CN1947739A - Traditional Chinese medicine composition for treating dermal titillation and chronic eczema and its prepn. method - Google Patents
Traditional Chinese medicine composition for treating dermal titillation and chronic eczema and its prepn. method Download PDFInfo
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Abstract
A composite Chinese medicine for treating skin itching and chronic eczema is prepared from 5 Chinese-medicinal materials including flavescent sophora root, liquorice root, borneol, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to field of medicaments, particularly relating to Chinese medicine is the treatment skin pruritus made of raw material, Chinese medicine composition of chronic eczema and preparation method thereof.
Background technology
Eczema is a kind of anaphylaxis dermatosis, is a kind ofly to have a scytitis reaction of obviously oozing out tendency by what multiple internal and external factor caused, belongs to the IV allergic reaction type, and its morbidity accounts for department of dermatologry out-patient's about 15%.Skin pruritus is a kind of no constitutional skin lesion, and the itching skin disease of secondary lesions such as scratch, blood crusts, pigmentation and lichenification is only arranged, and its sickness rate is 10.5%.Both are both the commonly encountered diseases and the frequently-occurring disease of department of dermatologry, its clinical manifestation all is subjective symptom with the pruritus, skin lesion has desquamation, scratch, blood crusts, plumpness, rough with or with erythema, pimple etc., the state of an illness is touching, is easy to repeatedly, with the passing of time easily cause patient's mood anxiety, lassitude even neurasthenia symptoms such as headache, insomnia occur, has a strong impact on patient's quality of life and physical and mental health.
Eczema belongs to the traditional Chinese medical science " eczema ", " acute eczema ", " stubborn dermatitis " category, and pruritus belongs to the traditional Chinese medical science " pruritus caused by wind pathogen ", " pruritus " category, and primary symptom is pruritus, erythema, pimple, and the course of disease is touching.Motherland's medical science thinks that this class disease is always not anti-because of congenital natural disposition, or old body void or weakness due to chronic disease diseases caused by exogenous pathogenic factor wind, wet, pathogenic heat, interior must not catharsis, must not reach thoroughly outward, the four stages in the course of an epidemic febrile disease discord, skin loses in profit and supports; Or the wind syndrome due to blood-deficiency dryness-transformation, skin loses due to make moist.Skin pruritus is many because of affection due to external wind and heat, the damp and hot love of internal injury or blood-deficiency leading to hyperactivity of the liver, and living air slaking are dry, and failure of skin and muscle to be nourished forms.Ancient doctor's nationality has following record, and " General Treatise on the Cause and Symptoms of Diseases pruritus caused by wind pathogen time " said: " the pruritus caused by wind pathogen person is the empty wind-engaging of body, and wind is gone into space between skin and muscles, fights mutually with vim and vigour, and all is to and between the skin.Pathogen is little, can not impact to be pain, so but pruritus also "." the surgery card is controlled the pandect pruritus " said: " pruritus all over there is no the skin ulcer scabies, scratches more than "." surgery great achievement " has following famous judgement: " wind is contained and then to be itched, cover to be the wind person, the mark of fire also, all wind heat visitors and skin, the foxtail millet person that had an itch, controlling should dispelling wind, as the Radix Sophorae Flavescentis ball etc.; If excessive in the wind heat, blood deficiency is had an itch, and works as removing heat from blood again and moisturizes ".Chronic eczema then is that damp and hot malicious heresy is accumulate for a long time, and residual poison is unclear, or consumption impairment of the spleen stomach-Yin blood, and wind is given birth in dryness-transformation, or the positive QI-insufficiency of prolonged illness is felt wind again, wet, pathogenic heat forms." General Treatise on the Cause and Symptoms of Diseases acute eczema " said: " acute eczema is that heart man has wind heat, sends out in skin.Nascent very little, the back pain of itching earlier forms skin ulcer ... "; Discuss infantile eczema and say " children's's the five internal organs have heat, and the smoked skin of sending out is rolled over by rheumatism ... " outward." surgeon's complete works " cloud: " pathogen becomes it for acute eczema, invasion of the body by blended pathogenic wind and dampness, and pruritus becomes skin ulcer ".As seen, the pathogenesis of skin pruritus, chronic eczema is it with deficiency of YIN-blood always, and be its mark with wind, wet, pathogenic heat, the latter directly causes skin pruritus, even the main cause of clinical symptoms such as erythema, pimple, desquamation, scratch, blood crusts are plump, rough, lichenification.
At present, modern doctor trained in Western medicine mainly adopts antihistaminic, vitamin, hormone medicine etc. for the treatment of skin pruritus, chronic eczema.External ointment preparation mostly is hormones ointment, though hormone medicine antiinflammatory, effect antipruritic and that minimizing is oozed out are compared very fast, but very fast recurrence after the drug withdrawal, life-time service easily causes many untoward reaction, increase and pigmentation as pachylosis, pore, therefore, there is very big drawback as routine administration.
Chinese medicine has a long history for the treatment of primary disease, and great mass of data proves that oral medicinal herb and external all can obtain effect preferably.It is reported that these type of curative effect of disease of external curing such as Chinese medicine Radix Sophorae Flavescentis, Radix Cynanchi Paniculati, Herba Menthae, Borneolum Syntheticum are good, side effect is little.Such as Radix Sophorae Flavescentis function heat clearing and damp drying, the effect of dispelling wind for relieving itching, the Luo Rongzi report [Radix Sophorae Flavescentis Oleum Radix Arnebiae (Oleum Radix Lithospermi) treatment infant eczema 118 examples. medical Leader, 2002; 21 (9): 570～571] adopt Radix Sophorae Flavescentis Oleum Radix Arnebiae (Oleum Radix Lithospermi) affected part of exterior coating, treatment infant eczema 118 examples, total effective rate reaches 95.8%, and side effect is little.The Luo Weidan report [lotion of compound flavescent sophora root treatment eczema 60 examples. Chinese skin cypridology magazine, 2002; 16 (2): 125～126] adopt lotion of compound flavescent sophora root treatment eczema 60 examples, similar with external corticosteroid hormone preparation (Pevisone) curative effect.Radix Cynanchi Paniculati has the effect that " treat all over body pruritus due to wind pathogen drying " reach " removing rheumatism ", it is reported single Radix Cynanchi Paniculati external curing pruritus vulvae effective [Xu Jun. the single Radix Cynanchi Paniculati is treated pruritus vulvae. Journal of Traditional Chinese Medicine, 2001; 42 (9): 521]; Modern pharmacological research also shows, Radix Cynanchi Paniculati have antiallergic action and immunoregulatory effect [Zhou Guomao, Shen Qin. the experimentation of Radix Cynanchi Paniculati antiallergic action. Chinese combination of Chinese and Western medicine skin cypridology magazine, 2004; 3 (2): 126～128].Herba Menthae is pungent in flavor and cool in property, kind wind and heat dispersing, Han Yongsheng [compound recipe Herba Menthae tincture treatment itching skin disease 600 routine observation of curative effect. external treatment with Chinese medicine magazine, 2003; 12 (3): 46] clinical studies show by large sample: all kinds of itching skin disease effects of Herba Menthae external curing are remarkable, and total effective rate reaches 100%.Borneolum Syntheticum is refrigerant antipruritic, is department of dermatologry medicine for external use commonly used, and Borneolum Syntheticum is main prescription external curing skin pruritus and eczema instant effect, side effect little [Guo Jianguo, He Yi. the ice black pigment used by women in ancient times to paint their eyebrows looses and is main treatment infantile eczema 364 examples. the Sichuan traditional Chinese medical science, 2000; 18 (2): 48; Li Yongxin, what reduces. hundred wine treatments of Realgar skin pruritus, 32 examples. and external treatment with Chinese medicine magazine, 1997; 6 (4): 35].
As from the foregoing, Chinese medicine external curing skin pruritus, chronic eczema are evident in efficacy, but also exist dosage form fall behind, use inconvenient, Transdermal absorption is poor, bioavailability is low, easily come off, influence deficiencies such as attractive in appearance.Therefore, research Chinese medicine for external application efficient, easy to use, that side effect is little is pressing for of clinical treatment.
