CN1268390C - Applicaton of alpha interferon in external used medicine for treating eczema - Google Patents
Applicaton of alpha interferon in external used medicine for treating eczema Download PDFInfo
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- CN1268390C CN1268390C CN 200410008527 CN200410008527A CN1268390C CN 1268390 C CN1268390 C CN 1268390C CN 200410008527 CN200410008527 CN 200410008527 CN 200410008527 A CN200410008527 A CN 200410008527A CN 1268390 C CN1268390 C CN 1268390C
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Abstract
The present invention relates to an application of alpha inteferon in preparing an externally applied medicine used for treating eczema, particularly to the application of alpha2a interferon and alpha2b interferon in preparing the externally applied medicine used for treating eczema. The externally applied medicine is directly applied to the affected parts, and the medicine directly permeates skin; the externally applied medicine has the advantages of direct action, no seepage, convenient operation, thorough treatment, no recurrence, mild medicinal property and no dryness of peripheral skin.
Description
Technical field
The present invention relates to application, especially α-2a interferon and α-2b interferon the application in the medicine for external use of preparation treatment eczema of interferon-alpha in the medicine for external use of preparation treatment eczema.
Background technology
Eczema (Eczema-Dermatitis) is that a kind of that the inside and outside factor by multiple complexity causes has the pleomorphism skin lesion and the scytitis reaction of oozing out tendency is easily arranged.Subjective symptoms acute pruritus, the state of an illness can not healed easily repeatedly for many years.The caused delayed allergy of multiple often inside and outside factor interaction, it is relevant with the allergic diathesis of body, neural Nervous and Mental Factors, allergy allergy etc. to fall ill.
The eczema clinical manifestation is:
(1) acute eczema: can betide any position of health, be common in head, face, ear after, breast, distal limbs and pudendum etc. locate normal the symmetrical distribution.Infringement is pleomorphism.The point-like erythema that first-selected appearance majority is intensive on the skin and the pimple and the papulovesicle (the substrate flushing of pimple has slight edema) of foxtail millet grain size, and become phlysis very soon, the broken back of bleb forms the point-like erosion and reaches incrustation etc.Subjective symptoms is violent pruritus, and causalgia is arranged, and Chang Yin scratches or the hot water laundering, causes the further diffusion towards periphery of rotten face, makes the skin lesion indefinite border.If processing is proper, inflammation alleviates, and desquamation occurs, and erythra can disappear in week at 2-3, as deals with improperly, and the course of disease prolongs, and easily develops into subacute and chronic eczema.
(2) subacute eczema: the transitive state between acute and chronic eczema, when the redness of acute eczema, ooze out etc. after acute inflammation alleviates, pathological changes has little pimple, has minority papulovesicle, phlysis, slight rotten to the corn, incrustation and squama etc. concurrently.Gargalesthesia is still very violent.Handle properly, can fully recover in several weeks, otherwise easily develop into chronic eczema or acute attack once more.
(3) chronic eczema: how to be transformed by acute and subacute eczema.Infringement is chronic inflammatory disease.The pars affecta skin plumpness, erythra shows as kermesinus, and rough surface has desquamation, incrustation, lichenization occurs and chaps, and has that pigmentation, scratch, point-like are oozed out, blood crusts and squama etc.How relatively skin lesion limitation, and pruritus is than play or paroxysmal, and pruritus was particularly serious when chance was hot or sleeping.Course of disease protracted course of disease can be delayed several months or several years.
In addition, dermatitis and eczema Chang Zuowei synonym are used to refer to a kind of scytitis, represent the atopic reaction of skin for all materials such as chemicals, albumen, antibacterial and funguses.Eczema one speech does not have special implication, and dermatitis then has the meaning of qualification.If replace eczema as the diagnosis term with dermatitis, then refer to corium, epidermis association response, it can be acute, subacute and chronic.This three can unite existence.
