CN106924178A - A kind of Oxiconazole Nitrate nanometer emulsifiable paste and preparation method thereof - Google Patents
A kind of Oxiconazole Nitrate nanometer emulsifiable paste and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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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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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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Abstract
The invention provides a kind of Oxiconazole Nitrate nanometer emulsifiable paste, this nanometer of emulsifiable paste includes Oxiconazole Nitrate nano-emulsion and gel-type vehicle.Take Oxiconazole Nitrate, glycerine and tromethamine to be dissolved in distilled water, obtain water phase；Taking ethylparaben, vitamine C palmitate and Xin Kui acid glycerides, lecithin and vitamin E obtain oil phase again；To be sheared with dispersion machine under water phase and oil phase water bath condition, colostrum is obtained, then use nanometer homogenizer；Take in Hydroxypropyl methylcellulose, sodium carboxymethylcellulose addition distilled water, make it fully swelling；Finally Oxiconazole Nitrate nano-emulsion and gel-type vehicle are stirred and evenly mixed, finally prepared Oxiconazole Nitrate nanometer emulsifiable paste.Oxiconazole Nitrate is made nano-emulsion by the present invention so that medicine has good dispersiveness and permeability in itself, then is made gel preparation, improves the adhesiveness to epidermis, uniform application, and be readily cleaned.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of Oxiconazole Nitrate nanometer emulsifiable paste and preparation method thereof.
Background technology
Oxiconazole Nitrate (Oxiconazole nitrate) is imidazoles broad-spectrum antifungal medicine of new generation, in nineteen eighty-three
In Switzerland, listing is applied to clinic first, and subsequent its medicinal external emulsifiable paste agent, lotion are in the multinational listing such as the U.S., Britain, Japan.Mesh
Before, clinically it is mainly used in tinea pedis, jock itch, caused by being infected because of red trichophyta, sycosis trichophyte or acrothesium floccosum
Ringworm of the body, because of the treatment of the superficial mycosis diseases such as the pityriasis caused by the small Bacillus of chaff rash.
The growth that Oxiconazole Nitrate suppresses fungi is relevant with the synthesis of ergosterol is prevented：Ergosterol is fungal cell
The main constituents of film, mobility, asymmetry, integrality to cell membrane etc. all have a major impact；Oxiconazole Nitrate
Suppress the synthesis of ergosterol by suppressing P-450DM, cause the destruction of fungal cell membrane 26S Proteasome Structure and Function, so as to play anti-
Bacterium, bactericidal action.In recent years, Oxiconazole Nitrate is widely studied and application with the antifungal activity of its efficient, wide spectrum.
Nosomycosis can be divided into according to infection aspect：Superficial infection, subcutaneous infection and general infection, wherein, superficial fungi sense
Dye is most commonly seen in clinic skin disease.Superficial fungal infection, also known as superficial mycoses, refers to invade skin, hair by dermatophyte
Hair and toenail, the class disease caused by the parasitic or saprophytic keratin tissue in epidermal keratinocytes, hair and deck.Superficial mycosis
The sick incidence of disease is high, and with certain infectiousness, therefore its prevalence is quite wide, spreads over regions of the world, is also common in China
Frequently-occurring disease.Ringworm of the body, jock itch, tinea of feet and hands and pityriasis etc. are clinically common pathogenic fungi of superficial mycosis, and its infection and fungi are rich
Collection position focuses primarily upon skin epidermis, and unimpinged to corium and hypodermis.Therefore, with the targeting of local epidermis
Treatment of the external preparation to such disease has positive meaning, and the treatment of superficial mycoses is carried out using such preparation, percutaneously gives
Medicine can rapidly, specifically reach disease sites and play curative effect after medicine, and clinical practice is with the obvious advantage.
Percutaneous dosing refers to be administered by skin surface, to reach a kind of method of administration of locally or systemically therapeutic action.
