CN105535481A - Externally vagina applied compound traditional Chinese medicine gel and preparation method thereof - Google Patents

Externally vagina applied compound traditional Chinese medicine gel and preparation method thereof Download PDF

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CN105535481A
CN105535481A CN201511012861.2A CN201511012861A CN105535481A CN 105535481 A CN105535481 A CN 105535481A CN 201511012861 A CN201511012861 A CN 201511012861A CN 105535481 A CN105535481 A CN 105535481A
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parts
mixture
following material
radix
antiseptic
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蒲敬北
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Hubei Green Unbounded Biotechnology Co Ltd
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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Abstract

The invention provides externally vagina applied compound traditional Chinese medicine gel. The gel is prepared from the following components in parts by weight: 0.5-30 parts of bletilla striata, 0.5-30 parts of salviae miltiorrhizae, 0.5-30 parts of Chinese gall, 0.5-30 parts of rheum officinale, 0.5-30 parts of scutellaria baicalensis, 0.5-30 parts of cortex phellodendri, 0.5-30 parts of rhizoma atractylodis, 0.5-30 parts of radix sophorae flavescentis, 0.5-30 parts of coptis chinensis, 0.5-30 parts of gardenia yellow, 0.5-30 parts of fructus cnidii, 0.5-10 parts of semiaquilegia adoxoides, 0.5-10 parts of fructus evodiae, 0.2-1 part of fructus zanthoxyli, 0.5-30 parts of dandelion, 0.5-30 parts of Chinese violet, 0.5-30 parts of chrysanthemum indicum, 0.5-30 parts of lonicera japonica, 0.5-30 parts of agrimonia pilosa ledeb, 0.5-30 parts of cockscomb flower, 0.2-2 parts of sulfur powder, 6.3-20 parts of an emulsifier, 0.4-2 parts of a penetration enhancer, 0.3-4 parts of preservative, 2.1-5.5 parts of a thickening agent and 1.5-6 parts of pH regulator. The externally vagina applied compound traditional Chinese medicine gel preparation enables positive cervical HPV infection to become negative, and can be used for stopping development of cervical cancer and treating multiple acute and chronic cervicitis and vaginitis.

Description

A kind of vagina externally used compound Traditional Chinese medicine gel and preparation method thereof
Technical field
The present invention relates to and a kind ofly treat vagina Chinese medicine for outer use of multiple gynecological vaginal infection disease and preparation method thereof, particularly relate to a kind of vagina externally used compound Traditional Chinese medicinal gel preparation that cervical HPV infection sun is turned out cloudy and preparation method thereof.
Background technology
Woman uterus vaginal infection is that disease is often sent out by gynecological, and modern medicine many employings antibiotic or synthesis of chemicals are treated, and along with the extensive use of antibiotic and chemicals, its drug resistance and toxicity more and more show.The classical formula toxicity of ancient Chinese medicine is little, and the advantage not easily forming drug resistance is subject to the attention of the world of medicine again.
In recent years, the health and lives of global middle and aged women in the occurred frequently positive serious threat of cervical cancer, and cervical HPV infection is the evil arch-criminal causing cervical cancer, and cervical HPV infection incidence rate finds that there is now more than 20 and plants high-risk hypotype.Over one hundred kind low danger hypotype, only has and effectively removes HPV, could the efficient generation preventing cervical cancer.Modern medicine is vaccinate for the prevention of cervical HPV infection, but current limit four kinds, and expensive, the prevention phase is short, and need repeatedly inject, treatment means is injection of interferon, and its toxic and side effects is large, and the course for the treatment of is long, and cure rate is low, is difficult to promote.The means of Modern medical therapy cervix uteri CIN pathological changes are cervix uteri ring cutting (Leep), this surgical operation, and injury and sequela can hardly be avoided.Medical circle expects a kind of high curative effect, and AT medical science is born.
Summary of the invention
The technical problem to be solved in the present invention is: the defect overcoming existing woman uterus vaginal infection, treatment of human cervical cancer poisonous side effect of medicine is large, the course for the treatment of is long, cure rate is low, be difficult to popularization, there is provided a kind of alternative vagina externally used compound Traditional Chinese medicinal gel preparation to treat multiple cervicovaginitis, invention formulation can make cervical HPV infection sun turn out cloudy simultaneously, thus blocks generation and the progress of cervical cancer.
In order to solve the problems of the technologies described above, the present invention proposes following technical proposal: a kind of vagina externally used compound Traditional Chinese medicine gel, and it is made up of the following component according to weight parts:
Pseudobulbus Bletillae (Rhizoma Bletillae) 0.5-30 part, Radix Salviae Miltiorrhizae 0.5-30 part, Galla Chinensis 0.5-30 part, Radix Et Rhizoma Rhei 0.5-30 part, Radix Scutellariae 0.5-30 part, Cortex Phellodendri 0.5-30 part, Rhizoma Atractylodis 0.5-30 part, Radix Sophorae Flavescentis 0.5-30 part, Rhizoma Coptidis 0.5-30 part, Gardenia Yellow 0.5-30 part, Fructus Cnidii 0.5-30 part, Radix Semiaquilegiae 0.5-10 part, Fructus Evodiae 0.5-10 part, Pericarpium Zanthoxyli 0.2-1 part, Herba Taraxaci 0.5-30 part, Herba Violae grass 0.5-30 part, Flos Chrysanthemi Indici 0.5-30 part, Flos Lonicerae 0.5-30 part, Herba Agrimoniae 0.5-30 part, Flos Celosiae Cristatae 0.5-30 part, Cosan 0.2-2 part, emulsifying agent 6.3-20 part, penetration enhancer 0.4-2 part, antiseptic 0.3-4 part, thickening agent 2.1-5.5 part, PH regulator 1.5-6 part.
