CN106728819A - A kind of medicine and preparation method for treating chronic dermatitis - Google Patents

A kind of medicine and preparation method for treating chronic dermatitis Download PDF

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Publication number
CN106728819A
CN106728819A CN201610989457.9A CN201610989457A CN106728819A CN 106728819 A CN106728819 A CN 106728819A CN 201610989457 A CN201610989457 A CN 201610989457A CN 106728819 A CN106728819 A CN 106728819A
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medicine
chronic dermatitis
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preparation
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傅天锡
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/21Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/75Rutaceae (Rue family)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8964Anemarrhena
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    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/8968Ophiopogon (Lilyturf)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/31Extraction of the material involving untreated material, e.g. fruit juice or sap obtained from fresh plants
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/30Extraction of the material
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    • AHUMAN NECESSITIES
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The present invention relates to medical science and field of pharmacology, more particularly to a kind of medicine and preparation method for treating chronic dermatitis.Medicine of the present invention is the oral formulations being prepared from reference to traditional Chinese medicine theory and newest pharmaceutical research achievement and using modern crafts means by Echinacea purpurea, cymose buckwheat rhizome, catchweed bedstraw herb, oriental wormwood, balsam pear, Dicliptera chinensis, purslane, amaranth, the root of Dahurain angelica, lily, globe amaranth, sanchi flower, Radix Glycyrrhizae etc., preferably capsule, tablet and granule.Show through pharmacodynamic experiment research, medicine of the present invention has preferable therapeutic action to chronic dermatitis, and the present invention is easy to control the quality, convenient use, high safety;All raw materials are all from natural medicinal plant or conventional food, without any chemical addition agent, long-term taking is safe and reliable, can be from the tolerance and compliance for largely improving patient, so as to provide new selection scheme for the long-term treatment of chronic dermatitis patient, it is well suited for current clinical demand.

Description

A kind of medicine and preparation method for treating chronic dermatitis
Technical field
The present invention relates to medical science and field of pharmacology, more particularly to a kind of medicine for treating chronic dermatitis and preparation side Method.
Background technology
Chronic dermatitis are chronic anaphylaxis dermatitis, often switch to stubbornness because acute, subacute dermatitis recurrent exerbation is not healed Property dermatitis, also can due to often scratching, friction, stimulate thus morbidity start when switch to chronic dermatitis, typical symptom is There is the unsharp erythema of circumference, oedema, pigmentation, furfur in skin part, and serious can also have blister, bleb and gruel It is rotten, feel and can produce and very itch after itch and burning pain, especially heat, few patients can occur together constitutional symptom, such as heating, fear Cold, headache, weak, nauseous and general malaise etc., even palpitaition, delirium or shock.
The pathogenic factor of chronic dermatitis is broadly divided into internal factor and external factor, and wherein internal factor includes:Patient Allergic constitution, endocrine and metabolic disorders, digestive tract function disorder, mental function disorder, fatigue, focal infection, vein are bent , hidrosis, stress, dry skin etc., can all cause the generation or recurrence of chronic dermatitis;External factor includes:Often The anaphylactogens such as contact spices, dyestuff, cosmetics, cleaning agent, seafood products, pollen, dust.Additionally, the traditional Chinese medical science thinks intractable skin It is scorching often because of intemperance of taking food, be addicted to drink or overfeeding pungent stimulation cause food.
Except pachyderma, dermatoglyph intensification, infiltration, outside the common sympton such as pigmentation, chronic dermatitis are topmost certainly Feel that symptom is violent itch, especially itch degree is difficult to restrain oneself after heated at dermatitis position, and the scratching of patient can be pierced further Swash diseased region, so as to aggravate the state of an illness, can additionally trigger multiple infection, cause diseased region occur swelling, blister, erosion, The secondary affections such as sepage, ulcer, and such lesion is often difficult healing, can be caused seriously to the attractive in appearance and normal life of patient Influence, and bring huge psychology and stress to patient.
