CN107510715A - A kind of Flos Buddlejae extract eye-drops preparations and preparation method thereof - Google Patents
A kind of Flos Buddlejae extract eye-drops preparations and preparation method thereof Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/56—Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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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- 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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- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- 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 Flos Buddlejae extract eye-drops preparations 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, add antioxidant, preservative and isotonic regulator, it is dissolved in water for injection, stirs, adds pH adjusting agent, and inject water to 1L, after well mixed, filtering with microporous membrane, sterilizing, the eye drops for producing the present invention is dispensed.Product of the present invention can be used for the symptomatic treatment of the ophthalmic inflammations such as conjunctivitis.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of eye-drops preparations and its preparation method using butterflybush flower as raw material.
Background technology
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.
Clinical practice：For ophthalmology, for acute and chronic conjunctivitis, there is Chi Mai in all mesh（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.It is overall next
Say, butterflybush flower is presented with the deficiency of liver-yin and kidney-yin and has hot person preferably to treat chronic conjunctivitis.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of Flos Buddlejae extract eye-drops preparations, preferably eye drip liquor
Type.
The technical solution adopted by the present invention is as follows：
A kind of preparation method of Flos Buddlejae extract eye-drops preparations, 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,
After well mixed, filtering with microporous membrane, sterilizing, the eye drops for producing the present invention is dispensed；
Wherein, butterflybush flower eye-drops preparations includes following component：
It is Flos Buddlejae extract 0.5-20g, pH adjusting agent 0.1-20g, isotonic regulator 1-100g, solubilizer 0.1-20g, anti-
Rotten agent 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, eye drops of the invention can be used for the symptomatic treatment of the inflammation of eye section such as conjunctivitis, 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, injects water to 1L, micropore
Membrane filtration, 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, filtering with microporous membrane, sterilizing, dispense and produce.
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, filtering with microporous membrane, sterilizing, dispenses and produce.
Claims (7)
1. a kind of preparation method of Flos Buddlejae extract eye-drops preparations, 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, concentration, it is 1.05-1.15 to be concentrated into concentrate proportion；
（2）, after concentrate lets cool, it is about 60% to add ethanol to its concentration thereto under stirring, after standing 24 hours,
Supernatant is extracted, reclaims ethanol；
（3）, add into the decoction after recovery ethanol the water of 5 times of volumes, with salt acid for adjusting pH to 4-5, centrifugation, take supernatant
Loading 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 elute 3 column volumes, collect ammoniacal liquor eluent, be concentrated under reduced pressure, be dried in vacuo, produce Flos Buddlejae extract；
（4）, the antioxidant of recipe quantity added into water for injection mixed dissolution, then add pH adjusting agent and stir, obtain molten
Liquid；
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, mixing is equal
After even, filtering with microporous membrane, sterilizing, the eye drops for producing the present invention is dispensed；
Wherein, the eye-drops preparations of Flos Buddlejae extract, including following component：
It is Flos Buddlejae extract 0.5-20g, pH adjusting agent 0.1-20g, isotonic regulator 1-100g, solubilizer 0.1-20g, anti-
Rotten agent 0.01-5g, antioxidant 0.02-5g.
2. the preparation method of Flos Buddlejae extract eye-drops preparations according to claim 1, it is characterised in that described antioxygen
Agent is one or more of groups in sodium thiosulfate, sodium pyrosulfite, sodium hydrogensulfite, sodium sulfite, natrium adetate
Close.
3. the preparation method of Flos Buddlejae extract eye-drops preparations according to claim 1, it is characterised in that described pH is adjusted
Section agent is one or more of groups in hydrochloric acid, sodium hydroxide, sodium acid carbonate, sodium carbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate
Close.
4. the preparation method of Flos Buddlejae extract eye-drops preparations according to claim 1, it is characterised in that described solubilising
Agent is one or more of combinations in Tween-80, propane diols, poloxamer.
5. the preparation method of Flos Buddlejae extract eye-drops preparations according to claim 1, it is characterised in that described anti-corrosion
Agent is one or more of groups in ethyl hydroxy benzoate, methyl hydroxybenzoate, benzalkonium chloride, benzalkonium bromide, anesin, benzyl carbinol
Close.
6. the preparation method of Flos Buddlejae extract eye-drops preparations according to claim 1, it is characterised in that described is isotonic
Conditioning agent is one or more of combinations in sodium chloride, glucose, mannitol, boric acid and borax.
7. according to the Flos Buddlejae extract eye-drops preparations described in claim any one of 1-6, it is characterised in that described is ophthalmically acceptable
Preparation is eye drops.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610423765.5A CN107510715A (en) | 2016-06-15 | 2016-06-15 | A kind of Flos Buddlejae extract eye-drops preparations and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610423765.5A CN107510715A (en) | 2016-06-15 | 2016-06-15 | A kind of Flos Buddlejae extract eye-drops preparations and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20210082008A (en) * | 2019-12-24 | 2021-07-02 | 경희대학교 산학협력단 | Anti-inflammatory composition comprising buddleja davidii extract |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1628759A (en) * | 2004-10-13 | 2005-06-22 | 凌沛学 | Chinese medicinal formulation for treating asthenopia syndrome and its preparation method |
| WO2013049957A1 (en) * | 2011-10-08 | 2013-04-11 | Li Daihong | Compound traditional chinese medicine eyedrop |
| CN103816228A (en) * | 2014-03-05 | 2014-05-28 | 陶春梅 | Prescription for treating conjunctival xerosis and preparation method thereof |
-
2016
- 2016-06-15 CN CN201610423765.5A patent/CN107510715A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1628759A (en) * | 2004-10-13 | 2005-06-22 | 凌沛学 | Chinese medicinal formulation for treating asthenopia syndrome and its preparation method |
| WO2013049957A1 (en) * | 2011-10-08 | 2013-04-11 | Li Daihong | Compound traditional chinese medicine eyedrop |
| CN103816228A (en) * | 2014-03-05 | 2014-05-28 | 陶春梅 | Prescription for treating conjunctival xerosis and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 张须学: "《天然药物化学》", 30 September 2012, 西安交通大学出版社 * |
| 欧阳云 等: "密蒙花滴眼液对去势雄兔泪腺细胞炎症因子TNF-α、IL-1β的影响", 《2014年全国中医眼科名家学术研讨会论文汇编》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20210082008A (en) * | 2019-12-24 | 2021-07-02 | 경희대학교 산학협력단 | Anti-inflammatory composition comprising buddleja davidii extract |
| KR102369744B1 (en) | 2019-12-24 | 2022-03-03 | 경희대학교 산학협력단 | Anti-inflammatory composition comprising buddleja davidii extract |
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