CN101721361A - Pervone vincamine injection and preparation process thereof - Google Patents
Pervone vincamine injection and preparation process thereof Download PDFInfo
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- CN101721361A CN101721361A CN200910227968A CN200910227968A CN101721361A CN 101721361 A CN101721361 A CN 101721361A CN 200910227968 A CN200910227968 A CN 200910227968A CN 200910227968 A CN200910227968 A CN 200910227968A CN 101721361 A CN101721361 A CN 101721361A
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- vincamine
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Abstract
The invention provides a pervone vincamine injection and a preparation process thereof, relating to the technical field of pervone vincamine injections and preparation processes thereof. The injection is a solution type injection or frozen powder injection, and the solution type injection is divided into a water injection and a drug-carried type infusion solution, wherein the contained active constituent is the pervone vincamine, and the pervone vincamine can exit in the form of soluble salt. The invention has the advantages that compared with the prior art, the injection has the characteristics of unique formulation, convenient use, fast curative effect, safety, reliability and the like, and is applied to the clinical treatment, in particular to the intravenous injection for some patients who can not swallow drugs due to all kinds of reasons or can not carry out the oral administration due to the gastrointestinal tract dysfunction; and the preparation process is simple, convenient and economical, is easy for industrial production, has high economic and social benefits, and solves the key problem that the solubility of the pervone vincamine is lower in water because the pervone vincamine belongs to alkaloids in tryptophane system. It is especially significant to develop a pervone vincamine aqueous solution applied to the clinical treatment.
Description
Technical field
The present invention relates to Pervone vincamine injection and preparing technical field thereof.
Background technology
Vincamine is a kind of alkaloid that extracts from the apocynaceae plant Herba Catharanthi Rosei, but the cerebral blood flow increasing amount plays direct effect or works indirectly by increasing the brain metabolism as vasodilator.Studies show that the oxidation Decomposition metabolism of glucose can be kept and recover to vincamine, and then make the physiological carbon dioxide tension recover normal,, increase the cerebral blood flow of ischemic region, improve the utilization rate of brain blood oxygen to keep or to recover cerebrovascular physiological expansion.Vincamine also can suppress platelet to be built up, and improves hemorheological characteristics, thereby microcirculation is produced good effect.During medication, vincamine can make ishemic part reduce, improving memory and improvement behavior, but do not cause arterial partial pressure of oxygen or blood pressure.
According to foreign data: during oral vincamine treatment cerebral blood supply insufficiency, 2～4 weeks reached ceiling effect.If increase intramuscular administration every day on oral basis, the maximum clinical effect is advanced to occurred in second week.Vincamine can be distributed in the tissue widely, also can see through blood-cerebrospinal fluid barrier, and its distribution half-life is 2 hours.It is fat-soluble so the bioavailability of oral aqueous solution is lower, is 15%～25%.
The clinic trial vincamine is in hyperpietic's treatment, and every day, oral 5～20mg was totally 3～8 months, without any side effects, even dose reaches 100mg and also has no adverse reaction.Once treated the dissimilar hyperpietic of 31 examples, 16 examples obtain good result, and its characteristics are that hypotensive effect is not outstanding, and subjective sensation obviously improves.Vincamine improves hyperpietic's neurological symptom, is that back a kind of pharmacological action of vincamine is noticeable especially in recent years because it has blood vessel dilating and improves the effect of brain inner blood circulation.The apoplexy that cerebral atherosclerosis causes and the mental status have lowly been represented the big class disease in neural and the psychosis.Many in the apoplexy case is that circulatory disorders causes the brain dysbolismus because the cerebral thrombosis plug causes that thromboembolism causes circulatory disorders, even produces the local brain tissue necrosis, therefore press for the cerebral blood flow increasing amount, and vincamine just is being suitable for the requirement of this respect.
Existing vincamine preparation is tablet and capsule, though existing tablet and capsule convenient drug administration, but need to obtain rapidly high blood drug level in many cases, often need intravenously administrable, particularly can not eat because of various reasons or gastrointestinal function obstacle and patient that can not oral administration more needs to use injection to some.Because it is the lower characteristic of the dissolubility of alkaloid in water that vincamine belongs to tryptophan, so exploitation is applicable to that the vincamine aqueous solution preparation of clinical treatment has special meaning.