For the treatment of chronic dermatitis, medicinal treatment, including oral formulations and local external used medicine are mainly used at present Therapy, conventional oral formulations include that antihistamine, cetirizine, Loratadine, glucocorticoid, aspirin and indoles are beautiful It is pungent etc.;Local topical medicine with anti-inflammatory, pacify, relieve pain as principle of reatment, mainly have calamine lotion, glucocorticoid frost, 2.5% Indomethacin solution, Pa Fuoushumin cream and hydrocortisone butyrate cream etc..
Chinese traditional treatment then with " cool blood driving away summer heat ", it is " clearing heat and detoxicating " be principle of reatment, more using Chinese medicine lotion for external use, make its property of medicine From superficies to interior through fur space between skin and muscles, penetrate into deep skin and reach the antipruritic purpose moisturized.
But, although there is the multi-medicament can chronic dermatitis be compared with effective treatment, but various kinds of drug at present The weak point of many is also there is over the course for the treatment of.For example, when carrying out western medicine to chronic dermatitis, will generally use To the medicine containing glucocorticoid, it is well known that can bring a series of adverse reaction commonly using glucocorticoid medicine, Such as the hyperfunction syndrome of adrenal cortex function (moon shaped face, buffalo hump, hypertension, crinosity, oedema, diabetes, thinning of skin), Infection, induction or exacerbation canker are induced or aggravated, hypertension and atherosclerosis is induced, induce or is aggravated diabetes, bone Matter is loose, muscular atrophy, wound healing delay, induce phrenoplegia and epilepsy, to suppress upgrowth and development of children, femoral head bad Extremely, additionally, glucocorticoid medicine also has obvious withdrawal reaction and may produce more serious stimulation to skin, these Serious adverse reaction will largely reduce the tolerance and compliance of patient.On the other hand, for chronic dermatitis The Chinese medicine preparation for the treatment of is generally compound preparation, is mainly made up of the Chinese medicine of " cool blood driving away summer heat ", " clearing heat and detoxicating ", but these Chinese medicines are multiple Square preparation often exists and be difficult to Quality Control, take inconvenience, uncertain therapeutic efficacy the defect such as cuts.
To sum up, because the various treatment methods currently for chronic dermatitis all have great limitation in implementation process Property, therefore, still there is considerable conditions of patients to efficiently control.In consideration of it, being clinically badly in need of a kind of determined curative effect, peace The few new medicine of good perfection, adverse reaction.The present invention is obtained on the basis of extensive retrieval, Large-scale Screening, repeated authentication Obtained a kind of novel drugs for treating chronic dermatitis.Through experiment, there is medicine of the present invention preferably treatment to make to chronic dermatitis With, and the present invention is easy to control the quality, convenient use, high safety;The all raw materials of medicine of the present invention are all from natural medicinal plant Or conventional food, without any chemical addition agent, long-term taking is safe and reliable;The present invention is peroral dosage form, and be easy to carry kimonos With, can from the tolerance and compliance for largely improving patient, therefore, medicine of the present invention is especially suitable for current clinical need Ask, popularization and application of the invention there will be good market prospects and produce considerable economy and social benefit.
The content of the invention
The technical problem of solution
The present invention need solve problem be:Because the various treatment methods currently for chronic dermatitis are in implementation process All there is significant limitation, for example Western medicine adverse reaction is more, be also easy to produce withdrawal reaction, patient tolerability and compliance are poor, in Medicine compound preparation is difficult to Quality Control, take inconvenience, uncertain therapeutic efficacy cuts, and the above mentioned problem that existing medicine is present causes considerable stupid The solidity dermatitis patients state of an illness cannot be efficiently controlled.
Technical scheme
The present invention is intended to provide a kind of determined curative effect for treating chronic dermatitis, the new drug that security is good, adverse reaction is few Thing and preparation method thereof.
The medicine for the treatment of chronic dermatitis of the invention, it is characterised in that it is made up of the raw material that following weight is matched 's:
The weight proportion of above-mentioned raw materials is preferred:
The weight proportion of above-mentioned raw materials is further preferably:
The weight proportion of above-mentioned raw materials is further preferably:
The present invention treatment chronic dermatitis medicine can be any conventional pharmaceutical dosage form, preferably capsule, tablet, Granula.
