CN1771969A - Externally applied emulsion for treating dermatitis and eczema - Google Patents
Externally applied emulsion for treating dermatitis and eczema Download PDFInfo
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Abstract
The present invention is externally applied emulsion for treating dermatitis and eczema, and the emulsion is prepared with clobetasol propionate in 1 weight portions and borneol in 30-50 weight portions as the effective components and through conventional preparation process. The material for the emulsion includes also excipient of octadecanol, stearic acid, glycerol monostearate, liquid paraffin, glycerin, HR-S1 emulsifier, emulsifying silica oil and ethyl hydroxybenzoate. Animal experiments show that the emulsion of the present invention has the functions of resisting inflammation, resisting eczema, stopping itch and relieving pain, and may be used in clinical experiment.
Description
Technical field
The invention belongs to the medicinal preparation technical field of the product that contains raw material or itself and not clear structure, be specifically related to derive from the material of plant.
Background technology
Dermatosis is in the majority with the inflammatory skin disease, and except that minority inflammatory skin disease, the patient all has the pruritus of varying degree, and particularly modal dermatitis and eczema class dermatosis pruritus is particularly outstanding, seriously influences patient's physical and mental health.Dermatitis, eczema class dermatosis are commonly encountered diseases, the frequently-occurring disease of department of dermatologry, and wherein dermatitis comprises contact dermatitis, atopic dermatitis, autosensitization dermatitis etc.
Contact dermatitis is modal dermatosis, accounts for 4～7% of department of dermatologry outpatient service amount according to estimates.Contact dermatitis is because the acute or chronic inflammatory reaction that takes place in skin, mucosa contact site behind certain material of contact.Can be divided into amphitypy according to the cause of disease: constitutional irritant reaction and contact sensitivity response, the former is caused that by the intense stimulus or the toxicity of contactant itself latter is typical delayed IV allergic reaction type.Wherein the primary stimulus reaction accounts for 70～80% of contact dermatitis again.Foreign statistic shows that occupational contact dermatitis accounts for dermatergosis 90～95%.
Diaper dermatitis is a kind of primary irritant dermatitis that betides baby buttocks, burst top, hypogastric region and diaper contact area, external genitalia position.The prevalence of foreign study report birth baby diaper inflammation in the time of 2 years old is estimated not wait from 4～15%, and these data are more on the low side than actual numerical value, because there are many patients not go to a doctor.
Atopic dermatitis is called " atoipc dermatitis " again, be a kind of scytitis disease relevant with genetic anaphylactic predisposition, involve child and teenager more, the position spreads all over face, neck, elbow, poples, extremity dorsal part etc., erythema, skin thickening, symptom such as coarse can appear in affected part, and the patient is many to increase with IgE in asthma, allergic rhinitis and the blood etc.Primary disease has increase trend over nearly 30 years, and foreign statistic accounts for crowd's 0.1～0.5%, and wherein the baby is about 3%.Inst. of Dermatology, Chinese Academy of Medical Sciences was once investigated the atopic dermatitis sickness rate of 7～20 years old population of adolescent, and total prevalence rate reaches 0.69% as a result.In the face of this colony occurred frequently of child, in 10 cities such as Beijing, Shanghai 0～6 years old preschooler investigated in 2002, report incidence is 3% as a result.
The morbidity of atopic dermatitis relates to many aspects such as gene, environmental factors, dysimmunity and pharmacological medium.In view of its clinical manifestation relevant with immunizing composition in the skin, so think that immunopathogenesis occupies significant bits.Think at present, various endogenous causes of ill (gene unconventionality change etc.) and exopathogenic factor (infection, allergen etc.) act on immunocyte in the body (comprise be fixed in the skin immunocyte and other dynamically enters the on-fixed immunocyte of skin), cause immunoreaction abnormity, and cause the generation of atopic dermatitis.
Eczema is high dermis and the epidermis inflammation that is caused by multiple inside and outside factor.Cause of disease complexity be it is generally acknowledged relevant with allergy.It is violent to scratch where it itches clinically, and there is the tendency of oozing out acute stage based on papulovesicle, and chronic phase easily shows effect repeatedly based on lichenification.