Summary of the invention
The purpose of this invention is to provide a kind of Pervone vincamine injection and preparation technology thereof, compared with the prior art, this injection have the dosage form uniqueness, easy to use, curative effect is rapid, characteristics such as safe and reliable, be used for muscle and intravenous administration, be applicable to clinical treatment, particularly can not eat because of various reasons or gastrointestinal function obstacle and patient that can not oral administration can intravenously administrables some; Its preparation technology is easy, economical, be easy to suitability for industrialized production, the economic and social benefits height, and having solved vincamine, to belong to tryptophan be the lower key issue of the dissolubility of alkaloid in water.
Pervone vincamine injection of the present invention comprises solution type injection agent and freeze-dried powder, and solution type injection agent is divided into aqueous injection and the transfusion of medicine carrying type, and active component is a vincamine.
One of the object of the invention is achieved in that Pervone vincamine injection, it is characterized in that being solution type injection agent or freeze-dried powder, solution type injection agent is divided into aqueous injection and the transfusion of medicine carrying type, and the active component that wherein contains is a vincamine, and vincamine exists with the form of soluble-salt.
The water soluble salt of described vincamine is the acylate that vincamine and organic acid form, or is the inorganic acid salt that forms with mineral acid.
Described inorganic acid salt is: vincamine hydrochlorate, vincamine sulfate, vincamine bromate; Described acylate is: vincamine tartrate or vincamine teprosilate.
Two of the object of the invention is achieved in that Pervone vincamine injection preparation technology, it is characterized in that making injection of solution agent or freeze-dried powder, the injection of solution agent be divided into aqueous injection and and and medicine carrying type transfusion, wherein active component is a vincamine, vincamine exists with the form of soluble-salt.
The water soluble salt of described vincamine is the acylate that vincamine and organic acid form, or is the inorganic acid salt that forms with mineral acid.
Described inorganic acid salt is: vincamine hydrochlorate, vincamine sulfate or vincamine bromate etc.; Described acylate is: vincamine tartrate or vincamine teprosilate etc.
Used mineral acid can be: example hydrochloric acid, sulphuric acid, boric acid, bromic acid, phosphoric acid, iodic acid etc., organic acid can be: acetic acid, lactic acid, ascorbic acid, citric acid, tartaric acid, tea propane sulfonic acid, citric acid etc., wherein one or more.
Injection can be by forming as the Changchun amine salt of pharmacodynamic raw materials or vincamine and salt forming agent, antioxidant, and it is formed weight portion ratio and can be vincamine: salt forming agent: antioxidant=3～18: 0.1～1.2: 1～10.
Described composition ratio by weight is preferably, vincamine: salt forming agent: antioxidant=5～15: 0.4～1.2: 1～5.
Described antioxidant can be sodium sulfite, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, thiourea, cysteine, methionine, vitamin C or disodiumedetate (EDTA-disodium) etc., wherein one or more.
Technology can adopt following steps:
A, measure as the vincamine of pharmacodynamic raw materials and salt forming agent, antioxidant, and get pH value regulator, medical active carbon and water for injection ready by prescription; Injection is formed by weight, and ratio is vincamine: salt forming agent: antioxidant=3～18: 0.1～1.2: 1～10;
B, add proper amount of water for injection in the container in preparation, getting load weighted salt forming agent and vincamine adds in the preparation container successively, vincamine is dissolved fully, add load weighted antioxidant again, stirring makes it to dissolve fully, after-teeming is penetrated water to full dose, regulate pH to 2.0～5.0, stir, add the absorption of medical active carbon, the amount of used medicinal charcoal is about 0.01～0.04%, filters.
Aqueous injection is that the aqueous solution by the vincamine water soluble salt forms through sterilization; Medicine carrying type transfusion is that the aqueous solution by the vincamine water soluble salt adds an amount of osmotic pressure regulator and forms through pressure sterilizing, comprises sodium chloride injection and glucose injection; Freeze-dried powder is to add an amount of proppant by the aqueous solution of vincamine water soluble salt to form through lyophilization.
Proppant in the above-mentioned freeze-dried powder can adopt various medicinal proppants commonly used, is preferably in mannitol, glucose, sorbitol, sodium chloride, dextran, sucrose, lactose, gelatin hydrolysate and the Polyethylene Glycol one or more; One or more in mannitol, sorbitol, dextran, lactose, gelatin hydrolysate and the Polyethylene Glycol more preferably.
The above-mentioned regulator that is used to regulate pH value can be used hydrochloric acid, acetic acid, citric acid, tartaric acid, acidic amino acid, sodium bicarbonate, sodium acetate, ethylenediamine, basic amino acid etc., and in preferably citric acid, tartaric acid, sodium bicarbonate or the sodium acetate one or more.