Suitable percutaneous drug administration preparation, can control the speed and degree of percutaneous penetration of drugs, can rapid, specific delivering after it is administered
Curative effect is played to superficial infection site, with certain targeting meaning；Simultaneously as drug targeting is enriched in epidermis, so that
Make its less or hardly penetrate into skin corium, it is to avoid medicine is further absorbed into entirely after penetrating into cortex by the way that capillary is rapid
Body is circulated, and reduces the toxic and side effect as caused by systemic Absorption and adverse reaction, improves the safely, effectively and clinical of medication
Compliance.Therefore, treatment of such percutaneous drug administration preparation to superficial mycoses has great clinical practice advantage and prospect.
But, the Oxiconazole Nitrate emulsifiable paste in currently existing technology focuses primarily upon epidermis in actual use, difficult
To penetrate into skin corium so that medicine is difficult to play effectiveness, due to epidermis gather also so that sensitive group be relatively also easy to produce it is bad anti-
Should.
The content of the invention
It is an object of the invention to provide a kind of Oxiconazole Nitrate nanometer emulsifiable paste and preparation method thereof.
To reach above-mentioned purpose, the concrete technical scheme that the present invention takes is：
A kind of Oxiconazole Nitrate nanometer emulsifiable paste, this nanometer of emulsifiable paste includes Oxiconazole Nitrate nano-emulsion and gel-type vehicle.
The Oxiconazole Nitrate nano-emulsion includes Oxiconazole Nitrate, 1-3% glycerine and the 0.1-0.4% ammonia of 4-8%
Butantriol, 0.1-0.3% ethylparabens, 0.02-0.05% vitamine C palmitates and the pungent certain herbaceous plants with big flowers acid glycerides of 10-20%, 2-
The vitamin E of 5% lecithin and 0.1-0.3%.
The gel-type vehicle includes Hydroxypropyl methylcellulose, the sodium carboxymethylcellulose of 0.5-2% of percentage 2-6%.
The preparation method of the Oxiconazole Nitrate nano-emulsion is：Oxiconazole Nitrate, glycerine and tromethamine are taken first
It is dissolved in distilled water, stirring is completely dissolved to Oxiconazole Nitrate, obtains water phase；Taking ethylparaben, vitamin C palmitic acid again
Ester and Xin Kui acid glycerides, lecithin and vitamin E accelerate stirring well mixed to solution, obtain oil phase；By water phase and oil
Sheared with dispersion machine under phase water bath condition, colostrum is obtained, then use nanometer homogenizer, it is standby after room temperature cooling.
Wherein, be the Oxiconazole Nitrate of 4-8% by mass percent, 1-3% glycerine and 0.1-0.4% tromethamines it is molten
In 100-140mL distilled water, stirred under 60-80 DEG C of water bath condition.
It is 0.1-0.3% ethylparabens, 0.02-0.05% vitamine C palmitates and 10-20% by mass percent
The vitamin E of pungent certain herbaceous plants with big flowers acid glyceride, 2-5% lecithin and 0.1-0.3% accelerates stirring to solution in 60-80 DEG C of water bath condition
It is well mixed.
Water phase and oil phase are sheared under 60-80 DEG C of water bath condition with dispersion machine, 12000-15000r/min, 8-10min,
Colostrum is obtained；Circulated 1-2 weeks with nanometer homogenizer 100-120bar pressure again, 6-8 is circulated under 1 000-1200bar pressure
It is week, standby after room temperature cooling.
The preparation method of the gel-type vehicle：Take in Hydroxypropyl methylcellulose, sodium carboxymethylcellulose addition distilled water, make it
It is fully swelling, and adjust pH.
The specific preparation method of the gel-type vehicle：Take the Hydroxypropyl methylcellulose of mass percent 2-6%, 0.5-2%
Sodium carboxymethylcellulose is added in 80-120ml distilled water, and adds 95% ethanol of 5-10ml and the propane diols of 0.5-1ml,
Being sufficiently stirred for preventing and treating overnight makes it fully swelling, and adjusts pH for 4.5-6.5.
