CN102872158A - External drug combination for curing eczema and preparation method thereof - Google Patents
External drug combination for curing eczema and preparation method thereof Download PDFInfo
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- CN102872158A CN102872158A CN2012102236931A CN201210223693A CN102872158A CN 102872158 A CN102872158 A CN 102872158A CN 2012102236931 A CN2012102236931 A CN 2012102236931A CN 201210223693 A CN201210223693 A CN 201210223693A CN 102872158 A CN102872158 A CN 102872158A
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Abstract
The invention discloses an external drug combination for curing eczema, which comprises the following ingredients in weight part: 100 to 350 parts of calcined and quenched calamine, 68 to 200 parts of borneol, 0.5 to 5 parts of muskone, 2 to 15 parts of borax, and 1 to 15 parts of paeonol. The invention also discloses preparation methods of ointment, gels, irrigation and cream of the external drug combination. The external drug combination has a reasonable formula, has the effects of clearing away heat and toxic material, eliminating dampness, eliminating the swelling and removing the necrotic tissue, and is applicable to the treatment of skin diseases, such as eczema. The method is simple, easy to operate, and suitable for industrial production.
Description
Technical field
The present invention relates to a kind of external Chinese medicine ointment agent for the treatment of eczema and preparation method thereof.
Background technology
Eczema (eczema) is that the inflammatory skin of a kind of common epidermis that is caused by multiple internal and external factor and high dermis is sick, and it is generally acknowledged with allergy has certain relation.Its clinical manifestation has the characteristics such as symmetry, exudative, itching skin disease, pleomorphism and recurrent.Eczema is a kind of dermatosis of easy recurrence, and treatment needs the recurrent medicine dedicated, also be a kind of allergic inflammation dermatoses with the erythra multiformity, symmetrical, violent pruritus shows effect, easily develops into chronic for feature repeatedly.Can betide any position of any age, but recur or aggravate the winter of being everlasting the tendency of oozing out be arranged any season, the chronic course of disease, easily repeatedly outbreak.
Clinical treatment
Doctor trained in Western medicine innerlich anwenden Therapeutic Principle: first-selected antihistaminic: two kinds of use in conjunction of multiselect, such as the first generation and second filial generation antihistaminic use in conjunction; But it should be noted that unsuitable similar drugs use in conjunction.Generally should not use glucocorticoid.Acute stage is oozed out obvious person can be with venoclysises such as calcium preparation, vitamin C, sodium thiosulfate to improve capillary permeability, and minimizing is oozed out.There is secondary infection person to add and uses effective antibacterial drug therapy.
The medicine for external use Therapeutic Principle: acute eczema is red and swollen obviously, have in a large number and ooze out, or the skin lesion of erosion, ulceration is arranged, and should use cold wet compress, commonly uses 3% boric acid solution.Red and swollen not serious, but vesicle, external zinc oil when sepage is few; There is when infection can use the ethacridine zinc oxid oil.Slight redness, pimple, vesicle and can use the Calamina (calcined and quenched) lotion during without sepage, rotten to the corn face.Subacute stage can be selected glucocorticoid Emulsion, paste; For preventing and control secondary infection, can add antibacterials.Chronic phase, can be selected ointment, plaster, liniment; Intractable limitation skin lesion can be made in the skin lesion of glucocorticoid and inject.
The multiplex chemistry of this type of disease of western medical treatment or hormone medicine have toxic and side effects and easily produce drug resistance.
Summary of the invention
In order to solve the problems of the technologies described above, the invention provides a kind of pharmaceutical composition for the treatment of eczema, add and subtract prescription according to traditional Chinese medicine theory, have good sterilization, removing dampness, antipruritic effect, modern pharmacy research also confirms that this medicine has antiinflammatory, antibiotic and itching-relieving action.Pharmaceutical composition provided by the invention is Chinese medicine preparation, does not contain hormone, does not produce drug resistance.The efficacy of a drug affected part of going directly, onset is rapid, is difficult for recurrence, breaks through the limitation of the issuable side effect of Western medicine and drug resistance, and prescription is original.
The externally-applied medicinal composition for the treatment of eczema provided by the invention, contain the composition of following parts by weight:
Calamina (calcined and quenched) 100～350;
Borneolum Syntheticum 68～200;
The artificial Moschus 0.5～5;
Borax 2～15;
Paeonol 1～15.
As optimal technical scheme, the externally-applied medicinal composition of above-mentioned treatment eczema, contain the composition of following parts by weight:
Calamina (calcined and quenched) 120～300;
Borneolum Syntheticum 80～170;
The artificial Moschus 0.8～4;
Borax 2～15;
Paeonol 2～10.
As optimal technical scheme, the externally-applied medicinal composition of above-mentioned treatment eczema is ointment, also contains the composition of following parts by weight:
Vaseline 300～804.5;
Dimethyl sulfoxine 5～30;
Lanoline 20～80.
As optimal technical scheme, the externally-applied medicinal composition of above-mentioned treatment eczema is gel, also contains the composition of following parts by weight:
Poly-Pyrusussuriensis fat-80 5 ~ 8;
Glycerol 450 ~ 550;
Gel-type vehicle 3 ~ 5;
Antiseptic 2 ~ 4;
Percutaneous absorption enhancer 2 ~ 4.
As optimal technical scheme, the externally-applied medicinal composition of above-mentioned treatment eczema is irrigation, also contains the composition of following parts by weight:
Glycerol 280 ~ 380;
Distilled water 220 ~ 320.
As optimal technical scheme, the externally-applied medicinal composition of above-mentioned treatment eczema is cream, also contains the composition of following parts by weight:
Vaseline 280 ~ 380;
Glycerol 200 ~ 300;
Hexadecanol 3 ~ 7;
Liquid paraffin 30 ~ 60;
Percutaneous absorption enhancer 1 ~ 3;
Emulsifying agent 2 ~ 6.
The invention provides the preparation method of the externally-applied medicinal composition ointment of above-mentioned treatment eczema, comprise the steps:
A, Calamina (calcined and quenched) is carried out water fly to process, get the Calamina (calcined and quenched) powder;
B, with the Calamina (calcined and quenched) powder facing-up of artificial Moschus, Borax, Borneolum Syntheticum, 1/5 weight, cross the 100-120 mesh sieve;
C, with the Calamina (calcined and quenched) powder mix homogeneously of step B gained medicated powder and 4/5 weight;
D, the mixed medicated powder of step C is pulverized by drug micronization, got former powder;
E, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
F, with after the vaseline fusing, sterilization, cooling;
G, lanoline is sterilized;
H, dimethyl sulfoxine is melted;
I, the vaseline that at first step F is obtained are put into material-compound tank, put into a half and stir; Secondly with dimethyl sulfoxine and lanoline congruent melting, filter and drop in the material-compound tank and stir; Paeonol aqueous solution with the former powder of step D gained, step e adds material-compound tank again, stirs.
The invention provides the preparation method of the externally-applied medicinal composition gel of above-mentioned treatment eczema, comprise the steps:
A, with described amount Calamina (calcined and quenched), Borax respectively water fly or be ground into fine powder;
B, with described amount artificial Moschus and Borneolum Syntheticum porphyrize, with steps A gained fine powder facing-up, cross 200 mesh sieves, comminution by gas stream, for subsequent use;
C, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, get distilled water, add poly-Pyrusussuriensis fat-80, the glycerol of described amount, stir evenly, add gel-type vehicle, place, treat that it expands naturally, gets clear gel; The medicated powder that step B is obtained, the paeonol aqueous solution that step C obtains evenly add in the clear gel and stir evenly, and get drug gel; Get again antiseptic and the Percutaneous absorption enhancer of described amount, add dissolve with ethanol, get alcoholic solution, under constantly stirring, ethanol is added in the drug gel, stir; Other gets sodium hydrate aqueous solution, joins in the above-mentioned gel under constantly stirring, and regulates pH value to 6.0 ~ 7.0, stirs evenly, and gets gel.