The present invention has following remarkable result: the deficiency that has overcome prior art, compared with the prior art, this injection have the dosage form uniqueness, easy to use, curative effect is rapid, characteristics such as safe and reliable, be applicable to clinical treatment, particularly can not eat because of various reasons or gastrointestinal function obstacle and patient that can not oral administration can intravenously administrables some; Its preparation technology is easy, economical, be easy to suitability for industrialized production, the economic and social benefits height, and having solved vincamine, to belong to tryptophan be the lower key issue of the dissolubility of alkaloid in water.Exploitation is applicable to that the vincamine aqueous solution preparation of clinical treatment has special meaning.
The specific embodiment
Be described further below in conjunction with embodiment, but not as a limitation of the invention.
Technological operation is as follows: get vincamine, salt forming agent, the antioxidant of recipe quantity, and get pH value regulator, medical active carbon and water for injection ready.The water for injection that in the preparation container, adds amount of preparation, get load weighted salt forming agent and vincamine and add successively in the preparing tank, vincamine is dissolved fully, add load weighted antioxidant again, stirring makes it to dissolve fully, after-teeming is penetrated water to full dose, regulates pH2.0～5.0, and stirred about 30 minutes the cooling back, add medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters, and wherein aqueous injection is that aqueous solution by vincamine forms through sterilization; Medicine carrying type transfusion is that the aqueous solution by vincamine adds an amount of osmotic pressure regulator and forms through pressure sterilizing, comprises 0.9% sodium chloride injection and 5% glucose injection; Freeze-dried powder is to add an amount of proppant by the aqueous solution of vincamine to form through lyophilization.
Proppant in the freeze-dried powder can adopt various medicinal proppants commonly used, is preferably in mannitol, glucose, sorbitol, sodium chloride, dextran, sucrose, lactose, gelatin hydrolysate or the Polyethylene Glycol one or more; One or more in mannitol, sorbitol, dextran, lactose, gelatin hydrolysate or the Polyethylene Glycol more preferably.
The regulator that is used to regulate pH value can be used hydrochloric acid, acetic acid, citric acid, tartaric acid, acidic amino acid, sodium bicarbonate, sodium acetate, ethylenediamine or basic amino acid etc., and in preferably citric acid, tartaric acid, sodium bicarbonate or the sodium acetate one or more.
According to clinical needs, this injection single dose specification is chosen as 0.1mg～100mg, 1ml～500ml.
Embodiment 1:
Take by weighing vincamine 10g, lactic acid 1.0g, place the preparation container, the water for injection that adds 2/3 amount of preparation, stirring is dissolved vincamine fully, add load weighted antioxidant sodium sulfite 2g again, (it is an amount of that freeze-dried powder need add proppant again) stirs and makes it to dissolve fully, after-teeming is penetrated water to the 2000ml full dose, with citron acid for adjusting pH to 2.0～5.0, stirred about 30 minutes, add medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters the back sterile filling and promptly gets the injection solution agent; If with above-mentioned injection solution agent lyophilization, to take out behind the vacuum gland, jewelling lid labeling promptly gets the lyophilizing finished product.
Embodiment 2:
Take by weighing vincamine 10g, lactic acid 1.0g, sodium chloride 18g, place the preparation container, the water for injection that adds 2/3 amount of preparation, stirring is dissolved vincamine fully, adds load weighted antioxidant sodium sulfite 2g again, stirring makes it to dissolve fully, after-teeming is penetrated water to the 2000ml full dose, with citron acid for adjusting pH to 2.0～5.0, stirs about 30 minutes, add medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters reuse 0.45 μ m microporous filter membrane aseptic filtration, be sub-packed in the infusion bottle by predetermined close, 115 ℃ of pressure sterilizings 30 minutes promptly.
Embodiment 3:
Take by weighing vincamine 10g, acetic acid 1.0g, place the preparation container, the water for injection that adds 2/3 amount of preparation, stirring is dissolved vincamine fully, add load weighted antioxidant sodium sulfite 2g again, (it is an amount of that freeze-dried powder need add proppant again) stirs and makes it to dissolve fully, after-teeming is penetrated water to the 2000ml full dose, with winestone acid for adjusting pH to 2.0～5.0, stirred about 30 minutes, add medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters the back sterile filling and promptly gets the injection solution agent; If with above-mentioned injection solution agent lyophilization, to take out behind the vacuum gland, jewelling lid labeling promptly gets the lyophilizing finished product.
