CN107510714A - A kind of pharmaceutical composition containing pranoprofen and preparation method thereof - Google Patents
A kind of pharmaceutical composition containing pranoprofen and preparation method thereof Download PDFInfo
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- CN107510714A CN107510714A CN201610422870.7A CN201610422870A CN107510714A CN 107510714 A CN107510714 A CN 107510714A CN 201610422870 A CN201610422870 A CN 201610422870A CN 107510714 A CN107510714 A CN 107510714A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/56—Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
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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
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
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Abstract
The present invention relates to a kind of pharmaceutical composition containing pranoprofen and preparation method thereof, comprise the following steps：By butterflybush flower medicinal material after water extract-alcohol precipitation, purify through polyamide column, eluted with 0.1% ammoniacal liquor, collect eluent, be concentrated under reduced pressure, be dried in vacuo, obtain Flos Buddlejae extract；By the Flos Buddlejae extract and solubilizer of gained, it is dissolved in water for injection, antioxidant, preservative and isotonic regulator are added, is dissolved in water for injection, is stirred, add pH adjusting agent, and 1L is injected water to, pranoprofen 1g is added, after dissolving and being well mixed, filtering with microporous membrane, sterilizing, dispense the eye drops for producing the present invention.Product of the present invention can be used for the symptomatic treatment of the ophthalmic inflammations such as conjunctivitis, keratitis, trachoma, blepharitis, eyes-affinity inflammation, sclerotitis, dacryoadenitis, dacryocystitis and ulcer of the cornea.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of to be used for by what pranoprofen and Flos Buddlejae extract formed
Treat the pharmaceutical composition of ophthalmic inflammation.
Background technology
Ophthalmic inflammation occupies larger ratio in ophthalmology disease, and current clinic common are conjunctiva caused by a variety of causes
Inflammation, keratitis, trachoma, blepharitis, eyes-affinity inflammation, sclerotitis, dacryoadenitis, dacryocystitis and ulcer of the cornea etc..Chemicals and some
Traditional Chinese medicine becomes for ophthalmic inflammation venereal disease has the effect of fine.
Pranoprofen（Pranoprofen), chemical name：(RS) -2- (10- hydrogen -9- Evil -1- naphthazine -6- bases) propionic acid, change
Learn structural formula：
Molecular formula：C15H13NO3, 255.27.
Pranoprofen is welfide companies（Yuan Ji good fortune Pharmaceutical Co., Ltd, the pharmacy of existing Mitsubishi）The Nonsteroidal anti-inflammatory of exploitation
Analgesic.It is eye drops that Senju Pharma Co., Ltd, which is developed, is listed in Japan within 1988.Clinically be used for blepharitis,
The symptomatic treatment of the inflammation of eye section such as conjunctivitis, keratitis, sclerotitis.
Chinese medicine butterflybush flower, alias cover flower, native brocade flower, chicken bone flower etc., dye meal flower etc., are the dry of loganiaceae plant butterflybush flower
Dry bud and its inflorescence.Spring flower harvests when not open, removes impurity, dries.This product is mostly the close poly- inflorescence branchlet of bud,
In irregular roundness taper, long 1.5~3cm.Surface lark or brown color, it is close by fine hair.Bud is in corynebacterium, and upper end is bigger,
Long 0.3~1cm, 0.1~0.2cm of diameter；Calyx mitriform, the fissure of tip 4；Corolla tubular, isometric or slightly long with calyx, tip 4 splits,
Sliver is avette；Stamen 4, raw in the middle part of corolla pipe.Matter is soft.Gas micro-perfume, it is mildly bitter flavor, pungent.Main product in Sichuan, Hubei, Hunan,
The ground such as Yunnan, Guangxi.
