CN104547303A - Externally used gel for treating gynecological inflammation and preparation method thereof - Google Patents
Externally used gel for treating gynecological inflammation and preparation method thereof Download PDFInfo
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- 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
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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)
- A61K36/19—Acanthaceae (Acanthus family)
- A61K36/195—Strobilanthes
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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)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
- A61K36/315—Isatis, e.g. Dyer's woad
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
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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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
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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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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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)
- A61K36/78—Saururaceae (Lizard's-tail family)
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- 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)
- A61K36/85—Verbenaceae (Verbena family)
- A61K36/855—Clerodendrum, e.g. glorybower
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/86—Violaceae (Violet family)
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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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
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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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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- 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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention belongs to the field of gynecological inflammation treating preparations and particularly relates to an externally used gel for treating gynecological inflammation and a preparation method thereof. The externally used gel is mainly prepared from the following raw materials in percentage by weight: 20-60% of a clear paste, 1-15% of a gel substrate, 0-5% of a permeation enhancer, 0-30% of a stabilizer, 0-3% of a preservative, 0-10% of a humectant and the balance of water, wherein the clear paste is prepared by processing the following medicinal raw materials: ash barks, heartleaf houttuynia herb, light yellow sophora roots, hairyvein agrimony, indigowoad leaves and viola philippica. Because the externally used gel is prepared from specific raw materials, the effective components of the product are enhanced greatly, the preparation cycle of the product is shortened, and the quality of the product is improved. The externally used gel has good adhesion and film-forming properties, and the gel can not cause the foreign body sensation in the vagina, can not damage the vagina and can not pollute clothes after being applied. The externally used gel is used externally and locally, and the medicines in the gel can take effect on the diseased part synergistically and directly so as to achieve a very good efficacy of treating woman vaginitis.
Description
Technical field
The present invention relates to gynecological inflammation formulation art, in particular to a kind of exterior-applied gel for the treatment of gynecological inflammation and preparation method thereof.
Background technology
The commonly encountered diseases that vaginitis (non-specific, mycotic, trichomonal vaginitis) is gynecological.Wherein common gynaecopathia mainly contains trichomonal vaginitis, bacterial vaginitis, monilial vaginitis, and they have following common disorders: leucorrhoea grow in quantity, pruritus vulvae, scorching hot, menoxenia, dysmenorrhea, amenorrhea etc.Clinical take profuse leukorrhea as cardinal symptom.Spring, Xia Erji fall ill more.Due to the effect of inflammation, often occur sagging distention in the smaller abdomen pain, the puckery pain of oliguria, leukorrhagia is sticky is unfavorable for passing of sperm, often causes woman infertility again, has a strong impact on the physical and mental health of women.The control of this kind of disease has caused the great attention of academia.The medicines such as current doctor trained in Western medicine many employings antibiotics carry out whole body or topical therapeutic, and its curative effect is affirmative.But because it is chemical synthetic drug, there are certain toxic and side effects and untoward reaction.If improper use, can dysbacteriosis be made, form Resistant strain, cause the touching difficulty of the state of an illness more; And the sterilization component of most of chemical drugs has serious stimulation to skin.
Chinese medicine leukorrheal diseases (vaginitis) have accumulated the clinical experience compared with horn of plenty, and documents and materials are also appeared in the newspapers repeatly.The form of Chinese drug of current treatment colpitis mainly contains suppository, tablet and lotion, and suppository and tablet use inconvenient, easily cause intravaginal to have foreign body sensation, and easy damaged vagina, play drug effect relatively slow, and suppository becomes liquid outflow after dissolving, pollution clothes simultaneously; Lotion more easily flows out vagina, pollution clothes, and such action time is short, and medicine is difficult to whole release.
Application number is 201210581283.4 disclose a kind of gynaecological gel and extracting method thereof, this gynaecological gel, be by each Chinese herb through appropriate distilled water immersion, fried, filter, obtained gel.But the coating of this gel is not so good, adhesive force is short of, and the holdup time is short, and absorbability is not good.
In view of this, special proposition the present invention.
Summary of the invention
The first object of the present invention is to provide a kind of exterior-applied gel for the treatment of gynecological inflammation, homogeneous exquisiteness, easily coating after launching, tack is strong, and the holdup time is long, without greasy feeling, easy cleaning, be easy to absorption, not pollution clothes, good stability, compare with other commercially available prod and have significant advantage, the gel toxic and side effects made is little, short treating period, cure rate is high, can also avoid the untoward reaction that applied chemistry medicine produces.
