CN106237029A - A kind of aloe antibiotic gel and preparation method thereof - Google Patents

A kind of aloe antibiotic gel and preparation method thereof Download PDF

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Publication number
CN106237029A
CN106237029A CN201610742068.6A CN201610742068A CN106237029A CN 106237029 A CN106237029 A CN 106237029A CN 201610742068 A CN201610742068 A CN 201610742068A CN 106237029 A CN106237029 A CN 106237029A
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aloe
extract
gel
herba saussureae
saussureae involueratae
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CN106237029B (en
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尹志明
刘动勤
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Wang Hongmei
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Jian Royal Beauty Health Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728Hyaluronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/285Aucklandia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/30Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/886Aloeaceae (Aloe family), e.g. aloe vera
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Liposomes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/51Nanocapsules; Nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/37Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction

Abstract

The invention provides a kind of aloe antibiotic gel, it is made up of following component by weight: hypromellose 0.2 10%, propylene glycol 1 10%, chlorhexidine acetate 0.1% 3%, hyaluronic acid 0.01 1%, Aloe extraction solution 1 10%, Herba Saussureae Involueratae extract 0.5 5%, Radix Arnebiae extract 0.5 5%, remaining is water;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract be the most liposome embedded or capsule of nano parcel.Present invention also offers the preparation method of this gel.The present invention can antiphlogistic antibacterial, regulate female reproductive system function, it is possible to play Chinese herbal medicine most of effective active composition, be suitable for long-term safety use.

Description

A kind of aloe antibiotic gel and preparation method thereof
[technical field]
The present invention relates to composite Chinese herbal gynecological gel, particularly relate to a kind of aloe antibiotic gel and preparation method thereof.
[background technology]
Reproductive tract infection is the key factor of harm women's health, and causing the basic reason of reproductive tract infection is easily to hide In the various conditioned pathogens of inside and outside pudendum, such as staphylococcus, streptococcus, escherichia coli, anaerobe, the pathogen that spreads through sex intercourse, white Color candidiasis and mycoplasma, chlamydia etc..When the change of human body internal and external environment during disequilibrium, pathogen will be staged an armed rebellion in an opponent's defence, Endanger healthy.
China's gynecological external use medicine includes Chinese patent medicine, antibiotic, chemosterilant and Chinese medicine and western medicine mixture etc., and wherein chemistry disappears Toxic agent gynecological external use medicine market at home occupies leading position, and leading position is occupied in Chinese medicine and western medicine mixture retail market at home. Although chemosterilant instant effect, but the toxic and side effects such as corrosivity are relatively large, also killed useful while killing pathogenic bacteria Bacterium, destroys the balance of intravaginal flora, and after causing inflammation relapse rate height, recurrence, refractory is more;Chinese medicine and western medicine mixture utilizes chemical composition Sterilization take stopgap measures, utilize Chinese medicine ingredients to effect a permanent cure, be a kind of method for the treatment of both the principal and secondary aspects of a disease, but most product weak curative effect, the state of an illness is the most repeatedly; Antibiotic easily produces drug resistance, once produces Resistant strain, even if being continuously increased drug dose, the state of an illness also can not get effectively Control, additionally, antibiotic destructible vaginal microbial flora balance, use rear inflammation relapse rate high.Chinese patent medicine has drug effect work gentle, secondary With little, meet the advantages such as China's women medication custom for a long time, several years ago occuping market leading position, but Chinese medicine preparation is universal There is drug effect relatively slow, the problem that the treatment phase is relatively long.
But, the above-described medicine used for gynecological inflammation, there is problems in that 1, the most almost Reproductive tract environment, mucosa self secretory function are all produced and destroy, thus cause reproduction office by all medications for gynecological inflammation The decline of portion's immunity, and cause pathogenic bacterium to develop immunity to drugs and drug resistance, final inflammation recurrent exerbation;2, prescription compatibility of medicines does not conforms to Reason, dosage form in-convenience in use, function is limited, and comprehensive therapeutic effect is inconspicuous;3, medicine afterwards is belonged to, it is impossible to as prevention and health care medicinal Product life-time service.
