CN1701808A - Emulsion of red sage root for injection and its preparation process - Google Patents
Emulsion of red sage root for injection and its preparation process Download PDFInfo
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Abstract
The invention discloses an emulsion of red sage root for injection and its preparation process, wherein the emulsion is prepared into the dosage forms of nano microemulsion or sub-nano microemulsion. Compared with the conventional salvia miltiorrhizae injections, the injection provided by the present invention has the advantages of accurate effecting constituents, small amount of administration, higher curative effects and less side effect.
Description
Technical field
The present invention relates to a kind of Danshen root injection, it contains Radix Salviae Miltiorrhizae extract, surfactant and water-bearing media, more specifically to the nanometer microemulsion type and the sub-nanometer emulsion type of these preparations.
Compare with commercially available Danshen root injection, these two kinds of novel forms have all that functional component is clear and definite, consumption is little, drug effect is remarkable and characteristics such as side effect is little.
Background technology
Radix Salviae Miltiorrhizae looses simply, the same SIWU TANG of merit.Radix Salviae Miltiorrhizae has obtained certainly as the curative effect of its treatment cardiovascular disease of oral formulations.Be the outstanding person of achievement in the research of activating blood circulation to dissipate blood stasis medicine.Discover that Radix Salviae Miltiorrhizae has good resisting coronary heart disease effect.Its effective ingredient mainly is danshensu (p-3,4 dihydroxy phenyl lactic acid) and TANSHINONES.
Its water solubility extract Radix Salviae Miltiorrhizae Injection be widely used in the clinical treatment cardiovascular and cerebrovascular disease reach 20 surplus year.
The effective ingredient that is separated to from the salvia-soluble position---danshensu (danshensu), i.e. D (+) β-(3, the 4-dihydroxy phenyl) lactic acid, Chinese scholar has been carried out many pharmacological researches, proves that it has multiple pharmacologically active.Such as: have the effect of dwindling myocardial infarct size and alleviating the course of disease; has protective effect to the rat heart muscle ischemia/reperfusion injury; effect with microcirculation improvement obstacle and reduction blood plasma lactic acid content; have the microcirculation improvement obstructive action, thereby improve the dysbolismus due to the cell hypoxic-ischemic.Clinical practice finds that danshensu can increase blood capillary fragility, and long-term transfusion can cause endothelial denudation.
From Radix Salviae Miltiorrhizae, extract total tanshinone, have coronary artery dilator, coronary blood flow increasing; Decreased heart rate increases myocardial contraction, improves the myocardial metabolism disorder and the cardiac function that cause after the anoxia; Anticoagulant; Promote tissue repair and effect such as antibiotic, antibacterial.Can be used as the treatment of angina pectoris and myocardial infarction, cerebral arteries and arteria retina and the formation of peripheral vein thrombosis, Behcet's syndrome, erythema nodosum.
For giving full play to the effect of this flavor medical material of Radix Salviae Miltiorrhizae, really make its effect that reaches efficacy enhancing and toxicity reducing, the spy has invented the active component of red sage root TANSHINONES and danshensu is made nanometer microemulsion type and inferior nano-emulsion novel form, and it is little to have a consumption, curative effect height, characteristics such as few side effects.
Summary of the invention
Along with going deep into of middle pharmaceutically active ingredient research, find that the technology of Radix Salviae Miltiorrhizae Injection employing has only been extracted a kind of effective site danshensu, the present invention has selected best extracting method for use through optimal process, and effective ingredient is extracted as far as possible fully.The present invention has also adopted nanometer microemulsion type or inferior nano-emulsion novel form, compares with traditional Radix Salviae Miltiorrhizae Injection, has that functional component is clear and definite, consumption is little, curative effect is high and characteristics such as side effect is little.