Contact dermatitis, eczema: acute stage is in the cell and intercellular edema, and sponge forms, vesicle in the epidermis, and the upper part of dermis edema, the slight cellular infiltration of blood vessel periphery is based on lymphocyte; Subacute stage is an intracellular edema, and sponge forms, and epidermis slightly thickens and parakeratosis in various degree, infiltration of more lymphocytes around the corium blood vessel; Chronic phase, thicken for the sour jujube skin, and trochanterellus prolongs, and hyperkeratosis and parakeratosis are arranged, and upper part of dermis is slight, and periangiitis disease is soaked into, and is mainly mastocyte, also the oxyphil cell can be arranged, and the blood capillary number increases, endotheliocytic swelling, hypertrophy.
Atopic dermatitis: common pathology and dermatitis, eczema are similar, and no specificity, immunohistochemical detection show that soaking into cell is mainly CD4
+The T cell.
The mode that dermatitis, eczema treatment can adopt whole body and local application to combine, wherein local application is the important means of dermatitis, eczema treatment.Glucocorticoid medicine is the most frequently used medicine, also comprises antihistaminic, immunosuppressant, antibacterium medicine, antifungal agent etc. in addition.
The external glucocorticoid, has especially obtained in the dermatitis and eczema anaphylactoid disease using widely in noninfective inflammatory skin disease because effect is rapid and evident in efficacy.Since nineteen fifty-two, the hydrocortisone emulsifiable paste came out, synthesized tens of kinds of effects different types of external glucocorticoid from weak to strong in the period of 50, and develop some added antibiotic and (or) the external glucocorticoid compound preparation of antifungal drug, as compound recipe Kenac Cream, compound recipe halometasone emulsifiable paste etc.Yet the long-term external of this class medicine may produce atrophoderma, telangiectasis, pigmentation, Perioral Dermatitis, easily untoward reaction such as secondary infection take place, if the whole body large tracts of land is used, also can cause adrenal cortex atrophy and systematic untoward reaction.
Be used for the treatment of at present dermatitis and eczema class external use medicine for treating dermatosis thing clinically suitable true, the PIYANPING emulsifiable paste of compound recipe Triamcinolone Acetonide, Pevisone emulsifiable paste, Peverson frost, compound recipe, PIKANG SHUANG, PIKANGWANG arranged, along peak health king, clobetasol, WUJI GAO.Above-mentioned external application preparation is because anti-inflammatory is strong or because antipruritic property is not good or make the prescription complexity owing to add the antibacterium antifungal, and range of application is dwindled, and easily takes place irritatedly, and its clinical efficacy all can not be satisfactory.
Summary of the invention
Technical problem to be solved by this invention is to overcome the shortcoming of said medicine, and the external ointment of the little treatment dermatitis and eczema of a kind of toxic and side effects evident in efficacy is provided.
Solve the problems of the technologies described above the technical scheme that adopted it be with the effective medicinal components of following weight parts proportioning routinely formulation method make ointment:
1 part of clobetasol propionate
30～50 parts of Borneolum Syntheticums
The preferred weight part proportioning for preparing medicine effective medicinal components of the present invention is:
1 part of clobetasol propionate
35～45 parts of Borneolum Syntheticums
The optimum weight part proportioning for preparing medicine effective medicinal components of the present invention is:
1 part of clobetasol propionate
40 parts of Borneolum Syntheticums
In proportioning of the present invention, by the conventional proportioning of ointment also proportioning octadecanol, stearic acid glyceryl monostearate, liquid Paraffin, glycerol, HR-S1 type emulsifying agent, emulsified silicone oil, ethyl hydroxybenzoate excipient are arranged, its consumption is chosen by the consumption of conventional excipients in the ointment.
In proportioning of the present invention, adopt clobetasol propionate, clobetasol propionate is a glucocorticoid, the external glucocorticoid has very strong local anti-inflammatory, antiallergic, edema effect, is one of the most frequently used medicine of department of dermatologry.Secondary infection is the common untoward reaction of glucocorticoid external.Antibacterial, fungus or viral infection influence the treatment of dermatitis and eczema, the immunology of antibacterial and dermatitis and eczema is in close relations, and therefore when using the Donisolone external, the coupling antibiotic can reduce the effect of pathogenic infection, reduce the untoward reaction of glucocorticoid, improve curative effect.