The further restriction of technique scheme is, described emulsifying agent is one or more mixture of following material: poloxamer, fatty alcohol-polyoxyethylene ether, Span series, TWEEN Series, fatty acid ester series, polyglyceryl fatty acid ester are serial;
Described penetration enhancer is one or more mixture of following material: Borneolum Syntheticum, Mentholum, azone, thiophene ketone or various short saturating aromatic oil;
Described antiseptic is one or more mixture of following material: thymol, Capmul MCM C8, dehydro sodium acetate, potassium sorbate, sodium benzoate, Nipagin ester, triclosan, triclocarban, chlorhexidine acetate, chlorhexidine gluconate, sodium diacetate;
Described thickening agent is one or more mixture of following material: sodium alginate, carbomer, xanthan gum, various natural polysaccharide and modification of polysaccharides, the various polymer of poloxamer;
Described PH regulator is one or more mixture of following material: sodium hydroxide, potassium hydroxide, acetic acid, sodium carbonate, potassium carbonate, triethanolamine, lactic acid, hydrochloric acid, citric acid.
The further restriction of technique scheme is, the preferred poloxamer of described emulsifying agent;
The preferred Borneolum Syntheticum of described penetration enhancer, Mentholum;
The preferred thymol of described antiseptic, Capmul MCM C8, dehydro sodium acetate;
The preferred sodium alginate of described thickening agent, carbomer;
The preferred sodium hydroxide of described PH regulator, potassium hydroxide, acetic acid.
In order to solve the problems of the technologies described above, the present invention proposes following technical proposal: a kind of manufacture method of vagina externally used compound Traditional Chinese medicine gel, comprises the following steps:
Step one, get Pseudobulbus Bletillae (Rhizoma Bletillae) 0.5-30 part, Radix Salviae Miltiorrhizae 0.5-30 part, Galla Chinensis 0.5-30 part, Radix Et Rhizoma Rhei 0.5-30 part, Radix Scutellariae 0.5-30 part, Cortex Phellodendri 0.5-30 part, Rhizoma Atractylodis 0.5-30 part, Radix Sophorae Flavescentis 0.5-30 part, Rhizoma Coptidis 0.5-30 part, Gardenia Yellow 0.5-30 part, Fructus Cnidii 0.5-30 part, Radix Semiaquilegiae 0.5-10 part, Fructus Evodiae 0.5-10 part, Pericarpium Zanthoxyli 0.2-1 part, and add emulsifying agent 0.3-5 part, said components is crushed to 10-1000 order, add boiled water, the weight of boiled water is about the 5-20 of above-mentioned gross weight doubly, dissolve in PH regulator 0.5-1.5 part, stir immersion 2 hours, again in stirring, 97-100 degree Celsius decoct 0.5-2 hour after, squeezing or centrifugal, all take decocting liquid, decocting liquid with in temperature (55-60 DEG C) vacuum method (-0.1MPa) evaporation be concentrated into and be about 60 parts of weight, discard medicinal residues, obtain concentrated solution,
Step 2, get Herba Taraxaci 0.5-30 part, Herba Violae grass 0.5-30 part, Flos Chrysanthemi Indici 0.5-30 part, Flos Lonicerae 0.5-30 part, Herba Agrimoniae 0.5-30 part, Flos Celosiae Cristatae 0.5-30 part, by said components coarse crushing 3-10 order, add boiled water, boiled water weight is that step 2 newly adds the 5-20 of the gross weight of component doubly, dissolve in PH regulator 0.5-1.5 part, soak 0.5-3 hour, in stirring, slow fire (98-100 DEG C) decocts 20-60 minute again, entirely get decocting liquid with in temperature (55-70 DEG C) vacuum (-0.1MPa) evaporation be concentrated into about 30 parts of weight, discard medicinal residues, obtain concentrated solution,
The concentrated solution that blend step one obtains and the concentrated solution that step 2 obtains, obtain mixed concentrated liquid;
Step 3, gets Cosan 0.2-2 part, penetration enhancer 0.4-2 part, emulsifying agent 2-5 part, above-mentioned three kinds of component wet grindings is become ultra-fine serosity, then admixes in the mixed concentrated liquid that step 2 obtains, obtains suspension;
Step 4, suspension step 3 obtained is warming up to 60-80 degree Celsius; 60-100 DEG C is heated to dissolve antiseptic 0.25-3 part with emulsifying agent 4-10 part, antiseptic course of dissolution needs Keep agitation more than 20 minutes, by the time solution completely as clear as crystal after again antiseptic solution is added the suspension after intensification, after stirring about 30 minutes, then dissolve in antiseptic 0.05-1 part; Obtain suspension;
Step 5, in the suspension that step 4 obtains, adds thickening agent 2.1-5.5 part powder of mix homogeneously, stirs, obtain gelinite;
Step 6, the pH value of the gelinite of determination step five, adds appropriate PH regulator 0.5-3 part and regulates PH to 4.0-4.8, weigh, and rear water feeding method or stirring evaporation regulate gross weight to be 100 parts.