The second object of the present invention is the preparation method of the exterior-applied gel providing a kind of described treatment gynecological inflammation, the method is simple, the exterior-applied gel of " killing parasites for relieving itching " of long, easy to use, the not easily leakage of, safety non-toxic obtained non-stimulated in conjunction with the characteristic of theory of Chinese medical science, time of contact, determined curative effect.
In order to realize above-mentioned purpose of the present invention, spy by the following technical solutions:
A kind of exterior-applied gel for the treatment of gynecological inflammation, be prepared from primarily of following raw material, by weight percentage, clear paste 20% ~ 60%, gel-type vehicle 1% ~ 15%, penetration enhancer 0% ~ 5%, stabilizing agent 0% ~ 30%, antiseptic 0% ~ 3%, wetting agent 0% ~ 10%, surplus is water;
Described clear paste is processed by the crude drug of following weight portion and is prepared from:
Cortex Fraxini 1 ~ 5 part, Herba Houttuyniae 0.5 ~ 3 part, Radix Sophorae Flavescentis 0.3 ~ 3 part, Herba Agrimoniae 0.3 ~ 3 part, Folium Isatidis 0.3 ~ 3 part, Herba Violae 0.5 ~ 4 part.
The present invention is directed to the deficiencies in the prior art, the exterior-applied gel of the treatment gynecological inflammation provided is that a class contains two or more, by solid-liquid two phase composition, the macromolecular network system with semi-solid property, coordinated between each raw material, the exterior-applied gel obtained has good adhesiveness and film forming characteristics, can tight adhesion long-time with site of action, and there is good biocompatibility.In addition, the present invention, by selecting specific raw material, substantially increases the effective ingredient of product, shortens the fabrication cycle of product, improves the quality of product; Further, surprised discovery, the pH value of the exterior-applied gel finally obtained closer to vagina environment, and smears the sense of rear intravaginal foreign, can not damage vagina, not easily pollution clothes.Local topical, all medicines share affected part of can going directly and play a role, and thus reach effect of extraordinary treatment female vagina.
In addition, component of the present invention adopts the raw material of Chinese medicine of pure natural, and its preparation is easy, medicine source is wide, cost is low, use safety, has no side effect.
Exterior-applied gel provided by the invention, in clear paste, effect of contained main flavour of a drug is:
Radix Sophorae Flavescentis: heat clearing and damp drying, killing parasites for relieving itching, diuresis.For hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, pudendal pruritus leukorrhagia, Jie tinea leprosy, has inhibitory action to various skin fungus, has killing action to trichomonas vaginitis.
Cortex Fraxini: be the bark of Oleaceae plants fraxinus rhynchophylla Hance, Fraxinus bungeana or Qinling Mountains Chinese ash.Nature and flavor are bitter, cold, return Liver Channel, gallbladder meridian.Function heat clearing and damp drying, antiasthmatic-antitussive, improving eyesight.Treatment bacillary dysentery, enteritis, leucorrhea, leukorrhagia pudendal pruritus, conjunctival congestion and swelling pain etc.
Herba Houttuyniae: acrid in the mouth, cold, return lung meridian.Heat-clearing and toxic substances removing, detumescence can treat skin ulcer, promoting urination to remove dampness, clearing away heat to cure dysentery, invigorating the stomach and promoting digestion, by the lung abscess, sore swollen toxin, hemorrhoidal hemorrhage, retention of heat in the spleen and stomach etc. of controlling excess-heat, pyretic toxicity, damp, disease heat are trouble.Modern pharmacology experiment shows, this product has the effect such as antibacterial, antiviral, raising immunity of organisms, diuresis.
Herba Agrimoniae: astringing to arrest bleeding, preventing the attack (or recurrence) of malaria, dysentery relieving, removing toxic substances.For hemoptysis, spit blood, control epistaxis and have specially good effect, malaria, de-power impairment caused by overstrain, carbuncle.
Folium Isatidis: heat-clearing and toxic substances removing, blood cooling and ecchymoses removing.For the high hot excessive thirst of calentura; Coma; Macule; Spit blood; Epistaxis; Jaundice; Dysentery; Erysipelas; Sore throat; Aphtha; Mumps.
Herba Violae: taste bitter, acrid, cold.GUIXIN, lung meridian.Have heat-clearing and toxic substances removing, removing heat from blood is subsided a swelling, and the effect of clearing away heat-damp and promoting diuresis, cures mainly furuncle, carbuncle, scrofula, jaundice, dysentery, diarrhoea, conjunctival congestion, sore throat, venom.
