The specific embodiment
The eczema scrotum traditional Chinese medical science generally is divided into two kinds of deficiency and excesss: real person is many because of damp invasion of lower energizer.Owing to have a liking for the pungent delicious food of food usually, or dampness of scrotum, perspiration soaks into, underwear friction and causing.Variations such as erosion is oozed out, incrustation appear in the visible pimple of scrotum, minor carbuncle, abscess after scratching brokenly, red red, the causalgia of skin of scrotum, and deficiency syndrome are many, and skin of scrotum thickens by the acute stage transformation, coarse as grass, black, pruritus is unbearably.To the suitable clearing away heat-damp and promoting diuresis of the treatment of excess syndrome, the deficiency syndrome skin moistening that then should nourish blood.
The Sui Dynasty Chao Yuanfang (550-630 A.D.) is put down in writing in " General Treatise on the Cause and Symptoms of Diseases ": " all skin ulcer persons of a specified duration, interior-heat is outer empty, by rheumatism is taken advantage of, then the women's head-ornaments health is all given birth to skin ulcer ".Ming Dynasty's Chen Shigong has replenished improper diet at " Waike Zhengzong, Orthodox Manual of External Diseases ", the cause of disease that interior life is damp and hot.Record in " Ling Shu Miraculous Pivot or Divine Axis determine gas ": " part of the body cavity above the diaphragm housing the heart and lungs exploitation, a surname grain rice flavor, fill body, pool hair at smoked skin, if irrigating of revealing of mist is meaning gas." " element ask the five internal organs generate a piece of writing " says: " and lung close fur, its flourish mao is also." so during insufficiency of lung-QI then skin lose nourish and cause dry matt, hair is withered, eczema very then.Eczema is the card of " deficiency in origin and excess in superficiality " as can be seen from above-mentioned argumentation, and " deficiency in origin " is meant asthenia of pulmonosplenic qi, " mark real " be meant wind, wet, heat three is evil in suffering from, and adopts the method for " inside and outside rule together " in view of the above.The pharmaceutical compositions of heat clearing and damp drying of the present invention, wind dispelling insecticide, promoting pus discharge and tissue regeneration strengthening in skin penetrates body, strengthens therapeutical effect, has improved the curative effect of controlling " mark ".Obtain ideal curative effect, be worth clinical expansion.
The traditional Chinese medical science thinks, the endogenous cause of ill of eczema insufficiency of the spleenly is stranded transformation failure of spleen by damp and hot; Exopathogenic factor is the damp and hot heresy of impression, fills in space between skin and muscles.Prolonged illness is deficient vital QI leading to lingering of pathogen then, stagnation of dampness due to deficiency of the spleen, or wind syndrome due to blood-deficiency is living dry, wind-dryness pent-up, skin cervical carcinoma with cachexia.Doctor trained in Western medicine is thought primary disease cause of disease complexity, is commonly considered as the allergy associated diseases, can be caused by factors such as allergy, disease factor, delayed ischemic neurological deficits and endocrine.Chinese traditional treatment divides damp-heat type, blood-deficiency and wind-dry type and stagnation of dampness due to deficiency of the spleen type clinically, whole body therapeutic was often ignored in the Chinese traditional treatment of eczema scrotum in the past, and only pay attention to topical therapeutic, treat based on the Chinese medicine external fumigation and washing merely, this method facts have proved poor effect, symptom maybe can be alleviated but be easy to recurrence, so the Chinese traditional treatment of eczema scrotum should be a basis with the whole body determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, in conjunction with topical therapeutic.For the heavier patient of pruritus erosion, suitably use the rapid patients in remission of Claritin energy of doctor trained in Western medicine, reduce patient's misery, the increase curative effect is deficiency of both the liver and kidney, deficiency of kidney-essence, so adopt the principle for the treatment of both the principal and secondary aspects of a disease.At interior liver and kidney tonifying, able-bodied its kidney source of training the kidney invigorating.
Radix Sophorae Flavescentis has another name called Albizzia kalkora in the side, and is cold in nature, and bitter in the mouth is gone into the heart, spleen, kidney three warps, and the effect of heat-clearing and toxic substances removing, dispeiling pathogenic wind and removing dampness is arranged.Modern medicine study shows: Radix Sophorae Flavescentis has good effect at antiviral, aspect such as antibiotic, and the function that reduces bacterial content is arranged, and reaches the purpose of bacteria growing inhibiting; Cortex Phellodendri, bitter cold, heat clearing and damp drying, modern pharmacological research confirms that Cortex Phellodendri has obvious antibacterial action to staphylococcus aureus, Streptococcus viridans etc.; Herba Hedyotidis Diffusae, Herba Patriniae, Radix Arnebiae (Radix Lithospermi), the Cortex Dictamni bitter cold, heat-clearing and toxic substances removing, expelling wind and removing dampness, the compatibility Cortex Phellodendri is strengthened the effect of removing damp to relieve itching; Fructus Cnidii, Rhizoma Smilacis Glabrae, Herba Portulacae energy dispeiling pathogenic wind and removing dampness, killing parasites for relieving itching, Radix Angelicae Dahuricae heat-clearing and toxic substances removing, nourshing blood and promoting blood circulation, promotion local blood circulation are repaired the atrophy mucosa, strengthen the anti-damage ability of mucosa, local inflammation is disappeared, Zaocys, Scolopendra, Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) treating the poisonous disease with poisonous drugs, the good medicine of a small amount of external energy removing the necrotic tissue and promoting granulation, antipruritic effect and promoting granulation; All medicine compatibilities take advantage of hot smoking to wash scrotum, make local symptom alleviate final the healing.
