CN103830175A - Tanshinone-containing emulsion and preparation method thereof - Google Patents
Tanshinone-containing emulsion and preparation method thereof Download PDFInfo
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- CN103830175A CN103830175A CN201210486137.3A CN201210486137A CN103830175A CN 103830175 A CN103830175 A CN 103830175A CN 201210486137 A CN201210486137 A CN 201210486137A CN 103830175 A CN103830175 A CN 103830175A
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Abstract
The invention provides a tanshinone emulsion and a preparation method thereof. The tanshinone emulsion provided by the invention contains tanshinone, water, oil, an isosmotic adjustment agent and a surfactant, and also can contain a stabilizer. Without an organic solvent and a solubilizer with toxic and side effects, the emulsion provided by the invention is non-allergic and has little side effect.
Description
Summary
The invention provides Emulsion of TANSHINONES and preparation method thereof.Tanshinone emulsion provided by the invention contains TANSHINONES, water, and oil, tune isotonic agent and surfactant, can also contain stabilizing agent.Emulsion provided by the invention is not containing the solubilizing agent of organic solvent and toxic side effect, and therefore without anaphylaxis, side effect is little.
Technical field
The present invention relates to a kind of Emulsion and preparation method thereof, relate to particularly Emulsion containing TANSHINONES and preparation method thereof.
Background technology
TANSHINONES also claims total tanshinone, it is the fat-soluble phenanthrenequione compound with bacteriostasis extracting from salviamiltiorrhizabung (labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bunge root), therefrom get more than 10 TANSHINONES monomers such as Tanshinone I, tanshinone IIA, tanshinone ⅡB, cryptotanshinone, different cryptotanshinone, wherein cryptotanshinone, dihydrotanshinone II, hydroxyl TANSHINONES, Methyl tanshinoate, 5 monomers of tanshinone ⅡB have antibacterial action, still have antiinflammatory, cooling effect.The sulfonated products sodium tanshinon IIA silate injection of tanshinone IIA can be water-soluble, proves that through clinic trial treatment angina pectoris effect is remarkable, and side effect is little, is the new drug of a treatment coronary heart disease.Many-sided effects such as that total tanshinone has is antibacterial, antiinflammatory, blood circulation promoting and blood stasis dispelling, promotion wound healing, long-term taking is there are no apparent side effect.TANSHINONES is insoluble in water, has limited to a great extent its application, and Given this inventor provides a kind of not containing organic solvent and the little tanshinone emulsion of toxic and side effects.
Summary of the invention
The invention provides the Emulsion that contains TANSHINONES.
The invention provides the preparation method of tanshinone emulsion.
Emulsion provided by the invention, contains TANSHINONES, oil, surfactant, tune isotonic agent and water, wherein TANSHINONES: oil: surfactant: adjusting the weight ratio of isotonic agent is 1:1-50:1-10:1-10.It can also contain stabilizing agent, can be cholesterol, long-chain alcohol (C14-22), oleic acid, linoleic acid or derivatives thereof, and consumption is 0-200 times of TANSHINONES.
Oil of the present invention refers to biological acceptable material, can be one or more in vegetable oil, animal oil, quintessence oil, mineral oil or artificial oil.Wherein, vegetable oil is selected from one or more in soybean oil, Semen Maydis oil, Oleum Arachidis hypogaeae semen, olive oil, Oleum Ricini, Petiolus Trachycarpi oil, Oleum Cocois, Oleum Brassicae campestris, Oleum sesami or Oleum Gossypii semen; Animal oil is selected from one or more in fish oil, oleic acid, Whale wax oil, single, double, triglyceride; Quintessence oil is selected from one or more in Fructus Schisandrae oil, Oleum Hippophae, peach kernel oil, almond oil, safflower oil, Oleum Camelliae, Radix Oenotherae erythrosepalae oil, Semen Tritici aestivi germ oil, perilla oil, litsea cubeba oil, Oleum Fructus Bruceae or Oleum Curcumae; Mineral oil is selected from one or more in aliphatic hydrocarbon, cerul hydrocarbon, aromatic hydrocarbon or paraffin oil; Artificial oil is selected from one or more in linoleic acid, conjugated linoleic acid, ethyl oleate, castor oil hydrogenated, hydrogenated groundnut, hydrogenated cottonseed oil, Ethyl linoleate, conjugated linoleic acid ethyl ester, self-emulsifying monostearate, pungent/caprin or glycerol triethyl.Be preferably the Oleum Glycines that is rich in triglyceride according to the physicochemical property of above-mentioned oil phase and to the helpfulness of human body.
