CN101371889A - A set of medicament prescription for treating skin tinea and preparation method thereof - Google Patents
A set of medicament prescription for treating skin tinea and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a drug formula for the treatment of skin tinea, the drug formula relates to monarch drug of lightyellow sophora root, minister drug of amur corktree bark, adjuvant drug of densefruit pittany root-bark, golden larch bark and messenger drug of borneol or extracted ingredient thereof which are taken as a first necessary component; the drug formula further relates to a second necessary component of a chemical antifungal agent and other auxiliary ingredients which need to be added by the formulation, and the drug formula can be prepared into various formulations through the different processes. The invention further discloses a preparation method thereof.
Description
Technical field
The invention belongs to medical technical field.
Technical background
Tinea is the common dermatosis that is caused by dermatophytes (shallow table tinea bacterium) infection, is the common frdquently encountered disease that long-term bundle is disturbed people, belongs to the persistent ailment in the dermatosis.Epidemiological study shows: general population's dermatophytosis infection rate accounts for 64.81%, and wherein, the prevalence of tinea pedis reaches 42.85%.Therefore, the efficient medicine for developmental research treatment tinea has extremely important meaning.
Though the medicine of using is many at present, cure rate and effective percentage are all undesirable.Though some medicine has inhibitory action to disease symptoms, after the medication untoward reaction more, the relapse rate height.As Medicated Liquid for Fungal Infection of Hand and Foot, though certain curative effect is arranged, it is slow to take effect, and the treatment effective percentage is not high, pain when putting on the skin, to affected part and around corrosion and zest big, cause easily and fester and concurrent infection.Use clinically at present more, what have higher rating is " Daktar ointment ".
The present invention is a kind of high-efficient medicament composition for the treatment of tinea, this pharmaceutical composition adopts the bonded method of Chinese medicine and western medicine, is prepared from conjunction with modern preparation technique, and product has been gathered the advantage that Western medicine effectively takes stopgap measures fast and the Chinese medicine effect effects a permanent cure lastingly, treatment effective percentage height, relapse rate is low.
The present invention (embodiment 9) has done the body outer suppressioning test of dermatophytes with the multiple dilution method, observes product of the present invention and " Daktar ointment " therapeutical effect to experimental guinea pig skin tinea.The result shows: the pharmaceutical composition of the present invention preparation and " Daktar ointment " cause the cotton-shaped dermatophytosis of tinea dermatophytes and trichophyton gypseum all has the obvious suppression effect to common, and the pharmaceutical composition fungistatic effect of the present invention's preparation obviously is better than " Daktar ointment ".
This bright first necessary component that relates to of pharmaceutical formulation is Chinese medicine Radix Sophorae Flavescentis, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum or its extraction composition; Wherein Radix Sophorae Flavescentis is a monarch drug, and Cortex Phellodendri is a ministerial drug, and Cortex Dictamni, Cortex Pseudolaricis are adjuvant drug, and Borneolum Syntheticum is a messenger drug.The existing countless from ancient times to the present clinical success case records of the synergistic function of Radix Sophorae Flavescentis, Cortex Phellodendri, the second necessary component that relates to is chemical antifungal agent and other auxiliary element.
Radix Sophorae Flavescentis wherein
Be monarch drug, its nature and flavor hardship, cold.GUIXIN, liver, stomach, large intestine, urinary bladder channel.Have heat clearing and damp drying, parasite killing, diuresis effect.Be used to treatment eczema, eczema, skin pruritus, scabies leprosy, external treatment trichomonal vaginitis.Modern pharmacological research shows: Radix Sophorae Flavescentis has the effect of antipathogen, human body immunity improving function.Have antibiotic and astriction.Experiment in vitro shows: 1% matrine has significantly bacteriostasis to dysentery bacterium, escherichia coli, Bacillus proteus, group B streptococcus and staphylococcus aureus.Decoct (8%), water decoction (1:3) has in various degree inhibitory action external to some common skin fungus.Precipitate with ethanol cream still has anti-trichomonal, an anti-ameba effect external.
According to putting down in writing in the Compendium of Material Medica, Radix Sophorae Flavescentis can be controlled pyretic toxicity wind, the irritated skin ulcer of giving birth to of musculus cutaneus." rubella arthralgia pain all over can not be born. breast neck umbilicus abdomen and nearly latent all right person, and also sialism expectorant, must not sleep night.With Radix Sophorae Flavescentis not one or two, two liang of Fructus Gleditsia, one liter in water is rubbed leaching juice.Stone implement is boiled into cream. and last nine WUZI are big.Every clothes 39. food back warm water clothes, just heal next day.”
The necessary component Cortex Phellodendri of another of pharmaceutical formulation of the present invention
Its nature and flavor hardship, cold is returned kidney, urinary bladder channel.Have heat clearing and damp drying, pathogenic fire purging except that steaming, detoxify the skin ulcer effect for the treatment of.Be used for that damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, skin infection swell and ache, the eczema pruritus.Modern pharmacological research shows: Cortex Phellodendri is effective to staphylococcus aureus, streptococcus pneumoniae, diphtheria corynebacterium, Streptococcus viridans, dysentery bacterium, escherichia coli, bacillus pyocyaneus, pathogenic fungus, its water decoction can also kill leptospira, and trichomonas vaginitis is also had effect.
