CN103169764B - Pharmaceutical composition for treating eczema and preparation method thereof - Google Patents
Pharmaceutical composition for treating eczema and preparation method thereof Download PDFInfo
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- CN103169764B CN103169764B CN201310068978.7A CN201310068978A CN103169764B CN 103169764 B CN103169764 B CN 103169764B CN 201310068978 A CN201310068978 A CN 201310068978A CN 103169764 B CN103169764 B CN 103169764B
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- 201000004624 Dermatitis Diseases 0.000 title claims abstract description 51
- 208000010668 atopic eczema Diseases 0.000 title claims abstract description 50
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 25
- 238000002360 preparation method Methods 0.000 title claims abstract description 12
- 239000000203 mixture Substances 0.000 claims abstract description 64
- 239000003814 drug Substances 0.000 claims abstract description 52
- 230000000694 effects Effects 0.000 claims abstract description 45
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- 241001135917 Vitellaria paradoxa Species 0.000 claims abstract description 13
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims abstract description 13
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000007765 cera alba Substances 0.000 claims abstract description 12
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims abstract description 12
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims abstract description 12
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims abstract description 12
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims abstract description 12
- 229940008099 dimethicone Drugs 0.000 claims abstract description 10
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 43
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 33
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 33
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- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 18
- MPDGHEJMBKOTSU-YKLVYJNSSA-N 18beta-glycyrrhetic acid Chemical compound C([C@H]1C2=CC(=O)[C@H]34)[C@@](C)(C(O)=O)CC[C@]1(C)CC[C@@]2(C)[C@]4(C)CC[C@@H]1[C@]3(C)CC[C@H](O)C1(C)C MPDGHEJMBKOTSU-YKLVYJNSSA-N 0.000 claims description 16
- MPDGHEJMBKOTSU-UHFFFAOYSA-N Glycyrrhetinsaeure Natural products C12C(=O)C=C3C4CC(C)(C(O)=O)CCC4(C)CCC3(C)C1(C)CCC1C2(C)CCC(O)C1(C)C MPDGHEJMBKOTSU-UHFFFAOYSA-N 0.000 claims description 16
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- WNIFXKPDILJURQ-UHFFFAOYSA-N stearyl glycyrrhizinate Natural products C1CC(O)C(C)(C)C2CCC3(C)C4(C)CCC5(C)CCC(C(=O)OCCCCCCCCCCCCCCCCCC)(C)CC5C4=CC(=O)C3C21C WNIFXKPDILJURQ-UHFFFAOYSA-N 0.000 claims description 16
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- WRUGWIBCXHJTDG-UHFFFAOYSA-L magnesium sulfate heptahydrate Chemical compound O.O.O.O.O.O.O.[Mg+2].[O-]S([O-])(=O)=O WRUGWIBCXHJTDG-UHFFFAOYSA-L 0.000 claims description 11
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 9
- 229930003427 Vitamin E Natural products 0.000 claims description 9
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 9
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- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 description 4
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention belongs to the technical field of medicines, and relates to a pharmaceutical composition for treating eczema and a preparation method thereof. The pharmaceutical composition for treating eczema comprises the following raw materials in parts by weight: 1-3 parts of white beeswax, 10-14 parts of white oil, 3-5 parts of C12-15 benzoate, 1-3 parts of isopropyl myristate, 1-3 parts of lanolin, 2-4 parts of shea butter, 1-3 parts of DC250 dimethicone, 0.1 part of methylparaben, 0.2 part of ethylparaben, 2-4 parts of PEG-30 dipolyhydroxystearate and the like. The pharmaceutical composition for treating eczema has the advantages of quick and strong treatment effect, good maintenance effect, difficult recurrence after healing, itching relieving, inflammation diminishing, sterilization and reduction of the histamine level of eczema skin. Experiments prove that the traditional Chinese medicine composition has ideal treatment effect on symptoms of erythema, skin damage, pruritus and the like of eczema patients.
Description
Technical field
The present invention's medicine technical field, relates to a kind of pharmaceutical composition for the treatment of eczema and preparation method thereof.
Background technology
Eczema be the one that caused by the endogenous causes of ill such as patient's heredity, immunity and exopathogenic factor have pleomorphism skin lesion and easily exudative inflammation react, cardinal symptom is pruritus and skin lesion.