In proportioning of the present invention, adopt Borneolum Syntheticum, natural Broneolum Syntheticum and synthetic borneol are arranged, natural Broneolum Syntheticum is the converted products of Dipterocarpaceae plant Borneolum Syntheticum Dryobalanops arornatica Gaerta.f. resin, or the crystallization of feverfew Herba Blumeae Balsamiferae Blumea balsamifera DC. leaf extraction, synthetic borneol is that raw material is through chemosynthesis with Camphora, Lignum Pini Nodi wet goods.Borneolum Syntheticum is the fat-soluble monoterpenes material of a micromolecule, and molecular weight is 154.25, and is water insoluble for Borneolum Syntheticum, isoborneol mixing raceme, is soluble in alcohol.Borneolum Syntheticum acrid in the mouth hardship, be slightly cold, GUIXIN, spleen, lung meridian have effects such as the refreshment of having one's ideas straightened out, logical all keys, the Compendium of Material Medica record, Borneolum Syntheticum has the effect of " logical all keys, loose stagnated fire ", has the effect of analgesic antiphlogistic, and the external curing dermatosis has the transdermal of promotion, antibiotic, antiinflammatory, analgesic effect.
Preparation method of the present invention is as follows:
Take by weighing clobetasol propionate and Borneolum Syntheticum by weight ratio and be dissolved in the ethanol, the weight ratio of ethanol and clobetasol propionate and Borneolum Syntheticum is 2.5: 1, and is airtight, standby.Conventional proportioning by ointment takes by weighing octadecanol, stearic acid, glyceryl monostearate, liquid Paraffin, HR-S1 type emulsifying agent, emulsified silicone oil is put heating in water bath and is molten into oil phase, 80 ℃ of insulations, in addition distilled water is heated to 90 ℃, add glycerol again and ethyl hydroxybenzoate is dissolved as water, 80 ℃ of insulations, water is slowly joined in the oil phase, and stir along a direction limit edged, complete to emulsifying, substrate is made in molding, when treating that substrate temperature is reduced to 40 ℃ ± 2 ℃, add the alcoholic solution of clobetasol propionate and Borneolum Syntheticum, stir, put cold, packing after the assay was approved, every pipe 20g makes product of the present invention.
The emulsifiable paste process test of pesticide effectiveness of the present invention:, suppress the rat acute inflammatory reaction that acute exudative inflammation reacts and Ovum Gallus domesticus album brings out that dimethylbenzene stimulates mice ear to bring out with emulsifiable paste partial smearing of the present invention administration; Suppress the generation and the development of mouse experiment eczema; The mice threshold of pain that the raising thermostimulation causes and histamine are to the itch-threshold of Cavia porcellus.Presentation of results, emulsifiable paste of the present invention have antiinflammatory, antieczematic, antipruritic, analgesic activity.
The specific embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
With production drug cream agent of the present invention 1000g is that the used effective medicinal components of example and adjuvant and weight proportion thereof are:
Clobetasol propionate 0.5g Borneolum Syntheticum 20g
Octadecanol 29g stearic acid 59g
Glyceryl monostearate 20g liquid Paraffin 73g
Glycerol 104g HR-S1 type emulsifying agent 24g
Emulsified silicone oil 24g ethyl hydroxybenzoate 1.5g
Distilled water adds to 1000g
Its preparation method is as follows:
Get clobetasol propionate 0.5g and Borneolum Syntheticum 20g and be dissolved in the 50ml ethanol, airtight, standby.Take by weighing octadecanol 29g, stearic acid 59g, glyceryl monostearate 20g, liquid Paraffin 73g, HR-S1 type emulsifying agent 24g, emulsified silicone oil 24g put heating in water bath and are molten into oil phase, 80 ℃ of insulations, in addition distilled water is heated to 90 ℃, add glycerol 104g again and ethyl hydroxybenzoate 1.5g is dissolved as water, 80 ℃ of insulations.Slowly join water in the oil phase then, and along a direction limit edged stirring, substrate is made in, molding complete to emulsifying, when treating that substrate temperature is reduced to 40 ℃ of left and right sides, add the alcoholic solution of clobetasol propionate and Borneolum Syntheticum, stir, put cold, packing after the assay was approved, every pipe 20g makes product of the present invention, and every gram contains medicinal effective ingredient 0.0205g.