[summary of the invention]
In order to solve the problems referred to above of the prior art, the present invention provides a kind of aloe antibiotic gel, it is possible to antiinflammatory Antibacterial, regulate female reproductive system function, it is possible to long-term safety uses.
It is a further object of the present invention to provide the preparation method of above-mentioned aloe antibiotic gel, it is possible to retain the big portion of Chinese herbal medicine Divide effective active composition.
The technical scheme is that
A kind of aloe antibiotic gel, it is characterised in that be made up of following component by weight: hypromellose 0.2-10%, propylene glycol 1-10%, chlorhexidine acetate 0.1%-3%, hyaluronic acid 0.01-1%, Aloe extraction solution 1-10%, Herba Saussureae Involueratae extract 0.5-5%, Radix Arnebiae extract 0.5-5%, remaining is water;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae (Radix Lithospermi) are extracted Thing is the most liposome embedded or capsule of nano wraps up.
The most concrete, above-mentioned aloe antibiotic gel is made up of following component by weight: hypromellose 0.2-8%, propylene glycol 1-8%, chlorhexidine acetate 0.1%-1%, hyaluronic acid 0.01-0.5%, Aloe extraction solution 1-8%, snow Lotus extract 0.5-2%, Radix Arnebiae extract 0.5-2%, remaining is water;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract The most liposome embedded or capsule of nano wraps up.
Concrete, the PH of above-mentioned aloe antibiotic gel be 4-5, PH regulator be sodium dihydrogen phosphate.This PH and the moon of human body Road environmental PH is close, will not destroy the flora maintaining the normal PH of vagina, will not destroy inside of human body balance, and side effect is little, permissible Life-time service.
Concrete, above-mentioned Aloe extraction solution is prepared by following methods: Fresh leaf of aloe is cleaned, peeling, sterilizing, put into cell Disintegrating machine is pulled an oar, and adds the pectase of 1-5% and the vitamin C of 0.3-0.5% in mass ratio, in 35-45 DEG C of water bath with thermostatic control Reacting 30 minutes, add activated carbon, the supernatant liquid that frozen centrifugation obtains after filtering is described Aloe extraction solution.This method obtains Aloe extraction solution yield is higher, pectase and ascorbic more preferable with the use of the antioxygenic property making extracting solution, in acidity Under the conditions of more stable.
Concrete, above-mentioned Herba Saussureae Involueratae extract is prepared by following methods: after taking Herba Saussureae Involueratae plant making beating filtration sterilization, in filtrate Being passed through liquid carbon dioxide and carry out supercritical extraction, extraction time is 5-10h, and extraction temperature is 40-50 DEG C, and extracting pressure is 15-25MPa。
Concrete, above-mentioned Radix Arnebiae extract is prepared by following methods: after taking paniculatum plants making beating filtration sterilization, in filtrate Being passed through liquid carbon dioxide and carry out supercritical extraction, extraction time is 5-10h, and extraction temperature is 30-40 DEG C, and extracting pressure is 15-25MPa。
Supercritical carbon dioxide extraction process is not through high temperature and dry run, it is possible to retain the more of Herba Saussureae Involueratae and Radix Arnebiae (Radix Lithospermi) Effective ingredient and biological activity, and there is no solvent that is poisonous or that have potential hazard, do not have that dissolvent residual brings asks Topic, safer, it is adaptable to food or the application of medicine.
The present invention another solution is that
The preparation method of a kind of above-mentioned aloe antibiotic gel, comprises the following steps:
1) by hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract the most individually with liposome embedded or capsule of nano parcel;
2) each component is weighed by formula;
3) liposome embedded or the hyaluronic acid of capsule of nano parcel, Herba Saussureae Involueratae extract, Radix Arnebiae extract are dissolved in water;
4) Aloe extraction solution, propylene glycol, chlorhexidine acetate, stirring and dissolving are added;
5) add hypromellose, be placed in constant temperature 30min in 55-65 DEG C of water-bath, with sodium dihydrogen phosphate regulation gel PH to 4-5, vacuum outgas, sterilizing, obtain described aloe antibiotic gel.
Concrete, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Owing to above-mentioned formula containing boiling point relatively Low effective ingredient, is not therefore suitable for high temperature sterilization, cellulose ester membrane can Ex-all microorganism from solution, make solution swimmingly Being passed through by filter, without falling into any unwanted material in filtrate, and filter easily cleans, easy and simple to handle.
