CN109364021A - A kind of injection vinpocetine - Google Patents
A kind of injection vinpocetine Download PDFInfo
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- CN109364021A CN109364021A CN201811255451.4A CN201811255451A CN109364021A CN 109364021 A CN109364021 A CN 109364021A CN 201811255451 A CN201811255451 A CN 201811255451A CN 109364021 A CN109364021 A CN 109364021A
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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
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/4375—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 nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Abstract
The present invention provides a kind of injection vinpocetine, by weight, comprising: injection vinpocetine S 10-30 parts by weight, citric acid 7-21 parts by weight, 90 parts by weight of mannitol, sorbierite 10-30 parts by weight, water 1800-2000 parts by weight.Vinpocetine is insoluble in water, and for the present invention by carrying out screening study to formulation and technology, discovery can achieve preferable solute effect by the pH value of regulating liquid medicine, and the type and dosage of pH adjusting agent has been determined.The use of mannitol and sorbierite, it can be avoided auxiliary material benzyl alcohol contained in existing injection formula to be not easy to be absorbed by the body, it accumulates for a long time in injection site, it will lead to the necrosis of Surrounding muscles, serious person, the problem of even influencing the development of bone, the present invention improves the stability and safety of the medicine using other auxiliary materials and technology.
Description
Technical field
The present invention relates to field of medicaments, specifically, being related to a kind of injection vinpocetine.
Background technique
Vinpocetine is a kind of natural drug that European Section scholar extracts from periwinkle, belongs to indoles alkaloid.
Since listing in 1978, because its significant clinical effectiveness and good safety, application range constantly expand, Europe is become
Beauty and Japan are for treating cardiovascular and cerebrovascular disease routine administration.A large amount of scientific researches in decades and clinical practice confirmation, Changchun
Western spit of fland can selectively improve cerebral blood circulation, increase cerebral blood flow (CBF), reduce cerebral vascular resistance and alleviate illness, adjust nerve and pass
Matter system function, various aspects protect brain from damage caused by due to anoxic, are to improve brain metabolism, prevent brain cell tissue from declining
One of old and therapeutic agent of nootropic effect, especially suitable for preventing and treating cerebral insufficiency, apoplexy and symptom related with aging,
And there is special effect to cognition and memory.Nineteen ninety-five by U.S.'s Life Extention magazine be classified as ten big anti-aging drugs it
One.
Vinpocetine can not only treat the prevention and treatment of cerebrovascular deficiency and its adverse consequences, moreover it is possible to improve health
The cerebration of people also has better effects to its functional symptoms.Therefore since the medicine Hungary listing after, it is many country
Imitated right is won, competitively exploitation listing, the compound preparation containing vinpocetine constantly come out, which is widely used in
Clinic makes numerous patients obtain effective treatment.In short, adverse reaction is few for vinpocetine, mild degree, tolerance is good, clinical
Pharmacological action is extensive, is the drug for having broad prospect of application.
Auxiliary material benzyl alcohol contained in existing injection formula is not easy to be absorbed by the body, and is accumulated for a long time in injection site,
It will lead to the necrosis of Surrounding muscles, serious person, or even influence the development of bone, so we are when researching and developing the kind, it is special
Ground avoids the auxiliary material, and the stability and safety of the medicine are improved using other auxiliary materials and technology.Therefore this product is developed
Kind, clinical application demand can be enriched, the market competitiveness of the kind is increased, and finally promotes the decline of the medicine price, it is convenient
Patient medication and the drug safety for improving patient.
Summary of the invention
The technical problem to be solved by the present invention is in view of the deficiencies of the prior art, provide a kind of injection vinpocetine.
The technical scheme to solve the above technical problems is that
A kind of injection vinpocetine, by weight, comprising: injection vinpocetine S 10-30 parts by weight, citric acid
7-21 parts by weight, 90 parts by weight of mannitol, sorbierite 10-30 parts by weight, water 1800-2000 parts by weight.
The beneficial effects of the present invention are: vinpocetine is insoluble in water, the present invention by carrying out screening study to formulation and technology,
It was found that can achieve preferable solute effect by the pH value of regulating liquid medicine, and the type and dosage of pH adjusting agent is determined
(10% citric acid soln, every gram of vinpocetine about need the citric acid soln of 7ml 10%).The use of mannitol and sorbierite,
It can be avoided auxiliary material benzyl alcohol contained in existing injection formula to be not easy to be absorbed by the body, be accumulated for a long time in injection site,
The problem of will lead to the necrosis of Surrounding muscles, serious person, or even influencing the development of bone, the present invention uses other auxiliary materials and technology
Improve the stability and safety of the medicine.
