CN105748436A - Paeonol niosome emulsifiable paste for external use and preparation method thereof - Google Patents
Paeonol niosome emulsifiable paste for external use and preparation method thereof Download PDFInfo
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Abstract
The invention relates to paeonol niosome emulsifiable paste. The paste is prepared by the following steps: paeonol, a nonionic surfactant, cholesterol and the like are used for preparing a niosome suspension by a self assembly mode; the suspension, paraffin, glyceryl monostearate, vaseline, propylene glycol, ethyl p-hydroxybenzoate and other auxiliary materials are used for preparing a niosome emulsion; the paste can be partially applied to skin, and can treat allergic dermatitis and eczema with skin whitening effects. The prepared niosomes have round forms, uniform particle size distribution, and high encapsulation efficiency. The paeonol niosome emulsifiable paste has good uniformity and stable properties, and in vitro rat and mouse skin experiment results prove that intracutaneous retention volume of medicaments is substantially increased with slow releasing effects. The partially applied position of the paeonol niosome emulsifiable paste has a high medicament utilization rate and substantial medicament reservoir slow releasing effects, and curative effects are improved.
Description
Technical field
The present invention relates to paeonol vesicle emulsion agent and preparation method thereof, as local skin medication, various scytitis, eczema can be treated and have the effect of whitening.
Background technology
Paeonol (paeonol, it is called for short Pae), also known as paeonol, mainly from Asclepiadaceae plant Radix Cynanchi Paniculati Cynanchumpaniculatum (Bunge) Kitagawa dry root or herb and Ranunculaceae Paeonia plant Paeonia suffruticosa PaeoniasuffruticosaAndr, Radix Paeoniae P.lactifloraPall. root bark extract the active component separated, bitter in the mouth, pungent, it is a kind of micromolecular phenolic compound, white acicular crystal, its molecular weight is 166.18, and molecular formula is C9H10O3, there is the multiple pharmacologically actives such as antiinflammatory, antiallergic, antibacterial, calm, hypnosis, analgesia.Paeonol percutaneous dosing, for the treatment of the disease such as eczema, allergic dermatitis, overcomes the shortcomings such as easily recurrence after classical hormonal class medicine drug withdrawal, side effect are big；Research in recent years finds that paeonol can suppress the activity of TYR enzyme in melanocyte and melanic generation, and mottle, skin pruritus, Corii Bovis seu Bubali etc. are had good therapeutical effect.But owing to its poorly water-soluble, fusing point are low, volatile and the shortcoming such as poor stability, limit its use and curative effect.Vesicle is the novel targeted drug-supplying system of the one grown up on liposome basis, vesicle and liposome belong to particle type drug-supplying system together, but vesicle has had both many advantages of liposome: biocompatibility, cellular affinity, non-immunogenicity etc., and have significantly through skin ability.Early-stage Study we applied for " PEGization paeonol nonionic surfactant vesicle and preparation method thereof ", number of patent application is 2014106864661, this patent efficiently solves that paeonol poorly water-soluble, fusing point be low, volatile and the shortcoming such as poor stability, based on this application, we will creatively imagine and be combined with conventional ointment by paeonol vesicle, be prepared into a kind of external paeonol vesicle emulsifiable paste.
Formula 1-1 paeonol structure formula
What ointment referred to that medicine and appropriate substrate are made a kind of easily coats the half of skin, mucosa or wound surface
Solid external application preparation.The substrate of ointment includes greasing base, water-soluble base, emulsion-type substrate.Its
The ointment that middle employing emulsion-type substrate is made is also called ointment.Emulsion-type substrate is to be borrowed by aqueous phase, oil phase
Emulsifying agent act on the semisolid matrix that uniform temperature is emulsified, oil-in-water type (O/W) can be divided into
With water-in-oil type (W/O) two class, profit, due to the Action of Surfactant of emulsifying agent, is all had certain affinity by emulsion-type substrate.Ointment mainly has protection wound surface, greasy skin and local therapeutic effects, it is possible to for symptoms such as subacute, chronic dermatosis and skin prurituss, but avoids for rotten to the corn, ulcer and suppurative wound surface.Emulsifiable paste Chinese medicine release penetrance is better, is compared to that greasing base is more easy to apply, cleans and skin is had protective effect.
The change of and people vision of life serious for global environmental pollution in recent years, all kinds of dermatosis sickness rate in each big city of China, relapse rate all present the trend of spreading unchecked, melanin deposition, dermatitis, eczema dermatosis are common clinical and frequently-occurring disease, the cause of disease of this type of disease is complicated, relates to many factors.At present dermatitis and eczema be there is no specific short.Therefore in conjunction with the vesicle ointment of vesicle Yu emulsifiable paste advantage, as dermatologic, there is significant high-efficiency low-toxicity feature, be remarkably improved the therapeutic effect of paeonol.