Danshen root injection novel form of the present invention, it contains Radix Salviae Miltiorrhizae extract, surfactant and water-bearing media.This injection is a kind of aqueous dispersion, the mean diameter of decentralized photo≤0.5 micron, and the concentration of extract is 0.01%～5% in the injection.Wherein contain TANSHINONES letones and salvianolic acid material in the Radix Salviae Miltiorrhizae extract.The content of the content of tanshinone material in liposoluble extract is 50-99.99%, and salvianolic acid class material content in water solubility extract is 50-99.99%.
The liposoluble constituent of Radix Salviae Miltiorrhizae mostly is conjugation quinone, ketone compounds greatly, has the orange-yellow and orange red of feature.Mainly contain: Tanshinone I, tanshinone, TANSHINONES, cryptotanshinone, hydroxyl TANSHINONES, Methyl tanshinoate, methine Radix Salviae Miltiorrhizae quinone, Przewaquinone A Przewatanshinquinone A, Przewatanshinquinone B Przewaquinone B., penta element, miltirone, dihydro Radix Salviae Miltiorrhizae quinone, tanshinol, hydroxyl TANSHINONES, fall TANSHINONES, tetrahydrochysene Radix Salviae Miltiorrhizae quinone, iso tanshinone, different cryptotanshinone, Radix Salviae Miltiorrhizae quinone, dihydro miltirone, diterpene perinaphthenone, danshenspiroketallactone, salviol, Radix Salviae Miltiorrhizae aldehyde etc.
The water soluble ingredient of Radix Salviae Miltiorrhizae is mainly the salvianolic acid material, mainly contains saivianic acid A and also claims danshensu: dihydroxy benzenes lactic acid, danshensuan B, sahianic acid C, the acid of amber pool, salvianolic acid, salvianolic acid B, salvianolic acid F, sitosterol, ursolic acid protocatechualdehyde, the acid of Singapore coffee, Hesperetic acid, rosmarinic acid, rosmarinic acid methyl ester, ferruginal, tigogenin, carnosol etc.
Surfactant is selected from one or more in phospholipid (plant phospholipid, animal phospholipid, synthetic phospholipid), propylene glycol, fatty glyceride, solutolHS15, labrosol, Tweens, poloxamer series, polyoxyethylene fatty acid ester, Polyethylene Glycol and derivant series thereof, hydroxypropyl, the hydroxypropyl T-cyclodextrin;
Can also add triglyceride in the surfactant or as the glycerol of isotonic agent, wherein triglyceride comprises vegetable oil or medium chain triglyceride, can also add fatty acid or aliphatic alcohol or its sodium salt as co-emulsifier, cholic acid or deoxycholic acid and sodium salt thereof, wherein the carbon number that comprises of fatty acid or aliphatic alcohol can be from 6-24, antioxidant such as tocopherol (vitamin E) or L-ascorbyl palmitate can also be added, cosolvent ethanol can also be added.
Emulsion of red sage root for injection of the present invention can be made the tanshinone material separately nano-emulsion preparation or inferior nano-emulsion preparation, and the salvianolic acid material is made liquid drugs injection, during administration with tanshinone emulsion with danshensu liquid drugs injection dilution posterior vein drop or inject; Also the tanshinone material can be made the decentralized photo of Emulsion, during the salvianolic acid material is soluble in the aqueous phase, during administration with an amount of 0.9% sodium chloride solution or 5% glucose dilution posterior vein drop or inject.Its preparation method is as follows:
A) the tanshinone material is dissolved in triglyceride or the ethyl oleate, make oil phase in 50-90 ℃ of high-speed stirred, all the other components are dissolved in the suitable quantity of water, make water in 50-90 ℃ of high-speed stirred, the biphase 50-90 of being mixed in of a profit ℃ high-speed stirred is made primary emulsion, regulates pH value 5.0-7.0.
B) get primary emulsion in above-mentioned (a), water for injection adds to recipe quantity, is transferred in the high pressure dispersing emulsification machine emulsifying repeatedly.To emulsion droplet mean diameter≤0.5 micron.