At present, treat the method for eczema both at home and abroad more.For the eczema of pruritus, generally adopt the Therapeutic Method of the partial smearing such as 1% hydrocortisone emulsifiable paste, 0.5% hydrocortisone butyrate ointment, 0.1% Kenac Cream; Cause the patient of exudative inflammation for skin lesion, smear in conjunction with 2% mupirocin ointment, 0.05% berberine emulsifiable paste, 1% erythromycin ointment, prevent that Secondary cases antibacterial from infecting.
Owing to adopting external supplementary glucocorticoid treatment eczema, this class medicine side effect is large, repeated multiple times use, easily there is erubescence, telangiectasis, xerosis cutis, coarse etc., and transferring steroid-dependent dermatitis to, treatment is got up more difficult, has the shortcoming easily repeatedly occurring.
Summary of the invention
For solving the defect existing in above-mentioned prior art, the object of the invention be to provide a kind of have promote eczema patients self skin immunization power, reduce the histamine levels of ill skin part and prevent that disease sites antibacterial from infecting the pharmaceutical composition of the treatment eczema of multiple efficacies.
Technical scheme of the present invention, for a kind of pharmaceutical composition for the treatment of eczema is provided, comprises that the raw material of following weight portion mixes:
Wherein oil phase component is: the DC250 dimethicone of the lanoline of the C12-15 benzoate of the cera alba of 1-3 part, the white oil of 10-14 part, 3-5 part, the Semen Myristicae bean isopropyl propionate of 1-3 part, 1-3 part, the shea butter of 2-4 part, 1-3 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 2-4 part;
Water component is: the diphhydramine hydrochloride of the glycerol of 4-6 part, the Magnesium sulfate heptahydrate of 0.8-1.2 part, 0.8-1.2 part, the purified water of 55-60 part;
Medicine activity component is: the Mentholum of the propylene glycol of 3-5 part, the enoxolone of 0-0.5 part, 0-0.3 part, the paeonol of 0.1 part.
In the pharmaceutical composition of preferred above-mentioned treatment eczema, the weight part ratio of described oil phase component, water component and active component is: 31.8 parts of oil phase component, 64 parts of water components, 4.2 parts of active components.
In the pharmaceutical composition of preferred above-mentioned treatment eczema, comprise oil phase component, water component and the active component of following weight portion:
Wherein oil phase component is: the cera alba of 3 parts, the white oil of 12 parts, the C12-15 benzoate of 4 parts, the Semen Myristicae bean isopropyl propionate of 2 parts, the lanoline of 2 parts, the shea butter of 3 parts, the DC250 dimethicone of 2 parts, the vitamin E of 0.3 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 3 parts;
Water component is: the glycerol of 5 parts, the Magnesium sulfate heptahydrate of 1.2 parts, the diphhydramine hydrochloride of 1.0 parts, the purified water of 57 parts;
Medicine activity component is: the propylene glycol of 4 parts, the enoxolone of 0.5 part, the Mentholum of 0.3 part, the paeonol of 0.1 part.
Another technical scheme of the present invention, for a kind of preparation method of pharmaceutical composition for the treatment of eczema is provided, comprises the following steps:
1) the oil phase component raw material that takes following weight portion throw in oil phase container the cera alba, the white oil of 10-14 part, the C12-15 benzoate of 3-5 part, the Semen Myristicae bean isopropyl propionate of 1-3 part, the lanoline of 1-3 part, the shea butter of 2-4 part, the DC250 dimethicone of 1-3 part, the vitamin E of 0-0.5 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 2-4 part of oil mixture A:1-3 part;
The water component raw material that takes following weight portion throw in water container the glycerol, the Magnesium sulfate heptahydrate of 0.8-1.2 part, the diphhydramine hydrochloride of 0.8-1.2 part, the purified water of 55-60 part of aqueous mixture B:4-6 part;
The medicine activity component raw material that takes following weight portion throw in medicine activity component container medicine activity component mixture C: the Mentholum of the propylene glycol of 3-5 part, the enoxolone of 0-0.5 part, 0-0.3 part, the paeonol of 0.1 part;
2) respectively oil mixture A is heated to 80-85 DEG C, aqueous mixture B is heated to 80-85 DEG C,
Pharmaceutically active group container mixture B is heated to 60-65 DEG C, when heating, stirs respectively, when each mixture reaches after said temperature, keeps stirring 30 minutes;
3), to oil phase container vacuum-pumping, in the time that the vacuum of oil phase container reaches 0.05Mpa, aqueous mixture B is pumped in oil phase container, add 80-85 DEG C of insulation after mixture B, continue to stir 30 minutes, utilize high speed homogenization device to carry out homogenizing, setting speed is 4000rpm, and homogenizing time is 10 minutes;
4) oil water mixture of step 3) gained oil phase container is cooled to 60-65 DEG C, slowly adds the medicine activity component mixture C of having dissolved, insulation, continues to stir 20-30 minute to obtain mixture D;
5) by step 4) mixture D be cooled to 35-40 DEG C, utilize high speed homogenization device to carry out homogenizing,
Setting speed is 4000rpm, and homogenizing time is 10-15 minute; After reaching requirement, the mixture mastic viscosity in oil phase container goes out container ageing.
