CN101112444A - Medicine for treating dermatological disease and vaginal tickle and gall gynaecologic disease - Google Patents

Medicine for treating dermatological disease and vaginal tickle and gall gynaecologic disease Download PDF

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CN101112444A
CN101112444A CNA2007100185031A CN200710018503A CN101112444A CN 101112444 A CN101112444 A CN 101112444A CN A2007100185031 A CNA2007100185031 A CN A2007100185031A CN 200710018503 A CN200710018503 A CN 200710018503A CN 101112444 A CN101112444 A CN 101112444A
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medicine
skin
disease
realgar
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杨喜雅
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SHANXI GUANAI PHARMACEUTICAL CO Ltd
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SHANXI GUANAI PHARMACEUTICAL CO Ltd
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Abstract

The present invention relates to a drug for treating the diseases of dermatology and gynecological pruritus swelling and pain diseases of vulvae, the drug is composed of the following raw materials with the weight ratio: 11percent to 13 percent Taiwan juniper, 11 percent to 13 percent savoury rhododendron leaf, 11 percent to 13 percent artemisia sieversiana, 11 percent to 13 percent ephedra herb, 11 percent to 13 percent myricaria, 0.6 percent to 0.8percent bear ball powder, 9 percent to 11 percent przewalskia tangutica maxim., 9 percent to 11 percent realgar, 5 percent to 7 percent chalcanthite, 0.2 percent to 0.4 percent musk, and 10 percent to 12 percent peppermint, the sum of the raw materials is 100 percent; the preparation method is that the realgar in the formulation is carried out the levigation into the fine powder. The musk is ground into the fine powder additionally. The chalcanthite and bear ball powder are dissolved and filtered by using small amount of warm water, the Taiwan juniper, savoury rhododendron leaf, artemisia sieversiana and the peppermint are distilled by water vapor and extracted the volatile oil, the water is added in the drug residues and other medicinal materials for boiling for two times, the first time lasts for 3 hours, and the second time lasts for 2.5 hours, the boiled liquid is merged and filtered, the filtrate is concentrated to the clear paste with the relative density of 1.20 to 1.25 (at 50 DEG C), which is evenly mixed with the fine powders and solution, the volatile oil is sprayed, then the even agitating and packaging are carried out to prepare the product.

Description

A kind of swell and ache medicine of disease of cutaneous diseases and pruritus vulvae that is used for the treatment of
Technical field
The present invention relates to a kind of medicine, particularly a kind of swell and ache medicine of disease of cutaneous diseases and pruritus vulvae that is used for the treatment of, this medicine is specially adapted to acute and chronic dermatitis, skin pruritus, the tinea manuum, tinea pedis and gynecological inflammation.
Background technology
Acute and chronic dermatitis, skin pruritus, hands, tinea pedis are common skin section diseases clinically.Tinea pedis is the most common among the general crowd, and the tinea manuum is many, and the two clinical manifestation is roughly similar by due to the tinea pedis infection, though also variant, generally can divide three types: vesicle type, intertrigo type and squama keratinization type.Acute and chronic dermatitis, the skin pruritus clinical manifestation is skin pruritus originally, later on because the stimulation of excessively scratching, and Secondary cases dermatosiss such as scratch, blood crusts, pimple occur.Hands, tinea pedis come down to a kind of dermatomycosis, and its basic pathology is: shallow table portion fungal infection often is Epidermophyton and trichophyton, and skin lesion Chang Yin grabs and scratches and secondary infection.Acute and chronic dermatitis, the cause of disease of skin pruritus is like excited with to suppress dysequilibrium relevant with nervous system dysfunction, cerebral cortex.Main inducing has neural Nervous and Mental Factors, diet, gastrointestinal function obstacle, endocrine disturbance and part to be subjected to stimulations such as woolen knitwear, hard collar or chemical substance.Hands, tinea pedis treatment are gone up many based on medicine for external use, handle earlier when infection is arranged and infect, and the disease of effecting a permanent cure then is to suppress, to kill fungus.Acute and chronic dermatitis, it is the vicious cycle that blocking-up is scratched and caused, local topical medicine or whole body therapeutic then that primary and foremost purpose is gone up in the skin pruritus treatment.Chinese medical theory thinks that hands, tinea pedis are attacked by pathogenic wind toxic, damp outside being; Interior is that blood is dry, damp-heat in the spleen and stomach, and strongly fragrant in skin, exogenous damp and endogenous dampness are beset by troubles, satisfy and send out a primary disease.And acute and chronic dermatitis, the many heresies of skin pruritus by diseases caused by exogenous pathogenic factor rheumatism, endogenous cause of ill feelings will is unsuccessful, depression of liver-QI, visceral dysfunction, the diet impairment caused by overstrain causes wind, wet, heat to accumulate long-pending skin and form.Their basic pathogenesis is based on the exopathogen invasion and attack, should be to dispel exopathogen in treatment.
At present common medicine is with antifungal agent, antihistamine drug, the medicine of regulating function of nervous system is main, wherein comparatively the common chemical medicine has griseofulvin, the miconazole of nystatin or topical application and clotrimazole, and H1 receptor antagonist, vitamin B group etc., but can produce bigger untoward reaction in using.Can cause headache as griseofulvin, feel sick, diarrhoea, erythra; And peripheral neuritis, ataxia, lethargy, dizzy, faint, the reaction of nervous system such as the dimness of vision, animal experiment proves that this medicine has teratogenesis; And easily recurrence is infected again after the medication.Nystatin toxicity is big, heavy dose of oral cause nauseating, vomiting, diarrhoea.Allergy such as erythra can appear after the miconazole medication.Clotrimazole can produce psychologic nervous system reactions such as depression, hallucination, disorientation.The H1 receptor antagonist can produce calmness, and is drowsiness, the weak maincenter of Denging suppresses phenomenon, and xerostomia, and anorexia is felt sick digestive tract reactions such as vomiting.Vitamin B group still can cause erythra, anaphylaxiss such as medicine heat, even anaphylactic shock takes place; Erubescence, pruritus, dizziness are arranged once in a while; Take in a large number and agitation, tired, inappetence can occur.Chinese medicine commonly used lacks generally acknowledges effective preparation, and general uncertain therapeutic efficacy is cut, and clinical observation on the therapeutic effect is more, and animal experiment research is less.And in treatment, dispel a certain exopathogen only unilaterally, and ignore the wholistic therapy effect.Therefore in hands, tinea pedis, acute and chronic dermatitis in the treatment of skin pruritus, still lacks good effect, the ideal medicament that side effect is little.