Concrete, the aperture of above-mentioned cellulose ester membrane is 0.2-0.5 micron.This pore diameter range be enough to tissue bacterial, and (>=1 is micro- Rice) and brood cell's (>=0.5 micron) enter within filter opening, effectively removing antibacterial and brood cell.
Concrete, the aperture of above-mentioned cellulose ester membrane is 0.22 micron.Can effectively sterilize, can guarantee that again certain filtration Speed.
The present invention has a following useful technique effect: 1) formula of the present invention have employed the formula of Integrated TCM, tool Having the multi-efficiencies such as antiinflammatory, sterilization, anticancer, maintenance, Multiple components cooperates, synergism, and bactericidal range is wide, killing effect Good, to such as gonococcus, according to substance, mycoplasma herpesvirus, candidiasis, staphylococcus, trichomonal vaginitis, gram-negative bacteria, HIV The multiple pathogens such as virus all have killing action, safely and effectively;2) formula of the present invention remains Aloe, Herba Saussureae Involueratae, Radix Arnebiae (Radix Lithospermi) very Many effective ingredient, extract process temperature low, and are wrapped up by liposome embedded or capsule of nano, retain it as far as possible biological alive Property;3) the formula PH of the present invention is close with vaginal environment PH of human body, will not destroy the flora maintaining the normal PH of vagina, will not break Bad inside of human body balances, and side effect is little, and is soluble formulation, without greasy feeling, and can be with life-time service;4) the formula peace of the present invention Complete gentle, in addition to antiinflammatory, bactericidal action, shikonin extract can reduce vaginal hemorrhage, strengthen Monitoring Ovarian Function, Aloe extraction solution energy Enough providing nutritional labeling, promote wound healing, Herba Saussureae Involueratae extracting solution can promote the synthesis of upper gland 17-hydroxy-11-dehydrocorticosterone, regulation female reproductive system System function, enhancing Monitoring Ovarian Function, from stopping blooding to healing into, growth is in vagina, and comprehensive function is good;5) the preparation side of the present invention Method obtains Aloe, Herba Saussureae Involueratae, Radix Arnebiae extract process not through high temperature, dehydration process, capture in plant cell and contain Most of active component, remain in that the biological activity of every kind of composition simultaneously, more can play its effectiveness;6) preparation of the present invention Method will be by liposome embedded or capsule of nano technique for packing, can not be steady when being 4-5 by materials different for dissolubility and PH The fixed material existed is dispersed in gel, and inhibits the stimulation of the uterine myometrium of polysaccharide in Herba Saussureae Involueratae, Good effect, reliability is high;7) preparation method of the present invention does not apply solvent that is any harmful or that have potential hazard, and product is not There is problem of solvent residual, safety is high.
[detailed description of the invention]
Below in conjunction with specific embodiment, the present invention is described further.
Embodiment provided below also is not used to limit the scope that the present invention is contained, and described step is not to use To limit its execution sequence.Those skilled in the art combine existing common knowledge and are the present invention conspicuously improved, also fall Within entering the protection domain of application claims.
Embodiment one
A kind of aloe antibiotic gel, is made up of following component: hypromellose 0.2%, propylene glycol by weight 1%, chlorhexidine acetate 0.1%, hyaluronic acid 0.01%, Aloe extraction solution 1%, Herba Saussureae Involueratae extract 0.5%, Radix Arnebiae extract 0.5%, remaining is water;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract is the most liposome embedded or receives Rice encapsulation.The PH of above-mentioned aloe antibiotic gel is 4.5, and PH regulator is sodium dihydrogen phosphate.This PH and the vagina of human body Environmental PH is close, will not destroy the flora maintaining the normal PH of vagina, will not destroy inside of human body balance, and side effect is little, Ke Yichang Phase uses.
Described Aloe extraction solution is prepared by following methods: by Fresh leaf of aloe clean, peeling, sterilizing, put into biomixer Making beating, adds pectase and the vitamin C of 0.3% of 1% in mass ratio, reacts 30 minutes in 35 DEG C of waters bath with thermostatic control, add Activated carbon, the supernatant liquid that frozen centrifugation obtains after filtering is described Aloe extraction solution.
