CN106511269A - Curcumin nano suspension ophthalmic preparation and preparing method - Google Patents
Curcumin nano suspension ophthalmic preparation and preparing method Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention discloses a curcumin nano suspension ophthalmic preparation and a preparing method. The curcumin nano suspension ophthalmic preparation is a curcumin ophthalmic nano suspension preparation or a curcumin ophthalmic nano suspension gel and is prepared by adding an ophthalmic preparation pharmaceutic adjuvant in curcumin. The curcumin nano suspension ophthalmic preparation has the advantages that the solubility and dissolving-out speed of the curcumin are significantly improved, effective absorption of medicine is increased, residence time in an eye is extended, drug bioavailability is improved, and the curcumin nano suspension ophthalmic preparation can be used to treat the diseases such as a cataract. According to the gel, the residence time of the medicine in the eye can be extended, the number of administration times and the administration dosage can be reduced, the compliance of a patient is improved, and meanwhile the side effect of the medicine is reduced. The preparation method has a feasible process, controllable quality, and quite wide industrialization prospects.
Description
Technical field
The present invention relates to the medicine of ophthalmic diseasess, more particularly, to a kind of curcumin nano suspension ophthalmic preparation and preparation side
Method.
Background technology
Cataract is first place in the world blinding factor, while and the primary diseases causing blindness of China.Research shows white interior
Barrier occurs in evolution degree, free radical and relative oxidative stress be cause crystalline lenses physiological function to change, it is final
Cause cataractous hinge.
Curcumin is extracted from the rhizome of Zingiberaceae Curcuma (curcuma L.) plant Rhizoma Curcumae Longae, Rhizoma Curcumae, Radix Curcumae etc.
Natural constituent is planted, molecular formula is C21H20O6.Curcumin is poorly water soluble drugs, with unsaturated aliphatic and phenolic hydroxyl group, energy
Proton blocking free chain reaction, external anti-selenite induced catatract effect and wound of the existing document to curcumin crude drug are provided
Cataract effect is investigated, and as a result shows that curcumin can postpone the generation of selenite induced catatract, develop and suppress advanced low-grade
Traumatic cataract is formed.But, as curcumin stability is poor, dissolubility is little, vivo biodistribution availability is extremely low etc., limit
Curcumin being applied clinically and popularized in eye.How to improve curcumin disadvantages mentioned above, prepare bioavailability height, good patient compliance
Eye drip ophthalmic preparation, become the problem urgently to be resolved hurrily of pharmacy worker in recent years.
Nano suspension is not use any carrier, by pure drug particle under a small amount of stabilizer function high degree of dispersion
The submicron dispersion system of colloid formed in disperse medium, particle diameter is typically in 10-1000nm.Its specific surface area is big, medicine energy
Enough rapid dissolutions, the low problem of effectively solving drug solubility.
Gel for eye use has preferable biocompatibility often with hydrophilic high molecular material as carrier, is semi-solid preparation, can
Extend the action time of medicine, reduce administration number of times, can overcome that eye drop bioavailability is low, Eye ointments it is greasy it is not easy to apply with
And the shortcomings of suspensoid ophthalmic uncomfortable.
There is not yet curcumin nanosuspension and curcumin nano suspension gel are used for cataractous treatment.
The content of the invention
First purpose of the present invention is to provide a kind of dissolubility that can significantly improve curcumin, dissolution rate and increases medicine
Effective absorption of thing, prolongation eye holdup time, the Rhizoma Curcumae Longae improved drug bioavailability, can be used for the diseases such as treatment cataract
Plain nanometer suspension ophthalmic preparation.
Second object of the present invention is to provide a kind of preparation method of curcumin nano suspension ophthalmic preparation.
What first purpose of the present invention was realized in：
A kind of curcumin nano suspension ophthalmic preparation, is characterized in that：Curcumin nano suspension ophthalmic preparation is the ophthalmically acceptable nanometer of curcumin
Suspensoid or the ophthalmically acceptable nanometer suspension gel of curcumin.
A, curcumin nano suspension ophthalmic preparation are the ophthalmically acceptable nano suspension of curcumin：
Containing following component by weight in the ophthalmically acceptable nano suspension of 100mL curcumins：
Curcumin：0.05-10.0g；
Stabilizer：0.01-40.0g；
Osmotic pressure regulator：0.01-10.0g；
PH adjusting agent：0.01-2.0g；
Preservative：0.02-1.0g；
Antioxidant：0.01-5.0g；
Metal-chelator：0.001-0.1g
Balance of water for injection.