Preferably, in the preparation method of the pharmaceutical composition of above-mentioned treatment eczema, the weight part ratio of oil phase component described in described step 1), water component and active component is: 30-35 part oil phase component, 60-65 part water component, 3.5-5 part active component.
Preferably, in the preparation method of the pharmaceutical composition of above-mentioned treatment eczema, described step 1) is:
The oil phase component raw material that takes following weight portion throw in oil phase container the cera alba, the white oil of 12 parts, the C12-15 benzoate of 4 parts, the Semen Myristicae bean isopropyl propionate of 2 parts, the lanoline of 2 parts, the shea butter of 3 parts, the DC250 dimethicone of 2 parts, the vitamin E of 0.3 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 3 parts of oil mixture A:3 part;
The water component raw material that takes following weight portion throw in water container the glycerol, the Magnesium sulfate heptahydrate of 1.2 parts, the diphhydramine hydrochloride of 1.0 parts, the purified water of 57 parts of aqueous mixture B:5 part;
The medicine activity component raw material that takes following weight portion throw in medicine activity component container medicine activity component mixture C: the propylene glycol of 4 parts, the enoxolone of 0.5 part, the Mentholum of 0.3 part, the paeonol of 0.1 part.
Preferably, in the preparation method of the pharmaceutical composition of above-mentioned treatment eczema, in described step 3), water pumps in oil phase container with the flow velocity of 1L/ minute, keeps oil phase container 500rpm high-speed stirred simultaneously.
Beneficial effect of the present invention: the pharmaceutical composition for the treatment of eczema of the present invention forms according to science compatibility, there is powerful treatment effect fast, have good maintenance action, once healing simultaneously, be difficult for recurrence, there are itch stopping and diminish inflammation, sterilization and three kinds of effects of reduction eczema skin histamine levels simultaneously.Be different from the eczema treatment method of external supplementary glucocorticoid, the pharmaceutical composition that the present invention treats eczema has added class adrenal hormone and adrenotrophic hormone material enoxolone, by the immunity of eczema patients self skin, promote the mineralocorticoid physiological level of self secreting of skin, thereby play effect of antipruritic.Through experiment showed, to symptoms such as eczema patients erythema, skin lesion and prurituss to there is desirable therapeutic effect.
Detailed description of the invention
By describing technology contents of the present invention, structural feature in detail, being realized object and effect, be explained in detail below in conjunction with embodiment.
Pharmaceutical composition of the present invention has added class adrenal hormone and adrenotrophic hormone material enoxolone, by the immunity of eczema patients self skin, promotes the mineralocorticoid physiological level of self secreting of skin, thereby plays effect of antipruritic.From in essence, be different from the eczema treatment method of external supplementary glucocorticoid.
The natural wool fat that Chinese medicine compositions of the present invention is added, for skin provides a complicated lipid combination, can imitate and strengthen original natural lipid combination function in skin.Lanoline can supplement double-layer of lipoid, and strengthens the barrier function of skin.For preventing that the skin of eczema is subject to the stimulation of extraneous undesirable element, plays a protective role.Meanwhile, can repair eczema damaged skin and resist the infection that damaged skin is avoided antibacterial and fungus.
The shea butter that Chinese medicine compositions of the present invention is added, the most approaching with the indices of human body sebum secretion, be rich in undersaturated fatty acid, strengthen the performance of keeping humidity of skin, can be moistened impaired eczema skin, be there is the damaged part of promotion reepithelialization simultaneously.