The invention provides the preparation method of the externally-applied medicinal composition irrigation of above-mentioned treatment eczema, it is characterized in that, comprise the steps:
A, with Calamina (calcined and quenched), Borax respectively water fly or be ground into fine powder;
B, artificial Moschus, Borneolum Syntheticum two flavor Chinese medicine porphyrizes with steps A gained fine powder facing-up, are crossed 200 mesh sieves;
C, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, step B and step C gained are evenly mixed, add glycerol and distilled water.
The invention provides the preparation method of the externally-applied medicinal composition cream of above-mentioned treatment eczema, comprise the steps:
A, with Calamina (calcined and quenched), Borax respectively water fly or be ground into fine powder;
B, artificial Moschus, Borneolum Syntheticum two flavor Chinese medicine porphyrizes are crossed 200 mesh sieves;
C, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, the hexadecanol of getting described amount, liquid paraffin, vaseline, Percutaneous absorption enhancer are put in the beaker, heat fused in the water-bath, and insulation gets oil phase; Get steps A gained medicated powder and place beaker, add distilled water, add again emulsifying agent, glycerol after stirring, stir, be heated to 80 ℃ in the water-bath, and with step C gained paeonol aqueous solution mixing with it, get water; Above-mentioned oil phase is slowly added aqueous phase, constantly be stirred to condensation, treat that temperature is down to below 60 ℃, add again step B gained medicated powder and stir, get product.
Being analyzed as follows of active ingredient among the present invention:
Calamina (calcined and quenched): nature and flavor are sweet, and are flat.Return the stomach warp, have the detoxifcation improving acuity of vision and removing nebula, the antipruritic sore of removing dampness.Be used for conjunctival congestion and swelling pain, marginal blepharitis, nebula film bulbar conjunctiva polyp, ulcer being unable to heal, pus is dripping, eczema, skin pruritus.
Borneolum Syntheticum: hot, bitter, be slightly cold.GUIXIN, spleen, lung meridian.Has the refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.Be used for calentura coma, convulsions, stagnation of QI sudden syncope, the attacked by pestiferous factors stupor, conjunctival congestion, aphtha, laryngopharynx swelling and pain, auditory meatus is suppurated.
Artificial Moschus: suffering, temperature.GUIXIN, spleen channel; The refreshment of having one's ideas straightened out is arranged, promoting blood circulation to restore menstrual flow, the merit of reducing swelling and alleviating pain is used for the calentura coma, the apoplexy syncope due to accumulation of phlegm, stagnation of QI sudden syncope, the attacked by pestiferous factors stupor, amenorrhea, insane abdominal mass, the difficult labour stillborn fetus, trusted subordinate's sudden pain, the carbuncle scrofula, laryngopharynx swelling and pain falls and pounces on the pain of injury, and arthralgia pain is numb.
Borax: sweet, salty, cold.Attach to the lung and stomach meridians.The external heat-clearing and toxic substances removing, detumescence, anticorrosion; Removing heat from the lung and dissipating phlegm for oral administration.Be used for acute tonsillitis, pharyngolaryngitis, laryngopharynx swelling and pain, aphtha of the mouth and tongue, stomatitis, gingivitis, otitis media, conjunctival congestion and swelling pain, tinea versicolor.
Paeonol: paeonol is extract a kind of Chinese crude drug out from the root bark of the national flower Flos Moutan of China.By bibliographical information, paeonol has analgesia, antiinflammatory, analgesic and suppress allergic effect.To pressing the pain due to the physics such as tail, acetic acid or the chemical factor, has obvious analgesic activity.To by the inflammatory reaction due to carrageenin, Ovum Gallus domesticus album, formaldehyde, histamine, 5-hydroxy tryptamine, Kallidin I, dimethylbenzene and the endotoxin etc., has obvious inhibitory action.To the fervescence that Typhoid Vaccine, triple vaccine etc. causes, has obvious refrigeration function.All inhibited to II, III, IV allergic reaction type.Have the effects such as calmness, hypnosis, antibiotic, antiinflammatory, antioxidation, blood pressure lowering, aspect daily use chemicals, paeonol can suppress O2-free-radical generating in the cell, can make skin whitening, with fossil pigments Reduction fading in the skin, the effects such as silt dissipating rashes, antiinflammatory, reducing swelling and alleviating pain, antiallergic, antiviral disappear.Mottle, myalgia, skin pruritus, psoriasis, zona shingles, eczema are had preferably treatment and health-care effect, in addition, preferably effect is arranged in toothpaste, gargarism, dentifrice, toothache drops.
The present invention fills a prescription rationally, plays altogether the effect of heat-clearing and toxic substances removing, dampness removing to stop itchin, removing the necrotic tissue and promoting granulation, applicable treatment eczema skin diseases.Technique is simple, and easy operating is suitable for suitability for industrialized production.
Medicine of the present invention can also adopt the conventional method of Chinese medicine preparation to be prepared into any conventional external preparation.Needed various conventional adjuvants when for example medicine of the present invention being added the preparation different dosage form are prepared into any conventional exterior-applied formulation such as lubricant, antioxidant, absorbent etc. with the method for Chinese medicinal of routine, such as ointment, gel, oiliness ointment etc.
Usage and dosage: behind the cleaning affected part, every day 3 times, evenly smear the affected part.
The present invention compares with existing Technology, has the following advantages and effect:
1, a kind of externally-applied medicinal composition for the treatment of eczema provided by the invention.Effect with heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, removing the necrotic tissue and promoting granulation is applicable to the positive disease of boil.It has that therapeutic effect is good, curative effect fast, toxicity is extremely low, be easy to carry about with one, and is easy to use.
2, the invention provides the preparation method of the externally-applied medicinal composition (comprising ointment, gel, irrigation, cream) of above-mentioned treatment eczema, method technique is simple, easy operating, is suitable for suitability for industrialized production.
3, the present invention adopts the modern refining extractive technique of Chinese medicine that the key component in the prescription is prepared, and has obviously improved the absorbance of medicine, and the pharmacological action effect of main effective ingredient is significantly higher than conventional formulation.
4, the present invention fills a prescription rationally.Each drug distribution of filling a prescription is extremely wide, aboundresources., pharmacopeia contained Chinese medicine commonly used by Calamina (calcined and quenched), Borneolum Syntheticum, Borax, artificial Moschus four flavors and Cortex Moutan extract paeonol form, and material is cheap and easy to get.
5, dosage form of the present invention is advanced, makes things convenient for the patient to use.This agent is evident in efficacy, effect is rapid, toxicity is extremely low, and easily carries, and is easy to use.And the time can not bring the advantage of any inconvenience to the patient in treatment, and the present invention compares with other Therapeutic Method, and it has exempted the shortcomings such as the misery of loaded down with trivial details, knife needle of fumigation and wash method and skin allergy.The present invention is particularly suitable for treating the eczema Dermatology.
6, by this externally-applied medicinal composition pharmacodynamic study is shown, this prescription has than drug activity at antiinflammatory, the aspect such as antibacterial, antipruritic.
The specific embodiment
Embodiment one:
The treatment eczema external Chinese medicine ointment agent that the present embodiment provides, contain the composition of following parts by weight:
Calamina (calcined and quenched) 120;
Borneolum Syntheticum 68;
The artificial Moschus 0.5;
Borax 2;
Paeonol 1;
Vaseline 804.5;
Dimethyl sulfoxine 5;
Lanoline 20.
