CN108066460B - A preparation for treating dermatomycosis - Google Patents
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K2236/30—Extraction of the material
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention belongs to the technical field of medicines, and discloses a preparation for treating dermatophytosis, which is prepared from the following raw materials: fenticonazole nitrate, dried orange peel extract and giant knotweed rhizome extract. The preparation of the invention can effectively treat skin infection of various fungi.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a preparation for treating dermatomycosis.
Background
Dermatophytosis, also known as fungal dermatosis, refers to a large group of infectious diseases of human skin and skin appendages such as mucous membranes, hair and nails caused by pathogenic fungi. Is a superficial fungal infectious disease caused by dermatophyte invading the epidermis. Clinically, the blister is mostly in the form of blister scales, the damage is mostly limited to one side, small blisters are generated at the beginning, the number of the small blisters is different, the blister liquid desquamates after being dried, the range is gradually enlarged, the skin at the position of desquamation for a long time is rough and thickened, the skin lines are wide and deep, the normal luster and the flexibility are lost, and the feeling of coarse sand is felt when the skin is touched.
Fenticonazole nitrate, the English chemical name 1- [2- (2, 4-dichlorphenyl) -2- [ [4- (phenylthio) phenyl ] methoxy ] ethyl-1H-imidozole monate. The name of Chinese culture is 1- [2- (2,4-dichlorophenyl) -2- [ [4- (benzenethio) phenyl ] methoxy ] ethyl-1H-imidazole nitrate; the molecular formula is C24H20Cl2N2 OS. HNO 3.
Fenticonazole nitrate is an imidazole broad-spectrum antifungal agent used for treating superficial fungal and vaginal candidiasis infections. The drug was approved for marketing in Italy in 1986, and the dosage forms include cream, spray and pessary. The action mechanism is that the phospholipid of the cell wall of the fungus cell is in an unstable state by inhibiting the hydroxylation of cytochrome P-450 of the fungus cell, so that the fungus cell is broken and necrotized, however, the medicine is easy to stop taking the medicine repeatedly, and the treatment and recovery time is long. The results are also unsatisfactory in terms of the near and far term efficacy achieved. And can cause certain toxic and side effects, such as renal toxicity, hepatotoxicity and the like, and can also induce the generation of drug resistance. The inventor's prior patent technology ' CN104623252A, a compound fenticonazole nitrate preparation and application thereof ' adopts a mode of combining Chinese and western medicines, reduces fenticonazole nitrate and reduces toxic and side effects, but the preparation adopts more Chinese herbal medicine components and increases the cost, and once one or more of the raw material medicines are in failure, the preparation cannot be produced, thereby bringing huge loss to enterprises.
The pericarpium Citri Tangerinae is dry mature pericarp of Rutaceae plant fructus Citri Tangerinae and its cultivar, and pericarpium Citri Tangerinae extract contains abundant volatile oil and flavonoids, and has effects of resisting oxidation, eliminating free radical and inhibiting bacteria. Rhizoma Polygoni Cuspidati is dried rhizome and root of Polygonum cuspidatum of Polygonaceae, contains abundant saponin and flavonoids, and has antiseptic, antibacterial and antiviral effects.
Disclosure of Invention
In order to overcome the drawbacks of the prior art, the present invention provides a formulation for the treatment of dermatophytosis.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a preparation for treating dermatomycosis is prepared from the following raw materials: fenticonazole nitrate, dried orange peel extract and giant knotweed rhizome extract.
The compound is prepared from the following raw materials:
10g of fenticonazole nitrate, 10g of dried orange peel extract, 10g of giant knotweed rhizome extract, 40725 g of poloxamer, 18815 g of poloxamer, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of disodium ethylenediamine tetraacetic acid and 470g of distilled water.
Further, the preparation method of the preparation comprises the following steps:
heating fenticonazole nitrate, pericarpium citri reticulatae extract, polygonum cuspidatum extract, poloxamer 407, poloxamer 188 and glycerol to 65 ℃, and stirring at 100rpm for 10min under the condition of heat preservation to obtain a component A;
dissolving sodium benzoate and disodium ethylene diamine tetraacetate in distilled water, adding carbomer and propylene glycol to fully dissolve, and uniformly mixing to obtain a component B;
and (3) uniformly mixing the component A and the component B to obtain the composition.