The enoxolone that Chinese medicine compositions of the present invention is added belongs to class adrenal hormone and adrenotrophic hormone material, has the antiinflammatory action of Phenylbutazone or hydrocortisone sample.The granuloma induced by implantation of cotton pellets of enoxolone to rat and formaldehyde swelling of the feet, subcutaneous granulomatous inflammation etc. all have inhibitory action, its antiinflammatory to tire to be about that cortisone or hydrogenation can pine 1/10.The rat experiment arthritis that enoxolone on Carrageenan causes has inhibitory action, Cavia porcellus anaphylaxis due to horse serum or egg albumen is all had to inhibitory action in various degree, its anti-inflammatory, antianaphylaxis and inhibition capillary permeability, antihistamine or to reduce cell relevant to the reactivity stimulating.Meanwhile, acute inflammation is had and diminished inflammation and antipruritic effect inhibitory action.
The paeonol that Chinese medicine compositions of the present invention is added has analgesia, antiinflammatory, antipyretic and suppress allergic effect.To pressing the pain due to the physics such as tail, acetic acid or chemical factor, there is obvious analgesic activity.To the inflammatory reaction by due to carrageenin, Ovum Gallus domesticus album, formaldehyde, histamine, 5-hydroxy tryptamine, Kallidin I, dimethylbenzene and endotoxin etc., there is obvious inhibitory action.
The diphenhydramine that Chinese medicine compositions of the present invention is added has the effect of antihistaminic H1 receptor, and nervus centralis is had to stronger inhibitory action, prevents irritated allergy.Antipruritic, diminishing inflammation and reducing histamine acts in eczema healing process simultaneously and plays the part of and have extremely important effect.
Embodiment 1
1) by throwing to oil phase container and obtain oil mixture A:2.0 kilogram cera alba, 12.0 kilograms of white oils, 4.0 kilograms of C12-15 benzoate, 2.0 kilograms of isopropyl myristates, 2.0 kilograms of lanolines, 3.0 kilograms of shea butters, 2.0 kilograms of DC250 dimethicones, 0.3 kilogram of vitamin E, 0.1 kilogram of methyl hydroxybenzoate, 0.2 kilogram of ethyl hydroxybenzoate, 3.0 kilograms of PEG-30 dimerization hydroxy stearic acid esters hereinafter referred to as each component of heavy oil phase, each component of oil phase is added to oil phase container.
By throwing to oil phase container and obtain aqueous mixture B:5.0 kilogram glycerol, 1.2 kilograms of Magnesium sulfate heptahydrate, 1.0 kilograms of diphhydramine hydrochlorides, 57.0 kilograms of purified water hereinafter referred to as each component of heavy water phase, each component of water is added in water container.
By the medicine activity component of weighing below throw in medicine activity component container medicine activity component mixture C: 4.0 kilograms of propylene glycol, 0.5 kilogram of enoxolone, 0.3 Mentholum, 0.1 kilogram of paeonol, add medicine activity component in medicine activity component container.
2) oil mixture A is heated to 80-85 DEG C, aqueous mixture B is heated to 80-85 DEG C, pharmaceutically active group container mixture B is heated to 60-65 DEG C, when heating, stir respectively, when each mixture reaches after said temperature, keep stirring 30 minutes;
3) to oil phase container vacuum-pumping, in the time that the vacuum of oil phase container reaches 0.05Mpa, by aqueous mixture B, pump in oil phase container with the flow velocity of 1L/ minute, keep oil phase container 500rpm high-speed stirred, until water component materials adds completely simultaneously; Keep 500rpm high-speed stirred, continue 30 minutes;
80 DEG C, 4000rpm high speed homogenization 10 minutes;
4) continue to keep 500rpm high-speed stirred, in oil phase container chuck, pass into cooling water, be cooled to 60-65 DEG C, add said medicine active component; Keep 500rpm high-speed stirred, continue 20 minutes;
5) in oil phase container chuck, pass into cooling water, be cooled to 35-40 DEG C, 4000rpm high speed homogenization 15 minutes, according to the viscosity of mastic, adjusts the operating time of high speed homogenization, mastic viscosity is on the low side, continue high speed homogenization, mastic viscosity reaches after requirement, can go out container ageing, after ageing 12 hours, fill.
