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CN107308104A - A kind of preparation method of gynecological gel - Google Patents

A kind of preparation method of gynecological gel Download PDF

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Publication number
CN107308104A
CN107308104A CN201710524860.9A CN201710524860A CN107308104A CN 107308104 A CN107308104 A CN 107308104A CN 201710524860 A CN201710524860 A CN 201710524860A CN 107308104 A CN107308104 A CN 107308104A
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CN
China
Prior art keywords
alkannin
gel
glycerine
preservative
dipotassium glycyrrhizinate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201710524860.9A
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Chinese (zh)
Inventor
魏元刚
方文杰
杨永安
钟慧
易铭
左婧
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nanjing purple source Kang medicine technology Co., Ltd.
Original Assignee
JIANGSU NAIQUE BIOLOGICAL ENGINEERING TECHNOLOGY Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by JIANGSU NAIQUE BIOLOGICAL ENGINEERING TECHNOLOGY Co Ltd filed Critical JIANGSU NAIQUE BIOLOGICAL ENGINEERING TECHNOLOGY Co Ltd
Priority to CN201710524860.9A priority Critical patent/CN107308104A/en
Publication of CN107308104A publication Critical patent/CN107308104A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • A61K31/122Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a kind of preparation method of gynecological gel.Gel is formulated by weight by following raw material:Alkannin 0.01~0.05%, dipotassium glycyrrhizinate salt 0.1~0.5%, poloxamer 2~12%, glycerine 8~25%, propane diols 0.1~5%, preservative 0.05~0.5%, carbomer 0.1~0.5%, purified water 56~89.64%.Specific preparation method of the invention is as follows:(1) weigh carbomer by proportion and add glycerine, stirring is allowed into pasty state;(2) poloxamer, glycerine, alkannin, dipotassium glycyrrhizinate salt, purified water, 85 DEG C of heating stirring dissolvings of preservative are added;(3) triethanolamine is added dropwise, to PH5.0~6.0, stops stirring, discharging is filling.The Chinese medical extract alkannin that the present invention is added acts synergistically with dipotassium glycyrrhizinate salt, with anti-inflammatory, hemostasis, promotes effect of cell metabolism, can rapidly permeate into skin, repairs skin texture, reaches sterilization, the effect for improving immunity, diminishing inflammation.