The preparation method of above-mentioned treatment eczema external Chinese medicine ointment agent the steps include:
A, Calamina (calcined and quenched) is carried out water fly to process, get the Calamina (calcined and quenched) powder;
B, with the Calamina (calcined and quenched) powder facing-up of artificial Moschus, Borax, Borneolum Syntheticum, 1/5 weight, cross the 100-120 mesh sieve;
C, with the Calamina (calcined and quenched) powder mix homogeneously of step B gained medicated powder and 4/5 weight;
D, mixed medicated powder is pulverized by drug micronization, got former powder;
E, paeonol is added 70 ~ 80 ℃ of dissolvings of an amount of distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
F, with vaseline after 80～100 ℃ of fusings of temperature control, 115～120 ℃ of sterilizations of temperature control are cooled to 70～80 ℃ with sterilized vaseline;
G, with lanoline in 115～120 ℃ of sterilizations of temperature control;
H, with 55～65 ℃ of dimethyl sulfoxine temperature controls to fusing;
I, at first vaseline is put into material-compound tank, put into a half and stir; Secondly with dimethyl sulfoxine and lanoline congruent melting, filter and drop in the material-compound tank and stir; Again the former powder of step D gained, step e gained paeonol aqueous solution are added material-compound tank, stir.Fill, and get final product.
By carrying out respectively influence factor's test (comprising: hot test, high humility test, strong illumination test) under 2005 editions two appendix XIXC pharmaceutical preparation of the Chinese Pharmacopoeia stability test guideline item, investigate the situation of change of its character, uniformity, content, granularity, related substance.Each experimental result shows, the ointment of the present embodiment is up to specification, and under influence factor's experimental condition (high temperature, high humidity, illumination), every investigation project is without significant change, and the ointment that shows the present embodiment is on heat, light, the wet steady quality that affects.
Embodiment two:
The treatment eczema external Chinese medicine ointment agent that the present embodiment provides, contain the composition of following parts by weight:
Calamina (calcined and quenched) 150;
Borneolum Syntheticum 80;
The artificial Moschus 0.8;
Borax 5;
Paeonol 2;
Vaseline 727;
Dimethyl sulfoxine 5;
Lanoline 30.
The preparation method of above-mentioned treatment eczema external Chinese medicine ointment agent the steps include:
A, Calamina (calcined and quenched) is carried out water fly to process, get the Calamina (calcined and quenched) powder;
B, with the Calamina (calcined and quenched) powder facing-up of artificial Moschus, Borax, Borneolum Syntheticum, 1/5 weight, cross the 100-120 mesh sieve;
C, with the Calamina (calcined and quenched) powder mix homogeneously of step B gained medicated powder and 4/5 weight;
D, mixed medicated powder is pulverized by drug micronization, got former powder;
E, paeonol is added 70 ~ 80 ℃ of dissolvings of an amount of distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
F, with vaseline after 80～100 ℃ of fusings of temperature control, 115～120 ℃ of sterilizations of temperature control are cooled to 70～80 ℃ with sterilized vaseline;
G, with lanoline in 115～120 ℃ of sterilizations of temperature control;
H, with 55～65 ℃ of dimethyl sulfoxine temperature controls to fusing;
I, at first vaseline is put into material-compound tank, put into a half and stir; Secondly with dimethyl sulfoxine and lanoline congruent melting, filter and drop in the material-compound tank and stir; Again the former powder of step D gained, step e gained paeonol aqueous solution are added material-compound tank, stir.Fill, and get final product.
By carrying out respectively influence factor's test (comprising: hot test, high humility test, strong illumination test) under 2005 editions two appendix XIXC pharmaceutical preparation of the Chinese Pharmacopoeia stability test guideline item, investigate the situation of change of its character, uniformity, content, granularity, related substance.Each experimental result shows, the ointment of the present embodiment is up to specification, and under influence factor's experimental condition (high temperature, high humidity, illumination), every investigation project is without significant change, shows that ointment of the present invention is on heat, light, the wet steady quality that affects.
Embodiment three:
The treatment eczema external Chinese medicine ointment agent that the present embodiment provides, contain the composition of following parts by weight:
Calamina (calcined and quenched) 220
Borneolum Syntheticum 200
The artificial Moschus 4
Borax 8
Paeonol 5
Vaseline 564
Dimethyl sulfoxine 20
Lanoline 50
The preparation method of above-mentioned treatment eczema external Chinese medicine ointment agent the steps include:
A, Calamina (calcined and quenched) is carried out water fly to process, get the Calamina (calcined and quenched) powder;
B, with the Calamina (calcined and quenched) powder facing-up of artificial Moschus, Borax, Borneolum Syntheticum, 1/5 weight, cross the 100-120 mesh sieve;
C, with the Calamina (calcined and quenched) powder mix homogeneously of step B gained medicated powder and 4/5 weight;
D, mixed medicated powder is pulverized by drug micronization, got former powder;
E, paeonol is added 70 ~ 80 ℃ of dissolvings of an amount of distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
F, with vaseline after 80～100 ℃ of fusings of temperature control, 115～120 ℃ of sterilizations of temperature control are cooled to 70～80 ℃ with sterilized vaseline;
G, with lanoline in 115～120 ℃ of sterilizations of temperature control;
H, with 55～65 ℃ of dimethyl sulfoxine temperature controls to fusing;
I, at first vaseline is put into material-compound tank, put into a half and stir; Secondly with dimethyl sulfoxine and lanoline congruent melting, filter and drop in the material-compound tank and stir; Again the former powder of step D gained, step e gained paeonol aqueous solution are added material-compound tank, stir.Fill, and get final product.
By carrying out respectively influence factor's test (comprising: hot test, high humility test, strong illumination test) under 2005 editions two appendix XIXC pharmaceutical preparation of the Chinese Pharmacopoeia stability test guideline item, investigate the situation of change of its character, uniformity, content, granularity, related substance.Each experimental result shows, the ointment of the present embodiment is up to specification, and under influence factor's experimental condition (high temperature, high humidity, illumination), every investigation project is without significant change, shows that ointment of the present invention is on heat, light, the wet steady quality that affects.
Embodiment four:
The treatment eczema external Chinese medicine ointment agent that the present embodiment provides, contain the composition of following parts by weight:
Calamina (calcined and quenched) 300
Borneolum Syntheticum 170
The artificial Moschus 5
Borax 15
Paeonol 10
Vaseline 300
Dimethyl sulfoxine 30
Lanoline 80
The preparation method of above-mentioned treatment eczema external Chinese medicine ointment agent the steps include:
A, Calamina (calcined and quenched) is carried out water fly to process, get the Calamina (calcined and quenched) powder;
B, with the Calamina (calcined and quenched) powder facing-up of artificial Moschus, Borax, Borneolum Syntheticum, 1/5 weight, cross the 100-120 mesh sieve;
C, with the Calamina (calcined and quenched) powder mix homogeneously of step B gained medicated powder and 4/5 weight;
D, mixed medicated powder is pulverized by drug micronization, got former powder;
E, paeonol is added 70 ℃ of dissolvings of an amount of distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
F, with vaseline after 80～100 ℃ of fusings of temperature control, 115～120 ℃ of sterilizations of temperature control are cooled to 70～80 ℃ with sterilized vaseline;
G, with lanoline in 115～120 ℃ of sterilizations of temperature control;
H, with 55～65 ℃ of dimethyl sulfoxine temperature controls to fusing;
I, at first vaseline is put into material-compound tank, put into a half and stir; Secondly with dimethyl sulfoxine and lanoline congruent melting, filter and drop in the material-compound tank and stir; Again the former powder of step D gained, step e gained paeonol aqueous solution are added material-compound tank, stir.Fill, and get final product.