Embodiment 2
1) by throwing to oil phase container and obtain oil mixture A:1 kilogram cera alba, 10 kilograms of white oils, 3 kilograms of C12-15 benzoate, 1 kilogram of isopropyl myristate, 1 kilogram of lanoline, 2 kilograms of shea butters, 1 kilogram of DC250 dimethicone, 0.3 kilogram of vitamin E, 0.1 kilogram of methyl hydroxybenzoate, 0.2 kilogram of ethyl hydroxybenzoate, 3 kilograms of PEG-30 dimerization hydroxy stearic acid esters hereinafter referred to as each component of heavy oil phase, each component of oil phase is added to oil phase container.
By throwing to oil phase container and obtain aqueous mixture B:4 kilogram glycerol, 0.8 kilogram of Magnesium sulfate heptahydrate, 0.8 kilogram of diphhydramine hydrochloride, 55 kilograms of purified water hereinafter referred to as each component of heavy water phase, each component of water is added in water container.
Throw to medicine activity component container and obtain medicine activity component mixture C by the medicine activity component of weighing below: 3 kilograms of propylene glycol, 0.5 kilogram of enoxolone, 0.3 kilogram of Mentholum, 0.1 kilogram of paeonol, add medicine activity component in medicine activity component container.
2) oil mixture A is heated to 80-85 DEG C, aqueous mixture B is heated to 80-85 DEG C, pharmaceutically active group container mixture B is heated to 60-65 DEG C, when heating, stir respectively, when each mixture reaches after said temperature, keep stirring 30 minutes;
3) to oil phase container vacuum-pumping, in the time that the vacuum of oil phase container reaches 0.05Mpa, by aqueous mixture B, pump in oil phase container with the flow velocity of 1L/ minute, keep oil phase container 500rpm high-speed stirred, until water component materials adds completely simultaneously; Keep 500rpm high-speed stirred, continue 30 minutes;
80 DEG C, 4000rpm high speed homogenization 10 minutes;
4) continue to keep 500rpm high-speed stirred, in oil phase container chuck, pass into cooling water, be cooled to 60-65 DEG C, add said medicine active component; Keep 500rpm high-speed stirred, continue 20 minutes;
5) in oil phase container chuck, pass into cooling water, be cooled to 35-40 DEG C, 4000rpm high speed homogenization 15 minutes, according to the viscosity of mastic, adjusts the operating time of high speed homogenization, mastic viscosity is on the low side, continue high speed homogenization, mastic viscosity reaches after requirement, can go out container ageing, after ageing 12 hours, fill.
Embodiment 3
1) by throwing to oil phase container and obtain oil mixture A:3 kilogram cera alba, 14 kilograms of white oils, 5 kilograms of C12-15 benzoate, 3 kilograms of isopropyl myristates, 3 kilograms of lanolines, 4 kilograms of shea butters, 3 kilograms of DC250 dimethicones, 0.5 kilogram of vitamin E, 0.1 kilogram of methyl hydroxybenzoate, 0.2 kilogram of ethyl hydroxybenzoate, 3 kilograms of PEG-30 dimerization hydroxy stearic acid esters hereinafter referred to as each component of heavy oil phase, each component of oil phase is added to oil phase container.
By throwing to oil phase container and obtain aqueous mixture B:6 kilogram glycerol, 1.2 kilograms of Magnesium sulfate heptahydrate, 1.2 kilograms of diphhydramine hydrochlorides, 60 kilograms of purified water hereinafter referred to as each component of heavy water phase, each component of water is added in water container.
Throw to medicine activity component container and obtain medicine activity component mixture C by the medicine activity component of weighing below: 5 kilograms of propylene glycol, 0.5 kilogram of enoxolone, 0.3 kilogram of Mentholum, 0.1 kilogram of paeonol, add medicine activity component in medicine activity component container.
2) oil mixture A is heated to 80-85 DEG C, aqueous mixture B is heated to 80-85 DEG C, pharmaceutically active group container mixture B is heated to 60-65 DEG C, when heating, stir respectively, when each mixture reaches after said temperature, keep stirring 30 minutes;
3) to oil phase container vacuum-pumping, in the time that the vacuum of oil phase container reaches 0.05Mpa, by aqueous mixture B, pump in oil phase container with the flow velocity of 1L/ minute, keep oil phase container 500rpm high-speed stirred, until water component materials adds completely simultaneously; Keep 500rpm high-speed stirred, continue 30 minutes;
80 DEG C, 4000rpm high speed homogenization 10 minutes;
4) continue to keep 500rpm high-speed stirred, in oil phase container chuck, pass into cooling water, be cooled to 60-65 DEG C, add said medicine active component; Keep 500rpm high-speed stirred, continue 20 minutes;
5) in oil phase container chuck, pass into cooling water, be cooled to 35-40 DEG C, 4000rpm high speed homogenization 15 minutes, according to the viscosity of mastic, adjusts the operating time of high speed homogenization, mastic viscosity is on the low side, continue high speed homogenization, mastic viscosity reaches after requirement, can go out container ageing, after ageing 12 hours, fill.