Summary of the invention
The objective of the invention is to, a kind of swell and ache medicine of disease of cutaneous diseases and pruritus vulvae that is used for the treatment of is provided, this medicine proves through animal experiment study and drug effect, pharmacology test, this medicine has antiinflammatory, antipruritic, antibacterial, pain relieving, analgesic, the effect that improves cellular immunization, to treating acute and chronic dermatitis, pudendal pruritus due to the skin pruritus, the tinea manuum, tinea pedis and the gynecological inflammation disease that swells and ache has good therapeutical effect.
In order to realize above-mentioned task, the present invention takes following technical solution:
A kind of swell and ache medicine of disease of cutaneous diseases and pruritus vulvae that is used for the treatment of is characterized in that this medicine that makes is made up of following raw materials according and weight ratio thereof: Juniperus oxycedrus: 11%~13%, Rhododendron: 11%~13%, Artemisia sieversiana Willd.: 11%~13%, Herba Ephedrae: 11%~13%, Cacumen Myricariae Germanicae; 11%~13%, Fel Ursi powder; 0.6%~0.8%, Tangut Przewalskia: 9%~11%, Realgar: 9%~11%, Chalcanthitum: 5%~7%, Moschus: 0.2%~0.4%, Herba Menthae: 10%~12%, the summation of raw material is 100%.
Manufacturing method for above mentioned medicine follows these steps to preparation:
Realgar water is flown into fine powder, and Moschus is the porphyrize powder in addition;
Chalcanthitum, Fel Ursi powder filter with a small amount of warm water dissolving respectively, obtain Chalcanthitum and Fel Ursi powder solution;
Juniperus oxycedrus, Rhododendron, Artemisia sieversiana Willd., Herba Menthae are used water vapour distillation volatile oil, and medicinal residues and Herba Ephedrae, Tangut Przewalskia, Cacumen Myricariae Germanicae decoct with water secondary, 3 hours for the first time, 2.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.20-1.25 (50 ℃);
With clear paste and above-mentioned Realgar and Moschus fine powder and Chalcanthitum and Fel Ursi powder solution mix homogeneously, spray into volatile oil, stir evenly, packing, promptly.
The swell and ache medicine of disease of the treatment cutaneous diseases of the present invention preparation and pruritus vulvae is the brown liquid that contains small amount of precipitate; Gas delicate fragrance has heat-clearing and toxic substances removing, and removing the necrotic tissue and promoting granulation, pain relieving, itching relieving effect are applicable to acute and chronic dermatitis, skin pruritus, the tinea manuum, tinea pedis; Pudendal pruritus due to the gynecological inflammation symptom that swells and ache.
The specific embodiment
The swell and ache medicine of disease of cutaneous diseases and pruritus vulvae that is used for the treatment of of the present invention, this medicine that makes is made up of following raw materials according and weight ratio thereof: Juniperus oxycedrus: 11%~13%, and Rhododendron: 11%~13%, Artemisia sieversiana Willd.: 11%~13%, Herba Ephedrae: 11%~13%, Cacumen Myricariae Germanicae; 11%~13%, Fel Ursi powder; 0.6%~0.8%, Tangut Przewalskia: 9%~11%, Realgar: 9%~11%, Chalcanthitum: 5%~7%, Moschus: 0.2%~0.4%, Herba Menthae: 10%~12%, the summation of raw material is 100%.
Below to the prescription in the property of Chinese materia medica be further explained:
Juniperus oxycedrus
For Cupressaceae plant Juniperus rigida Sieb.et Zucc., Juniperus oxycedrus, Siberia Juniperus oxycedrus, high mountain cypress with band leaf twig and fruit medicine.Main product in Tibet, SOUTH OF GANSU, Sichuan, Yunnan; Ground such as south, Shaanxi, Anhui, Fujian, Taiwan, western part, Hubei, Guizhou.Gather the twig of being with leaf summer, autumn, collecting fruit dried respectively.
[property of medicine] is bitter, puckery, cold.
[effect] heat-clearing and toxic substances removing.
[application]
1, " brilliant pearl book on Chinese herbal medicine " record: " the Juniperus oxycedrus fruit is controlled the sick diffusion of red crust, skin pruritus, hemorrhoid.”
2. Four-Volume Medical Code record: " the clear kidney-heat of leaf (containing twig), parasite killing is controlled nephropathy, kidney-heat syndrome, bladder heat.The red crust of fruit convergence is sick, detoxifcation, and parasite killing is treated the sick diffusion of red crust disease, skin pruritus, hemorrhoid.”
Rhododendron
Be the ericad Rhododendron, be used as medicine with flower, leaf or band leaf twig.Main product is in Eastern Tibet, Qinghai and SOUTH OF GANSU.The Sheng of the blooming phase plucks, and plucks Hua Heye respectively, dries.
[property of medicine] leaf: bitter, puckery, warm.Flower: hot, temperature, light.
[effect] leaf: cold relieving, detoxifcation.Flower: nourishing kidney tonifying.