Fructus Cnidii suffering, hardship, temperature; Slightly poisonous.Return kidney channel.Cure mainly warming the kidney to invigorate YANG, dampness is dispeled the wind, parasite killing.Be used for sexual impotence, cold womb, cold-damp leukorrhagia, arthralgia chiefly caused by damp pathogen lumbago; The external treatment vulval eczema, married woman's pudendal pruritus; Eczema scrotum is gynecological external use good medicine." Bencao Jingshu " carries: Fructus Cnidii, and bitter in the mouth is flat; " not Lu " be hot sweet nontoxic; Modern detailed its abnormal smells from the patient, when the warm-dryness syndrome of must holding concurrently, sun also.So swell and ache in housewife people's the moon, man's impotence pruritus due to damp pathogen removes stagnated QI, sharp joint, malignant boil." not Lu " warming the middle warmer and descending qi makes married woman's Zifu heat, and the man is cloudy strong, has made us son.Lid can dehumidify with tongue, temperature energy cold expelling, and suffering can be moistened kidney, and sweet energy strengthening the spleen is so can remove the wet disease of viscera connecting with this channel of all deficiency and coldness of married woman man.Cold-damp was both removed, and then disease is gone, performance Yiyang, thus disease, and have tonification also.
Cortex Phellodendri heat clearing and damp drying, pathogenic fire purging are removed and are steamed, and skin ulcer is treated in detoxifcation.Be used for damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity is warded off, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, eczema pruritus.The stir-baked CORTEX PHELLODENDRI with salt solution nourishing YIN to lower pathogenic fire.Be used for hyperactivity of fire caused by deficiency of YIN, the night sweat hectic fever due to YIN-deficiency." Chinese pharmacopoeia is carried the power of Cortex Phellodendri heat clearing and damp drying, and is similar to Radix Scutellariae, Rhizoma Coptidis, but is good to remove the damp and hot of the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels.
The Radix Sophorae Flavescentis hardship, cold.GUIXIN, liver, stomach, large intestine, urinary bladder channel heat clearing and damp drying, parasite killing, diuresis.Be used for hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy; External treatment eczema scrotum often is used in combination with Cortex Phellodendri, is the colpitic external use gynaecological good medicine of treatment.
Herba Hedyotidis Diffusae is Herba Hedyotidis Diffusae, two leaves, Herba Commelinae Bengalensis, Chinese Lobelia again.Mildly bitter flavor, sweet, cold.Go into stomach, large intestine, small intestine meridian, the clearing up internal heat by using drugs of bitter in taste and cold in nature detoxifcation, sweet cold eliminating damp-heat has stronger removing toxicity for eliminating carbuncles effect to carbuncle, pharyngalgia, snakebite etc.Generally be used for the treatment of sore, laryngopharynx swelling and pain, abdominalgia with intestinal abscess, venom, also be used for the puckery pain of pyretic stranguria, dysuria.Be the good medicine of damp eliminating of drawing out pus by applying a plaster to the affected part.
The Herba Patriniae nature and flavor are bitter flat, have the effect of heat-clearing and toxic substances removing, evacuation of pus removing blood stasis with potent drugs.Can cure acute appendicitis, dysentery, leucorrhea with red and white discharge, the stagnant stomachache of the stasis of blood in puerperal, conjunctival congestion and swelling pain.Go into stomach, large intestine, Liver Channel.Cure mainly heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus, blood circulation promoting competent silt.Be used for acute appendicitis, lung abscess and sore and toxic, the breast abdomen pain due to the excess-heat stasis of blood stagnates, the stagnant stomachache of the stasis of blood in puerperal waits disease.
Rhizoma Smilacis Glabrae is sweet, light, and is flat.Return liver, stomach warp.The function dehumidifying, detoxifcation, easing joint movement.Be used for damp and hot stranguria with turbid discharge, leukorrhagia, carbuncle, the limbs contracture due to the scrofula, scabies, mercurialism, muscles and bones contracture pain, scrofula, skin infection.Now be mainly used in damp and hot sore clinically, normal and compatibilities such as Cortex Dictamni, the Fructus Kochiae, Radix Sophorae Flavescentis, Rhizoma Atractylodis are with usefulness.
Radix Arnebiae (Radix Lithospermi) is cold in nature, sweet in the mouth, salty.GUIXIN, Liver Channel.Cure mainly removing heat from blood, invigorate blood circulation, the detoxifcation rash.Be used for that heat in blood poison is contained, purple black, the measles without adequate eruption of macule, skin infection, dermatomycosis, burn due to hot liquid or fire.Clearing away heat and cooling blood is used for measles, the calentura skin eruption, and dermatomycosis, hematuria, stranguria with blood, dysentery, skin infection is separated erysipelas." book on Chinese herbal medicine justice " carries: Radix Arnebiae (Radix Lithospermi), and the abnormal smells from the patient bitter cold, and the color purple is gone into blood, so the heat of cleaning blood system.Ancient to control the accumulation of heat of internal organs, the then special treatment of smallpox infections of descendant is treated skin eruption, all positive purport of heat clearing and blood cooling and hold concurrently.
