CN102028705B - Gynecologic article containing biological antifungal components - Google Patents

Gynecologic article containing biological antifungal components Download PDF

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Publication number
CN102028705B
CN102028705B CN201010527060.0A CN201010527060A CN102028705B CN 102028705 B CN102028705 B CN 102028705B CN 201010527060 A CN201010527060 A CN 201010527060A CN 102028705 B CN102028705 B CN 102028705B
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epsilon
gynecologic
polylysine
grams
gynecological
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CN102028705A (en
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陈旭良
刘晓曼
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Tibet Bezhuya Pharmaceutical Group Co ltd
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TIBET BEIZHUYA PHARMACEUTICAL CO Ltd
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Abstract

The invention relates to a gynecologic article containing biological antifungal components for preventing and treating gynecologic diseases clinically in the medicine field. The main active component is epsilon-polylysine, and the gynecologic article belongs to the fields of clinically used medicine and medical appliances. The gynecologic article used for preventing and treating the gynecologic diseases has good antifungal effect, high safety and no toxic side effect after entering the human body. The invention has the advantages of simple preparation process, low cost, high product stability, good clinical value and social significance of popularization and use.

Description

A kind of gynecological's articles for use containing biological antipathogenic composition
Technical field
The present invention relates to field of medicaments for a kind of gynecological's articles for use containing biological antipathogenic composition that prevent clinically and treat gynaecopathia, main active, for containing epsilon-polylysine, belongs to medicine and the medical apparatus and instruments category of clinical use.
Background technology
Gynaecopathia sickness rate was continuous rising situation in recent years, and vulvitis, vulval ulcer, vaginitis, uterine erosion etc. perplex the commonly encountered diseases frequently-occurring disease of modern female especially, and easily recurrence and cross infection.According to Ministry of Public Health investigation statistics, show, the women in life sickness rate of Symptomatic gynaecopathia is 75%, wherein approximately have half women to experience multiple relapse, after many women fall ill because of be subject to traditional view to affect mental pressure huge, have a strong impact on numerous women's health with physically and mentally healthy.At present a lot of patients adopt vagina administration mode to prevent and treat gynaecopathia, but life-time service contains sterilization, disinfection composition vagina preparation can be killed intravaginal normal flora, destroy intravaginal ecological environment, allow pathogenic bacteria take advantage of a weak point, thereby bring out all kinds of gynecological inflammations.
For this reason, the present invention proposes a kind of gynecological's articles for use containing biological antipathogenic composition, and its main active is epsilon-polylysine, can broad-spectrum antibacterial and without any side effect, can not cause the adverse consequencess such as intravaginal Flora Disturbance, drug resistance yet.
Epsilon-polylysine (ε-PL, molecular formula C 180h 362n 60) be that Japan screens and synthetic auxotype antibacterial at first.It is a kind of microbial metabolic products of biology, through separation and Extraction, refines and the fermented product of acquisition, connects the poly-l-lysine of carboxyl and amino group by peptide bond, is a kind of polypeptide with bacteriostasis efficacy.Because it has special molecular structure, thereby thering is special physics, chemistry and pharmacological properties, epsilon-polylysine has strong bacteriostasis, the membrane structure that it can destroy microorganisms, the material, energy and the information transmission that cause cell are interrupted, and finally cause cell death.Gram positive bacteria, gram negative bacteria, yeast, mycete are all had to good fungistatic effect, and very good to difficult escherichia coli, the Salmonella fungistatic effect suppressing of other antibacterial, thermostability bacillus cereus and some viruses are also had to inhibitory action.
Epsilon-polylysine is very good to the fungistatic effect of the pathogenic bacterium such as the common escherichia coli of intravaginal, staphylococcus aureus, in very low concentration, just can play inhibitory action.It is reported, when epsilon-polylysine concentration reaches 25mg/L, to staphylococcus aureus bacteriostasis clearly, and concentration is while reaching 50mg/L, plays bactericidal action; Colibacillary minimal inhibitory concentration is 5~10mg/L.But epsilon-polylysine is less to the inhibitory action of mycete.
Epsilon-polylysine has high safety, and Japan lists epsilon-polylysine in the bio-additive that allows interpolation in food in 1989, at US and European, has also listed food additive scope in.It is a kind of In Vitro Bacteriostasis agent of wide spectrum simultaneously, enter nutrition aminoacid---the lysine that can be decomposed into needed by human after human body, and one of lysine eight seed amino acids that to be human body necessary, therefore, epsilon-polylysine can not cause the adverse consequencess such as intravaginal Flora Disturbance, drug resistance after using.
Epsilon-polylysine good stability, has the features such as good water solubility, heat stability and the pH scope of application are wide, under various different conditions, all can use.Experiment shows, 80 ℃ of processing 60min of its aqueous solution, 100 ℃ of processing 30min, 120 ℃ of processing 20min character are all stablized, constant to colibacillary minimal inhibitory concentration, after heat treatment heat sterilization, microorganism is still had to bacteriostatic activity, and fungistatic effect is relatively stable in pH 5~8 scopes.
Other antibiotic property materials such as epsilon-polylysine and ethanol, glycine, thiamine alkyl sulfate have good cooperative effect, for example polylysine is 50ug/ml for colibacillary minimal inhibitory concentration, ethanol is 5% for colibacillary minimal inhibitory concentration, and both mix use and only need 0.025% ethanol of 5ug/ml polylysine just escherichia coli just to be had to strong inhibitory action.Epsilon-polylysine and other biological antiseptic, as compound uses such as glycine, malic acid, acetic acid, lactic acid natamycins, not only can make up the epsilon-polylysine deficiency poor to mycete fungistatic effect, and the corresponding consumption that reduces polylysine, thereby reduce the use cost of antibacterial.