Compared with prior art, the present invention has following beneficial effect:
One, the purposes ancient Chinese medicinal formulae SANHUANG Detoxication Decoction and wuwei xiaodu drink exploitation made new advances and usage." the SANHUANG Detoxication Decoction (Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Radix Et Rhizoma Rhei, Gardenia Yellow " and " wuwei xiaodu drink (Herba Taraxaci, Herba Violae, Flos Lonicerae, Flos Chrysanthemi Indici, Radix Semiaquilegiae) " of Chinese medicine is the classics recipe of heat-clearing and toxic substances removing.Often be used as " heat clearing away by old docter of TCM, pathogenic fire purging, removing toxic substances ", treatment laryngopharynx swelling and pain or " large hot delirium, send out speckle jaundice, tell nosebleed hematochezia " and " heat-clearing and toxic substances removing, dissipation furuncle carbuncle " use, modern medicine thinks that this two prescription all has the antiviral effect of broad-spectrum sterilization antiinflammatory, it is main that usage is drunk oral mainly with soup, occasionally stick with paste external curing sores ulceration of skin as washing liquid or cream, the present inventor thinks cervicovaginal disease, pathogeny mostly still is ' damp-heat vaginal discharge ", wet, heat or fire-toxin are for suffering from, therefore two prescriptions of heat-clearing and toxic substances removing can be worked in coordination with the nucleus used as vagina externally used antimicrobial antivirus gel preparation, coordinate Rhizoma Osmundae, Radix Sanguisorbae, Radix Sophorae Flavescentiss etc. drive damp and hot medicine, be used for the various vagina cervical infection of prevention and therapy, particularly be used as the nucleus of anti-cervical HPV infection formula.Through the clinical verification of inventor's more than two decades, this pharmaceutical formulation was through course for the treatment of of 7-14 days, all effective for multiple acute and chronic cervicovaginal inflammation (comprising trichomonal vaginitis, bacterial vaginitis, candidal vaginitis, chronic cervicitis etc.), effective percentage reaches 99%, and cure rate reaches 90%.Through the course for the treatment of of 3-6 month, cervical HPV negative conversion rate reached 80%, and through following up a case by regular visits to 1-2, HPV negative conversion rate does not change, and shows that its anti-HPV effect is affirmed lastingly.
Two, cold relieving is warmed up the Chinese Traditional Medicine composition Fructus Evodiae in palace, Pericarpium Zanthoxyli, integration be applied to external preparation, reach regulating menstruation by the approach of vagina administration, the special pharmacological effect of warm uterus, promoting blood circulation and stopping pain, killing parasites for relieving itching.
The composition three, Cosan, Herba Agrimoniae, Flos Celosiae Cristatae, thymol etc. with antibacterial protozoacide effect is applied to the effect reaching the various gynecological infection of prevention and therapy in vaginal jellies.Herba Agrimoniae, Flos Celosiae Cristatae are commonly used to treat various gynecological infection " panacea ", but be commonly used for decoct and take orally, and the present inventor is innovatively by its auxiliary element as vagina externally used antimicrobial protozoacide slow releasing agent, and effect is more better than taking orally, and side effect is less.
Detailed description of the invention
The present invention proposes a kind of vagina externally used compound Traditional Chinese medicine gel, and it is made up of the following component according to weight parts:
Pseudobulbus Bletillae (Rhizoma Bletillae) 0.5-30 part, Radix Salviae Miltiorrhizae 0.5-30 part, Galla Chinensis 0.5-30 part, Radix Et Rhizoma Rhei 0.5-30 part, Radix Scutellariae 0.5-30 part, Cortex Phellodendri 0.5-30 part, Rhizoma Atractylodis 0.5-30 part, Radix Sophorae Flavescentis 0.5-30 part, Rhizoma Coptidis 0.5-30 part, Gardenia Yellow 0.5-30 part, Fructus Cnidii 0.5-30 part, Radix Semiaquilegiae 0.5-10 part, Fructus Evodiae 0.5-10 part, Pericarpium Zanthoxyli 0.2-1 part, Herba Taraxaci 0.5-30 part, Herba Violae grass 0.5-30 part, Flos Chrysanthemi Indici 0.5-30 part, Flos Lonicerae 0.5-30 part, Herba Agrimoniae 0.5-30 part, Flos Celosiae Cristatae 0.5-30 part, Cosan 0.2-2 part, emulsifying agent 6.3-20 part, penetration enhancer 0.4-2 part, antiseptic 0.3-4 part, thickening agent 2.1-5.5 part, PH regulator 1.5-6 part.
Described emulsifying agent is one or more mixture of following material: poloxamer, fatty alcohol-polyoxyethylene ether, Span series, TWEEN Series, fatty acid ester series, polyglyceryl fatty acid ester are serial.
The preferred poloxamer of described emulsifying agent.
Described penetration enhancer is one or more mixture of following material: Borneolum Syntheticum, Mentholum, azone, thiophene ketone or various short saturating aromatic oil.
The preferred Borneolum Syntheticum of described penetration enhancer, Mentholum.
Described antiseptic is one or more mixture of following material: thymol, Capmul MCM C8, dehydro sodium acetate, potassium sorbate, sodium benzoate, Nipagin ester, triclosan, triclocarban, chlorhexidine acetate, chlorhexidine gluconate, sodium diacetate.
The preferred thymol of described antiseptic, Capmul MCM C8, dehydro sodium acetate.
Described thickening agent is one or more mixture of following material: sodium alginate, carbomer, xanthan gum, various natural polysaccharide and modification of polysaccharides, the various polymer of poloxamer.
The preferred sodium alginate of described thickening agent, carbomer.
Described PH regulator is one or more mixture of following material: sodium hydroxide, potassium hydroxide, acetic acid, sodium carbonate, potassium carbonate, triethanolamine, lactic acid, hydrochloric acid, citric acid.
The preferred sodium hydroxide of described PH regulator, potassium hydroxide, acetic acid.