In the proportioning of present embodiment, the weight portion of each component of effective medicinal components is:
1 part of clobetasol propionate
40 parts of Borneolum Syntheticums
Embodiment 2
With production drug cream agent of the present invention 1000g is that the used effective medicinal components of example and adjuvant and weight proportion thereof are:
Clobetasol propionate 0.66g Borneolum Syntheticum 19.84g
Octadecanol 29g stearic acid 59g
Glyceryl monostearate 20g liquid Paraffin 73g
Glycerol 104g HR-S1 type emulsifying agent 24g
Emulsified silicone oil 24g ethyl hydroxybenzoate 1.5g
Distilled water adds to 1000g
Its preparation method is identical with embodiment 1.Every gram contains medicinal effective ingredient 0.0205g.
In the proportioning of present embodiment, the weight portion of each component of effective medicinal components is:
1 part of clobetasol propionate
30 parts of Borneolum Syntheticums
Embodiment 3
With production drug cream agent of the present invention 1000g is that the used effective medicinal components of example and adjuvant and weight proportion thereof are:
Clobetasol propionate 0.40g Borneolum Syntheticum 20.1g
Octadecanol 29g stearic acid 59g
Glyceryl monostearate 20g liquid Paraffin 73g
Glycerol 104g HR-S1 type emulsifying agent 24g
Emulsified silicone oil 24g ethyl hydroxybenzoate 1.5g
Distilled water adds to 1000g
Its preparation method is identical with embodiment 1.Every gram contains medicinal effective ingredient 0.0205g.
In the proportioning of present embodiment, the weight portion of each component of effective medicinal components is:
1 part of clobetasol propionate
50 parts of Borneolum Syntheticums
In order to verify the therapeutic effect of medicine of the present invention to dermatitis and eczema, the applicant adopts medicine of the present invention (name the is called imperial special skin emulsifiable paste during test) ointment of the embodiment of the invention 1 proportioning preparation, entrust preclinical medicine portion of Xi'an Jiaotong University Medical College pharmacology department to carry out pharmacodynamics test, various test situation are as follows:
Test objective: adopt the whole animal test, observe the antiinflammatory of emulsifiable paste of the present invention, antipruritic, analgesia and the effects such as influence of experimental Eczema Model, the effect of reflection emulsifiable paste of the present invention with cure mainly, for clinical trial provides theoretical foundation.
Trial drug: emulsifiable paste of the present invention, 10g/ props up, and middle test agent provides lot number 050128 by the rich source of Xi'an Jiaotong University Science ﹠ Technology Park biological medicine company limited; Excipient provides lot number 050128-01 by the rich source of Xi'an Jiaotong University Science ﹠ Technology Park biological medicine company limited.
Contrast medicine: WUJI GAO, Fujian Pacific Pharmacy Co.,Ltd, lot number 050201; 2, the 4-dinitrochlorobenzene, Shanghai reagent one factory, lot number 970501, with preceding with acetone solution; Histamine phosphate, Shanghai Inst. of Biochemistry, Chinese Academy of Sciences produces, lot number 20010312.
Test apparatus: YLS-7A toes volume determination instrument, Shandong Academy of Medical Sciences equipment station produces; The JA1003 electronic balance, Shanghai Precision Scientific Apparatus Co., Ltd produces.
Experimental animal: ICR strain white mice, male and female half and half, body weight 18～22g, the certification of fitness " the moving card of Shan doctor word 08-004 number "; SD strain rat, male and female half and half, body weight 200～250g, the certification of fitness " the moving card of Shan doctor word 08-005 number "; The short wool breed Cavia porcellus, male and female half and half, body weight 250～300g, the certification of fitness " the moving card of Shan doctor word 08-019 number "; Provide by Xi'an Jiaotong University Medical College's Experimental Animal Center.
The animal sub-cage rearing, the food solid feed, the drinking water freedom, feedstuff is provided by Xi'an Jiaotong University Medical College's Experimental Animal Center.18～20 ℃ of room temperatures, relative humidity 60%～70%.
Statistical disposition: between organizing with the Excel2000 statistical software relatively or self t check relatively.