The medicine capsule of present invention treatment chronic dermatitis can be prepared by the following method and form:
1) by Echinacea purpurea, cymose buckwheat rhizome, catchweed bedstraw herb, oriental wormwood, Dicliptera chinensis, purslane, amaranth, the root of Dahurain angelica, lily, globe amaranth, Sanchi flower, Chinese sumac, the root of bidentate achyranthes, radix bupleuri, the root bark of shaggy-fruited dittany, climbing groundsel, Sweet Broomwort Herb, the wind-weed, the tuber of dwarf lilyturf, tribulus terrestris, saline cistanche, Poria cocos and sweet The mixing of herbal medicine material, water rinsing, dry, crush after plus 8-12 times measure water, after immersion 1 hour, decoct 1-3 hour, liquid filtration is filtered Liquid is standby, repeats the dregs of a decoction to decoct 2-3 times under the same conditions, and merging filtrate obtains mixing medicine after being concentrated under reduced pressure into small size Material extract concentrated solution;
2) fresh bitter water is rinsed, is squeezed the juice after remove seed, gained squeezeding juice is through centrifuged supernatant using the molecular weight that dams For the milipore filter of 500-1000 carries out ultrafiltration, gained filter residue is freeze-dried that balsam pear juice freeze-dried powder is standby;Gained filtrate with it is upper State after mixing medicinal substances extract concentrate merges and be spray-dried, obtain spray dried powder standby;
3) spray dried powder obtained in above steps and balsam pear juice freeze-dried powder are mixed, are fully mixed in mixer, 8-20 mesh sieves are crossed after granulation, is dried, with 8-20 mesh sieve whole grains, capsule is filled after sterilization, packed, obtain final product this medicine capsule.
Further, the preparation method of medicinal tablet of the present invention and granule is:Step with it is above-mentioned 1), 2) step, the 3) step Carried out by the conventional method for preparing tablet and granule in this area, this medicinal tablet and granule is obtained.
Beneficial effect
The present invention obtains one kind and treats chronic dermatitis on the basis of extensive retrieval, Large-scale Screening, repeated authentication Novel drugs.The medicine of present invention treatment chronic dermatitis overcomes some shortcomings present in existing medicine, through examination Test, medicine of the present invention has preferable therapeutic action, and present invention property easy to control the quality, easy to use, safe to chronic dermatitis Well;The all raw materials of medicine of the present invention are all from natural medicinal plant or conventional food, without any chemical addition agent, long-term clothes With safe and reliable;The present invention be peroral dosage form, be easy to carry and take, can from largely improve patient tolerance and Compliance, so that for the long-term treatment of chronic dermatitis patient provides new selection scheme;Therefore, medicine of the present invention is especially suitable for Current clinical demand, popularization and application of the invention will have good market prospects and produce considerable economic and social effect Benefit.
Specific embodiment
Embodiments of the present invention are illustrated below by way of specific instantiation, those skilled in the art can be by this specification Disclosed content understands other advantages of the invention and effect easily.The present invention can also be by specific realities different in addition The mode of applying is embodied or practiced, the various details in this specification can also based on different viewpoints with application, without departing from Various modifications or alterations are carried out under spirit of the invention.
Before the specific embodiment of the invention is further described, it should be appreciated that protection scope of the present invention is not limited to down State specific specific embodiment;It is also understood that the term used in the embodiment of the present invention is specific specific in order to describe Embodiment, rather than in order to limit the scope of the invention;In description of the invention and claims, unless in text Explicitly point out in addition, singulative " one ", " one " and " this " include plural form.
When embodiment provides number range, it should be appreciated that except non-invention is otherwise noted, two ends of each number range Any one numerical value can select between point and two end points.Unless otherwise defined, in the present invention all technologies for using and Scientific terminology is identical with the meaning that those skilled in the art of the present technique are generally understood that.Except the specific method, equipment used in embodiment, Outside material, grasp and record of the invention according to those skilled in the art to prior art can also be used and this Any method, equipment and material in the similar or equivalent prior art of method, equipment described in inventive embodiments, material come real The existing present invention.
