CN106798783A - Gynaecology's multifunctional contraceptive gel - Google Patents
Gynaecology's multifunctional contraceptive gel Download PDFInfo
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- 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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/346—Platycodon
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- A61K36/07—Basidiomycota, e.g. Cryptococcus
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- 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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/288—Taraxacum (dandelion)
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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)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/808—Scrophularia (figwort)
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- A—HUMAN NECESSITIES
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- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- 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
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- 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
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- 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
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- 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
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract
The present invention relates to gynaecology's multifunctional contraceptive gel, mainly solve the problems, such as that the active ingredient benzalkonium bromide in traditional conception control gel in the prior art has toxic and side effect, the present invention is by using gynaecology's multifunctional contraceptive gel, in parts by weight, including 15~25 parts of Chinese medical extract, medical science is subjected to 700~1300 parts of auxiliary material；The Chinese medical extract includes extract I and extract II；The extract I includes Radix Platycodonis extract；The extract II includes at least one in Radix Scrophulariae extract and dandelion extract；The acceptable auxiliary material of the medical science includes gelatinizing agent 5~10, and the gelatinizing agent includes the technical scheme of Carbomer, preferably solves the technical problem.
Description
Technical field
The present invention relates to gynaecology's multifunctional contraceptive gel, more particularly to having concurrently makes mankind spermatozoon lose mobility (referred to as
Inactivation) effect and the gynaecology's multifunctional contraceptive gel with gynaecology's antiphlogistic effects.
Background technology
The nineties in 20th century, researcher has invented a kind of new contraceptive by years of researches, is claimed by people
Be " liquid sheath ", also someone be referred to as " stealthy sheath ", its essence is a kind of bio-adhesive sustained release conception control gel, letter
Referred to as " conception control gel ", this gel surface sees with contraceptive jelly do not have much difference, and outward appearance is semi liquid state shape, than jelly somewhat
More sticky, laying method is similar to, but the inert base of conception control gel is different from jelly, and its inert base is gel, without
It is jelly.Gel is a kind of new bionic technology preparation, is put into vagina, can be spread out in vagina immediately,
With vaginal mucosa close adhesion, layer protecting film is formed, the composition that can efficiently suppress motility of sperm is mounted in the gel
On.Therefore, visually be referred to as conception control gel " liquid sheath " or " stealthy sheath " by people.
The A of CN 101889974 disclose a kind of with gynaecology's conception control gel that benzalkonium bromide is mainly contraception composition, but we
Know that benzalkonium bromide is a kind of cationic surfactant of chemical synthesis, as cationic surfactant benzalkonium bromide not
When intake human body, it may occur that the symptom such as gastrointestinal irritation, dysphoria, myasthenia, cyanosis, spasm, severe patient can be because of respiratory paralysis
And it is dead.Further relate in the report for causing allergic conjunctivitis, hypopsia and contact dermatitis etc..
In addition, healthy reproduction has turned into the core of human development.Reproductive system is descent of man, and especially women undertakes
Human survival produces offspring most important reproductive function, so there is special health risk.There is document report (CN
103341106 A) in ripe married femle, 87.5% female friend is suffering from different degrees of RTI, thus
Trigger various health problems and social concern.To mitigate or curing women's genital tract infection, people have carried out various general knowledge.
CN103110572A discloses the anti-inflammatory gel using chitosan iodine as major antibacterial composition.But iodine is acted on as sterilization component
The tender and lovely epithelial of people has certain stimulation.
The content of the invention
One of the technical problem to be solved in the present invention is to provide a kind of new gynaecology's multifunctional contraceptive gel, and it can not only
Overcoming the active ingredient benzalkonium bromide in traditional conception control gel in the prior art has the defect of toxic and side effect, while contraception
Have the effectiveness of gynaecology's anti-inflammatory concurrently and overcome the side effect of iodine.
The second technical problem to be solved by the present invention is that the corresponding gynaecology's multifunctional contraceptive of one of above mentioned problem coagulates
The preparation method of glue.
To solve one of above-mentioned technical problem, technical scheme is as follows：
Gynaecology's multifunctional contraceptive gel, in parts by weight, including 15~25 parts of Chinese medical extract, medical science is subjected to auxiliary material
700~1300 parts；The Chinese medical extract includes extract I and extract II；The extract I includes Radix Platycodonis extract；Institute
Stating extract II includes at least one in Radix Scrophulariae extract and dandelion extract；The acceptable auxiliary material of the medical science includes plastic
Agent 5~10, the gelatinizing agent includes Carbomer.