One, antiinflammatory test of the present invention
1, emulsifiable paste of the present invention is to the influence (mice auricular concha swelling method) of chmice acute inflammation
50 of mices are divided into 5 groups at random, 10 every group.Negative control group gives excipient 0.2g/ only, and 0.1g//time, totally 2 times; Positive controls gives WUJI GAO 0.2g/ only, and 0.1g//time, totally 2 times; Emulsifiable paste small dose group of the present invention gives emulsifiable paste 0.05g/ of the present invention only, and 0.025g//time, totally 2 times; Dosage group in the emulsifiable paste of the present invention gives emulsifiable paste 0.1g/ of the present invention only, and 0.05g//time, totally 2 times; The heavy dose of group of emulsifiable paste of the present invention gives emulsifiable paste 0.2g/ of the present invention only, and 0.1g//time, totally 2 times.Each is organized, and all auris dextra shell partial smearing is to the 1st medicine, and administration is after 60 minutes, and every Mus auris dextra is coated with dimethylbenzene 0.1ml and causes inflammation, and left ear is as normal control.And then be coated with medicine the 2nd time with method.Put to death mice after causing scorching 1 hour, take off the bilateral auricle, divide its weight that has another name called, as the swelling degree, represent the acute inflammation degree, be calculated as follows suppression ratio with the swelling degree with the difference of two auricle weight with the card punch of diameter 9mm.The results are shown in Table 1.
Table 1 emulsifiable paste of the present invention to the influence of chmice acute inflammation (x ± s, n=10)
| Group | Dosage (g/ only) | Swelling degree (mg) | Suppression ratio (%) |
| Negative control group | 14.0±3.9 | ||
| Positive controls | 0.2 | 9.9±2.2* | 29.3 |
| Emulsifiable paste low dose of the present invention | 0.05 | 13.2±3.2 | 5.7 |
| Dosage in the emulsifiable paste of the present invention | 0.1 | 9.6±1.8** | 31.4 |
| Emulsifiable paste heavy dose of the present invention | 0.2 | 6.4±1.6** | 54.3 |
Compare * P＜0.05, * * P＜0.01 with negative control group
By table 1 as seen, emulsifiable paste of the present invention suppresses the acute exudative inflammation reaction that dimethylbenzene stimulates mice ear to bring out, the swelling degree is reduced, compare with negative control group, among the present invention, heavy dose of group has significant difference (P＜0.01), points out emulsifiable paste of the present invention that the effect of anti-chmice acute exudative inflammation is arranged.The positive control drug WUJI GAO also can suppress the acute exudative inflammation reaction that dimethylbenzene stimulates mice ear to bring out.
2, emulsifiable paste of the present invention is to the influence (rat foot claw edema method) of rat acute inflammation
50 of rats are divided into 5 groups at random, 10 every group.Negative control group gives excipient 0.6g/ only, and 0.3g//time, totally 2 times; Positive controls gives WUJI GAO 0.6g/ only, and 0.3g//time, totally 2 times; Emulsifiable paste small dose group of the present invention gives emulsifiable paste 0.15g/ of the present invention only, and 0.075g//time, totally 2 times; Dosage group in the emulsifiable paste of the present invention gives emulsifiable paste 0.3g/ of the present invention only, and 0.15g//time, totally 2 times; The heavy dose of group of emulsifiable paste of the present invention gives emulsifiable paste 0.6g/ of the present invention only, and 0.3g//time, totally 2 times.Rat foot claw partial smearing administration 1 time, after 60 minutes, the right back sufficient sole of the foot intradermal injection 10% Ovum Gallus domesticus album 0.1ml of every Mus causes inflammation, and then with method coating 1 time, cause before the inflammation and cause scorching back 30 minutes, 1 hour, 2 hours, 4 hours and measure the right back sufficient pawl volume of rat with rat toes volume determination instrument, so that the difference of sufficient pawl volume is represented the acute inflammation degree as the swelling degree with the swelling degree before and after scorching.The results are shown in Table 2.