Embodiment 1
A kind of medicine for treating chronic dermatitis, this medicine is that the raw material matched by following weight is made:
Preparation method is as follows:
1) by Echinacea purpurea, cymose buckwheat rhizome, catchweed bedstraw herb, oriental wormwood, Dicliptera chinensis, purslane, amaranth, the root of Dahurain angelica, lily, globe amaranth, Sanchi flower, Chinese sumac, the root of bidentate achyranthes, radix bupleuri, the root bark of shaggy-fruited dittany, climbing groundsel, Sweet Broomwort Herb, the wind-weed, the tuber of dwarf lilyturf, tribulus terrestris, saline cistanche, Poria cocos and sweet The mixing of herbal medicine material, water rinsing, dry, crush after plus 8 times of amount water, after immersion 1 hour, decoct 2 hours, liquid filtration, filtrate is standby With, the dregs of a decoction being repeated to decoct 3 times under the same conditions, merging filtrate obtains mixing medicinal material extract after being concentrated under reduced pressure into small size Thing concentrate;
2) fresh bitter water is rinsed, is squeezed the juice after remove seed, gained squeezeding juice is through centrifuged supernatant using the molecular weight that dams Milipore filter for 500 carries out ultrafiltration, and gained filter residue is freeze-dried that balsam pear juice freeze-dried powder is standby;Gained filtrate mixes with above-mentioned Medicinal substances extract concentrate is spray-dried after merging, and obtains spray dried powder standby;
3) spray dried powder obtained in above steps and balsam pear juice freeze-dried powder are mixed, are fully mixed in mixer, 12 mesh sieves are crossed after granulation, is dried, with 14 mesh sieve whole grains, capsule is filled after sterilization, packed, obtain final product this medicine capsule.
Embodiment 2
A kind of medicine for treating chronic dermatitis, this medicine is that the raw material matched by following weight is made:
Preparation method is as follows:
1) by Echinacea purpurea, cymose buckwheat rhizome, catchweed bedstraw herb, oriental wormwood, Dicliptera chinensis, purslane, amaranth, the root of Dahurain angelica, lily, globe amaranth, Sanchi flower, Chinese sumac, the root of bidentate achyranthes, radix bupleuri, the root bark of shaggy-fruited dittany, climbing groundsel, Sweet Broomwort Herb, the wind-weed, the tuber of dwarf lilyturf, tribulus terrestris, saline cistanche, Poria cocos and sweet The mixing of herbal medicine material, water rinsing, dry, crush after plus 10 times of amount water, after immersion 1 hour, decoct 3 hours, liquid filtration, filtrate is standby With, the dregs of a decoction being repeated to decoct 2 times under the same conditions, merging filtrate obtains mixing medicinal material extract after being concentrated under reduced pressure into small size Thing concentrate;
2) fresh bitter water is rinsed, is squeezed the juice after remove seed, gained squeezeding juice is through centrifuged supernatant using the molecular weight that dams Milipore filter for 800 carries out ultrafiltration, and gained filter residue is freeze-dried that balsam pear juice freeze-dried powder is standby;Gained filtrate mixes with above-mentioned Medicinal substances extract concentrate is spray-dried after merging, and obtains spray dried powder standby;
3) spray dried powder obtained in above steps and balsam pear juice freeze-dried powder are mixed, are fully mixed in mixer, Then this medicinal tablet is obtained by the conventional method for preparing tablet thereof in this area.