Summary of the invention
The purpose of this invention is to provide a kind of skin pruritus, chronic eczema better efficacy, littler Chinese medicine composition of side effect for the treatment of.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
The consumption of each component of medicine of the present invention and proportioning obtain with Test Summary by groping in a large number through the inventor, and each component raw material survival dose and proportioning all have curative effect preferably in following ranges: Radix Sophorae Flavescentis 5～60 weight portions, Radix Cynanchi Paniculati 5～60 weight portions, Radix Glycyrrhizae 2～60 weight portions, Oleum menthae 0.05～5 weight portion, Borneolum Syntheticum 0.05～5 weight portion.
Preferred each component raw material survival dose: Radix Sophorae Flavescentis 10～45 weight portions, Radix Cynanchi Paniculati 8～45 weight portions, Radix Glycyrrhizae 5～30 weight portions, Oleum menthae 0.1～1 weight portion, Borneolum Syntheticum 0.1～1 weight portion.Further preferred each component raw material survival dose: Radix Sophorae Flavescentis 15～30 weight portions, Radix Cynanchi Paniculati 10～20 weight portions, Radix Glycyrrhizae 7.5～15 weight portions, Oleum menthae 0.2～0.5 weight portion, Borneolum Syntheticum 0.2～0.5 weight portion.
Each best component raw material survival dose: Radix Sophorae Flavescentis 20 weight portions, Radix Cynanchi Paniculati 15 weight portions, Radix Glycyrrhizae 10 weight portions, Oleum menthae 0.25 weight portion, Borneolum Syntheticum 0.25 weight portion.
Oleum menthae in the above-mentioned raw materials medicine can also replace with Herba Menthae 5～50 weight portions.
Selected medicine Radix Sophorae Flavescentis, Radix Cynanchi Paniculati, Radix Glycyrrhizae, Oleum menthae (or Herba Menthae), the Borneolum Syntheticum with removing damp-heat, dispelling wind for relieving itching effect of medicine of the present invention formed Chinese medicine compound, Radix Sophorae Flavescentis nature and flavor bitter cold in the side, GUIXIN, liver, stomach, large intestine, urinary bladder channel, the function heat clearing and damp drying, dispelling wind for relieving itching, " not Lu " record " removes latent heat ", " treatment malignant boil "; The Radix Cynanchi Paniculati property and flavor of peppery and warm is returned liver, stomach warp, and function dispelling wind for relieving itching, " Bencao Tujing " are put down in writing it and " treated all over body pruritus due to wind pathogen drying ", and two medicines are we's monarch altogether.Herba Menthae suffering, cold, kind wind and heat dispersing, refrigerant antipruritic we's the minister that is altogether of Borneolum Syntheticum, the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription makes for assistant.All medicines share the effect of playing removing damp-heat, dispelling wind for relieving itching altogether.
Medicine of the present invention can be made any preparation on the pharmaceutics; Preferably make external preparation forms such as gel, unguentum, ointment, plaster, cream, paste, oil preparation, Emulsion, tincture, medicated wine, aerosol, spray, liniment, patch, cataplasma, lotion.
The preparation of the effective ingredient of the described present composition and preparation can adopt following method: the preparation of methods such as water extraction, decoction and alcohol sedimentation technique, extraction, infusion process, percolation, reflux extraction, continuous backflow extraction method, ultrasonic extraction, microwave extraction method, macroreticular resin absorbing method.For example, crude drug decocting or alcohol extraction can be added the substrate mixing then, make the ointment external; Also crude drug can be ground into fine powder, cross 100～120 mesh sieves, add substrate, mix homogeneously is made paste and is used; But in order to make each crude drug of this medicine bring into play drug effect better, the present invention preferably adopts following technology to extract to raw material, make gel, but this can not limit protection scope of the present invention.
Basic technology is:
Get crude drug, Radix Sophorae Flavescentis, Radix Glycyrrhizae are decocted with water, filter, merging filtrate gets Radix Sophorae Flavescentis, licorice water extract; Get Herba Menthae chopping and be placed in the volatile oil extractor, extract after adding water saturates, collect the volatile oil of gained, it is standby to place refrigerator and cooled to hide; Other gets Radix Cynanchi Paniculati and adds water distillation, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues decoct with water again, and merging filtrate and Radix Sophorae Flavescentis, licorice water extract concentrating under reduced pressure add ethanol, leave standstill, filter, collect filtrate, add powdered activated carbon, reflux, centrifugal, get supernatant and reclaim ethanol and concentrated, get drug extract.
Get distilled water, add Polysorbate, glycerol, stir evenly, be sprinkled into carbomer, place, treat its natural swelling, get carbomer solution; Other gets sodium hydroxide solution, constantly stirs down, adds in the carbomer solution, gets clear gel; Drug extract added in the clear gel stir evenly, drug gel; Get paeonol, Oleum menthae, Borneolum Syntheticum, ethyl hydroxybenzoate, laurocapram again, add dissolve with ethanol, get ethanol liquid; Under constantly stirring, ethanol liquid is added in the drug gel, stir evenly, fill promptly gets the gel finished product.
The preparation method of further preferred medicine of the present invention is as follows:
Get crude drug, Radix Sophorae Flavescentis, Radix Glycyrrhizae are decocted with water 1～3 time, add 5～10 times of amounts of water, decocted 1～3 hour, filter, merging filtrate gets Radix Sophorae Flavescentis, licorice water extract; Get the Herba Menthae chopping and be placed in the volatile oil extractor, add 6～15 times of water, extracted 2～10 hours, collect the volatile oil of gained, it is standby to place refrigerator and cooled to hide; Other gets Radix Cynanchi Paniculati, adds 6～12 times of water gagings, distills 1～3 hour, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, collect medicinal liquid, medicinal residues add 5～10 times of water gagings again and decocted 1～3 hour, merging filtrate, be evaporated to relative density about 1.0～1.3 60 ℃ the time with Radix Sophorae Flavescentis, licorice water extract, add 60～99% ethanol and reach 40～80% to containing the alcohol amount, left standstill 12～36 hours, filter, collect filtrate, add 30～60g powdered activated carbon, refluxed 20～60 minutes, centrifugal 10～30 minutes (1000～5000r/min), get supernatant reclaim ethanol and be concentrated in the time of 60 ℃ relative density about 1.0～1.6, drug extract.
Get distilled water 200～1000ml, add Tween-80 0.5～5g, glycerol 50～200g, stir evenly,, be sprinkling upon in the aqueous solution, place, treat its natural swelling, get carbomer solution H type carbomer 5～30g; Other gets sodium hydroxide solution 50～200ml, constantly stirs down, adds in the carbomer solution, gets clear gel; Drug extract added in the clear gel stir evenly, drug gel; Get paeonol, Oleum menthae, Borneolum Syntheticum, ethyl hydroxybenzoate 0.5～5g, laurocapram 5～50g again, add ethanol 20～200ml dissolving, get ethanol liquid; Under constantly stirring, ethanol liquid is added in the drug gel, adjust gross weight to 1000g with distilled water, stir evenly, fill promptly gets the gel finished product.
The preparation method of best medicine of the present invention is as follows:
Get crude drug, Radix Sophorae Flavescentis, Radix Glycyrrhizae are decocted with water secondary, add 8 times of water gagings the first time and decocted 2 hours, add 6 times of water gagings for the second time and decocted 1.5 hours, filter, merge filtrate twice, get Radix Sophorae Flavescentis, licorice water extract; Get the Herba Menthae chopping and be placed in the volatile oil extractor, add 12 times of water, extract and collect the volatile oil of gained, till no longer increasing to oil mass, it is standby to place refrigerator and cooled to hide; Other gets Radix Cynanchi Paniculati and adds 10 times of water gagings distillation 2 hours, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues add 8 times of water gagings again and decocted 1.5 hours, merge twice filtrate and Radix Sophorae Flavescentis, licorice water extract and be evaporated to relative density about 1.1 in the time of 60 ℃, add 95% ethanol and reach 60%, left standstill 24 hours, filter to containing the alcohol amount, collect filtrate, add the 45g powdered activated carbon, refluxed centrifugal 20 minutes (3000r/min) 40 minutes, get supernatant reclaim ethanol and be concentrated in the time of 60 ℃ relative density about 1.3, drug extract.