[application]
1. " month king's medicine is examined " record: the tower profit " is controlled dragon, red crust, Baconic's disease, Deficiency and coldness of spleen and stomach, dyspepsia, being not acclimatized.”
2. " bright 30 chapters of releasing " record: warm in nature, control Baconic's disease, pneumonopathy pain, singultus.
3. " brilliant pearl book on Chinese herbal medicine " record: " nourishing lengthens one's life the tower profit, controls cold Baconic's disease.”
Artemisia sieversiana Willd.
For the feverfew Artemisia sieversiana Willd., with all herbal medicine.Main product in North China, northwest, each provinces and regions, northeast.Full-bloom stage is plucked, and chooses except that dead leaf, and it is standby to dry in the shade.
[property of medicine] flavor is little sweet, bitter, cool in nature.
[effect] looses swollen, hemostasis.
[application]
1. " product pearl book on Chinese herbal medicine " record: " hemostasis of bank crust, dissipation limb edema.”
2. " form metaphor " record: Bai Kanba abnormal smells from the patient sweetness, effect is loose swollen, controls furuncle, and pneumonopathy, sharp kidney are drawn in holder.
Herba Ephedrae
Dry herb stem for Ephedraceae plant plait Herba Ephedrae, epheday intermedia or ephedra equisetina.Main product in Hebei, Shanxi, Xinjiang, Inner Mongol.Tap green herb stem autumn, dry.
[property of medicine] feeble QI perfume (or spice), puckery, little hardship.
[effect] diaphoresis cold expelling, depressed lung-energy dispersing, inducing diuresis to remove edema.
[application]
1. Herba Ephedrae one medicine begins to be stated from " herbal classic ".Record Ephedrae Decoction one side in the treatise on Febrile Diseases of Han dynasty after, back physicians from a family for generations family thinks that all Herba Ephedrae is the key medicine of relieving the exterior syndrome by diaphoresis, relieving cough and asthma simply.The work of this product in order to disperse with lung qi dispersing be main, as join then relieving the exterior syndrome by diaphoresis of Ramulus Cinnamomi, join then relieving cough and asthma of Semen Armeniacae Amarum, join then lung qi dispersing cold expelling of Rhizoma Zingiberis, join Gypsum Fibrosum then lung qi dispersing expel the heat-evil, in Mahuang Fuzi Xixin Tang, join Radix Aconiti Lateralis Preparata then warming the meridian deliver, in YANGHE TANG, join the then warm cold expelling heresy of Cortex Cinnamomi, a surname venting QI-blood.In sum, the clinical practice of Herba Ephedrae mainly is the effect of getting its a surname, two aspects of loosing.
2. Herba Ephedrae suffering warm in nature is loose, can the diaphoresis cold expelling and induce sweat the wind rash of can loosing again.With controlling the caused fever with chills of affection of exogenous wind-cold, disease such as lossless, normal and Ramulus Cinnamomi mutual reinforcement between is a usefulness, and the effect of relieving the exterior syndrome by diaphoresis is arranged.
Cacumen Myricariae Germanicae
For suspend plant Cacumen Myricariae Germanicae etc. belongs to various plants together, be used as medicine with twig.Main product in Tibet, ground such as Qinghai, Gansu.Spring, summer gather, and the clip twig dries.
[property of medicine] puckery, sweet, cool in nature.
[effect] heat-clearing and toxic substances removing.
[application]
1. " brilliant pearl book on Chinese herbal medicine " record: my clear loosing of wood difficult to understand held the scorchingly hot of accumulation for a long time, is used as medicine with flower, leaf, red twig.
2. " ancestors' oral account " record: I separates wood difficult to understand the meat poison, cooperates poison, and this product can not be got wrong.
Fel Ursi powder
For Carnivora Ursidae black bear, be used as medicine with gallbladder.Main product is in Tibet, Qinghai and other places.After catching black bear, cut open the belly and get gallbladder, dry in the shade.
[property of medicine] is bitter, cold.
[effect] heat-clearing and toxic substances removing, spasmolytic make eye bright, the parasite killing hemostasis.
[application]
1. " brilliant pearl book on Chinese herbal medicine " record: the Fel Ursi hemostasis, removing the necrotic tissue, granulation promoting is held back erosion.
2. " Tibetan medicine and pharmacology a collection of selected materials " record: Fel Ursi is the treasure of some animal gallbladders, can defend tenaciously CUN KOU, and detoxifcation is cured the wound, and removing heat from the gallbladder makes eye bright.Cure mainly angiorrhexis, various skin infection, gallbladder disease, order disease.
Tangut Przewalskia
Be the plant of Solanaceae Tangut Przewalskia, be used as medicine with root, rhizome and seed.Main product in Tibet, ground such as Qinghai, SOUTH OF GANSU and western Sichuan.Tap during fruit maturation August, dries, and lays seed.Autumn end treats to excavate root when plant is withered, and wash clean dries, or section is dried.
[property of medicine] is bitter, cold.
[effect] is relieving convulsion, parasite killing, antiinflammatory.
[application]
" brilliant pearl book on Chinese herbal medicine " record: Tang Chong be divided into black, white, spend three kinds.Its effect parasite killing.The diseases caused by retention of the body fluid of harnessing the Yellow River, gastropathy.
2. " Bao Shu complies with one's wishes " claims Tang can control manic-depressive psychosis towards the loud, high-pitched sound guarantor.
Realgar
Be sulfide-based mineral yellow family Realgar, after excavating, decontamination.
[property of medicine] is hot, warm; Poisonous.
[effect] detoxifcation parasite killing, removing dampness and eliminating phlegm, preventing the attack (or recurrence) of malaria.
[application]
Be used for the carbuncle furuncle, snake bite and insect sting, abdominal pain due to worm stagnation, infantile convulsion, malaria.