By carrying out respectively influence factor's test (comprising: hot test, high humility test, strong illumination test) under 2005 editions two appendix XIXC pharmaceutical preparation of the Chinese Pharmacopoeia stability test guideline item, investigate the situation of change of its character, uniformity, content, granularity, related substance.Each experimental result shows, ointment of the present invention is up to specification, and under influence factor's experimental condition (high temperature, high humidity, illumination), every investigation project is without significant change, shows that ointment of the present invention is on heat, light, the wet steady quality that affects.
Embodiment five:
The treatment eczema external application Chinese medicine gel that the present embodiment provides, contain the composition of following parts by weight:
Calamina (calcined and quenched) 100;
Borneolum Syntheticum 160;
The artificial Moschus 3;
Borax 10;
Paeonol 15;
Poly-Pyrusussuriensis fat-80 7.5;
Glycerol 506.5;
Carbomer-980 4;
Ethyl hydroxybenzoate 2;
Laurocapram 3.
The preparation method of above-mentioned treatment eczema external application Chinese medicine gel, in this embodiment, gel-type vehicle is preferably carbomer-980, and antiseptic is preferably ethyl hydroxybenzoate, and Percutaneous absorption enhancer is preferably laurocapram, the steps include:
A, with Calamina (calcined and quenched), Borax respectively water fly or be ground into impalpable powder;
B, artificial Moschus, Borneolum Syntheticum two flavor Chinese medicine porphyrizes with steps A gained fine powder facing-up, are crossed 200 mesh sieves, and comminution by gas stream is for subsequent use;
C, paeonol added in the hot distilled water dissolve, get the paeonol aqueous solution;
D, get distilled water, add poly-Pyrusussuriensis fat-80, the glycerol of described amount, stir evenly, add carbomer-980, place, treat that it expands naturally, get carbomer-980 clear gel; The fine powder that step B is obtained, the paeonol aqueous solution that step C obtains evenly add in the clear gel and stir evenly, and get drug gel; Get ethyl hydroxybenzoate and the laurocapram of described amount, add 2 ~ 4 times of amounts of both weight dissolve with ethanol, get ethanol, under constantly stirring, ethanol is added in the drug gel, stir; Other gets sodium hydrate aqueous solution, joins in the above-mentioned gel under constantly stirring, and regulates pH value to 6.0 ~ 7.0, stirs evenly, and gets product.
By carrying out respectively influence factor's test (comprising: hot test, high humility test, strong illumination test) under 2005 editions two appendix XIXC pharmaceutical preparation of the Chinese Pharmacopoeia stability test guideline item, investigate the situation of change of its character, uniformity, content, related substance, granularity.Each experimental result shows, gel of the present invention is up to specification, and under influence factor's experimental condition (high temperature, high humidity, illumination), every investigation project is without significant change, and the gel that shows the present embodiment is on heat, light, the wet steady quality that affects.
Embodiment six:
The treatment eczema external application Chinese medicine irrigation that the present embodiment provides, contain the composition of following parts by weight:
Calamina (calcined and quenched) 350;
Borneolum Syntheticum 100;
The artificial Moschus 2;
Borax 8;
Paeonol 2;
Glycerol 308;
Distilled water 300.
The preparation method of above-mentioned treatment eczema external application Chinese medicine irrigation the steps include:
A, with Calamina (calcined and quenched), Borax respectively water fly or be ground into impalpable powder;
B, artificial Moschus, Borneolum Syntheticum two flavor Chinese medicine porphyrizes with steps A gained fine powder facing-up, are crossed 200 mesh sieves, and comminution by gas stream is for subsequent use;
C, will paeonol add in 70 ~ 80 ℃ of distilled water and dissolve, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, step B, step C gained are evenly mixed, add glycerol and distilled water, fully stir, get final product.
By carrying out respectively influence factor's test (comprising: hot test, high humility test, strong illumination test) under 2005 editions two appendix XIXC pharmaceutical preparation of the Chinese Pharmacopoeia stability test guideline item, investigate the situation of change of its character, content, related substance, dispersibility, microorganism.Each experimental result shows, the irrigation of the present embodiment is up to specification, and under influence factor's experimental condition (high temperature, high humidity, illumination), every investigation project is without significant change, and the irrigation that shows the present embodiment is on heat, light, the wet steady quality that affects.
Embodiment seven:
The treatment eczema external-application cream that the present embodiment provides, contain following percentage by weight:
Calamina (calcined and quenched) 230;
Borneolum Syntheticum 130;
The artificial Moschus 3;
Borax 8;
Paeonol 4;
Vaseline 313;
Glycerol 250
Hexadecanol 5;
Liquid paraffin 50;
Azone 2;
Dodecyl sodium sulfate 5.
The preparation method of above-mentioned treatment eczema external-application cream, wherein antiseptic is preferably azone, and Percutaneous absorption enhancer is preferably dodecyl sodium sulfate, the steps include:
A, with Calamina (calcined and quenched), Borax respectively water fly or be ground into impalpable powder;
B, artificial Moschus, Borneolum Syntheticum two flavor Chinese medicine porphyrizes are crossed 200 mesh sieves, and are for subsequent use;
C, will paeonol add in 70 ~ 80 ℃ of distilled water and dissolve, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, get a certain amount of hexadecanol, liquid paraffin, vaseline, azone and put in the beaker, heat fused in the water-bath, 80 ℃ of insulations, this is oil phase; Get steps A gained medicated powder and place beaker, add distilled water, add again dodecyl sodium sulfate, glycerol after stirring, evenly, be heated to 80 ℃ in the water-bath, and with step C gained solution mixing with it, and get final product, this is water; Above-mentioned oil phase is slowly added aqueous phase, constantly be stirred to condensation, treat that temperature is down to below 60 ℃, add again step B gained medicated powder and stir, get product.
By carrying out respectively influence factor's test (comprising: hot test, high humility test, strong illumination test) under 2005 editions two appendix XIXC pharmaceutical preparation of the Chinese Pharmacopoeia stability test guideline item, investigate the situation of change of its character, uniformity, content, granularity, related substance, lamination.Each experimental result shows, ointment of the present invention is up to specification, and under influence factor's experimental condition (high temperature, high humidity, illumination), every investigation project is without significant change, shows that ointment of the present invention is on heat, light, the wet steady quality that affects.
4.1 anti-inflammatory activity evaluation experimental of the present invention
4.1.1 external on Carrageenan of the present invention causes the impact of rat toes swelling
4.1.1.1 the foundation of experimental design
Carrageenin causes the inflammatory model that the rat paw edema model is classics, be usually used in screening and the evaluation of anti-inflammatory drug, its application is very extensive, the rat foot begins to be inflamed and swelling immediately behind the injection carrageenin, generally adopts the volumetric measurement method to measure its sufficient pawl volume, considers that the present invention is medicine for external use, adopted the girth that measuring method is measured of sufficient girth poor as index, can also be with both sides foot weight difference as index, in the concrete operations, Zhou Changfa is more accurate.