Cortex Dictamni is cold in nature, bitter in the mouth.Cure mainly heat clearing and damp drying, the detoxifcation of dispeling the wind.Be used for that damp and hot sore, yellow fluid are dripping, dermatomycosis, scabies skin ulcer leprosy, rheumatism pyretic arthralgia, jaundice dark coloured urine.The normal medicines such as Radix Sophorae Flavescentis, the Fructus Kochiae that cooperate are with using." book on Chinese herbal medicine is original " carries it: " control all mange, aversion to wind, scabies, Fructus Myricae rubrae, all skin ulcer pyretic toxicity."
Herba Portulacae acid, cold.Return liver, large intestine channel.Be applicable to dysentery, heat-clearing and toxic substances removing, cooling blood for hemostasis.Be used for toxic-heat and blood stasis, the carbuncle furuncle, dermatomycosis, erysipelas, snake bite and insect sting is had blood in stool, hemorrhoidal bleeding, metrostaxis." open value greatly surely new book on Chinese herbal medicine ": " Herba Portulacae, clothes not white all the year round." " Bencao Jingshu ": " and not white all the year round, always say its removing heat from blood benefit blood, disease is removed the light merit ear of body.”
The Radix Angelicae Dahuricae: meridian distribution of property and flavor: suffering, temperature.Attach to the lung and stomach meridians.Expelling wind and cold, understand things pain-stopping, detumescence and apocenosis, dampness leukorrhagia stopping.Be used for wind-damp dispelling, the evacuation of pus of invigorating blood circulation, granulation promoting pain relieving.Be used for headache, toothache, nasal sinusitis, hemorrhoidal hamorrhage anal fistula, leucorrhea with red and white discharge, ulcer sores, skin pruritus." Japan hanako materia medica ": control the conjunctival congestion bulbar conjunctiva polyp, and tire patching leakage landing, broken stagnated blood is mended fresh blood, acute mastitis, carbuncle on the back, scrofula, hemorrhoidal hamorrhage, hemorrhoid complicated by anal fistula, and evacuation of pus, desolation, scabies, the pain relieving granulation promoting is gone face Shao-defect scar.
Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) suffering, hardship, flat.Poisonous.Eliminating stagnation is relieved oedema or abdominal distension through diuresis or purgation, pain relieving, parasite killing.Be used for aqueous vapor swelling, tuberculous lymphadenitis; Scabies, tinea are controlled in external, kill fly, maggot "." herbal classic " carries it: main cough with dyspnea, removing mass is poly-, diet, cold and heat, aqueous vapor, malignant boil, the erosion of scrofula cellulitis, diseases due to noxious agents produced by various parasites.The a small amount of external of the Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) plays sterilization, the effect of chafe regeneration capacity.
Zaocys dispels the wind, collateral dredging, relieving convulsion.Be used for rheumatoid arthritis stubborn, numbness contracture, apoplexy facial hemiparalysis, hemiplegia, tic spasm, tetanus, leprosy scabies, scrofula malignant boil.Naja, Agkistrodon halys have been poisonous snake, and wind-damp dispelling, the meridian dredging effect are stronger, Zaocys and the two same usefulness, and it knowingly follows the example of a wrongdoer good.Be used for rheumatic arthralgia or rheumatoid arthritis, poker back etc.Zaocys has expelling wind and removing dampness and Detoxication, for urticaria, eczema abscess certain prevention or therapeutic effect is arranged also.
Radix Pulsatillae bitter in the mouth, cold in nature; Return stomach, large intestine channel; Has heat-clearing and toxic substances removing, eliminating pathogenic heat from blood to cure dysentery, the effect of removing dampness and killing parasites; Cure mainly pyretic toxicity dysentery, epistaxis, internal hemorrhoid with bleeding, leukorrhagia, pudendal pruritus, carbuncle skin ulcer, scrofula.. antibacterial action: the bright juice of the Radix Pulsatillae, decoct, ethanol extraction equals the external tangible antibacterial action that all has, can suppress staphylococcus aureus, bacillus pyocyaneus, dysentery bacterium, bacillus subtilis, Bacillus typhi, the growth of salmonella etc. Radix Pulsatillae antibiotic effective ingredient is protoanemonin and Anemonin, the former MIC is 1.2 * 105~3 * 105 to escherichia coli, staphylococcus aureus is 1.67 * 105, shigella is 1.67 * 10-8, tubercule bacillus is 2.5 * 10-8, and some other antibacterial is between 1.67 * 105~2.5 * 10-5. Anemonin is to diphtheria corynebacterium, staphylococcus, streptococcus, escherichia coli, the MIC of tubercule bacillus is between 8 * 10-5~2 * 10-6.
Scolopendra is salty, hot, temperature.Poisonous.Return liver, spleen, lung meridian suffering, temperature; Poisonous.Return Liver Channel.Function cures mainly, endogenous wind stopping spasmolytic, merit poison eliminating stagnation, removing obstruction in the collateral to relieve pain.Be used for infantile convulsion, the tic spasm, middle air port is askew, hemiplegia, tetanus, rheumatoid arthritis stubborn, skin infection, scrofula, venom.The toxicity of Scolopendra is to the skin malignant boil, and dermatitis has the effect of drawing out pus by applying a plaster to the affected part preferably.
