CN104434778A - Preparation method of polyhexamethylene guanidine gel and suppository - Google Patents
Preparation method of polyhexamethylene guanidine gel and suppository Download PDFInfo
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- CN104434778A CN104434778A CN201410603144.6A CN201410603144A CN104434778A CN 104434778 A CN104434778 A CN 104434778A CN 201410603144 A CN201410603144 A CN 201410603144A CN 104434778 A CN104434778 A CN 104434778A
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Abstract
The invention discloses a preparation method of polyhexamethylene guanidine gel and suppository and relates to the technical field of gynaecological sterilization medicaments. The polyhexamethylene guanidine gel and suppository are characterized in that the formula composition is as follows in percentage by mass: 0.1-1% of polyhexamethylene guanidine hydrochloride, 1% of synergist, 10% of PEG200, 1% of polyalcohol amine, 87-87.9% of purified water and 10-30% of dodecyl glycerol stearate. The medicine can be guanidine gel or suppository, is directly administrated, directly treats lesions, rapidly acts, and has a high cure rate; the medicine is free from medicine resistance and toxic and side effects, and has a good mucosa protection function.
Description
Technical field:
The present invention relates to gynecological's bactericidal agent technical field, be specifically related to the preparation method of polyhexamethylene guanidine gel and suppository.
Background technology:
Polyhexamethylene guanidine, has broad-spectrum; Valid density is low; Speed of action is fast; Stable in properties; Premium properties soluble in water; Can use at normal temperatures; Antibacterial, non-corrosiveness for a long time; Colourless, odorless; Nontoxic; Do not fire, not quick-fried, use safety; Moderate; Convenient transportation, can be described as best antibacterial, can the reagent of direct vagina administration but also do not have on the market now.
Summary of the invention:
The object of this invention is to provide the preparation method of polyhexamethylene guanidine gel and suppository, it can be gynecological gel or suppository, direct administration, through focus, and rapidly, cure rate is high in effect; Without Drug resistance, have no side effect, there is good mucosa.
In order to solve the problem existing for background technology, the present invention is by the following technical solutions: its quality consists of than formula: Polyhaxemethylenguanidine Hydrochloride 0.1%-1%, synergist 1%, PEG200 is 10%, polyvalent alcohol amine 1%, pure water 87%-87.9%, stearic acid lauric acid glycerol fat 10%-30%.
Its preparation method: the first step: add Polyhaxemethylenguanidine Hydrochloride, synergist, PEG200 successively in pure water according to aforementioned proportion, stirs 30 minutes; Second step: after stirring, slowly adds polyvalent alcohol amine (in above ratio), makes it progressively melt, avoid conglomeration to lump, until obtain even translucent gels, like this, just prepare polyhexamethylene guanidine gel in high-shear mixer; 3rd step: by the polyhexamethylene guanidine gel warming-in-water prepared to 50-70 DEG C, equally by stearic acid lauric acid glycerol fat warming-in-water to 50-70 DEG C, the latter slowly to be added according to the above ratio in the former and to stir 15-25 minute; 4th step: after stirring, by above-mentioned gel fill in suppository shell, suppository shell stops 20-30 minute in the cooling-water machine (-5 DEG C), then sealing obtain Polyhaxemethylenguanidine Hydrochloride suppository.
Pharmacological action of the present invention: this medicine dissolves release after entering vagina, with the cell membrane effect usually in elecrtonegativity antibacterial, destroy microorganisms storage power and nutrient carry necessary ion gradient, even cause endochylema seepage.In this product, effective ingredient becomes electropositive simultaneously, be easy to by electronegative each bacterioid, fungus, virus adsorb and be wound around, thus suppress the splitting function of pathogenic bacteria, make antibacterial lose fertility, add the respiration channel plugging microorganism, microorganism is choked to death rapidly.The sterilization mechanism of its uniqueness, does not develop immunity to drugs to each bacterioid, fungus, virus, and bactericidal effect is not by the impact of antibacterial, fungus, virus variation.
Beneficial effect of the present invention: it can be gynecological gel or suppository, direct administration, through focus, rapidly, cure rate is high in effect; After entering vagina can not absorb by vaginal mucosal epithelium cell, directly excrete with after pathogenic bacteria effect; The pathogenic bacteria principle (parcel pathogenic bacteria suppresses division to make it be choked to death) of killing of its uniqueness makes it without Drug resistance, and permanence operation does not subtract; Enter intravaginal not absorb and do not remain, directly excrete with after pathogenic bacteria effect, multinomial pharmacology shows, has no side effect, safe and reliable; To vaginal mucosa, also there is very strong covering protection ability, repair, improve mucosal barrier to the defense function of attack factor, there is balance normal flora and local analgesic effect.