The invention allows for the manufacture method of above-mentioned vagina externally used compound Traditional Chinese medicine gel, comprise the following steps:
Step one, get Pseudobulbus Bletillae (Rhizoma Bletillae) 0.5-30 part, Radix Salviae Miltiorrhizae 0.5-30 part, Galla Chinensis 0.5-30 part, Radix Et Rhizoma Rhei 0.5-30 part, Radix Scutellariae 0.5-30 part, Cortex Phellodendri 0.5-30 part, Rhizoma Atractylodis 0.5-30 part, Radix Sophorae Flavescentis 0.5-30 part, Rhizoma Coptidis 0.5-30 part, Gardenia Yellow 0.5-30 part, Fructus Cnidii 0.5-30 part, Radix Semiaquilegiae 0.5-10 part, Fructus Evodiae 0.5-10 part, Pericarpium Zanthoxyli 0.2-1 part, and add emulsifying agent 0.3-5 part, said components is crushed to 10-1000 order, add boiled water, the weight of boiled water is about the 5-20 of above-mentioned gross weight doubly, dissolve in PH regulator sodium hydroxide (or potassium hydroxide) 0.5-1.5 part, stir immersion 2 hours, again in stirring, 97-100 degree Celsius decoct 0.5-2 hour after, squeezing or centrifugal, all take decocting liquid, decocting liquid with in temperature (55-60 DEG C) vacuum method (-0.1MPa) evaporation be concentrated into and be about 60 parts of weight, discard medicinal residues, obtain concentrated solution,
Step 2, get Herba Taraxaci 0.5-30 part, Herba Violae grass 0.5-30 part, Flos Chrysanthemi Indici 0.5-30 part, Flos Lonicerae 0.5-30 part, Herba Agrimoniae 0.5-30 part, Flos Celosiae Cristatae 0.5-30 part, by said components coarse crushing 3-10 order, add boiled water, boiled water weight is that step 2 newly adds the 5-20 of the gross weight of component doubly, dissolve in PH regulator lactic acid 0.5-1.5 part, soak 0.5-3 hour, in stirring, slow fire (98-100 DEG C) decocts 20-60 minute again, entirely get decocting liquid with in temperature (55-70 DEG C) vacuum (-0.1MPa) evaporation be concentrated into about 30 parts of weight, discard medicinal residues, obtain concentrated solution,
The concentrated solution that blend step one obtains and the concentrated solution that step 2 obtains, obtain mixed concentrated liquid;
Step 3, gets Cosan 0.2-2 part, penetration enhancer 0.4-2 part, emulsifying agent 2-5 part, above-mentioned three kinds of component wet grindings is become the following serosity of particle diameter 1um, then admixes in the mixed concentrated liquid that step 2 obtains, obtains suspension;
Step 4, suspension step 3 obtained is warming up to 60-80 degree Celsius; 60-100 DEG C is heated to dissolve antiseptic 0.25-3 part with emulsifying agent 4-10 part, antiseptic course of dissolution needs Keep agitation more than 20 minutes, by the time solution completely as clear as crystal after again antiseptic solution is added the suspension after intensification, after stirring about 30 minutes, then dissolve in antiseptic 0.05-1 part; Obtain suspension;
Step 5, in the suspension that step 4 obtains, adds thickening agent 2.1-5.5 part powder of mix homogeneously, stirs, obtain gelinite;
Step 6, the pH value of the gelinite of determination step five, adds appropriate PH regulator 0.5-3 part and regulates PH to 4.0-4.8, weigh, and rear water feeding method or stirring evaporation regulate gross weight to be 100 parts.
The using method of above-mentioned vagina externally used compound Traditional Chinese medicine gel is as follows: above-mentioned vagina externally used compound Traditional Chinese medicine gel is dispensed into the self-supporting pencil of vaginal jellies, often prop up 3 grams, every night before sleep, cervicovaginal position self administration of medication one, except menstrual period.
Preparation embodiment 1
Step one, get the Pseudobulbus Bletillae (Rhizoma Bletillae) 0.5 part, Radix Salviae Miltiorrhizae 15 parts, Galla Chinensis 30 parts, Radix Et Rhizoma Rhei 15 parts, Radix Scutellariae 0.5 part, Cortex Phellodendri 15 parts, Rhizoma Atractylodis 30 parts, Radix Sophorae Flavescentis 0.5 part, Rhizoma Coptidis 15 parts, Gardenia Yellow 30 parts, Fructus Cnidii 15 parts, Radix Semiaquilegiae 0.5 part, Fructus Evodiae 10 parts, Pericarpium Zanthoxyli 1 part, and add emulsifying agent 0.3 part, said components is crushed to 10-1000 order, add boiled water, the weight of boiled water is 2000 parts, dissolve in PH regulator sodium hydroxide (or potassium hydroxide) 0.5 part, stir immersion 2 hours, again in stirring, 97-100 degree Celsius decoct 0.5-2 hour after, squeezing or centrifugal, all take decocting liquid, decocting liquid with in temperature (55-60 DEG C) vacuum method (-0.1MPa) evaporation be concentrated into and be about 60 parts of weight, discard medicinal residues, obtain concentrated solution,
Step 2, get Herba Taraxaci 15 parts, Herba Violae grass 30 parts, Flos Chrysanthemi Indici 0.5 part, Flos Lonicerae 15 parts, Herba Agrimoniae 15 parts, Flos Celosiae Cristatae 0.5 part, by said components coarse crushing 3-10 order, add boiled water, boiled water weight is 750 parts, dissolve in PH regulator lactic acid 0.5 part, soak 0.5-3 hour, then slow fire (98-100 DEG C) decocts 20-60 minute in stirring, entirely get decocting liquid with in warm (55-70 DEG C) vacuum (-0.1MPa) evaporation be concentrated into about 30 parts of weight, discard medicinal residues, obtain concentrated solution;
The concentrated solution that blend step one obtains and the concentrated solution that step 2 obtains, obtain mixed concentrated liquid;
Step 3, gets Cosan 1 part, penetration enhancer 0.4 part, emulsifying agent 5 parts, above-mentioned three kinds of component wet grindings is become ultra-fine serosity, then admixes in the mixed concentrated liquid that step 2 obtains, obtains suspension;
Step 4, suspension step 3 obtained is warming up to 60-80 degree Celsius; 60-100 DEG C is heated to dissolve antiseptic 0.25 part with emulsifying agent 4 parts, antiseptic course of dissolution needs Keep agitation more than 20 minutes, by the time solution completely as clear as crystal after again antiseptic solution is added the suspension after intensification, after stirring about 30 minutes, then dissolve in antiseptic 1 part; Obtain suspension;
Step 5, in the suspension that step 4 obtains, adds thickening agent 2.1 parts of powder of mix homogeneously, stirs, obtain gelinite;
Step 6, the pH value of the gelinite of determination step five, adds appropriate PH regulator 0.5-3 part and regulates PH to 4.0-4.8, weigh, and rear water feeding method or stirring evaporation regulate gross weight to be 100 parts.