4.1.1.2 experiment material
4.1.1.2.1 rat
SPF level SD kind rat, 160, body weight 140-200g, male and female half and half, Department Of Medicine, Peking University's Laboratory Animal Science section (SCXK (capital) 2006-0008) provides; Animal feeding is in animal housing of fundamental research institute of Chinese department of Chinese medicine institute, in the barrier environment, and credit number: the SYXK(capital) 2005-0024.Animal House is barrier system, artificial lighting, and in 12 hours light and shade cycles, temperature is controlled at 20～22 ℃ of scopes, and relative humidity is 40～70%, 15 times/h of rate of ventilation.Feedstuff provides credit number by Beijing section Australia feed corporation,Ltd that pulls together: SCXY (capital) 2005-0007.With 500ml plastics drinking bottle splendid attire pure water, arbitrarily drink for animal, change fresh drinking bottle every day.
4.1.1.2.2 reagent
Carrageenin (Sigma company, C1013-25G).
4.1.1.2.3 be subjected to test product
Provided by Mayinglong Pharmaceutical Group Co.,Ltd.
4.1.1.2.4 positive reference substance
The compound dexamethason acetate emulsifiable paste (Sanjiu Pharmaceutical Co., Ltd, 1101071S).
4.1.1.3 instrument and equipment
4.1.1.3.1 shaver
Easy simple liquid crystal hair cutter (HK918, the good awake Household Electrical Appliance Co., Ltd in Guangzhou)
4.1.1.3.2 electronic balance
(the more flat scientific instrument company limited in Shanghai YP10001), is used for weighing SD rat body weight to electronic balance; Sartorius 1212MP is used for the left and right rear toes weight of weighing SD rat.
4.1.1.3.3 medicine preparation instrument and reagent
Electric blender (D2015W type, Shanghai Si Le Instr Ltd.), electronic balance (BSA224S-CW type, Sai Duolisi scientific instrument (Beijing) company limited), electric-heated thermostatic water bath (DK-98-1 type, Tianjin Tai Site Instr Ltd.), liquid paraffin (lot number 20071105, Chemical Reagent Co., Ltd., Sinopharm Group).
4.1.1.4 experimental technique
4.1.1.3.1 grouping and administration
Get 160 SD rats, male and female half and half are divided into 8 groups, 20 every group.Blank group, matrix group, model group, Dexamethasone Acetate Cream group, one group of embodiment, two groups of embodiment, three groups of embodiment, four groups of embodiment.
4.1.1.3.2 model preparation and detection
Rat is pressed again random packet of body weight layering, every the left and right rear solid end ankle joint of rat upper end shank-feathering is shaved to the greatest extent, test front 1 day except the blank group, other are respectively organized, and rat is pre-outer to be coated with corresponding medicine or substrate twice: adjunct ingredient mixture, the model group that the blank group is not coated with, matrix group is smeared embodiment 1 is not coated with, the Dexamethasone Acetate Cream group is smeared Dexamethasone Acetate Cream, and four groups of the medicine group of one group of embodiment, embodiment two, three groups of embodiment and embodiment smear respectively the medicine that embodiment one to four makes.Experiment same day, (1% was dissolved in normal saline the left back whole toe subcutaneous injection chondrus ocellatus Holmes of rat of four groups of blank matrix group, model group, Dexamethasone Acetate Cream group, one group of embodiment, two groups of embodiment, three groups of embodiment and embodiment with the 0.25ml syringe, w/v), 0.2ml/ only, before the carrageenin injection, respectively survey the left ankle girth in shot carrageenin place in rear 1,3,6 hour with injection respectively, estimate its swelling by difference before and after its administration.
Utilize following formula to calculate the toes inhibitory rate of intumesce:
Percentage inhibition=
%
Wherein, C
tBe each time point rat toes girth behind the injection carrageenin, C
0Be rat toes girth before the injection carrageenin, C
t-C
0Be foot swelling.
4.1.1.3.3 statistical method
Data adopt the SPSS.17.0 statistical software with means standard deviation (s) expression, carry out the different time points one factor analysis of variance.
4.1.1.5 experimental result
By experiment, record and respectively organize toes girth after the swelling of 1,3,6 hour rat toes, its result such as table 3～table 8 after the modeling.
Table 1 the present invention on the swelling of ♂ rat toes after the toes girth impact (
S) n=10
Blank group and matrix group compare with model group respectively
##P＜0.05,
##P＜0.01. remains other several groups and compares * P＜0.05, * * P＜0.01 with model group respectively
Between blank group and the model group significant difference is arranged, the modeling success is described.Causing between Dexamethasone Acetate Cream group behind scorching 1h, 3h, the 6h, embodiment three and the model group has significant difference, and causing behind scorching 3h, the 6h has significant difference between the embodiment one and model group, points out this product to have certain antiinflammatory action.
Table 2 the present invention on the swelling of ♀ rat toes after the toes girth impact (
S) n=10
Blank group and matrix group compare with model group respectively
#P＜0.05,
##P＜0.01. remains other several groups and compares with model group respectively,
*P＜0.05,
*P＜0.01
Between blank group and the model group significant difference is arranged, the modeling success is described.Causing between Dexamethasone Acetate Cream group behind scorching 1h, 3h, the 6h, the present invention and the model group has significant difference, points out this prescription to have certain antiinflammatory action.
Table 3 on the swelling of rat toes after the toes girth impact (
S) n=20
Blank group and matrix group compare with model group respectively
#P＜0.05,
##P＜0.01. remains other several groups and compares with model group respectively,
*P＜0.05,
*P＜0.01
Between blank group and the model group significant difference is arranged, the modeling success is described.Causing between Dexamethasone Acetate Cream group behind scorching 1h, 3h, the 6h, the present invention and the model group has significant difference, points out this prescription to have certain antiinflammatory action.
Table 4 on the swelling of ♂ rat toes after left and right sides toes weight difference impact (
S) n=10
| Group | Left toes weight (g) | Right toes weight (g) | Toes weight difference (g) |
| The blank group | 1.39±0.074 | 1.40±0.059 | -0.02±0.036 ## |
| Matrix group | 1.63±0.140 | 1.38±0.105 | 0.25±0.053 ## |
| Model group | 1.87±0.108 | 1.42±0.061 | 0.46±0.084 |
| Dexamethasone Acetate Cream | 1.62±0.127 | 1.40±0.101 | 0.22±0.116 ** |
| Embodiment one | 1.82±0.205 | 1.50±0.107 | 0.32±0.135 ** |
| Embodiment two | 1.73±0.176 | 1.46±0.110 | 0.27±0.127 ** |
| Embodiment three | 1.78±0.142 | 1.56±0.163 | 0.22±0.151 ** |
| Embodiment four | 1.82±0.215 | 1.57±0.164 | 0.25±0.152 ** |
Blank group and matrix group compare with model group respectively
#P＜0.05,
##P＜0.01; Remain other several groups and compare with model group respectively,
*P＜0.05,
*P＜0.01
Between blank group and the model group significant difference is arranged, the modeling success is described.Between Dexamethasone Acetate Cream group, the present invention and the model group significant difference is arranged.
Table 5 on the swelling of ♀ rat toes after left and right sides toes weight difference impact (
S) n=10
| Group | Left toes weight (g) | Right toes weight (g) | Toes weight difference (g) |
| The blank group | 1.27±0.072 | 1.29±0.054 | -0.01±0.040 ## |
| Matrix group | 1.69±0.126 | 1.38±0.056 | 0.31±0.119 ## |
| Model group | 1.96±0.150 | 1.37±0.077 | 0.59±0.101 |
| Dexamethasone Acetate Cream | 1.51±0.087 | 1.24±0.059 | 0.27±0.074 ** |
| Embodiment one | 1.67±0.135 | 1.38±0.063 | 0.29±0.113 ** |
| Embodiment two | 1.69±0.232 | 1.36±0.799 | 0.33±0.091 ** |
| Embodiment three | 1.61±0.150 | 1.36±0.077 | 0.25±0.150 ** |
| Embodiment four | 1.56±0.143 | 1.37±0.115 | 0.19±0.152 ** |
Blank group and matrix group compare with model group respectively
#P＜0.05,
##P＜0.01; Remain other several groups and compare with model group respectively,
*P＜0.05,
*P＜0.01
Between blank group and the model group significant difference is arranged, the modeling success is described.Between Dexamethasone Acetate Cream group, the present invention and the model group significant difference is arranged.
