CN106237029B - A kind of aloe antibiotic gel and preparation method thereof - Google Patents
A kind of aloe antibiotic gel and preparation method thereof Download PDFInfo
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- CN106237029B CN106237029B CN201610742068.6A CN201610742068A CN106237029B CN 106237029 B CN106237029 B CN 106237029B CN 201610742068 A CN201610742068 A CN 201610742068A CN 106237029 B CN106237029 B CN 106237029B
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- saussurea involucrata
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/285—Aucklandia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
Abstract
The present invention provides a kind of aloe antibiotic gels, are grouped as in parts by weight by following group：Hydroxypropyl methylcellulose 0.2 10%, propylene glycol 1 10%, acetic acid chlorhexidine 0.1% 3%, hyaluronic acid 0.01 1%, extract solution from aloe 1 10%, Saussurea involucrata extract 0.5 5%, Radix Arnebiae extract 0.5 5%, remaining is water；Wherein individually liposome embedded or capsule of nano wraps up before mixing for hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract.The present invention also provides the preparation methods of the gel.The present invention can antiphlogistic antibacterial, adjust female reproductive system function, most of effective active composition of Chinese herbal medicine can be played, be suitble to long-term safety use.
Description
【Technical field】
The present invention relates to composite Chinese herbal gynecological gels more particularly to a kind of aloe antibiotic gel and preparation method thereof.
【Background technology】
Reproductive tract infection is an important factor for endangering women's health, and the basic reason for causing reproductive tract infection is easily latent
In the various conditioned pathogens of inside and outside private parts, such as staphylococcus, streptococcus, Escherichia coli, anaerobic bacteria, the pathogen that spreads through sex intercourse, white
Color candida albicans and mycoplasma, Chlamydia etc..When human body internal and external environment changes when disequilibrium, pathogen will take advantage of a weak point in opponent's defence and stage an armed rebellion,
Endanger health.
China's gynecological external use drug includes Chinese patent drug, antibiotic, chemosterilant and Chinese and Western medicament mixture etc., and wherein chemistry disappears
Gynecological external use drug market occupies leading position to toxic agent at home, and leading position is occupied in retail market to Chinese and Western medicament mixture at home.
For chemosterilant although quick, the toxic side effects such as corrosivity are relatively large, also killed while killing germ beneficial
Bacterium destroys the balance of intravaginal flora, refractory after cause inflammation high recurrence rate, recurrence to be cured；Chinese and Western medicament mixture utilizes chemical composition
Sterilization take stopgap measures, effected a permanent cure using traditional Chinese medicine ingredients, be a kind of method for the treatment of both manifestation and root cause of disease, but most product weak curative effect, the state of an illness is easily repeatedly；
Antibiotic easy tos produce drug resistance, once antibody-resistant bacterium is generated, even if cannot be effective if being continuously increased the drug dose state of an illness
Control uses rear inflammation high recurrence rate in addition, antibiotic destructible vaginal flora balances.Chinese patent drug is mild with drug effect, pair is made
With it is small, meet the advantages that China women medication for a long time custom, several years ago occuping market leading position, but Chinese medicine preparation is universal
It is slower that there are drug effects, the relatively long problem for the treatment of phase.
However, it is above-described for drug used by gynaecological imflammation, it has the following problems：1, at present on the market almost
All medications for gynaecological imflammation generate destruction to genital tract environment, mucous membrane itself secreting function, so as to cause reproduction office
The decline of portion's immunity, and pathogenic bacteria is caused to develop immunity to drugs and drug resistance, final inflammation recurrent exerbation；2, prescription compatibility of medicines does not conform to
Reason, dosage form is inconvenient to use, and function is limited, comprehensive therapeutic effect unobvious；3, belong to subsequent drug, cannot function as prevention and health care medicinal
Product are used for a long time.
【Invention content】
In order to solve the above problem in the prior art, of the invention provides a kind of aloe antibiotic gel, being capable of anti-inflammatory
Antibacterial adjusts female reproductive system function, being capable of long-term safety use.
It is a further object of the present invention to provide the preparation methods of above-mentioned aloe antibiotic gel, can retain the big portion of Chinese herbal medicine
Divide effective active composition.