Preparation embodiment 2
Step one, get the Pseudobulbus Bletillae (Rhizoma Bletillae) 30 parts, Radix Salviae Miltiorrhizae 0.5 part, Galla Chinensis 15 parts, Radix Et Rhizoma Rhei 0.5 part, Radix Scutellariae 15 parts, Cortex Phellodendri 0.5 part, Rhizoma Atractylodis 15 parts, Radix Sophorae Flavescentis 15 parts, Rhizoma Coptidis 0.5 part, Gardenia Yellow 0.5 part, Fructus Cnidii 30 parts, Radix Semiaquilegiae 15 parts, Fructus Evodiae 0.5 part, Pericarpium Zanthoxyli 0.5 part, and add emulsifying agent 3 parts, said components is crushed to 10-1000 order, add boiled water, the weight of boiled water is 150 parts, dissolve in PH regulator sodium hydroxide (or potassium hydroxide) 1 part, stir immersion 2 hours, again in stirring, 97-100 degree Celsius decoct 0.5-2 hour after, squeezing or centrifugal, all take decocting liquid, decocting liquid with in temperature (55-60 DEG C) vacuum method (-0.1MPa) evaporation be concentrated into and be about 60 parts of weight, discard medicinal residues, obtain concentrated solution,
Step 2, get Herba Taraxaci 0.5 part, Herba Violae grass 15 parts, Flos Chrysanthemi Indici 30 parts, Flos Lonicerae 0.5 part, Herba Agrimoniae 30 parts, Flos Celosiae Cristatae 15 parts, by said components coarse crushing 3-10 order, add boiled water, boiled water weight is 800 parts, dissolve in PH regulator lactic acid 1 part, soak 0.5-3 hour, then slow fire (98-100 DEG C) decocts 20-60 minute in stirring, entirely get decocting liquid with in warm (55-70 DEG C) vacuum (-0.1MPa) evaporation be concentrated into about 30 parts of weight, discard medicinal residues, obtain concentrated solution;
The concentrated solution that blend step one obtains and the concentrated solution that step 2 obtains, obtain mixed concentrated liquid;
Step 3, gets Cosan 0.2 part, penetration enhancer 1 part, emulsifying agent 2 parts, above-mentioned three kinds of component wet grindings is become ultra-fine serosity, then admixes in the mixed concentrated liquid that step 2 obtains, obtains suspension;
Step 4, suspension step 3 obtained is warming up to 60-80 degree Celsius; 60-100 DEG C is heated to dissolve antiseptic 1.5 parts with emulsifying agent 7 parts, antiseptic course of dissolution needs Keep agitation more than 20 minutes, by the time solution completely as clear as crystal after again antiseptic solution is added the suspension after intensification, after stirring about 30 minutes, then dissolve in antiseptic 0.05 part; Obtain suspension;
Step 5, in the suspension that step 4 obtains, adds thickening agent 5.5 parts of powder of mix homogeneously, stirs, obtain gelinite;
Step 6, the pH value of the gelinite of determination step five, adds appropriate PH regulator 0.5-3 part and regulates PH to 4.0-4.8, weigh, and rear water feeding method or stirring evaporation regulate gross weight to be 100 parts.
Preparation embodiment 3
Step one, get the Pseudobulbus Bletillae (Rhizoma Bletillae) 15 parts, Radix Salviae Miltiorrhizae 30 parts, Galla Chinensis 0.5 part, Radix Et Rhizoma Rhei 30 parts, Radix Scutellariae 30 parts, Cortex Phellodendri 30 parts, Rhizoma Atractylodis 0.5 part, Radix Sophorae Flavescentis 30 parts, Rhizoma Coptidis 30 parts, Gardenia Yellow 15 parts, Fructus Cnidii 0.5 part, Radix Semiaquilegiae 10 parts, Fructus Evodiae 5 parts, Pericarpium Zanthoxyli 0.2 part, and add emulsifying agent 5 parts, said components is crushed to 10-1000 order, add boiled water, the weight of boiled water is 2500 parts, dissolve in PH regulator sodium hydroxide (or potassium hydroxide) 1.5 parts, stir immersion 2 hours, again in stirring, 97-100 degree Celsius decoct 0.5-2 hour after, squeezing or centrifugal, all take decocting liquid, decocting liquid with in temperature (55-60 DEG C) vacuum method (-0.1MPa) evaporation be concentrated into and be about 60 parts of weight, discard medicinal residues, obtain concentrated solution,
Step 2, get Herba Taraxaci 30 parts, Herba Violae grass 0.5 part, Flos Chrysanthemi Indici 15 parts, Flos Lonicerae 30 parts, Herba Agrimoniae 0.5 part, Flos Celosiae Cristatae 30 parts, by said components coarse crushing 3-10 order, add boiled water, boiled water weight is 1000 parts, dissolve in PH regulator lactic acid 1.5 parts, soak 0.5-3 hour, in stirring, slow fire (98-100 DEG C) decocts 20-60 minute again, entirely get decocting liquid with in temperature (55-70 DEG C) vacuum (-0.1MPa) evaporation be concentrated into about 30 parts of weight, discard medicinal residues, obtain concentrated solution;
The concentrated solution that blend step one obtains and the concentrated solution that step 2 obtains, obtain mixed concentrated liquid;
Step 3, gets Cosan 2 parts, penetration enhancer 2 parts, emulsifying agent 3 parts, above-mentioned three kinds of component wet grindings is become ultra-fine serosity, then admixes in the mixed concentrated liquid that step 2 obtains, obtains suspension;
Step 4, suspension step 3 obtained is warming up to 60-80 degree Celsius; 60-100 DEG C is heated to dissolve antiseptic 3 parts with emulsifying agent 10 parts, antiseptic course of dissolution needs Keep agitation more than 20 minutes, by the time solution completely as clear as crystal after again antiseptic solution is added the suspension after intensification, after stirring about 30 minutes, then dissolve in antiseptic 0.5 part; Obtain suspension;
Step 5, in the suspension that step 4 obtains, adds thickening agent 4 parts of powder of mix homogeneously, stirs, obtain gelinite;
Step 6, the pH value of the gelinite of determination step five, adds appropriate PH regulator 0.5-3 part and regulates PH to 4.0-4.8, weigh, and rear water feeding method or stirring evaporation regulate gross weight to be 100 parts.