In the treatment, the present invention appoints ancestor's Gu and does not obstinately follow tradition, take orally with external treatment, integral body to combine with the part, and with the invigorating the liver and kidney this, dual-purpose heat-clearing and toxic substances removing, dispelling wind for relieving itching washout are share inside and outside marking, thereby receive better therapeutic effect.
External pulvis preparation method of the present invention comprises: get Herba Portulacae 1000g, Radix Sophorae Flavescentis 1000g, Fructus Cnidii 1000g, Herba Hedyotidis Diffusae 1000g, Radix Arnebiae (Radix Lithospermi) 1000g, Cortex Dictamni 1000g, Rhizoma Smilacis Glabrae 1000g, Herba Patriniae 1000g, Cortex Phellodendri 1000g, Zaocys 1000g, Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 1000g, Radix Angelicae Dahuricae 1000g, Radix Et Rhizoma Rhei 1000g, Radix Pulsatillae 1000g, Scolopendra 1000g, choose the medical material in the prescription, the removal of impurity was soaked 30 minutes to 1 hour, heated and boiled 40 minutes is filtered filtrate for later use.Filtering residue adds water, and heating was boiled 30 minutes for the second time, refiltered filtrate for later use; Filtering residue adds water again, and heated and boiled is 30 minutes for the third time, filters.Three filtrates are lumped together, and heating is concentrated into pasty state, puts into baking oven, is controlled at 90 ℃, and the oven dry postcooling is ground into fine-powdered together into powder.Go in the plastic bag with every bag of 10g splitting, hip bath agent.Medicament usage: during treatment, get this product 10g and add 2000 milliliters of demibains of eliminating cold for resuscitation water, make medicinal liquid soak the pathological changes position 20 to 30 minutes, once a day.Per 5 days one courses of treatment.
Externally used paste of the present invention:
With Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 1500g, Zaocys 1500g and Scolopendra 1500g soak with ethanol, 70~85 ℃ of heat in back are extracted according to described ratio of weight and number, and used ethanol consumption is 10 times of amounts of the Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae), Zaocys and three kinds of medical material gross weights of Scolopendra; Heating concentrates ethanol extract, is concentrated into relative density and is 1.08 concentrated solution, stand for standby use; With all the other component Herba Portulacae 1500g, Radix Sophorae Flavescentis 1500g, Fructus Cnidii 1500g, Herba Hedyotidis Diffusae 1500g, Radix Arnebiae (Radix Lithospermi) 1500g, Cortex Dictamni 1500g, Rhizoma Smilacis Glabrae 1500g, Herba Patriniae 1500g, Cortex Phellodendri 1500g, Radix Angelicae Dahuricae 1500g, Radix Et Rhizoma Rhei 1500g, Radix Pulsatillae 1500g, mix by proportioning, drop into pulverizer and be ground into fine powder, put into the acid and alkali-resistance infusion kettle after fine powder sieves, at normal temperatures and pressures, flooded 10~15 days with ethanol is common, liquid and medicinal residues that dipping is good carry out squeeze and filter, get filtrate after the separation, and are mixed with aforementioned concentrated solution then.Above-mentioned two kinds of extracts are concentrated, mix vaseline or Cera Flava is made unguentum.
Cera Flava is the excretory wax of Apis, has astringent therapy, holds back skin ulcer, granulation promoting, analgesic function, is used for ulcer being unable to heal, ecthyma erosion, wound, burn and scald etc. outward, suppresses the local organization inflammation, promotes the histiocyte growth, quickens the healing of ulcer skin.Pharmacological testing proof Cera Flava extracting solution has parallel antibacterial action to bacillus larvae, honeycomb bacillus.Cera Flava is commonly used for the substrate of the excipient and the external-use ointment of Chinese patent medicine.Cera Flava is used as medicine as the substrate of ointment can regulate soft durometer, improves the release and the absorption of medicine.In Chinese medicine ointment of the present invention, Cera Flava also serves as the effect of substrate in performance convergence, granulation promoting pain relieving drug effect.
The preparation method of gel of the present invention: with described medicine Herba Portulacae 1500g, Radix Sophorae Flavescentis 1500g, Fructus Cnidii 1500g, Herba Hedyotidis Diffusae 1500g, Radix Arnebiae (Radix Lithospermi) 1500g, Cortex Dictamni 1500g, Rhizoma Smilacis Glabrae 1500g, Herba Patriniae 1500g, Cortex Phellodendri 1500g, Radix Angelicae Dahuricae 1500g, Radix Et Rhizoma Rhei 1500g, Radix Pulsatillae 1500g, Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 1500g, Zaocys 1500g and Scolopendra 1500g, chopping joins in the multi-function extractor, adds the water logging bubble 30~40 minutes, decocts twice, each 30~45 minutes, twice decoction liquor merged filtration, and filtrate decompression concentrates, and staticly settles 24~48 hours; Draw supernatant, stir after being heated to 40~50 ℃, under normal pressure, be condensed into ratio of weight and number and be 500 parts concentrated solution, add substrate, leave standstill, be frozen into glue.Described substrate is selected from: Tween-80, triethanolamine, propylene glycol, one or more in semi-synthetic fatty acid glyceride, poloxamer, Polyethylene Glycol, the lanoline.