Description

A kind of preparation method of gynecological gel
Technical field
The present invention relates to gynecologic medicine field, and more particularly to a kind of preparation method of gynecological gel.
Background technology
Women's health turns into the topic that everybody discusses warmly in recent years, and research shows that RTI has become women's health Potential threat, privates courses of infection can cause the generation of various gynecological diseases, trigger one of root of RTI to be each Kind easily hide in the conditioned pathogen of inside and outside private parts, such as staphylococcus, streptococcus, Escherichia coli, anaerobic bacteria, spread through sex intercourse cause of disease Body, Candida albicans and mycoplasma, Chlamydia etc..
From product characteristics, at present on the market gynaecology act on reproduction tract drug have effervescent tablet class, soft capsule class, punching Class, suppository class, spray class etc. are washed, action time is short, taken effect relatively slow;From product function, existing gyniatrics class Medicine adds substantial amounts of wide-spectrum bactericide, suppress gold-coloured staphylococci, Escherichia coli, Candida albicans etc. " harmful bacteria " and While pathogenic microorganisms, " beneficial bacterium " Bacillus acidi lactici can be also killed, is destroyed under the stabilization of intravaginal flora, immunity of organisms Drop, causes pathogenic bacteria to develop immunity to drugs and drug resistance, inflammation recurrent exerbation.
In existing patent documentation data storehouse, No. 201610701304.X《A kind of gynecological gel》And No. 200910309483.2 《It is a kind of to treat gel of gynaecological imflammation and preparation method thereof》Material combination is various, and antibacterial, anti-inflammatory effect is unknown, 201610701304.X number《Gynecological gel and preparation method thereof》It is the antimicrobial compositions of activated carbon and silver, contained suppression Bacterium composition can all destroy the colony balance of vagina, decline vagina resistance, influence genital tract health.
Alkannin is a kind of naphthalene quinones substance extracted from Asian puccoon, and the peculiar natural anti-inflammatory of Asian puccoon, epidermis reparation are lived Property composition, and have certain antibacterial, antioxidation activity, using safety, effect is good.With anti-inflammatory, hemostasis, promote skin regeneration, carefully Effect of born of the same parents' metabolism, can rapidly permeate into skin, repair skin texture, reach sterilization, diminish inflammation, improve immunity of organisms and pre- Effect of anti-gynecological disease.
Dipotassium glycyrrhizinate salt, which is that effective component extracting is refined from radix glycyrrhizae, to be formed, antibacterial containing with strengthen immunity, Sterilization, a variety of physiologically active ingredients of antiallergy effect.With alkannin collective effect, sterilization, effect of antiallergic reparation are enhanced.
Advantage of the invention is that:
(1)This product with the addition of alkannin, dipotassium glycyrrhizinate salt, the enhancing of inhibiting bacteria and diminishing inflammation function, and side effect is not present to human body, It is made after gel and is easier to be absorbed by the body, improves the curative effect of medicine.
(2)Without rinsing when using, the purpose that prevention is cured the disease can be played by being detained in intravaginal, and its effective acting time can To maintain more than 12 hours, then it can be naturally drained with vaginal fluid in vitro, due to itself pale red(The face of alkannin Color), can be discovered during discharge.
(3)Gynecological gel is glutinous thick liquid, is difficult outflow, can be distributed in well among vagina again.
(4)Gynecological gel, the aobvious acidity of pH, for maintaining the normal sour environment of intravaginal, can suppress some pathogen Growth, strengthen vagina immunocompetence.
(5)Poloxamer is added, is protected " beneficial bacterium ", the balance of flora inside vagina is maintained.
The content of the invention
It is an object of the invention to develop a kind of gynecological gel, for vagina cleaning, nursing, sterilization, anti-inflammatory, repair Multiple skin texture, prevention gynaecology relevant disease, improves immunity of organisms, so as to reach the protective effect to women privates.
To achieve these goals, the invention provides the woman that the preparation method of gynecological gel, the preparation method are prepared Section's gel viscosity is moderate, alkannin, the addition of radix glycyrrhizae, enhances sterilization, effect of anti-inflammatory prophylaxis of gynaecological disorders;In addition, pool Lip river Husky nurse can protect profitable strain, prevent because arriving internal flora imbalance, prophylaxis of gynaecological disorders.
The present invention is solved its technical problem and realized using following technical scheme:
A kind of gynecological gel, alkannin 0.01~0.05%, preferably 0.03%;Dipotassium glycyrrhizinate salt 0.1~0.5%, be preferably 0.2%;Poloxamer 2~12%, preferably 4%;Glycerine 8~25%, preferably 20%;Propane diols 0.1~5%, preferably 3%;It is anti- Rotten agent 0.05~0.5%, preferably 0.29%;Carbomer 0.1~0.5%, preferably 0.3%;Purified water 56~89.64%.
A kind of preparation method of gynecological gel:
(1)Weigh carbomer and add glycerine, stir into pasty state;
(2)Poloxamer, bactericide, glycerine, dipotassium glycyrrhizinate salt, transparent xanthan gum, preservative, propane diols is added to be made Bright swelling solution, after swelling solution is cooled to room temperature, adds after alkannin and pigment, ultrasonic dissolution into swelling solution and stirs equal It is even;