Embodiment 4 the present invention treat the result of use analysis of the pharmaceutical composition of eczema
80 examples be collection have erythema and ooze out skin lesion, with pruritus symptom eczema patients, patient is divided into 2 groups at random, every group of 40 examples.In 80 routine patients, male 44 examples, female's 36 examples; Age 1-10 year, 3 years old mean age.The course of disease was from 1 week to 1 month; Mainly be distributed in pudendum, buttocks, face.Patient all without significant difference (P>0.05), has the property of analogy in age, sex, course of disease degree.
Experimental technique
The 1st group of 40 routine eczema patients, after skin first cleans with the normal saline of sterilizing, the pharmaceutical composition of preparing in above-described embodiment is smeared at erythema and skin lesion position, every day 2 to 3 times, according to the rehabilitation situation of eczema skin, erythema disappears, skin lesion has been repaired, and just discontinues medication, and generally the time of smearing is 3 days to 2 weeks.The 2nd group of 40 routine eczema patients, skin is also that first the normal saline with sterilizing is clean, smears 0.05% Kenac Cream in erythema and skin lesion position, every day 2 to 3 times, same according to the rehabilitation situation of skin, skin rehabilitation, just discontinue medication.After medication 1 month, whether random access, by respondent, is observed and is recurred.
Evaluation criterion
After medication, according to the cross-reference of eczema skin, the erythema of eczema and skin lesion disappear, and are judged to be effectively; If after medication 2 weeks, the erythema of eczema and skin lesion situation, do not obtain good change, and it is invalid to be judged to be.The total number of persons of computational methods=effectively patient's quantity/this group investigation of effective percentage %.
Experimental result
After investigation statistics, the 1st group of 40 routine eczema patients, the number of erythema and skin lesion rehabilitation is 36 people, effective percentage is 90%; The 2nd group of 40 routine eczema patients, the number of rehabilitation is 37 people, effective percentage is 92.5%.
The result of example shows by experiment, and medicine compositions set forth in the present invention, to symptoms such as eczema patients erythema, skin lesion and prurituss, has effective rehabilitation efficacy.
The foregoing is only embodiments of the invention; not thereby limit the scope of the claims of the present invention; every equivalent structure or conversion of equivalent flow process that utilizes description of the present invention to do; or be directly or indirectly used in other relevant technical fields, be all in like manner included in scope of patent protection of the present invention.
Claims (6)
1. a pharmaceutical composition for the treatment of eczema, is characterized in that, is mixed by the raw material of following weight portion:
Wherein oil phase component is: the DC250 dimethicone of the lanoline of the C12-15 benzoate of the cera alba of 1-3 part, the white oil of 10-14 part, 3-5 part, the Semen Myristicae bean isopropyl propionate of 1-3 part, 1-3 part, the shea butter of 2-4 part, 1-3 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 2-4 part;
Water component is: the diphhydramine hydrochloride of the glycerol of 4-6 part, the Magnesium sulfate heptahydrate of 0.8-1.2 part, 0.8-1.2 part, the purified water of 55-60 part;
Medicine activity component is: the Mentholum of the propylene glycol of 3-5 part, the enoxolone of 0-0.5 part, 0-0.3 part, the paeonol of 0.1 part;
The weight part ratio of described oil phase component, water component and active component is: 31.8 parts of oil phase component, 64 parts of water components, 4.2 parts of active components.