General used substrate can be: semi-synthetic fatty acid glyceride, lanoline, Polyethylene Glycol, the proportioning of medicine fine powder and substrate is 1: 2~1: 4, be preferably 1: 3, or adopt poloxamer poloxamer as substrate, it has been widely used as the hydrophilic matrix of suppository, have the following advantages: the dissolubility than other substrate is soft, quick, and drug loading is also higher.
The preparation method of liniment of the present invention:
Earlier the Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 1500, Zaocys 1500g and Scolopendra 1500g are put into the ethanol heating extraction three times, with the extracting solution usefulness of purchasing silently;
Again with described all the other component Herba Portulacae 1500g, Radix Sophorae Flavescentis 1500g, Fructus Cnidii 1500g, Herba Hedyotidis Diffusae 1500g, Radix Arnebiae (Radix Lithospermi) 1500g, Cortex Dictamni 1500g, Rhizoma Smilacis Glabrae 1500g, Herba Patriniae 1500g, Cortex Phellodendri 1500g, Radix Angelicae Dahuricae 1500g, Radix Et Rhizoma Rhei 1500g, Radix Pulsatillae 1500g, mix by proportioning, decoct with water 3 times, each 1-2 hour, decoction liquor is mixed; After then said extracted liquid being mixed, heating is condensed into pasty state, and the time spent directly is applied in the affected part.
Toxicology test:
The acute oral toxicity test report
One, experiment purpose: powder of the present invention is to acute oral toxicity effect and the intensity of mice
Two, material and method:
1. tried thing: powder of the present invention; Character: pitchy powdery
2. sample pre-treatments: take by weighing 15 duplicate samples, add the 500ml boiled water, soaked 2 hours, as stock solution.
3. experimental animal: one grade of Kunming mouse, 20, female, male half and half, body weight 18-22 grams; Provide by Shandong medical college Experimental Animal Center;
Three, test method: (a time maximum limit is mensuration)
Select 20 of healthy adult mices, body weight 18-22 gram, female, hero half and half, the dosage design is female to be 6000m part/k part BW, male is 6000m part/k part BW, irritates stomach by 0.1ml/10 part BW per os and is tried thing.Irritate the preceding animal fasting of stomach 12 hours, freely drink water.Give normal diet after irritating stomach, observed for two weeks, record poisoning symptom and death condition.
Four, result of the test:
In 14 day observation period, the no abnormal reaction of animal subject does not have death, the postmortem no abnormality seen.Female, male mice acute oral LD 50 is greater than 5000m part/k part/BW.
Five, conclusion:
Judge the nontoxic level in the true border of powder of the present invention according to acute toxicity grading criteria in " disinfection technology standard " (1999).
The cumulative toxicity test report
One, test method: (dosage escalation cumulative coefficient method)
Experiment material: the same, be kunming mice.Select 20 healthy mices for use, female, male each 10, dosage designs per 4 days and is first phase, each issue dosage is respectively 0.10LD 50,0.15LD 50,0.22LD 50,0.34LD 50,0.50LD 50, and the LD 50 female, male mice of this sample is 5000m part/k part BW (five dosage be 500,750,1100,1700,2500m part/k part BW).Weighed once in per 4 days, and adjusted dosage, press 0.1ml/10 part BW per os and irritate stomach.After 20 days, animal does not have death condition takes place, and cumulative coefficient is calculated in off-test.
Two, result of the test:
To being tried 20 days handss of thing, female, buck does not all have death condition and takes place by ascending-dose.Calculate cumulative coefficient greater than 5.
Three, brief summary:
Judge that according to cumulative toxicity grade scale in " disinfection technology standard " (1999) powder of the present invention belongs to weak cumulative toxicity to the mice cumulative toxicity.
The acute skin irritation test report
One, experiment purpose: detect stimulation/corrosiveness and the intensity of unguentum to laboratory animal skin
Two, material and method:
1. tried thing: title: unguentum of the present invention
2. laboratory animal: one grade big ear white race rabbit, 4, female, body weight 2.1-2.3k part; Provide by Shandong medical college biology department Experimental Animal Center;
3. test method:
Select for use the intact healthy family of skin to exempt from 4, its spinal column both sides, back were cut left and right each the about 3cm * 3cm of unhairing area by hair in preceding 24 hours in test.Get during test and tried to be applied to a side skin of unhairing surface on two layers of gauze that thing 0.2ml is applied to 2.5cm * 2.5cm, oilpaper covers, immobilization with adhesive tape.Opposite side skin is as blank.Seal after 4 hours, dismantle, and remove the residual thing that tried with the warm water cleaning, the position dermoreaction is smeared in the observation in 1,24 and 48 hour after removal is tried thing, and scoring.
Three, experimental result: any erythema does not appear in laboratory animal skin, redness, inflammation phenomenon.
Four, brief summary: judge that according to skin irritation reaction standards of grading in " disinfection technology standard " (1999) ointment of the present invention belongs to nonirritant to the animal skin stimulus intensity.、
Repeatedly skin irritation test testing result following (based on unguentum) of the present invention:
(1), material and method
1, experimental animal feeding environment room temperature is 22 ℃ ± 2 ℃, relative humidity: 60%-70%.