[time treasure say] meridian is few cloudy monarch fire to changing, thus the bitter cold of Radix Sophorae Flavescentis, Cortex Phellodendri, all can the kidney invigorating, cover and get its bitter dampness, cold heat extraction is also.Hot air wind producing, the humidogene worm is so can control the wind parasite killing again.Only kidney water is weak and mutually fiery victor is suitable with it.Scorchingly hot foot swells to have a pain and desires the person of taking off.Radix Sophorae Flavescentis boils wine and steeps it.
Cortex Dictamni
The abnormal smells from the patient hardship, cold, nontoxic.Have heat clearing and damp drying, the Detoxication of dispeling the wind, modern medicine proves: can treat damp and hot sore, yellow fluid is dripping, eczema, scabies skin ulcer leprosy, rheumatism pyretic arthralgia.
According to putting down in writing in the Compendium of Material Medica, Cortex Dictamni can be treated the yellow cellulitis of wind syndrome of head, and cough with dyspnea drenches drop, swollen Pu in woman's the moon, the dead flesh of arthralgia chiefly caused by damp pathogen, unable to flex and stretch the extremities start-stop row step.Herbal classic.Treatment extremity uneasiness, the time row abdomen in big hot drink water, desire to walk to call out, pediatric epilepsy scared, married woman's puerperal surplus pain.Lu not.It is red mashed to control all pyretic toxicity wind, aversion to wind, wind skin ulcer scabies, and the eyebrow loss of hairs is crisp, and musculus cutaneus is anxious, high fever aversion to cold, analgesic Huang, wine Huang, acute jaundice, paddy Huang, labor Huang.Zhen Quan.Get round by bribery, sharp nine orifices and blood vessels, logical small intestinal aqueous vapor, disease during the sky row, the headache eye is painful.It spends same merit.Bright greatly.The cold benefaction of [time treasure say] Cortex Dictamni gas, bitter in the mouth is dry, and foot is lunar, Yangming Channel dries the medicine of a warm nature also.Double staff too yin, yang is bright, is various jaundice syndromes migratory arthralgia key medicine.The skin ulcer section that the physicians from a family for generations only execute, shallow.
Cortex Pseudolaricis: the hot temperature of property, poisonous.Has the killing parasites for relieving itching effect.Effective to the scabies pruritus.
Borneolum Syntheticum: hot, bitter, be slightly cold.The refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.
The characteristics of pharmaceutical formulation of the present invention are:
One: help with Cortex Dictamni, Cortex Pseudolaricis with traditional Radix Sophorae Flavescentis, Cortex Phellodendri the monarch and his subjects prescription, Borneolum Syntheticum is a messenger drug.Their mutual synergism strengthens its sterilization, heat-clearing and toxic substances removing, the pruritus of dispelling effect greatly, brought into play that the effect of Chinese medicine use in conjunction is lasting, comprehensive adjustment human immunologic function's advantage.Another distinguishing feature of the present invention is: the Western medicine antibacterials of above-mentioned Chinese prescription with trace are combined, use the specific drug that special process is prepared into the treatment tinea.Because Western medicine antibacterials consumption is little, has both brought into play the characteristics that the quick produce effects of Western medicine is taken stopgap measures, and has reduced its drug side effect again, has avoided patient to use antibiotic Western medicine to be easy to generate chemical sproof shortcoming, thereby has reached the purpose of comprehensive raising therapeutic effect.
Summary of the invention
The purpose of this invention is to provide specific medicament pharmaceutical formulation of one group of treatment tinea and preparation method thereof.
The present invention relates to the pharmaceutical formulation of one group of treatment tinea, it comprises the first necessary component, by the weight of final pharmaceutical formulation,
0.1 the Radix Sophorae Flavescentis of～30 weight %;
0.01 the Cortex Phellodendri of～20 weight %;
0.001 the Cortex Dictamni of～15 weight %;
0.001 the Cortex Pseudolaricis of～15 weight %;
0.01 the Borneolum Syntheticum of～10 weight %;
Radix Sophorae Flavescentis in the above component, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum all are meant effective ingredient that the drug powder that directly is processed into by them or its obtain by extraction separation and then the pharmaceutical preparation that is prepared into.
The second necessary component, by the weight of final pharmaceutical formulation,
0.001 the chemical antifungal drug of～3 weight %.
And the various preparations that are prepared from by different process of other auxiliary element.
Chemical antifungal drug in the pharmaceutical formulation of the present invention is meant: contain be selected from terbinafine, naftifine, butenafine,, the mixture of a kind of or any two or more arbitrary proportion in the tolnaftate, amorolfine, miconazole nitrate, miconazole, bifonazole, clotrimazole, econazole, ketoconazole, oxiconazole, sertaconazole, sulconazole, tioconazole, terconazole (triaconazole), ciclopiroxolamin, undecylenic acid.
This pharmaceutical formulation is one group of pharmaceutical preparation that is exclusively used in the treatment tinea.
The present invention also provides the preparation method of described this medicine, and it comprises:
By the weight of final pharmaceutical formulation, the Radix Sophorae Flavescentis of 0.1～30 weight %, the Cortex Phellodendri of 0.01～20 weight %, the Cortex Dictamni of 0.001～15 weight %, the Cortex Pseudolaricis of 0.001～15 weight %, the Borneolum Syntheticum of 0.01～10 weight % are extracted the medicine active ingredient with following any method.
Method one: the water enchroachment (invasion) bubble with 3～10 times of crude drug weight extracted 2～48 hours; Filter, collect filtrate; Extract repeatedly 2～5 times with the method, merge filtrate, get medicine active ingredient aqueous solution.
Method two: the decocting with 3～10 times of crude drug weight boiled 0.5～3 hour; Filter, collect filtrate; Extract repeatedly 2～5 times with the method, merge filtrate, get medicine active ingredient aqueous solution.