Vinpocetine has a variety of effects, can improve cerebral metabolism, blood flow and hemorheology properties.
1, neuroprotection: vinpocetine can alleviate the cytotoxicity of excitatory amino acid induction, inhibit voltage
The sodium-ion channel and calcium channel of dependence, NMDA and ampa receptor, enhance the neuroprotection of adenosine.
2, promote cerebrum metabolism: vinpocetine can increase cerebral tissue to the intake of glucose and oxygen with disappear
Consumption improves the anoxia endurance of brain, reinforces the transport that brain sole energy source-glucose-penetrates blood-brain barrier, by glucose
Metabolism be transformed into more favorable aerobic metabolism access.Vinpocetine alternative inhibits calcium ion-calmodulin to rely on
It is horizontal to increase cGMP and cAMP in brain for cGMP- phosphodiesterase.The concentration and ATP/AMP ratio of ATP can be improved in vinpocetine；
Norepinephrine and serotonin in brain is promoted to update.Vinpocetine also Wheat Protein.
3, improve brain microcirculation: vinpocetine can inhibit platelet aggregation, reduction pathologic blood viscosity increases, it is red to increase
Deformability deformability of cells inhibits red blood cell intake adenosine, vinpocetine can also promote tissue by reducing the oxygen affinity of red blood cell
O_2 transport.
4, selectivity increases cerebral blood flow: vinpocetine can increase the brain supply percentage of cardiac output, reduce brain
Parameter (such as blood pressure, cardiac output, pulse, peripheral blood vessel drag overall) of the vascular resistence without influencing body circulation, vinpocetine is not
It can cause " Steal phenomenon ".And during the administration, it can also promote the Low perfusion for being damaged (there are no necrosis) locally to lack
The blood supply (stealing the overturning of blood effect) in blood region.
Further, the preparation method of the injection vinpocetine includes the following steps:
1) water of about 900-1000 parts by weight is added in dense preparing tank, adds mannitol, the 10-30 parts by weight of 90 parts by weight
Sorbierite stirring and dissolving, be added active carbon stirring, adsorb it sufficiently, filtering decarbonization to dilute preparing tank, then cools down later
Solution 1；
2) by suitable citric acid citric acid soln soluble in water for being configured to mass fraction 10%, it is slowly added to 10-30
The vinpocetine of parts by weight is stirred to dissolution (citric acid soln that every gram of vinpocetine about needs 7ml10%), and wetting is added
The activated carbon adsorption of 0.1% (g/ml), filtering decarbonization obtain solution 2；
3) solution 2 is added in 1 and will be mixed evenly, survey pH value, with 10% citric acid soln tune pH to 3.0-4.0,
Remaining water is added；
4) after mixing evenly, sample detection；
5) it after detection is qualified, in medical filtration to fluid reservoir (surge tank), is filtered again to the medical fluid receiving tank of bottling department
Middle progress is filling.
Further, in the step 1 water and temperature is≤80 DEG C, the additional amount of active carbon is 0.2% (g/ml), described
Filtering uses aperture for 0.45 μm of polypropylene microporous filter membrane；The temperature that cools down is≤40 DEG C.
Further, in the step 2 citric acid solution temperature≤40 DEG C, the adsorption time of active carbon is 20 minutes, institute
Stating filtering uses aperture for 0.45 μm of polypropylene microporous filter membrane.
Further, the mixing time in the step 4) is 5 minutes.
Further, the sample detection in the step 4), including primary detection and the detection of quality inspection portion, the primary are detected as
Open sample cock, take a sample to check visible foreign matters and acidity；Quality inspection portion is detected as after primary detection is qualified, with triangular pyramidal bottle
The detection that sampling 100ml send Quality Mgmt Dept to carry out intermediate products content and pH value.
Further, it in the step 5), filters carry out refined filtration using polyethersulfone millipore filter twice, the polyether sulfone is micro-
The aperture of hole filter membrane is 0.22 μm.
Further, the preparation method further includes 6) freeze-drying step: plate temperature is arranged -45 DEG C or less and keeps the temperature about 1
~3 hours, drying temperature≤35 DEG C, the moisture content < 4% of freeze-dried products；Gradual heating: heating plate layer rises for 1 hour when beginning
Temperature is to -10 DEG C；It is warming up to 10 DEG C within 2 hours later, is warming up to 20 DEG C within 5 hours later, be warming up within 2 hours later 35 DEG C and keep the temperature 6
Hour.
Specific embodiment
Principles and features of the present invention are described with reference to embodiments, the given examples are served only to explain the present invention,
It is not intended to limit the scope of the present invention.
