Summary of the invention
The technical problem to be solved in the present invention provides the dermopathic external medicine composition of a kind of effective treatment.
For achieving the above object, the present invention is by the following technical solutions:
The dermopathic external medicine composition of a kind of treatment is made by the Radix Et Rhizoma Rhei and the Rhizoma Cimicifugae of following parts by weight: Radix Et Rhizoma Rhei 5-20 part, Rhizoma Cimicifugae 20-40 part.
The dermopathic external medicine composition of a kind of treatment is made by the Radix Et Rhizoma Rhei and the Rhizoma Cimicifugae of following parts by weight: 10 parts of Radix Et Rhizoma Rhei, 30 parts of Rhizoma Cimicifugaes.
China's Traditional Chinese medical theory thinks that herpes zoster is because depression of liver-QI, spleen channel retention of damp-heat in the interior, excessive skin and giving birth to.The main effect of Chinese medicine composition of the present invention is a clearing away heat and cooling blood, the detoxifcation pain relieving.Be mainly used in the liver and gall fire is contained, the spleen channel retention of damp-heat in the interior causes herpes zoster and all kinds of dermatosiss such as the eczema due to herpes simplex and the interior knot of noxious dampness, erysipelas, all kinds of outside infection that staphylococcus aureus, bacillus pyocyaneus, escherichia coli are caused also has certain effect.
Radix Et Rhizoma Rhei is the dry root and rhizome of polygonum rheum palmatum Rheum palmatum L., Rheum tanguticum Rheum tanguticum Maxim.exBalf or Rheum officinale Rheum officinale Baill..The main place of production: Gansu, Qinghai, Sichuan etc.Function cures mainly: purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation.Be used for the excess-heat constipation, stagnant stomachache, dysentery is not well, jaundice due to damp-heat, heat in blood is told nosebleed, conjunctival congestion, pharyngeal swelling, abdominalgia with intestinal abscess, carbuncle furuncle, blood stasis amenorrhea, traumatic injury, external treatment burn due to hot liquid or fire etc.
Rhizoma Cimicifugae is the dry rhizome of the big SANYE Rhizoma Cimicifugae of ranunculaceae plant Cimicifuga heracleifolia Kom., Rhizoma Cimicifugae Cimicifugadahurica (Turcz.) Maxim. of Xingan or Rhizoma Cimicifugae Cimicifuga foetida L..The main place of production: provinces such as Shaanxi, Heilungkiang, Liaoning, Hebei, Sichuan.Function cures mainly: deliver rash, heat-clearing and toxic substances removing, elevate a turnable ladder yang-energy.Be used for headache due to pathogenic wind-heat, toothache, aphtha, laryngopharynx swelling and pain, measles without adequate eruption, YANG toxin syndrome is sent out speckle; Proctoptosis, uterine prolapse.
Novelty of the present invention is to provide the aforementioned pharmaceutical compositions as active component, and those of ordinary skills use the known technology of galenic pharmacy, can prepare various exterior-applied formulations commonly used.
The dermopathic Chinese medicine for outer use of a kind of treatment is made up of above-mentioned Chinese medicine composition and pharmaceutics acceptable auxiliary.
Described Chinese medicine for outer use is selected from a kind of in powder, tincture, rubber-emplastrum, ointment, liniment, suppository and the aerosol.
Powder means the powder preparation that one or more Chinese crude drugs are mixed and made into, and is divided into oral powder and external pulvis.
Cataplasma is coated the external preparation of making on the cloth after meaning medicinal substances extract, medicine and suitable hydrophilic matrix mixing.The substrate that cataplasma is commonly used has sodium polyacrylate, sodium carboxymethyl cellulose, Sorbitol, polyvinyl alcohol, gelatin, glycerol etc.
Tincture means the supernatant liquid preparation that medicine is made with the ethanol extraction of normal concentration or dissolving, and also the dilution of available stream extractum is made.Tincture can be used dissolution method, dilution method, infusion process or percolation preparation.
Rubber-emplastrum is coated the external preparation on the cloth after meaning substrate mixings such as medicinal substances extract, medicine and rubber.