Get distilled water 500ml, add Tween-80 2g, glycerol 100g, stir evenly,, be sprinkling upon in the aqueous solution, place, treat its natural swelling, get carbomer solution H type carbomer 15g; Other gets sodium hydroxide solution 100ml, constantly stirs down, adds in the carbomer solution, gets clear gel; Drug extract added in the clear gel stir evenly, drug gel; Get paeonol, Oleum menthae, Borneolum Syntheticum, ethyl hydroxybenzoate 2g, laurocapram 20g again, add ethanol 50ml dissolving, get ethanol liquid; Under constantly stirring, ethanol liquid is added in the drug gel, adjust gross weight to 1000g with distilled water, stir evenly, fill promptly gets the gel finished product.
More than form when producing and to increase or to reduce according to corresponding ratio, as large-scale production can be unit with kilogram or with ton, small-scale production can be a unit with gram also, and weight can increase or reduce, but the crude drug material weight proportion constant rate between each composition.After above various extractions are refining; for ease of clinical practice; the drug extract that obtains at last and paeonol, Oleum menthae, Borneolum Syntheticum fine powder etc. can be added corresponding substrate; make required dosage form; comprise common external preparation such as unguentum, ointment, plaster, cream, paste, oil preparation, Emulsion, tincture, medicated wine, aerosol, spray, liniment, patch, cataplasma, lotion, these preparations also should belong to the content of the present invention's protection.
Beneficial effect:
Pharmaceutical composition of the present invention has the effect of removing damp-heat, dispelling wind for relieving itching, has curative effect preferably for skin pruritus, chronic eczema.In order to confirm the effect of this pharmaceutical composition, the inventor has carried out zoopery and clinical experiment respectively, and used medicine in the experiment " anti-inflammatory anti-itch gel " makes by optimal proportion of the present invention.
Experimental example one anti-inflammatory anti-itch gel is to the observation of the influence of eczema, pruritus and allergy animal model and antiinflammatory, the effect of reduction capillary permeability
1 material
1.1 medicine
The anti-inflammatory anti-itch gel, 3 kinds of concentration, quite the crude drug amount be respectively 0.364,0.91,2.28g/g, provide by this institute preparation laboratory, lot number is respectively 040203B
2, 040202,040203A
1, for the local skin medication.
The control gel agent is the anti-inflammatory anti-itch gel substrate, does not contain crude drug, is provided by this institute preparation laboratory, and lot number is 040203C, for the local skin medication.
Dexamethasone tablet, the 15mg/ sheet is provided by Zhejiang Province XianJu Pharmacy stock Co., Ltd, and lot number is 030904.Put porphyrize in the mortar, with control gel agent preparation, content is 10mg/g, for the local skin medication.
Essential balm is provided by Fujian Qingshan Zhangzhou Spices Co., Ltd, and lot number is 030209.
1.2 reagent
Acetone is produced by Shanghai solvent factory, lot number 021105.
2.4 dinitrochlorobenzene (DNCB) is sold by Beijing company of China Drug Co., lot number 990619.Be made into 5%, 1% and 0.1% DNCB solution external with acetone.
Histamine phosphate (HA) is provided by Shanghai Inst. of Biochemistry, Chinese Academy of Sciences, lot number 010212.Be mixed with 0.01% to 0.12% HA concentration with normal saline, Concentraton gradient is 0.01%.
Chondrus ocellatus Holmes is a sigma company product, and lot number is c-4014.
Dimethylbenzene is Henan Jiaozuo City chemical industry three factory's products, and lot number is 010517.
AZO-blue provides (import packing) by Shanghai chemical reagent purchasing and supply station chemical reagent work, and lot number is 95-04-29.
1.3 animal
The SD rat, secondary is provided by laboratory animal room of this institute, and the quality certification number is No. 035, the real moving word of Hunan section.
The NIH mice, secondary is provided by Hunan Hygienic ﹠ Epidemic Prevention Station laboratory animal breeding farm, and the quality certification number is No. the 04th, the real moving accurate word (95) of Hunan doctor.
Albino guinea-pig, regular grade is provided by Hunan Hygienic ﹠ Epidemic Prevention Station experimental animal feeding field.
Mus is provided by west, Shanghai pul-Bi Kai laboratory animal company limited with full-valence pellet feed.
Cavia porcellus is provided by Hunan Hygienic ﹠ Epidemic Prevention Station experimental animal feeding field with full-valence pellet feed.
2 methods and result
2.1 statistical analysis technique
Test data is represented with x ± SD, judges the group difference significance with the t check.
2.2 the anti-inflammatory anti-itch gel is to the influence of Cavia porcellus contact eczema model
60 of extracting waste Cavia porcelluss, body weight 240 ± 20g, male and female half and half are divided into 6 groups by sex body weight stratified random, 10 every group.Except that control gel agent treated animal, all the other 5 treated animals,, excite with inboard local outer being coated with of 0.1%DNCB solution 100 μ l auris dextras after 2 weeks with being coated with sensitization outside the 5%DNCB solution 25 μ l parts respectively at the cropping of nape portion, and 1 time weekly, totally 4 times.The 4th excites back 72 hours, except that control gel agent treated animal auris dextra inboard is coated with the control gel agent, other 5 groups are coated with control gel agent, anti-inflammatory anti-itch gel 0.364,0.91, a 2.28g/g3 concentration and dexamethasone 10mg/g respectively at animal auris dextra inboard, the about 0.1mm of thickness of covering, every day 1 time, totally 14 times.Next day after the last administration, measure animal left side ear and auris dextra interior thickness respectively with slide gauge, be calculated as follows auris dextra swelling value.
Auris dextra swelling value (mm)=auris dextra thickness (mm)-left ear thickness (mm)
Put to death animal, get auris dextra, paraffin embedding, section, hematoxylin-eosin staining, mm is calculated in tissues observed change one by one under the light microscopic
2Corium soaks into number of inflammatory cells.
Compare with the control gel agent, Eczema Model animal auris dextra swelling value and corium soak into number of inflammatory cells obviously to be increased; With Eczema Model relatively, anti-inflammatory anti-itch gel concentration is 0.91 and 2.28g/g and dexamethasone concentration can obviously reduce animal auris dextra swelling value during for 0.01g/g and corium soaks into number of inflammatory cells, increases the effect that reduces auris dextra swelling value with dosage and strengthens; When anti-inflammatory anti-itch gel concentration is 0.364g/g, act on by not obvious (table 1).
Table 1. anti-inflammatory anti-itch gel to the influence of Cavia porcellus contact eczema model (x ± SD, n=10)
| Medicine | Drug level (g/g) | Auris dextra swelling value (mm) | Number of inflammatory cells is (individual/mm 2) |
| Control gel agent Eczema Model anti-inflammatory anti-itch gel dexamethasone | - - 0.364 0.91 2.28 0.01 | 0.012±0.008 0.237±0.048 +++ 0.205±0.064 * 0.178±0.068 ** 0.145±0.035 *** 0.138±0.041 ** | 1.90±1.66 67.9±11.7 ++ 63.6±9.4 * 56.2±6.5 ** 49.6±13.9 *** 48.5±10.7 *** |
Compare with the control gel agent:
++P＜0.05,
+++P＜0.01; Compare with Eczema Model:
*P＞0.05,
*P＜0.05,
* *P＜0.01.
Histopathologic examination shows, does not see obvious pathological change for the Cavia porcellus auris dextra epidermis of control gel agent; The slight keratinization of Eczema Model group Cavia porcellus ear epidermis, excessively epidermis thickens, and the intradermal massive inflammatory cells infiltrated is mainly lymphocyte, minority eosinophilic granulocyte, vasodilation, endotheliocytic swelling; Thicken for the Cavia porcellus epidermis of anti-inflammatory anti-itch gel and dexamethasone slightly, intradermal has inflammatory cell infiltration, but obviously reduces the vascular endothelial cell mild swelling.