Embodiment 3
A kind of medicine for treating chronic dermatitis, this medicine is that the raw material matched by following weight is made:
Preparation method is as follows:
1) by Echinacea purpurea, cymose buckwheat rhizome, catchweed bedstraw herb, oriental wormwood, Dicliptera chinensis, purslane, amaranth, the root of Dahurain angelica, lily, globe amaranth, Sanchi flower, Chinese sumac, the root of bidentate achyranthes, radix bupleuri, the root bark of shaggy-fruited dittany, climbing groundsel, Sweet Broomwort Herb, the wind-weed, the tuber of dwarf lilyturf, tribulus terrestris, saline cistanche, Poria cocos and sweet The mixing of herbal medicine material, water rinsing, dry, crush after plus 12 times of amount water, after immersion 1 hour, decoct 1 hour, liquid filtration, filtrate is standby With, the dregs of a decoction being repeated to decoct 2 times under the same conditions, merging filtrate obtains mixing medicinal material extract after being concentrated under reduced pressure into small size Thing concentrate;
2) fresh bitter water is rinsed, is squeezed the juice after remove seed, gained squeezeding juice is through centrifuged supernatant using the molecular weight that dams Milipore filter for 1000 carries out ultrafiltration, and gained filter residue is freeze-dried that balsam pear juice freeze-dried powder is standby;Gained filtrate is mixed with above-mentioned Close after medicinal substances extract concentrate merges and be spray-dried, obtain spray dried powder standby;
3) spray dried powder obtained in above steps and balsam pear juice freeze-dried powder are mixed, are fully mixed in mixer, Then this medicinal granule is obtained according to the conventional process for producing granula in this area.
Pharmacodynamic information
This test objective is to observe and verify Chinese medicine composition of the present invention (medicine in embodiment 2) to chronic dermatitis Therapeutic effect.
This experiment agents useful for same is as follows:
1. test medicine:Chinese medicine composition;Unit is provided:Self-control;Proterties and physicochemical property:Brown ceramic powder.
2. control drug:Chinese medicine composition (is not added with Echinacea purpurea, other each raw material proportionings are identical with test medicine) in formula; Unit is provided:Self-control;Proterties and physicochemical property:Brown ceramic powder.
3. positive drug:Loratadine;Production unit:Nanjing sage and medicine company limited company, lot number:A154217.
4. modeling agent:Fluorescein-5-isothiocyanate;Production unit:Shang Hai Tuo Yang bio tech ltd.
5. sterilized water for injection, production unit:Qidu Pharmaceutical Co., Ltd., Shandong Prov., lot number:2A14150503.
Experimental animal:
Animal species:BALB/c mouse inbred lines
Animal Sex:Female
Animal level:Cleaning grade
The weight of animals:18~22g;The weight of animals is between the 80%~120% of the sex animal average weight.
Number of animals:50
Experimental animal is originated:Beijing Vital River Experimental Animals Technology Co., Ltd.;Experimental animal production licence number: SCXK (capital) 2012-0001;The Quality of Experimental Animals quality certification is numbered:11400700103783;Production licence signs and issues unit:North Science and Technology Commission of capital city.
The reasons why experimental animal selects:This experiment is the mark used in medicine non-clinical study from BALB/c mouse inbred lines Quasi- animal, with substantial amounts of background data, genetic background understands, the reaction to medicine is more stable, and individual difference is smaller, raises Convenient, the bodily form is smaller, is easy to test operation, saves test sample, and be the discovery that properly when same or like test sample is studied Animal model.
Test sample is prepared:
Preparation time and frequency:The administration same day carries out the preparation of test sample, and solvent is prepared 1 time for 1 week.
Test medicine compound method:Chinese medicine composition is configured to suspension of the concentration as 25.0mg/ml with water.
Control drug compound method:Chinese medicine composition (without Echinacea purpurea) is configured to concentration mixing as 25.0mg/ml with water Suspension.
Positive drug compound method:Loratadine is configured to suspension of the concentration as 0.125mg/ml with water.