Further, the air conditioner is provided with a fan,
the preparation method of the dried orange peel extract comprises the following steps:
taking pericarpium citri reticulatae, crushing, sieving with a 200-mesh sieve to obtain pericarpium citri reticulatae powder, placing the pericarpium citri reticulatae powder in a reaction kettle, adding 85% ethanol which is five times of the weight of the pericarpium citri reticulatae powder for leaching for three times, each time for 6 hours, combining leaching liquor obtained in the three times, concentrating under reduced pressure until no alcohol exists, and finally freezing and drying at low temperature to obtain the pericarpium citri reticulatae extract.
Further, the air conditioner is provided with a fan,
the preparation method of the giant knotweed extract comprises the following steps:
pulverizing rhizoma Polygoni Cuspidati, sieving with 100 mesh sieve, performing high-voltage pulse electric field treatment, adding into 70% ethanol with weight of five times, heating to 50 deg.C, stirring and extracting at 100rpm under heat preservation for 2 hr, filtering, collecting filtrate, distilling the filtrate under reduced pressure until ethanol is removed, and vacuum freeze drying to obtain rhizoma Polygoni Cuspidati extract.
Preferably, the first and second electrodes are formed of a metal,
the parameters of the high-voltage pulse electric field treatment are as follows: the electric field strength was 20kv/cm, the total treatment time was 200. mu.s, the pulse width was 4. mu.s, and the pulse frequency was 400 pps.
The invention mainly includes but is not limited to the following aspects:
according to the invention, through multi-factor analysis and specific tests, the compatibility of the extracts of the dried orange peel and the giant knotweed rhizome and the fenticonazole nitrate is found, the synergistic performance is good, the skin infection of various fungi can be effectively treated, the compatibility of various traditional Chinese medicines and the fenticonazole nitrate is avoided, the cost is low, the pharmacological action is relatively clear, and the production stagnation caused by the failure of one or more raw material medicines in a large number of raw material types is avoided; the dried orange peel is extracted by a simple ethanol extraction process, so that the dried orange peel is simple, and the extract contains flavone and volatile oil and has good antibacterial performance; the giant knotweed rhizome is extracted by high-voltage pulse electric field assisted ethanol, can obtain saponin and flavonoid substances with higher content, and has good antibacterial effect.
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the present application, the present invention will be described more clearly and completely below with reference to specific embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
A preparation for treating dermatomycosis is prepared from the following raw materials: fenticonazole nitrate, dried orange peel extract and giant knotweed rhizome extract;
the compound is prepared from the following raw materials:
10g of fenticonazole nitrate, 10g of dried orange peel extract, 10g of giant knotweed rhizome extract, 40725 g of poloxamer, 18815 g of poloxamer, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of disodium ethylenediamine tetraacetic acid and 470g of distilled water.
The preparation method comprises the following steps:
heating fenticonazole nitrate, pericarpium citri reticulatae extract, polygonum cuspidatum extract, poloxamer 407, poloxamer 188 and glycerol to 65 ℃, and stirring at 100rpm for 10min under the condition of heat preservation to obtain a component A;
dissolving sodium benzoate and disodium ethylene diamine tetraacetate in distilled water, adding carbomer and propylene glycol to fully dissolve, and uniformly mixing to obtain a component B;
and (3) uniformly mixing the component A and the component B to obtain the composition.
The preparation method of the dried orange peel extract comprises the following steps:
taking pericarpium citri reticulatae, crushing, sieving with a 200-mesh sieve to obtain pericarpium citri reticulatae powder, placing the pericarpium citri reticulatae powder in a reaction kettle, adding 85% ethanol which is five times of the weight of the pericarpium citri reticulatae powder for leaching for three times, each time for 6 hours, combining leaching liquor obtained in the three times, concentrating under reduced pressure until no alcohol exists, and finally freezing and drying at low temperature to obtain a pericarpium citri reticulatae extract;
the preparation method of the giant knotweed extract comprises the following steps:
crushing giant knotweed rhizome, sieving with a 100-mesh sieve, performing high-voltage pulse electric field treatment, adding the giant knotweed rhizome into 70% ethanol with the weight of five times of the giant knotweed rhizome, heating to 50 ℃, stirring and extracting for 2 hours at 100rpm under the condition of heat preservation, filtering and collecting filtrate, performing reduced pressure distillation on the filtrate until no ethanol exists, and performing vacuum freeze drying to obtain a giant knotweed rhizome extract; the parameters of the high-voltage pulse electric field treatment are as follows: the electric field strength was 20kv/cm, the total treatment time was 200. mu.s, the pulse width was 4. mu.s, and the pulse frequency was 400 pps.