Chalcanthitum
[property of medicine] sour in the mouth is salty, warm in nature.
[effect] loose and become silted up, detoxifcation, and emetic, parasite killing is held back skin ulcer.
[application]
" brilliant pearl book on Chinese herbal medicine " record: Chalcanthitum removes the furuncle carbuncle, broken painful abdominal mass tumor, removing nebula barrier.
The artificial Moschus
[property of medicine] is hot, warm.
[effect] refreshment of having one's ideas straightened out, promoting blood circulation to restore menstrual flow, reducing swelling and alleviating pain.
[application]
" brilliant pearl book on Chinese herbal medicine " record: Moschus is a juice class elite medicine, detoxifcation, and parasite killing, antiinflammatory is warded off dirtyly, controls nephropathy.
Herba Menthae
[property of medicine] is hot, cool.
[effect] dispelling wind-heat, refresh oneself, rash.
[application] be used for pathogenic wind-warm from the beginning of, the headache, conjunctival congestion, sore throat, aphtha etc.
Below in conjunction with embodiment and drug effect, the present invention is described in further detail for pharmacological testing.
Embodiment 1:
Prescription: Juniperus oxycedrus 120g, Rhododendron 120g, Artemisia sieversiana Willd. 120g, Herba Ephedrae 120g, Cacumen Myricariae Germanicae 120g, Fel Ursi powder 7g, Tangut Przewalskia 100g, Realgar 100g, Chalcanthitum 60g, artificial Moschus 3g, Herba Menthae 110g; Make 1000ml.
Method for making: the Realgar water in the above-mentioned prescription flies into fine powder.
Moschus is the porphyrize powder in addition.
Chalcanthitum, Fel Ursi powder filter with a small amount of warm water dissolving respectively, obtain Chalcanthitum and Fel Ursi powder solution; Juniperus oxycedrus, Rhododendron, Artemisia sieversiana Willd., Herba Menthae are used water vapour distillation volatile oil, medicinal residues and all the other medicinal raw materials (Herba Ephedrae, Tangut Przewalskia, Cacumen Myricariae Germanicae) decoct with water secondary, 3 hours for the first time, 2.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.20-1.25 (50 ℃);
Clear paste and above-mentioned Realgar and Moschus fine powder and Chalcanthitum and Fel Ursi powder solution mix homogeneously spray into volatile oil, stir evenly, and packing, promptly.
Character: this product is the brown liquid that contains small amount of precipitate; Gas delicate fragrance.
Discrimination method:
(1) get this product 30ml, add strong ammonia solution 1ml, extract 2 times with the chloroform jolting, each 20ml, merge extractive liquid, volatilizes, and residue adds methanol 1ml makes dissolving, as need testing solution.Other gets the ephedrine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 0.3mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel g thin-layer plate, with n-butyl alcohol-glacial acetic acid-water (8: 2: 1) is developing solvent, launch, take out, dry, spray is with 1% ethanol solution of ninhydrin, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get this product 30ml, add strong ammonia solution 1ml, extract 2 times with the ether jolting, each 20ml, merge extractive liquid, is waved to 2ml, as need testing solution.Other gets Rhododendron control medicinal material 1g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw need testing solution 5ul, reference substance solution 6u1, put respectively on same silica gel g thin-layer plate, with cyclohexane extraction-acetone-strong ammonia solution (8: 6: 0.3) is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(3) get this product 30ml, extract, get acetic acid ethyl fluid, be concentrated into 2ml, as need testing solution with ethyl acetate 20ml jolting.Other gets Tangut Przewalskia control medicinal material 1g, adds ethyl acetate 20ml, and supersound process 30 minutes filters, and filtrate is concentrated into 2ml medical material solution in contrast.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw need testing solution 5ul, control medicinal material solution 6ul, put respectively on same silica gel g thin-layer plate, with chloroform-toluene-formic acid-acetone (4: 4: 0.1: 0.6) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color; Spray is with 10% sulphuric acid second solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical puce speckle.
Inspection item:
Relative density: should be not less than 1.02 (appendix VIIA of Chinese Pharmacopoeia version in 2005).
PH value: should be 3.5~5.5 (appendix VIIG of Chinese Pharmacopoeia version in 2005).
Arsenic trioxide is limited the quantity of: get this product 150ml, shake up, precision is measured 10ml, filters filtrate for later use.Residue washs 2 times with dilute hydrochloric acid, each 10ml, and cleaning mixture and filtrate merge, and put in the 1000ml volumetric flask, add water to scale, shake up.Precision is measured 2ml, puts in the 100ml volumetric flask, and thin up shakes up to scale; Precision is measured 2ml, adds hydrochloric acid 5ml and water 21ml, checks that according to arsenic salt inspection technique (appendix IXF first method of Chinese Pharmacopoeia version in 2005) gained arsenic speckle color must not be deeper than standard arsenic speckle.
Other: should meet every regulation relevant under the lotion item (appendix IS of Chinese Pharmacopoeia version in 2005).
N-butanol extract: get this product, mixing, precision is measured 30ml, extract 5 times (30ml, 30ml, 30ml, 10ml, 10ml) with water saturated n-butyl alcohol jolting, merge n-butanol extracting liquid, put in the evaporating dish that is dried to constant weight evaporate to dryness, 105 ℃ of dryings 3 hours, in the dislocation drying receptacle, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, promptly.
This product contains n-butanol extract must not be less than 1.2%.
Assay is measured according to high performance liquid chromatography (appendix VID).
Chromatographic condition and system suitability test are filler with the octadecylsilane chemically bonded silica; With acetonitrile-0.1% phosphoric acid solution (containing 0.1% triethylamine) (3: 97) is mobile phase; The detection wavelength is 205nm.Number of theoretical plate calculates by the ephedrine hydrochloride peak should be not less than 4000.