Modeling method:
50 mouse fasting 12 hours, 0.5% Fluorescein-5-isothiocyanate is applied after every mouse web portion then is picked into hair (solvent is acetone:Dibutyl phthalate=1:1) 400ul sensitization, applies 0.5% fluorescein -5- on the 5th day different in mouse right ear Rhodanate 20ul is excited, and left ear applies corresponding solvent (acetone/dibutyl phthalate) as negative control, before exciting and Rear 24h feelers are excited to measure left and right ear thickness, feeler distal end is mutually pressed close to ensure measurement every time with mouse helix inner edge Position it is consistent, △ T=excite rear 24h ears thickness-excite vestibule thickness, ear swelling degree to change with (△ T ± standard deviations) table Show.Result shows:Excite visible 49 mouse (1 death) auris dextra redness of rear 24h naked eyes, thicken substantially, through measurement, model is right Ear swelling degree and the true epidermal thickness of ear ear more left than negative control are significantly thickened, and illustrate this dermatitis model modeling success.
Experiment packet:
40 near mouse of selective body heavy phase, are randomly divided into 4 groups, i.e. positive controls from 49 modeling successful mouse (with Loratadine suspension oral gavage), test sample group (with Chinese medicine composition suspension oral gavage), comparison medicine group are (with without Echinacea purpurea Chinese medicine composition suspension oral gavage), blank control group (with water for injection gavage).
Medication:
Method of administration:Oral administration gavage is administered.
Dosage rate and cycle:It is administered once daily, successive administration 14 days.
Administering mode and dosage:Test sample group:250mg/kg body weight, is administered by 0.1ml/10g body weight, and daily morning weighs After body weight, test sample suspension is given.Positive drug group:1.25mg/kg body weight, is administered by 0.1ml/10g body weight, and daily morning claims After weighing sb., Loratadine suspension is given.Comparison medicine group administering mode is identical with test sample group.Blank control group:It is daily early After morning weighs in, water for injection is given by 0.1ml/10g body weight.
Living animal Testing index:
General clinical observation:Including but not limited to death condition, the state of mind, behavioral activity, morbidity, breathing, secretion, Excrement and diet and drinking-water situation etc..
Detailed clinical is observed:Including but not limited to the state of mind, behavioral activity, skin, by hair, eyes, ear, nose, abdomen Portion, external genital organs, anus, four limbs, foot and breathing.
Body weight:All animals determine body weight with before packet after the receipt, and determine body weight before the dying euthanasia of animal.
Ear swelling degree is detected:
Detection time:24h, D4, D7, D14 before modeling, before first administration and after first administration.
Detection method:Feeler is determined.
Determine numerical value:Determine every time and repeat to survey three times to average.
Result of the test:Test sample group and positive drug group show significant antiinflammatory action, and comparison medicine group has than more significant Antiinflammatory action, during experiment, 24h is substantially unchanged after the change of each group animal ear swelling degree is mainly shown as administration, D4, D7 Test sample group and positive drug group ear thickness are obviously improved, and comparison medicine group has some improvement, and blank control group is without bright Aobvious change, D14 test sample group ear swelling situations have been wholly absent, and positive drug group and comparison medicine group have slight ear swelling, empty White control group ear swelling situation has been alleviated.
Ear swelling degree table before and after each test group animal administration of table 1
Note:Ear swelling degree shown in table:Auris dextra thickness/left ear thickness × 100%, n=10;
" * " represent with group be administered before compared with P≤0.05;
" * * " represent with group be administered before compared with P≤0.01;
" * * * " represent with group be administered before compared with P≤0.001.
From in terms of ear swelling degree result before and after the administration of each test group animal, compared with vestibule swelling is administered, after first administration 24h each group animal ear swelling degree is substantially unchanged, and D4, D7 test sample group and positive drug group ear thickness are obviously improved, right Had some improvement according to medicine group ear thickness, and blank control group, without significant change, D14 test sample group ear swelling situations are complete Mistake is totally disappeared, positive drug group and comparison medicine group still have slight ear swelling, and blank control group ear swelling situation has been alleviated.