What the stabilizer was risen in the present invention is to form nanometer formulation and reach Stabilization, selected from following material, bag
Combination in any containing one or more in following material：Polysorbas20, polysorbate60, Tween 80, span 20, sorbester p17, Myrij 35,
Sodium laurylsulfate, sodium lauryl sulphate, lecithin, polyvinyl alcohol, polyvinylpyrrolidone, crosslinked polyethylene pyrrolidine
Ketone, vinyl pyrrolidone-vinyl acetate copolymer, ethylene-vinyl acetate copolymer, poloxamer, Polyethylene Glycol, methyl
Cellulose, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose, carbomer, sodium sulfite, Asia
Sodium bisulfate, sodium thiosulfate, edetic acid, edetate edetic acid, arabo-ascorbic acid and its sodium salt, thiourea, acrylic resin
One kind or any mixture in class, cellulose and its derivates, polyoxyethylene castor oil, tyloxapol.
The preferred poloxamer of the stabilizer, Tween 80, PVP K30, sodium carboxymethyl cellulose, acrylic acid
Resin RL100 and ethyl cellulose.
The osmotic pressure regulator is Sodium Chloride, Polyethylene Glycol, glycerol, glucose, sodium carbonate, sodium bicarbonate, phosphoric acid hydrogen
One or more in disodium, sodium dihydrogen phosphate, boric acid, Borax, Mannitol and Propylene Glycol.
The pH adjusting agent be NaOH, HCl, citric acid, triethanolamine, trishydroxymethylaminomethane, boric acid, sodium borate,
One or more in acetic acid and sodium acetate, sodium carbonate, sodium bicarbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate.
The preservative is thimerosal, sorbic acid, phenylmercuric acetate, Benzalkonii Chloridum, benzalkonium bromide, sodium benzoate, benzene oxygen second
One or more in alcohol, methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben and chlorobutanol.
The antioxidant is sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, thiourea, Vitamin E, dimension
One or more in raw element A, vitamin C and carotene.
The metal-chelator is ethylenediaminetetraacetic acid（Ethylene Diamine Tetraacetic Acid, EDTA）、
One or more in EDTA-2Na, EDTA-Ca and EDTA-2K.
Due to being ophthalmic preparation, to meet medicine preparation standard, the water is distilled water or water for injection.
B, curcumin nano suspension ophthalmic preparation are the ophthalmically acceptable nanometer suspension gel of curcumin：
Containing following component by weight in the ophthalmically acceptable nanometer suspension gel of 100mL curcumins：
Curcumin：0.1-20.0g；
Gel-type vehicle：0.2-20g；
Stabilizer：0.02-80.0g；
Osmotic pressure regulator：0.01-10.0g；
PH adjusting agent：0.01-2.0g；
Preservative：0.02-1.0g；
Antioxidant：0.01-5.0g；
Metal-chelator：0.001-0.1g；
Balance of water for injection.
What the stabilizer was risen in the present invention is to form nanometer formulation and reach Stabilization, selected from following material, bag
Combination in any containing one or more in following material：Polysorbas20, polysorbate60, Tween 80, span 20, sorbester p17, Myrij 35,
Sodium laurylsulfate, sodium lauryl sulphate, lecithin, polyvinyl alcohol, polyvinylpyrrolidone, crosslinked polyethylene pyrrolidine
Ketone, vinyl pyrrolidone-vinyl acetate copolymer, ethylene-vinyl acetate copolymer, poloxamer, Polyethylene Glycol, methyl
Cellulose, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose, carbomer, sodium sulfite, Asia
Sodium bisulfate, sodium thiosulfate, edetic acid, edetate edetic acid, arabo-ascorbic acid and its sodium salt, thiourea, acrylic resin
One kind or any mixture in class, cellulose and its derivates, polyoxyethylene castor oil, tyloxapol.
The stabilizer poloxamer, Tween 80, PVP K30, sodium carboxymethyl cellulose, acrylic resin
RL100 and ethyl cellulose.
The gel-type vehicle is gel rubber material and the blended use of thickening agent, and gel rubber material is selected from following material, comprising with
The combination in any of one or more in lower material：Poloxamer, shitosan, polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl
Methylcellulose, hydroxypropyl cellulose, methylcellulose, carboxymethyl cellulose, sodium alginate and its derivant, arabic gum,
It is tragcanth, guar gum, carbomer, phytohemagglutinin, hyaluronic acid, xanthan gum, shitosan, dextrin and derivant, transparent
Matter acid sodium, shitosan, sodium glycerophosphate, alginate, gellan gum, deacetylated gellan gum, carbopol, Polycarbophil, Tai Luo
Sha Bo.