(3)Be added dropwise triethanolamine, it is stirring while adding to uniform, supplement purified water constant volume, after stir;
(4)Stop stirring, discharging;It is filling.
Embodiment
The present invention is made with reference to specific embodiment further to explain.
Raw material sources explanation:Alkannin, dipotassium glycyrrhizinate salt by Jiangsu Nai Que biotechnologies Co., Ltd inside Personnel extract gained.
Embodiment 1
(1)Each raw material is weighed by mass percentage;
(2)Carbomer 0.3% is added into appropriate glycerine, heating stirring is allowed to dissolve;Add poloxamer 4%, glycerine 20%, Transparent swelling solution is made in dipotassium glycyrrhizinate salt 0.2%, preservative 0.29%, propane diols 3%, Purified Water q. s;
(3)It is cooled to after room temperature, is stirred after adding alkannin 0.03%, ultrasonic dissolution;
(4)Triethanolamine is being slowly added dropwise into swelling solution(10%)5.5%, plus purified water constant volume, stir;
(5)Stop stirring, discharging;It is filling.
Embodiment 2
(1)Each raw material is weighed by mass percentage;
(2)Carbomer 0.1% is added into appropriate glycerine, pasty state is stirred into;Add poloxamer 2%, glycerine 8%, glycyrrhizic acid two Transparent swelling solution is made in sylvite 0.1%, preservative 0.05%, propane diols 4%, Purified Water q. s;
(3)It is cooled to after room temperature, is stirred after adding alkannin 0.04%, ultrasonic dissolution;
(4)PH adjusting agent triethanolamine is being slowly added dropwise into swelling solution(10%)4%, plus purified water constant volume, stir;
(5)Stop stirring, discharging;It is filling.
Embodiment 3
(1)Each raw material is weighed by mass percentage;
(2)Carbomer 0.5% is added into appropriate glycerine, pasty state is stirred into;Add poloxamer 10%, glycerine 25%, glycyrrhizic acid Transparent swelling solution is made in di-potassium 0.5%, preservative 0.5%, propane diols 5%, Purified Water q. s;
(3)It is cooled to after room temperature, is stirred after adding alkannin 0.05%, ultrasonic dissolution;
(4)PH adjusting agent triethanolamine is being slowly added dropwise into swelling solution(10%)8%, plus purified water constant volume, stir;
(5)Stop stirring, discharging;It is filling.
Embodiment 4
(1)Each raw material is weighed by mass percentage;
(2)Carbomer 0.2% is added into appropriate glycerine, pasty state is stirred into;Add poloxamer 5%, glycerine 10%, glycyrrhizic acid Transparent swelling solution is made in di-potassium 0.4%, preservative 0.35%, propane diols 1%, Purified Water q. s;
(3)It is cooled to after room temperature, is stirred after adding alkannin 0.01%, ultrasonic dissolution;
(4)Triethanolamine is being slowly added dropwise into swelling solution(10%)5%, plus purified water constant volume stirs;
(5)Stop stirring, discharging;It is filling.
Embodiment 5
(1)Each raw material is weighed by mass percentage;
(2)Carbomer 0.4% is added into appropriate glycerine, pasty state is stirred into;Add poloxamer 6%, glycerine 15%, glycyrrhizic acid Di-potassium 0.3%, preservative 0.4%, propane diols 2%, Purified Water q. s transparent swelling solution is made;
(3)It is cooled to after room temperature, is stirred after adding alkannin 0.02%, ultrasonic dissolution;
(4)Triethanolamine is being slowly added dropwise into swelling solution(10%)8%, plus purified water constant volume stirs;
(5)Stop stirring, discharging;It is filling.
Embodiment 6
(1)The bacteriostatic test and data of inventive gel agent:
(2)Gel prepared by embodiment 1-5 to staphylococcus aureus, Escherichia coli, Candida albicans carry out 2,5,10, The effect of 20 minutes, as a result such as table 1
Table 1
Negative control:Culture medium has seldom bacterium colony.
As a result show inventive gel agent to staphylococcus aureus, Escherichia coli, Candida albicans average bacteriostasis rate For 90%.
Embodiment 7:
Inventive gel agent is to human clinical trial's data:
Case selection:Patient 760, wherein age 20-55 Sui, the people of bacterial vaginitis 285, the people of colpomycosis 270, drop The people of worm property vaginitis 205.
Cardinal symptom:Leucorrhea increasing, pruritus vulvue pain can be with frequent micturition, urgent urination or intercourse pain, visible vulva during inspection And vagina mucosa goes out hyperemia.Distinguish visible trichomonad or fungi during trichomonas or colpomycosis patient's vaginal fluid microscopy, Bacterial vaginitis BV is checked and is positive.
The embodiment 1-5 specifically used method of gel is:Use 2 times daily, 5 grams every time, be applied directly to vagina.
Control group is cloudy using clean that, application method:2 times a day, every time 10 milliliters, vagina cleaner is used.
Outcome measure:
Recovery from illness:Subjective symptoms is disappeared, and vagina cleanness degree (I), vaginal swab culture is turned out cloudy;
Effectively:Subjective symptoms mitigates, and vagina cleanness degree (II), vaginal swab culture only has a small number of mycelial growths, is no more than 10;
It is invalid:Feel normally without improvement, vagina cleanness degree is unchanged, and vaginal swab culture is unchanged.
Curative effect is shown in Table 2
Table 2
In summary, gynecological gel of the present invention have to staphylococcus aureus, Escherichia coli, Candida albicans preferably suppress and Insect killing effect, has good curative effect on treatment gynecological disease.
It can be seen that from the average inhibition and human clinical trial's data comparison for acting on different strain different time:This Invention gynecological gel optimal components proportioning is carbomer 0.3%, poloxamer 4%, glycerine 20%, dipotassium glycyrrhizinate salt 0.2%, anti-corrosion Agent 0.29%, propane diols 3%, alkannin 0.03%, remaining component are purified water.