Carbomer is the high molecular polymer of acrylic acid and allyl sucrose crosslinking, to reach the formulation requirement of gel, this
Art personnel can the suitable model of reasonable selection, such as but not limited to Carbomer include be selected from carbomer 934, Carbomer
At least one in 934P, Acritamer 940 and Carbopol 941.For ease of counting on year-on-year basis, specific embodiment of the invention part is adopted
Use Acritamer 940.
In above-mentioned technical proposal, the extract I in terms of extract bulk drug medicine materical crude slice weight:Extract II be chosen as (1~
1.5)：(0.05~0.5).
In above-mentioned technical proposal, in parts by weight, the acceptable auxiliary material of the medical science preferably includes 1~3 part of NMF, for example
But it is not limited to 1.5 parts, 2 parts, 2.5 parts etc..
In above-mentioned technical proposal, in parts by weight, the acceptable auxiliary material of the medical science preferably includes 800~1200 parts of water, example
Such as, but not limited to, 850 parts, 900 parts, 950 parts, 1000 parts, 1050 parts, 1100 parts, 1150 parts etc..
In above-mentioned technical proposal, described NMF preferably include selected from glycerine, xylitol, the alkali metal salt of lactic acid,
At least one in the triethanolamine salt of lactic acid and aloe.
In above-mentioned technical proposal, the Chinese medical extract can use ethanol water to be obtained for Extraction solvent is extracted.
In above-mentioned technical proposal, the Chinese medical extract more preferably use carbon dioxide for extractant in the supercritical state
Extraction is obtained.
In above-mentioned technical proposal, the pressure extracted under supercriticality is preferably 8~36MPa.
In above-mentioned technical proposal, the temperature extracted under supercriticality is preferably 35~80 DEG C.
In above-mentioned technical proposal, extract I further preferably includes ginseng extract, and ginseng extract and Radix Platycodonis extract are in suppression
Sperm motility aspect processed has synergy.
In above-mentioned technical proposal, as preferred the first technical scheme, while including Radix Platycodonis extract, ginseng extract
And Radix Scrophulariae extract, now ginseng extract and Radix Scrophulariae extract have synergy in terms of motility of sperm is suppressed.With
Extract bulk drug medicine materical crude slice weight meter more preferably ginseng extract is 0.05~0.5 with Radix Platycodonis extract, such as but not limited to
0.05、0.06、0.07、0.08、0.09、0.1、0.11、0.12、0.13、0.14、0.15、0.2、0.25、0.3、0.35、0.4、
0.45、0.5；The ratio between Radix Scrophulariae extract and Radix Platycodonis extract are 0.05~0.5, such as but not limited to 0.05,0.06,0.07,
0.08th, 0.09,0.1,0.11,0.12,0.13,0.14,0.15,0.2,0.25,0.3,0.35,0.4,0.45,0.5 etc..
In above-mentioned technical proposal, as preferred second technical scheme, while including Radix Platycodonis extract, ginseng extract
And dandelion extract, now there is collaboration to make in terms of motility of sperm is suppressed for ginseng extract and dandelion extract
With.It is 0.05~0.5 to count more preferably ginseng extract and Radix Platycodonis extract with extract bulk drug medicine materical crude slice weight, for example but is not limited
In 0.05,0.06,0.07,0.08,0.09,0.1,0.11,0.12,0.13,0.14,0.15,0.2,0.25,0.3,0.35,
0.4th, 0.45,0.5 etc.；The ratio between dandelion extract and Radix Platycodonis extract be 0.05~0.5, such as but not limited to 0.05,
0.06、0.07、0.08、0.09、0.1、0.11、0.12、0.13、0.14、0.15、0.2、0.25、0.3、0.35、0.4、0.45、
0.5 etc..