In order to increase the chemiluminescence between each raw material, the exterior-applied gel obtained reaches better effect, as homogeneous exquisiteness, easily coating after launching, tack is strong, holdup time is long, without greasy feeling, easy cleaning, be easy to absorption, not pollution clothes, good stability etc., preferably, by weight percentage, clear paste 20% ~ 60%, gel-type vehicle 1% ~ 15%, penetration enhancer 0.5% ~ 5%, stabilizing agent 0.5% ~ 15%, antiseptic 0.2% ~ 3%, wetting agent 0.5% ~ 10%, surplus is water.
More preferably, by weight percentage, clear paste 30% ~ 50%, gel-type vehicle 5% ~ 10%, penetration enhancer 1% ~ 4%, stabilizing agent 1% ~ 10%, antiseptic 0.5% ~ 1.5%, wetting agent 1% ~ 8%, surplus is water.
Particularly, described gel-type vehicle is one or more in gelatin, agar, sodium alginate, xanthan gum, Resina persicae, carbomer, carboxyethyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone.The gel-type vehicle of these kinds can form the macromolecular network system of better semi-solid property, make each stock dispersion wherein, the homogeneous exquisiteness of the exterior-applied gel obtained, easily coating after launching, tack is strong, holdup time is long, without greasy feeling, easy cleaning, is easy to absorption, not pollution clothes, good stability.
Wherein, in certain embodiments, gel-type vehicle is any one in gelatin, agar, sodium alginate, xanthan gum, Resina persicae, carbomer, carboxyethyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone; In certain embodiments, gel-type vehicle is wantonly two kinds in gelatin, agar, sodium alginate, xanthan gum, Resina persicae, carbomer, carboxyethyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone; In certain embodiments, gel-type vehicle is more than three kinds in gelatin, agar, sodium alginate, xanthan gum, Resina persicae, carbomer, carboxyethyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone; Etc..
More preferably, described gel-type vehicle is one or more in carboxymethyl cellulose, sodium carboxymethyl cellulose, methylcellulose.More preferably, described gel-type vehicle is sodium carboxymethyl cellulose.
Preferably, described penetration enhancer is one or more in natural Broneolum Syntheticum, Mentholum, azone, dimethyl sulfoxide, ethanol, propylene glycol.This several penetrating agent not only has the better compatibility with other raw materials, and the exterior-applied gel obtained is easy to after smearing absorb.
More preferably, described penetration enhancer is any one or two kinds of in natural Broneolum Syntheticum, propylene glycol.
Preferably, described stabilizing agent is one or more in tween 80, propylene glycol, ethanol, carbomer, hydroxypropyl emthylcellulose, polyoxyethylene sorbitan monoleate.These stabilizing agents not only have the better compatibility with other raw materials, and mix the more homogeneous of rear each stock dispersion with other raw materials, and the exterior-applied gel performance obtained is more stable.
More preferably, described stabilizing agent is one or more in polyoxyethylene sorbitan monoleate, propylene glycol, hydroxypropyl emthylcellulose.
Preferably, described wetting agent is one or more in glycerol, propylene glycol, vitamin C, vitamin e, sorbitol, nature moisturizing factor.Empirical tests, these wetting agents not only have the better compatibility with other raw materials, and the exterior-applied gel obtained forms thin film at the skin surface smeared, and make the effective active composition of exterior-applied gel constantly immerse affected part, action time is effective lastingly.
In order to postpone the corruption that growth of microorganism or chemical change cause, do not affect other performances of this exterior-applied gel, preferably, described antiseptic is one or more in sodium benzoate, parabens and salt thereof, phenethanol, sorbic acid or its salt.Wherein, the salt of parabens is its sodium salt, potassium salt etc.; Sorbate can be potassium sorbate, sodium sorbate etc.
In order to increase the chemiluminescence of effective active composition in clear paste, to reach better therapeutic effect, preferably, described clear paste is processed by the crude drug of following weight parts and is prepared from:
Cortex Fraxini 3 parts, Herba Houttuyniae 2 parts, Radix Sophorae Flavescentis 1.5 parts, Herba Agrimoniae 1.5 parts, Folium Isatidis 1.5 parts, Herba Violae 2.5 parts.
Preferably, described clear paste is prepared by following methods:
Get described crude drug, decoct with water 2 ~ 3 times, each amount of water is 8 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters;
Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.10 ~ 1.15 (60 DEG C), adds ethanol and makes the volumn concentration of ethanol reach 75% ~ 80%, and after stirring, precipitate with ethanol leaves standstill;
Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 ~ 1.25 (60 DEG C), obtains described clear paste.
Not only effective active composition is high for the clear paste that the method obtains, and safety, non-stimulated to human body.
Present invention also offers the preparation method of exterior-applied gel, comprise the following steps:
Get stabilizing agent, mix with described clear paste after thin up, obtain the first mixture;
Described wetting agent, antiseptic, gel-type vehicle and water are mixed, and fully swelling, obtain the second mixture;
By the first mixture, the second mixture and described penetration enhancer mix homogeneously, to obtain final product.