A kind of injection vinpocetine, by weight, comprising: injection vinpocetine S 10-30 parts by weight, citric acid
7-21 parts by weight, 90 parts by weight of mannitol, sorbierite 10-30 parts by weight, water 1800-2000 parts by weight.Vinpocetine is insoluble in
Water, by carrying out screening study to formulation and technology, discovery can achieve preferable dissolution effect by the pH value of regulating liquid medicine for we
Fruit, and (10% citric acid soln, every gram of vinpocetine about need the Chinese holly of 7ml 10% to the type and dosage that pH adjusting agent has been determined
Rafter acid solution).The use of mannitol and sorbierite can be avoided auxiliary material benzyl alcohol contained in existing injection formula and be not easy
It is absorbed by the body, accumulates the necrosis that will lead to Surrounding muscles in injection site, serious person for a long time, or even influence the development of bone
The problem of, the present invention improves the stability and safety of the medicine using other auxiliary materials and technology.
As further scheme of the invention, the preparation method of the injection vinpocetine includes the following steps:
1) water of about 900-1000 parts by weight is added in dense preparing tank, adds mannitol, the 10-30 parts by weight of 90 parts by weight
Sorbierite stirring and dissolving, be added active carbon stirring, adsorb it sufficiently, filtering decarbonization to dilute preparing tank, then cools down later
Solution 1；
2) by suitable citric acid citric acid soln soluble in water for being configured to mass fraction 10%, it is slowly added to recipe quantity
Vinpocetine stir to dissolution (citric acid soln that every gram of vinpocetine about needs 7ml10%), 0.1% (g/ of wetting is added
Ml activated carbon adsorption), filtering decarbonization obtain solution 2；
3) solution 2 is added in 1 and will be mixed evenly, survey pH value, with 10% citric acid soln tune pH to 3.0-4.0,
Remaining water is added；
4) after mixing evenly, sample detection；
5) it after detection is qualified, in medical filtration to fluid reservoir (surge tank), is filtered again to the medical fluid receiving tank of bottling department
Middle progress is filling.
As further scheme of the invention, in the step 1 water and temperature is≤80 DEG C, the additional amount of active carbon is
0.2% (g/ml), the filtering use aperture for 0.45 μm of polypropylene microporous filter membrane；The temperature that cools down is≤40 DEG C.
As further scheme of the invention, solution temperature≤40 DEG C of citric acid, the absorption of active carbon in the step 2
Time is 20 minutes, and the filtering uses aperture for 0.45 μm of polypropylene microporous filter membrane.
As further scheme of the invention, the mixing time in the step 4) is 5 minutes,
As further scheme of the invention, sample detection in the step 4), including primary detection and the inspection of quality inspection portion
It surveys, the primary is detected as opening sample cock, take a sample to check visible foreign matters and acidity；Quality inspection portion is detected as closing in primary detection
After lattice, the detection that 100ml send Quality Mgmt Dept to carry out intermediate products content and pH value is sampled with triangular pyramidal bottle；
As further scheme of the invention, in the step 5), filters carried out using polyethersulfone millipore filter twice
Refined filtration, the aperture of the polyethersulfone millipore filter are 0.22 μm.
As further scheme of the invention, the preparation method further includes 6) freeze-drying step: by plate temperature setting-
45 DEG C or less and heat preservation about 1~3 hour, drying temperature≤35 DEG C, the moisture content < 4% of freeze-dried products；Heating plate layer, gradual liter
Temperature: -10 DEG C are warming up within 1 hour when beginning；It is warming up to 10 DEG C within 2 hours later, is warming up to 20 DEG C within 5 hours later, rise within 2 hours later
Temperature is to 35 DEG C and keeps the temperature 6 hours.
Embodiment 1
The present invention provides a kind of injection vinpocetine, comprising: injection vinpocetine S 10g, citric acid 7g, mannitol
90g, sorbierite 10g, and said mixture is settled in 2L water.
Embodiment 2
The present invention provides a kind of injection vinpocetine, comprising: injection vinpocetine S 20g, citric acid 14g, sweet dew
Alcohol 90g, sorbierite 20g, and said mixture is settled in 2L water.
Embodiment 3
The present invention provides a kind of injection vinpocetine, comprising: injection vinpocetine S 30g, citric acid 21g, sweet dew
Alcohol 90g, sorbierite 30g, and said mixture is settled in 2L water.