Table 2 emulsifiable paste of the present invention to the influence of rat acute inflammation (x ± s, n=10)
| Group | Dosage (g/ only) | Swelling degree (ml) | |||
| 30min | 1h | 2h | 4h | ||
| Negative control group | 0.95±0.18 | 1.09±0.20 | 1.04±0.34 | 0.82±0.25 | |
| Positive controls | 0.6 | 0.82±0.32 | 0.81±0.12** | 0.80±0.18 | 0.68±0.15 |
| Emulsifiable paste low dose of the present invention | 0.15 | 0.88±0.24 | 0.93±0.18 | 0.92±0.17 | 0.76±0.16 |
| Dosage in the emulsifiable paste of the present invention | 0.3 | 0.81±0.19 | 0.81±0.10** | 0.80±0.15 | 0.67±0.12 |
| Emulsifiable paste heavy dose of the present invention | 0.6 | 0.77±0.35 | 0.73±0.13** | 0.71±0.28* | 0.61±0.18* |
Compare * P＜0.05, * * P＜0.01 with negative control group
By table 2 as seen, emulsifiable paste topical of the present invention can suppress the generation and the development of the rat acute inflammation that Ovum Gallus domesticus album brings out, compare with negative control group, significant difference (P＜0.01) was arranged after the administration of dosage group in the emulsifiable paste of the present invention in 1 hour, significant difference (P＜0.05 or P＜0.01) was arranged after the administration of heavy dose of group in 1,2,4,6 hour.Illustrate that emulsifiable paste of the present invention has Chinese People's Anti-Japanese Military and Political College's Mus acute exudative inflammation effect.The positive control drug WUJI GAO also can suppress the rat acute exudative inflammation reaction that Ovum Gallus domesticus album brings out.
Two, emulsifiable paste of the present invention is to the influence of experimental Eczema Model
60 of mices are divided into 6 groups at random, 10 every group.The normal control group, partial smearing excipient 0.1g//time; Model control group, partial smearing excipient 0.1g//time; Positive controls, partial smearing WUJI GAO 0.1g//time; Emulsifiable paste group of the present invention, partial smearing emulsifiable paste 0.025,0.05 of the present invention, 0.1g/ only/time.Press the list of references method and make the mice Eczema Model.Except that the normal control group, all the other are respectively organized mouse back and shave hair, and partial smearing 7% dinitrochlorobenzene 0.1ml sensitization excited at inboard partial smearing 0.1% dinitrochlorobenzene of mouse right ear 5 μ l after 5 days, excited 1 time totally 5 times in per 3 days.From exciting the beginning administration for the first time, smear medicine in the mouse right ear inboard, 1 time/day.Following index is observed in the last administration after 24 hours: mice ear incrustation rate, auricle swelling degree is got auricle and is done common pathology inspection.The results are shown in Table 3.
Table 3 emulsifiable paste of the present invention is to the influence of mouse experiment Eczema Model (x ± s)
| Group | Dosage (g/ only) | Number of animals (only) | Swelling degree (mg) | Incrustation rate (%) |
| Negative control group | 10 | 0.20±0.63** | 0 | |
| Model control group | 0.1 | 10 | 9.10±1.79 | 90 |
| Positive controls | 0.1 | 10 | 2.00±1.56** | 20 |
| Emulsifiable paste low dose of the present invention | 0.025 | 10 | 2.10±1.52** | 30 |
| Dosage in the emulsifiable paste of the present invention | 0.05 | 10 | 2.00±1.41** | 10 |
| Emulsifiable paste heavy dose of the present invention | 0.1 | 10 | 1.33±1.94** | 0 |
Compare * P＜0.05, * * P＜0.01 with model control group.
By table 3 as seen, emulsifiable paste of the present invention suppresses the generation and the development of mouse experiment eczema, and ear's swelling degree is reduced, local incrustation reduces, compare with model control group, each dosage group all has significant difference (P＜0.01), points out emulsifiable paste of the present invention that the effect of anti-mouse experiment eczema is arranged.The positive control drug WUJI GAO also can suppress the generation and the development of mouse experiment eczema.
Three, the antipruritic test of emulsifiable paste of the present invention
40 of Cavia porcelluss are divided into 5 groups at random, and 8 every group, negative control group gives excipient 0.6g/ only, and 0.3g//time, totally 2 times; Positive controls gives WUJI GAO 0.6g/ only, and 0.3g//time, totally 2 times; Emulsifiable paste small dose group of the present invention gives emulsifiable paste 0.15g/ of the present invention only, and 0.075g//time, totally 2 times; Dosage group in the emulsifiable paste of the present invention gives emulsifiable paste 0.3g/ of the present invention only, and 0.15g//time, totally 2 times; The heavy dose of group of emulsifiable paste of the present invention gives emulsifiable paste 0.6g/ of the present invention only, and 0.3g//time, totally 2 times.Test and shaved hair, local application 1 time to each group Cavia porcellus right back instep in preceding 1 day.Test the same day, the unhairing place is abraded gently the degree of being with rubescent, the about 1cm of area with coarse sandpaper
2, local repaste medicine 1 time.After the last administration 10 minutes, every 3 minutes successively by low concentration to high concentration, smear histamine 0.05ml/ only to the right back instep of Cavia porcellus, histamine concentration is followed successively by 1.0 * 10
-4, 2.0 * 10
-4, 3.0 * 10
-4, 4.0 * 10
-413 * 10
-4, 14 * 10
-4, 15 * 10
-4Mmol/L.When pruritus reaction appears in Cavia porcellus, promptly lick right back sufficient wound site, or till not occurring the pruritus reaction yet to maximum concentration.Accumulate every Cavia porcellus and lick the itch-threshold of the right back histamine total amount that is given when sufficient (the histamine amount of Cavia porcellus tolerance) as Cavia porcellus.The results are shown in Table 4.