2.3 the anti-inflammatory anti-itch gel causes the influence of mice delayed hypersensitivity to DNCB
Get 60 of NIH mices, body weight 21.0 ± 1.5g, male and female half and half are divided into 6 groups by sex body weight stratified random, 10 every group.Respectively mouse web portion is shaved hair 3 * 3cm
2After, the 1st group is normal control, the 2nd group is the delayed hypersensitivity model, shaves mao part and all is coated with the control gel agent; Other treated animals are shaved mao part and are coated with anti-inflammatory anti-itch gel 0.364,0.91, a 2.28g/g3 concentration and dexamethasone 0.1g/g concentration respectively, the about 0.1mm of thickness of covering, and every day 1 time, administration is 8 days altogether.After the 1st administration 24 hours, except that the 1st treated animal, all the other each treated animal abdominal paries were shaved mao part and all are coated with 5%DNCB0.04ml sensitization; Administration the 7th day, except that the 1st treated animal, all the other each treated animal auris dextras all are coated with 1%DNCB0.04ml and excite.Put to death animal in 1 hour after the last administration, get mouse spleen and thymus, be calculated as follows spleen coefficient and thymus coefficient.
Organ coefficient (%)=organ weights (g)/body weight (g) * 100%
Lay the homalographic auricle with the 8mm card punch at mice ears corresponding site then,, be calculated as follows swelling value and inhibitory rate of intumesce and weigh mice delayed hypersensitivity situation with AB204 type scales/electronic balance weighing.
Auris dextra swelling value (mg)=auris dextra heavy (mg)-left ear heavy (mg)
Inhibitory rate of intumesce (%)=(model group swelling value-administration group swelling value)/model group swelling value * 100%
With the delayed hypersensitivity model relatively, anti-inflammatory anti-itch gel concentration is 0.91,2.28g/g and dexamethasone concentration can obviously reduce mouse right ear swelling value during for 0.01g/g, inhibitory rate of intumesce is respectively 25.7%, 35.0% and 40.0%; Anti-inflammatory anti-itch gel concentration does not have obvious effect (table 2) during for 0.364g/g.
Table 2. anti-inflammatory anti-itch gel to DNCB cause the mice delayed hypersensitivity influence (x ± SD, n=10)
| Medicine | Drug level (g/g) | Auris dextra swelling value (mg) | Inhibitory rate of intumesce (%) |
| Control gel agent delayed hypersensitivity model anti-inflammatory anti-itch gel dexamethasone | - - 0.364 0.91 2.28 0.01 | -- 7.08±1.63 6.26±1.22 * 5.26±1.13 ** 4.60±1.18 *** 4.25±2.19 *** | -- -- 11.6 25.7 35.0 40.0 |
Compare with the delayed hypersensitivity model:
*P＞0.05,
*P＜0.05,
* *P＜0.01.
Compare with the control gel agent, DNCB causes the delayed hypersensitivity mouse thymus and the spleen coefficient all increases.With the delayed hypersensitivity model relatively, anti-inflammatory anti-itch gel concentration is that 2.28g/g and dexamethasone concentration can obviously reduce delayed hypersensitivity mouse thymus coefficient during for 0.01g/g; Anti-inflammatory anti-itch gel concentration is 0.91,2.28g/g and dexamethasone concentration can obviously reduce delayed hypersensitivity mouse spleen coefficient during for 0.01g/g; Anti-inflammatory anti-itch gel concentration is time effect not obvious (table 3) for 0.364g/gg.
Table 3. anti-inflammatory anti-itch gel to the influence of delayed hypersensitivity mouse immune organ (x ± SD, n=10)
| Medicine | Drug level (g/g) | Thymus coefficient (%) | Spleen coefficient (%) |
| Control gel agent delayed hypersensitivity model anti-inflammatory anti-itch gel dexamethasone | - - 0.364 0.91 2.28 0.01 | 0.231±0.074 0.248±0.064 + 0.213±0.068 * 0.197±0.034 * 0.167±0.042 ** 0.164±0.035 ** | 0.659±0.022 0.755±0.056 +++ 0.701±0.097 * 0.640±0.123 ** 0.577±0.078 *** 0.561±0.082 *** |
Compare with the control gel agent:
+P＞0.05,
+++P＜0.01; Compare with the delayed hypersensitivity model:
*P＞0.05,
*P＜0.05,
* *P＜0.01.
2.4 the anti-inflammatory anti-itch gel is to the influence of Cavia porcellus pruritus model
Get 50 of Cavia porcelluss, body weight 300 ± 28g, male and female half and half are divided into 5 groups by sex body weight stratified random, 10 every group.Shave the about 1cm of hair for the right back instep of Cavia porcellus
2, shave a mao next day, 5 treated animals are given control gel agent, anti-inflammatory anti-itch gel 0.364,0.91,3 concentration of 2.28g/g and essential balm (original concentration) respectively, shave mao local application 1 time, and thickness of covering is about 0.1mm.Behind the coating 24 hours, shaving the hair part abrades with coarse sandpaper, repaste medicine 1 time, after 10 minutes, scratch is local dripped 1 HA every 3 minutes, and HA concentration is since 0.01%, each concentration increases progressively 0.01%, each volume is 50 μ l, later adds right backly stopping when sufficient to Cavia porcellus, with the HA total amount of progressively increasing as the Cavia porcellus itch-threshold.
With the control gel agent relatively, anti-inflammatory anti-itch gel concentration is 0.91,2.28g/g and essential balm (original concentration) can obviously improve Cavia porcellus HA itch-threshold; Anti-inflammatory anti-itch gel concentration has the trend that improves Cavia porcellus HA itch-threshold during for 0.364g/; The anti-inflammatory anti-itch gel has with concentration increases the enhanced trend of effect (table 4) that improves Cavia porcellus HA itch-threshold.
Table 4. anti-inflammatory anti-itch gel to the influence of Cavia porcellus HA itch-threshold value (x ± SD, n=10)
| Medicine | Drug level (g/g) | HA itch-threshold value (μ g) |
| Control gel agent anti-inflammatory anti-itch gel essential balm | -- 0.364 0.91 2.28 -- | 51.5±30.9 101.0±48.4 * 142.0±71.5 ** 210.5±80.5 *** 213.5±106.4 *** |
Compare with the control gel agent:
*P＞0.05,
*P＜0.05,
* *P＜0.01.
2.5 the anti-inflammatory anti-itch gel causes the influence of rat paw edema to chondrus ocellatus Holmes
Get 50 of SD rats, body weight 168 ± 12g, all male, be divided into 5 groups by the body weight stratified random, 10 every group.The right back vola of 5 treated animals is coated with control gel agent, anti-inflammatory anti-itch gel 0.364,0.91,3 kinds of concentration of 2.28g/g and a kind of concentration of dexamethasone 0.01g/g respectively, and thickness of covering is about 0.1mm, uses immobilization with adhesive tape behind the coating, and every day 1 time, coating is 7 days altogether.Behind the last coating 1 hour, the right back sufficient sole of the foot of rat was injected 1% carrageenin 0.1ml and is caused inflammation, cause scorching before and cause scorching back and used the right back sufficient sole of the foot thickness of vernier caliper measurement respectively in 1,2,4 hour, be calculated as follows right back pedal swelling rate.
Swelling rate (%)=(cause scorching metapedes sole of the foot thickness-cause scorching front foot sole of the foot thickness)/cause scorching front foot sole of the foot thickness * 100%
With the control gel agent relatively, chondrus ocellatus Holmes causes scorching back 1 hour, anti-inflammatory anti-itch gel concentration is that 2.28g/g and dexamethasone concentration can obviously reduce rat paw edema rate due to the carrageenin during for 0.01g/g, effect lasts till that carrageenin causes scorching back 4 hours; Chondrus ocellatus Holmes causes scorching back 2 hours, and anti-inflammatory anti-itch gel concentration is 0.364,0.91 can obviously reduce rat paw edema rate due to the carrageenin, causes effect in scorching back 4 hours disappear (table 5) to carrageenin.
Table 5. anti-inflammatory anti-itch gel to chondrus ocellatus Holmes cause rat paw edema influence (x ± SD, n=10)
| Medicine | Drug level (g/g) | Cause scorching front foot sole of the foot thickness (mm) | Cause scorching back h) right back pedal swelling rate (%) | ||
| 1 | 2 | 4 | |||
| Control gel agent anti-inflammatory anti-itch gel dexamethasone | - 0.364 0.91 2.28 0.01 | 4.81±0.37 4.92±0.31 * 4.93±0.42 * 4.88±0.52 * 4.84±0.47 * | 36.7±0.9 1.1±11.9 * 8.4±8.5 * 5.4±5.9 ** 4.4±5.6 ** | 47.0±7.5 38.4±8.6 * 34.5±11.4 ** 31.7±10.1 *** 31.4±8.2 *** | 42.2±8.5 35.6±12.1 * 34.4±11.7 * 31.0±11.5 ** 30.9±8.5 *** |
Compare with the control gel agent:
*P＞0.05,
*P＜0.05,
* *P＜0.01.
