CN1785172A - Transfusion contg. tanshinone II A sodium sulfonate and its prepn. method - Google Patents
Transfusion contg. tanshinone II A sodium sulfonate and its prepn. method Download PDFInfo
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- CN1785172A CN1785172A CN 200510094782 CN200510094782A CN1785172A CN 1785172 A CN1785172 A CN 1785172A CN 200510094782 CN200510094782 CN 200510094782 CN 200510094782 A CN200510094782 A CN 200510094782A CN 1785172 A CN1785172 A CN 1785172A
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Abstract
A perfusion of tanshinone IIA-sodium sulfonate for treating coronary heart disease, angina pectoris, myocardiac infarction and ventricular early heartbeat contains tanshinone IIA sodium sulfonate (0.002-0.16 Wt%), antioxidizing agent (0-20), solubilizer (0-20), osmosis pressure regulator (0.3-75) and the water for perfusion. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of medicine that cardiovascular disease is had good curative effect and preparation method thereof, the present invention relates to a kind of sodium tanshinone IIA sulfate transfusion and preparation method more precisely, belong to medicine and preparing technical field thereof.
Background technology
Radix Salviae Miltiorrhizae has the effect of hemostasis, promoting blood flow to regulate menstruation, the relieving restlessness that clears away heart-fire of shaking of dispelling.What the traditional Chinese medical science had " Radix Salviae Miltiorrhizae drink, the same SIWU TANG of merit " simply says that its effect has some idea of.Radix Salviae Miltiorrhizae is to myocardial protective effect, and energy blood vessel dilating, atherosclerosis, antithrombotic form, and Radix Salviae Miltiorrhizae is one of basic role of its phlegm reduction of blood circulation promoting to periphery and the microcirculatory improvement of internal organs.Radix Salviae Miltiorrhizae to gram positive bacteria particularly staphylococcus aureus stronger inhibitory action is arranged.Its effective ingredient is fat-soluble two mushroom chemical compounds and water miscible phenolic acid compound, comprises Tanshinone I, dihydrotanshinone I, tanshinone, Tanshinone II B, danshensu, salvianolic acid etc.
Tanshinone is one of fat-soluble effective ingredient in the Radix Salviae Miltiorrhizae, is the cherry red acicular crystals.But because of it is insoluble in water, so the intestines and stomach absorption difference after the administration, clinical onset of action is slow.Sodium tanshinone IIA sulfate is the new soluble derivative that the tanshinone sulfonation forms, and its liposoluble constituent can be dissolved in the water well.Symptom to coronary heart disease, angina pectoris, cardiovascular disease such as uncomfortable in chest in clinic trial has certain curative effect, can improve the ischemic electrocardiogram.Sodium tanshinone IIA sulfate injection (small-volume injection) is by two manufacturer production of Shanghai No.1 Bio-Chemical Pharmacetical Industry Co., Ltd and Jilin Arbeila Medicine Holding(Tonghua) Co., Ltd..
Sodium tanshinone IIA sulfate injection (small-volume injection) is in sterilization process, and because of sodium tanshinone IIA sulfate decomposes the generation tanshinone on a small quantity, and tanshinone is water insoluble, can the clarity of preparation be exerted an influence, and then influences the drug safety of product.This brings certain difficulty, sodium tanshinone IIA sulfate injection (small-volume injection) need be diluted to the central use of transfusion when clinical use to production storage and transportation, and this also makes troubles to clinical application.Company has announced a kind of sodium tanshinone IIA sulfate glucose injection (CN1640391) in Seagate, Kunming medicine research and development before this, decompose in the time of can not solving sodium tanshinone IIA sulfate and be subjected to high temperature by its method and generate water insoluble tanshinone, produce macroscopic insoluble microparticle, make the clarity of preparation can not meet the requirement of injection, and then influence the drug safety of product.
Summary of the invention
The present invention is directed to the deficiencies in the prior art, a kind of sodium tanshinone IIA sulfate transfusion and preparation method are provided.
The present invention takes following technical scheme to realize:
A kind of sodium tanshinone IIA sulfate transfusion, composed of the following components by weight percentage, sodium tanshinone IIA sulfate 0.002%～0.16%, antioxidant 0%～20%, it is characterized in that it also comprises solubilizing agent 0%～20%, osmotic pressure regulator 0.3%～75%, all the other are water for injection.
Aforesaid antioxidant be in potassium sulfite, Potassium acid sulfite, potassium metabisulfite, ascorbic acid, sodium thiosulfate, thioglycerol, thiourea, glycine, sorbitol, propyl gallate, disodium edetate, propylene glycol, the glycerol one or more.Molecular weight gets final product by this area normal ranges.