C) after the Emulsion of getting above-mentioned (b) filtered, inflated with nitrogen fill, sterilization were both.
The extraction process step of Radix Salviae Miltiorrhizae:
Get Radix Salviae Miltiorrhizae 1500g, add 8 times of amount 50-80% alcohol reflux three times, 1.5h for the first time, second and third time 1.0h, collecting decoction, filter, filtrate decompression is concentrated into does not have alcohol flavor, cold preservation 24-48h, modified polyamide resin column or polyamide resin column on the supernatant, wash with water earlier, reuse 20-70% ethanol elution, ethanol elution are received to do and are promptly got the total salvianolic acid material.Precipitation is fully dissolved with 95% ethanol, and cold preservation is filtered, and filtrate is recycled to about ethanol content 5%-20%, by the polyamide column purification, reclaims ethanol to small size, leaves standstill crystallize, is drying to obtain the total tanshinone powder below 80 ℃.
Specific embodiment
Embodiment 1 (sub-nanometer emulsion type)
Prescription one: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, phosphatidase 10 .5%-4.0%, glycerol 1.0%-6.0%, triglyceride 5%-20%, oleic acid 1.0%-6.0%, tocopherol 0.01%-1.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in an amount of organic solvent, add refined soybean oil or midchain oil 10g, oleic acid 3g, high-speed stirred makes mix homogeneously, removes organic solvent in 60 ℃ of distilling under reduced pressure, makes oil phase; Take by weighing salvianolic acid material (total tanshinone content 80%) 120mg, soybean phospholipid 2.0g, glycerol 3g, tocopherol 50mg, make abundant dispersion, make water in 60 ℃ of high-speed stirred.The biphase mixing of profit is made primary emulsion in 60 ℃ of-80 ℃ of high-speed stirred.Get primary emulsion, water for injection adds to recipe quantity, and regulating pH value is 5.0～7.0, is transferred in the high pressure dispersing emulsification machine, emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly, and aseptic filtration, inflated with nitrogen fill, sterilization are both.
Prescription two: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, phosphatidase 10 .5%-4.0%, glycerol 1.0%-6.0%, triglyceride 5%-20%, oleic acid 1.0%-6.0%, tocopherol 0.01%-1.0%, PEG400/6000.5%-5.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in an amount of organic solvent, add refined soybean oil or midchain oil 10g, oleic acid 3g, high-speed stirred makes mix homogeneously, removes organic solvent in 60 ℃ of distilling under reduced pressure, makes oil phase; Take by weighing salvianolic acid material (total tanshinone content 80%) 120mg, soybean phospholipid 2.0g, glycerol 3g, educate phenol 50mg, ethylene glycol 400/600 1.0g makes abundant dispersion in 60 ℃ of high-speed stirred, makes water.The biphase mixing of profit is made primary emulsion in 60 ℃ of high-speed stirred.Get primary emulsion, water for injection adds to recipe quantity, and regulating pH value is 5.0～7.0, is transferred in the high pressure dispersing emulsification machine, emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly, and the fill of aseptic filtration inflated with nitrogen, sterilization are both.
Prescription three: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, phosphatidase 10 .5%-4.0%, solutolHS15 0.5%-3.0%, glycerol 1.0%-6.0%, triglyceride 5%-20%, oleic acid 1.0%-6.0%, tocopherol 0.01%-1.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in an amount of organic solvent, add refined soybean oil or midchain oil 10g, oleic acid 3g, high-speed stirred makes mix homogeneously, removes organic solvent in 60 ℃ of distilling under reduced pressure, makes oil phase; Take by weighing salvianolic acid material (total tanshinone content 80%) 120mg, soybean phospholipid 1.5g, solutolHS15 1.0g, glycerol 3g, tocopherol 50mg and make abundant dispersion, make water in 60 ℃ of high-speed stirred.The biphase mixing of profit is made primary emulsion in 60 ℃ of high-speed stirred.Get primary emulsion, water for injection adds to recipe quantity, and regulating pH value is 5.0～7.0, is transferred in the high pressure dispersing emulsification machine, emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly, and the fill of aseptic filtration inflated with nitrogen, sterilization are both.