In above-mentioned technical proposal, as preferred the third technical scheme, while being extracted including Radix Platycodonis extract, ginseng
Thing, Radix Scrophulariae extract and dandelion extract, now between ginseng extract, Radix Scrophulariae extract and dandelion extract three
Suppressing motility of sperm aspect has ternary facilitation effect.The more preferably ginseng extract in terms of extract bulk drug medicine materical crude slice weight
With Radix Platycodonis extract be 0.05~0.5, such as but not limited to 0.05,0.06,0.07,0.08,0.09,0.1,0.11,0.12,
0.13rd, 0.14,0.15,0.2,0.25,0.3,0.35,0.4,0.45,0.5 etc.；The ratio between Radix Scrophulariae extract and Radix Platycodonis extract
Be 0.05~0.5, such as but not limited to 0.05,0.06,0.07,0.08,0.09,0.1,0.11,0.12,0.13,0.14,
0.15th, 0.2,0.25,0.3,0.35,0.4,0.45,0.5 etc.；The ratio between dandelion extract and Radix Platycodonis extract for 0.05~
0.5, such as but not limited to 0.05,0.06,0.07,0.08,0.09,0.1,0.11,0.12,0.13,0.14,0.15,0.2,
0.25th, 0.3,0.35,0.4,0.45,0.5 etc..
In above-mentioned technical proposal, as the most preferred technical scheme, when include Radix Platycodonis extract, ginseng extract, spirit
Sesame extract, Radix Scrophulariae extract and dandelion extract, reach best in terms of now suppressing motility of sperm.It is former with extract
Material medicine medicine materical crude slice weight meter more preferably ginseng extract and Radix Platycodonis extract are 0.05~0.5, such as but not limited to 0.05,0.06,
0.07th, 0.08,0.09,0.1,0.11,0.12,0.13,0.14,0.15,0.2,0.25,0.3,0.35,0.4,0.45,0.5 etc.
Deng；The ratio between Ganodenna Lucidum P.E and Radix Platycodonis extract are 0.05~0.5, such as but not limited to 0.05,0.06,0.07,0.08,
0.09th, 0.1,0.11,0.12,0.13,0.14,0.15,0.2,0.25,0.3,0.35,0.4,0.45,0.5 etc.；Dandelion carries
Take the ratio between thing and Radix Platycodonis extract for 0.05~0.5, such as but not limited to 0.05,0.06,0.07,0.08,0.09,0.1,
0.11st, 0.12,0.13,0.14,0.15,0.2,0.25,0.3,0.35,0.4,0.45,0.5 etc..
In above-mentioned technical proposal, alkali metal salt described in the NMF is sodium salt and/or sylvite.
In above-mentioned technical proposal, the Chinese medical extract can use ethanol water to be obtained for Extraction solvent is extracted.
In above-mentioned technical proposal, the concentration of alcohol of ethanol water is preferably 55~75% in terms of weight concentration, for example but
It is not limited to 55%, 60%, 65%, 70%, 75%.The specific embodiment of the invention uses 65% for the sake of on year-on-year basis.
In above-mentioned technical proposal, used as non-restrictive, the method extracted using ethanol water can be, but not limited to
Comprise the following steps：
(1) extract two to four times successively:
Extract first：
The Chinese medicine material medicine medicine materical crude slice is taken, is soaked 0.5~2 hour with 6~15 times of ethanol water of the Chinese medicine weight,
0.5~2h of backflow, filters to obtain filtrate and first filter residue first；
Extract for second：
Filter residue first is taken, is soaked 0.5~2 hour with the ethanol water equivalent to 6~15 times of the Chinese medicine weight, backflow
0.5~2h, filters to obtain second filtrate and second filter residue；
Third time is extracted：
Second filter residue is taken, is soaked 0.5~2 hour with the ethanol water equivalent to 6~15 times of the Chinese medicine weight, returned
0.5~2h of stream, filters to obtain third time filtrate and third time filter residue；
4th extraction：
Third time filter residue is taken, is soaked 0.5~2 hour with the ethanol water equivalent to 6~15 times of the Chinese medicine weight, returned
0.5~2h of stream, filters to obtain the 4th filtrate and the 4th filter residue；
(2) above-mentioned filtrate is concentrated.
It is optional including drying after the concentration of step (2) in above-mentioned technical proposal.
In above-mentioned technical proposal, those skilled in the art are it is understood that in order to reach the purpose of the present invention, the Chinese medicine is carried
The pure working substance form that have to be not necessarily dried after step (2) in thing preparation process and even dried to constant weight is taken, to contain
The concentrate fluid form of the solid, paste or high concentration of certain moisture content can also, as long as substance content is suitable, namely button
Except water impurity in extract, extra amount of water in corresponding adjustment formula, whole water content are aequum in maintaining formula, and being also can
With.