The eczema of several specific types all has above-mentioned general pathological change, but also has characteristics separately:
A. heterogeneous eczema (Atopic dermatitis): based on the pathological change of chronic dermatitis, high dermis blood vessel peripheral lymphoid cellular infiltration, mastocyte increases;
B. nummular eczema (Nummular eczema): tissue resembles based on subacute dermatitis, parakeratosis widely, and there is vesicle in the epidermis that is dispersed at different positions;
C. pompholyx eczema (Dyshidrotic eczema): in the thicker epidermis of horny layer, can see sponge edema type vesicle.
The treatment of eczema can be divided into:
(1) general control: after eczema takes place, note the skin clean health, avoid stimulating again, be sure not to scratch, hot water scalds, soap is washed and be coated with the strong medicine for external use of zest.
(2) whole body therapeutic: can use antihistaminic class medicine, corticosteroid hormone and tranquilizer, or carry out the nonspecific desensitization treatment.Antihistaminic class medicine can be antipruritic, as hismanal.Acute or subacute universal eczema can quiet notes 5% calcium bromide or 10% calcium gluconate.To oozing out obvious person, available Radix Rehmanniae injection for treating.To extensive secondary infection person is arranged, cooperate and use effective antibiotic therapy.；
(3) topical therapeutic: should gentle, nonirritant.
But, the heavy dose of external hormone preparation of long period or short-term, also can addiction cause the drug dependence dermatitis, its side effect performance has kind more than 20 approximately, and modal is that the state of an illness takes a turn for the better rapidly after the medication, continue external a period of time, in case after the drug withdrawal, crimson, tenderness, pruritus, breach, desquamation can take place at innerlich anwenden position a couple of days (particularly facial), so that pustule takes place, primary affection increases the weight of, and is referred to as the dermatitis that bounces again.Can cause that also And such as obesity, hirsutism, acne, blood sugar increasing, hypertension, sodium retention, edema, the reduction of blood potassium, menoxenia, osteoporosis, aseptic necrosis of bone, gastric and duodenal ulcers send out disease, also can cause certain infringement to kidney.Also can cause a series of substance metabolism disorders such as body sugar, protein, fat and Water-Electrolyte, destroy the defence system of body and suppress the immunoreation ability.
Research both at home and abroad at present is to use interferon to carry out the method for whole body therapeutic more, exists the unconspicuous shortcoming of Skin Cell effect.As everyone knows, not only onset is slow for whole body interferon therapy local skin disease, and can be with systemic side effects.Now, the technology of mass preparation interferon-alpha is ripe, if can study the interferon-alpha medicine for external use of successfully treating eczema, reaches the purpose that improves drug effect, makes things convenient for administration, then not only can promote the well-being of mankind, and have good economic benefits.
Summary of the invention
The invention provides the application of interferon-alpha in the medicine for external use of preparation treatment eczema.
In above-mentioned application, described eczema can be acute eczema, subacute eczema or chronic eczema, also can be that two or more whiles or the priority in them is present in same skin area.
In above-mentioned application, described interferon-alpha can be α-2a interferon, also can be α-2b interferon.α-2a interferon and α-2b interferon can adopt existing technology to prepare, preferred gene engineered recombinant human interferon.
In above-mentioned application, described medicine for external use can be to make in the following dosage forms any one: ointment, Emulsion, solution, aerosol.These dosage forms can adopt existing technology to prepare, preferred ointment, Emulsion and solution.In various preparations, the concentration of interferon-alpha is 5 * 10
4IU/ml-5 * 10
6IU/ml.
So-called among the present invention " ointment " is meant that medicine and suitable substrate makes the paste external preparation of d spiss.For example, the interferon-alpha solution lyophilized powder mixing of stabilizing treatment is prepared into the oiliness ointment in greasing base (as vaseline, liquid paraffin, lanoline etc.); The interferon-alpha solution of stabilizing treatment is dissolved in water-soluble base (as Polyethylene Glycol) and is prepared into the water-soluble ointment agent.