Enumerate the case of several application vagina externally used compound of the present invention Traditional Chinese medicine gel treatment below
Case one
Defend * orchid, 28 years old, people from Changsha, in May, 2007, suffer from trichomonal vaginitis, external invention formulation 7 days and healing.Continue medication 7 days.Follow up a case by regular visits to 1 year after drug withdrawal, do not recur again.
Case two
Poplar * show, 37 years old, Guangzhou Huadu people, in JIUYUE, 2008, suffered from bacterial vaginosis, and external invention formulation five days and odorless are without secretions, and continue medication 10 days, thorough rehabilitation, follows up a case by regular visits to 1 year, does not recur again.
Case three
Li Mei *, 40 years old, people from Wenzhou, in April, 2010, because of drug resistance candidal vaginitis repeatedly pruritus outbreak control, eliminate pruritis completely through invention formulation external 10 days, continue use after 20 days, bacterium inspection candidiasis is negative, and drug withdrawal, follows up a case by regular visits to and do not recur for 3 years.
Case four
Deng * Jie, 55 years old, people from Suzhou, in July, 2009, because of bacillary after menolipsis, monilial vaginitis recurrent exerbation was controlled, and through invention formulation external drug withdrawal after month, follows up a case by regular visits to 5 years, infective vaginitis does not occur.
Case five
Younger sister * Liao, 41 years old, people of Guangzhou, because pruritus of vagina was to various big hospital diagnosis and treatment 1 year, did not draw definite cause of disease conclusion in 2006, and symptom still, the spring in 2007, with invention formulation external after 20 days, eliminate completely by symptom, continues medication drug withdrawal in February, follow up a case by regular visits to and do not recur for 5 years.
Case six
Journey * beautiful jade, 40 years old, Shenzhen people, in March, 2010 because of menstrual period long, dark through color, lower abdomen has a dull ache to examine, and advise it with invention formulation with after 20 days, pass through all are normal later.
Case seven
The beautiful * of hair, 51 years old, people from Shenzhen, in JIUYUE, 2008, did not heal because pelvic inflammatory disease is prolonged, and suffering from takes medicine has an injection to control, external invention formulation 2 months, confirms pelvic inflammatory disease rehabilitation through diagnostic imaging, continues medication drug withdrawal in 3 months, follows up a case by regular visits to and do not recur for 5 years.
Case eight
Its * of Rhizoma Zingiberis Recens, 55 years old, people from Guangzhou, health check-up in 2009 found that cervical HPV 16 is positive, checks still positive, start external invention formulation in May, 2010 and turn out cloudy for 6 months, steadiness medication drug withdrawal after 3 months, follow up a case by regular visits to and do not recur for 3 years after 1 year.
Case nine
Yellow * is glad, 41 years old, Shenzhen people, in October, 2008 health check-up find cervix uteri hpv18,51,56 positive, through invention formulation external 6 months, three kinds of viruses all turned negative, and continued medication drug withdrawal after 3 months, followed up a case by regular visits to 5 years, and HPV all continues negative.
The present invention has following beneficial effect:
One, the purposes ancient Chinese medicinal formulae SANHUANG Detoxication Decoction and wuwei xiaodu drink exploitation made new advances and usage." the SANHUANG Detoxication Decoction (Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Radix Et Rhizoma Rhei, Gardenia Yellow " and " wuwei xiaodu drink (Herba Taraxaci, Herba Violae, Flos Lonicerae, Flos Chrysanthemi Indici, Radix Semiaquilegiae) " of Chinese medicine is the classics recipe of heat-clearing and toxic substances removing.Often be used as " heat clearing away by old docter of TCM, pathogenic fire purging, removing toxic substances " treat laryngopharynx swelling and pain or " large hot delirium, send out speckle jaundice, tell nosebleed hematochezia " and " heat-clearing and toxic substances removing, dissipation furuncle carbuncle " use, modern medicine thinks that this two prescription all has the antiviral effect of broad-spectrum sterilization antiinflammatory, it is main that usage is drunk oral mainly with soup, occasionally stick with paste external curing sores ulceration of skin as washing liquid or cream, the present inventor thinks cervicovaginal disease, pathogeny mostly still is ' damp-heat vaginal discharge ", wet, heat is for suffering from, therefore two prescriptions of heat-clearing and toxic substances removing can be worked in coordination with the nucleus used as vagina externally used antimicrobial antivirus gel preparation, be used for the various vagina cervical infection of prevention and therapy, particularly be used as the nucleus of anti-cervical HPV infection formula.Through the clinical verification of inventor's more than two decades, this preparation was through course for the treatment of of 7-14 days, all effective for multiple acute and chronic cervicovaginal inflammation (comprising trichomonal vaginitis, bacterial vaginitis, candidal vaginitis, chronic cervicitis etc.), effective percentage reaches 99%, and cure rate reaches 90%.Through the course for the treatment of of 3-6 month, cervical HPV negative conversion rate reached 80%, and through following up a case by regular visits to 1-2, HPV negative conversion rate changes, and shows that its anti-HPV effect is affirmed lastingly.