Table 6 on the swelling of rat toes after left and right sides toes weight difference impact (
S) n=20
| Group | Left toes weight (g) | Right toes weight (g) | Toes weight difference (g) |
| The blank group | 1.33 0.091 | 1.34
 |
-0.01
 |
| Matrix group | 1.66
 |
1.38
 |
0.28 0.094 ## |
| Model group | 1.91
 |
1.39
 |
0.52
 |
| Dexamethasone Acetate Cream | 1.57
 |
1.32
 |
0.25
 |
| Embodiment one | 1.75
 |
1.44
 |
0.31
 |
| Embodiment two | 1.71 0.142 | 1.41 0.103 | 0.30 0.112 ** |
| Embodiment three | 1.69
 |
1.46
 |
0.23
 |
| Embodiment four | 1.69
 |
1.47
 |
0.22
 |
Blank group and matrix group compare with model group respectively
#P＜0.05,
##P＜0.01; Remain other several groups and compare with model group respectively,
*P＜0.05,
*P＜0.01
Experimental result shows: the improvement situation of toes girth after the swelling of rat toes, the present invention's prompting has certain antiphlogistic effects.
4.1.2 xylol of the present invention causes the impact of mice ear
4.1.2.1 the foundation of experimental design
Dimethylbenzene is the proinflammatory agent of commonly using, and scribbles outward to cause mice ear, shows as thickness increase, weight increase.Be coated with outside dimethylbenzene after 10 minutes, be coated with the embodiment of the invention 1 ~ 4 outward, by detecting ear weight difference and thickness difference, can demonstrate the therapeutical effect of medicine.
4.1.2.2 experiment material
4.1.2.2.1 animal
120 of ICR mices, SPF level, female, hero half and half, body weight 18-22g.Available from Beijing Vital River Experimental Animals Technology Co., Ltd., licence numbering: the SCXK(capital) 2006-0009.
4.1.2.2.2 feedstuff
Available from Beijing section Australia feed corporation,Ltd that pulls together, product license SCXK(capital) 2009-0012.
4.1.2.2.3 animal feeding
The duration of test animal feeding is in the institute Animal House, Experimental Establishment licence SYXK(capital) 2010-0032.Animal House is barrier system, artificial lighting, and in 12 hours light and shade cycles, temperature is controlled at 20～22 ℃ of scopes, and relative humidity is 40～70%, 15 times/h of rate of ventilation.Animal feeding is in plastics mice rearging cage, 5 in every cage.Change the mouse cage bedding and padding every day once.With 500ml plastics drinking bottle splendid attire pure water, arbitrarily drink for animal, change fresh drinking-water every day.
4.1.2.2.4 medicine
Provided by Mayinglong Pharmaceutical Group Co.,Ltd by test product.The compound dexamethason acetate emulsifiable paste (Sanjiu Pharmaceutical Co., Ltd, 1101071S).
4.1.2.2.5 reagent
Dimethylbenzene, Beijing North fine chemicals Co., Ltd lot number: 20090325.
4.1.2.2.6 instrument
The rigorous analysis balance, model: BP110S.
The accurate thickness measurement equipment of SM-112 type Japan TECLOCK company.
Card punch, operating theater instruments.
4.1.2.3 experimental technique
4.1.2.3.1 animal grouping
Get healthy ICR mice and evenly be divided at random 7 groups by body weight, every group of 16 male and female half and half.
4.1.2.3.2 operational approach
Every mouse right ear tow sides are coated with dimethylbenzene, 50ul/ only causes inflammation, left ear is not done any processing, after causing scorching rear 10 minutes, model group is not coated with, the Dexamethasone Acetate Cream group is smeared Dexamethasone Acetate Cream, matrix group is smeared the adjunct ingredient mixture (vaseline of embodiment 1, dimethyl sulfoxine, lanoline), one to four group of embodiment smears respectively embodiment one, embodiment two, embodiment three, the medicine that embodiment four makes, cause scorching rear 2 hours, take off neck and put to death animal, cut two ears about every Mus, measure ear thickness, with 8mm diameter card punch the mice ears are downcut with the position homalographic, divide another name two auricle weight, deduct left ear thickness as swelling take auris dextra thickness, deduct left auricle weight as swelling take auris dextra sheet weight.
4.1.2.3.3 date processing:
Each is organized data and all represents with average ± standard deviation, combination 1, combination 2, combination 3, combination 4 and matrix group and matched group relatively, the result checks with t and analyzes.
Table 7 the present invention on the impact of mice ear (
± s) n=16
| Group | Weight difference (mg) | Thickness difference (mm) |
| Model group | 13.59±3.59 | 0.18±0.06 |
| Dexamethasone Acetate Cream | 9.15±3.56 * | 0.16±0.05 |
| Matrix group | 10.16±4.50 | 0.18±0.05 |
| Embodiment one | 8.28±3.43 ** | 0.15±0.05 |
| Embodiment two | 7.51±3.10 *** | 0.14±0.04 |
| Embodiment three | 7.47±2.84 *** | 0.14±0.04 |
| Embodiment four | 6.33±4.13 *** | 0.10±0.04 ** |
Compare with model group
*P＜0.05,
*P＜0.01,
* *P＜0.001.
Interpretation of result: dimethylbenzene is the proinflammatory agent of commonly using, and scribbles outward to cause mice ear, shows as thickness increase, weight increase.No matter of the present invention group of swollen degree of ear that can significantly reduce after the caused by dimethylbenzene xylene inflammation is all to show good improvement effect on the weight or on the thickness.
4.2 antibacterial activity evaluation experimental of the present invention
4.2.1 the foundation of experimental design
This experiment adopts the mode of mixing culture medium to carry out the antibacterial activity evaluation.
4.2.2 experiment material
4.2.2.1 antibacterial, fungus
4.2.2.2.1 type strain
Staphylococcus aureus 26112(ATCC25923), escherichia coli 44113(ATCC25922), Pseudomonas aeruginosa 10211(ATCC27853), Candida albicans 98001-3b, Klebsiella pneumonia 46114-8, staphylococcus epidermidis 26069-6, Aspergillus niger type strain CMCC (F) 98003.
4.2.2.2.2 clinical separation strain
Staphylococcus aureus 331, escherichia coli 117 and 178, bacillus pyocyaneus 209, Candida albicans 1, Klebsiella pneumonia 160, staphylococcus epidermidis 104.
Respectively by 307 hospitals of the Chinese People's Liberation Army and Beijing hydrops pool hospital and Peking University First Hospital's Bacteriology Room isolation identification and provide.
4.2.2.2 bacteria culture media
Nutrient agar, lot number 090525; Nutrient broth medium, lot number 090923; Improvement Martin agar culture medium, lot number 101027; Improvement Martin culture medium, lot number 1102142.
Supervise by Nat'l Pharmaceutical ﹠ Biological Products Control Institute, Beijing three medicine scientific and technological development companies produce.
4.2.2.3 laboratory sample
Being subjected to test product is that the present invention makes medicine, is provided by Mayinglong Pharmaceutical Group Co.,Ltd.