The thickening agent is selected from following material, the combination in any comprising one or more in following material：Dextrin and spread out
Biological, sodium alginate and its derivant, polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl methyl cellulose (hypromellose
Element), hydroxypropyl cellulose, methylcellulose, carboxymethyl cellulose, arabic gum, tragcanth, guar gum, carbomer, plant
Thing agglutinin, hyaluronic acid, xanthan gum, shitosan, dextrin and derivant, tyloxapol.
The osmotic pressure regulator is Sodium Chloride, Polyethylene Glycol, glycerol, glucose, sodium carbonate, sodium bicarbonate, phosphoric acid hydrogen
One or more in disodium, sodium dihydrogen phosphate, boric acid, Borax, Mannitol and Propylene Glycol.
The pH adjusting agent be NaOH, HCl, citric acid, triethanolamine, trishydroxymethylaminomethane, boric acid, sodium borate,
One or more in acetic acid and sodium acetate, sodium carbonate, sodium bicarbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate.
The preservative is thimerosal, sorbic acid, phenylmercuric acetate, Benzalkonii Chloridum, benzalkonium bromide, sodium benzoate, benzene oxygen second
One or more in alcohol, methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben and chlorobutanol.
The antioxidant is sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, thiourea, Vitamin E, dimension
One or more in raw element A, vitamin C and carotene.
The metal-chelator is one or more in EDTA, EDTA-2Na, EDTA-Ca and EDTA-2K.
Due to being ophthalmic preparation, to meet medicine preparation standard, the water is distilled water or water for injection.
What second object of the present invention was realized in：
A kind of preparation method of curcumin nano suspension ophthalmic preparation, is characterized in that：Curcumin nano suspension ophthalmic preparation is Rhizoma Curcumae Longae
The ophthalmically acceptable nano suspension of element, preparation method are comprised the following steps：
（1）, stabilizer is dissolved in 100mL waters for injection in obtain stabiliser solution, then that curcumin is scattered in stabilizer is molten
In liquid, curcumin suspension is obtained；
（2）, to step（1）Gained curcumin suspension using high-speed shearing machine, dispersing emulsification machine, high pressure homogenizer, Probe Ultrasonic Searching or
Ball mill is processed, and curcumin nanosuspension is obtained；
（3）, in nano suspension add osmotic pressure regulator, pH adjusting agent, antioxidant, metal-chelator；
（4）, fill obtain final product the ophthalmically acceptable nano suspension of curcumin.
Or, a kind of preparation method of curcumin nano suspension ophthalmic preparation, is characterized in that：Curcumin nano suspension ophthalmic preparation
For the ophthalmically acceptable nanometer suspension gel of curcumin, preparation method is comprised the following steps：
（1）, stabilizer obtain stabiliser solution in being dissolved in 50-70mL waters for injection；Add curcumin to mix, obtain curcumin
Suspension；
（2）, to step（1）Gained curcumin suspension using high-speed shearing machine, dispersing emulsification machine, high pressure homogenizer, Probe Ultrasonic Searching or
Ball mill is processed, and curcumin nanosuspension A is obtained；
（3）, using surplus water for injection dissolving gel-type vehicle, stir, obtain gel-type vehicle aqueous solution B；
（4）, curcumin nanosuspension A and gel-type vehicle aqueous solution B mixed, add osmotic pressure regulator, pH adjusting agent, with
PH value and osmotic pressure are adjusted, metal-chelator, antioxidant, preservative is added, is added water for injection to 100mL, fill obtains final product Rhizoma Zingiberis Recens
The ophthalmically acceptable nanometer suspension gel of flavin.
The beneficial effect of the ophthalmically acceptable nano suspension of curcumin：Supplementary product kind and use contained by the ophthalmically acceptable nano suspension of the curcumin
Amount is less, and curcumin is the solid nanoparticles existed with certain crystal formation or unformed state；After eye drip use, can be
Conjunctiva is intracapsular and anterior corneal surface is detained the long period, while higher drug level is conducive to the cornea medicine that Concentraton gradient is relied on
Through, bioavailability is improved, extends action time, raising curative effect.Curcumin nano suspension ophthalmic preparation and common suspensoid
Compare, particle diameter is less, faster, ocular absorption speed and degree are just bigger, the ophthalmically acceptable system of curcumin nano suspension for drug-eluting speed
Drug particles in agent have larger surface area, have certain adhesion in eye, can improve the degree of absorption of medicine, extend
Action time.