In above-mentioned technical proposal, each filtrate in step (1) is merged into mixing filtrate the step of carry out step (2) again,
Or each filtrate carries out step (2) and then the dried object of each filtrate is mixed respectively, can reach the object of the invention.
Said extracted method can respectively carry out step (1) and operate with single kind of bulk drug medicine materical crude slice, it is also possible to by above-mentioned gel
In all Chinese medical extracts bulk drug medicine materical crude slice mixing after carry out step (1) operation.
In above-mentioned technical proposal, each filtrate that can be obtained step (1) individually carries out step (2), now preferably will
Used after each time the dried object of filtrate is well mixed；Each filtrate that step (1) can also be obtained is walked after merging
Suddenly (2).
In order to operation is easy, promotion is soaked together using all bulk drug medicine materical crude slice mixture ethanol waters, also, respectively
Secondary filtrate carries out step (2) after merging.
In above-mentioned technical proposal, preferably dried after step (2) concentration.
Used as non limiting example, the use ethanol water of the Chinese medical extract used in conception control gel of the present invention is proposed
More preparation can be：
By the raw material prepared slices of Chinese crude drugs mixture in the gel of above-mentioned technical proposal, obtain each extraction through step (1) and obtain
Filtrate, each filtrate is merged, it is the 30~35% of former merging filtrate to concentrate filtrate to volumes at 40~60 DEG C, is subsequently placed in
Original volume 20~25% is concentrated on 80~99 DEG C of water-baths, in 40~80 DEG C, gauge pressure is dry for -0.07~-0.09MPa vacuum
It is dry, crush.
It is to use carbon dioxide to be extracted in the supercritical state for extractant to extract better method compared with ethanol water
Arrive.The Chinese medical extract for obtaining is extracted using CO 2 supercritical to be used to prepare conception control gel of the invention, relatively uses ethanol
The Chinese medical extract that extraction with aqueous solution is obtained has the effect for preferably suppressing motility of sperm.
Those skilled in the art know how the concrete technology for selecting super CO 2 supercritical to extract, such as between being
Skill of knocking off or continuous processing.It is also known that how to select specific process parameter, the pressure of carbon dioxide supercritical extraction is for example but not
It is limited to 8~36MPa (non limiting example such as 10MPa, 15MPa, 20MPa, 30MPa, etc. in the range of this)；Carbon dioxide surpasses
The temperature of critical extraction be such as, but not limited to 35~80 DEG C (such as 40 DEG C of non limiting example in the range of this, 45 DEG C, 50 DEG C, 55
DEG C, 60 DEG C, 65 DEG C, 70 DEG C, 75 DEG C, etc.)；For making supercritical carbon dioxide flow in series through Chinese herb medicine materical crude slice fixed bed
The continuous extraction fixed-bed process of layer, the mass space velocity non limiting example of supercritical carbon dioxide is 0.1~30hr-1, herein
In the range of non limiting example be 0.5hr-1、1hr-1、1.5hr-1、2hr-1、2.5hr-1、3hr-1、3.5hr-1、4hr-1、4.5hr-1、5hr-1、5.5hr-1、6hr-1、6.5hr-1、7hr-1、7.5hr-1、8hr-1、8.5hr-1、9hr-1、9.5hr-1、10hr-1、15hr-1、20hr-1、25hr-1, etc.；The time non-limiting scope that Chinese herb medicine materical crude slice is continuously extracted is 1~10 hour,
In the range of this non-limiting further citing be 1.5 hours, 2.0 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, it is 4.5 small
When, 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours, 8.5 hours, 9 hours and 9.5 hours etc..
One skilled in the art will appreciate that the CO 2 fluid containing Chinese medical extract is in separation circuit after extraction process
Carbon dioxide is gone out by decompression separation and to can be used to preparing present invention contraception solidifying as the thick Chinese medical extract of condensed phase
The raw material of the Chinese medical extract of glue, but also available taking a step forward dry, pulverize, and sieve.Those skilled in the art are to dry work
Skill condition with reasonable selection, but can advise that dry condition is that gauge pressure is dry for -0.07~-0.09MPa vacuum in 40~80 DEG C
It is dry.