Finally by Oxiconazole Nitrate nano-emulsion and gel-type vehicle 5-8 in mass ratio：1, it is slowly stirred at ambient temperature
Mix, then 3-6min is processed under Ultrasonic Conditions, finally prepared Oxiconazole Nitrate nanometer emulsifiable paste.
Beneficial effects of the present invention are：Oxiconazole Nitrate is made nano-emulsion by the present invention so that medicine has good in itself
Good dispersiveness and permeability, then gel preparation is made, the adhesiveness to epidermis is improve, uniform application, and be readily cleaned.This
Invention has good epidermal permeability so that drug effect is given full play to, and reduces adverse reaction.It is prepared by the present invention
Nano-emulsion has selected lecithin and vitamin E, and good influence, and lecithin and Wei Sheng are generated for the emulsifying effectiveness of product
Plain E has preferable repairing effect for skin, reduces the invasive of medicine and other compositions to skin；Finally prepared in emulsifiable paste
Shi Jinhang ultrasonications so that nano-emulsion and gel can be mixed fully, further improve dispersiveness and stability.
Specific embodiment
Below by way of specific embodiment, the present invention is further described, is wrapped according to the modification that embodiment Spirit Essence is made
Containing within the scope of the present invention.
Embodiment 1：
(1) preparation of Oxiconazole Nitrate nano-emulsion：By Oxiconazole Nitrate that mass percent is 4%, 1% glycerine and
0.1% tromethamine is dissolved in 100mL distilled water, and stirring is completely dissolved under 60-80 DEG C of water bath condition, obtains water phase；Again by matter
Amount percentage be 0.1% ethylparaben, 0.02% vitamine C palmitate and 10% pungent certain herbaceous plants with big flowers acid glyceride, 2% lecithin with
And 0.1% vitamin E accelerates stirring well mixed to solution in 60-80 DEG C of water bath condition, obtains oil phase；By water phase and oil phase
Sheared with dispersion machine under 60-80 DEG C of water bath condition, 12000r/min, 8min, colostrum is obtained；Nanometer homogenizer 100bar is used again
Circulated 1 week under pressure, circulated 6 weeks under 1 000bar pressure, it is standby after room temperature cooling；
(2) preparation of gel-type vehicle：Take Hydroxypropyl methylcellulose, 0.5% sodium carboxymethylcellulose of mass percent 2%
In addition 80ml distilled water, and 95% ethanol of 5ml and the propane diols of 0.5ml are added, being sufficiently stirred for preventing and treating overnight fills it
Divide swelling, and adjust pH for 4.5-6.5；
(3) by Oxiconazole Nitrate nano-emulsion and gel-type vehicle in mass ratio 5：1, it is slowly stirred at ambient temperature mixed
It is even, then 3min is processed under Ultrasonic Conditions, Oxiconazole Nitrate nanometer emulsifiable paste is finally obtained.
Embodiment 2：
(1) preparation of Oxiconazole Nitrate nano-emulsion：By Oxiconazole Nitrate that mass percent is 8%, 3% glycerine and
0.4% tromethamine is dissolved in 140mL distilled water, and stirring is completely dissolved under 60-80 DEG C of water bath condition, obtains water phase；Again by matter
Amount percentage be 0.3% ethylparaben, 0.05% vitamine C palmitate and 20% pungent certain herbaceous plants with big flowers acid glyceride, 5% lecithin with
And 0.3% vitamin E accelerates stirring well mixed to solution in 60-80 DEG C of water bath condition, obtains oil phase；By water phase and oil phase
Sheared with dispersion machine under 60-80 DEG C of water bath condition, 15000r/min, 10min, colostrum is obtained；Nanometer homogenizer is used again
Circulated 2 weeks under 120bar pressure, circulated 8 weeks under 1200bar pressure, it is standby after room temperature cooling；
(2) preparation of gel-type vehicle：The Hydroxypropyl methylcellulose of mass percent 6%, 2% sodium carboxymethylcellulose is taken to add
In entering 120ml distilled water, and 95% ethanol of 10ml and the propane diols of 1ml are added, being sufficiently stirred for preventing and treating overnight makes its abundant
It is swelling, and pH is adjusted for 4.5-6.5；
(3) by Oxiconazole Nitrate nano-emulsion and gel-type vehicle in mass ratio 8：1, it is slowly stirred at ambient temperature mixed
It is even, then 6min is processed under Ultrasonic Conditions, Oxiconazole Nitrate nanometer emulsifiable paste is finally obtained.