Ointment means the semi-solid external preparation that medicine, medical material fine powder, medicinal substances extract and suitable substrate are mixed and made into.That substrate commonly used is divided into is oil, water solublity and emulsion-type substrate.Wherein use the also title ointment of emulsion-type substrate.The substrate that ointment is commonly used has lipophile substrate such as vaseline, liquid Paraffin, lanoline, Cera Flava, vegetable oil, glyceryl monostearate, high fatty alcohol; Water-soluble basees such as Polyethylene Glycol, glycerinum amyli, glycerin gelatine, sodium carboxymethyl cellulose; The substrate that the emulsifying agents such as derivatives class of soap class, fatty alcohol sulphuric acid esters, high fatty alcohol and polyhydric alcohol esters, polyoxyethylene ether form.Can add wetting agent and Percutaneous absorption enhancer in case of necessity.
Liniment means medicinal substances extract, medical material fine powder or volatile medicine, the clarification made from ethanol, oil or The suitable solvent or the liquid preparation for external application of suspendible.The dispersant that liniment is commonly used has water, ethanol, liquid Paraffin, vegetable oil, glycerol etc.
Suppository means that medicinal substances extract or medicated powder and suitable substrate make the solid preparation for cavity/canal drug administration.Suppository substrate commonly used is semi-synthetic fatty acid glyceride, cocoa butter, Myrj 45, hydrogenated vegetable oil, glycerin gelatine, polyethylene glycols or other suitable substrate.Can add surfactant in some substrate makes medicine be easy to discharge and absorbed by body.
Aerosol means that medicinal substances extract or medical material fine powder are contained in the withstand voltage tight envelope container with special valve system with the propellant that suits, and by the pressure of propellant content is the preparation of fine mist or the ejection of other forms during use.
Do not contain propellant, content is called spray with the preparation of form ejection such as vaporific by the pressure of manual pump.Aerosol and spray are formed by content and are divided into solution-type, emulsion-type or suspension type.Be divided into respiratory tract suction, skin or mucosal drug delivery etc. by route of administration.
Described pharmaceutics acceptable auxiliary includes but not limited to water, ethanol, octadecanol, glycerol, simethicone, gelatin, vaseline, starch, liquid Paraffin, lanoline, Cera Flava, vegetable oil, Sorbitol, Arlacel-60, polyvinyl alcohol, Span, high fatty alcohol, sodium polyacrylate, sodium carboxymethyl cellulose, glyceryl monostearate, the soap class, the fatty alcohol sulphuric acid esters, the polyhydric alcohol esters, the derivatives class of polyoxyethylene ether, semi-synthetic fatty acid glyceride, cocoa butter, Myrj 45, triethanolamine, sodium lauryl sulphate, ethyl hydroxybenzoate, in the propyl p-hydroxybenzoate one or more.
Described pharmaceutical composition is used to prepare the application of the medicine for the treatment of herpes zoster.
Described pharmaceutical composition is used to prepare the application of the dermatosis due to the treatment bacterial infection, comprises staphylococcus aureus, escherichia coli, bacillus pyocyaneus, Bacillus proteus and B family streptococcal infection associated diseases.
Prescription compatibility of medicines of the present invention is rigorous, and merit is specially imitated work, and the crude drug wide material sources are with low cost.Make the externally used compound preparation of Transdermal absorption simultaneously, directly act on diseased region, make drug effect rapid.Through the checking of the drug effect of clinical principium, determined curative effect, rapid-action, transference cure is fast, and is safe in utilization.
The invention will be further described below in conjunction with the specific embodiment, and all this areas of doing according to the disclosure of invention are any to be equal to replacement, all belongs to protection scope of the present invention.