It is an amount of that the ephedrine hydrochloride reference substance is got in the preparation of reference substance solution, and accurate the title decides, and the hydrochloric acid solution that adds 0.1mol/L is made the solution that every 1ml contains 35 μ g, promptly.
The preparation precision of need testing solution is measured this product 5ml, adds water 10ml and strong ammonia solution 5ml, with 5 (30ml of ether extraction, 30ml, 20ml, 20ml, 20ml), merge ether solution, add ethanol solution hydrochloride (1 → 20) 2ml, mixing, low temperature reclaim solvent to doing, and residue adds ethanol 5ml makes dissolving, be transferred in the 25ml volumetric flask, add the 0.1mol/L hydrochloric acid solution and be diluted to scale, shake up, promptly.
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.
Specification: every bottled 150ml, every 1ml contain Herba Ephedrae with ephedrine hydrochloride (C 10H 15NOHCI) meter must not be less than 12 μ g.
Function cures mainly: heat-clearing and toxic substances removing, removing the necrotic tissue and promoting granulation, pain relieving, antipruritic.Be used for acute and chronic dermatitis, skin pruritus, the tinea manuum, tinea pedis; Pudendal pruritus due to the gynecological inflammation swells and ache.
Usage and dosage: external, get this product 10~20ml, add warm water 1000ml, embathe the affected part, 2~3 times on the one; Also but stock solution is directly cleaned the affected part.
Taboo: anemia of pregnant woman's forbidding; Skin has damaged person's forbidding; The careful usefulness in mucosa place.
Points for attention: (1) must guard against inlet.
(2) this product contains Realgar, unsuitable long-term, large tracts of land use.
(3), shake up the back and use if any small amount of precipitate.
Embodiment 2:
Prescription: Juniperus oxycedrus 110g, Rhododendron 110g, Artemisia sieversiana Willd. 110g, Herba Ephedrae 110g, Cacumen Myricariae Germanicae 110g, Fel Ursi powder 7.5g, Tangut Przewalskia 115g, Realgar 115g, Chalcanthitum 65g, artificial Moschus 2.5g, Herba Menthae 125g; Make 1000ml.
Other is all with embodiment 1.
Need to prove that the foregoing description can exemplify many, owing to the heat and toxic materials clearing away medicine that mostly is of the application's employing, therefore the scope at above-mentioned raw materials all can realize purpose of the present invention.Do not exemplify one by one at this.
To be my company's scientific research develop in conjunction with Chinese medicine basic theories and modern medicine and pharmacology theory according to clinical experience for many years from the member the clean health lotion of skin prescription.This side's reasonable recipe, evident in efficacy, have no side effect, be the acute and chronic dermatitis of treatment, skin pruritus, the pudendal pruritus due to the tinea manuum, tinea pedis and the gynecological inflammation advanced medicine of disease that swells and ache.This side by Juniperus oxycedrus, Rhododendron, Artemisia sieversiana Willd., Herba Ephedrae etc. ten simply Chinese medicine form, be monarch drug wherein with Juniperus oxycedrus, Rhododendron, Artemisia sieversiana Willd., play heat-clearing and toxic substances removing altogether, removing the necrotic tissue and promoting granulation, pain relieving, antipruritic merit diminish inflammation the purpose of antalgesic-antipruritic to reach; Herba Ephedrae, Cacumen Myricariae Germanicae heat-clearing and toxic substances removing; Tangut Przewalskia, Realgar tool parasite killing, detoxifcation, the effect of antiinflammatory; Four ministerial drugs in the side of being altogether; Help simultaneously with Herba Menthae, Chalcanthitum a surname looses, holds back skin ulcer, and then reaches the purpose of detoxifcation, removing the necrotic tissue and promoting granulation; With Fel Ursi powder, artificial Moschus is messenger drug, plays heat-clearing and toxic substances removing altogether, granulation promoting, pain relieving, antipruritic merit.
Specify: with the clean health lotion of skin that hereinafter occurs, the lotion that all refers to swell and ache treatment cutaneous diseases of the present invention and pruritus vulvae the medicine of disease makes.
The clean health lotion of skin Pharmacodynamic test of active extract
1, antiinflammatory action
The rat capillary permeability influenced 40 of SD rats, body weight 200~250g, male and female half and half, be divided into 5 groups at random, skin of abdomen coating every day 1 time, for three days on end, 1h after the art time administration, tail vein injection 0.5% azovan blue 10ml/kg, lumbar injection 0.6%HAC10ml/kg takes off neck and puts to death rat behind the 20min immediately, cut off skin of abdomen, repeatedly wash the abdominal cavity with dirt reason saline, collect merging washing liquid 6ml, get the 3ml supernatant, with the distilled water proportional diluted, the centrifugal 5min of 5000r/min with the absorbance of UV1221 spectrophotometric determination supernatant at the 590nm place, the results are shown in Table 1.The clean health lotion of skin can suppress the capillary permeability increase that acetic acid causes significantly, and certain dose-effect relationship is arranged.
The influence of table 1 pair capillary permeability (
Figure A20071001850300111
, n=8)
Group Dosage (ml/kg) Optical absorbance
The clean health lotion of the clean health lotion of the clean health lotion of Oleum Camelliae safflower oil skin skin skin 0.35 2.14 2.14 4.28 8.56 0.932±0.237 0.554±0.209 ** 0.813±0.209 0.626±0.145 * 0.543±0.125 **
Compare with matched group *P<0.05, *P<0.01
2, itching-relieving action
30 of Cavia porcelluss, body weight 250~300g, male and female have concurrently, divide 5 groups at random, the previous day hair are shaved on each right back instep of group Cavia porcellus in experiment.Test the same day, with the coarse sandpaper scratch Cavia porcellus right back instep about 1cm in unhairing place 2Coating again divides into groups, 10min after the last administration, beginning is only dripped 0.01% 0.05ml/ of histamine phosphate on wound surface, after this press 0.01%, 0.02%, 0.03% every 3min ... concentration is incremented to 0.1% (calculating by 0.1% greater than 0.1% concentration) and begins to lick right back foot until Cavia porcellus.Later licking the right back histamine phosphate's accumulation total amount that is given when sufficient with Cavia porcellus is itch-threshold.The results are shown in Table 2.As seen the clean health lotion of skin can obviously improve the itch-threshold of Cavia porcellus, and has tangible dose-effect relationship.