Embodiment 3：
(1) preparation of Oxiconazole Nitrate nano-emulsion：By Oxiconazole Nitrate that mass percent is 6%, 2% glycerine and
0.3% tromethamine is dissolved in 120mL distilled water, and stirring is completely dissolved under 60-80 DEG C of water bath condition, obtains water phase；Again by matter
Amount percentage be 0.2% ethylparaben, 0.04% vitamine C palmitate and 15% pungent certain herbaceous plants with big flowers acid glyceride, 3% lecithin with
And 0.2% vitamin E accelerates stirring well mixed to solution in 60-80 DEG C of water bath condition, obtains oil phase；By water phase and oil phase
Sheared with dispersion machine under 60-80 DEG C of water bath condition, 14000r/min, 9min, colostrum is obtained；Nanometer homogenizer 119bar is used again
Circulated 1 week under pressure, circulated 7 weeks under 1100bar pressure, it is standby after room temperature cooling；
(2) preparation of gel-type vehicle：The Hydroxypropyl methylcellulose of mass percent 4%, 1% sodium carboxymethylcellulose is taken to add
In entering 100ml distilled water, and 95% ethanol of 8ml and the propane diols of 0.8ml are added, being sufficiently stirred for preventing and treating overnight makes its abundant
It is swelling, and pH is adjusted for 4.5-6.5；
(3) by Oxiconazole Nitrate nano-emulsion and gel-type vehicle in mass ratio 6：1, it is slowly stirred at ambient temperature mixed
It is even, then 4min is processed under Ultrasonic Conditions, Oxiconazole Nitrate nanometer emulsifiable paste is finally obtained.
Comparative example 1：
(1) preparation of Oxiconazole Nitrate nano-emulsion：By Oxiconazole Nitrate that mass percent is 6%, 2% glycerine and
0.3% tromethamine is dissolved in 120mL distilled water, and stirring is completely dissolved under 60-80 DEG C of water bath condition, obtains water phase；Again by matter
Amount percentage be 0.2% ethylparaben, 0.04% vitamine C palmitate and 15% pungent certain herbaceous plants with big flowers acid glyceride, 3% lecithin with
And 0.2% vitamin E accelerates stirring well mixed to solution in 60-80 DEG C of water bath condition, obtains oil phase；By water phase and oil phase
Sheared with dispersion machine under 60-80 DEG C of water bath condition, 14000r/min, 9min, colostrum is obtained；Nanometer homogenizer 119bar is used again
Circulated 1 week under pressure, circulated 7 weeks under 1100bar pressure, it is standby after room temperature cooling；
(2) preparation of gel-type vehicle：The Hydroxypropyl methylcellulose of mass percent 4%, 1% sodium carboxymethylcellulose is taken to add
In entering 100ml distilled water, and 95% ethanol of 8ml and the propane diols of 0.8ml are added, being sufficiently stirred for preventing and treating overnight makes its abundant
It is swelling, and pH is adjusted for 4.5-6.5；
(3) by Oxiconazole Nitrate nano-emulsion and gel-type vehicle in mass ratio 6：1, it is slowly stirred at ambient temperature mixed
It is even, Oxiconazole Nitrate nanometer emulsifiable paste is finally obtained.