2. a pharmaceutical composition for the treatment of eczema, is characterized in that, is mixed by oil phase component, water component and the active component of following weight portion:
Wherein oil phase component is: the cera alba of 3 parts, the white oil of 12 parts, the C12-15 benzoate of 4 parts, the Semen Myristicae bean isopropyl propionate of 2 parts, the lanoline of 2 parts, the shea butter of 3 parts, the DC250 dimethicone of 2 parts, the vitamin E of 0.3 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 3 parts;
Water component is: the glycerol of 5 parts, the Magnesium sulfate heptahydrate of 1.2 parts, the diphhydramine hydrochloride of 1.0 parts, the purified water of 57 parts;
Medicine activity component is: the propylene glycol of 4 parts, the enoxolone of 0.5 part, the Mentholum of 0.3 part, the paeonol of 0.1 part.
3. a preparation method for the treatment of the pharmaceutical composition of eczema, is characterized in that, comprises the following steps:
1) the oil phase component raw material that takes following weight portion throw in oil phase container the cera alba, the white oil of 10-14 part, the C12-15 benzoate of 3-5 part, the Semen Myristicae bean isopropyl propionate of 1-3 part, the lanoline of 1-3 part, the shea butter of 2-4 part, the DC250 dimethicone of 1-3 part, the vitamin E of 0-0.5 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 2-4 part of oil mixture A:1-3 part;
The water component raw material that takes following weight portion throw in water container the glycerol, the Magnesium sulfate heptahydrate of 0.8-1.2 part, the diphhydramine hydrochloride of 0.8-1.2 part, the purified water of 55-60 part of aqueous mixture B:4-6 part;
The medicine activity component raw material that takes following weight portion throw in medicine activity component container medicine activity component mixture C: the Mentholum of the propylene glycol of 3-5 part, the enoxolone of 0-0.5 part, 0-0.3 part, the paeonol of 0.1 part;
2) respectively oil mixture A is heated to 80-85 DEG C, aqueous mixture B is heated to 80-85 DEG C, and medicine activity component mixture C is heated to 60-65 DEG C, when heating, stirs respectively, when each mixture reaches after said temperature, keeps stirring 30 minutes;
3) to oil phase container vacuum-pumping, in the time that the vacuum of oil phase container reaches 0.05Mpa, aqueous mixture B is pumped in oil phase container, add 80-85 DEG C of insulation after mixture B, continue to stir 30 minutes, utilize high speed homogenization device to carry out homogenizing, setting speed is 4000rpm, and homogenizing time is 10 minutes;
4) by step 3) oil water mixture of gained oil phase container is cooled to 60-65 DEG C, slowly adds the medicine activity component mixture C of having dissolved, and insulation, continues to stir 20-30 minute to obtain mixture D;
5) by step 4) gained mixture D is cooled to 35-40 DEG C, utilizes high speed homogenization device to carry out homogenizing, and setting speed is 4000rpm, and homogenizing time is 10-15 minute; After reaching requirement, the mixture mastic viscosity in oil phase container goes out container ageing.
4. the preparation method of the pharmaceutical composition for the treatment of eczema according to claim 3, it is characterized in that described step 1) described in the weight part ratio of oil phase component, water component and active component be: 30-35 part oil phase component, 60-65 part water component, 3.5-5 part active component.
5. the preparation method of the pharmaceutical composition for the treatment of eczema according to claim 3, is characterized in that, described step 1) be:
The oil phase component raw material that takes following weight portion throw in oil phase container the cera alba, the white oil of 12 parts, the C12-15 benzoate of 4 parts, the Semen Myristicae bean isopropyl propionate of 2 parts, the lanoline of 2 parts, the shea butter of 3 parts, the DC250 dimethicone of 2 parts, the vitamin E of 0.3 part, the methyl hydroxybenzoate of 0.1 part, the ethyl hydroxybenzoate of 0.2 part, the PEG-30 dimerization hydroxy stearic acid ester of 3 parts of oil mixture A:3 part;
The water component raw material that takes following weight portion throw in water container the glycerol, the Magnesium sulfate heptahydrate of 1.2 parts, the diphhydramine hydrochloride of 1.0 parts, the purified water of 57 parts of aqueous mixture B:5 part;
The medicine activity component raw material that takes following weight portion throw in medicine activity component container medicine activity component mixture C: the propylene glycol of 4 parts, the enoxolone of 0.5 part, the Mentholum of 0.3 part, the paeonol of 0.1 part.
6. the preparation method of the pharmaceutical composition for the treatment of eczema according to claim 3, is characterized in that, described step 3) in aqueous mixture B pump in oil phase container with the flow velocity of 1L/ minute, keep oil phase container 500rpm high-speed stirred simultaneously.
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