Table 4 emulsifiable paste of the present invention is to the itching-relieving action of mouse skin pruritus (x ± s)
| Group | Dosage (g/ only) | Number of animals (only) | Itch-threshold (histamine phosphate total amount μ g) |
| Negative control group | 8 | 19.00±9.25 | |
| Positive controls | 0.6 | 8 | 37.63±21.25* |
| Emulsifiable paste low dose of the present invention | 0.15 | 8 | 21.69±8.14 |
| Dosage in the emulsifiable paste of the present invention | 0.3 | 8 | 30.72±11.14* |
| Emulsifiable paste heavy dose of the present invention | 0.6 | 8 | 77.56±48.03** |
Compare * p＜0.05, * * p＜0.01 with negative control group
By table 4 as seen, emulsifiable paste of the present invention can obviously improve the Cavia porcellus itch-threshold, with negative control group relatively, in, heavy dose of group has significant difference (P＜0.05 or P＜0.01), illustrates that emulsifiable paste of the present invention has itching-relieving action preferably.The positive control drug WUJI GAO also can improve the Cavia porcellus itch-threshold.
Four, the analgesic test of emulsifiable paste of the present invention
Licking metapedes with mice and show as pain with 55 ℃ of the constant water temperatures of instrument with the experiment of YD-4 type physiological and pharmacological is many, is threshold of pain index from mice contact hot plate to licking the metapedes required time.Measure the secondary threshold of pain in advance, the mice that is averaged the threshold of pain and is 10～30s is participated in the experiment.Get 50 of mices, be divided into 5 groups at random, 10 every group, negative control group gives excipient 0.1g/ only; Positive controls gives WUJI GAO 0.1g/ only, emulsifiable paste of the present invention is little, in, heavy dose of group, only give emulsifiable paste 0.025,0.05 of the present invention, 0.1g/ respectively.The all sufficient sole of the foot partial smearing of each group administration 1 time.Measured the mice threshold of pain respectively in 30,60,90,120 minutes before the administration and after the administration, greater than 60 seconds, calculated with 60 seconds as the threshold of pain.
The results are shown in Table 5.
Table 5 emulsifiable paste of the present invention to the influence of the mice threshold of pain (x ± s, n=10)
| Group | Dosage (g/ only) | The threshold of pain (s) | ||||
| Before the administration | 30min after the administration | 60min | 90min | 120min | ||
| Negative control group | 20.2±4.2 | 22.4±4.1 | 23.3±3.2 | 24.0±4.4 | 23.4±4.5 | |
| Positive controls | 0.1 | 19.7±4.1 | 22.4±5.9 | 24.6±8.8 | 28.6±6.6 | 33.6±6.6** |
| Low dose of the present invention | 0.025 | 19.9±3.2 | 21.9±3.8 | 23.5±3.0 | 22.8±2.9 | 22.9±3.8 |
| Dosage among the present invention | 0.05 | 19.7±3.7 | 24.4±3.7 | 25.6±5.0 | 29.6±6.2* | 32.6±4.7** |
| Heavy dose of the present invention | 0.1 | 22.7±6.4 | 29.3±8.9* | 34.0±14.2* | 35.6±11.5** | 35.9±11.5** |
Compare * P＜0.05, * * P＜0.01 with negative control group
By table 5 as seen, emulsifiable paste of the present invention can improve the mice threshold of pain, compare with negative control group, in significant difference (P＜0.05 or P＜0.01) was arranged after the administration of dosage group in 90 minutes, 120 minutes, significant difference (P＜0.05 or P＜0.01) was all arranged in 30 minutes, 60 minutes, 90 minutes, 120 minutes after the administration of heavy dose of group, the pain of pointing out emulsifiable paste of the present invention that the mice thermostimulation is caused has certain analgesic activity.The positive control drug WUJI GAO does not have obvious analgesic activity.