Stability test, embodiment 1-3 and sample obtained in comparative example 1 are placed in one week in 50 DEG C and lighting box, test
PH and color change, as a result such as following table, and it can be seen from the results that embodiment 1-3 stability is higher than comparative example 1, that is, take
The stability of emulsifiable paste can be significantly improved after ultrasonication.
| Color | pH | |
| Embodiment 1 | It is colourless | 6.3 |
| Embodiment 2 | It is colourless | 6.4 |
| Embodiment 3 | It is colourless | 6.7 |
| Comparative example 1 | It is faint yellow | 6.0 |
Then clinical test, subject's selection are carried out：Selection has typical clinical symptom, and fungus microscope examination result is positive
Ringworm of the body patient 30 is made a definite diagnosis, two groups of A, B is divided into immediately：A groups 15 (male 7, women 8), the course of disease 2 months~3 years, averagely
1.1 years；B groups 15 (male 8, women 7), the course of disease -1 year 2 months, all patients do not apply other antifungal drugs.
The general commercially available Oxiconazole Nitrate emulsifiable paste of ringworm of the body A groups application is treated, and specially takes appropriate even application in trouble
Place, daily administration 2 times, is administered continuously two weeks, observes and record therapeutic effect；Make nitric acid in ringworm of the body B groups Application Example 2 by oneself difficult to understand
Former times health azoles nano-emulsion preparation is treated specially take appropriate even application in affected part, daily administration 2 times, is administered continuously two weeks,
Statistics curative effect, see the table below.By therapeutic effect it can also be seen that invention formulation is controlled compared with general Oxiconazole Nitrate emulsifiable paste
Therapeutic effect more preferably, also demonstrates its transdermal effect good.
| Cure | Better effects | General effect | It is invalid | |
| A groups | 10 | 1 | 1 | 3 |
| B groups | 12 | 2 | 1 | 0 |
The preferred embodiments of the present invention are the foregoing is only, is not intended to limit the invention, for the skill of this area
For art personnel, the present invention can have various modifications and variations.It is all within the spirit and principles in the present invention, made any repair
Change, equivalent, improvement etc., should be included within the scope of the present invention.
Claims (8)
1. a kind of Oxiconazole Nitrate nanometer emulsifiable paste, it is characterised in that this nanometer of emulsifiable paste include Oxiconazole Nitrate nano-emulsion and
Gel-type vehicle.
2. Oxiconazole Nitrate as claimed in claim 1 nanometer emulsifiable paste, it is characterised in that the Oxiconazole Nitrate nano-emulsion
Including Oxiconazole Nitrate, 1-3% glycerine and 0.1-0.4% tromethamines that mass percent is 4-8%, 0.1-0.3% Buddhist nun
The golden ethyl ester of pool, 0.02-0.05% vitamine C palmitates and the pungent certain herbaceous plants with big flowers acid glycerides of 10-20%, 2-5% lecithin and 0.1-
0.3% vitamin E.
3. Oxiconazole Nitrate as claimed in claim 1 nanometer emulsifiable paste, it is characterised in that the gel-type vehicle includes quality hundred
Divide than Hydroxypropyl methylcellulose, the sodium carboxymethylcellulose of 0.5-2% for 2-6%.
4. the preparation method of Oxiconazole Nitrate nanometer emulsifiable paste described in claim 1, it is characterised in that Oxiconazole Nitrate is received
The preparation method of rice milk is：Take Oxiconazole Nitrate, glycerine and tromethamine first to be dissolved in distilled water, stirring to nitric acid Austria's former times
Health azoles is completely dissolved, and obtains water phase；Again taking ethylparaben, vitamine C palmitate and Xin Kui acid glycerides, lecithin and
Vitamin E accelerates stirring well mixed to solution, obtains oil phase；To be sheared with dispersion machine under water phase and oil phase water bath condition, system
Colostrum is obtained, then uses nanometer homogenizer, it is standby after room temperature cooling；Take Hydroxypropyl methylcellulose, sodium carboxymethylcellulose and add distilled water
In, make it fully swelling, and adjust pH；Finally by Oxiconazole Nitrate nano-emulsion and gel-type vehicle 5-8 in mass ratio：1, in room
Mixing is slowly stirred under the conditions of temperature, then 3-6min is processed under Ultrasonic Conditions, finally prepared Oxiconazole Nitrate nanometer emulsifiable paste.