The preparation method of exterior-applied gel provided by the invention, the method is simple, obtained exterior-applied gel active constituent content is high, each material composition dispersion is homogeneous, homogeneous exquisiteness, easily coating after launching, tack is strong, holdup time is long, without greasy feeling, easy cleaning, be easy to absorb, not pollution clothes, good stability, overcome the conventional Chinese medicine lotion holdup time short, easy outflow, the shortcoming of poor stability, it compares with commercially available prod significant advantage, the gel toxic and side effects made is little, short treating period, cure rate is high, the untoward reaction that applied chemistry medicine produces can also be avoided.
Compared with prior art, beneficial effect of the present invention is:
(1) exterior-applied gel for the treatment of gynecological inflammation provided by the invention, dosage form is novel, both the shortcoming of conventional dosage forms had been overcome, while antiinflammatory sterilization, there is good intermiscibility, strong adhesion, foreign sense, to reach better heat clearing and damp drying, parasite killing, effect except leukorrhagia stopping of itching, clinical practice vaginitis;
(2) the present invention is using the raw material of Chinese medicine of pure natural as main active, and its preparation is easy, medicine source is wide, cost is low, safe without toxic side effect; By selecting specific each raw material, substantially increasing the effective ingredient of product, shortening the fabrication cycle of product, improve the quality of product;
(3) exterior-applied gel provided by the invention, each raw material cooperatively interacts, the pH value of obtained exterior-applied gel is closer to vagina environment, and smear the sense of rear intravaginal foreign, vagina can not be damaged, not easily pollution clothes, local topical, all medicines share affected part of can going directly and play a role, and thus reach effect of extraordinary treatment female vagina;
(4) preparation method of exterior-applied gel provided by the invention, the method is simple, obtained exterior-applied gel active constituent content is high, each material composition dispersion is homogeneous, homogeneous exquisiteness, easily coating after launching, tack is strong, holdup time is long, without greasy feeling, easy cleaning, be easy to absorb, not pollution clothes, good stability, overcome the conventional Chinese medicine lotion holdup time short, easy outflow, the shortcoming of poor stability, it compares with commercially available prod significant advantage, the gel toxic and side effects made is little, short treating period, cure rate is high, the untoward reaction that applied chemistry medicine produces can also be avoided.
Detailed description of the invention
Below in conjunction with embodiment, embodiment of the present invention are described in detail, but it will be understood to those of skill in the art that the following example only for illustration of the present invention, and should not be considered as limiting the scope of the invention.Unreceipted actual conditions person in embodiment, the condition of conveniently conditioned disjunction manufacturer suggestion is carried out.Agents useful for same or the unreceipted production firm person of instrument, being can by the conventional products of commercially available acquisition.
Embodiment 1
Get following raw material: by weight, Cortex Fraxini 5 parts, Herba Houttuyniae 3 parts, Radix Sophorae Flavescentis 2 parts, Herba Agrimoniae 2 parts, Folium Isatidis 2 parts, Herba Violae 3 parts;
The Six-elements such as Cortex Fraxini are decocted with water extraction three times, each amount of water is 8 times, and each decocting time is 1.5 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.15 (60 DEG C), and add ethanol and make to reach 75% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.25 (60 DEG C), obtains clear paste, for subsequent use;
Borneolum Syntheticum powder is broken into impalpable powder, for subsequent use;
Get polyoxyethylene sorbitan monoleate, ethanol, mix with described clear paste after thin up, obtain the first mixture;
Propylene glycol, sodium carboxymethyl cellulose are added in the water of 6 times amount, stirs, put heating and thermal insulation in water-bath and stir 30 minutes, fully swelling, obtain the second mixture;
By the first mixture, the second mixture and Borneolum Syntheticum fine powder, stir, cooling, in separating device vaginal administration device, obtains exterior-applied gel;
Wherein, by weight percentage, clear paste 50%, gel-type vehicle 1%, penetration enhancer 0.5%, stabilizing agent 0.5%, wetting agent 8%, surplus is water.
Embodiment 2
Get following raw material: by weight, Cortex Fraxini 3 parts, Herba Houttuyniae 2 parts, Radix Sophorae Flavescentis 1.5 parts, Herba Agrimoniae 1.5 parts, Folium Isatidis 1.5 parts, Herba Violae 2.5 parts;
The Six-elements such as Cortex Fraxini are decocted with water extraction three times, each amount of water is respectively 10,10,8 times, and each decocting time is respectively 2,1.5,1 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.10 (60 DEG C), and add ethanol and make to reach 80% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 (60 DEG C), obtains clear paste, for subsequent use;
Sodium carboxymethyl cellulose, methylcellulose, carboxyethyl cellulose are mixed with suitable quantity of water, stirs, put heating and thermal insulation in water-bath and stir 30 minutes, fully swelling, obtain the second mixture;
Clear paste and the second mixture are stirred, cooling, in separating device vaginal administration device, obtains exterior-applied gel;
Wherein, by weight percentage, clear paste 60%, gel-type vehicle 10%, surplus is water.