Traditional Chinese medicine thinks, butterflybush flower has a wind-dispelling, cool blood, moistens liver, the effect of improving eyesight.《Kaibao Bencao》Record：Butterflybush flower
Main glaucoma skin screen, red puckery more eye secretion and tears, Chi Mai in the mesh that disappears, children's bran beans and infantile malnutrition due to digestive disturbances or intestinalparasites gas attack eye.Modern study shows, its chemical composition master
To be a variety of flavonoids such as buddleo-glucoside, robinin.Clinically it is usually used in ophthalmology, for acute and chronic conjunctivitis, has in all mesh red
Arteries and veins（Conjunctival congestion）, eye secretion and tears（More tears and there is mucoid secretion）, blurred vision（Blurring of vision）, photophobia（Keep in dark place）Person, no matter true
Disease or the chronic diseases marked by deficiency of vital energy, it can apply.On the whole, butterflybush flower is presented with the deficiency of liver-yin and kidney-yin and has hot person more suitable to treat chronic conjunctivitis
Preferably.
The content of the invention
It is an object of the invention to provide a kind of pharmaceutical composition being made up of pranoprofen and Flos Buddlejae extract, the group
Compound can be used for treating various conjunctivitis, keratitis, trachoma, blepharitis, eyes-affinity inflammation, sclerotitis, dacryoadenitis, dacryocystitis and cornea
The ophthalmic inflammations such as ulcer.
The technical solution adopted by the present invention is as follows：
A kind of preparation method of the pharmaceutical composition containing pranoprofen, is comprised the technical steps that：
1st, 1-10 parts by weight butterflybush flower medicinal materials are weighed, are placed in extraction vessel, add the 4-10 times of water measured, heating is boiled,
1-4 hours are kept under fluidized state, are filtrated to get first time extract solution；The 2-5 times of water measured is added again, heating is boiled,
0.5-2 hours are kept under fluidized state, are filtrated to get second of extract solution.It extract solution will merge twice, be well mixed, concentration,
It is 1.05-1.15 to be concentrated into concentrate proportion；
2nd, after concentrate is let cool, it is about 60% to add ethanol to its concentration thereto under stirring, after standing 24 hours, is taken out
Supernatant is taken, reclaims ethanol；
3rd, the water of 5 times of volumes is added into the decoction after recovery ethanol, with salt acid for adjusting pH to 4-5, centrifugation, is taken on supernatant
Sample is to the polyamide column handled well, and after eluting 2 column volumes with pH4-5 sour water, neutrality is washed to purifying, then with 0.1%
Ammoniacal liquor elutes 3 column volumes, collects ammoniacal liquor eluent, is concentrated under reduced pressure, and is dried in vacuo, produces Flos Buddlejae extract；
4th, the Flos Buddlejae extract and solubilizer obtained by step 3 are weighed by recipe quantity, is dissolved in water for injection, adds anti-oxidant
Agent, preservative and isotonic regulator, are dissolved in water for injection, and stir, and add pH adjusting agent, and inject water to 1L,
Pranoprofen 1g is added, after dissolving and being well mixed, filtering with microporous membrane, sterilizing, dispenses the eye drops for producing the present invention.
Wherein, the pharmaceutical composition containing pranoprofen includes following component：
Pranoprofen 1g, Flos Buddlejae extract 0.5-20g, pH adjusting agent 0.1-20g, isotonic regulator 1-100g, solubilizer
0.1-20g, preservative 0.01-5g, antioxidant 0.02-5g.
Further, preferable antioxidant be sodium thiosulfate, sodium pyrosulfite, sodium hydrogensulfite, sodium sulfite, according to ground
One or more of combinations in acid disodium.
Further, preferable pH adjusting agent is hydrochloric acid, sodium hydroxide, sodium acid carbonate, sodium carbonate, disodium hydrogen phosphate, phosphoric acid
One or more of combinations in sodium dihydrogen.
Further, preferable solubilizer is one or more of combinations in Tween-80, propane diols, poloxamer.
Further, preferable preservative be ethyl hydroxy benzoate, methyl hydroxybenzoate, benzalkonium chloride, benzalkonium bromide, anesin,
One or more of combinations in benzyl carbinol.
Further, preferable isotonic regulator is one kind or several in sodium chloride, glucose, mannitol, boric acid and borax
The combination of kind.