Prescription four: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, phosphatidase 10 .5%-4.0%, solutolHS15 0.5%-3.0%, glycerol 1.0%-6.0%, triglyceride 5%-20%, oleic acid 1.0%-6.0%, tocopherol 0.01%-1.0%, PEG400/600 0.1%-5.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in an amount of organic solvent, add refined soybean oil or midchain oil 10g, oleic acid 3g, high-speed stirred makes mix homogeneously, removes organic solvent in 60 ℃ of distilling under reduced pressure, makes oil phase; Take by weighing salvianolic acid material (total tanshinone content 80%) 120mg, soybean phospholipid 1.3g, solutolHS15 1.0g, glycerol 3g, tocopherol 50mg, PEG400 0.5g and make abundant dispersion, make water in 60 ℃ of high-speed stirred.The biphase mixing of profit is made primary emulsion in 60 ℃ of high-speed stirred.Get primary emulsion, water for injection adds to recipe quantity, and regulating pH value is 5.0～7.0, is transferred in the high pressure dispersing emulsification machine, emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly, and the fill of aseptic filtration inflated with nitrogen, sterilization are both.
Prescription five: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, phosphatidase 10 .5%-4.0%, solutolHS15 0.5%-3.0%, glycerol 1.0%-6.0%, triglyceride 5%-20%, oleic acid 1.0%-6.0%, tocopherol 0.01%-1.0%, PEG400/600 0.1%-5.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in an amount of organic solvent, add refined soybean oil or midchain oil 10g, oleic acid 3g, high-speed stirred makes mix homogeneously, removes organic solvent in 60 ℃ of distilling under reduced pressure, makes oil phase; Take by weighing salvianolic acid material (total tanshinone content 80%) 120mg, soybean phospholipid 1.3g, solutolHS15 1.0g, glycerol 3g, tocopherol 50mg, PEG400/600 0.4g and make abundant dispersion, make water in 60 ℃ of high-speed stirred.The biphase mixing of profit is made primary emulsion in 60 ℃ of high-speed stirred.Get primary emulsion, water for injection adds to recipe quantity, and regulating pH value is 5.0～7.0, is transferred in the high pressure dispersing emulsification machine, emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly, and the fill of aseptic filtration inflated with nitrogen, sterilization are both.
Prescription six: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, contain phospholipid 0.5%-4.0%, glycerol 1.0%-6.0%, ethyl oleate 5%-20%, oleic acid 1.0%-6.0%, tocopherol 0.01%-1.0%, water for injection adds to 100%.
Taking by weighing TANSHINONES (total tanshinone content 93%) 100mg is dissolved in an amount of organic solvent, add ethyl oleate 10g, oleic acid 3g, high-speed stirred makes mix homogeneously, remove organic solvent in 60 ℃ of distilling under reduced pressure, make oil phase: take by weighing salvianolic acid material (total tanshinone content 80%) 120mg, soybean phospholipid 2.0g, glycerol 3g, tocopherol 50mg and make abundant dispersion, make water in 60 ℃ of high-speed stirred.The biphase mixing of profit is made primary emulsion in 60 ℃ of high-speed stirred.Get primary emulsion, water for injection adds to recipe quantity, and regulating pH value is 5.0～7.0, is transferred in the high pressure dispersing emulsification machine, emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly, and the fill of aseptic filtration inflated with nitrogen, sterilization are both.