Embodiment 3
Get following raw material: by weight, Cortex Fraxini 3 parts, Herba Houttuyniae 2 parts, Radix Sophorae Flavescentis 1.5 parts, Herba Agrimoniae 1.5 parts, Folium Isatidis 1.5 parts, Herba Violae 2.5 parts;
The Six-elements such as Cortex Fraxini are decocted with water extraction three times, each amount of water is respectively 10,10,8 times, and each decocting time is respectively 2,1.5,1 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.10 (60 DEG C), and add ethanol and make to reach 80% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 (60 DEG C), obtains clear paste, for subsequent use;
Borneolum Syntheticum powder is broken into impalpable powder, for subsequent use;
Get tween 80, hydroxypropyl emthylcellulose and ethanol, mix with described clear paste after thin up, obtain the first mixture;
Vitamin e, sorbitol, sodium alginate, xanthan gum are mixed with suitable quantity of water, stirs, put heating and thermal insulation in water-bath and stir 40 minutes, fully swelling, obtain the second mixture;
By the first mixture, the second mixture and Borneolum Syntheticum fine powder, stir, cooling, in separating device vaginal administration device, obtains exterior-applied gel;
Wherein, by weight percentage, clear paste 40%, gel-type vehicle 5%, penetration enhancer 1%, stabilizing agent 5%, wetting agent 10%, surplus is water.
Embodiment 4
Get following raw material: by weight, Cortex Fraxini 3 parts, Herba Houttuyniae 2 parts, Radix Sophorae Flavescentis 1.5 parts, Herba Agrimoniae 1.5 parts, Folium Isatidis 1.5 parts, Herba Violae 2.5 parts;
The Six-elements such as Cortex Fraxini are decocted with water extraction three times, each amount of water is respectively 10,10,8 times, and each decocting time is respectively 2,1.5,1 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.10 (60 DEG C), and add ethanol and make to reach 80% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 (60 DEG C), obtains clear paste, for subsequent use;
Get polyoxyethylene sorbitan monoleate, mix with described clear paste after thin up, obtain the first mixture;
Propylene glycol, vitamin e, sorbitol, sodium carboxymethyl cellulose are mixed with water, stirs, put heating and thermal insulation in water-bath and stir 30 minutes, fully swelling, obtain the second mixture;
By the first mixture, the second mixture and dimethyl sulfoxide, stir, cooling, in separating device vaginal administration device, obtains exterior-applied gel;
Wherein, by weight percentage, clear paste 30%, gel-type vehicle 10%, penetration enhancer 5%, stabilizing agent 10%, wetting agent 1%, surplus is water.
Embodiment 5
Get following raw material: by weight, Cortex Fraxini 3 parts, Herba Houttuyniae 0.5 part, Radix Sophorae Flavescentis 0.3 part, Herba Agrimoniae 3 parts, Folium Isatidis 0.3 part, Herba Violae 4 parts;
The Six-elements such as Cortex Fraxini are decocted with water extraction 2 times, each amount of water is 10 times, and each decocting time is respectively 2 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.15 (60 DEG C), and add ethanol and make to reach 78% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 (60 DEG C), obtains clear paste, for subsequent use;
Get carbomer, hydroxypropyl emthylcellulose, mix with described clear paste after thin up, obtain the first mixture;
Vitamin C, nature moisturizing factor, gelatin, agar, sodium benzoate are mixed with suitable quantity of water, stirs, put heating and thermal insulation in water-bath and stir 30 minutes, fully swelling, obtain the second mixture;
First mixture, the second mixture, Mentholum and azone are mixed, stir, cooling, in separating device vaginal administration device, obtains exterior-applied gel;
Wherein, by weight percentage, clear paste 20%, gel-type vehicle 15%, penetration enhancer 4%, stabilizing agent 15%, wetting agent 5%, antiseptic 1.5%, surplus is water.