Summary of the invention the present invention aims to provide a kind of for preventing clinically and a kind of gynecological's articles for use containing biological antipathogenic composition for the treatment of gynaecopathia, specific as follows:
1, the present invention relates to a kind of gynecological's articles for use containing biological antipathogenic composition, its main active is epsilon-polylysine.
2, the present invention relates to a kind of gynecological's articles for use containing biological antipathogenic composition, its dosage form refers to the regular dosage forms such as washing liquid, suppository, gel, capsule for vagina and tablet, also comprise that sorptive materials such as adopting absorbent cotton and nonwoven fabric makes band absorbent cotton bolt, cotton sliver, protective pad, sanitary towel, wet tissue, all can adopt the conventional adjuvant of above preparation and prior art to prepare.
3, a kind of gynecological's articles for use containing biological antipathogenic composition that the present invention relates to, the unit content of epsilon-polylysine in every gram or every ml of formulation is 1 μ g~200000 μ g, and the unit content that preferred version is epsilon-polylysine in every gram or every ml of formulation is 50 μ g~1000 μ g.
4, in the solution that epsilon-polylysine is 5~8 at pH value, fungistatic effect is best, and what therefore the present invention relates to is a kind of containing in gynecological's articles for use of biological antipathogenic composition, can also add pH value regulator.
5, epsilon-polylysine and ethanol, organic acid (acetic acid, lactic acid, malic acid, maleic acid etc.), glyceride, glycine have good synergism, what the present invention relates to is a kind of containing in gynecological's articles for use of biological antipathogenic composition, can also add above synergist; Addition and synergist kind according to the content of epsilon-polylysine than determining with dosage form situation.
6, epsilon-polylysine is poor to the fungistatic effect of mycete, so in prescription, the anti-mildew mushroom antipathogenic composition such as compatibility Nipagin ester, natamycin forms compound preparation and can expand antimicrobial spectrum, and clinical effectiveness is better.Natamycin has antibacterial activity to nearly all yeast and mycete, but invalid to antibacterial, protozoacide or sick element.Most of mycetes just can be suppressed when concentration 0.5~6ug/mL, but some mycete needs 10~25ug/mL.Most of yeast just can be suppressed in the concentration of 1.0~5.0ug/mL; Under 22mg/kg concentration, effect has killing action to Candida albicans, Aspergillus flavus.What the present invention relates to is a kind of containing in gynecological's articles for use of biological antipathogenic composition, can add the antibacterial such as biotinylated biomolecule antibacterial natamycin and make compound preparation.The proportion of composing of every gram or the every milliliter biological unit content of compound preparation is: 1 part~100 parts epsilon-polylysines, 1 part~10 parts natamycins, preferred version is 50 parts of epsilon-polylysines, 30 parts of natamycins.
7, a kind of gynecological's articles for use containing biological antipathogenic composition that the present invention relates to, its purposes is for pudendum cleaning, the prevention of vaginitis, cervicitis, cervical erosion, gynecopathy such as pelvic inflammatory disease and treatment.
8, a kind of gynecological's articles for use containing biological antipathogenic composition that the present invention relates to, can require to select and add the pharmaceutic adjuvant that appropriate difference requires according to dosage form.
The present invention is for prevention and the treatment of gynaecopathia, and not only good antimicrobial effect, simultaneously safe, has no side effect after entering human body.Preparation technology of the present invention is simple, with low cost, and product stability is high, the social meaning that has good clinical value and promote the use of.
Preparation method of the present invention is shown in the specific embodiment.
Specific embodiment the present invention can be illustrated with embodiment below
Embodiment 1 the technology of the present invention is prepared gynecological's articles for use.
Prescription:
Distilled water 10000ml
50 grams of epsilon-polylysines
Acetic acid is appropriate
Oleum menthae 5ml
Make 100 bottles
Preparation method:
1, in above prescription ratio precision, take 5 grams of epsilon-polylysine raw materials;
2, epsilon-polylysine is put in 10000ml distilled water, be stirred to completely and dissolve;
3, add Oleum menthae 5ml, be stirred to evenly;
4, slowly splash into acetic acid, make between pH value to 5.5~6.0;
5, according to every bottle of 100ml fill under purification condition, sealing;
6, detect after qualified and deposit.
Embodiment 2 the technology of the present invention are prepared gynecological suppository.
Prescription:
2000 grams of S-40
1 gram of epsilon-polylysine
0.6 gram of natamycin
Make 1000 pieces
Preparation method:
1, in above prescription ratio precision, take 1 gram of epsilon-polylysine raw material, 0.6 gram of natamycin.
2, get S-40 melts in water-bath;
3,, by epsilon-polylysine, natamycin raw material porphyrize, add the substrate of above-mentioned fusing to grind evenly;
4,, according to 2 grams every, mould is filled with in insulation, obtains suppository;
5, detect deposit after qualified standby.
Embodiment 3 the technology of the present invention are prepared gynecological's effervescent tablet.
Prescription:
5 grams of epsilon-polylysines
3 grams of natamycins
100 grams of lactose
220 grams of microcrystalline Cellulose
220 grams of citric acids
110 grams of sodium bicarbonate
Make 1000
Preparation method:
1, according to recipe quantity precision, take each supplementary material;
2, mix supplementary material, wear into fine powder, sieve;
3, tabletting and get final product.
Embodiment 3 the technology of the present invention are prepared medical device product---gynecological's absorbent-type tampon.
Prescription:
5 grams of epsilon-polylysines
Medicinal purified water 1000ml
1000 of defat tampons
Make 1000
Preparation method:
1, according to recipe quantity precision, take epsilon-polylysine;
2, epsilon-polylysine is dissolved in medicinal purified water, stirs;
3, according to every 1ml dosage by the solution absorbs configuring in defat tampon;
4, heat, dry defat tampon;
5, every of the defat tampon after drying is packed separately, obtained.
The invention is not restricted to above specific implementation method.