The itching-relieving action test of the clean health lotion of table 2 skin (
Figure A20071001850300112
, n=6)
Group Dosage (ml/kg) Itch-threshold (μ g)
The clean health lotion of the clean health lotion of the clean health lotion of Oleum Camelliae PIKANG SHUANG skin skin skin 0.35 25mg 2.14 4.28 8.56 1.75+1.21 20.17±7.81 ** 2.58±2.08 9.42±5.94 * 21.0±8.36 **
Compare with matched group *P<0.05, *P<0.01
3, bacteriostasis
External bacteriostasis is diluted reagent (original liquid concentration 0.98gml with corresponding culture medium -1), it is some to get test tube, and every pipe adds reagent 1mL, and every adds 0.1mL through 10 -3The fresh bacterium liquid of dilution (Candida albicans was by dilution in 1: 800).Putting in 37 ℃ of incubators, cultivate 18h, is minimum inhibitory concentration (MIC) with the least concentration that does not form bacterium colony in the test tube.The bacterial strain matched group adds not dosing of bacterium.The result shows that the clean health lotion of skin all has in various degree inhibitory action to staphylococcus aureus, escherichia coli, gonococcus, bacillus pyocyaneus, Candida albicans, especially to gonococcus sensitivity (seeing Table 3).
The external bacteriostatic experiment of table 3
Strain The clean health lotion of skin MIC (gml -1) JIEERYIN XIYE MIC (mlml -1)
Staphylococcus aureus e coli gonococcus Bacillus proteus Candida albicans 0.242 0.121 0.06 0.121 0.121 0.416 0.208 0.208 0.242 0.208
4, cellular immune function test
50 of ICR male white mouses, body weight (21.2 ± 2.9) g is divided into 5 groups at random, every Mus intramuscular injection every day phytohaemagglutinin 10mg/kg, be total to 3d, experimental group subcutaneous injection every day medicine is 0.1ml/ simultaneously, matched group injection equivalent normal saline, be total to 8d, 8d cuts tail, gets the blood push jack, Wright's staining, the oil mirror is 200 lymphocytes of counting, lymphoblast, transitional-cell down, calculates their shared percentage rate respectively.3 dosage groups of the clean health lotion of skin all can make mice that the PHAL conversion reaction is strengthened as a result, the percentage rate of lymphoblast, transitional-cell and matched group more all have significant difference (P<0.05) through rank test, illustrate that it can improve lymphocytic responsibility, promptly improves cellular immune function.Compare with the JIEERYIN group, both curative effect there was no significant differences (P>0.05) see Table 4.
The influence of table 4 pair mouse lymphocyte conversion reaction (
Figure A20071001850300121
, n=10)
Group Lymphoblast (%) Transitional-cell (%)
The clean health lotion of clean health lotion 100% skin of clean health lotion 50% skin of matched group JIEERYIN group 10% skin 18.67±3.89 26.08±4.19* 26.92±4.56* 27.10±4.38* 27.17±4.23* 38.75±6.25 40.75±5.66 44.75±6.86* 44.70±6.79 44.67±6.75*
Compare with matched group *P<0.05,
5, analgesic effect
Adopt 44 of mouse writhing method analgesic test NIH mices, male and female half and half, body weight 18~22g, divide 5 groups at random, the mouse web portion cropping is after skin coating every day 1 time, for three days on end, 1h after the last administration, lumbar injection 0.6% acetic acid 10ml/kg, the writhing response number of times of mice the results are shown in Table 5 in the record 15min.The clean health lotion of skin high dose group can significantly reduce the writhing response number of times of mice.
Table 5 mouse writhing method analgesic test (
Figure A20071001850300131
, n=9)
Group Dosage (ml/kg) Turn round body number of times (inferior)
The clean health lotion of the clean health lotion of the clean health lotion of Oleum Camelliae safflower oil skin skin skin 0.35 2.14 2.14 4.28 8.56 25.8±16.0 11.1±5.78 * 15.4±8.47 15.1±7.80 11.8±7.98 *
Compare with matched group *P<0.05,
6, refrigeration function
Influence to rabbit fever models due to the bacterial endotoxin is got healthy white rabbit, male and female half and half, 2.0~2.2kg, measure body temperature every day 1~2 time, more than the 3d, make rabbit adapt to the body temperature operation continuously, between 38.6~39.5 ℃ of the selection body temperature, fluctuation 0.3 ℃ with interior person, be divided into 4 groups at random, 6 every group, remove positive controls ig and give aspirin (0.1gkg-1), all the other 3 groups of rabbit abdominal part depilations are coated with respectively with distilled water, the clean health lotion 4.28 of skin, 8.56mlkg -1, administration scope 5 * 4cm 21h after the administration, every rabbit is all from auricular vein injection endotoxin standard substance 50Eukg -1, attacking back 0.5,1,2,3,4 in endotoxin, 6h respectively surveys body temperature 1 time, is radix with rabbit body temperature meansigma methods before the administration, calculates each minute point rabbit body temperature and changes, and changes with each time point body temperature and does the t check.Body temperature raises gradually after the results are shown in Table 7. distilled water group rabbit injection endotoxin, reaches the peak in 1h, and body temperature slightly descends subsequently, reaches the peak the 2nd time in 4h, and continues to 6h, the clean health lotion of skin 8.56mlkg -1The dosage group can resist that rabbit body temperature raises due to the iv endotoxin 0.5h, and effect continues to 6h, with the distilled water group relatively, significant difference (P<0.01 or P<0.05) is arranged.Positive drug aspirin also has remarkable inhibitory action, and prompting skin clean health lotion can obviously suppress rabbit infective fever due to the endotoxin.