The specific embodiment
Embodiment 1. preparation ointments
Radix Et Rhizoma Rhei 44g Rhizoma Cimicifugae 132g
Octadecanol 80g glyceryl monostearate 20g Arlacel-60 2g
Liquid Paraffin 100g propyl p-hydroxybenzoate 0.12g triethanolamine 10g
Glycerol 150g ethyl hydroxybenzoate 0.24g sodium lauryl sulphate 1.5g
Simethicone 5g
More than two the flavor medical materials, add 8 times of amounts of 80% ethanol, reflux, extract, three times, each 2 hours, merge extractive liquid, filtered, filtrate is concentrated into relative density 1.15-1.20 (60 ℃) clear paste, add octadecanol, glyceryl monostearate, Arlacel-60, liquid Paraffin, simethicone, heating (85 ℃) makes dissolving, and it is standby to stir.Other gets triethanolamine, glycerol, sodium lauryl sulphate, ethyl hydroxybenzoate, propyl p-hydroxybenzoate heats (85 ℃) makes fusion, mixes with above-mentioned clear paste, adds water and makes 1000g, stirs, promptly.
Embodiment 2. preparation liniments
Radix Et Rhizoma Rhei 15g, Rhizoma Cimicifugae 60g, two flavor pulverizing medicinal materials become coarse powder, and it is airtight to add 70% ethanol 500ml, floods 20 days, and jolting was 1 time in per 2 days.Filter, on filter, add 70% ethanol to 500ml, promptly.
Embodiment 3. preparation tinctures
Radix Et Rhizoma Rhei 20g, Rhizoma Cimicifugae 40g, be ground into coarse powder, mixing is according to the percolation (appendix IO of version Pharmacopoeia of People's Republic of China in 2005) under extractum and the extractum item, make solvent with 80% ethanol, flood after 48 hours slowly percolation, collect percolate, be adjusted to 400ml with 80% ethanol, filter, promptly.
The test of embodiment 4. extracorporeal antivirus effects
One. material:
1. medicine: rise yellow gram pain ointment: according to the ointment of embodiment 1 preparation;
Ftibamzone Ointment: the Beijing XieHe medicine Factory produces.
Virazole: Hubei Province's institute of Pharmaceutical Industry is produced.
2. biomaterial: Hep-2 cell: people's laryngeal carcinoma passage cell HEP-2 strain, available from Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
Virus liquid: herpes simplex virus I, II type (HSV-I, II), available from Virology Inst., Chinese Academy of Preventive Medical Science, used by Beijing's pharmaceutical analysis institute laboratory back of going down to posterity.
Two. method:
Undertaken by pilot study that virus virulence is measured and drug toxicity is measured, result of the test is calculated through the Reed-Muench method, draw liter yellow gram bitterly ointment be TC50=4.46mg cream/ml to 50% toxic concentration of Hep-2 cell, TC0=3.12mg cream/ml.TC50=2.24mg cream/the ml of matched group Ftibamzone Ointment, TC0=1.56mg cream/ml.Formally test: 96 holes have grown up to the Hep-2 cell plates of monolayer, add viral liquid, adsorbed 1 hour, and the venom of preventing or cure a disease that inclines, with 5 concentration of reagent dilution, every concentration adds 3 holes, establishes cell contrast and virus control.Cultivated 3 days in 37 ℃, 5%CO2, observe CPE.Calculate 50% valid density (EC50) and therapeutic index TI=TC50/EC50 with the Reed-Muench method.
Three. result: see Table 1.
Table 1 liter yellow gram pain ointment is to the influence of herpes simplex virus I and II type
Medicine | | Test number (TN) | Virus HSV-I | Virus HSV-II |
Rise yellow gram pain ointment | EC
50 TI
| 1 2 1 2 | 1.12 0.94 4.0 4.7 | 0.94 0.94 4.7 4.7 |
Ftibamzone Ointment | EC
50 TI
| 1 2 1 2 | 0.66 0.56 3.4 4.0 | 0.56 0.56 4.0 4.0 |
Virazole | | | + | + |
Annotate: "+" has inhibitory action.
Conclusion: rise yellow gram pain ointment, herpes simplex virus I-type and II type cytopathogenic effect are had obvious inhibitory action.
Embodiment 5. the present invention infect the influence of guinea pig skin to herpesvirus (HIV-I)
One. material:
1. medicine: rise yellow gram pain ointment: according to the ointment of embodiment 1 preparation;
Ftibamzone Ointment: the Beijing XieHe medicine Factory produces.