Described Herba Saussureae Involueratae extract is prepared by following methods: after taking Herba Saussureae Involueratae plant making beating filtration sterilization, be passed through liquid in filtrate State carbon dioxide carries out supercritical extraction, and extraction time is 5h, and extraction temperature is 40 DEG C, and extracting pressure is 15MPa.
Described Radix Arnebiae extract is prepared by following methods: after taking paniculatum plants making beating filtration sterilization, be passed through liquid in filtrate State carbon dioxide carries out supercritical extraction, and extraction time is 5h, and extraction temperature is 30 DEG C, and extracting pressure is 15MPa.
Supercritical carbon dioxide extraction process is not through high temperature and dry run, it is possible to retain the more of Herba Saussureae Involueratae and Radix Arnebiae (Radix Lithospermi) Effective ingredient and biological activity, and there is no solvent that is poisonous or that have potential hazard, do not have that dissolvent residual brings asks Topic, safer, it is adaptable to food or the application of medicine.
The present invention another solution is that
The preparation method of a kind of above-mentioned aloe antibiotic gel, comprises the following steps:
1) by hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract the most individually with liposome embedded or capsule of nano parcel;
2) each component is weighed by formula;
3) liposome embedded or the hyaluronic acid of capsule of nano parcel, Herba Saussureae Involueratae extract, Radix Arnebiae extract are dissolved in water;
4) Aloe extraction solution, propylene glycol, chlorhexidine acetate, stirring and dissolving are added;
5) add hypromellose, be placed in constant temperature 30min in 55 DEG C of water-baths, with the PH of sodium dihydrogen phosphate regulation gel extremely 4.5, vacuum outgas, sterilizing, obtain described aloe antibiotic gel.
Concrete, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Owing to above-mentioned formula containing boiling point relatively Low effective ingredient, is not therefore suitable for high temperature sterilization, cellulose ester membrane can Ex-all microorganism from solution, make solution swimmingly Being passed through by filter, without falling into any unwanted material in filtrate, and filter easily cleans, easy and simple to handle.
Concrete, the aperture of above-mentioned cellulose ester membrane is 0.22 micron.Can effectively sterilize, can guarantee that again certain filtration Speed.
Embodiment two
A kind of aloe antibiotic gel, is made up of following component: hypromellose 10%, propylene glycol by weight 10%, chlorhexidine acetate 3%, hyaluronic acid 1%, Aloe extraction solution 10%, Herba Saussureae Involueratae extract 5%, Radix Arnebiae extract 5%, its Yu Weishui;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract be the most liposome embedded or capsule of nano Parcel.The PH of above-mentioned aloe antibiotic gel is 4.6, and PH regulator is sodium dihydrogen phosphate.This PH connects with vaginal environment PH of human body Closely, will not destroy the flora maintaining the normal PH of vagina, will not destroy inside of human body balance, side effect is little, can be with life-time service.
Described Aloe extraction solution is prepared by following methods: by Fresh leaf of aloe clean, peeling, sterilizing, put into biomixer Making beating, adds pectase and the vitamin C of 0.5% of 5% in mass ratio, reacts 30 minutes in 45 DEG C of waters bath with thermostatic control, add Activated carbon, the supernatant liquid that frozen centrifugation obtains after filtering is described Aloe extraction solution.
Described Herba Saussureae Involueratae extract is prepared by following methods: after taking Herba Saussureae Involueratae plant making beating filtration sterilization, be passed through liquid in filtrate State carbon dioxide carries out supercritical extraction, and extraction time is 10h, and extraction temperature is 50 DEG C, and extracting pressure is 25MPa.
Described Radix Arnebiae extract is prepared by following methods: after taking paniculatum plants making beating filtration sterilization, be passed through liquid in filtrate State carbon dioxide carries out supercritical extraction, and extraction time is 10h, and extraction temperature is 40 DEG C, and extracting pressure is 25MPa.
Supercritical carbon dioxide extraction process is not through high temperature and dry run, it is possible to retain the more of Herba Saussureae Involueratae and Radix Arnebiae (Radix Lithospermi) Effective ingredient and biological activity, and there is no solvent that is poisonous or that have potential hazard, do not have that dissolvent residual brings asks Topic, safer, it is adaptable to food or the application of medicine.