The clean health lotion of table 6 skin to the influence of rabbit fever models due to the bacterial injection endotoxin (
Figure A20071001850300132
, n=6)
Group Dosage kg -1 Body temperature before the injection Injection back fervescence value
0.5h 1h 2h 3h 4h 6h
The clean health of the clean health skin of distilled water aspirin skin 0.1g 8.56ml 4.28ml 39.1±0.3 39.2±0.3 39.1±0.3 39.1±0.3 0.33±0.23 0.23±0.22 0.07±0.05 *0.25±0.16 1.12±0.19 0.70±0.11 ** 0.53±0.23 ** 0.76±0.22 * 0.98±0.15 0.72±0.13 **0.68±0.17 **0.77±0.16 * 1.05±0.10 0.80±0.11 **0.78±0.15 **0.85±0.16 * 1.20±0.09 0.90±0.14 **0.88±0.12 **1.02±0.12 * 0.87±0.08 0.60±0.24 * 0.65±0.18 * 0.72±0.12 *
Compare with distilled water, *P<0.05, *P<0.01.
7, to the influence of vaginal mucosa multiple dosing
SD ♀ rat, body weight (220 ± 20) g is divided into two groups at random, 6 every group.1. the clean health lotion of skin group (0.98g/mL is in crude drug); 2. blank group (equal-volume distilled water).With the Mus irrigation stomach device each is organized used reagent 0.2mL and inject in the rat vagina, every interval 1h administration 1 time, every day 3 times, in continuous 1 week, 24h puts to death animal after the last administration, gets the vagina tissue inspection.Group of perusal administration as a result and matched group all do not have redness, hyperemia, and pathological change is not also seen by histopathologic examination.
The clean health lotion of skin toxicity test
1, acute toxicity test
1.1 guinea pig skin is prepared the preceding 24h of administration, and guinea pig back spinal column diamond wool is sloughed, the depilation area is 40cm 2About, 24h checks whether skin of unhairing scratches because of unhairing, and injured as skin, this Cavia porcellus should not be as the acute toxicity testing of intact skin after the unhairing; With the sterilization needle point unhairing skin of sterilizing is scratched, seeing has oozing of blood degree of being, this Cavia porcellus is as the acute toxicity testing of damaged skin.
1.2 method and observation experiment are divided into 4 groups, be two dosage groups of normal skin, two dosage groups of damaged skin, every group 10, every of low dose group gives the clean health lotion of skin 1mL, every of high dose group gives the clean health lotion of skin 5mL, to be tried thing and be applied to back part of animal depilation district equably, the high dose group gradation is coated with, treat the dried back of each medicine repaste next time, use nonirritant gauze and immobilization with adhesive tape at last, to after being tried thing 24h, remove the residual thing that tried with warm water, removal is tried behind the thing 1,24,48,72h to the seven days, every day observed and recorded animal skin hair, the variation of eye and mucosa, breathe, the central nervous system, extremity activity etc. has not poisoning manifestations, if meet animal dead, pathological examination is carried out in postmortem in time and perusal in case of necessity.
1.3 The acute toxicity tests shows, is tried thing 1h in removal and begins to observe, until the 7th day, the activity of normal skin group laboratory animal is looked for food normally freely, and coating place skin and hair gloss is normal, eye and mucosa no change, breathe no abnormally, do not see that nervus centralis has unusual performance; Do not see that Cavia porcellus has the whole body toxic reaction, none animal dead; The damaged skin group occurs the redness behind the damaged skin coating, and other sign and normal skin group are no abnormal.Show that two kinds of dosage of the clean health lotion of skin do not produce acute toxic reaction, just the use of skin injury place can make red swelling of the skin.
2. anti-allergic effects
30 of albino guinea-pigs, body weight 250~300g is divided into 3 groups at random, and 10 every group, male and female half and half, elder generation is unhairing 3cm * 3cm on the skin of left side, back, the 2nd day coating.The 1st group is coated with the clean health lotion of skin 2ml, and two groups are coated with vaseline 2g, and three groups are coated with 1% dinitrochlorobenzene (DNCB) 0.2ml, all use glass paper, gauze, immobilization with adhesive tape keeps 6h, the same again coating in the 7th day and 14 days each 1 time, carry out provocative test behind the 14d, unhairing 3cm * 3cm on the skin of right side, back, one, two, three group is coated with the clean health lotion of skin 1ml respectively, vaseline 1g, 1%DNCB0.2ml.Remove behind the 6h and be coated with thing, observe at once, and in 24,48,72h observes skin allergy.
It is rubescent that DNCB group Cavia porcellus excites the skin at position to be moderate, Mild edema, and showing has sensitization.And clean health lotion of skin and vaseline group are not found anaphylaxis.
3, long term toxicity test
40 of wistar rats, body weight 200~230g, male and female half and half are divided into 4 groups at random, every group 10, the unhairing 6cm * 7cm on skin of back of elder generation, the 2nd day begins coating or blank (vaseline), and 1,2,3 groups of each coatings of medicine are respectively 4,8,16ml/kg, 28d continuously.Except that skin is obviously rubescent, do not see other toxic reactions, animal activity, diet, hair, mucosa are all as usual, behind the 28d about weight increase 20g.Blood parameters, hemogram and matched group do not have significant difference (table 7,8), the heart, liver, spleen, lung, kidney, stomach, intestinal, uterus, testis gross examination of skeletal muscle, the all no abnormal phenomenon of medicine group and matched group, medicine is heavy dose of group of the clean health lotion of skin and matched group for 3 groups, the skin and the heart, liver, spleen, lung, nephridial tissue section microscopy are not found the pathological change relevant with medicine.