Embodiment 6
Get following raw material: by weight, Cortex Fraxini 1 part, Herba Houttuyniae 2 parts, Radix Sophorae Flavescentis 3 parts, Herba Agrimoniae 3 parts, Folium Isatidis 3 parts, Herba Violae 0.5 part;
The Six-elements such as Cortex Fraxini are decocted with water extraction three times, each amount of water is 8 times, and each decocting time is respectively 2,1,1 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.15 (60 DEG C), and add ethanol and make to reach 75% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.25 (60 DEG C), obtains clear paste, for subsequent use;
Get tween 80, mix with described clear paste after thin up, obtain the first mixture;
Vitamin e, methylcellulose, potassium sorbate and suitable quantity of water are mixed, puts heating and thermal insulation in water-bath and stir 30 minutes, fully swelling, obtain the second mixture;
By the first mixture, the second mixture and dimethyl sulfoxide, stir, cooling, in separating device vaginal administration device, obtains exterior-applied gel;
Wherein, by weight percentage, clear paste 40%, stabilizing agent 2%, gel-type vehicle 10%, penetration enhancer 5%, wetting agent 8%, antiseptic 3%, surplus is water.
Embodiment 7
Get following raw material: by weight, Cortex Fraxini 1 part, Herba Houttuyniae 2 parts, Radix Sophorae Flavescentis 3 parts, Herba Agrimoniae 3 parts, Folium Isatidis 3 parts, Herba Violae 0.5 part;
The Six-elements such as Cortex Fraxini are decocted with water extraction three times, each amount of water is 8 times, and each decocting time is respectively 2,1,1 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.15 (60 DEG C), and add ethanol and make to reach 75% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.25 (60 DEG C), obtains clear paste, for subsequent use;
Borneolum Syntheticum powder is broken into impalpable powder, for subsequent use;
Get tween 80, propylene glycol, ethanol, carbomer, hydroxypropyl emthylcellulose, add suitable quantity of water dilution after and clear paste mix, obtain the first mixture;
Nature moisturizing factor, sodium alginate, xanthan gum, Resina persicae, carbomer, phenethanol and excess water are mixed, puts heating and thermal insulation in water-bath and stir 30 minutes, fully swelling, obtain the second mixture;
By the first mixture, the second mixture and Borneolum Syntheticum fine powder, stir, cooling, in separating device vaginal administration device, to obtain final product;
Wherein, by weight percentage, clear paste 20%, stabilizing agent 30%, gel-type vehicle 15%, penetration enhancer 1%, wetting agent 0.5%, antiseptic 0.5%, surplus is water;
Adopt special container to inject intravaginal, retain more than 20 minutes.Every night once, within 7 days, be a course for the treatment of.
Embodiment 8
Get following raw material: by weight, Cortex Fraxini 2 parts, Herba Houttuyniae 1 part, Radix Sophorae Flavescentis 1 part, Herba Agrimoniae 1.5 parts, Folium Isatidis 1.2 parts, Herba Violae 1 part;
The Six-elements such as Cortex Fraxini are decocted with water extraction three times, each amount of water is 8 times, and each decocting time is respectively 2,1,1 hours, and extracting solution merges, and filters; Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.15 (60 DEG C), and add ethanol and make to reach 75% containing alcohol content, after stirring, precipitate with ethanol leaves standstill; Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.25 (60 DEG C), obtains clear paste, for subsequent use;
Borneolum Syntheticum powder is broken into impalpable powder, for subsequent use;
Resina persicae, sodium carboxymethyl cellulose, phenethanol, sodium sorbate and water are mixed, adds and put heating and thermal insulation in water-bath and stir 30 minutes, fully swelling, obtain the second mixture;
By clear paste, the second mixture and Borneolum Syntheticum fine powder, stir, cooling, in separating device vaginal administration device, to obtain final product;
Wherein, by weight percentage, clear paste 30%, gel-type vehicle 5%, penetration enhancer 2%, antiseptic 1.5%, surplus is water;
Adopt special container to inject intravaginal, retain more than 20 minutes.Every night once, within 7 days, be a course for the treatment of.
Experimental example 1
Vaginal irritation effects is tested
Exterior-applied gel any one of embodiment 1-8 obtained detects according to " GLP " the i.e. requirement of GLP of State Food and Drug Administration's JIUYUE in 2003 execution on the 1st.Be specially and follow State Food and Drug Administration's " Chemical induced irritation, anaphylaxis and hemolytic investigative technique guideline " 2005 execution.
Detect and find, the external-use gel that embodiment 1-8 obtains all shows no skin irritation the 1st day and the 7th day irritation test result, shows that exterior-applied gel provided by the invention has higher safety.