Conclusion (of pressure testing): emulsifiable paste partial smearing of the present invention administration, suppress the rat acute inflammatory reaction that acute exudative inflammation reacts and Ovum Gallus domesticus album brings out that dimethylbenzene stimulates mice ear to bring out; Suppress the generation and the development of mouse experiment eczema; The mice threshold of pain that the raising thermostimulation causes and histamine are to the itch-threshold of Cavia porcellus.Presentation of results, emulsifiable paste of the present invention have antiinflammatory, antieczematic, antipruritic, analgesic activity.
Function of the present invention: antiinflammatory, antipruritic, pain relieving.
The present invention cures mainly: dermatitis, eczema.
Specification of the present invention: the every pipe 20g of drug cream agent of the present invention, every gram contains medicinal effective ingredient 0.0205g.
Usage and dosage of the present invention: every day 3 times, a little evenly is applied to the affected part at every turn.
Storage of the present invention: the shady and cool dry place of sealing storage.
Effect duration of the present invention: 2 years.
Claims (3)
1, a kind of external ointment for the treatment of dermatitis and eczema, it is characterized in that it be with the effective medicinal components of following weight parts proportioning routinely formulation method make ointment:
1 part of clobetasol propionate
30～50 parts of Borneolum Syntheticums
In proportioning of the present invention, by the conventional proportioning of ointment also proportioning octadecanol, stearic acid glyceryl monostearate, liquid Paraffin, glycerol, HR-S1 type emulsifying agent, emulsified silicone oil, ethyl hydroxybenzoate excipient are arranged, its consumption is chosen by the consumption of conventional excipients in the ointment.
2,, it is characterized in that wherein the weight portion proportioning of each effective medicinal components is according to the external ointment of the described treatment dermatitis and eczema of claim 1:
1 part of clobetasol propionate
35～45 parts of Borneolum Syntheticums
3,, it is characterized in that wherein the weight portion proportioning of each effective medicinal components is according to the external ointment of the described treatment dermatitis and eczema of claim 1:
1 part of clobetasol propionate
40 parts of Borneolum Syntheticums.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510096263 CN1771969A (en) | 2005-10-31 | 2005-10-31 | Externally applied emulsion for treating dermatitis and eczema |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510096263 CN1771969A (en) | 2005-10-31 | 2005-10-31 | Externally applied emulsion for treating dermatitis and eczema |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1771969A true CN1771969A (en) | 2006-05-17 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510096263 Pending CN1771969A (en) | 2005-10-31 | 2005-10-31 | Externally applied emulsion for treating dermatitis and eczema |
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| Country | Link |
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| CN (1) | CN1771969A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168893A (en) * | 2015-11-03 | 2015-12-23 | 陈薇 | Traditional Chinese medicine cream for treating eczema as well as preparation method and application of traditional Chinese medicine cream |
| CN106075120A (en) * | 2016-07-01 | 2016-11-09 | 宁波希诺亚海洋生物科技有限公司 | A kind of Eczema Creams agent |
| CN108685842A (en) * | 2018-06-28 | 2018-10-23 | 河南科技大学第附属医院 | A kind of Western medicine externally used paste and preparation method thereof |
-
2005
- 2005-10-31 CN CN 200510096263 patent/CN1771969A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168893A (en) * | 2015-11-03 | 2015-12-23 | 陈薇 | Traditional Chinese medicine cream for treating eczema as well as preparation method and application of traditional Chinese medicine cream |
| CN106075120A (en) * | 2016-07-01 | 2016-11-09 | 宁波希诺亚海洋生物科技有限公司 | A kind of Eczema Creams agent |
| CN106075120B (en) * | 2016-07-01 | 2019-09-20 | 宁波希诺亚海洋生物科技有限公司 | A kind of Eczema Creams agent |
| CN108685842A (en) * | 2018-06-28 | 2018-10-23 | 河南科技大学第附属医院 | A kind of Western medicine externally used paste and preparation method thereof |
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