2. biomaterial: Cavia porcellus, Xueyaun Road, Haidian District, Beijing City tonneau laboratory animal plant provides, the animal quality certification number the 069th total No. 024.50, be divided into 5 groups at random.
Virus liquid: herpes simplex virus I, II type (HSV-I, II), available from Virology Inst., Chinese Academy of Preventive Medical Science, used by Beijing's pharmaceutical analysis institute laboratory back of going down to posterity.
Two. method:
With the guinea pig back unhairing, 2 infected areas before and after marking off, penetrate into deep skin deeply with No. 9 syringe needles, be evenly perverse 7 pins of Flos Mume sample, except that the normal control group, HIV-I virus drips in the perverse district of pin, in infecting the back the 5th day, every Mus is got reagent respectively and drips in each infected area, is coated with out with aseptic glass rod, treat continuous 5 days 1 time every day.Infect contrast and give sterile distilled water.
Three. result: see Table 2.
Table 2 liter yellow gram pain ointment is to the inhibitory action (n=10) of herpesvirus infection Cavia porcellus
Group | Dosage (g/kg) | Beginning medication natural law |
2 | 3 | 4 | 5 | 6 |
The model group ftibamzone rises yellow large, medium and small | -- 0.04 0.58 0.29 0.14 | 2.6±0.70 2.0±0.94 1.8±0.79
* 1.9±0.88 1.9±0.88
| 2.7±0.67 1.7±1.06
* 1.5±1.08
** 1.6±0.97
** 1.7±0.82
** | 2.6±0.70 1.5±0.98
** 1.4±1.08
** 1.4±1.08
** 1.6±0.97
* | 2.3±1.06 1.0±1.05
* 0.7±0.82
** 0.7±0.67
** 0.9±0.88
** | 2.0±1.25 0.7±0.82
* 0.6±0.84
** 0.6±0.84
** 0.7±0.82
* |
Annotate: compare with model group: * P<0.05; * P<0.01
Conclusion: rising yellow gram pain ointment institute try out amount has stronger protective effect to the guinea pig skin of herpesvirus (HSV-I) infection, obviously suppresses herpesvirus (HSV-I) infection.
Embodiment 6. the present invention infect the influence of HSV-II virus to mouse vagina
One. material:
1. medicine: rise yellow gram pain ointment: according to the ointment of embodiment 1 preparation;
Ftibamzone Ointment: the Beijing XieHe medicine Factory produces.
2. biomaterial: the ICR mice, body weight 18 ± 1g, Beijing Vital River Experimental Animals Technology Co., Ltd. provides, and 55, is divided into 5 groups at random.
Virus liquid: herpes simplex virus I, II type (HSV-I, II), available from Virology Inst., Chinese Academy of Preventive Medical Science, used by Beijing's pharmaceutical analysis institute laboratory back of going down to posterity.
Two. method:
Inject mouse vagina with HSV-II stock solution and cause infection.In infecting the back the 5th, draw each dosage reagent respectively with aspirator and inject in the mouse vagina, 1 time/day, continuous 5 days.Day by day write down every group of pathological changes mice number of elements at different levels, carry out statistical disposition.
Three. result: see Table 3.
Table 3 liter yellow gram pain ointment infects herpesvirus to mouse vagina inhibitory action (n=11)
Group | Dosage (g/kg) | Beginning medication natural law |
2 | 3 | 4 | 5 | 6 |
The model group ftibamzone rises yellow large, medium and small | -- 0.034 0.44 0.22 0.11 | 2.5±0.82 2..2±0..87 2.1±0.83 2.0±0.89 2.1±0.94 | 2.6±0.67 1.8±0.87
* 1.7±0.90
* 1.6±1.03
* 1.8±0.87
* | 2.5±0.82 1.4±1.21
* 1.3±1.10
** 1.2±1.16
* 1.3±1.10
** | 2.2±1.08 1.1±1.14
* 1.0±1.10
* 0.9±1.14
* 1.1±1.14
* | 1.9±1.22 0.8±1.17
* 0.5±0.93
** 0.5±0.93
** 0.7±1.19
* |
Annotate: compare with model group: * P<0.05; * P<0.01
Conclusion: rise yellow gram pain ointment and can obviously alleviate, show stronger antivirus action because of infecting the swelling of external genitals that herpesvirus (HSV-II) causes.