Detailed description of the invention:
Below in conjunction with accompanying drawing, the present invention is described in detail.
In order to make object of the present invention, technical scheme and advantage clearly understand, below in conjunction with the drawings and the specific embodiments, the present invention is further elaborated.Should be appreciated that detailed description of the invention described herein only in order to explain the present invention, be not intended to limit the present invention.
This detailed description of the invention is by the following technical solutions: its quality consists of than formula: Polyhaxemethylenguanidine Hydrochloride 0.1%-1%, synergist 1%, PEG200 is 10%, polyvalent alcohol amine 1%, pure water 87%-87.9%, stearic acid lauric acid glycerol fat 10%-30%.
Its preparation method: the first step: add Polyhaxemethylenguanidine Hydrochloride, synergist, PEG200 successively in pure water according to aforementioned proportion, stirs 30 minutes; Second step: after stirring, slowly adds polyvalent alcohol amine (in above ratio), makes it progressively melt, avoid conglomeration to lump, until obtain even translucent gels, like this, just prepare polyhexamethylene guanidine gel in high-shear mixer; 3rd step: by the polyhexamethylene guanidine gel warming-in-water prepared to 50-70 DEG C, equally by stearic acid lauric acid glycerol fat warming-in-water to 50-70 DEG C, the latter slowly to be added according to the above ratio in the former and to stir 15-25 minute; 4th step: after stirring, by above-mentioned gel fill in suppository shell, suppository shell stops 20-30 minute in the cooling-water machine (-5 DEG C), then sealing obtain Polyhaxemethylenguanidine Hydrochloride suppository.
Pharmacological action of the present invention: this medicine dissolves release after entering vagina, with the cell membrane effect usually in elecrtonegativity antibacterial, destroy microorganisms storage power and nutrient carry necessary ion gradient, even cause endochylema seepage.In this product, effective ingredient becomes electropositive simultaneously, be easy to by electronegative each bacterioid, fungus, virus adsorb and be wound around, thus suppress the splitting function of pathogenic bacteria, make antibacterial lose fertility, add the respiration channel plugging microorganism, microorganism is choked to death rapidly.The sterilization mechanism of its uniqueness, does not develop immunity to drugs to each bacterioid, fungus, virus, and bactericidal effect is not by the impact of antibacterial, fungus, virus variation.
Effect of the present invention:
One, broad spectrum kill pathogenic microorganism, antiinflammatory action:
1, mycete effect is killed: have extremely strong killing action to Candida albicans, Candida glabrata; There is sterilization to the guinea pig vaginitis of candida albicans infection and promote the effect that inflammation is recovered.
2, virus-killing action: this product has direct deactivation to syncytial virus, influenza virus A 1 and A3 type and parainfluenza virus I type, has inhibitory action to HPV, encephalitis b virus, type III adenovirus.
3, kill bacteria effect: staphylococcus aureus, staphylococcus epidermidis, α-streptococcus, β can be killed--the antibacterials such as streptococcus, micrococcus luteus, Diplococcus gonorrhoeae, escherichia coli, bacillus pyocyaneus, bacillus cereus, corynebacterium vaginale, diphtheroid, bacteroides fragilis, digestive tract bacillus, Bacillus typhi, vibrio cholera, dysentery bacterium, tubercule bacillus.
4, protozoacide effect: there is anti-infectious function to ameba, infusorian etc.
5, antiinflammatory action: have antiinflammatory action to Oleum Tiglii, carrageenin induced mice local inflammation.
Two, the renewal reparation of inflammation equivalent damage tissue is promoted.
Three, organism immune response is promoted: increase end slightly blood vessel leukocyte count, strengthen cytophagous phagocytic activity.
Four, antitumaous effect: directly suppress and destruction of cancer cells, but normal tissue is without impact.Cervical cancer can be prevented by anti-HPV.Suppress tissue abnormalities hypertrophy, promote hyperplastic tissue's atrophy.
Toxicity of the present invention (vagina administration):
1. long term toxicity test shows: rat this gel of life-time service or suppository to rat organ after one's own heart, lung, kidney, brain, adrenal gland, thymus, stomach, intestinal, the internal organs histopathologic examination such as bladder be showed no abnormal change.
2. acute toxicity test shows: have no animal dead and other acute toxic reactions.
3. skin anaphylactic test shows: have no and produce anaphylaxis to guinea pig skin.This gel or suppository have inhibitory action to the pruritus that histamine causes;
4. Vaginal irritation effects test shows: single and repeatedly give this gel or suppository, to the equal nonirritant of rat vagina mucosa.