The technical scheme is that：
A kind of aloe antibiotic gel, which is characterized in that be grouped as in parts by weight by following group：Hydroxypropyl methylcellulose
0.2-10%, propylene glycol 1-10%, acetic acid chlorhexidine 0.1%-3%, hyaluronic acid 0.01-1%, extract solution from aloe 1-10%,
Saussurea involucrata extract 0.5-5%, Radix Arnebiae extract 0.5-5%, remaining is water；Wherein hyaluronic acid, Saussurea involucrata extract, Asian puccoon extraction
Individually liposome embedded or capsule of nano wraps up object before mixing.
Further specifically, above-mentioned aloe antibiotic gel is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose
0.2-8%, propylene glycol 1-8%, acetic acid chlorhexidine 0.1%-1%, hyaluronic acid 0.01-0.5%, extract solution from aloe 1-8%, snow
Lotus extract 0.5-2%, Radix Arnebiae extract 0.5-2%, remaining is water；Wherein hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract
Individually liposome embedded before mixing or capsule of nano package.
Specifically, the PH of above-mentioned aloe antibiotic gel is 4-5, PH conditioning agents are sodium dihydrogen phosphate.The moon of the PH and human body
Road environmental PH is close, will not destroy the flora for maintaining the normal PH of vagina, will not destroy inside of human body balance, Small side effects, can be with
It is used for a long time.
Specifically, above-mentioned extract solution from aloe is made by following methods：Fresh leaf of aloe is cleaned, peeling, is sterilized, cell is put into
Crusher is beaten, and the vitamin C of the pectase and 0.3-0.5% of 1-5% is added in mass ratio, in 35-45 DEG C of water bath with thermostatic control
Reaction 30 minutes, is added activated carbon, and the supernatant liquid obtained after refrigerated centrifuge filtering is the extract solution from aloe.What the method obtained
Extract solution from aloe yield higher, pectase and ascorbic be used cooperatively make the antioxygenic property of extracting solution more preferable, in acidity
Under the conditions of it is more stable.
Specifically, above-mentioned Saussurea involucrata extract is made by following methods：After taking saussurea involucrata plant to be beaten filtration sterilization, in filtrate
It is passed through liquid carbon dioxide and carries out supercritical extract, extraction time 5-10h, extraction temperature is 40-50 DEG C, and extracting pressure is
15-25MPa。
Specifically, above-mentioned Radix Arnebiae extract is made by following methods：After taking paniculatum plants to be beaten filtration sterilization, in filtrate
It is passed through liquid carbon dioxide and carries out supercritical extract, extraction time 5-10h, extraction temperature is 30-40 DEG C, and extracting pressure is
15-25MPa。
Supercritical carbon dioxide extracting process does not pass through high temperature and drying process, can retain the more of saussurea involucrata and Asian puccoon
Active ingredient and its bioactivity, and without toxic or have the solvent of potential hazard, there is no what dissolvent residual was brought to ask
Topic, it is safer, it is suitable for the application of food or drug.
The present invention another technical solution be：
A kind of preparation method of above-mentioned aloe antibiotic gel, includes the following steps：
1) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are individually wrapped up with liposome embedded or capsule of nano；
2) each component is weighed by formula；
3) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract that liposome embedded or capsule of nano wraps up are dissolved in water；
4) extract solution from aloe, propylene glycol, acetic acid chlorhexidine, stirring and dissolving is added；
5) hydroxypropyl methylcellulose is added, is placed in constant temperature 30min in 55-65 DEG C of water-bath, gel is adjusted with sodium dihydrogen phosphate
PH to 4-5, vacuum outgas, sterilizing obtain the aloe antibiotic gel.
Specifically, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Due in above-mentioned formula contain boiling point compared with
Low active ingredient, therefore be not suitable for high temperature sterilization, cellulose ester membrane can from solution cleared microorganism, make solution swimmingly
Passed through by filter, without falling into any unwanted substance of institute in filtrate, and filter is easy to clean, easy to operate.
Specifically, the aperture of above-mentioned cellulose ester membrane is 0.2-0.5 microns.The pore diameter range is enough tissue bacterial, and (>=1 is micro-
Rice) and (>=0.5 micron) of brood cell enter within filter opening, effectively remove and degerm and brood cell.
Specifically, the aperture of above-mentioned cellulose ester membrane is 0.22 micron.It can effectively sterilize and certain filtering
Speed.