Comparative example 1
A preparation for treating dermatomycosis is prepared from the following raw materials:
10g of fenticonazole nitrate, 40725 g of poloxamer, 18815 g of poloxamer, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of disodium ethylenediamine tetraacetic acid and 490g of distilled water.
The preparation method comprises the following steps:
heating fenticonazole nitrate, poloxamer 407, poloxamer 188 and glycerol to 65 ℃, and stirring at 100rpm for 10min under the condition of heat preservation to obtain a component A;
dissolving sodium benzoate and disodium ethylene diamine tetraacetate in distilled water, adding carbomer and propylene glycol to fully dissolve, and uniformly mixing to obtain a component B;
and (3) uniformly mixing the component A and the component B to obtain the composition.
Comparative example 2
A preparation for treating dermatomycosis is prepared from the following raw materials: fenticonazole nitrate, dried orange peel extract;
the compound is prepared from the following raw materials:
10g of fenticonazole nitrate, 10g of dried orange peel extract, 40725 g of poloxamer, 18815 g of poloxamer, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of disodium ethylenediamine tetraacetic acid and 480g of distilled water.
The preparation method comprises the following steps:
heating fenticonazole nitrate, dried orange peel extract, poloxamer 407, poloxamer 188 and glycerol to 65 ℃, and stirring at 100rpm for 10min under the condition of heat preservation to obtain a component A;
dissolving sodium benzoate and disodium ethylene diamine tetraacetate in distilled water, adding carbomer and propylene glycol to fully dissolve, and uniformly mixing to obtain a component B;
and (3) uniformly mixing the component A and the component B to obtain the composition.
The preparation method of the dried orange peel extract comprises the following steps:
taking pericarpium citri reticulatae, crushing, sieving with a 200-mesh sieve to obtain pericarpium citri reticulatae powder, placing the pericarpium citri reticulatae powder in a reaction kettle, adding 85% ethanol which is five times of the weight of the pericarpium citri reticulatae powder for leaching for three times, each time for 6 hours, combining leaching liquor obtained in the three times, concentrating under reduced pressure until no alcohol exists, and finally freezing and drying at low temperature to obtain the pericarpium citri reticulatae extract.
Comparative example 3
A preparation for treating dermatomycosis is prepared from the following raw materials: fenticonazole nitrate, giant knotweed rhizome extract;
the compound is prepared from the following raw materials:
10g of fenticonazole nitrate, 10g of giant knotweed rhizome extract, 40725 g of poloxamer, 18815 g of poloxamer, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of disodium ethylenediamine tetraacetic acid and 480g of distilled water.
The preparation method comprises the following steps:
heating fenticonazole nitrate, polygonum cuspidatum extract, poloxamer 407, poloxamer 188 and glycerol to 65 ℃, and stirring at 100rpm for 10min under the condition of heat preservation to obtain a component A;
dissolving sodium benzoate and disodium ethylene diamine tetraacetate in distilled water, adding carbomer and propylene glycol to fully dissolve, and uniformly mixing to obtain a component B;
and (3) uniformly mixing the component A and the component B to obtain the composition.
The preparation method of the giant knotweed extract comprises the following steps:
crushing giant knotweed rhizome, sieving with a 100-mesh sieve, performing high-voltage pulse electric field treatment, adding the giant knotweed rhizome into 70% ethanol with the weight of five times of the giant knotweed rhizome, heating to 50 ℃, stirring and extracting for 2 hours at 100rpm under the condition of heat preservation, filtering and collecting filtrate, performing reduced pressure distillation on the filtrate until no ethanol exists, and performing vacuum freeze drying to obtain a giant knotweed rhizome extract; the parameters of the high-voltage pulse electric field treatment are as follows: the electric field strength was 20kv/cm, the total treatment time was 200. mu.s, the pulse width was 4. mu.s, and the pulse frequency was 400 pps.