Experimental example 2
The exterior-applied gel that embodiment 1-8 is obtained is respectively used to clinical verification, is specially: select 360 vaginitis patients at random, be divided into 12 groups, wherein, 1-8 group smears the obtained exterior-applied gel of embodiment 1-8, and 9-12 group is matched group, wherein, the obtained clear paste of embodiment 2 is smeared for 9 groups; Smear the obtained clear paste of embodiment 4 for 10 groups; Smear the obtained clear paste of embodiment 5 for 11 groups; Smear the obtained clear paste of embodiment 8 for 11 groups.All medicines all adopt special container to inject intravaginal, and retaining more than 20 minutes, every night once, 7 days is a course for the treatment of.After using 3 courses for the treatment of, statistics effect.Wherein, cure as transference cure; Effectively for symptom is clearly better; Invalid is that symptom is without significant change.The result obtained is as shown in table 1.
The therapeutic effect of patient between the different group of table 1
| Group | Cure | Effectively | Invalid |
| Group 1 | 25 | 5 | 0 |
| Group 2 | 24 | 6 | 0 |
| Group 3 | 26 | 4 | 0 |
| Group 4 | 26 | 4 | 0 |
| Group 5 | 24 | 6 | 0 |
| Group 6 | 28 | 2 | 0 |
| Group 7 | 25 | 5 | 0 |
| Group 8 | 27 | 3 | 0 |
| Group 9 | 18 | 11 | 1 |
| Group 10 | 17 | 12 | 1 |
| Group 11 | 15 | 12 | 3 |
| Group 12 | 16 | 12 | 2 |
As can be seen from Table 1, the exterior-applied gel for the treatment of gynecological inflammation provided by the invention is remarkable to vaginitis patient outcomes, and in use, exterior-applied gel provided by the invention has good adhesiveness and film forming characteristics, smear the sense of rear intravaginal foreign, can tight adhesion long-time with site of action, can not vagina be damaged, not easily pollution clothes; And matched group uses with clear paste direct injection, poor adhesion, smearing rear intravaginal has foreign body sensation, uncomfortable, easily slides out, pollution clothes, and assimilation effect is poor, and therapeutic effect is poor.
Typical clinical case
1, poplar, 35 years old, leucorrhoea grow in quantity, often with bean curd slag specimen foreign body, pudendum humidity, pruritus, scorching hot, to check in secretions a little containing infusorian, mycete III, is diagnosed as colpitis mycotica with trichomoniasis, after using 2 courses for the treatment of of medicine of the present invention, infusorian, mycete disappear, and pudendal pruritus, the transference cure such as scorching hot, do not recur so far.
2, Hu, 41 years old, vaginal secretions increased, and leucorrhea vicidity is dense, lark, and with abnormal flavour is pruritus vulvae, scorching hot, skin of vulva festers redness, with symptoms such as dysurea, urgent micturition, hematurias, on inspection in secretions containing infusorian, mycete III, anaerobic bacillus(cillus anaerobicus); Be diagnosed as the comprehensive vaginitis of trichomonas mycete, after using 3 courses for the treatment of of medicine of the present invention, vaginal secretions inspection is normal, and malaise symptoms disappears, and does not recur so far.
3, journey, 27 years old, profuse leukorrhea, yellow skin is as pus, and pudendum, vagina are very itched as worm climbs, companion's urine urgency-frequency dysurea, dry mouth with bitter taste, and vexed difficulty is slept, and yellow urine is short, red tongue, yellow and greasy fur, stringy and rolling pulse; Check pudendum, vagina flushing, secretions increase, yellow skin, band bad smell.Look into leucorrhea and have infusorian, examine as trichomonal vaginitis, after using 3 courses for the treatment of of this medicine, every inspection is normal, and malaise symptoms disappears, and does not recur so far.
Although illustrate and describe the present invention with specific embodiment, however it will be appreciated that can to make when not deviating from the spirit and scope of the present invention many other change and amendment.Therefore, this means to comprise all such changes and modifications belonged in the scope of the invention in the following claims.
Claims (10)
1. treat the exterior-applied gel of gynecological inflammation for one kind, it is characterized in that, be prepared from primarily of following raw material, by weight percentage, clear paste 20% ~ 60%, gel-type vehicle 1% ~ 15%, penetration enhancer 0% ~ 5%, stabilizing agent 0% ~ 30%, antiseptic 0% ~ 3%, wetting agent 0% ~ 10%, surplus is water;
Described clear paste is processed by the crude drug of following weight portion and is prepared from:
Cortex Fraxini 1 ~ 5 part, Herba Houttuyniae 0.5 ~ 3 part, Radix Sophorae Flavescentis 0.3 ~ 3 part, Herba Agrimoniae 0.3 ~ 3 part, Folium Isatidis 0.3 ~ 3 part, Herba Violae 0.5 ~ 4 part.