When Chinese medical extract preparation is carried out using CO 2 supercritical technology, each Chinese medicine can be selected individually to carry
Take, part Chinese traditional medicine composition is extracted, and is used in mixed way in required ratio after obtaining extract, it is also possible to by required whole medicine materical crude slice needed for
Mix after ratio mixing and extract, can reach comparable technique effect.Carried to prepare Chinese medicine on year-on-year basis, in embodiment of the present invention
When taking thing, extracted together after the required prepared slices of Chinese crude drugs are mixed in required ratio.
If the extract obtained using commercially available approach, also can be directly used for the compounding of inventive gel, simply conventional water,
The extract effect that ethanol or ethanol water are obtained is poor, but still can obtain comparable contraceptive effect.
No matter extracted using above-mentioned ethanol water or extracted using CO 2 supercritical technology, Chinese medicine during solid-state
Extract can exclusively carry out crushing and grinding mode can be using those commonly used in the art, and such as dry pulverization process or wet type are ground
Milling is broken can.Even by concentration, dry, powder processed can also in the spray drying of one.Granular size after crushing does not have
It is better that the thinner effect of particle of especially limitation, but extract is played.The standard screen of such as but not limited to described extract powder
Mesh number is 80~800 mesh, used as the mesh of non limiting example 100,120 mesh, 180 mesh, 200 mesh, 300 mesh, 400 mesh, 500 mesh, 600
Mesh, 700 mesh etc..Being made extract nano particle using nanometer technology of the prior art is used effect more preferable.In order to
On year-on-year basis, specific embodiment of the invention part is the powder by 100 mesh sieves.
For ease of on year-on-year basis, in specific embodiment, aloe is also using the powder by 100 mesh sieves
In above-mentioned technical proposal, the title of all Chinese medicines comes from《Pharmacopoeia of People's Republic of China》The rule of (version in 2015)
It is fixed.
In above-mentioned technical proposal, balloonflower root is Campanulaceae balloonflower root (latin name Platycodon grandiflorus
(Jacq.) A.DC.) the medicine materical crude slice that is made of dry root.
In above-mentioned technical proposal, ginseng used is Araliaceae ginseng (latin name Panax ginseng C.A.Mey.)
Dry root and the medicine materical crude slice that is made of rhizome.
In above-mentioned technical proposal, ganoderma lucidum is On Polyporaceae red sesame (the entitled Ganoderma lucidum of Latin
(Leyss.ex Fr.) Karst.) or purple sesame (entitled Ganoderma sinense Zhao, the Xu et Zhang of Latin) drying
The medicine materical crude slice that fructification is made.The ganoderma lucidum in two kinds of sources can reach the purpose of the present invention, but red sesame effect is better than purple sesame.Only for
On year-on-year basis, ganoderma lucidum described in specific embodiment of the invention part uses red sesame, is not intended to the present invention and purple sesame forecloses.
In above-mentioned technical proposal, radix scrophulariae used is goatweed radix scrophulariae (latin name Scrophularia
Ningpoensis Hemsl) the medicine materical crude slice that is made of dry root.
In above-mentioned technical proposal, dandelion is feverfew dandelion (the entitled Taraxacum mongolicum of Latin
Hand.-Mazz.), alkali ground dandelion (the entitled Taraxacum borealisinense Kitam. of Latin) or sibling species plant
Dry herb.For ease of on year-on-year basis, specific embodiment of the invention part uses feverfew dandelion.
In above-mentioned technical proposal, aloe is preferably liliaceous plant aloe barbadensis Miller described in Chinese Pharmacopoeia version in 2015
The JUICE CONCENTRATION drying shrinkage thing of (the entitled Aloe barbadensis Miller of Latin) leaf, field of medicaments is practised and is referred to as " old aloe ".
A kind of network structure is disclosed based on gynaecology's multifunctional contraceptive gel inventor of the present invention and intercepts sperm technology.This hair
The Carbomer of bright use forms space framework in gel of the present invention, forms dense space with molecular separating force in the present invention
Network structure, straight 10% size through being sperm head of maximum of net assembling structure, passes by sperm tail, and head cannot pass by,
Destroy the motoricity of sperm.
To solve the two of above-mentioned technical problem, technical scheme is as follows：
The preparation method of the gynaecology's multifunctional contraceptive gel described in the technical scheme of one of above-mentioned technical problem is without special
Limitation, is in any order well mixed each composition.