Surfactant of the present invention can be amphoteric surfactant, non-ionic surface active agent.Wherein amphoteric surfactant is selected from one or more in fabaceous lecithin, egg yolk lecithin, phosphatidylcholine, PHOSPHATIDYL ETHANOLAMINE, serinephosphatide, lipositol, phosphatidic acid, cephalin or hydrogenated phospholipid; Non-ionic surface active agent is selected from one or more in sucrose-fatty esters (as sucrose ester), spans, Tweens, polyoxyethylene fatty acid ester class (as Myrij Myrij), polyoxyethylene aliphatic alcohol ether class (as Bian Ze Brij), Cetomacrogol class or poloxamer class (as poloxamer).Through toxicology and physio-chemical study screening, it is preferably one or more in soybean phospholipid, egg yolk lecithin, hydrogenated phospholipid or polyoxyethylene polyoxypropylene block polymer (poloxamer).
Tune isotonic agent of the present invention is glycerol.
Tanshinone emulsion provided by the invention, the content of active component is 0.1～100mg/ml.
Prepare tanshinone emulsion, generally adopt organic solvent to dissolve TANSHINONES, so not only cause the content of active component in residual organic solvent in injection but also oil phase lower, therefore bring difficulty to clinical application.The inventor, through a large amount of experimentatioies, provides a kind of preparation method of tanshinone emulsion, and the method does not adopt organic solvent, and has met the needed ginsenoside's oil phase of clinical drug effect high concentration.
The preparation method of tanshinone emulsion provided by the invention is: TANSHINONES and surfactant are first dissolved in oil, can also add stabilizing agent, under heating state (30-90 ° of C), be mixed to clear and bright, then by the surfactant being soluble in the aqueous phase and adjust isotonic agent be distributed in water.In the oil solution that contains TANSHINONES being added to water under high-speed stirred, form thick Emulsion.The thick Emulsion of gained is by ultrasonic disintegrator, the further emulsifying of high pressure dispersing emulsification machine, must place stablize, epigranular, nontoxic Emulsion.
Tanshinone emulsion provided by the invention is not containing the solubilizing agent of organic solvent and toxic side effect, and therefore without anaphylaxis, side effect is little; And the content of active component is higher in nano-emulsion oil phase provided by the invention, meet the required high concentration of clinical drug effect, this Emulsion can also change the distribution of saponin in human body simultaneously, improves the bioavailability of medicine.
The specific embodiment
Preparation example 1: prepare tanshinone emulsion
By 0.5g TANSHINONES, 1.2g egg yolk lecithin, 0.04g oleic acid joins in 10g refined soybean oil, and heating (60-90 ° of C) is mixed to clear and brightly, obtains containing TANSHINONES 50mg/g oil solution.1.2g poloxamer, 2.25g glycerol are dispersed in water for injection and obtain water, and under stirring condition, the oil solution that drips the phospholipid that contains TANSHINONES obtains oil phase in water dispersion, makes thick Emulsion, adds water to 100ml.By obtained thick Emulsion under the condition of pressure 100Mpa, by the further emulsifying of dispersing emulsification machine, can be in 115 ℃ after emulsifying finishes, 30min sterilizing, subpackage obtains the Emulsion of 5mg/ml.
Preparation example 2: prepare tanshinone emulsion
0.5g TANSHINONES, 2g fabaceous lecithin, 0.5g oleic acid are joined in 10g refined soybean oil, and heating, is mixed to clear and brightly, obtains the oil solution containing TANSHINONES 50mg/g.2.25g glycerol, 1.2g poloxamer are added to and in water for injection, are prepared as water.Under stirring condition, drip the oil solution of the phospholipid that contains TANSHINONES in water dispersion, make thick Emulsion, add water to 100ml.By obtained thick Emulsion under the condition of pressure 100Mpa, by the further emulsifying of dispersing emulsification machine, can be in 115 ℃ after emulsifying finishes, 30min sterilizing, subpackage obtains the Emulsion of 5mg/ml.