The integration such as Chinese Traditional Medicine composition Fructus Evodiae, Pericarpium Zanthoxyli of two, cold relieving being warmed up palace is applied to external preparation, reaches regulating menstruation, the special pharmacological effect of warm uterus, promoting blood circulation and stopping pain by the approach of vagina administration.
The composition three, Cosan, Herba Agrimoniae, Flos Celosiae Cristatae, thymol etc. with antibacterial protozoacide effect is applied to the effect reaching the various gynecological infection of prevention and therapy in vaginal jellies.Herba Agrimoniae, Flos Celosiae Cristatae are commonly used to treat various gynecological infection " panacea ", but be commonly used for decoct and take orally, and the present inventor is innovatively by its auxiliary element as antibiotic external used slow releasing agent, and effect is more better than taking orally, and side effect is less.

Claims (6)

1. a vagina externally used compound Traditional Chinese medicine gel, is characterized in that, it is made up of the following component according to weight parts:
Pseudobulbus Bletillae (Rhizoma Bletillae) 0.5-30 part, Radix Salviae Miltiorrhizae 0.5-30 part, Galla Chinensis 0.5-30 part, Radix Et Rhizoma Rhei 0.5-30 part, Radix Scutellariae 0.5-30 part, Cortex Phellodendri 0.5-30 part, Rhizoma Atractylodis 0.5-30 part, Radix Sophorae Flavescentis 0.5-30 part, Rhizoma Coptidis 0.5-30 part, Gardenia Yellow 0.5-30 part, Fructus Cnidii 0.5-30 part, Radix Semiaquilegiae 0.5-10 part, Fructus Evodiae 0.5-10 part, Pericarpium Zanthoxyli 0.2-1 part, Herba Taraxaci 0.5-30 part, Herba Violae grass 0.5-30 part, Flos Chrysanthemi Indici 0.5-30 part, Flos Lonicerae 0.5-30 part, Herba Agrimoniae 0.5-30 part, Flos Celosiae Cristatae 0.5-30 part, Cosan 0.2-2 part, emulsifying agent 6.3-20 part, penetration enhancer 0.4-2 part, antiseptic 0.3-4 part, thickening agent 2.1-5.5 part, PH regulator 1.5-6 part.
2. a kind of vagina externally used compound Traditional Chinese medicine gel according to claim 1, it is characterized in that, described emulsifying agent is one or more mixture of following material: poloxamer, fatty alcohol-polyoxyethylene ether, Span series, TWEEN Series, fatty acid ester series, polyglyceryl fatty acid ester are serial;
Described penetration enhancer is one or more mixture of following material: Borneolum Syntheticum, Mentholum, azone, thiophene ketone or various short saturating aromatic oil;
Described antiseptic is one or more mixture of following material: thymol, Capmul MCM C8, dehydro sodium acetate, potassium sorbate, sodium benzoate, Nipagin ester, triclosan, triclocarban, chlorhexidine acetate, chlorhexidine gluconate, sodium diacetate;
Described thickening agent is one or more mixture of following material: sodium alginate, carbomer, xanthan gum, various natural polysaccharide and modification of polysaccharides, poloxamer, various polymer;
Described PH regulator is one or more mixture of following material: sodium hydroxide, potassium hydroxide, acetic acid, sodium carbonate, potassium carbonate, triethanolamine, lactic acid, hydrochloric acid, citric acid.
3. a kind of vagina externally used compound Traditional Chinese medicine gel according to claim 2, is characterized in that, the preferred poloxamer of described emulsifying agent;
The preferred Borneolum Syntheticum of described penetration enhancer, Mentholum;
The preferred thymol of described antiseptic, Capmul MCM C8, dehydro sodium acetate;
The preferred sodium alginate of described thickening agent, carbomer;
The preferred sodium hydroxide of described PH regulator, potassium hydroxide, acetic acid.