4.2.2.4 positive control drug
Benzylpenicillin sodium for injection, lot number: 110369024, produced by Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Shiyao Group, as positive control drug, be used for bacteriostatic experiment.
4.2.3 experimental technique
Adopt In Vitro Bacteriostasis laboratory method (agar dilution).Reagent is added in the Nutrient agar that has melted with 1/14 ratio, and do serial doubling dilution, pour into into the plating medium that contains different liquor strengths.In addition use turbidimetry, will increase each strain of 16 hours of bacterium than turbid to the Maxwell No. 1 pipe (300,000,000 bacterium/ml), again each bacterium is cooked suitable dilution, each is drawn 5 μ l and drips on flat board, establishes simultaneously the antibacterial contrast, positive drug contrasts.The plate of having inoculated is placed 37 ℃ of incubators, and observed result after 24 hours records each bacteria growing situation and minimum inhibitory concentration MIC.
Table 8 the present invention is to the inhibitory action of each bacterial strain
Annotate: (1) "-" asepsis growth, "+" has bacteria growing.The penicillin contrast all suppresses trial bacterium.
(2) staphylococcus aureus type strain (NO.1), staphylococcus aureus clinical separation strain 331(NO.2), escherichia coli type strain (NO.3), escherichia coli clinical separation strain 117(NO.4), escherichia coli clinical separation strain 178(NO.5), Pseudomonas aeruginosa (NO.6), bacillus pyocyaneus clinical separation strain 209(NO.7), Candida albicans type strain (NO.8), Candida albicans clinical separation strain 1(NO.9), Klebsiella pneumonia type strain (NO.10), Klebsiella pneumonia clinical separation strain 160(NO.11), staphylococcus epidermidis type strain (NO.12), staphylococcus epidermidis clinical separation strain 104(NO.13), Aspergillus niger type strain CMCC (F) 98003(NO.14).
Show by above-mentioned bacteriostatic experiment, the present invention is stronger to the bacteriostasis of other outer antibacterial of Aspergillus niger.According to the result of table 8, can calculate average minimum inhibitory concentration of the present invention (MIC), as shown in table 9 below.
Table 9 agent of the present invention is to average minimum inhibitory concentration (the MIC) (unit: mg/ml) of each bacterium
| The gold Portugal | The table Portugal | Large intestine | Green pus | Pneumonia | Bai Nian | |
| The present invention | 1.751±0 | 1.97±2.167 | 3.502±0 | 3.502±0 | 2.627±1.238 | 3.502±0 |
Experiment conclusion: the present invention except to Aspergillus niger completely without effect, 13 bacterial strains of trial 6 kinds of bacterium are all had in various degree inhibitory action.
4.3 the antipruritic active appraisal experiment of the present invention
4.3.1 the foundation of experimental design
Pruritus is one of modal symptom of eczema, on antiinflammatory, antibiotic basis, further observes its itching-relieving action, has meaning for the activity of thoroughly evaluating various combination.It is the antipruritic evaluation model of commonly using that histamine phosphate causes the local pruritus reaction model of Cavia porcellus, selects this model to carry out activity rating for this reason.
4.3.2 experiment material
4.3.2.1 Cavia porcellus
Cleaning level, body weight 250--300g, male, 50, Xueyaun Road, Haidian District, Beijing City tonneau laboratory animal plant provides, the quality certification number: the SCXK(capital) 2005-0003; The duration of test animal feeding is in the institute Animal House, Experimental Establishment licence SYXK(capital) 2010-0032.Animal House is barrier system, artificial lighting, and in 12 hours light and shade cycles, temperature is controlled at 20～22 ℃ of scopes, and relative humidity is 40～70%, 15 times/h of rate of ventilation.Animal feeding is in the Cavia porcellus rearging cage, 5 in every cage.Change the mouse cage bedding and padding every day once.With 500ml plastics drinking bottle splendid attire pure water, arbitrarily drink for animal, change fresh drinking-water every day.
4.3.2.2 reagent
Histamine phosphate, the brilliant pure Industrial Co., Ltd. in Shanghai product, CAS:51-74-1, lot number: 34428.
4.3.2.3 be subjected to test product
Provided by Mayinglong Pharmaceutical Group Co.,Ltd.Positive reference substance is the halcinonide emulsifiable paste, Guangdong Shunfeng Pharmaceutical Co., Ltd's product, lot number: 20110101.
4.3.3 experimental technique
Get healthy guinea pig by the body weight random packet, be respectively blank substrate matched group, positive drug halcinonide emulsifiable paste matched group, one group of embodiment, two groups of embodiment, three groups of embodiment, four groups of embodiment.Each is organized the right back dorsal portion of Cavia porcellus and shaves a mao 2.5cm * 2.5cm, respectively tested material evenly is applied to and shaves the hair-fields, dosage is each 0.1g, the administration area is 1.5cm * 1.5cm approximately, be administered twice every day, the upper and lower noon respectively is administered once, and blank substrate matched group and positive drug control group are smeared the tester that gives same dose, successive administration 2 days.Administration the 3rd day abrades respectively with coarse sandpaper and to shave hair and sentence and injure epidermis, has slight oozing of blood to be degree.Be coated with respectively tested material or tester 1 time in the wound part, behind the coating 10min, remove medicine, drip 0.01% histamine phosphate, 0.05 mL at every Cavia porcellus wound surface place respectively, after this comply with 0.01%, 0.02% every 3min, 0.03%, 0.04%, 0.05% progressive concentration only is 0.05 ml/ at every turn, until Cavia porcellus is when occurring later licking metapedes, record the total amount of histamine that every Cavia porcellus gives, take this total amount as itch-threshold, and the itch-threshold of each treated animal relatively.
Table 10 the present invention on histamine phosphate cause the local pruritus reaction of Cavia porcellus impact (
S)
| Group | Unguentum dosage (g) | Number of animals (only) | Itch-threshold (the histamine total amount/mg) |
| Blank substrate contrast | 0.2 | 8 | 0.046±0.015 |
| Positive drug control group | 0.2 | 8 | 0.261±0.174 ** |
| Embodiment one | 0.2 | 9 | 0.331±0.224 ** |
| Embodiment two | 0.2 | 8 | 0.157±0.188 |
| Embodiment three | 0.2 | 8 | 0.208±0.177 * |
| Embodiment four | 0.2 | 9 | 0.207±0.178 * |
Compare * P＜0.05 with blank substrate matched group, * * P＜0.01
Experiment conclusion: above result shows, the present invention can improve the Cavia porcellus itch-threshold to some extent, suppresses the skin pruritus that caused by histamine, with blank substrate matched group comparing difference significance arranged, and prompting the present invention has certain itching-relieving action.
5, clinical efficacy data
Meet the clinical manifestation of acute eczema, subacute eczema and chronic eczema, Chinese medical discrimination belongs to eczema syndrome of excessive dampness-heat and insufficiency of the spleen wet card case 39 examples of accumulateing, and the medicine-less allergy history did not take steroid or Loratadine or external in nearly 2 weeks and crosses anabolic agent; Without gestation or women breast-feeding their children; Without cardiovascular, cerebrovascular, liver, kidney, the serious diseases such as hemopoietic system, mental sickness enter group by medical order random packet method and observe.Man's 19 examples, women 20 examples, 18～65 years old age, average (47.90+13.05) year, the course of disease 1 week～14 year, average (11.87+21.98) individual month, acute eczema 10 examples wherein, subacute eczema 15 examples, chronic eczema 14 examples.The patient uses the externally-applied medicinal composition of the embodiment of the invention 1 ~ 7 arbitrary prepared treatment eczema: evenly impose on the affected part, every day three times.