The particle diameter of the ophthalmically acceptable nano suspension of curcumin can pass through the power and ultrasonic time and tune for changing Probe Ultrasonic Searching
The pressure and change cycle-index of section high pressure homogenize is adjusted.
The beneficial effect of the ophthalmically acceptable nanometer suspension gel of curcumin：Fully utilize the excellent of nano suspension and gel
Point, further improves the bioavailability of curcumin, greatly improves the compliance of patient.
It is an advantage of the current invention that：Significantly improve the dissolubility of curcumin, dissolution rate and increased the effective of medicine
Absorb, extend the eye holdup time, improve drug bioavailability, can be used to treat the diseases such as cataract, gel can
Extend retention time of the medicine in eye, reduce administration number of times and dosage, not only increase patient's compliance, while reducing
Side effects of pharmaceutical drugs.It is the formulation preparation method feasible process, quality controllable, there is boundless industrialization prospect.
Specific embodiment
For a better understanding of the present invention, present disclosure is further elucidated with reference to embodiment, but the present invention
Content is not limited solely to the following examples.
Embodiment 1-3：The ophthalmically acceptable nano suspension of curcumin
Note："/" is represented and is not added with.
The preparation method of the ophthalmically acceptable nano suspension of curcumin is as follows：
（1）Stabilizer is dissolved in 100mL waters for injection and obtains stabiliser solution, then medicine is scattered in into stabiliser solution
In；
（2）Using high speed shearing emulsification method, rotating speed is 16000rpm, shear time 6min, mean diameter is obtained left at 30 microns
Then above-mentioned just suspension is carried out high pressure homogenize, controls homogenizing temperature for 10 degrees Celsius by right first suspension, and homogenization is such as
Under：First in 200bar, 400bar, 600bar, 800bar circulation homogenizing 6 times, then circulate 20 times under 1000bar pressure, adjust
Section pH and osmotic pressure, obtain nanocrystal, add preservative, antioxidant, metal-chelator, fill to obtain final product.
Embodiment 4-7：The ophthalmically acceptable nanometer suspension gel of curcumin
Note："/" is represented and is not added with.
The preparation method of the ophthalmically acceptable nanometer suspension gel of curcumin, comprises the following steps：
（1）Stabilizer is dissolved in 50-70mL waters for injection and obtains stabiliser solution, then medicine is scattered in into stabiliser solution
In；
（2）Using ball mill, the use of zirconium oxide is abrasive media, 35Hz grindings 7 hours, taking-up preparation are filtered to remove grinding medium
Matter, is obtained nano suspension A；
（3）Using the water for injection dissolving gel-type vehicle of surplus, stir, obtain gel-type vehicle aqueous solution B, A and B are mixed
It is even, pH value and osmotic pressure are adjusted, metal-chelator, antioxidant or preservative is added, is added water for injection to 100mL, fill is
.
8 pharmacodynamic evaluation of embodiment
Used test preparation is：Embodiment 5
Selenite induced catatract rat model is set up, matched group and model group animal give normal saline（5 microlitres/20g）, administration group move
Thing gives the curcumin suspension of same volume, curcumin nano suspension gel, is administered three times a day, continues 8 days.Except matched group
Outside animal, normal saline solutions of 30min of each group animal after first administration after nape part subcutaneous injection sodium selenite.Institute
There is animal after experiment terminates, put to death, cut rapidly eyeball, separate crystalline lenses, determine crystalline lenses total number born
（SOD）Vigor, malonaldehyde（MDA）And glutathion（GSH）Content.Blank group, mould are measured by the method for total SOD detection kit
Type group, curcumin suspension group, curcumin nano suspension glucosamine gel group SOD vigor be respectively (65.2 ± 4.5), (24.1 ±
1.1)、(47.7±5.1)、(58.1±7.0) U·mg prot-1, MDA contents be respectively (3.4 ± 0.4), (18.8 ± 0.4),
(9.4±0.6)、(6.0±2.1) mol·mL-1, GSH contents be respectively (49.9 ± 0.9), (17.5 ± 1.8), (19.1 ±
1.1)、(38.1±2.6) mg·g prot-1。
Claims (5)
1. a kind of curcumin nano suspension ophthalmic preparation, it is characterised in that：Curcumin nano suspension ophthalmic preparation is curcumin eye
With nano suspension or the ophthalmically acceptable nanometer suspension gel of curcumin.