2.6 anti-inflammatory anti-itch gel xylol causes the influence of mice auricle swelling
Get 50 of NIH mices, body weight 21 ± 2g, male and female half and half are divided into 5 groups by sex body weight stratified random, 10 every group.The wide inboard of 5 treated animal auris dextras is coated with control gel agent, anti-inflammatory anti-itch gel 0.364,0.91,3 kinds of concentration of 2.28g/g and a kind of concentration of dexamethasone 0.01g/g respectively, and thickness of covering is 0.1mm, and every day 1 time, coating is 7 days altogether.Behind the last coating 1 hour, auris dextra is wide inboard with distilled water flush away medicine, dry cotton ball is cleaned, be coated with dimethylbenzene 0.05ml, put to death animal after 30 minutes, lay the homalographic auricle with the 8mm card punch at mice left and right sides ears corresponding site,, be calculated as follows swelling value and inhibitory rate of intumesce with AB204 type scales/electronic balance weighing.
Auris dextra swelling value (mg)=auris dextra heavy (mg)-left ear heavy (mg)
Inhibitory rate of intumesce (%)=(model group swelling value-administration group swelling value)/model group swelling value * 100%
With the control gel agent relatively, anti-inflammatory anti-itch gel concentration is 0.91,2.28g/g and dexamethasone concentration can obviously reduce the wide swelling value of dimethylbenzene induced mice auris dextra during for 0.01g/g, inhibitory rate of intumesce is respectively 40.9%, 49.4 and 55.2%; Anti-inflammatory anti-itch gel concentration does not have obvious effect (table 6) during for 0.364g/g.
The influence of table 6. anti-inflammatory anti-itch gel xylol induced mice auricle edema (x ± SD, n=10)
| Medicine | Drug level (g/g) | Auris dextra swelling value (mg) | Inhibitory rate of intumesce (%) |
| Control gel agent anti-inflammatory anti-itch gel dexamethasone | - 0.364 0.91 2.28 0.01 | 8.00±2.31 6.05±3.02 * 4.73±2.72 ** 4.05±2.90 *** 3.58±1.35 *** | - 24.4 40.9 49.4 55.2 |
Compare with the control gel agent:
*P＞0.05,
*P＜0.05,
* *P＜0.01.
2.7 the anti-inflammatory anti-itch gel is to the influence of rat skin capillary permeability
Get 50 of SD rats, body weight 222 ± 20g, male and female half and half are divided into 5 groups by sex body weight stratified random, 10 every group.About 4 * the 4cm of hair is shaved at 5 treated animals back of the body middle part
2, be coated with control gel agent, anti-inflammatory anti-itch gel 0.364,0.91,3 kinds of concentration of 2.28g/g and a kind of concentration of dexamethasone 0.01g/g respectively, the about 0.1mm of thickness of covering, every day 1 time, coating 7 days.Behind the last coating 1 hour, pentobarbital sodium 50mg/kg intraperitoneal injection of anesthesia, femoral venous catheter; Every Mus back is shaved a mao local subcutaneous and is injected 0.1% histamine solution, 200 μ l, simultaneously inject 1% azovan blue 4ml/kg from femoral venous catheter, sacrificed by decapitation after 20 minutes, take off animal and shave a mao position skin, lay indigo plant with 2cm diameter card punch and dye skin graft, put into the 10ml test tube, add 7: 3 acetone normal saline solution 2ml, soaked 2 hours, repeat 1 time, merge soak, add 7: 3 acetone normal saline solutions to 5ml, the gross weight sheet was hatched 96 hours in 45 ℃ of calorstats together, per minute 2000 changes, and centrifugal 10 minutes, gets supernatant, survey trap at wavelength 610nm place with 7230 type spectrophotometers, calculate azovan blue concentration the soak from the azovan blue standard curve.
With the control gel agent relatively, anti-inflammatory anti-itch gel concentration is 0.91,2.28g/g and dexamethasone can reduce azovan blue concentration in the animal skin graft soak during for 0.01g/g; Anti-inflammatory anti-itch gel concentration is time effect not obvious (table 7) for 0.364g/g.
Table 7. anti-inflammatory anti-itch gel to the influence of rat skin capillary permeability (x ± SD, n=10)
| Medicine | Drug level (g/g) | Azovan blue concentration (μ g/ml) |
| Control gel agent anti-inflammatory anti-itch gel dexamethasone | - 0.364 0.91 2.28 0.01 | 0.449±0.110 0.366±0.120 * 0.337±0.090 ** 0.297±0.080 *** 0.289±0.060 *** |
Compare with the control gel agent:
*P＞0.05,
*P＜0.05,
* *P＜0.01.
The clinical data of experimental example two anti-inflammatory anti-itch gels treatment skin pruritus, chronic eczema
Clinical research (one)
One, data and method
1 physical data
Case 460 examples are included in this research altogether in, take randomized blocks, and 300 examples (wherein chronic eczema 120 examples, skin pruritus 180 examples), matched group 160 examples (chronic eczema 80 examples, skin pruritus 80 examples) are organized in treatment.All cases all meet the case choice criteria.
Diagnostic criteria with reference to Ministry of Public Health " new Chinese medicine clinical guidance principle " chronic eczema, skin pruritus.
1.1 treat preceding two groups of sexes, age ratio
Male 149 examples are organized in treatment, women 151 examples, the oldest 70 with, minimum 18 years old, mean age (40.41 ± 13.99) year; Matched group man 87 examples, women 73 examples, the oldest 70 years old, minimum 18 years old, mean age (41.04 ± 15.05) year.Treatment group and matched group patient are aspect sex, age, and there was no significant difference (P＞0.05) has comparability.
1.2 the preceding two groups of courses of disease of chronic eczema treatment relatively
The treatment group course of disease is the shortest 15 days, elder 3 years, average course of disease (436 ± 963.2); The matched group course of disease is the shortest 21 days, elder 5 years, average course of disease (486.3 ± 945.3).Compare there was no significant difference (P＞0.05)
1.3 the preceding two groups of courses of disease of skin pruritus treatment relatively
The treatment group course of disease is the shortest 1 day, and is the longest 3 years, average course of disease (470.1 ± 1344.3) sky; The matched group course of disease is the shortest 3 days, and is the longest 3 years, average course of disease (435.6 ± 868.2) sky, and two groups are compared there was no significant difference (P＞0.05).
1.4 the cardinal symptom integration relatively
Relevant formulation cardinal symptom integration quantitative criteria with reference to " new Chinese medicine treatment eczema gets the clinical research guideline " and " new Chinese medicine treatment pruritus caused by wind pathogen gets the clinical research guideline ".Before and after the treatment patient's main clinic symptoms by asymptomatic, light, in, heavy degree carries out the classification balance statistics of keeping the score, each cardinal symptom equivalance is divided relatively before the treatment, except that the pruritus degree of treatment group than matched group heavy (P＜0.05), difference (P＞0.05) that relatively there are no significant between all the other cardinal symptom groups has comparability.
2 medications
Treatment group: the agent of externally applied anti-inflammation Itch Stopping Gel, one day 3 times.
Matched group: externally used compound snake-fat ointment, one day 3 times.
The course of treatment: 14 days, two groups of viewing durations all must not merge use other antihistaminic, tranquilizer and other external used medicine.
The observation of 3 health giving qualities
3.1 eczema: observe pruritus degree, onset time, skin lesion area, picture of the tongue, pulse condition, related symptoms, Signs, by asymptomatic, light, in, heavy degree keeps the score, before treatment, after the treatment the 1st weekend, second weekend each observed and recorded 1 time.
3.2 skin pruritus: observe skin pruritus degree, pruritus area, scratch and blood crusts situation, pachyderma degree, picture of the tongue, pulse condition and related symptoms, sign.Before treatment, treatment afterwards the 1st weekend, second weekend each observed and recorded 1 time.