Summary of the invention
The present invention is directed to the existing external preparation of above reflection and treat dermopathic deficiency, with paeonol for model drug, advantage in conjunction with its pharmacological action, the preparation method providing a kind of vesicle emulsifiable paste being different from common external preparation, preparation including the preparation of paeonol vesicle and vesicle gel thereof, and verified by Animal skin, said preparation is conducive to attachment and the moistening on pharmaceutical through skin top layer, the permeability of skin is good, drug depot slow releasing medicine can be partially formed, persistently maintain the drug level that local is high, thus being conducive to improving bioavailability, reduce toxic and side effects, improve curative effect.The feature of vesicle emulsifiable paste is: bag can be made to be loaded in the drug transdermal speed in similar biofilm structure vesicle for local skin use and efficiency improves, and then strengthen the medicine enrichment at site of action, reduce toxic and side effects, significantly improve the deficiency of existing preparation, high-efficiency low-toxicity treatment Related Skin Diseases.
The purpose of the present invention is realized by techniques below measure:
1. paeonol vesicle emulsifiable paste prescription of the present invention is made up of following material: paeonol 10-25mg, Span6020-100mg, cholesterol 20-60mg, glycerol monostearate 5-10g, octadecanol 60-120g, white vaseline 100-150g, tween 80 20-40g, disodium hydrogen phosphate 0.5-1.0g, citric acid 0.5-1.0g, propylene glycol 80-120g, ethylparaben 2-5g, distilled water are appropriate.
2. the preparation method of paeonol vesicle emulsifiable paste of the present invention
Prepared by paeonol vesicle: be dissolved in organic solvent by paeonol, nonionic surfactant, membrane stabilizer, long circulating adjuvant and film additive, this organic solvent is selected from dichloromethane, chloroform, acetone, methanol, ethanol, ether, oxolane or isopropanol and combination in any thereof, then pass through vaporization at high temperature and remove organic solvent, and heating melts to constitute organic facies to (50 ± 2) DEG C；Being under 1000rpm stirring at rotating speed, organic facies be slowly at the uniform velocity expelled in 60mL aqueous phase, at (50 ± 2) DEG C, constant temperature stirring 2.5h, makes organic solvent volatilize completely, obtains paeonol vesicle.
Prepared by paeonol vesicle emulsifiable paste: weigh recipe quantity glyceryl monostearate, octadecanol, white vaseline are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80, disodium hydrogen phosphate, citric acid, propylene glycol, ethylparaben, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 600r/min, emulsifying temperature is 80 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.
Detailed description of the invention
Embodiment 1Paeonol vesicle emulsifiable paste, it consists of:
Paeonol 20mg, Span6080mg, cholesterol 20mg, DCP 20mg, water for injection 60mL, dehydrated alcohol 5mL, emulsification times 3h.The paeonol nonionic surfactant vesicle envelop rate that the method obtains is 46.66%, drug loading 6.67%；
Weigh glyceryl monostearate 5g, octadecanol 100g, white vaseline 100g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 20g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 100g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 80 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is fine and smooth uniformly, and granularity is less, water is oily not stratified.
Embodiment 2Paeonol vesicle emulsifiable paste, it consists of:
Paeonol 25mg, Span6080mg, cholesterol 20mg, DCP 10mg, water for injection 100mL, dehydrated alcohol 5mL, emulsification times 2h, the paeonol nonionic surfactant vesicle envelop rate that the method obtains is 46.90%, drug loading 8.69%；
Weigh glyceryl monostearate 5g, octadecanol 120g, white vaseline 100g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 20g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 100g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 60 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is fine and smooth uniformly, and granularity is less, water is oily not stratified.
Embodiment 3Paeonol nonionic surfactant vesicle, it consists of:
Paeonol 25mg, Span6090mg, cholesterol 30mg, DCP 10mg, water for injection 60mL, dehydrated alcohol 8mL, emulsification times 3h, the envelop rate of the paeonol nonionic surfactant vesicle that the method obtains is 63.26%, drug loading 10.2%；
Weigh glyceryl monostearate 5g, octadecanol 120g, white vaseline 100g are mixed and heated to 70 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 20g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 100g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 70 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 60 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is moderate, and granularity is less, water is oily not stratified.