The product of the present invention and the excellent results of preparation method are：
1st, pharmaceutical composition of the invention is made up of pranoprofen and Flos Buddlejae extract, the two synergy, can be used for tying
The symptomatic treatment of the inflammation of eye section such as film inflammation, blepharitis, keratitis, sclerotitis；
2nd, it is that medicinal material is simple and easy to get the advantages of the preparation method of eye drops of the invention, production craft step is few, and cost is low.
Embodiment
With reference to embodiment, the present invention is described in further detail.The following example is merely to illustrate the present invention,
And it should not be taken as limiting the scope of the invention.
Flos Buddlejae extract in the embodiment of the present invention is as described above, by butterflybush flower medicinal material after water extract-alcohol precipitation, to pass through
Polyamide column purifies, and is eluted with 0.1% ammoniacal liquor, collects eluent, is concentrated under reduced pressure, and is dried in vacuo, obtains Flos Buddlejae extract.
Embodiment 1
Flos Buddlejae extract 0.5g and Tween-80 1g are weighed, is dissolved in water for injection, adds sodium thiosulfate 3g, oxybenzene
Ethyl ester 0.2g and sodium chloride 15g, is dissolved in water for injection, and adds hydrochloric acid 0.5ml and stirs, inject water to 1L, adds
Pranoprofen 1g, after dissolving and being well mixed, filtering with microporous membrane, sterilizing, dispense and produce.
Embodiment 2
Flos Buddlejae extract 20g, Tween-80 1g and propane diols 10g are weighed, is dissolved in water for injection, adds sodium hydrogensulfite
3g, benzalkonium chloride 0.1g and sodium chloride 10g, are dissolved in water for injection, and add sodium hydroxide 0.1g and stir, add water for injection
To 1L, pranoprofen 1g is added, after dissolving and being well mixed, filtering with microporous membrane, sterilizing, dispenses and produces.
Embodiment 3
Flos Buddlejae extract 10g, Tween-80 1g and propane diols 10g are weighed, is dissolved in water for injection, adds sodium pyrosulfite
2g, natrium adetate 2g, benzalkonium bromide 0.1g, sodium chloride 10g and glucose 50g, are dissolved in water for injection, and add sodium hydroxide
0.2g stirs, and injects water to 1L, adds pranoprofen 1g, after dissolving and being well mixed, filtering with microporous membrane, goes out
Bacterium, dispense and produce.
Claims (7)
1. a kind of pharmaceutical composition containing pranoprofen and preparation method thereof, it is characterised in that comprise the following steps：
（1）, weigh 1-10 parts by weight butterflybush flower medicinal materials, be placed in extraction vessel, add the 4-10 times of water measured, heating boils,
1-4 hours are kept under fluidized state, are filtrated to get first time extract solution；The 2-5 times of water measured is added again, heating is boiled,
0.5-2 hours are kept under fluidized state, are filtrated to get second of extract solution；It extract solution will merge twice, be well mixed, it is dense
Contracting, it is 1.05-1.15 to be concentrated into concentrate proportion；（2）, after concentrate lets cool, ethanol is added thereto extremely under stirring
Its concentration is about 60%, after standing 24 hours, extracts supernatant, reclaims ethanol；（3）, to recovery ethanol after decoction in add 5
The water of times volume, with salt acid for adjusting pH to 4-5, centrifugation, supernatant loading is taken to the polyamide column handled well, with pH4-5 acid
After 2 column volumes of water elution, neutrality is washed to purifying, then 3 column volumes are eluted with 0.1% ammoniacal liquor, collects ammoniacal liquor elution
Liquid, it is concentrated under reduced pressure, is dried in vacuo, produces Flos Buddlejae extract；（4）, the antioxidant of recipe quantity added water for injection mixing molten
Solution, then add pH adjusting agent and stir, obtain solution；
Weigh the Flos Buddlejae extract and solubilizer obtained by step 3 by recipe quantity, be dissolved in water for injection, add preservative and
Isotonic regulator, stir, be then added into the solution obtained by step 4, and inject water to 1L, add general
Ibuprofen 1g is drawn, after dissolving and being well mixed, after being well mixed, filtering with microporous membrane, sterilizing, dispenses the eye drip for producing the present invention
Liquid；
Wherein, the pharmaceutical composition of the invention containing pranoprofen, including following component：
Pranoprofen 1g, Flos Buddlejae extract 0.5-20g, pH adjusting agent 0.1-20g, isotonic regulator 1-100g, solubilizer
0.1-20g, preservative 0.01-5g, antioxidant 0.02-5g.
