mixed melting thing of polyoxyethylene monostearate and poloxamer, stirring and evenly mixing, join dripping in pill dripping machine and become ball, wipe the liquid coolant on drop pill surface, dry, obtain chitosan gel rubber drop pill.
Embodiment 4
A kind of formula of the chitosan gel rubber drop pill antibacterial for gynecological is as table 4:
Sodium chloride is dissolved in purified water, be prepared into sodium chloride solution, then the chitosan of high molecular and low-molecular-weight chitosan are added in sodium chloride solution, make uniform chitosan sodium chloride suspension, then gellan gum is added, add proper amount of acetic acid and regulate pH to 5.5 ~ 6.5, obtain recombination chitosan gel.Added by recombination chitosan gel in the polyoxyethylene monostearate of melting and the mixed melting thing of glycerin gelatine, stirring and evenly mixing, joins dripping in pill dripping machine and becomes ball, wipe the liquid coolant on drop pill surface, dry, obtains chitosan gel rubber drop pill.
Adopt dilution plate counting method to measure antibacterial and reduce percentage rate (i.e. bacteriostasis rate), evaluate the external inhibition to antibacterial of this chitosan gel rubber drop pill.
Chitosan gel rubber drop pill as obtained in above-described embodiment, fungistatic effect is good, all more than 99% is reached to the antibacterial ability of gram positive bacteria and gram-negative bacteria, for the treatment of gynecological's monilial vaginitis, bacterial vaginitis, trichomonal vaginitis or cervicitis etc., there is the advantages such as curative effect is good, safety is high, good biocompatibility.
Claims (10)
1., for the chitosan gel rubber drop pill that gynecological is antibacterial, it is characterized in that each component comprising following mass percent:
The recombination chitosan 8 ~ 10% of high molecular weight chitosan and low-molecular weight chitoglycan;
Sodium chloride: 0.1 ~ 1mol/l;
Gellant: 0.05 ~ 5%
Acidulant, regulates pH to 5.5 ~ 6.5;
Basic compose: 60% ~ 95%;
Purified water: appropriate.
2. chitosan gel rubber drop pill according to claim 1, is characterized in that: the molecular weight of the chitosan of high molecular is for being greater than 9 × 10
4u, deacetylation 85 ~ 95%, the molecular weight of low-molecular-weight chitosan is lower than 1.5 × 10
3u, deacetylation 98 ~ 100%; Wherein both ratios are 1.8 ~ 2.2:3.8 ~ 4.2, and the mass fraction of recombination chitosan is 8 ~ 10%.
3. chitosan gel rubber drop pill according to claim 1, it is characterized in that: high molecular used and low-molecular weight chitoglycan also comprise chitosan derivatives, as carboxymethyl chitosan, methyl chitosan silver, chitosan quaternary ammonium salt, chitosan hydrochlorate, chitosan lactate, chitosan acetate, sulfated chitosan or Chitosan oligosaccharide.
4. according to the chitosan gel rubber drop pill shown in claim 1, it is characterized in that: gellant is selected from two or more compositionss in gelatin, carrageenan, gellan gum, xanthan gum or sodium alginate, its mass fraction is 0.05 ~ 5%.
5. chitosan gel rubber drop pill according to claim 1, is characterized in that: the concentration making the sodium chloride solution of suspension with recombination chitosan is 0.1 ~ 1mol/l.
6. chitosan gel rubber drop pill according to claim 1, is characterized in that: acidulant used is propanoic acid, acetic acid or propanoic acid-acetic acid, and the pH of the recombination chitosan gel of gained is between 5.5 ~ 6.5.
7. chitosan gel rubber drop pill according to claim 1, is characterized in that: substrate used is in Macrogol 4000, polyethylene glycol 6000, stearic acid, polyoxyethylene monostearate, poloxamer, glycerin gelatine two kinds or more compositionss.
8. chitosan gel rubber drop pill according to claim 1, it is characterized in that preparing by the following method and obtaining: high molecular and low-molecular-weight recombination chitosan (1.8 ~ 2.2:3.8 ~ 4.2) are mixed in suspension with certain density sodium-chloride water solution (0.1 ~ 1mol/l), then gellant mixing is added, acidulant regulates pH to 5.5 ~ 6.5, obtains recombination chitosan gel.
9. recombination chitosan gel is added in matrix melt, stirring and evenly mixing, join dripping in pill dripping machine and become ball, obtain chitosan gel rubber drop pill.
10. chitosan gel rubber drop pill according to claim 1, it is characterized in that: the chitosan gel rubber drop pill of gained is to gram positive bacteria as Candida albicans, staphylococcus aureus, streptococcus etc. and gram-negative bacteria such as escherichia coli, bacillus pyocyaneus, Salmonella etc. have good bacteriostasis, and suppression ratio is up to more than 99%.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547199A (en) * | 2015-01-12 | 2015-04-29 | 石河子大学 | Antibacterial composition for vagina 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 |
| CN105919926A (en) * | 2016-06-29 | 2016-09-07 | 江苏开源康达医疗器械有限公司 | Carbomer cervical gel and preparation method thereof |
| CN108553426A (en) * | 2018-06-01 | 2018-09-21 | 广东药科大学 | A kind of chitosan dripping 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 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2004525954A (en) * | 2001-04-12 | 2004-08-26 | メディカーブ・アクチエボラーグ | Foamable solid composition |
| 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 |
| CN104027300B (en) * | 2014-07-07 | 2016-01-13 | 江苏瑞京科技发展有限公司 | A kind of antibacterial chitosan gel rubber agent and preparation method thereof |
-
2014
- 2014-10-17 CN CN201410551578.6A patent/CN104257620B/en active Active
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547199A (en) * | 2015-01-12 | 2015-04-29 | 石河子大学 | Antibacterial composition for vagina 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 |
| CN105919926A (en) * | 2016-06-29 | 2016-09-07 | 江苏开源康达医疗器械有限公司 | Carbomer cervical gel and preparation method 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 |
| CN108553426A (en) * | 2018-06-01 | 2018-09-21 | 广东药科大学 | A kind of chitosan dripping pill and preparation method thereof |
| WO2019227745A1 (en) * | 2018-06-01 | 2019-12-05 | 广东药科大学 | Chitosan dropping pill and preparation method therefor |
| 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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| CN104257620B (en) | 2017-06-09 |
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