The present invention has technique effect beneficial below：1) formula of the invention uses the formula of Integrated TCM, tool
There are the multi-efficiencies such as anti-inflammatory, sterilization, anticancer, maintenance, Multiple components to cooperate, act synergistically, bactericidal range is wide, killing effect
It is good, to such as gonococcus, according to substance, mycoplasma herpesviral, candida albicans, staphylococcus, trichomonas vaginalis, gram-negative bacteria, HIV
The multiple pathogens such as virus have killing effect, safely and effectively；2) formula of the invention remains aloe, saussurea involucrata, Asian puccoon very
More active ingredients, extraction process temperature is low, and is wrapped up by liposome embedded or capsule of nano, and it is living to retain its biology as far as possible
Property；3) the vaginal environment PH of formula PH of the invention and human body is close, will not destroy the flora for maintaining the normal PH of vagina, will not break
Bad inside of human body balances, Small side effects, and is soluble formulation, and no greasy feeling can be used for a long time；4) formula of the invention peace
Complete mild, in addition to anti-inflammatory, bactericidal effect, shikonin extract can reduce colporrhagia, enhancing Monitoring Ovarian Function, extract solution from aloe energy
Nutritional ingredient is enough provided, promotes wound healing, saussurea involucrata extracting solution that can promote upper gland cortin synthesis, adjust female reproductive system
System function, enhancing Monitoring Ovarian Function, for growth in vagina, comprehensive function is good from stopping blooding to healing into；5) preparation side of the invention
Obtained in method aloe, saussurea involucrata, Radix Arnebiae extract process not pass through high temperature, dehydration process, capture in plant cell and contain
Most of active constituent, while still maintaining the bioactivity of each ingredient, can more play its effectiveness；6) preparation of the invention
Method will be by liposome embedded or capsule of nano technique for packing, cannot be steady when by the different substance of dissolubility and PH being 4-5
Fixed existing substance is dispersed in gel, and inhibits the stimulation of the uterine myometrium of polysaccharide in saussurea involucrata,
Good effect, reliability are high；7) preparation method of the invention is without any solvent being harmful to or have potential hazard of application, and product is not
There are problem of solvent residual, safe.
【Specific implementation mode】
Below in conjunction with specific embodiment, the present invention is described further.
Embodiment provided below be not to limit the range that is covered of the present invention, described step nor with
Sequence is executed to limit its.Those skilled in the art are the present invention in conjunction with existing common knowledge conspicuously improved, also fall
Enter the present invention claims protection domain within.
Embodiment one
A kind of aloe antibiotic gel, is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose 0.2%, propylene glycol
1%, acetic acid chlorhexidine 0.1%, hyaluronic acid 0.01%, extract solution from aloe 1%, Saussurea involucrata extract 0.5%, Radix Arnebiae extract
0.5%, remaining is water；Wherein hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are individually liposome embedded before mixing or receive
Rice encapsulation.The PH of above-mentioned aloe antibiotic gel is that 4.5, PH conditioning agents are sodium dihydrogen phosphate.The vagina of the PH and human body
Environmental PH is close, will not destroy the flora for maintaining the normal PH of vagina, will not destroy inside of human body balance, Small side effects, Ke Yichang
Phase uses.
The extract solution from aloe is made by following methods：Fresh leaf of aloe is cleaned, peeling, is sterilized, biomixer is put into
Mashing is added 1% pectase and 0.3% vitamin C, is reacted 30 minutes in 35 DEG C of waters bath with thermostatic control in mass ratio, is added
Activated carbon, the supernatant liquid obtained after refrigerated centrifuge filtering are the extract solution from aloe.
The Saussurea involucrata extract is made by following methods：After taking saussurea involucrata plant to be beaten filtration sterilization, liquid is passed through in filtrate
State carbon dioxide carries out supercritical extract, extraction time 5h, and extraction temperature is 40 DEG C, extracting pressure 15MPa.
The Radix Arnebiae extract is made by following methods：After taking paniculatum plants to be beaten filtration sterilization, liquid is passed through in filtrate
State carbon dioxide carries out supercritical extract, extraction time 5h, and extraction temperature is 30 DEG C, extracting pressure 15MPa.
Supercritical carbon dioxide extracting process does not pass through high temperature and drying process, can retain the more of saussurea involucrata and Asian puccoon
Active ingredient and its bioactivity, and without toxic or have the solvent of potential hazard, there is no what dissolvent residual was brought to ask
Topic, it is safer, it is suitable for the application of food or drug.