The clean health lotion of table 7 skin skin toxicology test---to the influence (n=10) of hemogram
Group Hemoglobin g/L RBC number * 10 12/L Leukocyte count * 10 9/L Leukocyte differential count (%) Platelet count * 10 9/L
Lymphocyte Neutrophilic granulocyte Mononuclear cell
3 groups of matched groups of 2 groups of medicines of 1 group of medicine of medicine 156.6±14.7 152.0±8.34 152.9±8.25 157.0±11.0 5.34±0.72 5.18±0.48 5.12±0.23 5.35±0.51 11.4±1.08 11.6±1.11 11.7±1.41 11.1±0.82 66.5±3.71 65.8±5.90 67.7±4.90 68.2±3.32 29.0±3.77 29 8±5.94 27.1±5.17 27.1±3.30 4.30±0.94 4.40±1.57 4.20±1.22 4.30±0.63 445.6±18.1 463.1±35.5 455.3±26.8 446.1±22.7
The clean health lotion of table 8 skin skin toxicology test---to the influence of blood biochemical
Group AST (Ka Menshi unit) ALT (Ka Menshi unit) BUn (mmol/L) Cr (umol/L) AKP (King unit)
3 groups of matched groups of 2 groups of medicines of 1 group of medicine of medicine 9.3±1.9 8.9±1.9 8.4±1.9 8.5±1.1 20.7±7.8 21.2±5.3 20.3±6.0 19.9±4.1 5.3±1.1 4.8±1.0 5.2±1.1 4.8±1.1 71.6±14.1 67.7±10.3 73.4±12.8 69.3±12.7 20.7±14.4 28.1±12.7 21.4±13.3 21.3±11.5
The clean health lotion of continuous table table 8 skin skin toxicology test---to the influence of blood biochemical
Group GLu (mmol/L) TC (mmol/L) Bil (umol/L) TP (g/L) ALB (g/L)
3 groups of matched groups of 2 groups of medicines of 1 group of medicine of medicine 6.2±0.9 5.6±0.9 6.3±0.7 6.2±1.2 1.5±0.4 1.4±0.4 1.3±0.4 1.3±0.4 5.6±1.1 5.8±0.9 5.6±1.4 5.5±1.2 69.2±4.1 70.8±6.2 73.0±4.8 69.6±5.7 33.8±4.5 34.1±4.2 36.3±3.3 38.7±3.3
Annotate: AST (aspartic acid aminotransferase), ALT (ALT), Bun (blood urea nitrogen), Cr (flesh liver), AKP (alkali phosphatase), GIu (blood glucose), TC (T-CHOL), BIL (bilirubin), TP (total protein), ALB (albumin).
Conclusion: the result shows that two kinds of dosage of the clean health lotion of skin all do not produce acute toxic reaction, and just the use of skin injury place can make red swelling of the skin.In addition, the clean health lotion of skin does not have skin allergy.The heavy dose of group of long term toxicity test and matched group relatively, blood parameters, hemogram all do not have apparent property difference, illustrate that this medicine does not have toxicity under correct situation about using, can use safely.

Claims (2)

1. one kind is used for the treatment of the swell and ache medicine of disease of cutaneous diseases and pruritus vulvae, it is characterized in that, this medicine that makes is made up of following raw materials according and weight ratio thereof: Juniperus oxycedrus: 11%~13%, Rhododendron: 11%~13%, Artemisia sieversiana Willd.: 11%~13%, Herba Ephedrae: 11%~13%, Cacumen Myricariae Germanicae; 11%~13%, Fel Ursi powder; 0.6%~0.8%, Tangut Przewalskia: 9%~11%, Realgar: 9%~11%, Chalcanthitum: 5%~7%, Moschus: 0.2%~0.4%, Herba Menthae: 10%~12%, the summation of raw material is 100%.
2. described the swell and ache preparation method of medicine of disease of cutaneous diseases and pruritus vulvae that is used for the treatment of of claim 1 is characterized in that, follows these steps to preparation:
Realgar water is flown into fine powder, and Moschus is the porphyrize powder in addition;
Chalcanthitum, Fel Ursi powder filter with a small amount of warm water dissolving respectively, obtain Chalcanthitum and Fel Ursi powder solution;
Juniperus oxycedrus, Rhododendron, Artemisia sieversiana Willd., Herba Menthae are used water vapour distillation volatile oil, and medicinal residues and Herba Ephedrae, Tangut Przewalskia, Cacumen Myricariae Germanicae decoct with water secondary, 3 hours for the first time, 2.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.20-1.25 (50 ℃);
With clear paste and above-mentioned Realgar and Moschus fine powder and Chalcanthitum and Fel Ursi powder solution mix homogeneously, spray into volatile oil, stir evenly, packing, promptly.
CNA2007100185031A 2007-08-17 2007-08-17 Medicine for treating dermatological disease and vaginal tickle and gall gynaecologic disease Pending CN101112444A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606315A (en) * 2015-03-09 2015-05-13 李汶峰 External medicine for treating female vaginal itching and preparation method for external medicine
CN108663472A (en) * 2018-04-20 2018-10-16 国药集团德众(佛山)药业有限公司 The identification method of savoury rhododendron oil

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606315A (en) * 2015-03-09 2015-05-13 李汶峰 External medicine for treating female vaginal itching and preparation method for external medicine
CN108663472A (en) * 2018-04-20 2018-10-16 国药集团德众(佛山)药业有限公司 The identification method of savoury rhododendron oil

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