With reference to " new Chinese medicine clinical guidance principle ", observe pruritus degree, onset time, skin lesion area, picture of the tongue, pulse condition, relevant symptoms, Signs, by asymptomatic, light, in, heavy degree scores, before treatment, treatment afterwards the 1st weekend, the second weekend each observed and recorded 1 time, and formulate following curative effect determinate standard:
Produce effects: tcm symptom obviously alleviates, and the syndrome integration is treated front decline 〉=60%.
Effectively: tcm symptom alleviates, and the syndrome integration is treated front decline 〉=30%.
Invalid: tcm symptom is without obviously improving or increasing the weight of, and the syndrome integration is treated front decline＜30%, and somatic feature score reduces＜30%.
Therapeutic outcome: produce effects 31 people, effective 8 people, without Ineffective Cases, total effective rate is 100%.
Above embodiment is the preferred embodiment that proves absolutely that the present invention lifts, and protection scope of the present invention is not limited to this.Being equal to that those skilled in the art do on basis of the present invention substitutes or conversion, all within protection scope of the present invention.Protection scope of the present invention is as the criterion with claims.
Claims (10)
1. an externally-applied medicinal composition for the treatment of eczema is characterized in that, contains the composition of following parts by weight:
Calamina (calcined and quenched) 100～350;
Borneolum Syntheticum 68～200;
The artificial Moschus 0.5～5;
Borax 2～15;
Paeonol 1～15.
2. the externally-applied medicinal composition for the treatment of eczema according to claim 1 is characterized in that, contains the composition of following parts by weight:
Calamina (calcined and quenched) 120～300;
Borneolum Syntheticum 80～170;
The artificial Moschus 0.8～4;
Borax 2～15;
Paeonol 2～10.
3. the externally-applied medicinal composition for the treatment of eczema according to claim 1 and 2 is characterized in that, described externally-applied medicinal composition is ointment, also contains the composition of following parts by weight:
Vaseline 300～804.5;
Dimethyl sulfoxine 5～30;
Lanoline 20～80.
4. the externally-applied medicinal composition for the treatment of eczema according to claim 1 and 2 is characterized in that, described externally-applied medicinal composition is gel, also contains the composition of following parts by weight:
Poly-Pyrusussuriensis fat-80 5 ~ 8;
Glycerol 450 ~ 550;
Gel-type vehicle 3 ~ 5;
Antiseptic 2 ~ 4;
Percutaneous absorption enhancer 2 ~ 4.
5. the externally-applied medicinal composition for the treatment of eczema according to claim 1 and 2 is characterized in that, described externally-applied medicinal composition is irrigation, also contains the composition of following parts by weight:
Glycerol 280 ~ 380;
Distilled water 220 ~ 320.
6. the externally-applied medicinal composition for the treatment of eczema according to claim 1 and 2 is characterized in that, described externally-applied medicinal composition is cream, also contains the composition of following parts by weight:
Vaseline 280 ~ 380;
Glycerol 200 ~ 300;
Hexadecanol 3 ~ 7;
Liquid paraffin 30 ~ 60;
Percutaneous absorption enhancer 1 ~ 3;
Emulsifying agent 2 ~ 6.
7. the preparation method of the externally-applied medicinal composition for the treatment of eczema claimed in claim 3 is characterized in that, comprises the steps:
A, Calamina (calcined and quenched) is carried out water fly to process, get the Calamina (calcined and quenched) powder;
B, with the Calamina (calcined and quenched) powder facing-up of artificial Moschus, Borax, Borneolum Syntheticum, 1/5 weight, cross the 100-120 mesh sieve;
C, with the Calamina (calcined and quenched) powder mix homogeneously of step B gained medicated powder and 4/5 weight;
D, the mixed medicated powder of step C is pulverized by drug micronization, got former powder;
E, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
F, with after the vaseline fusing, sterilization, cooling;
G, lanoline is sterilized;
H, dimethyl sulfoxine is melted;
I, the vaseline that at first step F is obtained are put into material-compound tank, put into a half and stir; Secondly with dimethyl sulfoxine and lanoline congruent melting, filter and drop in the material-compound tank and stir; Paeonol aqueous solution with the former powder of step D gained, step e adds material-compound tank again, stirs.
8. the preparation method of the externally-applied medicinal composition for the treatment of eczema claimed in claim 4 is characterized in that, comprises the steps:
A, with described amount Calamina (calcined and quenched), Borax respectively water fly or be ground into fine powder;
B, with described amount artificial Moschus and Borneolum Syntheticum porphyrize, with steps A gained fine powder facing-up, cross 200 mesh sieves, comminution by gas stream, for subsequent use;
C, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, get distilled water, add poly-Pyrusussuriensis fat-80, the glycerol of described amount, stir evenly, add gel-type vehicle, place, treat that it expands naturally, gets clear gel; The medicated powder that step B is obtained, the paeonol aqueous solution that step C obtains evenly add in the clear gel and stir evenly, and get drug gel; Get again antiseptic and the Percutaneous absorption enhancer of described amount, add dissolve with ethanol, get alcoholic solution, under constantly stirring, ethanol is added in the drug gel, stir; Other gets sodium hydrate aqueous solution, joins in the above-mentioned gel under constantly stirring, and regulates pH value to 6.0 ~ 7.0, stirs evenly, and gets gel.
9. the preparation method of the externally-applied medicinal composition for the treatment of eczema claimed in claim 5 is characterized in that, comprises the steps:
A, with Calamina (calcined and quenched), Borax respectively water fly or be ground into fine powder;
B, artificial Moschus, Borneolum Syntheticum two flavor Chinese medicine porphyrizes with steps A gained fine powder facing-up, are crossed 200 mesh sieves;
C, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, step B and step C gained are evenly mixed, add glycerol and distilled water.
10. the preparation method of the externally-applied medicinal composition for the treatment of eczema claimed in claim 6 is characterized in that, comprises the steps:
A, with Calamina (calcined and quenched), Borax respectively water fly or be ground into fine powder;
B, artificial Moschus, Borneolum Syntheticum two flavor Chinese medicine porphyrizes are crossed 200 mesh sieves;
C, paeonol is added dissolved in distilled water, every gram paeonol is dissolved in 10 ~ 30mL distilled water, gets the paeonol aqueous solution;
D, the hexadecanol of getting described amount, liquid paraffin, vaseline, Percutaneous absorption enhancer are put in the beaker, heat fused in the water-bath, and insulation gets oil phase; Get steps A gained medicated powder and place beaker, add distilled water, add again emulsifying agent, glycerol after stirring, stir, be heated to 80 ℃ in the water-bath, and with step C gained paeonol aqueous solution mixing with it, get water; Above-mentioned oil phase is slowly added aqueous phase, constantly be stirred to condensation, treat that temperature is down to below 60 ℃, add again step B gained medicated powder and stir, get product.
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| CN106619823A (en) * | 2016-10-14 | 2017-05-10 | 柳州环山科技有限公司 | Ointment for therapy of eczema and preparation method of same |
| CN109106937A (en) * | 2018-07-09 | 2019-01-01 | 邱芳萍 | Application of the wood frog's fallopian tube collagen peptide in eczema is antipruritic |
| CN114748531A (en) * | 2022-05-26 | 2022-07-15 | 赵岩 | External itching relieving composition for hemodialysis patients and preparation method thereof |
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| CN114748531A (en) * | 2022-05-26 | 2022-07-15 | 赵岩 | External itching relieving composition for hemodialysis patients and preparation method thereof |
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| CN102872158B (en) | 2014-05-28 |
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