But dispersed gel is obtained, it is higher using following steps production efficiency：
The preparation method of gynaecology's multifunctional contraceptive gel any one of the technical scheme of one of above-mentioned technical problem, bag
Include following steps：
1) the glue liquid of gelatinizing agent and NMF is obtained；
2) by the Chinese medical extract and step 1) the glue liquid is well mixed；
3) pH is adjusted for 6~8 obtain gynaecology's multifunctional contraceptive gel.
In above-mentioned technical proposal, step 1) can carry out at normal temperatures, but preferably, in order to quickly obtain step 1)
In gel aqueous fluid step 1) can also heat and carry out, the temperature of heating can be selected from 50~90 DEG C, more specifically non-limiting
For example there are 55 DEG C, 60 DEG C, 65 DEG C, 70 DEG C, 75 DEG C, 80 DEG C, 85 DEG C etc..
In above-mentioned technical proposal, step 2) the temperature of mixing be not particularly limited, such as but not limited to 20~90 DEG C, make
For more specifically such as 25 DEG C of non limiting example, 30 DEG C, 35 DEG C, 40 DEG C, 45 DEG C, 50 DEG C, 55 DEG C, 60 DEG C, 65 DEG C, 70 DEG C,
75 DEG C, 80 DEG C, 85 DEG C etc..
Carbomer is a kind of highly hydrophilic anionic polymer, can be rapid swelling but insoluble in water.It is in water
In it is swelling after glue liquid it is acid relatively strong (such as 1% glue liquid pH is about 2.5~3.5), now viscosity is relatively low.When with alkali
And when, as Carbomer dissolving trend increases, clear solution is formed in low concentration, form translucent when concentration is larger
Gel, at pH=6~8, further there are the viscosity and denseness of maximum in pH=6.5~7, therefore the stronger glue liquid of acidity is used
Alkali is neutralized to pH=6~8, and preferably (such as but not limited to pH is 6.5,6.6,6.7,6.8,6.9,7.0 etc. for pH=6.5~7
Deng)) when, that is, generate the gel of transparent and stable.
In above-mentioned technical proposal, step 3) for adjusting the pH adjusting agent of pH it is medically acceptable alkali, for example but not
It is limited to potassium hydroxide, NaOH, triethanolamine etc..To count on year-on-year basis, specific embodiment of the invention part uses three second
Hydramine is used as step 3) pH adjusting agent.
To solve the three of above-mentioned technical problem, technical scheme is as follows：
Gynaecology's multifunctional contraceptive gel any one of the technical scheme of one of above-mentioned technical proposal is preparing contraception
Application in medicine and/or anti-inflammatory drug.
Contraceptive effect evaluation reference world health group in the specific embodiment of gynaecology's multifunctional contraceptive gel of the present invention
The Sander-Crameer methods for knitting (WHO) recommendation are carried out, specific as follows：
1st, laboratory apparatus
Inverted microscope (Japanese OLYMPUS productions, with thermostatic insulation device, 37 ± 0.1 DEG C of temperature control), water bath with thermostatic control
Case, 37 ± 0.1 DEG C of constant temperature, for preserving semen sample and conception control gel sample.
2nd, semen sample
25~35 years old healthy male person of participating in the experiment 40 is chosen, ascetic 5 days, masturbation method extracting extract is in the 25ml of clean sterilizing
In small beaker, liquefy 30min at 37 ± 0.1 DEG C, and the person's of the participating in the experiment seminal fluid that will meet following condition is well mixed as semen sample：
PH7.0~8.0, sperm motility 70~90%, energy a+b grades 50~80%, Jing Mi Du≤60 × 106/ ml, deformity essence
Sub- rate ﹤ 20%.
3rd, conception control gel sample
0.50g inventive gels are taken, conception control gel sample is dissolved to obtain with physiological saline 1000ml.
4th, external sperm deactivation experiment
Conception control gel sample 0.5ml is added in 0.5ml semen samples, mixing must mix observation liquid rapidly, starts meter
When, 1 is taken rapidly drips on slide, observe sperm motility situation, Continuous Observation 10 with inverted microscope (37 ± 0.1 DEG C of constant temperature)
Individual high power field, the mobility moment as timing end point is all lost using sperm, is experienced to timing end point from beginning timing
Time, sperm deactivation time was shorter as sperm deactivation time, and the contraceptive effect of conception control gel is better, and vice versa.