3.3 curative effect determinate standard: formulate following criterion with reference to " new Chinese medicine clinical guidance principle ": clinical recovery: tcm symptom obviously alleviates or disappears, and the syndrome integration descends 〉=90% before the treatment; Produce effects: tcm symptom obviously alleviates, and card Hou Jifen descends 〉=60% before the treatment; Effectively: tcm symptom alleviates, and card Hou Jifen descends 〉=30% before the treatment; Invalid: tcm symptom does not have obvious improvement or increases the weight of, and card Hou Jifen descends＜30% before the treatment, and the sign integration reduces＜30%.
4 safeties observation
Observe blood, urine, stool routine examination and ALT, BUN, Cr, electrocardiogram.Respectively do before and after the above case treatment of treatment group 1/2 once beginning a project, before treatment and treatment finish to check in back 7 days.
5 statistical analysiss
Enumeration data x
2Check, ranked data are analyzed with Ridit, and measurement data is checked with t.
Two, result
1 clinical general curative effect
The total effects of table 1 chronic eczema treatment group, matched group
| Group | N | Recovery from illness | Produce effects | Effectively | Invalid | Cure rate (%) | Obvious effective rate (%) | Total effective rate (%) |
| Treatment group matched group | 120 80 | 9 5 | 100 17 | 9 35 | 2 23 | 7.5 5.25 | 83.3 21.25 | 98.3 71.25 |
Annotate: compare P＜0.01 with matched group.
The total effects of table 2 skin pruritus treatment group, matched group
| Group | N | Recovery from illness | Produce effects | Effectively | Invalid | Cure rate (%) | Obvious effective rate (%) | Total effective rate (%) |
| Treatment group matched group | 180 80 | 10 2 | 153 17 | 14 29 | 3 32 | 5.5 2.5 | 85 21.25 | 98.4 60 |
Annotate: compare P＜0.01 with matched group.
The result shows that anti-inflammatory anti-itch gel treatment chronic eczema and skin pruritus curative effect are obvious, analyze through Ridit, and difference has significance, illustrates that the treatment group is better than matched group.
2 liang of curative effects of organizing cardinal symptom, Signs compare
The curative effect of cardinal symptom pruritus relatively before and after table 3 treatment
| Symptom | Group | Before the treatment | After the treatment | ||||||
| Do not have | Gently | In | Heavy | Do not have | Gently | In | Heavy | ||
| The pruritus degree | Treatment group matched group | 0 0 | 10 14 | 67 49 | 43 17 | 52 15 | 57 43 | 10 19 | 1 3 |
Annotate: self compares before and after the treatment, and the symptom curative effect has significant difference
The curative effect of table 4 pair skin pruritus cardinal symptom, sign relatively
| Symptom and sign | Group | Before the treatment | After the treatment | P | ||||||
| Do not have | Gently | In | Heavy | Do not have | Gently | In | Heavy | |||
| The pruritus degree | Treatment group matched group | 0 0 | 21 10 | 112 48 | 47 22 | 34 10 | 119 40 | 19 18 | 8 12 | ＜0.01 ＜0.01 |
| The pruritus area | Treatment group matched group | 0 0 | 27 8 | 71 30 | 82 42 | 35 10 | 109 32 | 21 20 | 15 18 | ＜0.01 ＜0.01 |
| Scratch | Treatment group matched group | 0 0 | 82 26 | 72 39 | 23 13 | 99 24 | 63 36 | 9 11 | 6 7 | ＜0.01 ＜0.01 |
| Plump degree | Treatment group matched group | 0 0 | 105 51 | 40 19 | 1 1 | 57 19 | 77 38 | 11 10 | 1 4 | 0.06 0.96 |
| Xerosis cutis | Treatment group matched group | 0 0 | 82 33 | 72 35 | 16 6 | 50 11 | 90 36 | 22 20 | 8 7 | ＜0.01 0.32 |
The result shows, the anti-inflammatory anti-itch gel can obviously alleviate patients with chronic eczema pruritus degree, compare before and after the treatment, difference all has significance (P＜0.01), simultaneously can obviously alleviate skin pruritus patient pruritus degree, dwindle the pruritus area, alleviate xerosis cutis, reduce scratch, relatively, difference all has highly significant (the P value is all less than 0.01) before and after the treatment, but to the curative effect of pachyderma degree not ideal enough (P＞0.05), this may improve slowly with the pachyderma pathological changes and still lack the course of treatment certain relation, need extend the period of treatment and just can observe definite curative effect; The scratch curative effect is better than matched group (P＜0.01).
3 these medicines of untoward reaction are not found obvious toxic and side effects in therapeutic process.
Clinical research (two)
Chronic eczema, skin pruritus and dermatitis class dermatosis patient 67 examples of in August, 2004-2005 year January in the outpatient service of Guangdong Provincial TCM Hospital department of dermatologry are included in this research altogether in.The result is as follows.
1 clinical data
1.1 physical data
Collect outpatient service chronic eczema, skin pruritus and dermatitis class dermatosis totally 67 examples altogether, wherein male 30 examples, women 37 examples; 35.6 ± 11.5 years old age, minimum 18 years old, maximum 81 years old; Chronic eczema 20 examples, skin pruritus 20 examples, winter dermatitis 18 examples, neurodermatitis 6 examples, seborrheic dermatitis 3 examples; The course of disease is the longest 10 years, and is the shortest 4 days.
1.2 case is included standard in
Meet chronic eczema, the skin pruritus of " new Chinese medicine clinical research guideline (trying) ", the diagnostic criteria person of dermatitis.12～85 years old age, male or female; The patient agrees to cooperate with doctor, participates on probation.
1.3 case exclusion standard
Skin lesion extensively and merge serious viscera disease, insane; Merge obvious antibacterial and fungus or viral infection: treat in preceding 1 week external corticosteroid formulations once, or whole body uses corticosteroid hormone or antihistaminic: known to the medicine allergy sufferers; Gestation and women breast-feeding their children.
1.4 case is rejected standard
Untoward reaction appears and drug withdrawal person; Do not reach not further consultation person on time by the doctor's advice medication; Other complication occurs and need abort person.
2 Therapeutic Method
Give patient's anti-inflammatory anti-itch gel and put the affected part outward on the skin, every day three times.7 days is 1 course of treatment, and the 2-3 week course of treatment is no longer than 4 weeks.
3 criterions of therapeutical effect and result
Before the treatment, after treatment 1 week, 2 weeks, 3 weeks, observe patient's subjective symptoms (pruritus) and nbjective symptom (comprising erythema, pimple, erosion, sepage, lichenization, scratch blood crusts, dry desquamation etc.), whole body situation (appetite, sleep, emotion) and carry out objective scoring, mark by 4 grades of point systems: 0=does not have, 1=is slight, the 2=moderate, 3=severe.Concrete computational methods: total mark * 100% before therapeutic index=(total mark before the treatment-treatment back total mark)/treatment.Recovery from illness: therapeutic index 〉=95%; Produce effects: therapeutic index 〉=60%; Effectively: therapeutic index 〉=30%; Invalid: therapeutic index＜30%.Recovery from illness adds up to effective percentage with produce effects.
Clinical efficacy: table 1 shows that anti-inflammatory anti-itch gel treatment chronic eczema, dermatitis class dermatosis 3 all backs cure rates are 59.7%, and obvious effective rate is 88.1%; Table 2 shows that each observation index comparing difference has extremely significantly meaning before and after the treatment of anti-inflammatory anti-itch gel.
Table 1 anti-inflammatory anti-itch gel is treated the dermopathic clinical efficacy of chronic chronic eczema, skin pruritus and dermatitis class relatively
| The sick kind | n | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage (%) |
| Chronic chronic eczema skin pruritus dermatitis in winter neurodermatitis seborrheic dermatitis | 20 20 18 6 3 | 12 12 13 2 1 | 6 6 3 3 1 | 1 2 1 0 0 | 1 0 1 1 1 | 90.0 90.0 88.9 83.3 66.7 |
The variation of symptom integral value before and after table 2 treatment
| Integrated value | Before the treatment | After the treatment | The t value | The p value |
| The dry furfur appetite of scratch scab, sleep mood are oozed out in n itch erythema papule, liver mossization erosion | 67 2.15±0.35 2.46±0.73 1.56±1.43 1.06±1.27 1.26±1.11 1.28±1.12 1.01±0.08 1.01±0.15 | 67 0.31±0.5 0.89±0.76 0.34±0.53 0 0.52±0.26 0.12±0.02 0.22±0.12 0.23±0.04 | 10.25 22.31 5.74 5.42 4.74 5.96 5.45 4.52 | ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 ＜0.01 |
Do not find skin allergy, infection and whole body toxic and side effects in the process of clinical application.