It is 0.5～1.5 drug extract that medicine active ingredient aqueous solution is condensed into proportion;
In drug extract, add 2～5 times of volume of ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate; Filtering residue with 2～5 times of volume ethanol dissolvings, leaves standstill again, removes by filter impurity, collects filtrate; With the inferior repeatedly operation of the method 3～5 times, merge filtrate;
According to the dosage form needs, the filtrate that the last step was obtained is through distillation, boils off ethanol to writing out a prescription requirement or do not have the alcohol flavor, the precursor medicinal liquid, standby;
By the weight of final pharmaceutical formulation, take by weighing the chemical antifungal drug of 0.001～3.0 weight % and the precursor medicinal liquid of other auxiliary element and above-mentioned preparation, the various preparations that are prepared from by different process.
The specific embodiment
Pharmaceutical formulation of the present invention comprises the Radix Sophorae Flavescentis of 0.1～30 weight %.Described Radix Sophorae Flavescentis in pharmaceutical composition of the present invention as monarch drug.Play heat clearing and damp drying, antibiotic and convergence, the effect of human body immunity improving function.
In the present invention, term Radix Sophorae Flavescentis, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum all are meant the drug powder that directly is processed into by them; " extraction composition " is meant that Radix Sophorae Flavescentis, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, the Borneolum Syntheticum in the described component separates the effective ingredient that obtains by water extraction.
Pharmaceutical formulation of the present invention better comprises the Radix Sophorae Flavescentis of 0.5-20 weight %, better comprises the Radix Sophorae Flavescentis of 0.8-10 weight %, preferably includes the Radix Sophorae Flavescentis of 1.5-5 weight %.
Pharmaceutical formulation of the present invention also comprises the Cortex Phellodendri of 0.01～20 weight %.Described Radix Sophorae Flavescentis as ministerial drug, plays heat clearing and damp drying in pharmaceutical composition of the present invention, pathogenic fire purging removes and steams, detoxifies and treat the skin ulcer effect.
Pharmaceutical formulation of the present invention better comprises the Cortex Phellodendri of 0.1-15 weight %, better comprises the Cortex Phellodendri of 0.3-10 weight %, preferably includes the Cortex Phellodendri of 0.5-5 weight %.
Pharmaceutical formulation of the present invention also comprises the Cortex Dictamni of 0.001～15 weight %.Described Cortex Dictamni in pharmaceutical composition of the present invention as adjuvant drug, heat clearing and damp drying, the detoxifcation of dispeling the wind.
Pharmaceutical formulation of the present invention better comprises the Cortex Dictamni of 0.01-10 weight %, better comprises the Cortex Dictamni of 0.3-5 weight %, preferably includes the Cortex Dictamni of 0.5-2 weight %.
Pharmaceutical formulation of the present invention also comprises the Cortex Pseudolaricis of 0.001～15 weight %.Described Cortex Pseudolaricis as adjuvant drug, has the killing parasites for relieving itching effect in pharmaceutical composition of the present invention.Effective to the scabies pruritus.
Pharmaceutical formulation of the present invention better comprises the Cortex Pseudolaricis of 0.1-10 weight %, better comprises the Cortex Pseudolaricis of 0.3-5 weight %, preferably includes the Cortex Pseudolaricis of 0.5-3 weight %.
Pharmaceutical formulation of the present invention also comprises the Borneolum Syntheticum of 0.01～10 weight %.Described Borneolum Syntheticum in pharmaceutical composition of the present invention as messenger drug, the refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.
Pharmaceutical formulation of the present invention better comprises the Borneolum Syntheticum of 0.1-5 weight %, better comprises the Borneolum Syntheticum of 0.3-3 weight %, preferably includes the Borneolum Syntheticum of 0.5-1.5 weight %.
Pharmaceutical formulation of the present invention also comprises an amount of cosolvent pharmaceutically commonly used, isoosmotic adjusting agent, cutaneous permeable agent, antiseptic, spice etc. at random according to the dosage form needs; Pharmaceutical formulation of the present invention also comprises pharmaceutically acceptable oils solvent and water according to the dosage form needs.
Chinese medicine ingredients in the pharmaceutical formulation of the present invention complements each other to the therapeutical effect of tinea, and effect is lasting, plays heat clearing and damp drying jointly, sterilizing and itch-relieving and convergence, the effect of human body immunity improving function.Brought into play Chinese medicine and effected a permanent cure, the comprehensive adjustment physical function, effect is lasting, the characteristics of difficult recurrence.
What pharmaceutical formulation of the present invention comprised the second necessary component also is the chemical antifungal drug of 0.001～3.0 weight %.In compositions, play the quick sterilization effect, remedy the slow shortcoming of Chinese medicine onset.
Pharmaceutical formulation of the present invention better comprises the chemical antifungal drug of 0.01-2.0 weight %, better comprises the chemical antifungal drug of 0.1-1.5 weight %, preferably includes the chemical antifungal drug of 0.2-1 weight %.
Chemical antifungal drug in the pharmaceutical formulation of the present invention is selected from the mixture of a kind of or any two or more arbitrary proportion in terbinafine, naftifine, butenafine, tolnaftate, amorolfine, miconazole nitrate, miconazole, bifonazole, clotrimazole, econazole, ketoconazole, oxiconazole, sertaconazole, sulconazole, tioconazole, terconazole (triaconazole), ciclopiroxolamin, the undecylenic acid.