So-called among the present invention " Emulsion " is meant the heterogeneous dispersion that two kinds of mutual exclusive liquid are formed, and is to be suspended in the another kind of liquid (dispersant) and the liquid preparation made from microspheroidal (decentralized photo) by a certain liquid.Character and biphase volume ratio according to emulsifying agent can get two classes Emulsion of different nature, i.e. oil/water and milk (O/W type) and water/oil breast (w/o type).For example, the interferon-alpha solution of stabilizing treatment is dissolved in oil-in-water emulsifiers (soda soap, triethanolamine soap class, poly yamanashi esters etc.) or is dissolved in water-in-oil emulsifier (calcium soap, aliphatic alcohol etc.) and is prepared into ointment.
So-called among the present invention " solution " is meant the clear and bright solution of non-volatile medicine or minority volatile medicine, is solvent mostly with water, and also having with ethanol, vegetable oil or other liquid is the solvent person.
So-called among the present invention " aerosol " is meant that medicine (and stabilizing agent) and the propellant that suits are loaded on the preparation of making in the pressure-resistant seal container with particular valve system; During use, borrow the pressure of propellant that content is the droplet ejection.For example, the interferon-alpha solution of stabilizing treatment is packed into and is prepared into spray in the spray device.
When concrete use medicine for external use treatment of the present invention eczema, the dosage form of medicine for external use should be decided according to the performance of clinical skin lesion: if obviously red and swollen, ooze out many persons and should select the solution cold wet compress, 3-6 time/day; If be erythema, pimple, lichenification person, available ointment, Emulsion, aerosol etc. are applied in the affected part, 2-4 time/day; Being vesicle, rotten to the corn person needs with aerosol etc., 2-4 time/day; Show as squama, incrustation person's usefulness ointment, aerosol etc., 2-4 time/day.
The external interferon-alpha is during to eczema treatment, and interferon-alpha can stimulate the local skin cell to produce interferon, plays therapeutical effect by the cell balance of regulating the local skin cell.Use according to the method described above, medication got final product obvious relief of symptoms in 3 days, and symptom the lighter can fully recover in 1 week, and the heavier person of symptom can fully recover January, and severe symptom can be fully recovered March.
Medicine for external use treatment eczema of the present invention has following advantage:
(1) medicine for external use directly is applied in the affected part, and directly to dermal osmosis, effect directly and can sepage, and is easy to use;
(2) thorough treatment can not recurred;
(3) property of medicine gentleness, drying can not take place in peripheral skin;
(4) do not influence sleep, do not need to cooperate and take antiallergic agent, solved the drowsiness and addiction of untoward reaction.
The specific embodiment
The following examples will be further explained the present invention, but the present invention is not limited only to these embodiment, the scope that these embodiment do not limit the present invention in any way.Some change that those skilled in the art is made within the scope of the claims and adjust also should be thought and belongs to this
Scope of invention.
Embodiment 1 preparation interferon-alpha ointment
Adopt conventional ointment preparation technology, make α-2a interferon ointment and α-2b interferon ointment respectively, its concentration is 5 * 10
4IU/ml.
Embodiment 2 preparation interferon-alpha Emulsions
Adopt conventional Emulsion preparation technology, make α-2a interferon Emulsion and α-2b interferon Emulsion respectively, its concentration is 5 * 10
5IU/ml.
Embodiment 3 preparation interferon-alpha solution
Adopt conventional formulations prepared from solutions technology, make α-2a interferon solution and α-2b interferon solution respectively, its concentration is 5 * 10
6IU/ml.
Embodiment 4 preparation interferon-alpha aerosols
Adopt conventional aerosol preparation technology, make α-2a interferon aerosol and α-2b interferon aerosol respectively, its concentration is 1 * 10
5IU/ml.