Prescription seven: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, contain phospholipid 0.5%-4.0%, solutolHS15 0.5%-3.0%, glycerol 1.0%-6.0%, ethyl oleate 5%-20%, oleic acid 1.0%-6.0%, tocopherol 0.01%-1.0%, PEG400/600 0.1%-5.0%, water for injection adds to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in an amount of organic solvent, add ethyl oleate 10g, oleic acid 3g, high-speed stirred makes mix homogeneously, removes organic solvent in 60 ℃ of distilling under reduced pressure, makes oil phase; Take by weighing salvianolic acid material (total tanshinone content 80%) 120mg, soybean phospholipid 1.3g, solutolHS15 1.0g, glycerol 3g, tocopherol 50mg, PEG400/600 500mg and make abundant dispersion, make water in 60 ℃ of high-speed stirred.The biphase mixing of profit is made primary emulsion in 60 ℃ of high-speed stirred.Get primary emulsion, water for injection adds to recipe quantity, and regulating pH value is 5.0～7.0, is transferred in the high pressure dispersing emulsification machine, emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly, and the fill of aseptic filtration inflated with nitrogen, sterilization are both.
Embodiment 2 (nanometer microemulsion type)
Prescription one: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, solutolHS15 0.2%-10.0%, dehydrated alcohol 0.01%-8%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in the 1g ethanol, add solutolHS15 1.5g and suitable quantity of water and make mix homogeneously in 40 ℃ of stirrings; Take by weighing salvianolic acid material (total tanshinone content 80%) 120mg and be dissolved in the suitable quantity of water, both are settled to 100ml at mixing, make microemulsion in 40 ℃ of high-speed stirred.Regulating pH value is 5.0～7.0, the fill of aseptic filtration inflated with nitrogen, and sterilization both got.
Prescription two: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, solutolHS15 0.2%-10.0%, dehydrated alcohol 0.01%-8%, ethyl oleate 0.01%-8%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in the 1g ethanol, add in ethyl oleate 0.5mg, solutolHS15 1.5g and the suitable quantity of water, make mix homogeneously in 40 ℃ of stirrings; Salvianolic acid material (total tanshinone content 80%) 120mg is dissolved in the suitable quantity of water, and both are settled to 100ml at mixing, and regulating pH value is 5.0～7.0, makes microemulsion in 40 ℃ of high-speed stirred.The fill of aseptic filtration inflated with nitrogen, sterilization both got.
Prescription three: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, solutolHS15 0.2%-10.0%, medium chain triglyceride 0.01%-5%, dehydrated alcohol 0.01%-8%, PEG400/600 0.1%-5.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in the 1g ethanol, add in solutolHS15 1.0g, medium chain triglyceride 0.3g and the suitable quantity of water, make mix homogeneously in 40 ℃ of stirrings; Salvianolic acid material (total tanshinone content 80%) 120mg, PEG400/600 300mg are dissolved in the suitable quantity of water, and both are settled to 100ml at mixing, and regulating pH value is 5.0～7.0, makes microemulsion in 40 ℃ of high-speed stirred.The fill of aseptic filtration inflated with nitrogen, sterilization both got.
Prescription four: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, phosphatidase 10 .2%-10.0%, dehydrated alcohol 0.01%-10%, hydroxypropyl 0.1%-5.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in the 1g ethanol, add in phosphatidase 11 .2g and the suitable quantity of water, make mix homogeneously in 40 ℃ of stirrings; Salvianolic acid material (total tanshinone content 80%) 120mg, hydroxypropyl 300mg are dissolved in the suitable quantity of water, and both are settled to 100ml at mixing, and regulating pH value is 5.0～7.0, makes microemulsion in 40 ℃ of high-speed stirred.The fill of aseptic filtration inflated with nitrogen, sterilization both got.
Prescription five: tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, tween 80 0.01%-2.0%, dehydrated alcohol 0.01%-8%, glycerol 0.01%-3.0%, water for injection add to 100%.
Take by weighing TANSHINONES (total tanshinone content 93%) 100mg and be dissolved in the 1g ethanol, add in tween 80 1g, glycerol 0.5g and the suitable quantity of water, make mix homogeneously in 40 ℃ of stirrings; Salvianolic acid material (total tanshinone content 80%) 120mg is dissolved in an amount of water for injection, and both are settled to 100ml at mixing, and regulating pH value is 5.0～7.0, makes microemulsion in 40 ℃ of high-speed stirred.The fill of aseptic filtration inflated with nitrogen, sterilization both got.