The present invention another solution is that
The preparation method of a kind of above-mentioned aloe antibiotic gel, comprises the following steps:
1) by hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract the most individually with liposome embedded or capsule of nano parcel;
2) each component is weighed by formula;
3) liposome embedded or the hyaluronic acid of capsule of nano parcel, Herba Saussureae Involueratae extract, Radix Arnebiae extract are dissolved in water;
4) Aloe extraction solution, propylene glycol, chlorhexidine acetate, stirring and dissolving are added;
5) add hypromellose, be placed in constant temperature 30min in 65 DEG C of water-baths, with the PH of sodium dihydrogen phosphate regulation gel extremely 4.6, vacuum outgas, sterilizing, obtain described aloe antibiotic gel.
Concrete, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Owing to above-mentioned formula containing boiling point relatively Low effective ingredient, is not therefore suitable for high temperature sterilization, cellulose ester membrane can Ex-all microorganism from solution, make solution swimmingly Being passed through by filter, without falling into any unwanted material in filtrate, and filter easily cleans, easy and simple to handle.
Concrete, the aperture of above-mentioned cellulose ester membrane is 0.5 micron.Can effectively sterilize, can guarantee that again certain filtration Speed.
Embodiment three
A kind of aloe antibiotic gel, is made up of following component: hypromellose 8%, propylene glycol 8% by weight, Chlorhexidine acetate 1%, hyaluronic acid 0.5%, Aloe extraction solution 8%, Herba Saussureae Involueratae extract 2%, Radix Arnebiae extract 2%, remaining is Water;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract be the most liposome embedded or capsule of nano bag Wrap up in.The PH of above-mentioned aloe antibiotic gel is 4.4, and PH regulator is sodium dihydrogen phosphate.This PH is close with vaginal environment PH of human body, Will not destroy the flora maintaining the normal PH of vagina, will not destroy inside of human body balance, side effect is little, can be with life-time service.
Described Aloe extraction solution is prepared by following methods: by Fresh leaf of aloe clean, peeling, sterilizing, put into biomixer Making beating, adds pectase and the vitamin C of 0.4% of 3% in mass ratio, reacts 30 minutes in 40 DEG C of waters bath with thermostatic control, add Activated carbon, the supernatant liquid that frozen centrifugation obtains after filtering is described Aloe extraction solution.
Described Herba Saussureae Involueratae extract is prepared by following methods: after taking Herba Saussureae Involueratae plant making beating filtration sterilization, be passed through liquid in filtrate State carbon dioxide carries out supercritical extraction, and extraction time is 6h, and extraction temperature is 45 DEG C, and extracting pressure is 20MPa.
Described Radix Arnebiae extract is prepared by following methods: after taking paniculatum plants making beating filtration sterilization, be passed through liquid in filtrate State carbon dioxide carries out supercritical extraction, and extraction time is 8h, and extraction temperature is 35 DEG C, and extracting pressure is 20MPa.
Supercritical carbon dioxide extraction process is not through high temperature and dry run, it is possible to retain the more of Herba Saussureae Involueratae and Radix Arnebiae (Radix Lithospermi) Effective ingredient and biological activity, and there is no solvent that is poisonous or that have potential hazard, do not have that dissolvent residual brings asks Topic, safer, it is adaptable to food or the application of medicine.
The present invention another solution is that
The preparation method of a kind of above-mentioned aloe antibiotic gel, comprises the following steps:
1) by hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract the most individually with liposome embedded or capsule of nano parcel;
2) each component is weighed by formula;
3) liposome embedded or the hyaluronic acid of capsule of nano parcel, Herba Saussureae Involueratae extract, Radix Arnebiae extract are dissolved in water;
4) Aloe extraction solution, propylene glycol, chlorhexidine acetate, stirring and dissolving are added;
5) add hypromellose, be placed in constant temperature 30min in 60 DEG C of water-baths, with the PH of sodium dihydrogen phosphate regulation gel extremely 4.4, vacuum outgas, sterilizing, obtain described aloe antibiotic gel.