The clinical effectiveness of embodiment 5 α-2b interferon formulation is observed
α-2b the interferon formulation of embodiment 1-4 preparation is used for clinical, carries out effect observation.
(1) physical data
50 people, wherein male 20 people, women 30 people; Age 12-16 year 13 people, 17-30 year 28 people, 30-50 year 9 people; Acute eczema 8 people, subacute eczema 15 people, chronic eczema 27 people.
(2) diagnostic criteria
Acute eczema: the pimple and the papulovesicle of intensive point-like erythema and foxtail millet grain size, and become phlysis very soon, the broken back of bleb forms the point-like erosion and reaches incrustation etc.; Violent pruritus has causalgia, makes the skin lesion indefinite border;
Subacute eczema: pathological changes has little pimple, has minority papulovesicle, phlysis, slight erosion, incrustation and squama etc. concurrently, and gargalesthesia is violent;
Chronic eczema: the pars affecta skin plumpness, the erythra kermesinus, rough surface has desquamation, incrustation, lichenization occurs and chaps, and has that pigmentation, scratch, point-like are oozed out, blood crusts and squama etc.; Pruritus is than play or paroxysmal, and pruritus was particularly serious when chance was hot or sleeping.
(3) Therapeutic Method
α-2b interferon formulation is all used in the treatment of this group, and the dosage form of medicine for external use is decided according to the performance of clinical skin lesion: if obviously red and swollen, ooze out many persons and should select the solution cold wet compress, 3-6 time/day; If be erythema, pimple, lichenification person, available ointment, Emulsion, aerosol etc. are applied in the affected part, 2-4 time/day; Being vesicle, rotten to the corn person needs with aerosol etc., 2-4 time/day; Show as squama, incrustation person's usefulness ointment, aerosol etc., 2-4 time/day.
(4) efficacy assessment standard
Recovery from illness (9-10 branch): illing skin reverts to normal condition, is as good as with other normal skins of patient;
Produce effects (4-8 branch): the eczema symptom obviously alleviates, and does not have the pain of itching;
Invalid (0-3 branch): the eczema symptom does not have obvious improvement.
The clinical efficacy result of the α-2b interferon formulation of embodiment 1-4 preparation is as shown in table 1.
The clinical efficacy result of table 1 α-2b interferon formulation
| Treatment time | Produce effects | Recovery from illness | Invalid |
| Obvious effective rate (%) | Cure rate (%) | Inefficiency (%) | |
| 3 days | 28 | 6 | 66 |
| 13 months January of week | 18 22 10 | 24 64 86 | 58 14 4 |
From the result of table 1 as can be seen, medication promptly had 28% the obvious relief of symptoms of patient in 3 days, and patient's recovery from illness of 6% is arranged simultaneously; Medication has 18% the obvious relief of symptoms of patient during 1 week, and patient's recovery from illness of 24% is arranged simultaneously, and effective percentage reaches 42%, and it is very fast to take effect; Medication had 10% the obvious relief of symptoms of patient in the time of 3 months, and patient's recovery from illness of 86% is arranged simultaneously, and effective percentage reaches 96%.
The clinical effectiveness of embodiment 6 α-2a interferon formulation is observed
α-2a the interferon formulation of embodiment 1-4 preparation is used for clinical, carries out effect observation.
(1) physical data
50 people, wherein male 24 people, women 26 people; Age 12-16 year 13 people, 17-30 year 32 people, 30-50 year 5 people; Acute eczema 5 people, subacute eczema 20 people, chronic eczema 25 people.
(2) diagnostic criteria
Identical with embodiment 5.
(3) Therapeutic Method
α-2a interferon formulation is all used in the treatment of this group, and the dosage form of medicine for external use is decided according to the performance of clinical skin lesion: if obviously red and swollen, ooze out many persons and should select the solution cold wet compress, 3-6 time/day; If be erythema, pimple, lichenification person, available ointment, Emulsion, aerosol etc. are applied in the affected part, 2-4 time/day; Being vesicle, rotten to the corn person needs with aerosol etc., 2-4 time/day; Show as squama, incrustation person's usefulness ointment, aerosol etc., 2-4 time/day.