5. reproductive function test shows: female Mus, in pregnancy rate, litter size, tire weight of living, has no change, this gel or suppository is described on rat reproductive function without impact.
The beneficial effect of this detailed description of the invention: it can be gynecological gel or suppository, direct administration, through focus, rapidly, cure rate is high in effect; After entering vagina can not absorb by vaginal mucosal epithelium cell, directly excrete with after pathogenic bacteria effect; The pathogenic bacteria principle (parcel pathogenic bacteria suppresses division to make it be choked to death) of killing of its uniqueness makes it without Drug resistance, and permanence operation does not subtract; Enter intravaginal not absorb and do not remain, directly excrete with after pathogenic bacteria effect, multinomial pharmacology shows, has no side effect, safe and reliable; To vaginal mucosa, also there is very strong covering protection ability, repair, improve mucosal barrier to the defense function of attack factor, there is balance normal flora and local analgesic effect.
The above is only in order to illustrate technical scheme of the present invention and unrestricted, other amendment that those of ordinary skill in the art make technical scheme of the present invention or equivalently to replace, only otherwise depart from the spirit and scope of technical solution of the present invention, all should be encompassed in the middle of right of the present invention.
Claims (2)
1. the preparation method of polyhexamethylene guanidine gel and suppository, is characterized in that its quality consists of than formula: Polyhaxemethylenguanidine Hydrochloride 0.1%-1%, synergist 1%, PEG200 is 10%, polyvalent alcohol amine 1%, pure water 87%-87.9%, stearic acid lauric acid glycerol fat 10%-30%.
2. the preparation method of polyhexamethylene guanidine gel and suppository, is characterized in that its preparation method: the first step: in pure water, add Polyhaxemethylenguanidine Hydrochloride, synergist, PEG200 successively according to aforementioned proportion, stirs 30 minutes; Second step: after stirring, slowly adds polyvalent alcohol amine (in above ratio), makes it progressively melt, avoid conglomeration to lump, until obtain even translucent gels, like this, just prepare polyhexamethylene guanidine gel in high-shear mixer; 3rd step: by the polyhexamethylene guanidine gel warming-in-water prepared to 50-70 DEG C, equally by stearic acid lauric acid glycerol fat warming-in-water to 50-70 DEG C, the latter slowly to be added according to the above ratio in the former and to stir 15-25 minute; 4th step: after stirring, by above-mentioned gel fill in suppository shell, suppository shell stops 20-30 minute in the cooling-water machine (-5 DEG C), then sealing obtain Polyhaxemethylenguanidine Hydrochloride suppository.
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105343165A (en) * | 2015-10-30 | 2016-02-24 | 卫国刚 | Polyhexamethylene guanidine propionate lotion, gel and suppository for department of gynecology |
CN108261467A (en) * | 2018-01-09 | 2018-07-10 | 江苏曦肤康生物制药有限公司 | A kind of skin bacteriostatic gel for treating recalcitrant dermal disease and preparation method thereof |
CN111939172A (en) * | 2020-03-06 | 2020-11-17 | 吉林云飞医药有限公司 | Disinfectant for women and preparation method thereof |
CN113230205A (en) * | 2021-05-22 | 2021-08-10 | 绍兴鸿瑞生物科技有限公司 | Gynecological gel preparation and preparation method and application thereof |
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CN103705535A (en) * | 2013-12-27 | 2014-04-09 | 王东宇 | Gynecological chitosan gel and preparation method thereof |
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CN101628035A (en) * | 2008-07-14 | 2010-01-20 | 烟台绿叶动物保健品有限公司 | Suppository for treating livestock endometritis |
CN103705535A (en) * | 2013-12-27 | 2014-04-09 | 王东宇 | Gynecological chitosan gel and preparation method thereof |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105343165A (en) * | 2015-10-30 | 2016-02-24 | 卫国刚 | Polyhexamethylene guanidine propionate lotion, gel and suppository for department of gynecology |
CN108261467A (en) * | 2018-01-09 | 2018-07-10 | 江苏曦肤康生物制药有限公司 | A kind of skin bacteriostatic gel for treating recalcitrant dermal disease and preparation method thereof |
CN111939172A (en) * | 2020-03-06 | 2020-11-17 | 吉林云飞医药有限公司 | Disinfectant for women and preparation method thereof |
CN113230205A (en) * | 2021-05-22 | 2021-08-10 | 绍兴鸿瑞生物科技有限公司 | Gynecological gel preparation and preparation method and application thereof |
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