Concrete embodiment
Medicine of the present invention can be prepared from by following enforcement, and following specific embodiment is an explanation of the invention, can not limit the present invention.
Embodiment 1: the preparation of gel
(a) get Radix Sophorae Flavescentis 20g, Radix Cynanchi Paniculati 15g, Radix Glycyrrhizae 10g, Oleum menthae 0.25g, Borneolum Syntheticum 0.25g is standby.
(b) the above five tastes are got Radix Sophorae Flavescentis, Radix Glycyrrhizae decocts with water secondary, add 8 times of water gagings for the first time and decoct 2 hours, add 6 times of water gagings for the second time and decoct 1.5 hours, filter, and merge filtrate twice, Radix Sophorae Flavescentis, licorice water extract; Other gets Radix Cynanchi Paniculati and adds 10 times of water gagings distillation 2 hours, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues add 8 times of water gagings again and decocted 1.5 hours, merge twice filtrate and Radix Sophorae Flavescentis, licorice water extract and be evaporated to about 1.1 (60 ℃ of heat are surveyed) of relative density, add 95% ethanol and reach 60%, left standstill 24 hours, filter to containing the alcohol amount, collect filtrate, add an amount of powdered activated carbon, refluxed centrifugal 20 minutes (3000r/min) 40 minutes, get supernatant and reclaim ethanol and be concentrated into about 1.3 (60 ℃ of heat are surveyed) of relative density, get drug extract;
It is an amount of to get distilled water, adds a certain amount of Tween-80, glycerol, stirs evenly, and H type carbomer is sprinkling upon in the aqueous solution in right amount, places, and treats its natural swelling, gets carbomer solution; It is an amount of that other gets sodium hydroxide solution, constantly stirs down, adds in the carbomer solution, gets clear gel; Drug extract added in the clear gel stir evenly, drug gel; Get paeonol, Oleum menthae, Borneolum Syntheticum and a certain amount of ethyl hydroxybenzoate, laurocapram again, add an amount of dissolve with ethanol, get ethanol liquid; Under constantly stirring, ethanol liquid is added in the drug gel, stir evenly, get product.
Embodiment 2: the preparation of cream
(a) get Radix Sophorae Flavescentis 60g, Radix Cynanchi Paniculati 60g, Radix Glycyrrhizae 60g, Oleum menthae 5g, Borneolum Syntheticum 5g is standby.
(b) the above five tastes are got Radix Sophorae Flavescentis, Radix Glycyrrhizae decocts with water secondary, add 8 times of water gagings for the first time and decoct 2 hours, add 6 times of water gagings for the second time and decoct 1.5 hours, filter, and merge filtrate twice, Radix Sophorae Flavescentis, licorice water extract; Other gets Radix Cynanchi Paniculati and adds 10 times of water gagings distillation 2 hours, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues add 8 times of water gagings again and decocted 1.5 hours, merge twice filtrate and Radix Sophorae Flavescentis, licorice water extract and be evaporated to about 1.1 (60 ℃ of heat are surveyed) of relative density, add 95% ethanol and reach 60%, left standstill 24 hours, filter to containing the alcohol amount, collect filtrate, add an amount of powdered activated carbon, refluxed centrifugal 20 minutes (3000r/min) 40 minutes, get supernatant and reclaim ethanol and be concentrated into about 1.3 (60 ℃ of heat are surveyed) of relative density, get drug extract;
Get a certain amount of hexadecanol, white oil, vaseline, azone and put in the beaker, heat fused in the water-bath, 80 ℃ of insulations, this is an oil phase; Get paeonol and drug extract places beaker, add distilled water again, add sodium lauryl sulphate, glycerol after the stirring and dissolving again, stir evenly, be heated to 80 ℃ in the water-bath, this is a water; Measure Oleum menthae and place beaker, add Borneolum Syntheticum, be stirred to dissolving fully, standby; Above-mentioned oil phase is slowly added aqueous phase, constantly be stirred to condensation, treat that temperature reduces to below 60 ℃, add mixed liquor, the spice of Oleum menthae and Borneolum Syntheticum, stir, get product.
Embodiment 3: the preparation of lotion
(c) get Radix Sophorae Flavescentis 40g, Radix Cynanchi Paniculati 30g, Radix Glycyrrhizae 30g, Herba Menthae 50g, Borneolum Syntheticum 2g is standby.
(d) the above five tastes are got Radix Sophorae Flavescentis, Radix Glycyrrhizae decocts with water secondary, add 8 times of water gagings for the first time and decoct 2 hours, add 6 times of water gagings for the second time and decoct 1.5 hours, filter, and merge filtrate twice, Radix Sophorae Flavescentis, licorice water extract; Get the Herba Menthae chopping and be placed in the volatile oil extractor, add 12 times of water, extract and collect the volatile oil of gained, till no longer increasing to oil mass, it is standby to place refrigerator and cooled to hide; Other gets Radix Cynanchi Paniculati and adds 10 times of water gagings distillation 2 hours, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues add 8 times of water gagings again and decocted 1.5 hours, merge twice filtrate and Radix Sophorae Flavescentis, licorice water extract and be evaporated to about 1.1 (60 ℃ of heat are surveyed) of relative density, add 95% ethanol and reach 60%, left standstill 24 hours, filter to containing the alcohol amount, collect filtrate, add an amount of powdered activated carbon, refluxed centrifugal 20 minutes (3000r/min) 40 minutes, get supernatant and reclaim ethanol and be concentrated into about 1.3 (60 ℃ of heat are surveyed) of relative density, get drug extract;
Get paeonol and drug extract places beaker, add a spot of ethanol, be stirred to dissolving fully, standby; Measure Oleum menthae and place beaker, add Borneolum Syntheticum, add small amount of ethanol again, be stirred to dissolving fully, standby; Above-mentioned two parts medicinal liquid is mixed, add glycerol, ethanol and distilled water, making ethanol content is 50%, and glycerol content is 20%, fully stirs to get final product.
Embodiment 4: the preparation of membrane
(e) get Radix Sophorae Flavescentis 5g, Radix Cynanchi Paniculati 5g, Radix Glycyrrhizae 2g, Oleum menthae 0.05g, Borneolum Syntheticum 0.05g is standby.
(f) the above five tastes are got Radix Sophorae Flavescentis, Radix Glycyrrhizae decocts with water secondary, add 8 times of water gagings for the first time and decoct 2 hours, add 6 times of water gagings for the second time and decoct 1.5 hours, filter, and merge filtrate twice, Radix Sophorae Flavescentis, licorice water extract; Other gets Radix Cynanchi Paniculati and adds 10 times of water gagings distillation 2 hours, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues add 8 times of water gagings again and decocted 1.5 hours, merge twice filtrate and Radix Sophorae Flavescentis, licorice water extract and be evaporated to about 1.1 (60 ℃ of heat are surveyed) of relative density, add 95% ethanol and reach 60%, left standstill 24 hours, filter to containing the alcohol amount, collect filtrate, add an amount of powdered activated carbon, refluxed centrifugal 20 minutes (3000r/min) 40 minutes, get supernatant and reclaim ethanol and be concentrated into about 1.3 (60 ℃ of heat are surveyed) of relative density, get drug extract;
Measure Oleum menthae and place beaker, add Borneolum Syntheticum, be stirred to dissolving fully, standby; Get paeonol and drug extract, ethyl hydroxybenzoate places beaker, adds a spot of ethanol, is stirred to fully dissolving, adds glycerol 4g, tween 80 1ml, fully stirs, and is standby; PVA-124 40g places beaker, and adding distil water 200ml heats in the water-bath, makes it to dissolve into glue, keeps the skin wet, and slowly joins in the ready medicinal liquid, stirs.Get clean glass plate or corrosion resistant plate, wipe, liquid paraffin on the repaste with 75% ethanol.The medicinal liquid that will add glue is poured on the ready plate, and the stand is even, and level is dried in the air to half-dried, and 60 ℃ of oven dry get final product in baking oven.