(4) efficacy assessment standard
Identical with embodiment 5.
The clinical efficacy result of the α-2a interferon formulation of embodiment 1-4 preparation is as shown in table 2.
The clinical efficacy result of table 2 α-2a interferon formulation
| Treatment time | Produce effects | Recovery from illness | Invalid |
| Obvious effective rate (%) | Cure rate (%) | Inefficiency (%) | |
| 3 months January of 3 days 1 weeks | 22 14 20 8 | 4 16 52 64 | 74 70 28 28 |
From the result of table 2 as can be seen, medication promptly had 22% the obvious relief of symptoms of patient in 3 days, and patient's recovery from illness of 4% is arranged simultaneously; Medication has 14% the obvious relief of symptoms of patient during 1 week, and patient's recovery from illness of 16% is arranged simultaneously, and effective percentage reaches 30%, quick result; Medication had 8% the obvious relief of symptoms of patient in the time of 3 months, and patient's recovery from illness of 64% is arranged simultaneously, and effective percentage reaches 72%.
The clinical effectiveness of embodiment 7 recombinanthumaninterferon's gels is observed
The outstanding of Jingan County of patented product (recombinanthumaninterferon's gel, the patent No.: ZL 97113357.3) that uses Zhaofeng Keda Pharmaceutics Co., Ltd., Hefei to produce can obviously improve the symptom of eczema, reduces relapse rate, and some actual cases in clinical are as follows.
(1) Guo, woman, 23 years old, General Office Clerk
The main suit: upper limb erythema, pain, pruritus, sepage a year and a half, companion's left leg increased the weight of 5 months.
History of present illness: too dry because of the Northwest the year before, air pollution is heavier, the whole skin drying, the upper limb symmetry is stretched side and erythema and pruritus are occurred subsequently, especially at night, contact hot water or eat the peppery food state of an illness and increase the weight of, before five months because the pressure of one's work left leg (two affected parts respectively the about 3 * 2cm of area and 3 * 1cm) and the right hand (about 0.5 * 0.5cm) develops into erosion from erythema.No whole body ill symptoms, sleep and appetite are normal, and defecation is no abnormal.
History of past illness: no family heredity history, free from infection history, vaccination on time.In JIUYUE, 2002 Ai Luosong unsatisfactory curative effect, xerosis cutis is heavy.Go in October, 2,002 second department of dermatologry professor Zhu of Affiliated Hospital of Xi'an Communications University to be diagnosed as eczema.Therapeutic scheme is: the interferon intramuscular injection once a day, totally one week; Oral ware is controlled woods once a day, one time one; This institute's research and development medicine (concrete composition is not clear) cooperates Pulvis Talci to treat January, no erythema and pruritus, small amount of coloring matter calmness, no after treatment, recurrence once more after February.In JIUYUE, 2003 uses Friendship Hospital's department of dermatologry development medicine (concrete composition is failed to understand) effective, but each chemicals (as: shampoo dew or bath gel etc.) that uses recurs every other day.
Medicine: use outstanding Jingan County separately
Therapeutic Method: each once is applied to the affected part to outstanding Jingan County sooner or later, massages one minute, altogether March.
Curative effect: fully recover, do not have erosion, pain, erythema and pruritus, the left leg and the right hand do not have recurrence through repeatedly using shampoo and bath gel.
(2) Wang, woman, 32 years old, medical personnel
The main suit: the right hand is carried on the back the erythra of showing effect repeatedly, companion's pruritus, 6～7 years.