Concrete, above-mentioned steps 5) sterilization be cellulose ester membrane filtration sterilization.Owing to above-mentioned formula containing boiling point relatively Low effective ingredient, is not therefore suitable for high temperature sterilization, cellulose ester membrane can Ex-all microorganism from solution, make solution swimmingly Being passed through by filter, without falling into any unwanted material in filtrate, and filter easily cleans, easy and simple to handle.
Concrete, the aperture of above-mentioned cellulose ester membrane is 0.2 micron.Can effectively sterilize, can guarantee that again certain filtration Speed.
By the following examples one to three and the antibiotic property test of comparative example one to four and vaginal irritation test this is described The beneficial effect of the invention.
Comparative example one
A kind of gel, is made up of following component: hypromellose 0.2%, propylene glycol 1%, acetic acid chlorine by weight Having determined 0.1%, hyaluronic acid 0.01%, Aloe extraction solution 1%, Herba Saussureae Involueratae extract 0.5%, Radix Arnebiae extract 0.5%, remaining is Water;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract are provided without liposome embedded or capsule of nano parcel.Remaining with Embodiment one is identical.
Comparative example two
A kind of gel, is made up of following component: hypromellose 0.2%, propylene glycol 1%, acetic acid chlorine by weight Having determined 0.1%, hyaluronic acid 0.01%, Aloe extraction solution 1%, remaining is water;Wherein hyaluronic acid the most individually fat Plastid embedding or capsule of nano parcel.Remaining is identical with embodiment one.
Comparative example three
A kind of gel, is made up of following component: hypromellose 0.2%, propylene glycol 1%, acetic acid chlorine by weight Having determined 0.1%, hyaluronic acid 0.01%, Herba Saussureae Involueratae extract 0.5%, remaining is water;Wherein Herba Saussureae Involueratae extract uses before combination Liposome embedded or capsule of nano wraps up.Remaining is identical with embodiment one.
Comparative example four
A kind of gel, is made up of following component: hypromellose 0.2%, propylene glycol 1%, acetic acid chlorine by weight Having determined 0.1%, hyaluronic acid 0.01%, Radix Arnebiae extract 0.5%, remaining is water;Wherein Radix Arnebiae extract uses before combination Liposome embedded or capsule of nano wraps up.Remaining is identical with embodiment one.
Antibiotic property is tested: antibiotic property test basis " Disposable Sanitary Accessory sanitary standard " appendix C regulation is carried out, and makees With 10 minutes time, result of the test such as following table:
Result of the test shows, 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 Hamster are randomly divided into 6 groups (mechanical stimulus group, matched group, experimental grouies), Often group 6, is injected separately into 1. mechanical stimulus group in each group rat vagina: normal saline;2. experimental group: embodiment one.3. compare Group: comparative example one to four.Change the syringe needle of 1mL syringe into rubber tube, inject the above-mentioned of 50 μ l in heat Mus intravaginal Gel mixture, holds female Mus 2min.Every day intravaginal administration once, successive administration 16d.Last puts to death animal after being administered 24h, Cutting vagina, first perusal, with or without the exception such as hyperemia, redness, ulcer, then takes out vagina tissue, by it closely, in, distal portion Do not fix with 10% formaldehyde, embedding, section, carry out histopathological examination.By the congestion of blood vessel of vaginal mucosal tissue generation, glue Film water is swollen, leukocyte infiltration, the scoring in various degree of 4 kinds of pathological changes of epithelium ulcer, each is with 1~4 member records, totally 16 points, total score Value represents that less than 4 points stimulation is the least, and 5~8 points represent slight and stimulate, and 9~12 points represent moderate stimulation, and 13~16 points represent tight Remise sharp.
From pathological section, Golden Hamster vagina epithelium is made up of mucous layer, muscle layer, adventitia three layers, mucous layer again by Epithelial layer and lamina propria are constituted.Epithelial layer is that stratified squamous epithelium is constituted, and lamina propria is connective tissue, containing a large amount of blood capillaries And lymphatic vessel.Muscle layer is made up of smooth muscle, vertical two-layer outside point internal ring.External mold is also made up of connective tissue, rich in elastic fiber and Smooth muscle.Muscle layer and the adventitia no abnormality seen of each group change, and mucous layer has slight variations.Mucosa lamina propria seen from matched group little Congestion of blood vessel edema, tube wall has cell infiltration, has inflammatory exudate in epithelial layer.Generally acknowledge by World Health Organization (WHO) Eckstcin standards of grading, each component value see table:
Group Congested Edema 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
Experiment results proved, the overall score of the embodiment of the present invention one is minimum, the least to the zest of vagina, is substantially less than Comparative example and mechanical stimulus group.