Conclusion (of pressure testing):
Test sample group and positive drug group are respectively provided with significant antiinflammatory action, and comparison medicine group has more significant antiinflammatory action, It is mainly manifested in:Respectively with Chinese medicine composition, positive drug, control drug to mouse stomach, successive administration 14 days, in administration 4 Test sample group and positive drug group just show certain antiinflammatory action after it, when administration 7 days, test sample group and positive drug group Antiinflammatory action clearly, mice ear degree is obviously improved, and comparison medicine group mice ear degree also has certain Improve, at the end for the treatment of administration in 14 days, test sample group ear swelling situation has been wholly absent, and positive drug group and comparison medicine group still have slightly Ear swelling, blank control group ear swelling situation alleviated, compared with each group administration vestibule swelling, test sample group and the positive Medicine group is respectively provided with pole significant difference (P≤0.001), and comparison medicine group has significant difference (P≤0.01), and blank control group also has Difference (P≤0.05), illustrates that this inflammatory reaction has certain self-healing property.During administration 14 days, this Chinese medicine composition and positive drug Loratadine is compared, and its antiinflammatory action has significant difference (P≤0.05), illustrates the long-term antiinflammatory action of this Chinese medicine composition Slightly it is better than positive drug Loratadine.When being administered 14 days, compared with comparison medicine, its antiinflammatory action also has statistics to this Chinese medicine composition Difference (P≤0.05) is learned, illustrates that the long-term antiinflammatory action of this Chinese medicine composition is substantially better than the control drug without Echinacea purpurea, therefore Illustrate effect of the Echinacea purpurea played in this Chinese medicine composition be it is extremely important and prominent, just because of Echinacea purpurea and other The synergy of raw medicinal material causes that this Chinese medicine composition is provided with preferably long-term antiphlogistic effects.
Clinical test
This test objective is to observe and verify that medicine of the present invention (medicine in embodiment 2) controls curative effect to chronic dermatitis Really.
First, case selection and packet
All 100, it is randomly divided into treatment group and control group, every group each 50.
Two groups of ages, sex, the course of disease, clinical manifestation and the not statistically significant (p of coincident with severity degree of condition comparing difference> 0.05)。
2nd, diagnosis basis and inclusive criteria
(1) age requirement 18-65 one full year of life;
(2) there is dermatitis medical history in nearly 6 months;
(3) chronic dermatitis clinical criteria is met;
(4) test in first 1 week and do not take other treatment medicine;
(5) without other serious organ diseases;
(6) agree to participate in this experiment, and signed Informed Consent Form.
3rd, exclusion standard
(1) age is below 18 one full year of life or 65 one full year of life above persons;
(2) gestational period or women breast-feeding their children;
(3) there are allergies, or allergic constitution person to Loratadine;
(4) it is associated with the severe primary disease patient such as angiocarpy, liver, kidney or hemopoietic system;
(5) psychiatric patient.
4th, treatment method
Treatment group:Tablet prepared by medicine (embodiment 2) of the present invention, 1.5 grams every time, 2 times a day, 30 days 1 courses for the treatment of;
Control group:Loratadine, each 10mg, one time a day, 30 days 1 courses for the treatment of.
5th, observation index and curative effect determinate standard
Observation index:
Clinical indices:Day by day clinical symptoms, sign change are observed during experiment, and monitors the hair of various adverse reactions closely Raw time, performance, degree, treatment and result.
Lab index:Blood, urine, feces routine, Liver and kidney function are checked before experiment and after being discontinued.
Curative effect evaluation is classified:
Level Four is divided into according to clinical symptoms, the overall improvement degree of sign:
Recovery from illness:Clinical symptoms, sign recover normal;
It is effective:The state of an illness is clearly better, but not yet recovers completely normal;
Improve:The state of an illness take a favorable turn, but not obvious enough;
It is invalid:The state of an illness is without improvement or adds severe one.
6th, treatment results
After treatment group and control group treat 30 days respectively, clinical efficacy statistics is referring to table 2 below.Can from table 2 Go out, using drug therapy chronic dermatitis of the present invention, wherein recovery from illness case load and total effective rate be significantly larger than comparison medicine chlorine thunder he It is fixed, so as to prove more preferably control curative effect than being obtained using Loratadine using drug therapy chronic dermatitis of the present invention Really, and it is taken security and there has also been significant raising.