History of present illness: 6, the right hand refers to use bandage after the wound before 7 years, cause is from childhood promptly to colloid allergy, pasting the bandage place takes place irritated, when not healing, participates in skin lesion operation, cause hand preceding sterilizing article (Swashes) sensitization of being performed the operation, after this hand contact is such as liquid detergent, detergent class chemical substance, the little pimple of skin pruritus and the back of the hand portion promptly takes place, use clobetasol throughout the year, WUJI GAO etc. contain the ointment of hormones and smear, use medicine can fully recover at the skin lesion place after 2～3 days continuously, but recurrence again after eating irritable food (as Fructus Capsici etc.) and contacting above-mentioned chemical substance, hospital diagnosis is " right hand allergic eczema ".Contacted detergent and liquid detergent because of doing housework day off before the first quarter moon, and forgotten that the skin lesion at 3～4 places (phlysis shape pimple) appears in timely coating, the right hand once more, companion's pruritus, pruritus is more very when quiet.
History of past illness: since the childhood promptly to colloid allergy, paste HUOXUE ZHITONG GAO, medical cloth adhesive plaster etc. as the part allergy promptly takes place, left lower limb shin front portion is once to medicine for external use " ZHENGHONGHUA YOU " allergy.
Medicine: use outstanding Jingan County separately.
Therapeutic Method: begin to smear outstanding Jingan County at the skin lesion place afternoon February 9 (Monday) in 2004, February 10, sensory symptoms did not increase the weight of and improvement to some extent, and pruritus obviously alleviates behind the coating.The outstanding Jingan County of external is continued in the back, and every day 2～4 times, pimple disappears gradually after 2～3 days, and continuous use does not stop always, has adhered to 2 weeks of medication, though the contact chemical substance does not have the recurrence sign.
(3) Zhu, woman, 24 years old, the worker of enterprise
The main suit: right hand portion is shown effect erythema, pimple companion's pruritus and sepage half a year repeatedly.
History of present illness: in by the end of September, 2003 the right hand erythema, pimple and pruritus appear, especially at night, contact hot water or eat the peppery food state of an illness and increase the weight of, October to Beijing Friendship Hospital goes to a doctor, be diagnosed as " right hand eczema ", give hospital from preparaton (concrete one-tenth is hard to tell) external, and oral ware controls woods once a day, one time one.Treat January, no erythema and pruritus, the small amount of coloring matter calmness is not carried out after treatment.After January, hair washing protopathy place next day recurrence erythra companion pruritus, the same treatment week given in no sepage again, but can recur again after the hair washing, for avoiding contacting shampoo, all wears glove when having one's hair wash afterwards at every turn.
History of past illness: no family heredity history, free from infection history, vaccination on time.
Medicine: use outstanding Jingan County separately.
Therapeutic Method: outstanding Jingan County is applied to the affected part, and massages one minute to promote drug absorption, sooner or later each once, the back skin lesion recovery from illness of one week of medication, only there is a little pigmentation the part, existing shared medicine March, does not have recurrence after contacting shampoo once more.
Claims (2)
1, the application of interferon-alpha in the medicine for external use of preparation treatment eczema is characterized in that: described eczema is acute eczema, subacute eczema or chronic eczema or multiple in them and deposits that described interferon is α-2b interferon.
2, application as claimed in claim 1 is characterized in that: described medicine for external use is to make in the following dosage forms any one: ointment, Emulsion, solution or aerosol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410008527 CN1268390C (en) | 2004-03-11 | 2004-03-11 | Applicaton of alpha interferon in external used medicine for treating eczema |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410008527 CN1268390C (en) | 2004-03-11 | 2004-03-11 | Applicaton of alpha interferon in external used medicine for treating eczema |
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| Publication Number | Publication Date |
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| CN1268390C true CN1268390C (en) | 2006-08-09 |
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| CN 200410008527 Expired - Lifetime CN1268390C (en) | 2004-03-11 | 2004-03-11 | Applicaton of alpha interferon in external used medicine for treating eczema |
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| Country | Link |
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