The present invention also provides the preparation method of described pharmaceutical formulation, and it comprises:
1. prepare medicine active ingredient extracting solution
Method one:, the Radix Sophorae Flavescentis of 0.1～30 weight %, the Cortex Phellodendri of 0.01～20 weight %, the Cortex Dictamni of 0.001～15 weight %, the Cortex Pseudolaricis of 0.001～15 weight %, the Borneolum Syntheticum of 0.01～10 weight % were extracted 2～48 hours with the water logging bubble with 3～10 times of crude drug weight by the weight of final pharmaceutical formulation; Filter, collect filtrate; Extract repeatedly 2～5 times with the method, merge filtrate, get the step of medicine active ingredient extracting solution.
Method two: by the weight of final pharmaceutical formulation, with the Borneolum Syntheticum of the Cortex Pseudolaricis of the Cortex Dictamni of the Cortex Phellodendri of the Radix Sophorae Flavescentis of 0.1～30 weight %, 0.01～20 weight %, 0.001～15 weight %, 0.001～15 weight %, 0.01～10 weight % with the water boiling and extraction of 3～10 times of crude drug weight 0.5～3 hour; Filter, collect filtrate; Extract repeatedly 2～5 times with the method, merge filtrate; Make the step of medicine active ingredient extracting solution.
2. medicine active ingredient extracting solution is concentrated into proportion and is 0.5～1.5 drug extract;
3. in drug extract, add 2～5 times of volume of ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate; With the inferior repeatedly operation of the method 3～5 times, merge filtrate; Get the alcoholic solution of medicine.
With the alcoholic solution of medicine through distillation, boil off ethanol to writing out a prescription requirement or do not have the alcohol flavor, the precursor medicinal liquid,
Standby;
5. by the weight of final pharmaceutical composition, take by weighing the chemical antifungal drug of 0.001～3 weight %, the precursor medicinal liquid that adds different auxiliary elements and above-mentioned preparation according to the dosage form needs prepares various preparations.
Following embodiment is used to further specify the present invention, it should be understood that the following example only is used for explanation and non-limiting scope of the present invention.
Embodiment 1
A kind of medicine breast spray for the treatment of tinea
(1) each set of dispense of medicine breast spray is than (making 1000ml) as shown in table 1.
Table 1
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 2 | 20.0 | Principal agent |
| Cortex Phellodendri | 1 | 10.0 | Principal agent |
| Cortex Dictamni | 0.5 | 5.0 | Principal agent |
| Cortex Pseudolaricis | 0.5 | 10.0 | Principal agent |
| Borneolum Syntheticum | 0.3 | 5.0 | Principal agent |
| Terbinafine | 1.0 | 10.0 | Principal agent |
| Soybean oil | 9.0 | 90.0 | Solvent |
| Ovum Gallus domesticus Flavus lecithin | 1.2 | 12.0 | Emulsifying agent |
| Medicinal water | 86.05 | 860.5 | Solvent |
(2) preparation of medicine breast spray
A. the Cortex Phellodendri of Jiang Radix Sophorae Flavescentis, 0.01～20 weight %, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum weigh 10 times water enchroachment (invasion) bubble 24 hours with crude drug; Filter, collect filtrate; Filtering residue weighs the water of 5 times of amounts again with crude drug, in kind extract repeatedly 3 times, merges to collect liquid, gets medicine active ingredient extracting solution, and is standby.
B. medicine active ingredient extracting solution distillation is concentrated into proportion and is 0.5～1.5 drug extract;
C. the ethanol that adds 3 times of extractum in drug extract stirs, and leaves standstill, and removes by filter impurity, collects filtrate; Filtering residue with 2～5 times of volume of ethanol dissolvings, leaves standstill again, removes by filter impurity, collects filtrate; Merging filtrate gets the alcoholic solution of medicine.
D. with the alcoholic solution of medicine through distillation, boil off ethanol to there not being the alcohol flavor, the precursor medicinal liquid, standby;
E. take by weighing recipe quantity terbinafine, soybean oil that Ovum Gallus domesticus Flavus lecithin is dissolved in recipe quantity in, standby.
F. precursor medicinal liquid of under the high-speed stirred d step being made and e go on foot the medicinal liquid of making and be mixed and made into colostric fluid under high-speed stirred;
G. with above-mentioned colostric fluid through high pressure homogenize 5 times;
H. filter, packing gets compositions breast spray.
Embodiment 2
A kind of drug solution spray for the treatment of tinea
(1) each set of dispense of drug solution spray is than (making 1000ml) as shown in table 2.
Table 2
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 8.0 | 80.0 | Principal agent |
| Cortex Phellodendri | 5.0 | 50.0 | Principal agent |
| Cortex Dictamni | 3.0 | 30.0 | Principal agent |
| Cortex Pseudolaricis | 3.0 | 30.0 | Principal agent |
| Borneolum Syntheticum | 1.0 | 10.0 | Principal agent |
| Miconazole nitrate | 0.5 | 5.0 | Principal agent |
| Ethanol | 40.0 | 400.0 | Solvent |
| Medicinal water | 39.5 | 395.0 | Solvent |
(2) preparation of drug solution spray
A. the Radix Sophorae Flavescentis of recipe quantity, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum being weighed 10 times decocting with crude drug boiled 1.5 hours; Filter, collect filtrate; Filtering residue weighs the water of 3 times of amounts again with crude drug, in kind extract merging filtrate 2 times; Make medicine active ingredient extracting solution, standby.