Embodiment 4Paeonol nonionic surfactant vesicle, it consists of:
Paeonol 20mg, Span6080mg, cholesterol 40mg, DCP 10mg, water for injection 100mL, dehydrated alcohol 5mL, emulsification times 3h, the envelop rate of the paeonol nonionic surfactant vesicle that the method obtains is 43.26%, drug loading 5.77%；
Weigh glyceryl monostearate 5g, octadecanol 120g, white vaseline 120g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 25g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 120g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 60 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is fine and smooth uniformly, and granularity is less, water is oily not stratified.
Embodiment 5Paeonol nonionic surfactant vesicle, it consists of:
Paeonol 30mg, Span6080mg, cholesterol 20mg, DCP 10mg, water for injection 100mL, dehydrated alcohol 8mL, emulsification times 2.5h, the envelop rate of the paeonol nonionic surfactant vesicle that the method obtains is 63.86%, drug loading 13.7%；
Weigh glyceryl monostearate 5g, octadecanol 120g, white vaseline 120g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 25g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 120g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 60 DEG C, emulsifying 25 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is rarer, and granularity is less, water is oily not stratified.
Embodiment 6Paeonol nonionic surfactant vesicle, it consists of:
Paeonol 20mg, Span6080mg, cholesterol 30mg, DCP 20mg, water for injection 60mL, dehydrated alcohol 8mL, emulsification times 3h, the envelop rate of the paeonol nonionic surfactant vesicle that the method obtains is 49.86%, drug loading 6.65%；
Weigh glyceryl monostearate 5g, octadecanol 120g, white vaseline 120g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 25g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 120g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 1000r/min, emulsifying temperature is 60 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is rarer, and granularity is less, water is oily not stratified.
Embodiment 7Paeonol nonionic surfactant vesicle, it consists of:
Paeonol 30mg, Span6080mg, cholesterol 20mg, DCP 15mg, water for injection 60mL, dehydrated alcohol 8mL, emulsification times 2h, the envelop rate of the paeonol nonionic surfactant vesicle that the method obtains is 65.65%, drug loading 13.6%；
Weigh glyceryl monostearate 5g, octadecanol 120g, white vaseline 120g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 25g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 120g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 70 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is fine and smooth uniformly, and granularity is less, water is oily not stratified.
Embodiment 8Paeonol nonionic surfactant vesicle, it consists of:
Paeonol 10mg, Span6065mg, Span4055mg, cholesterol 120mg, DCP 25mg, water for injection 100mL, dehydrated alcohol 5mL, emulsification times 3h, the envelop rate of the paeonol nonionic surfactant vesicle that the method obtains is 74.34%, drug loading 5.27%；
Weigh glyceryl monostearate 5g, octadecanol 120g, white vaseline 120g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 25g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 120g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 80 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is fine and smooth uniformly, and granularity is less, water is oily not stratified.
Embodiment 9Paeonol nonionic surfactant vesicle, it consists of:
Paeonol 10mg, Span6055mg, Span4065mg, cholesterol 100mg, DCP 30mg, water for injection 100mL, dehydrated alcohol 5mL, emulsification times 4h, the envelop rate of the paeonol nonionic surfactant vesicle that the method obtains is 80.09%, drug loading 4.25%；
Weigh glyceryl monostearate 5g, octadecanol 100g, white vaseline 120g are mixed and heated to 80 DEG C and are molten into oil phase；Separately weigh recipe quantity tween 80 25g, disodium hydrogen phosphate 0.5g, citric acid 0.5g, propylene glycol 80g, ethylparaben 3g, purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, speed of agitator is 800r/min, emulsifying temperature is 60 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continue stirring, it is down to 25 DEG C to temperature, detection, fill, packaging, to obtain final product.The vesicle emulsifiable paste mastic that the method obtains is fine and smooth uniformly, and granularity is less, water is oily not stratified.
Claims (7)
1. a paeonol vesicle emulsifiable paste, it is characterized in that: this vesicle emulsifiable paste is the vesicle suspension to wrap load paeonol, and Tween 80, paraffin, glyceryl monostearate, white vaseline, propylene glycol, ethylparaben, octadecanol, citric acid are that raw material is made.
2. paeonol vesicle emulsifiable paste according to claim 1, this vesicle emulsifiable paste is made up of following material:
Paeonol vesicle suspension containing paeonol 0.3-0.8g
Glyceryl monostearate 5-10g
Octadecanol 60-120g
White vaseline 100-150g
Tween 80 20-40g
Disodium hydrogen phosphate 0.5-1.0g
Citric acid 0.5-1.0g
Propylene glycol 80-120g
Ethylparaben 2-5g
Distilled water adds to 1000g.
3. paeonol vesicle emulsifiable paste according to claim 1, wherein paeonol vesicle suspension is made up of following material:
Paeonol 15-30mg
Nonionic surfactant 60-100mg
Membrane stabilizer 20-50mg
Film additive 20-50mg
Water for injection adds in right amount.