4. prepare a manufacture method for vagina externally used compound Traditional Chinese medicine gel as claimed in claim 1, it is characterized in that, comprise the following steps:
Step one, get Pseudobulbus Bletillae (Rhizoma Bletillae) 0.5-30 part, Radix Salviae Miltiorrhizae 0.5-30 part, Galla Chinensis 0.5-30 part, Radix Et Rhizoma Rhei 0.5-30 part, Radix Scutellariae 0.5-30 part, Cortex Phellodendri 0.5-30 part, Rhizoma Atractylodis 0.5-30 part, Radix Sophorae Flavescentis 0.5-30 part, Rhizoma Coptidis 0.5-30 part, Gardenia Yellow 0.5-30 part, Fructus Cnidii 0.5-30 part, Radix Semiaquilegiae 0.5-10 part, Fructus Evodiae 0.5-10 part, Pericarpium Zanthoxyli 0.2-1 part, and add emulsifying agent 0.3-5 part, said components is crushed to 10-1000 order, add boiled water, the weight of boiled water is about the 5-20 of above-mentioned gross weight doubly, dissolve in PH regulator 0.5-1.5 part, stir immersion 2 hours, again in stirring, 97-100 degree Celsius decoct 0.5-2 hour after, squeezing or centrifugal, all take decocting liquid, decocting liquid with in temperature (55-60 DEG C) vacuum method (-0.1MPa) evaporation be concentrated into and be about 60 parts of weight, discard medicinal residues, obtain concentrated solution,
Step 2, get Herba Taraxaci 0.5-30 part, Herba Violae grass 0.5-30 part, Flos Chrysanthemi Indici 0.5-30 part, Flos Lonicerae 0.5-30 part, Herba Agrimoniae 0.5-30 part, Flos Celosiae Cristatae 0.5-30 part, by said components coarse crushing 3-10 order, add boiled water, boiled water weight is that step 2 newly adds the 5-20 of the gross weight of component doubly, dissolve in PH regulator 0.5-1.5 part, soak 0.5-3 hour, in stirring, slow fire (98-100 DEG C) decocts 20-60 minute again, entirely get decocting liquid with in temperature (55-70 DEG C) vacuum (-0.1MPa) evaporation be concentrated into about 30 parts of weight, discard medicinal residues, obtain concentrated solution,
The concentrated solution that blend step one obtains and the concentrated solution that step 2 obtains, obtain mixed concentrated liquid;
Step 3, gets Cosan 0.2-2 part, penetration enhancer 0.4-2 part, emulsifying agent 2-5 part, becomes particle diameter to be less than 1um serosity above-mentioned three kinds of component wet grindings, then admixes in the mixed concentrated liquid that step 2 obtains, obtains suspension;
Step 4, suspension step 3 obtained is warming up to 60-80 degree Celsius; 60-100 DEG C is heated to dissolve antiseptic 0.25-3 part with emulsifying agent 4-10 part, antiseptic course of dissolution needs Keep agitation more than 20 minutes, by the time solution completely as clear as crystal after again antiseptic solution is added the suspension after intensification, after stirring about 30 minutes, then dissolve in antiseptic 0.05-1 part; Obtain suspension;
Step 5, in the suspension that step 4 obtains, adds thickening agent 2.1-5.5 part powder of mix homogeneously, stirs, obtain gelinite;
Step 6, the pH value of the gelinite of determination step five, adds appropriate PH regulator 0.5-3 part and regulates PH to 4.0-4.8, weigh, and rear water feeding method or stirring evaporation regulate gross weight to be 100 parts.
5. the manufacture method of vagina externally used compound Traditional Chinese medicine gel according to claim 4, it is characterized in that, described emulsifying agent is one or more mixture of following material: poloxamer, fatty alcohol-polyoxyethylene ether, Span series, TWEEN Series, fatty acid ester series, polyglyceryl fatty acid ester are serial;
Described penetration enhancer is one or more mixture of following material: Borneolum Syntheticum, Mentholum, azone, thiophene ketone or various short saturating aromatic oil;
Described antiseptic is one or more mixture of following material: thymol, Capmul MCM C8, dehydro sodium acetate, potassium sorbate, sodium benzoate, Nipagin ester, triclosan, triclocarban, chlorhexidine acetate, chlorhexidine gluconate, sodium diacetate;
Described thickening agent is one or more mixture of following material: sodium alginate, carbomer, xanthan gum, various natural polysaccharide and modification of polysaccharides, the various polymer of poloxamer;
Described PH regulator is one or more mixture of following material: sodium hydroxide, potassium hydroxide, acetic acid, sodium carbonate, potassium carbonate, triethanolamine, lactic acid, hydrochloric acid, citric acid.
6. the manufacture method of vagina externally used compound Traditional Chinese medicine gel according to claim 5, is characterized in that,
Described emulsifying agent is poloxamer;
Described penetration enhancer is one or more mixture of following material: Borneolum Syntheticum, Mentholum;
Described antiseptic is one or more mixture of following material: thymol, Capmul MCM C8, dehydro sodium acetate;
Described thickening agent is one or more mixture of following material: sodium alginate, carbomer;
Described PH regulator is one or more mixture of following material: sodium hydroxide, potassium hydroxide, acetic acid.
CN201511012861.2A 2015-12-31 2015-12-31 Externally vagina applied compound traditional Chinese medicine gel and preparation method thereof Pending CN105535481A (en)

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CN113730469A (en) * 2021-07-12 2021-12-03 江苏实干家生物科技有限公司 Pure traditional Chinese medicine gel for treating HPV infected cervical cancer and preparation method thereof
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11278583B2 (en) * 2018-03-29 2022-03-22 Zhuanshe DU Traditional Chinese medicine composition for treating diseases caused by human papillomavirus, preparation method and use thereof
CN108853287A (en) * 2018-08-07 2018-11-23 吉林省正肽生物科技有限公司 Pharmaceutical composition, gel preparation and the application of a kind of anti-human papilloma virus (anti-HPV) and anti-gynaecological imflammation
CN108853287B (en) * 2018-08-07 2021-06-15 吉林省正肽生物科技有限公司 Pharmaceutical composition for resisting human papilloma virus and gynecological inflammation, gel preparation and application
CN109200235A (en) * 2018-11-29 2019-01-15 张建青 A kind of Chinese materia medica preparation and preparation method thereof for eliminating HPV infection
CN112220900A (en) * 2020-09-27 2021-01-15 大连双迪科技股份有限公司 Antibacterial lotion and preparation method thereof
CN112138077A (en) * 2020-10-19 2020-12-29 青岛浩大生物科技工程有限责任公司 Marine polysaccharide private antibacterial gel and preparation method thereof
CN113181336A (en) * 2021-06-11 2021-07-30 陕西秦岭七药协同创新中心有限公司 Traditional Chinese medicine composition and preparation for treating gynecological diseases and preparation method and application thereof
CN113730469A (en) * 2021-07-12 2021-12-03 江苏实干家生物科技有限公司 Pure traditional Chinese medicine gel for treating HPV infected cervical cancer and preparation method thereof

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