Claims (5)

1. a kind of gynecological gel, it is characterised in that gel is formulated by weight by following raw material:Alkannin 0.01~ 0.05%th, dipotassium glycyrrhizinate salt 0.1~0.5%, poloxamer 2~12%, glycerine 8~25%, propane diols 0. 1~5%, preservative 0.05~0.5%, carbomer 0.1~0.5%, purified water 56~89.64%.
2. a kind of gynecological gel, it is characterised in that preparation method is comprised the steps of:
(1)Carbomer is weighed by proportion and adds glycerine, and stirring is allowed into pasty state;
(2)Add poloxamer, glycerine, alkannin, dipotassium glycyrrhizinate salt, purified water, 85 DEG C of heating stirring dissolvings of preservative;
(3)Triethanolamine is added dropwise, to PH5.0~6.0, stops stirring, discharging is filling.
3. gel according to claim 1, it is characterised in that described alkannin purity is more than 80%.
4. gel according to claim 1, it is characterised in that the purity of described dipotassium glycyrrhizinate salt is more than 70%.
5. preservative according to claim 1, it is characterised in that preservative can be Nipasol, oxybenzene formicester, oxybenzene One kind in second fat, benzene chlorethanol, or two or more mixtures.
CN201710524860.9A 2017-06-30 2017-06-30 A kind of preparation method of gynecological gel Pending CN107308104A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108721204A (en) * 2018-06-04 2018-11-02 南京紫源康医药科技有限公司 A kind of solubility alkannin microneedle patch and preparation method thereof
CN111658763A (en) * 2020-06-29 2020-09-15 牡丹江医学院 Gynecological antibacterial gel and preparation method thereof

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101095895A (en) * 2007-07-06 2008-01-02 韦建学 Externally-used medicament for the sanitation and health-care of female vagina and for treating gynecology vagina diseases and method for making the same
CN101721353A (en) * 2009-07-08 2010-06-09 济南宏瑞创博医药科技开发有限公司 Stable thermosensitive gelatin composite
CN103520315A (en) * 2013-09-27 2014-01-22 天津工业大学 Medicinal composition for treating gynecological vaginitis and preparation method of medicinal composition
CN106266212A (en) * 2016-08-31 2017-01-04 郭东军 Gynecological's anti-inflammatory gel
CN106309237A (en) * 2016-09-26 2017-01-11 杭州惠博士生物科技有限公司 Hyaluronic acid private part care gel and preparation method thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101095895A (en) * 2007-07-06 2008-01-02 韦建学 Externally-used medicament for the sanitation and health-care of female vagina and for treating gynecology vagina diseases and method for making the same
CN101721353A (en) * 2009-07-08 2010-06-09 济南宏瑞创博医药科技开发有限公司 Stable thermosensitive gelatin composite
CN103520315A (en) * 2013-09-27 2014-01-22 天津工业大学 Medicinal composition for treating gynecological vaginitis and preparation method of medicinal composition
CN106266212A (en) * 2016-08-31 2017-01-04 郭东军 Gynecological's anti-inflammatory gel
CN106309237A (en) * 2016-09-26 2017-01-11 杭州惠博士生物科技有限公司 Hyaluronic acid private part care gel and preparation method thereof

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樊红霞等: "紫草的组织培养和紫草素及其衍生物的生物合成", 《药学学报》 *
邓淑华等: "甘草酸盐抗菌作用的实验研究", 《承德医学院学报》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108721204A (en) * 2018-06-04 2018-11-02 南京紫源康医药科技有限公司 A kind of solubility alkannin microneedle patch and preparation method thereof
CN111658763A (en) * 2020-06-29 2020-09-15 牡丹江医学院 Gynecological antibacterial gel and preparation method thereof

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Effective date of registration: 20190118

Address after: Room 401, Building F7, No. 9 Weidi Road, Xianlin University Town, Xianlin Street, Qixia District, Nanjing, Jiangsu Province, 210000

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Address before: 212400 No. 16 Xianlin East Road, Baohua Town, Jurong City, Zhenjiang City, Jiangsu Province

Applicant before: JIANGSU NAIQUE BIOLOGICAL ENGINEERING TECHNOLOGY CO., LTD.

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Application publication date: 20171103