Embodiment 3 (pharmacodynamic study data)
Cause dog acute experiment myocardial infarction and ischemia model with the ligation arteria coronaria, adopt epicardial electrogram mapping myocardial ischemia scope and degree, quantitative tissue is learned (N-BT staining) and is measured myocardial infarct size.Observe the influence of injection of the present invention and commercially available Danshen root injection, the results are shown in accompanying drawing experimental dog myocardial ischemia and myocardial infarction.The result shows, embodiment of the invention 2:5mg/kg, embodiment of the invention 6:2.5mg/kg and 5mg/kg improve significantly to experimental acute dog myocardial ischemia, can significantly alleviate myocardial ischemia scope (N-ST), and its effect is better than Radix Salviae Miltiorrhizae Injection 0.5g/kg.
Annotate: 1: the normal saline group
2: Radix Salviae Miltiorrhizae Injection 0.5g/kg group
3: embodiment 2 (prescription one): 2.5mg/kg
4: embodiment 1 (prescription one): 5mg/kg
5: embodiment 1 (prescription five): 5mg/kg
Claims (10)
1, a kind of emulsion of red sage root for injection, it contains Radix Salviae Miltiorrhizae extract, surfactant and water-bearing media, it is characterized in that: this injection is a kind of aqueous dispersion, the mean diameter of decentralized photo≤0.5 micron, the concentration of extract is 0.01%～5.0% in the injection, is called microemulsion formulation or inferior nano-emulsion preparation on pharmaceutics.
2, according to Radix Salviae Miltiorrhizae Injection novel form in the claim 1:
(1) Radix Salviae Miltiorrhizae extract is characterized in that containing tanshinone material and salvianolic acid material, and wherein the content of tanshinone material in liposoluble extract is 50-99.99%, and salvianolic acid material content in water solubility extract is 50-99.99%.
(2) surfactant is characterized in that being selected from: one or more in phospholipid (plant phospholipid, animal phospholipid, synthetic phospholipid), propylene glycol, fatty glyceride, solutolHS15, labrosol, Tweens, poloxamer series, polyoxyethylene fatty acid ester, Polyethylene Glycol and derivant series thereof, hydroxypropyl, the hydroxypropyl gamma-cyclodextrin; Can also add triglyceride in the surfactant or as the glycerol of isotonic agent, wherein triglyceride comprises vegetable oil or medium chain triglyceride, can also add fatty acid or aliphatic alcohol or its sodium salt as co-emulsifier, cholic acid or deoxycholic acid and sodium salt thereof, wherein the carbon number that comprises of fatty acid or aliphatic alcohol can be from 6-24, antioxidant such as tocopherol (vitamin E) or L-ascorbyl palmitate can also be added, cosolvent ethanol can also be added.
3, according to emulsion of red sage root for injection among the claim 1-2, it is characterized in that by weight, contain tanshinone material 0.01%-2.0%, salvianolic acid material 0.01%-3.0%, surfactant 1.0%-30.0%, water for injection and add to 100%.
4, according to the surfactant in the claim 3, it is characterized in that by weight, contain phospholipid 0.5%-4.0%, glycerol 1.0%-6.0%, triglyceride 5%-20%, oleic acid 1.0%-6.0%; Can also contain tocopherol 0.01%-1.0%; Can also contain hydroxypropyl 0.5%-5.0% or PEG400/600 0.1%-5.0%.
5, according to the surfactant in the claim 3, it is characterized in that by weight, contain phospholipid 0.5%-4.0%, glycerol 1.0%-6.0%, triglyceride 5%-20%, oleic acid 1.0%-6.0%; Can also contain solutolHS15 0.5%-3.0%, tocopherol 0.01%-1.0%; Can also contain hydroxypropyl 0.5%-5.0% or PEG400/600 0.1%-5.0%.