Embodiment 7. analgesic test
One. material:
1. medicine: rise yellow gram pain ointment: according to the ointment of embodiment 1 preparation;
Votalin Ointment: Novartis Pharma AG.
2. biomaterial: get 50 of healthy ICR mices, male and female half and half, body weight 20-22g is divided into 5 groups at random by body weight.
Two. method:
1. front foot subcutaneous injection formalin is caused the influence of mice pain reaction: get 50 of healthy ICR mices, male and female half and half are divided into 5 groups at random by body weight, are respectively liter large, medium and small dosage group of yellow gram pain ointment, diclofenac positive controls, blank group.After the last administration 20 minutes, the formalin solution 15 μ l/ of the right front sufficient plantar subcutaneous injection 2% of mice only cause scorching back 30 minutes, and mice is inserted in the 1000ml beaker, observe the foot reaction of mice.Add up respectively with pain reaction classification integration.
2. Dichlorodiphenyl Acetate causes the influence of mouse writhing: get 50 of healthy ICR mices, male and female half and half are divided into 5 groups at random by body weight, are respectively liter large, medium and small dosage group of yellow gram pain ointment, diclofenac positive controls, blank group.The abdominal part administration is 4 days continuously, and the last administration is after 20 minutes, and mouse peritoneal is injected 0.6% acetum, turns round the body number of times in the incubation period and 15 minutes of generation writhing response behind the observed and recorded lumbar injection acetum.
Three. the result:
1. front foot subcutaneous injection formalin is caused the influence of mice pain reaction: the results are shown in Table 4.
Table 4 liter yellow gram pain ointment causes the influence of mice pain reaction to front foot subcutaneous injection formalin
Group | Number of animals (only) | The pain reaction fractional value | Suppression ratio (%) |
Dosage group small dose group in the heavy dose of group of blank group diclofenac matched group | 10 10 10 10 10 | 2.4±0.52 1.7±0.82* 1.8±0.63* 2.2±0.79 2.4±0.97 | 29.2 25.0 8.3 - |
Compare * p<0.05 with the blank group
Mice is smeared liter yellow gram pain ointment and can alleviate formalin and cause the mice pain reaction, and certain analgesic activity is arranged.With blank group comparing difference significance meaning (p<0.05) is arranged.
2. Dichlorodiphenyl Acetate causes the influence of mouse writhing: the results are shown in Table 5.
Table 5 liter yellow gram pain ointment Dichlorodiphenyl Acetate causes the influence of mouse writhing
Group | Number of animals (only) | Turn round body incubation period (second) | Turn round the body number of times in 15 minutes |
Dosage group small dose group in the heavy dose of group of blank group diclofenac matched group | 10 10 10 10 10 | 87.7±23.07 107.6±18.46* 108.9±19.75* 106.3±14.2* 105.5±16.37 | 17.7±4.14 11.1±3.70** 11.9±2.85** 17.4±6.40 18.9±7.23 |
Compare * p<0.05 with the blank group
Result of the test shows: what mouse peritoneal smeared liter that yellow gram pain ointment can alleviate the mice pain reaction that causes because of acetic acid turns round body incubation period; 0.34g crude drug/kg dosage can reduce writhing response number of times in the mice 15 minutes, with blank group comparing difference significance meaning (p<0.05) is arranged.
Embodiment 8. extracorporeal bacteria inhibitor tests
One. material:
1. medicine: rise yellow gram pain ointment: according to the ointment of embodiment 1 preparation;
Ftibamzone Ointment: the Beijing XieHe medicine Factory produces.
2. biomaterial:
Staphylococcus aureus: source: Beijing hydrops pool hospital and Peking University First Hospital's Bacteriology Room are identified
And provide.