Embodiment 5: the preparation of cataplasma
(g) get Radix Sophorae Flavescentis 10g, Radix Cynanchi Paniculati 15g, Radix Glycyrrhizae 10g, Herba Menthae 5g, Borneolum Syntheticum 0.5g is standby.
(h) the above five tastes are got Radix Sophorae Flavescentis, Radix Glycyrrhizae decocts with water secondary, add 8 times of water gagings for the first time and decoct 2 hours, add 6 times of water gagings for the second time and decoct 1.5 hours, filter, and merge filtrate twice, Radix Sophorae Flavescentis, licorice water extract; Get the Herba Menthae chopping and be placed in the volatile oil extractor, add 6 times of water, extract and collect the volatile oil of gained, till no longer increasing to oil mass, it is standby to place refrigerator and cooled to hide; Other gets Radix Cynanchi Paniculati and adds 10 times of water gagings distillation 2 hours, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues add 8 times of water gagings again and decocted 1.5 hours, merge twice filtrate and Radix Sophorae Flavescentis, licorice water extract and be evaporated to about 1.1 (60 ℃ of heat are surveyed) of relative density, add 95% ethanol and reach 60%, left standstill 24 hours, filter to containing the alcohol amount, collect filtrate, add an amount of powdered activated carbon, refluxed centrifugal 20 minutes (3000r/min) 40 minutes, get supernatant and reclaim ethanol and be concentrated into about 1.3 (60 ℃ of heat are surveyed) of relative density, get drug extract;
Measure Oleum menthae and place beaker, add Borneolum Syntheticum, be stirred to dissolving fully, standby; Get paeonol and drug extract, ethyl hydroxybenzoate places beaker, adds a spot of ethanol, is stirred to fully dissolving, and is standby; Selecting sodium polyacrylate, polyvinyl alcohol, glycerol, sodium carboxymethyl cellulose for use is the substrate prescription, and its proportioning is a polyvinyl alcohol: sodium polyacrylate: glycerol: sodium carboxymethyl cellulose is 0.8: 2.0: 1.0: 0.8.An amount of water will be added behind sodium polyacrylate and the glycerol mix homogeneously, add swelling is good polyvinyl alcohol and sodium carboxymethyl cellulose again, stir, add said medicine, behind the mix homogeneously, on cataplasma coating instrument coating, curing molding, cut apart, overlay film.Get final product.
Claims (10)
1, a kind of pharmaceutical composition that is used for the treatment of skin pruritus, chronic eczema is characterized in that this pharmaceutical composition is to be made by following materials of weight proportions medicine: Radix Sophorae Flavescentis 5～60 weight portions, Radix Cynanchi Paniculati 5～60 weight portions, Radix Glycyrrhizae 2～60 weight portions, Oleum menthae 0.05～5 weight portion, Borneolum Syntheticum 0.05～5 weight portion.
2, pharmaceutical composition as claimed in claim 1 is characterized in that wherein the consumption of each crude drug is: Radix Sophorae Flavescentis 10～45 weight portions, Radix Cynanchi Paniculati 8～45 weight portions, Radix Glycyrrhizae 5～30 weight portions, Oleum menthae 0.1～1 weight portion, Borneolum Syntheticum 0.1～1 weight portion.
3, pharmaceutical composition as claimed in claim 2 is characterized in that wherein the consumption of each crude drug is: Radix Sophorae Flavescentis 15～30 weight portions, Radix Cynanchi Paniculati 10～20 weight portions, Radix Glycyrrhizae 7.5～15 weight portions, Oleum menthae 0.2～0.5 weight portion, Borneolum Syntheticum 0.2～0.5 weight portion.
4, pharmaceutical composition as claimed in claim 3 is characterized in that wherein the consumption of each crude drug is: Radix Sophorae Flavescentis 20 weight portions, Radix Cynanchi Paniculati 15 weight portions, Radix Glycyrrhizae 10 weight portions, Oleum menthae 0.25 weight portion, Borneolum Syntheticum 0.25 weight portion.
5, pharmaceutical composition as claimed in claim 1 is characterized in that the Oleum menthae in the crude drug can also replace with Herba Menthae 5～50 weight portions.
6, preparation of drug combination method as claimed in claim 5 is characterized in that this method comprises following steps:
Get Radix Sophorae Flavescentis, Radix Glycyrrhizae decocts with water 1～3 time, adds 5～10 times of amounts of water, decocts 1～3 hour, filter, merging filtrate, Radix Sophorae Flavescentis, licorice water extract; Get the Herba Menthae chopping and be placed in the volatile oil extractor, add 6～15 times of water, extracted 2～10 hours, collect the volatile oil of gained, it is standby to place refrigerator and cooled to hide; Other gets Radix Cynanchi Paniculati, adds 6～12 times of water gagings, distills 1～3 hour, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, collect medicinal liquid, medicinal residues add 5～10 times of water gagings again and decocted 1～3 hour, merging filtrate, be evaporated to relative density about 1.0～1.3 60 ℃ the time with Radix Sophorae Flavescentis, licorice water extract, add 60～99% ethanol and reach 40～80% to containing the alcohol amount, left standstill 12～36 hours, filter, collect filtrate, add 30～60g powdered activated carbon, refluxed 20～60 minutes, centrifugal 10～30 minutes (1000～5000r/min), get supernatant reclaim ethanol and be concentrated in the time of 60 ℃ relative density about 1.0～1.6, drug extract; Drug extract, Oleum menthae and the paeonol that obtains added suitable adjuvant make required dosage form.
7, preparation of drug combination method as claimed in claim 6 is characterized in that this method comprises following steps:
Get Radix Sophorae Flavescentis, Radix Glycyrrhizae decocts with water secondary, adds for the first time 8 times of water gagings and decocts 2 hours, adds 6 times of water gagings for the second time and decocts 1.5 hours, filters, and merges filtrate twice, Radix Sophorae Flavescentis, licorice water extract; Get the Herba Menthae chopping and be placed in the volatile oil extractor, add 12 times of water, extract and collect the volatile oil of gained, till no longer increasing to oil mass, it is standby to place refrigerator and cooled to hide; Other gets Radix Cynanchi Paniculati and adds 10 times of water gagings distillation 2 hours, collects distillate, and the distillate standing over night is separated out paeonol, sucking filtration, the paeonol crystallization is standby; The residue decoction liquor is filtered, and collects medicinal liquid, and medicinal residues add 8 times of water gagings again and decocted 1.5 hours, merge twice filtrate and Radix Sophorae Flavescentis, licorice water extract and be evaporated to relative density about 1.1 in the time of 60 ℃, add 95% ethanol and reach 60%, left standstill 24 hours, filter to containing the alcohol amount, collect filtrate, add the 45g powdered activated carbon, refluxed centrifugal 20 minutes (3000r/min) 40 minutes, get supernatant reclaim ethanol and be concentrated in the time of 60 ℃ relative density about 1.3, drug extract; Drug extract, Oleum menthae and the paeonol that obtains added suitable adjuvant make required dosage form.
8, as preparation of drug combination method as described in the claim 7, it is characterized in that the drug extract that will make adds suitable adjuvant, makes external preparation commonly used.
9, as preparation of drug combination method as described in the claim 8, it is characterized in that by the external preparation that preferably obtains be gel, this method comprises the steps:
Get distilled water, add Polysorbate, glycerol, stir evenly, be sprinkled into carbomer, place, treat its natural swelling, get carbomer solution; Other gets sodium hydroxide solution, constantly stirs down, adds in the carbomer solution, gets clear gel; Drug extract added in the clear gel stir evenly, drug gel; Get paeonol, Oleum menthae, Borneolum Syntheticum, ethyl hydroxybenzoate, laurocapram again, add dissolve with ethanol, get ethanol liquid; Under constantly stirring, ethanol liquid is added in the drug gel, stir evenly, fill promptly gets gel.
10, be used for the treatment of application in the medicine of skin pruritus, chronic eczema as pharmaceutical composition as described in the claim 1,2,3,4 or 5 in preparation.
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