6, according to the surfactant in the claim 3, it is characterized in that by weight, contain phospholipid 0.5%-4.0%, glycerol 1.0%-6.0%, ethyl oleate 5%-20%, oleic acid 1.0%-6.0%; Can also contain solutolHS15 0.5%-3.0%, tocopherol 0.01%-1.0%; Can also contain PEG400/600 0.1%-5.0%.
7, according to the surfactant in the claim 3, it is characterized in that by weight, contain solutolHS15 0.2%-10.0%, dehydrated alcohol 0.01%-8%, medium chain triglyceride 0.01%-5%, can also contain PEG400/600 0.1%-5.0% or hydroxypropyl 0.1%-5.0%.
8, according to the surfactant in the claim 3, it is characterized in that by weight, contain phospholipid 0.2%-10.0%, dehydrated alcohol 0.01%-10%, can also contain PEG400/600 0.1%-5.0% or hydroxypropyl 0.1%-5.0%.
9, according to the surfactant in the claim 3, it is characterized in that by weight, contain tween 80 0.01%-2.0%, dehydrated alcohol 0.01%-8%, can also contain glycerol or triglyceride 0.01%-3.0%.
10, according to emulsion of red sage root for injection in the claim 1, it is characterized in that according to injection in the claim 1, the tanshinone material can be made nano-emulsion preparation or inferior nano-emulsion preparation separately, the salvianolic acid material is made liquid drugs injection, during administration with tanshinone emulsion with danshensu liquid drugs injection dilution posterior vein drop or inject; Also the tanshinone material can be made the decentralized photo of Emulsion, during the salvianolic acid material is soluble in the aqueous phase, during administration with an amount of 0.9% sodium chloride solution or 5% glucose dilution posterior vein drop or inject.Its preparation method is as follows:
A) the tanshinone material is dissolved in triglyceride or the ethyl oleate, make oil phase in 50-90 ℃ of high-speed stirred, all the other components are dissolved in the suitable quantity of water, make water in 50-90 ℃ of high-speed stirred, the biphase 50-90 of being mixed in of a profit ℃ high-speed stirred is made primary emulsion, and the adjusting pH value is 5.0-7.0.
B) get primary emulsion in above-mentioned (a), water for injection adds to recipe quantity, is transferred in the high pressure dispersing emulsification machine, and emulsifying is to emulsion droplet mean diameter≤0.5 micron repeatedly.
C) after the Emulsion of getting above-mentioned (b) filtered, inflated with nitrogen fill, sterilization were both.
Wherein the nanometer microemulsion formulation only needs high-speed stirred to form, and does not need the emulsifying of high pressure dispersing emulsification machine.
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| CN101933975A (en) * | 2010-09-08 | 2011-01-05 | 西北大学 | Method for preparing flos magnoliae volatile oil high-efficiency active site nano emulsion |
| CN103919759A (en) * | 2014-04-06 | 2014-07-16 | 吴静 | Pharmaceutical composition comprising salvianic acid a sodium and salvianolic acid F and preparation of pharmaceutical composition |
| CN110638756A (en) * | 2019-11-07 | 2020-01-03 | 辰风天然本草(北京)科技有限公司 | Composition containing cannabidiol and preparation method thereof |
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| CN103919759B (en) * | 2014-04-06 | 2016-03-16 | 吴静 | A kind of containing danshensu sodium, the pharmaceutical composition of salvia miltiorrhiza tanshinoate F and preparation thereof |
| CN110638756A (en) * | 2019-11-07 | 2020-01-03 | 辰风天然本草(北京)科技有限公司 | Composition containing cannabidiol and preparation method thereof |
| CN110638756B (en) * | 2019-11-07 | 2021-10-08 | 辰风天然本草(北京)科技有限公司 | Composition containing cannabidiol and preparation method thereof |
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