Escherichia coli: Beijing hydrops pool hospital and Peking University First Hospital's Bacteriology Room are identified and are provided.
Bacillus pyocyaneus: Beijing hydrops pool hospital and Peking University First Hospital's Bacteriology Room are identified and are provided.
Bacillus proteus: Beijing hydrops pool hospital and Peking University First Hospital's Bacteriology Room are identified and are provided.
B family streptococcus: Beijing hydrops pool hospital and Peking University First Hospital's Bacteriology Room are identified and are provided.
Two. method:
Adopt agar dilution that yellow gram pain ointment of reagent liter and the former ointment of Ftibamzone Ointment are added in the Nutrient agar that has melted with 1/8 ratio respectively, and do serial doubling dilution, each strain that will increase bacterium 16h is in addition done suitable dilution, drips on flat board, establish the antibacterial contrast simultaneously, the positive drug contrast.The plate of having inoculated is placed 37 ℃ of incubators, and observed result behind the 24h writes down each bacteria growing situation.See Table 6.
The yellow gram pain of table 6 liter ointment machin ftibamzone is to the average minimum inhibitory concentrations of various bacterium (MIC ± SD mg cream/ml)
| Gold Portugal (5) | Large intestine (5) | Green pus (5) | Distortion (5) | B chain (5) |
Rise yellow gram pain ointment | 34.4±17.1 | 25.0±8.6 | 43.8±17.1 | 40.6±21.0 | 50.0±17.1 |
Ftibamzone Ointment | 62.5±38.3 | 56.3±40.7 | 62.5±38.3 | 53.1±43.6 | 62.5±38.3 |
Annotate: the numeral in () is the bacterial strain number.
This shows that Chinese medicine composition of the present invention has obvious inhibitory action to herpes simplex virus I-type and II type cytopathogenic effect; Guinea pig skin to herpesvirus infection has stronger protective effect, obviously suppresses herpesvirus infection; Can obviously alleviate because of infecting the swelling of external genitals that herpesvirus causes; To the antibacterial of being tried, in various degree inhibitory action is all arranged as staphylococcus aureus, escherichia coli, bacillus pyocyaneus, Bacillus proteus, B family streptococcus etc.
Embodiment 9. clinical pharmacology researchs
One. medicine and case:
1. medicine: this Chinese medicine composition: prepare according to embodiment 1 method.
Aciclovir: Beijing Kang Dini company limited is produced.
2. case: select herpes zoster patient 103 examples, adopt the randomized controlled trial method, be divided into two groups, 60 examples are organized in treatment, matched group 43 examples.Treat the comparison of preceding two groups of patients at aspects such as age, sex, the course of disease, diseased regions, all credit is analysed by statistics, has comparability.
Two. method: the oral Aciclovir of matched group patient, every day 5 times, each 2, every 0.1g.
Treatment group patient uses this Chinese medicine composition merely, and every day each 1 time sooner or later, external is smeared (about every 7m in right amount according to the extent of disease size
2Smear 1g).
Efficacy assessment standard: fully recover for skin lesion disappears substantially, symptom and sign are obviously improved; Produce effects is that symptom and sign are improved; Progressive is that symptom and sign are improved; Invalidly slightly improve or increase the weight of for symptom and sign.
Three. the result:
Treat the ulcerative colitis efficacy result and see Table 7.
Table 7 liang group patient's curative effect relatively
Group | Total routine number | Cure | Effectively | Invalid | Total effective rate (%) |
Treatment group matched group | 60 43 | 31 16 | 25 19 | 4 8 | 93.33 81.40 |
Compare with matched group, P<0.05, treatment group curative effect is better than matched group, property that there were significant differences.
The main effect of this Chinese medicine composition is a clearing away heat and cooling blood, the detoxifcation pain relieving.Be mainly used in the liver and gall fire is contained, the spleen channel retention of damp-heat in the interior causes herpes zoster and all kinds of dermatosiss such as the eczema due to herpes simplex and the interior knot of noxious dampness, erysipelas, all kinds of outside infection that staphylococcus aureus, bacillus pyocyaneus, escherichia coli are caused also has certain effect.