Claims (1)

1.Yi Zhong gynecological effervescent tablet, is characterized in that making 1000 by following composition: 5 grams of epsilon-polylysines, 3 grams of natamycins, 100 grams of lactose, 220 grams of microcrystalline Cellulose, 220 grams of citric acids, 110 grams of sodium bicarbonate; Preparation method is:
(1) according to recipe quantity precision, take each supplementary material;
(2) mix supplementary material, wear into fine powder, sieve;
(3) tabletting and get final product.
CN201010527060.0A 2010-11-01 2010-11-01 Gynecologic article containing biological antifungal components Active CN102028705B (en)

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Publication number Priority date Publication date Assignee Title
CN102389743A (en) * 2011-06-14 2012-03-28 陈旭良 Formula of medical bacteriostatic humidifying solution
CN102326546A (en) * 2011-07-07 2012-01-25 郑州拜纳佛生物工程股份有限公司 Leave-on bio-bacteriostat
CN102941034A (en) * 2011-11-18 2013-02-27 曹青春 Medical humidification liquid having bacteriostasis function
CN103316330B (en) * 2012-06-28 2016-03-09 西藏贝珠雅药业有限公司 A kind of prescription of soft-tissue trauma nursing material and purposes
CN106726710B (en) * 2016-12-22 2019-10-18 北京刷新活力健康科技有限公司 A kind of effervescent tablet and the preparation method and application thereof containing polylysine and parahydroxyacet-ophenone
CN106943425A (en) * 2017-03-01 2017-07-14 北京德得创业科技有限公司 A kind of gynaecology sterilization gel of wound healing and preparation method and application
CN107823696A (en) * 2017-09-22 2018-03-23 北京大清生物技术股份有限公司 A kind of water suction biocidal property material for personal-care supplies and preparation method thereof
CN108186404A (en) * 2018-01-17 2018-06-22 南阳师范学院 A kind of vulva washing lotion containing polylysine and preparation method thereof
CN111202069A (en) * 2020-02-13 2020-05-29 军事科学院系统工程研究院卫勤保障技术研究所 Disinfectant, and preparation method and application thereof
CN114767708B (en) * 2022-05-23 2024-01-23 珠海凤凰高科生物制药有限公司 Stable gynecological antibacterial composition and gynecological care solution
CN115192696B (en) * 2022-07-13 2023-07-14 翔宇药业股份有限公司 Active antibacterial gynecological lotion and preparation method thereof

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WO2009037269A1 (en) * 2007-09-17 2009-03-26 Purac Biochem Bv New antibacterial agent based on fatty acid esters of hydroxy carboxylic acids
CN101822736A (en) * 2010-03-08 2010-09-08 深圳市倍安蒂科技有限公司 Novel biological bactericide and preparation method thereof

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Effective date of registration: 20240226

Address after: 850000 Yajiang Industrial Park, Qushui County, Lhasa, Xizang Autonomous Region

Patentee after: Tibet Bezhuya Pharmaceutical (Group) Co.,Ltd.

Country or region after: China

Address before: No. 39, Lhasa South Road, Naqu Town, Naqu Prefecture, Xizang Autonomous Region 852000

Patentee before: TIBET BEIZHUYA PHARMACEUTICAL Co.,Ltd.

Country or region before: China

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