Conception control gel of the invention has preferable external sperm inactivation efficiency, achieves preferable technique effect.
With specific embodiment, the present invention will be described in detail below.
Specific embodiment
【Comparative example 1】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 1:0:0:0 meter, take Chinese medicine material medicine medicine materical crude slice (for ease of than
Compared with, and the composition of bulk drug medicine materical crude slice is listed in table 1) and as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight space velocity
5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted obtains condensation product,
In 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Comparative example 2】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 0:1:0:0 meter, take Chinese medicine material medicine medicine materical crude slice (for ease of than
Compared with, and the composition of bulk drug medicine materical crude slice is listed in table 1) and as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight space velocity
5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted obtains condensation product,
In 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Comparative example 3】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 0:0:1:0 meter, take Chinese medicine material medicine medicine materical crude slice (for ease of than
Compared with, and the composition of bulk drug medicine materical crude slice is listed in table 1) and as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight space velocity
5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted obtains condensation product,
In 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Comparative example 4】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 0:0:0:1 meter, take Chinese medicine material medicine medicine materical crude slice (for ease of than
Compared with, and the composition of bulk drug medicine materical crude slice is listed in table 1) and as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight space velocity
5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted obtains condensation product,
In 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Embodiment 1】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 1:0:0:0.3 meter, take Chinese medicine material medicine medicine materical crude slice (for ease of
Compare, and the composition of bulk drug medicine materical crude slice be listed in table 1) as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight space velocity
5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted obtains condensation product,
In 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Embodiment 2】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 1:0:0.3:0 meter, take Chinese medicine material medicine medicine materical crude slice (for ease of
Compare, and the composition of bulk drug medicine materical crude slice be listed in table 1) as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight space velocity
5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted obtains condensation product,
In 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Comparative example 5】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 1:0.3:0:0 meter, take Chinese medicine material medicine medicine materical crude slice (for ease of
Compare, and the composition of bulk drug medicine materical crude slice be listed in table 1) as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight space velocity
5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted obtains condensation product,
In 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Embodiment 3】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 1:0.2:0.1:0 meter, takes Chinese medicine material medicine medicine materical crude slice (for just
In comparing, and the composition of bulk drug medicine materical crude slice is listed in table 1) as fixed bed, it is empty in 15MPa, 45 DEG C and carbon dioxide weight
Fast 5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted must condense
Thing, in 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery traditional Chinese medicine extraction
Thing.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Embodiment 4】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 1:0.2:0:0.1 meter, takes Chinese medicine material medicine medicine materical crude slice (for just
In comparing, and the composition of bulk drug medicine materical crude slice is listed in table 1) as fixed bed, it is empty in 15MPa, 45 DEG C and carbon dioxide weight
Fast 5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted must condense
Thing, in 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery traditional Chinese medicine extraction
Thing.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Embodiment 5】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Radix scrophulariae:The weight ratio of dandelion is 1:0.1:0.1:0.1 meter, taking Chinese medicine material medicine medicine materical crude slice (is
It is easy to compare, and the composition of bulk drug medicine materical crude slice is listed in table 1) as fixed bed, in 15MPa, 45 DEG C and carbon dioxide weight
Air speed 5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separating carbon dioxide from effluent is extracted must condense
Thing, in 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery traditional Chinese medicine extraction
Thing.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
【Embodiment 6】
1st, prepared by Chinese medical extract
By balloonflower root:Ginseng:Ganoderma lucidum:Radix scrophulariae:The weight ratio of dandelion is 1:0.1:0.1:0.1:0.1 meter, takes Chinese medicine material
Medicine medicine materical crude slice (for ease of comparing, and the composition of bulk drug medicine materical crude slice being listed in table 1) as fixed bed, 15MPa, 45 DEG C and two
Carbonoxide weight space velocity 5hr-1Under conditions of, carry out CO 2 supercritical and extract 5 hours, separate dioxy from effluent is extracted
Change carbon and obtain condensation product, in 60 DEG C, gauge pressure is vacuum dried condensation product for -0.08MPa, to constant weight, was ground into 100 mesh sieves and obtains powdery
Chinese medical extract.