The ingredient and its filling and package of injection in embodiment 1-4 see the table below:
The preparation process of injection medicament in above-described embodiment 1-3 is as follows:
1) water for injection of temperature≤80 DEG C of about 50% recipe quantity is added in dense preparing tank, recipe quantity mannitol, mountain is added
Pears alcohol stirring and dissolving, the active carbon that 0.2% (g/ml) of wetting is added after dissolution stirs 20 minutes, through 0.45 μm of miillpore filter
Then (polypropylene) filtering decarbonization cools to≤40 DEG C and obtains solution 1 to dilute preparing tank.
2) suitable citric acid is dissolved in be configured in≤40 DEG C of water for injection 10% citric acid soln, be slowly added to
The vinpocetine of recipe quantity is stirred to dissolution (citric acid soln that every gram of vinpocetine about needs 7ml10%), and wetting is added
The activated carbon adsorption of 0.1% (g/ml) 20 minutes obtains solution 2 through 0.45 μm of miillpore filter (polypropylene) filtering decarbonization.
3) solution 2 is added in 1 and will be mixed evenly, survey pH value, with 10% citric acid soln tune pH to 3.0-4.0,
Water for injection is mended to recipe quantity.
4) stirring is sampled after five minutes, sample cock is opened, after workshop checks that visible foreign matters and acidity are qualified, with three
Pyramid bottle sampling 100ml send Quality Mgmt Dept to carry out intermediate products detection, content, pH value etc.；
5) after intermediate products detection is qualified, with pneumatics, nitrogen or sanitary pump by medical fluid through 0.22 μm of filtering with microporous membrane extremely
In fluid reservoir (surge tank), then through twin-stage 0.22 μm of miillpore filter (poly (ether sulfone) film) filtering into the medical fluid receiving tank of bottling department into
Row is filling.
6) freeze drying process:
1. plate temperature is arranged -45 DEG C or less and keeps the temperature about 1~3 hour, drying temperature≤35 DEG C, the moisture content < of freeze-dried products
4%.
2. heating plate layer, by temperature programming:
Temperature program: -10 DEG C are warming up within about 1 hour；10 DEG C are warming up within about 2 hours, is warming up to 20 DEG C within about 5 hours, about 2 is small
When be warming up to 35 DEG C and keep the temperature about 6 hours and according to vacuum degree increasing degree judge shut down.
Vinpocetine has a variety of effects, can improve cerebral metabolism, blood flow and hemorheology properties.
1, neuroprotection: vinpocetine can alleviate the cytotoxicity of excitatory amino acid induction, inhibit voltage
The sodium-ion channel and calcium channel of dependence, NMDA and ampa receptor, enhance the neuroprotection of adenosine.
2, promote cerebrum metabolism: vinpocetine can increase cerebral tissue to the intake of glucose and oxygen with disappear
Consumption improves the anoxia endurance of brain, reinforces the transport that brain sole energy source-glucose-penetrates blood-brain barrier, by glucose
Metabolism be transformed into more favorable aerobic metabolism access.Vinpocetine alternative inhibits calcium ion-calmodulin to rely on
It is horizontal to increase cGMP and cAMP in brain for cGMP- phosphodiesterase.The concentration and ATP/AMP ratio of ATP can be improved in vinpocetine；
Norepinephrine and serotonin in brain is promoted to update.Vinpocetine also Wheat Protein.
3, improve brain microcirculation: vinpocetine can inhibit platelet aggregation, reduction pathologic blood viscosity increases, it is red to increase
Deformability deformability of cells inhibits red blood cell intake adenosine, vinpocetine can also promote tissue by reducing the oxygen affinity of red blood cell
O_2 transport.
4, selectivity increases cerebral blood flow: vinpocetine can increase the brain supply percentage of cardiac output, reduce brain
Parameter (such as blood pressure, cardiac output, pulse, peripheral blood vessel drag overall) of the vascular resistence without influencing body circulation, vinpocetine is not
It can cause " Steal phenomenon ".And during the administration, it can also promote the Low perfusion for being damaged (there are no necrosis) locally to lack
The blood supply (stealing the overturning of blood effect) in blood region.
Auxiliary material benzyl alcohol contained in injection formula in the prior art is not easy to be absorbed by the body, and accumulates injecting for a long time
Position, will lead to the necrosis of Surrounding muscles, serious person, or even influence the development of bone, thus we research and develop the kind when
It waits, specially avoids the auxiliary material, the stability and safety of the medicine are improved using other auxiliary materials and technology.Therefore it develops
This kind can enrich clinical application demand, increase the market competitiveness of the kind, and finally promote the decline of the medicine price,
Facilitate patient medication and improves the drug safety of patient.