Claims (10)

1. an aloe antibiotic gel, it is characterised in that be made up of following component by weight: hypromellose 0.2- 10%, propylene glycol 1-10%, chlorhexidine acetate 0.1%-3%, hyaluronic acid 0.01-1%, Aloe extraction solution 1-10%, Herba Saussureae Involueratae Extract 0.5-5%, Radix Arnebiae extract 0.5-5%, remaining is water;Wherein hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract exist The most liposome embedded or capsule of nano parcel before mixing.
Aloe antibiotic gel the most according to claim 1, it is characterised in that be made up of following component by weight: hydroxyl Third methylcellulose 0.2-8%, propylene glycol 1-8%, chlorhexidine acetate 0.1%-1%, hyaluronic acid 0.01-0.5%, Aloe is extracted Liquid 1-8%, Herba Saussureae Involueratae extract 0.5-2%, Radix Arnebiae extract 0.5-2%, remaining is water;Wherein hyaluronic acid, Aloe extraction solution, Herba Saussureae Involueratae extract, Radix Arnebiae extract are the most liposome embedded or capsule of nano wraps up.
Aloe antibiotic gel the most according to claim 1, it is characterised in that the PH of described aloe antibiotic gel is 4-5, PH Regulator is sodium dihydrogen phosphate.
Aloe antibiotic gel the most according to claim 1, it is characterised in that described Aloe extraction solution is by following methods system : by Fresh leaf of aloe clean, peeling, sterilizing, put into biomixer making beating, add in mass ratio 1-5% pectase and The vitamin C of 0.3-0.5%, reacts 30 minutes in 35-45 DEG C of water bath with thermostatic control, adds activated carbon, and frozen centrifugation obtains after filtering To supernatant liquid be described Aloe extraction solution.
Aloe antibiotic gel the most according to claim 1, it is characterised in that described Herba Saussureae Involueratae extract is by following methods system : after taking Herba Saussureae Involueratae plant making beating filtration sterilization, being passed through liquid carbon dioxide and carry out supercritical extraction in filtrate, extraction time is 5-10h, extraction temperature is 40-50 DEG C, and extracting pressure is 15-25MPa.
Aloe antibiotic gel the most according to claim 1, it is characterised in that described Radix Arnebiae extract is by following methods system : after taking paniculatum plants making beating filtration sterilization, being passed through liquid carbon dioxide and carry out supercritical extraction in filtrate, extraction time is 5-10h, extraction temperature is 30-40 DEG C, and extracting pressure is 15-25MPa.
7. the preparation method of the aloe antibiotic gel as described in any one of claim 1-5, it is characterised in that include following step Rapid:
1) by hyaluronic acid, Herba Saussureae Involueratae extract, Radix Arnebiae extract the most individually with liposome embedded or capsule of nano parcel;
2) each component is weighed by formula;
3) liposome embedded or the hyaluronic acid of capsule of nano parcel, Herba Saussureae Involueratae extract, Radix Arnebiae extract are dissolved in water;
4) Aloe extraction solution, propylene glycol, chlorhexidine acetate, stirring and dissolving are added;
5) add hypromellose, be placed in constant temperature 30min in 55-65 DEG C of water-bath, with the PH of sodium dihydrogen phosphate regulation gel extremely 4-5, vacuum outgas, sterilizing, obtain described aloe antibiotic gel.
The preparation method of aloe antibiotic gel the most according to claim 6, it is characterised in that described step 5) sterilization be Cellulose ester membrane filtration sterilization.
The preparation method of plants antimicrobial gel combination the most according to claim 6, it is characterised in that described cellulose ester membrane Aperture is 0.2-0.5 micron.
The preparation method of plants antimicrobial gel combination the most according to claim 6, it is characterised in that described cellulose ester membrane Aperture be 0.22 micron.
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