2, experimental animal: Japan large ear rabbit; Animal rank: regular grade; 4, male; Body weight 2 kg-3kg.
3, animal origin: Shandong medical college biology laboratory provides
(2), method 1, test basis: Ministry of Public Health " cosmetics health standard " (version in 2002) " skin irritation/corrosion test " the 6.4th " repeatedly skin irritation test ".2, sample treatment: direct as being tried thing with submitted sample.3, test procedure: 24h before the test, remove the hair of back part of animal spinal column both sides with child's hair cutter, remove scope 3cm * 3cm.Get and tried thing unguentum 0.5mL of the present invention, spread upon on the animal one side skin of unhairing, opposite side in contrast, application area 2.5cm * 2.5cm; Smear every day once, smear 14d continuously.Smear cropping at every turn, remove the residual thing that tried.Observed result behind the 1h is with reference to the scoring of " cosmetics health standard " (version in 2002) " skin irritation/corrosion test " skin irritation reaction standards of grading.
(3), result
All animals were smeared in the process at 14 days, were tried skin and erythema and edema phenomenon did not occur.Animal subject repeatedly skin irritation reacts average every day every animal integral mean value for " 0 ".
Other test result: under 20-21 ℃ of water bath condition, show through three repeated trials results, tincture 1.50% solution effects 20min of the present invention, to Candida albicans (ATCC10231) killing rate is that 99.90%, 3.00% solution effects 10min killing rate is 99.94%, 1.5% solution effects 15min is 99.94% to escherichia coli (8099), staphylococcus aureus (ATCC6538) killing rate.
Pharmacodynamics test
Experiment material:
1, tried thing and medicine: (1) externally used paste of the present invention (2), chlorphenamine, Kunming pharmaceutical factory production, lot number is 941105; (3), WUSHE ZHIYANG WAN, Guangzhou No.1 Chinese Pharmacy Factory production, lot number is 94080053; Piyanping ointment, three nine-day periods after the winter solstice pharmaceutical factory's production 2, animal: Kunming mouse, regular grade body weight 18~24g, animal housing of Shandong Medical University provides; The Wistar rat, regular grade, body weight 150~350g, biotic experiment animal housing of Shandong University provides; Cavia porcellus, body weight 200~300g, animal housing of Shandong Medical University provides.The animal male and female are all used.
Experimental technique and result:
One, to the effect of drug-induced animal skin pruritus
1, dextran is caused the influence of mouse skin pruritus
50 of mices, 5 groups of random packet: (1) blank group (distilled water 20ml/kg, ig); (2), the chlorphenamine matched group (4mg/kg, ig); (3), (2g/kg in pill weight, descends together, ig) the WUSHE ZHIYANG WAN matched group; (4), (4.5g/kg in the crude drug amount, descends together, ig) medicine low dose group of the present invention; (5), medicine high dose group of the present invention (9g/kg, ig).Each organizes mice respectively ig administration or distilled water 1 time, and behind the 30min, iv dextran 1 .25mg/kg write down every total degree and lasting total time that the mice pruritus takes place in 20 minutes.
The result shows that medicine of the present invention has obvious itching-relieving action to dextran induced mice skin pruritus, sees Table 1.With the blank group significant difference (P<0.01) is arranged relatively.
Table 1 medicine of the present invention is to the influence of dextran induced mice skin pruritus (X ± SD)
Group |
Dosage |
Number of animals |
The pruritus number of times |
The pruritus persistent period (second) |
Blank |
? |
10 |
28.8±6.7 |
164.5±30.5 |
Chlorphenamine |
4mg/kg |
10 |
6.5±3.6*** |
?12.1±3.3*** |
WUSHE ZHIYANG WAN |
2g/kg |
10 |
11.7±6.1*** |
?34.0±15.6*** |
Medicine low dose group of the present invention |
4.5g/kg |
10 |
?23.2±4.6* |
64.8±31.6* |
Medicine high dose group of the present invention |
9g/kg |
10 |
20.2±3.7*** |
?55.7±32.1*** |
Do t check, * P>0.05, * * * P<0.01 with the blank group
2, histamine is caused the influence of Cavia porcellus pruritus
50 of Cavia porcelluss, hair is shaved on right instep behind every Cavia porcellus, and uses the sand paper scratch mark, about 1 cm 2 of area, animal random packet subsequently: (1) blank group (10ml/kg, ig); (2) the chlorphenamine matched group (4mg/kg, ig); (3) the WUSHE ZHIYANG WAN matched group (1g/kg, ig); (4) medicine externally used paste low dose group of the present invention (2.3g/kg, ig); (5) medicine externally used paste high dose group of the present invention (4.5g/kg, ig).Every Cavia porcellus gastric infusion 1 time, after 30 minutes, right sufficient wound surface drips 0.01% histamine liquid in the back, after this complied with 0.01%, 0.02%, 0.03%, 0.04% every 3 minutes ... progressive concentration, only be 0.05ml/ at every turn, directly causing and Cavia porcellus occurs and later lick the right foot in back, is itch-threshold with the histamine total amount that occurs at last being given when Cavia porcellus later licks the right foot in back.
The result shows that medicine 4.5g/kg dosage group of the present invention can obviously improve itch-threshold, sees Table 2.With the blank group significant difference (P<0.01) is arranged relatively.