B. medicine active ingredient extracting solution distillation is concentrated into proportion and is 0.5～1.5 drug extract;
C. in drug extract, add 2～5 times of volume of ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate; Filtering residue with 2～5 times of volume of ethanol dissolvings, leaves standstill again, removes by filter impurity, collects filtrate; Merging filtrate gets the alcoholic solution of medicine.
D. the alcoholic solution with medicine contains ethanol 40% through being distilled to, and gets the precursor medicinal liquid, and is standby;
E. the miconazole nitrate that takes by weighing recipe quantity with the small amount of ethanol dissolving after, add in the above-mentioned precursor medicinal liquid.
F. filter, packing gets the drug solution spray.
Embodiment 3
A kind of medicinal tincture for the treatment of tinea
(1) each set of dispense of medicinal tincture is than (making 1000ml) as shown in table 3.
Table 3
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 15.0 | 150.0 | Principal agent |
| Cortex Phellodendri | 10.0 | 100.0 | Principal agent |
| Cortex Dictamni | 8.0 | 80.0 | Principal agent |
| Cortex Pseudolaricis | 8.0 | 80.0 | Principal agent |
| Borneolum Syntheticum | 3.0 | 30.0 | Principal agent |
| Clotrimazole | 1.5 | 15.0 | Principal agent |
| Ethanol | 30.0 | 300.0 | Solvent |
| Medicinal water | 24.5 | 245.0 | Solvent |
(2) preparation of medicinal tincture
A. Radix Sophorae Flavescentis, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, the Borneolum Syntheticum with recipe quantity steeped 24 hours with 3 times water logging;
B. in above-mentioned medicinal liquid, add the water that crude drug weighs 5 times of amounts once more, boiled 2.0 hours; Filter, collect filtrate;
C. filtering residue weighs the water of 3 times of amounts with crude drug, boils 2.0 hours, filters, and collects filtrate; In kind extract 2 times, merge b step, c step collection liquid; Get medicine active ingredient extracting solution, standby.
D. medicine active ingredient extracting solution distillation is concentrated into proportion and is 0.5～1.5 drug extract;
E. in drug extract, add 3～5 times ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate, get the alcoholic solution of medicine.
F. take by weighing recipe quantity miconazole nitrate, add in the alcoholic solution of said medicine, filter, packing gets tincture.
Embodiment 4
A kind of drug ointment agent for the treatment of tinea
(1) each set of dispense of drug ointment agent is than (making 1000ml) as shown in table 4.
Table 4
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 1.5 | 15.0 | Principal agent |
| Cortex Phellodendri | 0.75 | 7.5 | Principal agent |
| Cortex Dictamni | 0.5 | 5.0 | Principal agent |
| Cortex Pseudolaricis | 0.5 | 5.0 | Principal agent |
| Borneolum Syntheticum | 0.3 | 3.0 | Principal agent |
| Fluconazol | 1.0 | 10.0 | Principal agent |
| Vaseline | 7.25 | 72.5 | Substrate |
| Hexadecanol | 13.2 | 132.0 | Substrate |
| Liquid paraffin | 5.0 | 50.0 | Solvent |
| Medicinal water | 70.0 | 700.0 | Solvent |
(2) preparation of drug ointment agent
A. the Cortex Phellodendri of Jiang Radix Sophorae Flavescentis, 0.01～20 weight %, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum weigh 8 times decoction 1.5 hours with crude drug; Filter, collect filtrate;
B. filtering residue weighs the water of 4 times of amounts again with crude drug, decocts 1.5 hours, filters, and collects filtrate; Filtering residue in kind extracts 2 times again.Merge a and b filtrate collection liquid, get medicine active ingredient extracting solution, standby.
C. medicine active ingredient extracting solution distillation is concentrated into proportion and is 0.5～1.5 drug extract;
D. in drug extract, add 2～5 times of volume of ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate, get the alcoholic solution of medicine.
E. with the alcoholic solution of medicine through distillation, boil off ethanol and do not add water to recipe quantity to having the alcohol flavor, mending, pharmaceutical aqueous solution;
F. with liquid paraffin, hexadecanol, the vaseline of recipe quantity, dissolve the medicinal liquid oil solution, standby;
G. take by weighing recipe quantity fluconazol be dissolved in the small amount of ethanol, standby.
H. under the high-speed stirred e step made the medicinal liquid oil solution that medicinal liquid aqueous solution and f. step make and under high speed, be mixed and made into colostric fluid, and in the medicinal liquid adding colostric fluid with g step preparation; High speed shear stirred 5 minutes; Packing gets the drug ointment agent.
Embodiment 5
A kind of medicine liniment for the treatment of tinea
(1) each set of dispense of medicine liniment is than (making 1000ml) as shown in table 5.
Table 5
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 0.5 | 5.0 | Principal agent |
| Cortex Phellodendri | 0.2 | 2.0 | Principal agent |
| Cortex Dictamni | 0.1 | 1.0 | Principal agent |
| Cortex Pseudolaricis | 0.1 | 1.0 | Principal agent |
| Borneolum Syntheticum | 0.3 | 3.0 | Principal agent |
| Amorolfine | 0.5 | 5.0 | Principal agent |
| Ethanol | 50.0 | 500.0 | Solvent |
| Medicinal water | 48.3 | 483.0 | Solvent |
(2) preparation of medicine liniment
A. the Radix Sophorae Flavescentis of recipe quantity, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum being weighed 10 times decocting with crude drug boiled 2 hours; Filter, collect filtrate;
B. filtering residue weighs the water of 3 times of amounts with crude drug, decocts 2 hours; Filter, collect filtrate; Filtering residue in kind extracts 2 times again, merges the collection liquid in a step and b step; Get the effective ingredient extracting solution, standby.