2. the preparation method of the pharmaceutical composition according to claim 1 containing pranoprofen, it is characterised in that described
Antioxidant is the one or more in sodium thiosulfate, sodium pyrosulfite, sodium hydrogensulfite, sodium sulfite, natrium adetate
Combination.
3. the preparation method of the pharmaceutical composition according to claim 1 containing pranoprofen, it is characterised in that described
PH adjusting agent is one or more of in hydrochloric acid, sodium hydroxide, sodium acid carbonate, sodium carbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate
Combination.
4. the preparation method of the pharmaceutical composition according to claim 1 containing pranoprofen, it is characterised in that described
Solubilizer is one or more of combinations in Tween-80, propane diols, poloxamer.
5. the preparation method of the pharmaceutical composition according to claim 1 containing pranoprofen, it is characterised in that described
Preservative is one or more of in ethyl hydroxy benzoate, methyl hydroxybenzoate, benzalkonium chloride, benzalkonium bromide, anesin, benzyl carbinol
Combination.
6. the preparation method of the pharmaceutical composition according to claim 1 containing pranoprofen, it is characterised in that described
Isotonic regulator is one or more of combinations in sodium chloride, glucose, mannitol, boric acid and borax.
7. according to the pharmaceutical composition containing pranoprofen described in claim any one of 1-6, it is characterised in that described
Eye-drops preparations is eye drops.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610422870.7A CN107510714A (en) | 2016-06-15 | 2016-06-15 | A kind of pharmaceutical composition containing pranoprofen and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610422870.7A CN107510714A (en) | 2016-06-15 | 2016-06-15 | A kind of pharmaceutical composition containing pranoprofen and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108096298A (en) * | 2017-12-29 | 2018-06-01 | 广州仁恒医药科技股份有限公司 | A kind of eye drops containing pranoprofen and preparation method thereof |
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| CN1628759A (en) * | 2004-10-13 | 2005-06-22 | 凌沛学 | Chinese medicinal formulation for treating asthenopia syndrome and its preparation method |
| JP2005239658A (en) * | 2004-02-27 | 2005-09-08 | Taisho Pharmaceut Co Ltd | Ophthalmic agent |
| CN1823772A (en) * | 2006-03-24 | 2006-08-30 | 张宏业 | New pranoprofen eye drops and its preparation method |
| CN103816228A (en) * | 2014-03-05 | 2014-05-28 | 陶春梅 | Prescription for treating conjunctival xerosis and preparation method thereof |
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2016
- 2016-06-15 CN CN201610422870.7A patent/CN107510714A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005239658A (en) * | 2004-02-27 | 2005-09-08 | Taisho Pharmaceut Co Ltd | Ophthalmic agent |
| CN1628759A (en) * | 2004-10-13 | 2005-06-22 | 凌沛学 | Chinese medicinal formulation for treating asthenopia syndrome and its preparation method |
| CN1823772A (en) * | 2006-03-24 | 2006-08-30 | 张宏业 | New pranoprofen eye drops and its preparation method |
| CN103816228A (en) * | 2014-03-05 | 2014-05-28 | 陶春梅 | Prescription for treating conjunctival xerosis and preparation method thereof |
Non-Patent Citations (3)
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| 崔浩 等: "普拉洛芬滴眼液治疗中重度干眼病抗炎作用的共聚焦显微镜观察", 《航空航天医学杂志》 * |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108096298A (en) * | 2017-12-29 | 2018-06-01 | 广州仁恒医药科技股份有限公司 | A kind of eye drops containing pranoprofen and preparation method thereof |
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Application publication date: 20171226 |