2. exterior-applied gel according to claim 1, it is characterized in that, by weight percentage, clear paste 20% ~ 60%, gel-type vehicle 1% ~ 15%, penetration enhancer 0.5% ~ 5%, stabilizing agent 0.5% ~ 15%, antiseptic 0.2% ~ 3%, wetting agent 0.5% ~ 10%, surplus is water.
3. exterior-applied gel according to claim 1, it is characterized in that, by weight percentage, clear paste 30% ~ 50%, gel-type vehicle 5% ~ 10%, penetration enhancer 1% ~ 4%, stabilizing agent 1% ~ 10%, antiseptic 0.5% ~ 1.5%, wetting agent 1% ~ 8%, surplus is water.
4. the exterior-applied gel according to any one of claim 1-3, it is characterized in that, described gel-type vehicle is one or more in gelatin, agar, sodium alginate, xanthan gum, Resina persicae, carbomer, carboxyethyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, methylcellulose, polyvinylpyrrolidone.
5. the exterior-applied gel according to any one of claim 1-3, is characterized in that, described penetration enhancer is one or more in natural Broneolum Syntheticum, Mentholum, azone, dimethyl sulfoxide, ethanol, propylene glycol.
6. the exterior-applied gel according to any one of claim 1-3, is characterized in that, described stabilizing agent is one or more in tween 80, propylene glycol, ethanol, carbomer, hydroxypropyl emthylcellulose, polyoxyethylene sorbitan monoleate.
7. the exterior-applied gel according to any one of claim 1-3, is characterized in that, described wetting agent is one or more in glycerol, propylene glycol, vitamin C, vitamin e, sorbitol, nature moisturizing factor;
Described antiseptic be preferably in sodium benzoate, parabens and salt thereof, phenethanol, sorbic acid or its salt one or more.
8. exterior-applied gel according to claim 1, is characterized in that, described clear paste is processed by the crude drug of following weight parts and is prepared from:
Cortex Fraxini 3 parts, Herba Houttuyniae 2 parts, Radix Sophorae Flavescentis 1.5 parts, Herba Agrimoniae 1.5 parts, Folium Isatidis 1.5 parts, Herba Violae 2.5 parts.
9. exterior-applied gel according to claim 1, is characterized in that, described clear paste is prepared by following methods:
Get described crude drug, decoct with water 2 ~ 3 times, each amount of water is 8 ~ 10 times of described crude drug weight, and decocting time is 1 ~ 2 hour, filters;
Merging filtrate, leave standstill, getting supernatant concentration to relative density is 1.10 ~ 1.15 (60 DEG C), adds ethanol and makes the volumn concentration of ethanol reach 75% ~ 80%, and after stirring, precipitate with ethanol leaves standstill;
Get supernatant and reclaim ethanol, and to be concentrated into relative density be 1.20 ~ 1.25 (60 DEG C), obtains described clear paste.
10. the preparation method of the exterior-applied gel described in any one of claim 1-9, is characterized in that, comprises the following steps:
Get stabilizing agent, mix with described clear paste after thin up, obtain the first mixture;
Described wetting agent, antiseptic, gel-type vehicle and water are mixed, and fully swelling, obtain the second mixture;
By the first mixture, the second mixture and described penetration enhancer mix homogeneously, to obtain final product.
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| CN105106461A (en) * | 2015-10-06 | 2015-12-02 | 青岛辰达生物科技有限公司 | Traditional Chinese medicine gel for treating accumulated toxin rotten fester type pressure sores |
| CN105535867A (en) * | 2016-02-15 | 2016-05-04 | 福建艾女人生物科技有限公司 | Antibacterial gel special for gynecology and preparation method thereof |
| CN109288890A (en) * | 2018-11-28 | 2019-02-01 | 四川月天抗菌制剂有限公司 | A kind of antibiotic preparation and preparation method thereof |
| CN113230205A (en) * | 2021-05-22 | 2021-08-10 | 绍兴鸿瑞生物科技有限公司 | Gynecological gel preparation and preparation method and application thereof |
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| CN1840129A (en) * | 2006-01-23 | 2006-10-04 | 北京因科瑞斯生物制品研究所 | Gel for treating gynecological disease and preparation method thereof |
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| CN105535867A (en) * | 2016-02-15 | 2016-05-04 | 福建艾女人生物科技有限公司 | Antibacterial gel special for gynecology and preparation method thereof |
| CN109288890A (en) * | 2018-11-28 | 2019-02-01 | 四川月天抗菌制剂有限公司 | A kind of antibiotic preparation and preparation method thereof |
| CN113230205A (en) * | 2021-05-22 | 2021-08-10 | 绍兴鸿瑞生物科技有限公司 | Gynecological gel preparation and preparation method and application thereof |
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Application publication date: 20150429 |