Table 2 medicine of the present invention is to the influence of guinea pig skin pruritus reaction due to the histamine (X ± SD)
Group |
Dosage |
Number of animals |
Itch-threshold (histamine total amount, μ g) |
The blank group |
? |
10 |
?57.0±95.1 |
Chlorphenamine |
4mg/kg |
10 |
237.9±47.4*** |
WUSHE ZHIYANG WAN |
1g/kg |
10 |
181.0±106.7** |
Medicine low dose group of the present invention |
2.3g/kg |
10 |
?155.0±102.4* |
Medicine high dose group of the present invention |
4.5g/kg |
10 |
208.3±86.8*** |
Do t check, * P>0.05, * * P<0.05, * * * P<0.01 with the blank group
Two, medicine of the present invention causes the effect of non-immunity contact urticaria to dimethyl sulfoxine
50 of Cavia porcelluss, divide 5 groups at random: (1) blank group (10ml/kg, ig); (2) the chlorphenamine matched group (4 mg/kg, ig); (3) the WUSHE ZHIYANG WAN matched group (1g/kg, ig); (4) medicine externally used paste low dose group of the present invention (2.3g/kg, ig); (5) medicine externally used paste high dose group of the present invention (4.5g/kg, ig).Each organizes every Cavia porcellus gastric infusion 1 time, after 30 minutes, be coated with 80% dimethyl sulfoxine (dehydrated alcohol preparation), 50 μ l outside the auris dextra two sides, after this in 1 hour, 3 hours thickness with 4 points of vernier caliper measurement auricle, obtain meansigma methods, deduct the outer meansigma methods that is coated with preceding 4 points of dimethyl sulfoxine, difference is a Cavia porcellus auricle edema value.The result shows that medicine 4.5g/kg dosage group of the present invention causes the non-immunity contact urticaria to dimethyl sulfoxine antagonism, sees Table 3.With the blank group significant difference (P<0.05) is arranged relatively.
Table 3 medicine of the present invention is to (the X ± SD) of the bullate influence of Cavia porcellus ear due to the dimethyl sulfoxine
Do t check, * P>0.05, * * P<0.05, * * * P<0.01 with the blank group
Three. mouse tail vein is infected the effect of bacillus pyocyaneus
Get 30 of healthy mices, be divided into 3 groups at random, i.e. blank group, PIYANPING matched group, medicine group of the present invention, 10 every group, male and female half and half, adopt clinical isolating bacillus pyocyaneus, with every mouse tail vein injection 0.2ml of 1 * 10-1 concentration, the mouse infection bacillus pyocyaneus is smeared PIYANPING matched group and medicine group of the present invention (5g crude drug/kg) simultaneously after the prerun, successive administration 3 days, observed and recorded 7 days, the blank group was irritated stomach 1%CMC-Na solution 0.8ml totally 3 days every day, write down 7 days; The results are shown in Table 4.
Table 4 pair mouse tail vein infects the effect of bacillus pyocyaneus
Annotate: compare with matched group: * * P<0.01; Compare with positive controls: #P<0.05;-expression zero; By last table experimental result as can be seen, medicine group of the present invention has better pharmacological action.
Clinical data
1 clinical data
This organizes 100 examples, the age between 18~60 years old, average 35 years old; The course of disease is the shortest 7 days, and is the longest 2 years.Clinical syndrome differentiation is divided three types, wherein damp-heat type 58 examples, blood-deficiency and wind-dry type 28 examples, the spleen and stomach being stranded by dampness type 14 examples.
2 Therapeutic Method
2.1 tcm syndrome differentiation and treatment
2.1.1 large stretch of erythema appears in damp-heat type scrotum surrounding skin, or dense is arranged like foxtail millet grain size pimple, visible point-like erosion, there is serosity to ooze out, with pruritus or scorching hot Burning Pain sense, thirst with desire to drink, constipation with dry stool; oliguria; or it is not good to have diet concurrently, uncomfortable in chest, lassitude; red tongue with yellowish and greasy fur, stringy and rolling pulse.Method of treatment: clearing away heat-damp and promoting diuresis,
2.1.2 the blood-deficiency and wind-dry type course of disease is with the passing of time, the local skin drying, and thickening or squama sample decortication is arranged, skin becomes lichenification, itches round the clock very, and the companion is dizzy weak, the light red tongue white and thin fur, soft and thready pulse is unable.Method of treatment: nourishing blood to expel wind is antipruritic.
2.1.3 the spleen and stomach being stranded by dampness type mostly is eczema and fails in time correctly to treat, and delays with the passing of time to form, skin lesion only has the erosion of minority vesicle based on little pimple, squama and incrustation, and it is not good to have diet concurrently, lassitude, and pale tongue with white fur is greasy, rolling pulse.
2.2 method of treatment
Chinese medicine demibain external demibain treatment is based on heat-clearing and toxic substances removing, removing damp to relieve itching, and the side uses: Herba Portulacae 15g, Radix Sophorae Flavescentis 10g, Fructus Cnidii 15g, Herba Hedyotidis Diffusae 15g, Radix Arnebiae (Radix Lithospermi) 10g, Cortex Dictamni 10g, Rhizoma Smilacis Glabrae 10g, Herba Patriniae 15g, Cortex Phellodendri 15g, Radix Angelicae Dahuricae 15g, Radix Et Rhizoma Rhei 10g, Radix Pulsatillae 10g, Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 2g, Zaocys 3g and Scolopendra 5g, decocting extracting juice warm water demibain 15 minutes, every day 2 times.