5. the preparation method of Oxiconazole Nitrate as claimed in claim 4 nanometer emulsifiable paste, it is characterised in that by mass percent
For the Oxiconazole Nitrate of 4-8%, 1-3% glycerine and 0.1-0.4% tromethamines are dissolved in 100-140mL distilled water, 60-80
Stirred under DEG C water bath condition.
6. the preparation method of Oxiconazole Nitrate as claimed in claim 4 nanometer emulsifiable paste, it is characterised in that by mass percent
It is 0.1-0.3% ethylparabens, 0.02-0.05% vitamine C palmitates and the pungent certain herbaceous plants with big flowers acid glycerides of 10-20%, 2-5% ovum
The vitamin E of phosphatide and 0.1-0.3% accelerates stirring well mixed to solution in 60-80 DEG C of water bath condition.
7. the preparation method of Oxiconazole Nitrate as claimed in claim 4 nanometer emulsifiable paste, it is characterised in that by water phase and oil phase
Sheared with dispersion machine under 60-80 DEG C of water bath condition, 12000-15000r/min, 8-10min, colostrum is obtained；It is equal with nanometer again
Circulated 1-2 weeks under matter machine 100-120bar pressure, circulated 6-8 weeks under 1 000-1200bar pressure, it is standby after room temperature cooling.
8. the preparation method of Oxiconazole Nitrate as claimed in claim 4 nanometer emulsifiable paste, it is characterised in that the gel-type vehicle
Specific preparation method：Take the Hydroxypropyl methylcellulose of mass percent 2-6%, the sodium carboxymethylcellulose of 0.5-2% and add 80-
In 120ml distilled water, and 95% ethanol of 5-10ml and the propane diols of 0.5-1ml are added, being sufficiently stirred for preventing and treating overnight makes it
It is fully swelling, and pH is adjusted for 4.5-6.5.
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| CN201710195010.9A CN106924178A (en) | 2017-03-29 | 2017-03-29 | A kind of Oxiconazole Nitrate nanometer emulsifiable paste and preparation method thereof |
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| CN201710195010.9A CN106924178A (en) | 2017-03-29 | 2017-03-29 | A kind of Oxiconazole Nitrate nanometer emulsifiable paste and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102423293B (en) * | 2011-01-28 | 2013-05-29 | 舒泰神（北京）生物制药股份有限公司 | Microemulsion gel preparation of oxiconazole nitrate |
| CN103655459A (en) * | 2013-12-19 | 2014-03-26 | 中国药科大学 | Multifunctional microemlusion gel preparation and preparation process thereof |
-
2017
- 2017-03-29 CN CN201710195010.9A patent/CN106924178A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102423293B (en) * | 2011-01-28 | 2013-05-29 | 舒泰神（北京）生物制药股份有限公司 | Microemulsion gel preparation of oxiconazole nitrate |
| CN103655459A (en) * | 2013-12-19 | 2014-03-26 | 中国药科大学 | Multifunctional microemlusion gel preparation and preparation process thereof |
Non-Patent Citations (4)
| Title |
|---|
| 何兰 等: "《化学药品对照品图谱集—核磁共振》", 31 December 2014 * |
| 侯秋飞 等: "超声诱导凝胶研究进展", 《有机化学》 * |
| 薛巍 等: "《生物医用水凝胶》", 31 December 2012, 暨南大学出版社 * |
| 陆彬: "《药物新剂型与新技术 第2版》", 30 July 2005, 人民卫生出版社 * |
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Application publication date: 20170707 |