The present invention another technical solution be：
A kind of preparation method of above-mentioned aloe antibiotic gel, includes the following steps：
1) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are individually wrapped up with liposome embedded or capsule of nano；
2) each component is weighed by formula；
3) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract that liposome embedded or capsule of nano wraps up are dissolved in water；
4) extract solution from aloe, propylene glycol, acetic acid chlorhexidine, stirring and dissolving is added；
5) be added hydroxypropyl methylcellulose, be placed in constant temperature 30min in 55 DEG C of water-baths, with sodium dihydrogen phosphate adjust gel PH to
4.5, vacuum outgas, sterilizing obtains the aloe antibiotic gel.
Specifically, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Due in above-mentioned formula contain boiling point compared with
Low active ingredient, therefore be not suitable for high temperature sterilization, cellulose ester membrane can from solution cleared microorganism, make solution swimmingly
Passed through by filter, without falling into any unwanted substance of institute in filtrate, and filter is easy to clean, easy to operate.
Specifically, the aperture of above-mentioned cellulose ester membrane is 0.22 micron.It can effectively sterilize and certain filtering
Speed.
Embodiment two
A kind of aloe antibiotic gel, is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose 10%, propylene glycol
10%, acetic acid chlorhexidine 3%, hyaluronic acid 1%, extract solution from aloe 10%, Saussurea involucrata extract 5%, Radix Arnebiae extract 5%,
Yu Weishui；Wherein hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract before mixing individually liposome embedded or capsule of nano
Package.The PH of above-mentioned aloe antibiotic gel is that 4.6, PH conditioning agents are sodium dihydrogen phosphate.The vaginal environment PH of the PH and human body connects
Closely, the flora for maintaining the normal PH of vagina will not be destroyed, inside of human body balance will not be destroyed, Small side effects can be used for a long time.
The extract solution from aloe is made by following methods：Fresh leaf of aloe is cleaned, peeling, is sterilized, biomixer is put into
Mashing is added 5% pectase and 0.5% vitamin C, is reacted 30 minutes in 45 DEG C of waters bath with thermostatic control in mass ratio, is added
Activated carbon, the supernatant liquid obtained after refrigerated centrifuge filtering are the extract solution from aloe.
The Saussurea involucrata extract is made by following methods：After taking saussurea involucrata plant to be beaten filtration sterilization, liquid is passed through in filtrate
State carbon dioxide carries out supercritical extract, extraction time 10h, and extraction temperature is 50 DEG C, extracting pressure 25MPa.
The Radix Arnebiae extract is made by following methods：After taking paniculatum plants to be beaten filtration sterilization, liquid is passed through in filtrate
State carbon dioxide carries out supercritical extract, extraction time 10h, and extraction temperature is 40 DEG C, extracting pressure 25MPa.
Supercritical carbon dioxide extracting process does not pass through high temperature and drying process, can retain the more of saussurea involucrata and Asian puccoon
Active ingredient and its bioactivity, and without toxic or have the solvent of potential hazard, there is no what dissolvent residual was brought to ask
Topic, it is safer, it is suitable for the application of food or drug.
The present invention another technical solution be：
A kind of preparation method of above-mentioned aloe antibiotic gel, includes the following steps：
1) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are individually wrapped up with liposome embedded or capsule of nano；
2) each component is weighed by formula；
3) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract that liposome embedded or capsule of nano wraps up are dissolved in water；
4) extract solution from aloe, propylene glycol, acetic acid chlorhexidine, stirring and dissolving is added；
5) be added hydroxypropyl methylcellulose, be placed in constant temperature 30min in 65 DEG C of water-baths, with sodium dihydrogen phosphate adjust gel PH to
4.6, vacuum outgas, sterilizing obtains the aloe antibiotic gel.
Specifically, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Due in above-mentioned formula contain boiling point compared with
Low active ingredient, therefore be not suitable for high temperature sterilization, cellulose ester membrane can from solution cleared microorganism, make solution swimmingly
Passed through by filter, without falling into any unwanted substance of institute in filtrate, and filter is easy to clean, easy to operate.
Specifically, the aperture of above-mentioned cellulose ester membrane is 0.5 micron.It can effectively sterilize and certain filtering
Speed.