Vinpocetine is insoluble in water, and for the present invention by carrying out screening study to formulation and technology, discovery passes through regulating liquid medicine
PH value can achieve preferable solute effect, and determined pH adjusting agent type and dosage (10% citric acid soln, every gram
Vinpocetine about needs the citric acid soln of 7ml 10%).
The foregoing is merely presently preferred embodiments of the present invention, is not intended to limit the invention, it is all in spirit of the invention and
Within principle, any modification, equivalent replacement, improvement and so on be should all be included in the protection scope of the present invention.
Claims (8)
1. a kind of injection vinpocetine, which is characterized in that by weight, comprising: injection vinpocetine S 10-30 weight
Part, citric acid 7-21 parts by weight, 90 parts by weight of mannitol, sorbierite 10-30 parts by weight, water 1800-2000 parts by weight.
2. a kind of injection vinpocetine according to claim 1, which is characterized in that the system of the injection vinpocetine
Preparation Method includes the following steps:
1) water of about 900-1000 parts by weight is added in dense preparing tank, adds the mannitol of 90 parts by weight, the mountain of 10-30 parts by weight
Pears alcohol stirring and dissolving is added active carbon stirring, adsorbs it sufficiently, later filtering decarbonization to dilute preparing tank, then cool down to obtain solution
1；
2) by suitable citric acid citric acid soln soluble in water for being configured to mass fraction 10%, it is slowly added to 10-30 weight
The vinpocetine of part is stirred to dissolution, and activated carbon adsorption is added, and filtering decarbonization obtains solution 2；
3) solution 2 is added in 1 and is mixed evenly, survey pH value, with 10% citric acid soln tune pH to 3.0-4.0, be added
Remaining water；
4) after mixing evenly, sample detection；
5) after detection is qualified, medical filtration into fluid reservoir, filtered again into the medical fluid receiving tank of bottling department carry out it is filling.
3. a kind of injection vinpocetine according to claim 2, which is characterized in that in the step 1 water and temperature
It is≤80 DEG C, the additional amount of active carbon is 0.2% (g/ml), and the filtering uses aperture to filter for 0.45 μm of polypropylene microporous
Film；The temperature that cools down is≤40 DEG C.
4. a kind of injection vinpocetine according to claim 2, which is characterized in that citric acid is molten in the step 2
Temperature≤40 DEG C are solved, the adsorption time of active carbon is 20 minutes, and the filtering uses aperture to filter for 0.45 μm of polypropylene microporous
Film.
5. a kind of injection vinpocetine according to claim 2, which is characterized in that the mixing time in the step 4)
It is 5 minutes.
6. a kind of injection vinpocetine according to claim 2, which is characterized in that the sampling inspection in the step 4)
It surveys, including primary detection and the detection of quality inspection portion, the primary are detected as opening sample cock, take a sample to check visible foreign matters and acid
Degree；Quality inspection portion is detected as after primary detection is qualified, send Quality Mgmt Dept to carry out intermediate products content with triangular pyramidal bottle sampling 100ml
With the detection of pH value.
7. a kind of injection vinpocetine according to claim 2, which is characterized in that in the step 5), filter twice
Refined filtration is carried out using polyethersulfone millipore filter, the aperture of the polyethersulfone millipore filter is 0.22 μm.
8. according to a kind of any injection vinpocetine of claim 2-7, which is characterized in that the preparation method is also wrapped
Include, 6) freeze-drying step: plate temperature is arranged -45 DEG C or less and keeps the temperature about 1~3 hour, drying temperature≤35 DEG C, freeze-dried products
Moisture content < 4%；Gradual heating: heating plate layer is warming up to -10 DEG C in 1 hour when beginning；It is warming up to 10 DEG C within 2 hours later, it
It is warming up to 20 DEG C within 5 hours afterwards, is warming up within 2 hours later 35 DEG C and keeps the temperature 6 hours.
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| CN201811255451.4A CN109364021A (en) | 2018-10-26 | 2018-10-26 | A kind of injection vinpocetine |
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| CN101791310A (en) * | 2010-02-24 | 2010-08-04 | 王保明 | Vinpocetine medicine composition and preparation method thereof |
| US20180071390A1 (en) * | 2013-04-02 | 2018-03-15 | Themis Medicare Limited | Compositions of pharmaceutical actives containing diethylene glycol monoethyl ether or other alkyl derivatives |
| CN105213323A (en) * | 2014-05-30 | 2016-01-06 | 海南通用康力制药有限公司 | A kind of preparation method of injection vinpocetine lyophilized powder |
| CN105267160A (en) * | 2015-11-24 | 2016-01-27 | 河北智同生物制药有限公司 | Vinpocetine freeze-drying preparation composition for injection and preparing method thereof |
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