C. the distillation of effective ingredient extracting solution being concentrated into proportion is 0.5～1.5 drug extract;
D. in extractum, add 2～5 times of volume of ethanol of invasion cream amount, stir, leave standstill, remove by filter impurity, collect filtrate, get the alcoholic solution of medicine.
E. the alcoholic solution with medicine does not have the alcohol flavor through being distilled to, and adds medicinal water to recipe quantity; Filter, packing gets liniment.
Embodiment 6
A kind of medicine breast liniment for the treatment of tinea
(1) each set of dispense of medicine breast liniment is than (making 1000ml) as shown in table 6.
Table 6
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 4 | 40.0 | Principal agent |
| Cortex Phellodendri | 2 | 20.0 | Principal agent |
| Cortex Dictamni | 0.5 | 5.0 | Principal agent |
| Cortex Pseudolaricis | 0.5 | 5.0 | Principal agent |
| Borneolum Syntheticum | 0.3 | 3.0 | Principal agent |
| Naftifine | 0.5 | 5.0 | Principal agent |
| Butenafine | 0.5 | 5.0 | Principal agent |
| Soybean oil | 9.0 | 90.0 | Solvent |
| Ovum Gallus domesticus Flavus lecithin | 1.5 | 15.0 | Emulsifying agent |
| Medicinal water | 81.2 | 812.2 | Solvent |
(2) preparation of medicine breast
A. the Radix Sophorae Flavescentis of recipe quantity, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum are weighed 10 times water logging bubble 24 hours with crude drug; Filter, collect filtrate;
B. filtering residue weighs the water of 5 times of amounts with crude drug, soaks 24 hours; Filter, collect filtrate; Filtering residue in kind extracts 3 times again, merges a step, b step collection liquid; Get medicine active ingredient extracting solution, standby.
C. the distillation of medicine active ingredient extracting solution being concentrated into proportion is 0.5～1.5 drug extract;
D. in drug extract, add 2～5 times of volume of ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate; Filtering residue with 2～5 times of volume of ethanol dissolvings, leaves standstill again, removes by filter impurity, collects filtrate; Merging filtrate gets the alcoholic solution of medicine.
E. with the alcoholic solution of medicine through distillation, boil off ethanol to there not being the alcohol flavor, the precursor medicinal liquid, standby;
F. take by weighing recipe quantity naftifine, butenafine, Ovum Gallus domesticus Flavus lecithin be dissolved in the soybean oil of recipe quantity, standby.
G. precursor medicinal liquid of under the high-speed stirred e step being made and f. go on foot the medicinal liquid of making and be mixed and made into colostric fluid under high speeds;
H. with above-mentioned colostric fluid through high pressure homogenize 5 times; Filter, packing gets medicine breast liniment.
Embodiment 7
A kind of drug solution agent for the treatment of tinea
(1) each set of dispense of drug solution agent is than (making 1000ml) as shown in table 7.
Table 7
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 15.0 | 150.0 | Principal agent |
| Cortex Phellodendri | 10.0 | 100.0 | Principal agent |
| Cortex Dictamni | 5.0 | 50.0 | Principal agent |
| Cortex Pseudolaricis | 5.0 | 50.0 | Principal agent |
| Borneolum Syntheticum | 2.0 | 20.0 | Principal agent |
| Econazole | 0.3 | 3.0 | Principal agent |
| Ketoconazole | 0.2 | 2.0 | Principal agent |
| Ethanol | 30.0 | 300.0 | Solvent |
| Medicinal water | 32.5 | 325.0 | Solvent |
(2) preparation of drug solution agent
A. the Radix Sophorae Flavescentis of recipe quantity, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum being weighed 10 times decocting with crude drug boiled 1.5 hours; Filter, collect filtrate; Filtering residue weighs the water of 3 times of amounts with crude drug, and filtering residue in kind extracts 2 times again, merging filtrate; Make medicine active ingredient extracting solution, standby.
B. the distillation of medicine active ingredient extracting solution being concentrated into proportion is 0.5～1.5 drug extract;
C. in drug extract, add 2～5 times of volume of ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate; Filtering residue with 2～5 times of volume of ethanol dissolvings, leaves standstill again, removes by filter impurity, collects filtrate; Merging filtrate gets the alcoholic solution of medicine.
D. the alcoholic solution with medicine contains ethanol 30% through being distilled to, and gets the precursor medicinal liquid, and is standby;
E. the econazole, ketoconazole that takes by weighing recipe quantity with the small amount of ethanol dissolving after, add in the above-mentioned precursor medicinal liquid.
F. filter, packing gets the drug solution agent.
Embodiment 8
A kind of medicinal tincture for the treatment of tinea
(1) each set of dispense of medicinal tincture is than (making 1000ml) as shown in table 8.
Table 8
| The component title | Weight ratio (%) | Inventory (g) | Effect |
| Radix Sophorae Flavescentis | 20.0 | 200.0 | Principal agent |
| Cortex Phellodendri | 10.0 | 100.0 | Principal agent |
| Cortex Dictamni | 8.0 | 80.0 | Principal agent |
| Cortex Pseudolaricis | 8.0 | 80.0 | Principal agent |
| Borneolum Syntheticum | 3.0 | 30.0 | Principal agent |
| Ciclopiroxolamin | 1.0 | 10.0 | Principal agent |
| Undecylenic acid | 1.0 | 10.0 | Principal agent |
| Ethanol | 25.0 | 250.0 | Solvent |
| Medicinal water | 24.0 | 240.0 | Solvent |
(2) preparation of medicinal tincture
A. Radix Sophorae Flavescentis, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, the Borneolum Syntheticum with recipe quantity steeped 24 hours with 3 times water logging;
B. in above-mentioned medicinal liquid, add the water that crude drug weighs 5 times of amounts once more, boiled 2.0 hours, filter, collect filtrate;
C. filtering residue weighs the water of 3 times of amounts with crude drug, boils 2.0 hours, filters, and collects filtrate; Filtering residue in kind extracts 2 times again; Merge b step, c step collection liquid; Get medicine active ingredient extracting solution, standby.