2. curcumin nano suspension ophthalmic preparation according to claim 1, it is characterised in that：Curcumin nano is suspended ophthalmically acceptable
Preparation is the ophthalmically acceptable nano suspension of curcumin, containing following group by weight in the ophthalmically acceptable nano suspension of 100mL curcumins
Point：
Curcumin：0.05-10.0g；
Stabilizer：0.01-40.0g；
Osmotic pressure regulator：0.01-10.0g；
PH adjusting agent：0.01-2.0g；
Preservative：0.02-1.0g；
Antioxidant：0.01-5.0g；
Metal-chelator：0.001-0.1g
Balance of water for injection.
3. the preparation method of curcumin nano suspension ophthalmic preparation according to claim 1, it is characterised in that：Curcumin is received
Rice suspension ophthalmic preparation is the ophthalmically acceptable nano suspension of curcumin, and preparation method is comprised the following steps：
（1）, stabilizer is dissolved in 100mL waters for injection in obtain stabiliser solution, then that curcumin is scattered in stabilizer is molten
In liquid, curcumin suspension is obtained；
（2）, to step（1）Gained curcumin suspension using high-speed shearing machine, dispersing emulsification machine, high pressure homogenizer, Probe Ultrasonic Searching or
Ball mill is processed, and curcumin nanosuspension is obtained；
（3）, in nano suspension add osmotic pressure regulator, pH adjusting agent, antioxidant, metal-chelator；
（4）, fill obtain final product the ophthalmically acceptable nano suspension of curcumin.
4. curcumin nano suspension ophthalmic preparation according to claim 1, it is characterised in that：Curcumin nano is suspended ophthalmically acceptable
Preparation is the ophthalmically acceptable nanometer suspension gel of curcumin, containing following with weight in the ophthalmically acceptable nanometer suspension gel of 100mL curcumins
The component of gauge：
Curcumin：0.1-20.0g；
Gel-type vehicle：0.2-20g；
Stabilizer：0.02-80.0g；
Osmotic pressure regulator：0.01-10.0g；
PH adjusting agent：0.01-2.0g；
Preservative：0.02-1.0g；
Antioxidant：0.01-5.0g；
Metal-chelator：0.001-0.1g；
Balance of water for injection.
5. the preparation method of curcumin nano suspension ophthalmic preparation according to claim 1, it is characterised in that：Curcumin is received
Rice suspension ophthalmic preparation is the ophthalmically acceptable nanometer suspension gel of curcumin, and preparation method is comprised the following steps：
（1）, stabilizer obtain stabiliser solution in being dissolved in 50-70mL waters for injection；Add curcumin to mix, obtain curcumin
Suspension；
（2）, to step（1）Gained curcumin suspension using high-speed shearing machine, dispersing emulsification machine, high pressure homogenizer, Probe Ultrasonic Searching or
Ball mill is processed, and curcumin nanosuspension A is obtained；
（3）, using surplus water for injection dissolving gel-type vehicle, stir, obtain gel-type vehicle aqueous solution B；
（4）, curcumin nanosuspension A and gel-type vehicle aqueous solution B mixed, add osmotic pressure regulator, pH adjusting agent, with
PH value and osmotic pressure are adjusted, metal-chelator, antioxidant, preservative is added, is added water for injection to 100mL, fill obtains final product Rhizoma Zingiberis Recens
The ophthalmically acceptable nanometer suspension gel of flavin.
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| CN108653354A (en) * | 2018-08-15 | 2018-10-16 | 广东莱恩医药研究院有限公司 | A kind of ophthalmically acceptable ointment and its preparation method and application |
| CN108904562A (en) * | 2018-08-15 | 2018-11-30 | 广东莱恩医药研究院有限公司 | A kind of gel for eye and its preparation method and application |
| CN111053736A (en) * | 2019-12-12 | 2020-04-24 | 哈尔滨医科大学 | Curcumin nanosuspension, preparation method thereof and application thereof in sonodynamic therapy |
| CN113101233A (en) * | 2021-04-29 | 2021-07-13 | 山东理工大学 | Hand cream rich in tetrahydrocurcumin nano-selenium and preparation method thereof |
| CN113207880A (en) * | 2021-05-28 | 2021-08-06 | 江苏师范大学 | Curcumin nanocrystal with adjustable surface charge, and preparation method and antibacterial application thereof |
| WO2023012754A1 (en) | 2021-08-06 | 2023-02-09 | Foodvica, S.A. De C.V. | Ophthalmic composition for the treatment of visual disorders |
| CN114796384A (en) * | 2022-06-09 | 2022-07-29 | 金松亭 | Nanometer-level traditional Chinese medicine external suspension gel of compound traditional Chinese medicine and preparation method thereof |
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