Aforesaid osmotic pressure regulator is one or more of sodium chloride, magnesium chloride, ammonium sulfate, Chile saltpeter, potassium nitrate, Borax, boric acid, mannitol, sorbitol, glucose, fructose, xylitol, potassium chloride.Molecular weight gets final product by this area normal ranges.
Aforesaid solubilizing agent is one or more in tween, poloxamer, docusate sodium, sodium lauryl sulphate, benzalkonium chloride, benzethonium chloride, cetrimonium bromide, glycerin mono-fatty acid ester, polyoxyethylene sorbitan carboxylic ester, Isosorbide Dinitrate, Capryol 90, α cyclodextrin and derivant, beta cyclodextrin and derivant thereof, γ cyclodextrin and the derivant thereof.Molecular weight gets final product by this area normal ranges.
The preparation method of sodium tanshinone IIA sulfate transfusion of the present invention comprises that step is as follows:
1. infusion bottle, butyl rubber plug, rubber stopper, dacron membrane are handled by the conventional requirement of injection, and be standby;
2. the preparation of medicinal liquid;
3. taking liquid measure pH value make its between 3.5～5.5 and the content of sodium tanshinone IIA sulfate, osmotic pressure regulator make its by labelled amount between 90.0%～110.0%;
4. content and pH value qualified after, fine straining, fill, blooming is jumped a queue and is rolled lid;
5. sterilization;
6. storehouse entirely checks in.
Above-mentioned steps 2. the compound method of medicinal liquid be: get in the water for injection Agitation Tank of cumulative volume 80%, add 0.002%～0.16% sodium tanshinone IIA sulfate, 0.3%～75% osmotic pressure regulator, 0%～20% antioxidant and 0%～20% solubilizing agent stirring and dissolving, transfer pH value with acid or buffer salt, the needle-use activated carbon that adds cumulative volume 0.1 ‰ (g/ml), stir charcoal absorption 5～15 minutes, with adding water for injection behind the titanium filter stick filtering decarbonization, stir evenly to full dose.
Adopt 0.22um～0.44um mixed cellulose ester, nylon microporous filter membrane or politef microporous filter membrane fine straining at above-mentioned steps fine straining 4., fine straining is qualified to clarity, and the filtrate fill is in 50～500ml infusion bottle.
Above-mentioned sodium tanshinone IIA sulfate transfusion preparation method is characterized in that wherein the pressure sterilizing temperature of step (6) is 100 ℃～121 ℃, and the time is 15～45 minutes.
Preparation finishes, and goods are taken out, and seals, and promptly obtains the sodium tanshinone IIA sulfate transfusion.
Compared with prior art, excellent results of the present invention is as follows:
(1) the sodium tanshinone IIA sulfate injection is in producing the storage transportation, and sodium tanshinone IIA sulfate decomposes easily, and the tanshinone of generation is water insoluble, influences the quality problems such as clarity of preparation and influences clinical drug safety.Add solubilizing agent in transfusion, the tanshinone that it is produced in the production and transport process is water-soluble, can not produce macroscopic foreign body in the product like this, and it is clinical that transfusion can be applied to.
(2) sodium tanshinone IIA sulfate is more stable under acid condition, transfer pH value can make its sodium tanshinone IIA sulfate injection be the stable condition of slant acidity with acid or buffer salt, also can avoid sodium tanshinone IIA sulfate transfusion pH value in sterilization process to float bigger simultaneously.
(3) in the injection production process, add the activated carbon adsorption pyrogen usually.Active carbon also has absorption to principal agent in the absorption pyrogen.In the production process of sodium tanshinone IIA sulfate injection, not commensurability active carbon is to principal agent adsorbance difference, and the activated carbon dosage of selection 0%～0.05% is to the adsorbance minimum of principal agent.The described activated carbon dosage of a kind of sodium tanshinone IIA sulfate glucose injection that Seagate, Kunming medicine research and development company announces is 0.05%～0.1%, and the activated carbon dosage of this scope is bigger to the absorption of principal agent as can be known by experiment, can cause the waste of principal agent.
(4) in the transfusion production process, add osmotic pressure regulator, can make transfusion and isoosmotic while of blood of human body, also can hinder sodium tanshinone IIA sulfate and decompose, guarantee transfusion safety in use.