Embodiment three
A kind of aloe antibiotic gel, is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose 8%, propylene glycol 8%,
Acetic acid chlorhexidine 1%, hyaluronic acid 0.5%, extract solution from aloe 8%, Saussurea involucrata extract 2%, Radix Arnebiae extract 2%, remaining is
Water；Wherein hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract before mixing individually liposome embedded or capsule of nano packet
It wraps up in.The PH of above-mentioned aloe antibiotic gel is that 4.4, PH conditioning agents are sodium dihydrogen phosphate.The vaginal environment PH of the PH and human body is close,
The flora for maintaining the normal PH of vagina will not be destroyed, inside of human body balance will not be destroyed, Small side effects can be used for a long time.
The extract solution from aloe is made by following methods：Fresh leaf of aloe is cleaned, peeling, is sterilized, biomixer is put into
Mashing is added 3% pectase and 0.4% vitamin C, is reacted 30 minutes in 40 DEG C of waters bath with thermostatic control in mass ratio, is added
Activated carbon, the supernatant liquid obtained after refrigerated centrifuge filtering are the extract solution from aloe.
The Saussurea involucrata extract is made by following methods：After taking saussurea involucrata plant to be beaten filtration sterilization, liquid is passed through in filtrate
State carbon dioxide carries out supercritical extract, extraction time 6h, and extraction temperature is 45 DEG C, extracting pressure 20MPa.
The Radix Arnebiae extract is made by following methods：After taking paniculatum plants to be beaten filtration sterilization, liquid is passed through in filtrate
State carbon dioxide carries out supercritical extract, extraction time 8h, and extraction temperature is 35 DEG C, extracting pressure 20MPa.
Supercritical carbon dioxide extracting process does not pass through high temperature and drying process, can retain the more of saussurea involucrata and Asian puccoon
Active ingredient and its bioactivity, and without toxic or have the solvent of potential hazard, there is no what dissolvent residual was brought to ask
Topic, it is safer, it is suitable for the application of food or drug.
The present invention another technical solution be：
A kind of preparation method of above-mentioned aloe antibiotic gel, includes the following steps：
1) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are individually wrapped up with liposome embedded or capsule of nano；
2) each component is weighed by formula；
3) hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract that liposome embedded or capsule of nano wraps up are dissolved in water；
4) extract solution from aloe, propylene glycol, acetic acid chlorhexidine, stirring and dissolving is added；
5) be added hydroxypropyl methylcellulose, be placed in constant temperature 30min in 60 DEG C of water-baths, with sodium dihydrogen phosphate adjust gel PH to
4.4, vacuum outgas, sterilizing obtains the aloe antibiotic gel.
Specifically, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Due in above-mentioned formula contain boiling point compared with
Low active ingredient, therefore be not suitable for high temperature sterilization, cellulose ester membrane can from solution cleared microorganism, make solution swimmingly
Passed through by filter, without falling into any unwanted substance of institute in filtrate, and filter is easy to clean, easy to operate.
Specifically, the aperture of above-mentioned cellulose ester membrane is 0.2 micron.It can effectively sterilize and certain filtering
Speed.
By the following examples one to three and the antibiotic property experiment and vaginal irritation experiment of comparative example one to four illustrate this
Advantageous effect of the invention.
Comparative example one
A kind of gel is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose 0.2%, propylene glycol 1%, acetic acid chlorine
Determine 0.1%, hyaluronic acid 0.01%, extract solution from aloe 1%, Saussurea involucrata extract 0.5%, Radix Arnebiae extract 0.5%, remaining is
Water；Wherein hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are not wrapped up using liposome embedded or capsule of nano.Remaining with
Embodiment one is identical.
Comparative example two
A kind of gel is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose 0.2%, propylene glycol 1%, acetic acid chlorine
Determine 0.1%, hyaluronic acid 0.01%, extract solution from aloe 1%, remaining is water；Wherein hyaluronic acid independent fat before mixing
Plastid embeds or capsule of nano package.Remaining is identical as embodiment one.
Comparative example three
A kind of gel is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose 0.2%, propylene glycol 1%, acetic acid chlorine
Determine 0.1%, hyaluronic acid 0.01%, Saussurea involucrata extract 0.5%, remaining is water；Wherein Saussurea involucrata extract uses before mixing
Liposome embedded or capsule of nano package.Remaining is identical as embodiment one.