2nd, prepared by conception control gel
(1) by 8 parts of Acritamer 940s and 2 parts of aloes 1000 parts of water of addition, under stirring, 70 DEG C of solution are dissolved to obtain at 70 DEG C
I；
(2) 20 parts of powdery Chinese medical extracts are added into solution I, it is well mixed at 70 DEG C, obtain mixtures II；
(3) under stirring, pH is adjusted to 6.8 with triethanolamine, obtain the conception control gel.
3rd, the conception control gel test of pesticide effectiveness
The sperm Inactivation Effect of conception control gel is listed in table 1.
Inventor has found that the radix scrophulariae and/or dandelion extract as anti-inflammatory component are preventing and treating the micro- life of vagina detrimental
While thing, there is synergy to suppressing sperm motility, this can also can intuitively find out from the data on year-on-year basis of table 1.
In addition, from the sperm Inactivation Effect data of table 1 can also be seen that gynaecology's multifunctional contraceptive gel of the invention in institute
State Chinese medicine abstract and contain Radix Platycodonis extract, ginseng extract, Ganodenna Lucidum P.E, Radix Scrophulariae extract, dandelion extract simultaneously
When, reached in terms of suppressing motility of sperm best.
Table 1
Claims (10)
1. gynaecology's multifunctional contraceptive gel, in parts by weight, including 15~25 parts of Chinese medical extract, medical science is subjected to auxiliary material 700
~1300 parts；The Chinese medical extract includes extract I and extract II；The extract I includes Radix Platycodonis extract；It is described to carry
Taking thing II includes at least one in Radix Scrophulariae extract and dandelion extract；The acceptable auxiliary material of the medical science includes gelatinizing agent 5
~10, the gelatinizing agent includes Carbomer.
2. gynaecology's multifunctional contraceptive gel according to claim 1, it is characterized in that, Carbomer include selected from carbomer 934,
At least one in carbomer940, Acritamer 940 and Carbopol 941.
3. gynaecology's multifunctional contraceptive gel according to claim 1, it is characterized in that, in parts by weight, the medical science can connect
Included 1~3 part of NMF by auxiliary material.
4. gynaecology's multifunctional contraceptive gel according to claim 1, it is characterized in that, in parts by weight, the medical science can connect
Included 800~1200 parts of water by auxiliary material.
5. gynaecology's multifunctional contraceptive gel according to claim 3, it is characterized in that described NMF is included selected from the third three
At least one in alcohol, xylitol, the alkali metal salt of lactic acid, the triethanolamine salt and aloe of lactic acid.
6. gynaecology's multifunctional contraceptive gel according to claim 1, it is characterized in that the Chinese medical extract uses titanium dioxide
Carbon is obtained for extractant is extracted in the supercritical state.
7. gynaecology's multifunctional contraceptive gel according to claim 6, it is characterized in that the pressure for extracting is 8~36MPa.
8. gynaecology's multifunctional contraceptive gel according to claim 6, it is characterized in that the temperature extracted is 35~80 DEG C.
9. the preparation method of gynaecology's multifunctional contraceptive gel any one of claim 1~8, comprises the following steps：1) obtain
Obtain the glue liquid of gelatinizing agent and NMF；
2) by the Chinese medical extract and step 1) the glue liquid is well mixed；
3) pH is adjusted for 6~8 obtain gynaecology's multifunctional contraceptive gel.
10. application of the gel described in any one of claim 1~8 in contraceptive and/or anti-inflammatory drug is prepared.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109431975A (en) * | 2018-12-12 | 2019-03-08 | 上海美哈医药科技有限公司 | A kind of smart fiber gel and preparation method thereof of practising contraception of resistance |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265830A (en) * | 2016-08-31 | 2017-01-04 | 郭东军 | Conception control gel |
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2017
- 2017-03-18 CN CN201710162497.0A patent/CN106798783A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265830A (en) * | 2016-08-31 | 2017-01-04 | 郭东军 | Conception control gel |
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| LUBNA H. TAHTAMOUNI等: "Dandelion (Taraxacum officinale) decreases male rat fertility in vivo", 《JOURNAL OF ETHNOPHARMACOLOGY》 * |
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| CN109431975A (en) * | 2018-12-12 | 2019-03-08 | 上海美哈医药科技有限公司 | A kind of smart fiber gel and preparation method thereof of practising contraception of resistance |
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