Example 2
Toxicological study
First, acute toxicity test
40 rabbits were randomly divided into 4 groups of 10 rabbits each, each half of male and female, and the backs of the rabbits were depilated with 10% sodium sulfide, and the depilated area diameter was 4 cm. The preparation of the damaged skin adopts a sterilized iron file to cut (by taking blood seepage as a degree), 0.1, 0.5, 1.0 and 2.0ml of the preparation of the invention are respectively coated on a depilated area after hair removal and fixed by a non-irritant adhesive plaster, each animal is raised in cages, 1, 24, 48 and 72 hours to the seventh day after 24 hours of administration, the changes of the weight, fur, luster, diet, eyes and mucosa of the animal, the activities and the death conditions of the respiratory center, nervous system and four limbs are observed and recorded every day, and the rabbit is killed after seven days, and the changes of the organs such as the heart, the liver, the spleen, the lung, the kidney and the like are observed in an anatomical mode.
As a result: the preparation prepared by the invention has no adverse effect on the behaviors, activities, diet, fur luster, respiratory center, nervous system and body weight of the rabbits with damaged skin, and no rabbit dies. Seven days later, the rabbit was sacrificed, and no obvious abnormality was observed in the main organs such as heart, liver, spleen, lung, kidney, etc. by anatomical observation.
Second, irritation test
The research result shows that: the preparation has no irritation to normal and damaged skin of rabbits; the preparation of the invention has no sensitization effect on guinea pigs when being applied topically to the skin.
Example 3
1. Antifungal test:
adding 1ml of bacterial liquid (containing 100 ten thousand bacteria) into 10ml of liquid culture medium (containing different concentrations of drugs) with different concentrations in each tube, shaking uniformly, placing in an incubator for culturing for 72h, and observing the result. The broth is clear and the same as the control tube, so that the broth has an antibacterial effect; turbid broth, or biofilm growth, is considered to be non-bacteriostatic. The test strains are Candida albicans and Torulopsis glabrata respectively. The test drugs are example 1 and comparative examples 1 to 3, respectively; three parallel experiments are set for averaging, and the minimum inhibitory concentration (mg/L) of each group is shown in table 1:
TABLE 1
| Group of | Example 1 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
| Candida albicans | 3.15 | 6.32 | 4.51 | 5.03 |
| Torulopsis glabrata | 6.19 | 11.27 | 8.97 | 7.66 |
And (4) conclusion: the comparison shows that the minimum inhibitory concentration of the comparative example 1 is the highest, and the minimum inhibitory concentrations of the group of the example 1 to Candida albicans and the group of the Torulopsis glabrata are lower than those of the comparative examples 1-3, so that the pericarpium citri reticulatae extract and the polygonum cuspidatum extract can be matched with fenticonazole nitrate for use, and the synergistic bactericidal performance is good.
2. Animal experiments:
160 healthy guinea pigs were selected and divided into four groups of 40 animals each. The left, middle and right sides of the back of guinea pigs were used as affected areas and treated with four different drugs, respectively; i.e. observing the natural growth and decay after fungal infection. The hair diameter of each guinea pig in each of the three affected areas on the back was about 2 cm; artificially infecting Trichophyton mentagrophytes by conventional method until local infection is obviously formed on day 5, and performing medicinal treatment. The dosage of each infected part is 0.1ml, the medicine is taken twice a day, the medicine is continuously taken for 2 weeks, and skin lesions are observed;
the evaluation criteria of clinical efficacy are: the cure is the regression of skin lesions, the fungus microscopic examination is continuous and secondary negative, and no relapse occurs after the medicine is stopped; the ineffectiveness is that the skin lesion is not faded away and the fungus microscopic examination is positive; the recurrence is that skin lesions appear in situ after one week after the clinical recovery is stopped, and the fungus is positive by microscopic examination. The four test drugs are example 1 and comparative examples 1-3, respectively; see table 2 specifically:
TABLE 2
| Group of | Example 1 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
| Cure (only) | 32 | 21 | 27 | 28 |
| Invalid (only) | 0 | 5 | 4 | 1 |
| Relapse (only) | 8 | 14 | 9 | 11 |
And (4) conclusion: compared with the comparative example 1, the cure rates of the example 1 and the comparative examples 2-3 are higher than that of the comparative example 1, wherein the cure rate of the example 1 is the highest; the inefficiency and recurrence rates of example 1 were the lowest, 0 and 20%, respectively, the inefficiency and recurrence rates of comparative example 1 were the highest, up to 12.5% and 35%, the inefficiency and recurrence rates of comparative example 2 were 10% and 22.5%, respectively, and the inefficiency and recurrence rates of comparative example 3 were 2.5% and 27.5%, respectively.