The treatment group of table 2 and control group treat 30 days after curative effect comparision table
Group Number of cases Recovery from illness It is effective Improve It is invalid Total effective rate
Treatment group 50 19 17 14 0 100.0%
Control group 50 5 20 8 17 66.0%
Model case
Female 65 years old, suffers from dermatitis more than 10 years, and per there is recurrence every year, cardinal symptom shows as burning pain, furfur, extreme scabies Itch, and very itch with that can be produced after erythema and pigmentation, especially heat, blister and erosion occur after scratching, seriously Influence the normal life of patient.After medicine of the present invention has been taken 1 month, erythema and pruritis substantially mitigate patient, continue Medication 1 month, each skin symptom disappears substantially, follow-up 3 months after drug withdrawal, does not occur similar symptom again, it was demonstrated that medicine of the present invention There is good therapeutic action to chronic dermatitis.
The preferred embodiments of the disclosure and embodiment are explained in detail above, but the present invention is not limited to The above-described embodiment and examples, in the ken that those skilled in the art possess, can also not depart from the present invention Various changes can be made on the premise of design.

Claims (6)

1. a kind of medicine for treating chronic dermatitis, it is characterised in that it is that the raw material matched by following weight is made:
2. the medicine of chronic dermatitis is treated as claimed in claim 1, wherein the weight proportion of each raw material is:
3. the medicine of chronic dermatitis is treated as claimed in claim 1, wherein the weight proportion of each raw material is:
4. the medicine of chronic dermatitis is treated as claimed in claim 1, wherein the weight proportion of each raw material is:
5. as described in claim any one of 1-4 treatment chronic dermatitis medicine, it is characterised in that the medicine be capsule Agent, tablet or granule.
6. the preparation method of the medicine of chronic dermatitis is treated described in claim 5, it is characterised in that comprised the following steps:
1) by Echinacea purpurea, cymose buckwheat rhizome, catchweed bedstraw herb, oriental wormwood, Dicliptera chinensis, purslane, amaranth, the root of Dahurain angelica, lily, globe amaranth, pseudo-ginseng Flower, Chinese sumac, the root of bidentate achyranthes, radix bupleuri, the root bark of shaggy-fruited dittany, climbing groundsel, Sweet Broomwort Herb, the wind-weed, the tuber of dwarf lilyturf, tribulus terrestris, saline cistanche, Poria cocos and liquorice medicine Material mixing, water rinsing, dry, crush after plus 8-12 times measure water, after immersion 1 hour, decoct 1-3 hour, liquid is filtered, and filtrate is standby With, the dregs of a decoction are repeated to decoct 2-3 time under the same conditions, merging filtrate, it is concentrated under reduced pressure into after small size to obtain mixing medicinal material and carries Take thing concentrate;
2) fresh bitter water is rinsed, is squeezed the juice after remove seed, gained squeezeding juice is using the molecular weight that dams through centrifuged supernatant The milipore filter of 500-1000 carries out ultrafiltration, and gained filter residue is freeze-dried that balsam pear juice freeze-dried powder is standby;Gained filtrate with it is above-mentioned Mixing medicinal substances extract concentrate is spray-dried after merging, and obtains spray dried powder standby;
3) spray dried powder obtained in above steps and balsam pear juice freeze-dried powder are mixed, is fully mixed in mixer, pelletized 8-20 mesh sieves are crossed afterwards, is dried, with 8-20 mesh sieve whole grains, capsule is filled after sterilization, packed, obtain final product this medicine capsule;
The preparation method of this medicinal tablet and granule is:Step with it is above-mentioned 1), 2) step, the 3) step by the conventional preparation in this area The method of tablet and granule is carried out, and this medicinal tablet and granule is obtained.
CN201610989457.9A 2016-11-10 2016-11-10 A kind of medicine and preparation method for treating chronic dermatitis Withdrawn CN106728819A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107348496A (en) * 2017-07-05 2017-11-17 阎艺方 A kind of child nutrition replenishers of clearing lung-heat moistening lung

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107348496A (en) * 2017-07-05 2017-11-17 阎艺方 A kind of child nutrition replenishers of clearing lung-heat moistening lung

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Application publication date: 20170531