Comparative example four
A kind of gel is grouped as by following group in parts by weight：Hydroxypropyl methylcellulose 0.2%, propylene glycol 1%, acetic acid chlorine
Determine 0.1%, hyaluronic acid 0.01%, Radix Arnebiae extract 0.5%, remaining is water；Wherein Radix Arnebiae extract uses before mixing
Liposome embedded or capsule of nano package.Remaining is identical as embodiment one.
Antibiotic property is tested：Antibiotic property test basis《Disposable Sanitary Accessory sanitary standard》Appendix C regulation carries out, and makees
With 10 minutes time, test result such as following table：
Test result shows that the antibacterial effect of the embodiment of the present invention is apparently higher than comparative example, and antibacterial effect is strong.
Vaginal irritation is tested：36 female Golden Hamsters are randomly divided into 6 groups (mechanical stimulus group, control group, experimental groups),
Every group 6,1. mechanical stimulus group is injected separately into each group rat vagina：Physiological saline；2. experimental group：Embodiment one.3. compareing
Group：Comparative example one to four.It changes the syringe needle of 1mL syringes into rubber tube, injects the above-mentioned of 50 μ l in oestrus female mice intravaginal
Gel mixture holds female mice 2min.Daily intravaginal administration is primary, successive administration 16d.Last dose puts to death animal afterwards for 24 hours,
Cut vagina, first visually observe abnormal whether there is or not hyperemia, redness, ulcer etc., then take out vagina tissue, it is close, in, distally divide
It is not fixed, is embedded with 10% formaldehyde, slice carries out histopathological examination.By the congestion of blood vessel of vaginal mucosal tissue generation, glue
Film water is swollen, 4 kinds of leukocyte infiltration, epithelium ulcer lesions different degrees of scoring, each is with 1~4 member record, totally 16 points, total score
Value is less than 4 points and indicates to stimulate very small, 5~8 points of expression slight stimulations, and 9~12 points indicate moderate stimulation, and 13~16 points indicate tight
It remises sharp.
By pathological section as it can be seen that Golden Hamster vagina epithelium is made of mucous layer, muscle layer, three layers of outer membrane, mucous layer again by
Epithelial layer and lamina propria are constituted.Epithelial layer is constituted for stratified squamous epithelium, and lamina propria is connective tissue, contains a large amount of capillaries
And lymphatic vessel.Muscle layer is made of smooth muscle, is divided two layers vertical outside inner ring.External mold is also made of connective tissue, rich in elastomer and
Smooth muscle.The muscle layer and outer membrane no abnormality seen of each group change, and mucous layer has slight variations.The visible mucosa lamina propria of control group it is small
Congestion of blood vessel oedema has cell infiltration on tube wall, has inflammatory exudate in epithelial layer.Generally acknowledge by the World Health Organization
Eckstcin standards of grading, each group score value see the table below：
| Group | It is congested | Oedema | Leukocyte infiltration | Ulcer epithelium | Total score |
| Mechanical stimulus group | 1.21 | 1.26 | 1.20 | 1.06 | 4.73 |
| Embodiment one | 0 | 0 | 0.8 | 0.72 | 1.52 |
| Comparative example one | 0.1 | 0 | 1.03 | 0.98 | 2.11 |
| Comparative example two | 0.1 | 0.1 | 1.12 | 1.21 | 2.33 |
| Comparative example three | 1.15 | 1.08 | 1.03 | 0.62 | 3.88 |
| Comparative example four | 0.2 | 0.2 | 1.38 | 0.96 | 2.74 |
The overall score of experiment results proved, the embodiment of the present invention one is minimum, very small to the irritation of vagina, substantially less than
Comparative example and mechanical stimulus group.
Claims (6)
1. a kind of aloe antibiotic gel, which is characterized in that be grouped as in parts by weight by following group：Hydroxypropyl methylcellulose 0.2-
10%, propylene glycol 1-10%, acetic acid chlorhexidine 0.1%-3%, hyaluronic acid 0.01-1%, extract solution from aloe 1-10%, Saussurea involucrata extract
0.5-5%, Radix Arnebiae extract 0.5-5%, remaining is water；Wherein hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are equal before mixing
Individually liposome embedded or capsule of nano package；
The PH of the aloe antibiotic gel is 4-5, and PH conditioning agents are sodium dihydrogen phosphate；
The extract solution from aloe is made by following methods：Fresh leaf of aloe is cleaned, peeling, is sterilized, biomixer mashing is put into,
The vitamin C of the pectase and 0.3-0.5% of 1-5% is added in mass ratio, reacts 30 minutes, adds in 35-45 DEG C of water bath with thermostatic control
Enter activated carbon, the supernatant liquid obtained after refrigerated centrifuge filtering is the extract solution from aloe；
The Saussurea involucrata extract is made by following methods：After taking saussurea involucrata plant to be beaten filtration sterilization, liquid two is passed through in filtrate
Carbonoxide carries out supercritical extract, extraction time 5-10h, and extraction temperature is 40-50 DEG C, extracting pressure 15-25MPa；
The Radix Arnebiae extract is made by following methods：After taking paniculatum plants to be beaten filtration sterilization, liquid two is passed through in filtrate
Carbonoxide carries out supercritical extract, extraction time 5-10h, and extraction temperature is 30-40 DEG C, extracting pressure 15-25MPa.