D. the distillation of medicine active ingredient extracting solution being condensed into proportion is 0.5～1.5 drug extract;
E. in drug extract, add the ethanol of 5 times of extractum amounts, stir, leave standstill, remove by filter impurity, collect filtrate, get the alcoholic solution of medicine.
F. take by weighing recipe quantity ciclopiroxolamin, undecylenic acid add in the alcoholic solution of said medicine, filter, packing gets medicinal tincture.
Embodiment 9
The animal test of pesticide effectiveness
Purpose: advance copy invention pharmaceutical preparation is to the therapeutic effect of tinea.
Method: observe external inhibitory action to dermatophytes with the multiple dilution method; Affected part spray medicine is observed the therapeutical effect to experimental guinea pig skin tinea; Topical is observed the influence to rat paw edema and mice foot swelling.
The result: the medicine spray of the present invention preparation and tincture cause the cotton-shaped dermatophytosis of tinea dermatophytes and trichophyton gypseum all has the obvious suppression effect to common, and experimental tinea is also had obvious treatment effect and inflammation-resisting itch-stopping effect.
1. material
The healthy guinea pig 55 of body weight 250～300g.
The embodiment of the invention 1 preparation: medicine breast spray.
The embodiment of the invention 3 preparations: medicinal tincture.
Homemade 0.5% sodium carboxymethyl cellulose liquid.
The miconazole ointment commercially available product
Dermatophytes kind strain: microsporum lanosum, red mentagrophytes, trichophyton gypseum and acrothesium floccosum.
2. test apparatus GEX-9140MBE type electro-heating standing-temperature cultivator.
3. method
3.1. bacteriostatic test
The medicinal tincture and the miconazole ointment of the invention process embodiment 3 preparations are carried out carrying out the medicine bacteriostatic test with 2 times of dilution methods after the 1:10 dilution with the Sha Baolao culture fluid respectively, quantitatively add bacterium liquid, 37 ℃ of test tubes were cultivated 7 days, change the plate separation and Culture, every kind of each concentration of bacterium is got 10 bacterial strain multiple spots and is quantitatively inoculated, cultivated 7 days for 37 ℃, observe each
Under the concentration to the fungistatic effect result of different skin fungus.As table 1～2.
Table 1 medicinal tincture bacteriostatic test result
Annotate: "+" is the bacteriostatic test positive, asepsis growth; "-" is the bacteriostatic test feminine gender, and bacteria growing is arranged.
Table 2 miconazole ointment bacteriostatic test result
Annotate: "+" is the bacteriostatic test positive, asepsis growth; "-" is the bacteriostatic test feminine gender, and bacteria growing is arranged.
The medicinal tincture that the result should invent preparation causes the cotton-shaped dermatophytosis of tinea dermatophytes and trichophyton gypseum all has the obvious suppression effect to common, and the fungistatic effect of this medicinal tincture obviously is better than Daktar ointment.
3.2 to the effect of guinea pig skin treatment of fungal infections
Get 52 of 250～300g Cavia porcelluss at random, 10% sodium sulfide back depilation is (behind the 24h of 5cm * 6cm), by the sand paper centre scratch district of being 2cm * 2cm, district of will losing hair or feathers, to the severe oozing of blood, give three kinds of dermatophytes mixed liquors (microsporum lanosum, red mentagrophytes, trichophyton gypseum) 0.2mL and be applied in the damaged skin district, observe the skin infection situation every day, gave bacterium the 7th day, select to infect obvious person (local red and swollen, ooze out, skin the flakey sample occurs and changes) to look into three kinds of fungal culture positive in spot sampling.22 Cavia porcelluss are divided into 4 groups at random, two treatment groups are respectively original content, the medicine spray of 50% concentration (sample of the embodiment of the invention 1 preparation), positive controls is a miconazole ointment, negative control group is that 0.5% sodium carboxymethyl cellulose liquid 0.1mL (being equivalent to solution 0.1g) dosage is 0.1g and smears in infecting local uniform, every day 2 times, continuous 7 days, day by day observe the local patholoic change situation, the record state of an illness, get the inoculation of diseased region skin bacteria sample, carry out fungal culture, variation is estimated and the fungal culture situation is carried out statistical analysis to local patholoic change, as table 3.
Cavia porcellus pathological changes integrated value and average regression time x ± S are respectively organized in table 3 administration after 5 days
Annotate: with comparison before the medicine
*P＜0.001.
Result of the test shows: the medication group has the obvious treatment effect to experimental tinea.The medication group guinea pig skin fungal infection kitchen range state of an illness and negative control group relatively have evident difference (P＜0.001).Illustrate that medicine spray and miconazole ointment all have the obvious treatment effect to the cutaneous fungal infection kitchen range.Should invent the medicine spray of preparation on time faster than miconazole ointment in resolution of symptoms.