Embodiment 4:
Take by weighing vincamine 10g, acetic acid 1.0g, glucose 100g, place the preparation container, the water for injection that adds 2/3 amount of preparation, stirring is dissolved vincamine fully, adds load weighted antioxidant sodium sulfite 2g again, stirring makes it to dissolve fully, after-teeming is penetrated water to the 2000ml full dose, with winestone acid for adjusting pH to 2.0～5.0, stirs about 30 minutes, add medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters reuse 0.45 μ m microporous filter membrane aseptic filtration, be sub-packed in the infusion bottle by predetermined close, 115 ℃ of pressure sterilizings 30 minutes promptly.
Embodiment 5:
Take by weighing vincamine 12g, ascorbic acid 1.1g, place the preparation container, the water for injection that adds 2/3 amount of preparation, stirring is dissolved vincamine fully, add load weighted antioxidant sodium thiosulfate 2.5g again, (it is an amount of that freeze-dried powder need add proppant again) stirs and makes it to dissolve fully, after-teeming is penetrated water to the 2000ml full dose, with citron acid for adjusting pH to 2.0～5.0, stirred about 30 minutes, add medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters the back sterile filling and promptly gets the injection solution agent; If with above-mentioned injection solution agent lyophilization, to take out behind the vacuum gland, jewelling lid labeling promptly gets the lyophilizing finished product.
Embodiment 6:
Take by weighing vincamine 15g, ascorbic acid 1.2g, place the preparation container, the water for injection that adds 2/3 amount of preparation, stirring is dissolved vincamine fully, add load weighted antioxidant sodium pyrosulfite 2.5g again, (it is an amount of that freeze-dried powder need add proppant again) stirs and makes it to dissolve fully, after-teeming is penetrated water to the 2000ml full dose, regulate pH to 2.0～5.0 with sodium bicarbonate, stirred about 30 minutes the cooling back, adds medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters the back sterile filling and promptly gets the injection solution agent; If with above-mentioned injection solution agent lyophilization, to take out behind the vacuum gland, jewelling lid labeling promptly gets the lyophilizing finished product.
Embodiment 7:
Take by weighing vincamine 15g, tartaric acid 1.2g, place the preparation container, the water for injection that adds 2/3 amount of preparation, stirring is dissolved vincamine fully, add load weighted antioxidant sodium sulfite 2g again, (it is an amount of that freeze-dried powder need add proppant again) stirs and makes it to dissolve fully, after-teeming is penetrated water to the 2000ml full dose, with citron acid for adjusting pH to 2.0～5.0, stirred about 30 minutes the cooling back, adds medical active carbon absorption 15～20 minutes, the amount of used medicinal charcoal is about 0.03%, filters the back sterile filling and promptly gets the injection solution agent; If with above-mentioned injection solution agent lyophilization, to take out behind the vacuum gland, jewelling lid labeling promptly gets the lyophilizing finished product.
The proportioning of embodiment 8-11 and parameter select to see the following form 1, and (technology is the same, slightly).
Embodiment 8-11 raw material variety and quantitative proportion and parameter selection menu 1
| Embodiment 8 | Embodiment 9 | Embodiment 10 | Embodiment 11 | Embodiment 12 | Embodiment 13 | |
| Principal agent | Vincamine 3g | Vincamine 5g | Vincamine 8g | Vincamine 8g | Vincamine 18g | Vincamine 18g |
| Embodiment 8 | Embodiment 9 | Embodiment 10 | Embodiment 11 | Embodiment 12 | Embodiment 13 | |
| Salt forming agent | Hydrochloric acid 0.5g | Citric acid 0.6g | Tea propane sulfonic acid 0.8g | Citric acid 0.8g | Hydrochloric acid 1.2g | Tartaric acid 1.2g |
| Antioxidant | Thiourea 1.0g | Cysteine 1.0g | Methionine 1.5g | Vitamin C 1.5g | EDTA-disodium 3.0g | Sodium sulfite 3.0g |
| The pH value regulator | Sodium acetate is an amount of | Ethylenediamine is an amount of | Citric acid is an amount of | Sodium bicarbonate is an amount of | Tartaric acid is an amount of | Sodium acetate is an amount of |
| Medicinal carbon | In right amount | In right amount | In right amount | In right amount | In right amount | In right amount |
| Water for injection | ??2000ml | ??2000ml | ??2000ml | ??2000ml | ??2000ml | ??2000ml |
Claims (8)
1. Pervone vincamine injection is characterized in that being solution type injection agent or freeze-dried powder, and solution type injection agent is divided into aqueous injection and the transfusion of medicine carrying type, and the active component that wherein contains is a vincamine, and vincamine exists with the form of soluble-salt.