2. aloe antibiotic gel according to claim 1, which is characterized in that be grouped as in parts by weight by following group：Hydroxyl
Third methylcellulose 0.2-8%, propylene glycol 1-8%, acetic acid chlorhexidine 0.1%-1%, hyaluronic acid 0.01-0.5%, extract solution from aloe 1-
8%, Saussurea involucrata extract 0.5-2%, Radix Arnebiae extract 0.5-2%, remaining is water；Wherein hyaluronic acid, extract solution from aloe, saussurea involucrata carry
Take object, Radix Arnebiae extract individually liposome embedded before mixing or capsule of nano package.
3. such as the preparation method of claims 1 or 2 any one of them aloe antibiotic gel, which is characterized in that including following step
Suddenly：
1）Hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract are individually wrapped up with liposome embedded or capsule of nano；
2）Each component is weighed by formula；
3）Hyaluronic acid, Saussurea involucrata extract, Radix Arnebiae extract that liposome embedded or capsule of nano wraps up are dissolved in water；
4）Extract solution from aloe, propylene glycol, acetic acid chlorhexidine, stirring and dissolving is added；
5）Hydroxypropyl methylcellulose is added, is placed in constant temperature 30min in 55-65 DEG C of water-bath, the PH of gel is adjusted with sodium dihydrogen phosphate
To 4-5, vacuum outgas, sterilizing obtains the aloe antibiotic gel.
4. the preparation method of aloe antibiotic gel according to claim 3, which is characterized in that the step 5）Sterilization be
Cellulose ester membrane filtration sterilization.
5. the preparation method of aloe antibiotic gel according to claim 4, which is characterized in that the hole of the cellulose ester membrane
Diameter is 0.2-0.5 microns.
6. the preparation method of aloe antibiotic gel according to claim 5, which is characterized in that the hole of the cellulose ester membrane
Diameter is 0.22 micron.
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| CN111012879A (en) * | 2019-12-16 | 2020-04-17 | 苏州市多爱迷贸易有限公司 | Vaginal mucosa antibacterial gel and preparation method thereof |
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|---|---|---|---|---|
| CN102204880A (en) * | 2011-01-31 | 2011-10-05 | 普正药业股份有限公司 | Disinfectant gellant for gynaecological external use and its preparation method |
| CN104547344A (en) * | 2015-01-21 | 2015-04-29 | 何玉明 | Aloe care lotion and preparation method thereof |
| CN105168676A (en) * | 2015-09-25 | 2015-12-23 | 湖北穆兰同大科技有限公司 | Female safety antimicrobial gel and preparation method thereof |
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2016
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102204880A (en) * | 2011-01-31 | 2011-10-05 | 普正药业股份有限公司 | Disinfectant gellant for gynaecological external use and its preparation method |
| CN104547344A (en) * | 2015-01-21 | 2015-04-29 | 何玉明 | Aloe care lotion and preparation method thereof |
| CN105168676A (en) * | 2015-09-25 | 2015-12-23 | 湖北穆兰同大科技有限公司 | Female safety antimicrobial gel and preparation method thereof |
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Effective date of registration: 20220628 Address after: 343100 No. 267, Chuangxin Avenue, Jinggangshan economic and Technological Development Zone, Ji'an City, Jiangxi Province Patentee after: Wang Hongmei Address before: 343100 No. 267, Chuangxin Avenue, Jinggangshan economic and Technological Development Zone, Ji'an City, Jiangxi Province Patentee before: JI'AN YUMEILI HEALTH INDUSTRY Co.,Ltd. |