While the above data illustrate the embodiments of the present invention, it is not intended to limit the scope of the present invention, and it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present invention without inventive faculty.
Claims (1)
1. A preparation for treating dermatomycosis, which is prepared from the following raw materials:
10g of fenticonazole nitrate, 10g of dried orange peel extract, 10g of giant knotweed rhizome extract, 40725 g of poloxamer, 18815 g of poloxamer, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of disodium ethylenediamine tetraacetic acid and 470g of distilled water;
the preparation method of the preparation comprises the following steps:
1) mixing fenticonazole nitrate, pericarpium citri reticulatae extract, polygonum cuspidatum extract, poloxamer 407, poloxamer 188 and glycerol, heating to 65 ℃, and stirring at 100rpm for 10min under the condition of heat preservation to obtain a component A;
2) dissolving sodium benzoate and disodium ethylene diamine tetraacetate in distilled water, adding carbomer and propylene glycol to fully dissolve, and uniformly mixing to obtain a component B;
3) uniformly mixing the component A and the component B to obtain the composition;
the preparation method of the dried orange peel extract comprises the following steps:
taking pericarpium citri reticulatae, crushing, sieving with a 200-mesh sieve to obtain pericarpium citri reticulatae powder, placing the pericarpium citri reticulatae powder in a reaction kettle, adding 85% ethanol which is five times of the weight of the pericarpium citri reticulatae powder for leaching for three times, each time for 6 hours, combining leaching liquor obtained in the three times, concentrating under reduced pressure until no alcohol exists, and finally freezing and drying at low temperature to obtain a pericarpium citri reticulatae extract;
the preparation method of the giant knotweed extract comprises the following steps:
crushing giant knotweed rhizome, sieving with a 100-mesh sieve, performing high-voltage pulse electric field treatment, adding the giant knotweed rhizome into 70% ethanol with the weight of five times of the giant knotweed rhizome, heating to 50 ℃, stirring and extracting for 2 hours at 100rpm under the condition of heat preservation, filtering and collecting filtrate, performing reduced pressure distillation on the filtrate until no ethanol exists, and performing vacuum freeze drying to obtain a giant knotweed rhizome extract;
the parameters of the high-voltage pulse electric field treatment are as follows: the electric field strength was 20kv/cm, the total treatment time was 200. mu.s, the pulse width was 4. mu.s, and the pulse frequency was 400 pps.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1150026A (en) * | 1995-11-14 | 1997-05-21 | 随泽民 | External use arosol of giant knotweed rhizome for burn and scald |
| CN104587165A (en) * | 2015-01-12 | 2015-05-06 | 翔宇药业股份有限公司 | Preparation process of compound fenticonazole nitrate preparation |
-
2018
- 2018-02-08 CN CN201810127600.2A patent/CN108066460B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1150026A (en) * | 1995-11-14 | 1997-05-21 | 随泽民 | External use arosol of giant knotweed rhizome for burn and scald |
| CN104587165A (en) * | 2015-01-12 | 2015-05-06 | 翔宇药业股份有限公司 | Preparation process of compound fenticonazole nitrate preparation |
Non-Patent Citations (2)
| Title |
|---|
| 陈皮对浅部真菌的试管内抑菌实验及临床疗效观察;方玉复；等;《中国皮肤性病学杂志》;19971020;第11卷(第5期);275 * |
| 高压脉冲电场在提取天然产物中的应用;刘曦然；等;《食品工业》;20170120;第38卷(第1期);249-253 * |
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