2.3 western medical treatment
Extensive to eczema, the acute pruritus person can give antianaphylactic treatment, available calcium gluconate is quiet pushes away or beautiful can the injection intravenous injection, oral available second filial generation antihistamine drug is as loratadine etc.The external Miconazole Nitrate Cream.
3 therapeutic effect
3.1 curative effect determinate standard is cured: skin lesion disappears fully, transference cure; Produce effects: pruritus disappears, and the skin lesion area disappears〉70 %; Effectively: pruritus disappears substantially, skin lesion area 50 %~70 % that disappear; Invalid: still feel pruritus, the skin lesion area dwindles<50 %, even increases.
3.2 therapeutic effect sees Table 1.
Table 1 treatment group and matched group curative effect be [n (%)] relatively
Group |
n |
Cure |
Produce effects |
Effectively |
Invalid |
Total effective rate |
The treatment group |
50 |
41(82) |
5(10) |
3(6) |
1(2) |
98 |
Matched group |
50 |
21(42) |
14(28) |
7(14) |
8(16) |
84 |
Specific embodiment 1: Wang, man, 32 years old.Go to a doctor in May, 2008.The patient tells dampness of scrotum in this year, and pruritus is shown effect repeatedly, aggravates 15 days.The desire that holds a sinecure is depressed, big dry stool.Have a medical check-up: see that preceding inboard of right leg and scrotum place pachyderma are coarse, desquamation, pigment is darker, and obvious scratch is arranged, and blood stain is obvious.Tongue tip side of red, yellow and greasy fur, thready and rapid pulse.Be diagnosed as: damp-heat type eczema scrotum.External: Herba Portulacae 15g, Radix Sophorae Flavescentis 10g, Fructus Cnidii 15g, Herba Hedyotidis Diffusae 15g, Radix Arnebiae (Radix Lithospermi) 10g, Cortex Dictamni 10g, Rhizoma Smilacis Glabrae 10g, Herba Patriniae 15g, Cortex Phellodendri 15g, Radix Angelicae Dahuricae 15g, Radix Et Rhizoma Rhei 10g, Radix Pulsatillae 10g, Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 2g, Zaocys 3g and Scolopendra 5g, demibain every day 2 times, recovery from illness 2 courses of treatment.Follow up a case by regular visits to not recurrence so far.
Specific embodiment 2: Xiao, the man, 48 years old, went to a doctor in January, 2009, the main suit: the happiness food is peppery, and hemorrhoid are arranged, chronic prostatitis, sensation dampness of scrotum, evening, sleep was very itched, and scratched brokenly, and pruritus is shown effect repeatedly, aggravated 10 days, large stretch of erythema appears in the scrotum surrounding skin, or dense is arranged like foxtail millet grain size pimple, visible point-like erosion, there is serosity to ooze out, with pruritus or scorching hot Burning Pain sense, thirst with desire to drink, constipation with dry stool, oliguria is diagnosed as: blood-deficiency and wind-dry type eczema scrotum.External: Herba Portulacae 10g, Radix Sophorae Flavescentis 15g, Fructus Cnidii 10g, Herba Hedyotidis Diffusae 10g, Radix Arnebiae (Radix Lithospermi) 10g, Cortex Dictamni 15g, Rhizoma Smilacis Glabrae 10g, Herba Patriniae 15g, Cortex Phellodendri 15g, Radix Angelicae Dahuricae 10g, Radix Et Rhizoma Rhei 10g, Radix Pulsatillae 10g, Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 3g, Zaocys 3g and Scolopendra 4g, demibain every day 2 times, food such as avoid pungent food, scorching.Pruritus stops after 15 days, and medication is consolidated 2 courses of treatment, follows up a case by regular visits to after half a year and does not have recurrence.
Specific embodiment 3: wear certain, man, 52 years old, weak always, emaciation and sallow complexion has eczema scrotum to fail in time correctly to treat in one's early years, chronic prostatitis is serious, with the passing of time delay forms, and skin lesion only has the erosion of minority vesicle based on little pimple, squama and incrustation, it is not good to have diet concurrently, lassitude, pale tongue with white fur is greasy, rolling pulse.Be diagnosed as the spleen and stomach being stranded by dampness type eczema scrotum.External: Herba Portulacae 15g, Radix Sophorae Flavescentis 15g, Fructus Cnidii 10g, Herba Hedyotidis Diffusae 10g, Radix Arnebiae (Radix Lithospermi) 15g, Cortex Dictamni 15g, Rhizoma Smilacis Glabrae 10g, Herba Patriniae 15g, Cortex Phellodendri 15g, Radix Angelicae Dahuricae 10g, Radix Et Rhizoma Rhei 15g, Radix Pulsatillae 10g, Radix Euphorbiae Fischerianae (Radix Euphorbiae Ebracteolatae) 3g, Zaocys 3g and Scolopendra 4g,, demibain every day 2 times, pruritus stops after 15 days, and medication is consolidated 4 courses of treatment, follows up a case by regular visits to after half a year and does not have recurrence.