2. Pervone vincamine injection according to claim 1, the water soluble salt that it is characterized in that described vincamine are the acylate that vincamine and organic acid form, or are the inorganic acid salt that forms with mineral acid.
3. Pervone vincamine injection according to claim 2 is characterized in that described inorganic acid salt is: vincamine hydrochlorate, vincamine sulfate, vincamine bromate; Described acylate is: vincamine tartrate or vincamine teprosilate.
4. Pervone vincamine injection preparation technology is characterized in that making injection of solution agent or freeze-dried powder, the injection of solution agent be divided into aqueous injection and and and medicine carrying type transfusion, wherein active component is a vincamine, vincamine exists with the form of soluble-salt.
5. Pervone vincamine injection according to claim 4, the water soluble salt that it is characterized in that described vincamine are the acylate that vincamine and organic acid form, or are the inorganic acid salt that forms with mineral acid.
6. Pervone vincamine injection according to claim 5 is characterized in that described inorganic acid salt is: vincamine hydrochlorate, vincamine sulfate, vincamine bromate; Described acylate is: vincamine tartrate or vincamine teprosilate.
7. Pervone vincamine injection according to claim 4 is characterized in that adopting following steps:
A, measure as the vincamine of pharmacodynamic raw materials and salt forming agent, antioxidant, and get pH value regulator, medical active carbon and water for injection ready by prescription; Injection is formed by weight, and ratio is vincamine: salt forming agent: antioxidant=3～18: 0.1～1.2: 1～10;
B, add proper amount of water for injection in the container in preparation, getting load weighted salt forming agent and vincamine adds in the preparation container successively, vincamine is dissolved fully, add load weighted antioxidant again, stirring makes it to dissolve fully, after-teeming is penetrated water to full dose, regulate pH to 2.0～5.0, stir, add the absorption of medical active carbon, the amount of used medicinal charcoal is about 0.01～0.04%, filters.
8. according to claim 4,5,6 or 7 described Pervone vincamine injection preparation technologies, it is characterized in that aqueous injection is that aqueous solution by the vincamine water soluble salt forms through sterilization; Medicine carrying type transfusion is that the aqueous solution by the vincamine water soluble salt adds an amount of osmotic pressure regulator and forms through pressure sterilizing, comprises sodium chloride injection and glucose injection; Freeze-dried powder is to add an amount of proppant by the aqueous solution of vincamine water soluble salt to form through lyophilization.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200910227968 CN101721361B (en) | 2009-12-08 | 2009-12-08 | Pervone vincamine injection and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200910227968 CN101721361B (en) | 2009-12-08 | 2009-12-08 | Pervone vincamine injection and preparation process thereof |
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| CN101721361A true CN101721361A (en) | 2010-06-09 |
| CN101721361B CN101721361B (en) | 2013-06-26 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103869018A (en) * | 2014-03-27 | 2014-06-18 | 张家港威胜生物医药有限公司 | Method for measuring vincamine related substances through high performance liquid chromatography (HPLC) |
| 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 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1254057A (en) * | 1969-04-24 | 1971-11-17 | Louisette Olivier | Improvements in or relating to therapeutical composition containing vincamine |
| HU181940B (en) * | 1979-11-02 | 1983-11-28 | Richter Gedeon Vegyeszet | Process for producing solutions of vincane derivatives for parentheral application |
| CN1033973C (en) * | 1991-08-30 | 1997-02-05 | 东北制药总厂 | Preparation of vincamine amino acid ester |
| CN1042492C (en) * | 1991-10-31 | 1999-03-17 | 东北制药总厂 | Preparing method for apovincamine acid ethyl ester |
| CN1040325C (en) * | 1994-07-12 | 1998-10-21 | 东北制药总厂 | Application of "changchun" amine and its derivant for preparation of hair growing agent |
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2009
- 2009-12-08 CN CN 200910227968 patent/CN101721361B/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103869018A (en) * | 2014-03-27 | 2014-06-18 | 张家港威胜生物医药有限公司 | Method for measuring vincamine related substances through high performance liquid chromatography (HPLC) |
| 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 |
| CN105267160B (en) * | 2015-11-24 | 2019-05-14 | 河北智同生物制药股份有限公司 | A kind of injection vinpocetine lyophilized preparation composition and preparation method thereof |
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