One week of drug withdrawal, observe local patholoic change once more, none routine pathological changes of negative control disappears, and this medicine spray treatment group does not reappear pathological changes, and obviously pathological changes of an example appears again in Daktar ointment group.
Claims (6)
1. the pharmaceutical formulation of one group of treatment tinea, it comprises by the weight of final pharmaceutical formulation: as the first necessary component is the Radix Sophorae Flavescentis of 0.1～30 weight %, the Cortex Phellodendri of 0.01～20 weight %, the Cortex Dictamni of 0.001～15 weight %, the Cortex Pseudolaricis of 0.001～15 weight %, the Borneolum Syntheticum of 0.01～10 weight % or their extraction composition; As the second necessary component be the chemical antifungal drug of 0.001～3 weight % and owing to dosage form needs other auxiliary element add, the various preparations that are prepared from by different process.
2. according to the described pharmaceutical formulation of claim 1, it is characterized in that, described Radix Sophorae Flavescentis as the first necessary component, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum all are meant drug powder or its effective ingredient that obtains by extraction separation that directly is processed into by them, and then the different pharmaceutical preparation that is prepared into.
3. according to the described pharmaceutical formulation of claim 2, it is characterized in that the extraction process of effective component of Radix Sophorae Flavescentis, Cortex Phellodendri, Cortex Dictamni, Cortex Pseudolaricis, Borneolum Syntheticum is a water extraction method; Water extraction method can be water-extraction method or decocting method.
4. according to the described pharmaceutical formulation of claim 1, it is characterized in that described chemical antifungal drug is meant: contain be selected from terbinafine, naftifine, butenafine,, the mixture of a kind of or any two or more arbitrary proportion in the tolnaftate, amorolfine, miconazole nitrate, miconazole, bifonazole, clotrimazole, econazole, fluconazol, ketoconazole, oxiconazole, sertaconazole, sulconazole, tioconazole, terconazole (triaconazole), ciclopiroxolamin, undecylenic acid.
5. the preparation method of a pharmaceutical formulation preparation, it comprises:
Weight by final pharmaceutical formulation, with the Radix Sophorae Flavescentis of 0.1～30 weight %, the Cortex Phellodendri of 0.01～20 weight %, the Cortex Dictamni of 0.001～15 weight %, the Cortex Pseudolaricis of 0.001～15 weight %, the Borneolum Syntheticum of 0.01～10 weight %, extract the medicine active ingredient with following any method:
Method one: the water logging bubble with 3～10 times of crude drug weight extracted 2～48 hours, filtered, and collected filtrate; Extract repeatedly 2～5 times with the method, merge filtrate, get medicine active ingredient extracting solution.
Method two: with the water boiling and extraction of 3～10 times of crude drug weight 0.5～3 hour; Filter, collect filtrate; Extract repeatedly 2～5 times with the method, filter, merge filtrate, get medicine active ingredient extracting solution.
It is 0.5～1.5 drug extract that medicine active ingredient extracting solution is concentrated into proportion;
In drug extract, add 2～5 times of volume of ethanol of extractum amount, stir, leave standstill, remove by filter impurity, collect filtrate; Filtering residue with 2～5 times of volume ethanol dissolvings, leaves standstill again, removes by filter impurity, collects filtrate; With the inferior repeatedly operation of the method 3～5 times, merge filtrate, get the medicine alcoholic solution.
According to the dosage form needs, with the last step obtain the medicine alcoholic solution through distillation, boil off ethanol to writing out a prescription requirement or do not have alcohol flavor, the precursor medicinal liquid, standby;
By the weight of final pharmaceutical formulation, take by weighing the chemical antifungal drug of 0.001～3 weight % and the precursor medicinal liquid of other auxiliary element and above-mentioned preparation, prepare various preparations by different process.
6. according to the described pharmaceutical formulation of claim 1-5, it is characterized in that this pharmaceutical formulation is one group of pharmaceutical preparation that is exclusively used in the treatment tinea.
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| CNA2007100452225A CN101371889A (en) | 2007-08-24 | 2007-08-24 | A set of medicament prescription for treating skin tinea and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920103A (en) * | 2016-06-23 | 2016-09-07 | 施建有 | External spray for treating dermatophytosis and preparation method thereof |
| CN107441127A (en) * | 2017-09-01 | 2017-12-08 | 骆凌翔 | The compound effacement emulsion of suppression oxygen orientation medicine transdermal chronic disease one again |
| CN110898151A (en) * | 2019-12-20 | 2020-03-24 | 卓和药业集团有限公司 | A pharmaceutical composition for treating dermatophyte infection, and its preparation method |
| CN117180343A (en) * | 2023-09-19 | 2023-12-08 | 上海中医药大学附属岳阳中西医结合医院 | Traditional Chinese medicine composition for treating dermatophytosis and application thereof |
-
2007
- 2007-08-24 CN CNA2007100452225A patent/CN101371889A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920103A (en) * | 2016-06-23 | 2016-09-07 | 施建有 | External spray for treating dermatophytosis and preparation method thereof |
| CN107441127A (en) * | 2017-09-01 | 2017-12-08 | 骆凌翔 | The compound effacement emulsion of suppression oxygen orientation medicine transdermal chronic disease one again |
| CN110898151A (en) * | 2019-12-20 | 2020-03-24 | 卓和药业集团有限公司 | A pharmaceutical composition for treating dermatophyte infection, and its preparation method |
| CN117180343A (en) * | 2023-09-19 | 2023-12-08 | 上海中医药大学附属岳阳中西医结合医院 | Traditional Chinese medicine composition for treating dermatophytosis and application thereof |
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