Preparation example 3: prepare tanshinone emulsion
0.5g TANSHINONES, 3.0g egg yolk lecithin, 0.1g oleic acid are joined in the refining Oleum Glycines of 10g, be mixed to clear and brightly, obtain containing TANSHINONES 20mg/g oil solution.2.25g glycerol is added in water for injection, and under stirring condition, the egg yolk lecithin that slowly dropping contains TANSHINONES, the oil solution of oleic acid, in dispersion, are made thick Emulsion, add water to 100ml.By obtained thick Emulsion under pressure 100Mpa, by the further emulsifying of dispersing emulsification machine, can be in 115 ℃ after emulsifying, 30min sterilizing, subpackage obtains the Emulsion of 5mg/ml.
Preparation example 4: prepare tanshinone emulsion
By 1.0g TANSHINONES, 2.0g egg yolk lecithin, 0.06g oleic acid joins in the refining Oleum Glycines of 10g, and heating is mixed to clear and brightly, obtains containing TANSHINONES 100mg/g oil solution.1.2g poloxamer, 2.25g glycerol are dispersed to must water in water for injection.Under stirring condition, the oil solution that drips the phospholipid that contains TANSHINONES obtains oil phase in water dispersion, makes thick Emulsion, adds water to 100ml.By obtained thick Emulsion under the condition of pressure 100Mpa, by the further emulsifying of dispersing emulsification machine, can be in 115 ℃ after emulsifying finishes, 30min sterilizing, subpackage obtains the Emulsion of 10mg/ml.
Claims (8)
1. contain the Emulsion of people's TANSHINONES, it is characterized by and contain TANSHINONES, oil, surfactant, tune isotonic agent and water, wherein TANSHINONES: oil: surfactant: adjusting the weight ratio of isotonic agent is 1:1-50:1-10:1-10.
2. Emulsion according to claim 1, oil is one or more in vegetable oil, animal oil, quintessence oil, mineral oil, artificial oil.
3. Emulsion according to claim 2, oil is for being rich in the Oleum Glycines of triglyceride.
4. Emulsion according to claim 1, surfactant is zwitterionic surfactant or non-ionic surface active agent.
5. Emulsion according to claim 4, surfactant is one or more in soybean phospholipid, egg yolk lecithin, hydrogenated phospholipid or polyoxyethylene polyoxypropylene block polymer (poloxamer).
6. Emulsion according to claim 1, adjusting isotonic agent is glycerol.
7. Emulsion according to claim 1, it also contains stabilizing agent, and stabilizing agent is cholesterol, long-chain alcohol (C14-22), oleic acid, linoleic acid or derivatives thereof, and its consumption is 0-200 times of TANSHINONES.
8. the preparation method of the arbitrary described Emulsion of claim 1-7 joins TANSHINONES, surfactant in oil, can also add stabilizing agent, under heating condition (30-90 ° of C), be mixed to clear and bright, again the surfactant being soluble in the aqueous phase and tune isotonic agent are distributed in water, in the oil solution that contains TANSHINONES being added to water under high-speed stirred, form thick Emulsion, then by ultrasonic disintegrator, the further emulsifying of high pressure dispersing emulsification machine, to obtain final product.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210486137.3A CN103830175A (en) | 2012-11-26 | 2012-11-26 | Tanshinone-containing emulsion and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210486137.3A CN103830175A (en) | 2012-11-26 | 2012-11-26 | Tanshinone-containing emulsion and preparation method thereof |
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| CN103830175A true CN103830175A (en) | 2014-06-04 |
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| CN201210486137.3A Pending CN103830175A (en) | 2012-11-26 | 2012-11-26 | Tanshinone-containing emulsion and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107135645A (en) * | 2014-12-03 | 2017-09-05 | 凡诺华（英国）有限公司 | For the plant extracts and compound used in wound healing |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107135645A (en) * | 2014-12-03 | 2017-09-05 | 凡诺华（英国）有限公司 | For the plant extracts and compound used in wound healing |
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Application publication date: 20140604 |