(5) selected the transfusion dosage form, can directly carry out clinical use, avoid sodium tanshinone IIA sulfate injection or injection powder pin when clinical practice, to need to dilute the shortcoming that instils to venous patient again with jumbo sodium chloride or glucose injection earlier, alleviated clinical medical and nursing personnel workload.
(6) provide a kind of economical and practical novel form for clinical.
The sodium tanshinone IIA sulfate transfusion that is made by said method all complies with relevant regulations in the check of items such as content, pyrogen, aseptic, PH, clarity, particulate matter, and no antigen has no side effect.This product can increase coronary flow, improve the collateral circulation and the local blood supply of ischemic region cardiac muscle, improve the metabolism disorder of anoxia cardiac muscle, improve myocardial hypoxia tolerance, anticoagulant and antithrombotic form, dwindle laboratory animal ischemic myocardium infarct size, under doses, also can strengthen myocardial contraction.This medicine can be used for coronary heart disease, angina pectoris, myocardial infarction, also can be used for ventricular premature contraction.
The specific embodiment
Embodiment 1: sodium tanshinone IIA sulfate transfusion, component following (all by weight percentage)
Sodium tanshinone IIA sulfate 0.04g
Sodium chloride 0.45g
Thioglycerol 0.02
Tween 80 0.4g
Add the injection water to 50ml
Preparation method is as follows:
(1) infusion bottle, rubber stopper, dacron membrane are handled by the conventional requirement of injection, and be standby;
(2) preparation of medicinal liquid: get 80% water for injection in Agitation Tank, add principal agent and adjuvant stirring and dissolving.Transfer PH to 4.3, add 0.1 ‰ needle-use activated carbons, stir charcoal absorption 15 minutes,, stir evenly with adding water for injection behind the titanium filter stick filtering decarbonization to full dose.
(3) product detect in the middle of: the content of taking liquid mensuration pH value and sodium tanshinone IIA sulfate, sodium chloride;
(4) fill: after its content and pH value are qualified, adopt 0.22um microporous filter membrane fine straining qualified to clarity, fill is in infusion bottle, and blooming is jumped a queue and rolled lid;
(5) pressure sterilizing, 105 ℃ of pressure sterilizings 30 minutes, the cooling of spray hot water is offerd for sale;
(6) full inspection, packing
Embodiment 2: sodium tanshinone IIA sulfate transfusion, component following (all by weight percentage)
Sodium tanshinone IIA sulfate 0.04g
Sodium chloride 0.9g
Potassium metabisulfite 0.02g
Poloxamer 0.5
Water for injection 100ml is the same
Make transfusion by embodiment 1 method for making
Embodiment 3: sodium tanshinone IIA sulfate transfusion, component following (all by weight percentage)
Sodium tanshinone IIA sulfate 0.04g
Sodium chloride 0.9g
Potassium metabisulfite 0.3g
Poloxamer 0.5
Water for injection 100ml
Make transfusion by embodiment 1 method for making
Embodiment 4: sodium tanshinone IIA sulfate transfusion, component following (all by weight percentage)
Sodium tanshinone IIA sulfate 0.04g
Sodium chloride 0.9g
Potassium metabisulfite 0.3g
Tween 0.5g
Water for injection 100ml
Make transfusion by embodiment 1 method for making
Embodiment 5: sodium tanshinone IIA sulfate transfusion, component following (all by weight percentage)
Sodium tanshinone IIA sulfate 0.04g
Sorbitol 0.9g
Sodium pyrosulfite 0.3g
Tween 0.5g
Water for injection 100ml
Make transfusion by embodiment 1 method for making
For using active carbon, company has announced that the consumption of a kind of sodium tanshinone IIA sulfate glucose injection (CN1640391) active carbon is 0.05%～0.1% in Seagate, Kunming medicine research and development before this, and the data of activated carbon adsorption principal agent are provided:
| The consumption of active carbon | Content |
| 0 | 100.1 |
| 0.05％ | 99.87 |
| 0.1％ | 99.43 |
| 0.2％ | 97.3 |
The experimental practical situation of my company has used active carbon to adsorb, and it is as follows to principal agent absorption
| The consumption of active carbon | Content |
| 0 | 99.63％ |
| 0.01％ | 75.18％ |
| 0.025％ | 73.75％ |
| 0.05％ | 63.24％ |
| 0.1％ | 53.47％ |
By above-mentioned experimental result as can be known, active carbon is stronger to the principal agent absorbability, and increases with activated carbon dosage, and absorption increases to principal agent.Consider the needs of depyrogenation, so pin uses the activated carbon consumption between 0%～0.05% in process of production.