4. paeonol vesicle emulsifiable paste according to claim 3, it is characterized in that: described nonionic surfactant includes the fatty acid ester (fatty acid Pyrusussuriensis is smooth, i.e. Span class) of 1. anhydro sorbitol；2. the fatty acid ester (Polysorbate, i.e. Tween class) of polyethenoxy sorbitan；3. polyoxyethylene aliphatic alcohol ether (i.e. Brij class)；4. the amphipathic nature block polymer synthesized.
5. paeonol nonionic surfactant vesicle according to claim 1, its described membrane stabilizer is cholesterol, adds cholesterol and primarily serves the effect of membrane stabilizer, generally this effect is construed to filling effect in vesicle；Biomembranous mobility can not form too by force vesicle, after adding cholesterol, it is possible to significantly inhibits the motion of hydrocarbon chain in nonionic surfactant, reduces the mobility of film；Can also effectively prevent vesicle from being changed to liquid crystal state by glue crystalline state simultaneously, improve the stability of film and the retention rate of medicine, reduce the leakage of medicine and then improve slow release and the targeting of medicine.
6. paeonol vesicle according to claim 3, its described film additive is DCP, it is that a kind of negative charge derivant joins in vesicle system, because of the impact of charge repulsion between itself and nonionic surfactant, can effectively stop the gathering of vesicle, ensure integrity and the homogeneity of vesicle, and then can substantially reduce cell permeability, improve the physical stability of film and the spacing of multicell bi-layer membrane.
7. paeonol nonionic surfactant vesicle according to claim 1, it is through the following steps that prepare:
(1) vesicle is first prepared
Precision weighs paeonol 20mg, membrane stabilizer 20mg, film additive 40mg, long circulating adjuvant 30mg are dissolved in the dehydrated alcohol of 8mL, and heating in water bath constitutes organic facies to (50 ± 2) DEG C；It is under 1000rpm stirring at rotating speed, by organic facies fast injection to 60mL aqueous phase, constant temperature stirring 2.5h at (50 ± 2) DEG C, make organic solvent volatilize completely, obtain PEGization paeonol nonionic surfactant vesicle；
Prepare vesicle emulsifiable paste
Weigh recipe quantity glyceryl monostearate, octadecanol, white vaseline are mixed and heated to 80 DEG C and are molten into oil
Phase；Separately weigh recipe quantity tween 80, disodium hydrogen phosphate, citric acid, propylene glycol, ethylparaben,
Purified water, mixing, dissolving, aqueous phase as aqueous phase, is slowly added in oil phase to 80 DEG C by heating, and stirring turns
Speed is 600r/min, and emulsifying temperature is 80 DEG C, emulsifying 20 minutes, adds synthermal paeonol vesicle suspension in time being cooled to 45 DEG C, continues stirring, is down to 25 DEG C to temperature, obtains paeonol vesicle emulsifiable paste.
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| CN109498679A (en) * | 2018-12-27 | 2019-03-22 | 佛山科学技术学院 | A kind of compound Chinese medicinal preparation and preparation method thereof for treating eczema |
| CN114010554A (en) * | 2021-11-04 | 2022-02-08 | 安徽德正堂药业有限公司 | Sustained-release microcapsule wrapping traditional Chinese medicine extract and preparation method and application thereof |
| CN114767559A (en) * | 2022-05-14 | 2022-07-22 | 江苏华汀生物科技股份有限公司 | Azelaic acid liposome whitening cream and preparation method thereof |
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| CN109091482B (en) * | 2018-10-25 | 2020-04-17 | 闫玮钰 | Ointment for treating papular urticaria |
| CN109498679A (en) * | 2018-12-27 | 2019-03-22 | 佛山科学技术学院 | A kind of compound Chinese medicinal preparation and preparation method thereof for treating eczema |
| CN114010554A (en) * | 2021-11-04 | 2022-02-08 | 安徽德正堂药业有限公司 | Sustained-release microcapsule wrapping traditional Chinese medicine extract and preparation method and application thereof |
| CN114010554B (en) * | 2021-11-04 | 2023-11-24 | 安徽德正堂药业有限公司 | Sustained-release microcapsule for wrapping traditional Chinese medicine extract and preparation method and application thereof |
| CN114767559A (en) * | 2022-05-14 | 2022-07-22 | 江苏华汀生物科技股份有限公司 | Azelaic acid liposome whitening cream and preparation method thereof |
| CN114767559B (en) * | 2022-05-14 | 2024-05-10 | 江苏亨瑞生物医药科技有限公司 | Azelaic acid liposome whitening cream and preparation method thereof |
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