The foregoing description does not limit the present invention in any form, and all formed technical schemes of taking to be equal to replacement or equivalent transformation of form all drop within protection scope of the present invention.
Claims (9)
1, a kind of sodium tanshinone IIA sulfate transfusion, form by following ingredients by weight percentage: Tanshinone I I A sodium sulfonate 0.002%～0.16%, antioxidant 0%～20%, it is characterized in that it also comprises solubilizing agent 0%～20%, osmotic pressure regulator 0.3%～75%, all the other are water for injection.
2, according to the described a kind of sodium tanshinone IIA sulfate transfusion of claim 1, it is characterized in that wherein said antioxidant be in sulphite, Potassium acid sulfite, potassium metabisulfite, ascorbic acid, sodium thiosulfate, thioglycerol, thiourea, glycine, sorbitol, propyl gallate, disodium edetate, propylene glycol, the glycerol one or more.
3,, it is characterized in that wherein said osmotic pressure regulator is one or more of sodium chloride, magnesium chloride, ammonium sulfate, Chile saltpeter, potassium nitrate, Borax, boric acid, mannitol, sorbitol, fructose, xylitol, potassium chloride according to the described a kind of sodium tanshinone IIA sulfate transfusion of claim 1.
4, according to the described a kind of Tanshinone I I A sodium sulfonate transfusion liquid of claim 1, it is characterized in that wherein said solubilizing agent is one or more in tween, poloxamer, docusate sodium, sodium lauryl sulphate, benzalkonium chloride, benzethonium chloride, cetrimonium bromide, glycerin mono-fatty acid ester, polyoxyethylene sorbitan carboxylic ester, Isosorbide Dinitrate, Capryol 90, α cyclodextrin and derivant, beta cyclodextrin and derivant thereof, γ cyclodextrin and the derivant thereof.
5, the preparation method of the described sodium tanshinone IIA sulfate transfusion of a kind of claim 1, step is as follows:
(1) infusion bottle, butyl rubber plug, rubber stopper, dacron membrane are handled by the conventional requirement of injection, and be standby;
(2) preparation of medicinal liquid;
(3) taking liquid is measured pH value and is made them between 3.5～5.5 and the content of sodium tanshinone IIA sulfate, osmotic pressure regulator, make its by labelled amount between 90.0%～110.0%;
(4) content and pH value qualified after, fine straining, fill, blooming is jumped a queue and is rolled lid;
(5) sterilization;
(6) full inspection, packing, warehouse-in.
6, the preparation method of sodium tanshinone IIA sulfate transfusion according to claim 5, it is characterized in that, wherein the compound method of step (2) medicinal liquid is: get in the water for injection Agitation Tank of cumulative volume 80%, sodium tanshinone IIA sulfate, osmotic pressure regulator and the antioxidant and the solubilizing agent stirring and dissolving that add recipe quantity, transfer between pH value to 3.5～5.5 with acid or buffer salt, add needle-use activated carbon, stirring and adsorbing 5～15 minutes, with adding water for injection behind the titanium filter stick filtering decarbonization, stir evenly to full dose.
7, the preparation method of a kind of sodium tanshinone IIA sulfate transfusion according to claim 5, it is characterized in that, wherein the fine straining of step (4) adopts 0.15um～0.44um microporous filter membrane fine straining, and fine straining is qualified to clarity, and the filtrate fill is in 50～500ml infusion bottle.
8, sodium tanshinone IIA sulfate transfusion preparation method according to claim 5 is characterized in that wherein the pressure sterilizing temperature of step (6) is 100 ℃～121 ℃, and the time is 15～45 minutes.
9, sodium tanshinone IIA sulfate transfusion preparation method according to claim 6 is characterized in that activated carbon dosage is 0%～0.05%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510094782 CN1785172A (en) | 2005-10-13 | 2005-10-13 | Transfusion contg. tanshinone II A sodium sulfonate and its prepn. method |
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| CN 200510094782 CN1785172A (en) | 2005-10-13 | 2005-10-13 | Transfusion contg. tanshinone II A sodium sulfonate and its prepn. method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2011507948A (en) * | 2007-12-31 | 2011-03-10 | マゼンス インコーポレイテッド | Pharmaceutical composition for the treatment and prevention of heart disease |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2011507948A (en) * | 2007-12-31 | 2011-03-10 | マゼンス インコーポレイテッド | Pharmaceutical composition for the treatment and prevention of heart disease |
| EP2231148A4 (en) * | 2007-12-31 | 2011-04-27 | Mazence Inc | Pharmaceutical composition for the treatment and prevention of cardiac disease |
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