CN103027890B - Ibuprofen medicine composition for injection - Google Patents
Ibuprofen medicine composition for injection Download PDFInfo
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- CN103027890B CN103027890B CN201110300777.6A CN201110300777A CN103027890B CN 103027890 B CN103027890 B CN 103027890B CN 201110300777 A CN201110300777 A CN 201110300777A CN 103027890 B CN103027890 B CN 103027890B
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Abstract
The invention discloses an ibuprofen medicine composition for injection, which consists of ibuprofen and arginine glutamate, and is characterized in that the weight ratio of the ibuprofen to the arginine glutamate is 1:1.44. A preparation method of the medicine composition comprises the following steps of: taking injection water with weight being 70 percent of prescribed dosage, adding the arginine glutamate with prescribed dosage at 70-80DEG C, and agitating the mixture for dissolution; adding the ibuprofen with prescribed dosage and agitating the mixture till the ibuprofen is fully dissolved; adding medicinal charcoal into the solution, evenly agitating the mixture and standing the mixture; conducting suction filtration, replenishing the injection water to full dosage and evenly mixing the solution; determining the initial PH (potential of hydrogen) value, and regulating the pH value to 7.7 plus or minus 0.2 by using 4% sodium hydroxide solution and 10% hydrochloric acid solution according to the initial pH value; conducting refined filtration and filling; conducting sterilization; conducting lamp inspection; and warehousing the product to obtain the finished product. The ibuprofen medicine composition has high light stability, is reliable in quality and has more obvious advantages for product yield improvement, cost reduction, industrialization realization and better clinical application.
Description
Technical field
The present invention relates to the medicine in field of medicaments, especially relate to a kind of skin irritation little the ibuprofen medicinal composition and preparation method thereof of injection.
Background technology
Pain is a kind of Physiological Psychology activity of complexity, is one of modal symptom clinically.It comprises that noxious stimulation acts on the caused pain of body and feels, and the pain reaction of body to noxious stimulation.The pain sensation can be used as the one warning that body comes to harm, and causes the protective reaction of body series of defence, is the symbol of danger signal, impels people's urgent action, and hedging goes evil.
Heating is because heating activator acts on body, and then causes the generation of interior raw pyrogen (EP) to be incorporated to brain acting on thermotaxic centre, more so that the release of the maincenter medium that causes generating heat then cause and the change of set point finally cause heating.Main manifestations is that body temperature exceeds arm's length standard, or the sensation of own fever of the body discomfort.
Common name: ibuprofen;
English name: Ibuprofen;
Chemical name: 4-isobutyl group-Alpha-Methyl phenylacetic acid;
Structural formula:
Molecular formula: C
13h
18o
2;
Molecular weight: 206.28;
Physicochemical property: this product is white or off-white color crystalline powder; Odorless, bitter in the mouth.This product is dissolved in water, slightly molten in methanol, and slightly soluble in ethanol is almost insoluble in ethyl acetate.
Pharmacology type: NSAID (non-steroidal anti-inflammatory drug).
Mechanism of action: the mechanism of ibuprofen antiinflammatory refrigeration function is synthetic relevant with inhibition prostaglandin.Prostaglandin is a kind of endogenic pyrogen and inflammatory mediator, and ibuprofen is synthetic by suppressing Cycloxygenase (COX) and then suppressing prostaglandin (PG), alleviates and assembles the inflammatory reaction, heating and the pain that cause because of prostaglandin.
Indication: the pain to moderate that (1) is slight; (2) in, when severe pain as the adjuvant drug of opioid analgesic; (3) for antipyretic.
Usage and dosage: (1) pain: every 6 hours intravenous drip 400mg-800mg as required, the instillation time is more than 30 minutes.(2) fever: intravenous drip 400mg, more than 30 minutes, every 4-6 hour instillation 400mg or every 4 hours instillation 100-200mg as required afterwards.
The Yuan Yan producer of ibuprofen injection is Cumberland company of the U.S. (trade name: Caldolor; Specification: 4ml:400mg and 8ml:800mg; Dosage form: injection).In June, 2009 U.S.'s approval listing.
Application number be CN200810229131.1 disclosure of the invention the present invention relates to brufen composition, said composition contains ibuprofen and vitamin C and the pharmaceutic adjuvant for the treatment of effective dose, wherein ibuprofen and ascorbic weight ratio are 1: 1-1.4, preferably 1: 1.2, said composition can effectively reduce mouth and the bottleneck throat burn feeling that ibuprofen produces.
Application number is the ibuprofen medicinal composition that CN201010524942.1 discloses a kind of injection, by trometamol is joined in ibuprofen and arginine solution, thereby has improved the stability of ibuprofen medicinal composition in clinical practice.Experiment shows, present composition solution at least can stable existence after diluting with sodium chloride injection or glucose injection or sodium lactate ringer's injection 12 hours.
Application number is that CN201010134500.6 the invention provides a kind of injection that contains ibuprofen and preparation method thereof, its good stability of this injection, safe, therapeutic effect is good, injection of the present invention contains ibuprofen and arginine, wherein arginine: the mol ratio of ibuprofen is more than or equal to 1: 1.
Application number be CN201010524961.4 disclosure of the invention a kind of ibuprofen medicinal composition of injection, by potassium dihydrogen phosphate, sodium hydroxide are joined in ibuprofen and arginine solution, reach the suitableeest pH value, thereby improved the stability of ibuprofen medicinal composition in clinical practice.Experiment shows, present composition solution at least can stable existence after diluting with sodium chloride injection or glucose injection or sodium lactate ringer's injection 8 hours.
The invention of application number CN201010235300.X relates to a kind of pharmaceutical composition that contains ibuprofen of injection, is applicable to antiinflammatory, eases pain, brings down a fever, and can also be applied to the other diseases that ibuprofen can be alleviated.
The invention of application number CN201010112494.4 relates to a kind of ibuprofen injection and preparation method thereof.The concentration that it is characterized in that ibuprofen in this injection is 100mg/ml, adopts arginine as cosolvent, and the mol ratio of arginine and ibuprofen is more than or equal to 1: 1, and prepares the method for this injection.The injection dissolubility of making is good, adds in 0.9% sodium chloride injection or 5% glucose injection, and the concentration of ibuprofen is 4mg/ml or is less than 4mg/ml, solution clarification long-time stablizing.The patient's intravenous drip that is applicable to unsuitable oral administration is used.
A kind of ibuprofen injection of the disclosure of the invention of application number CN201110023170.8, it comprises ibuprofen and is selected from one or more the pharmaceutically acceptable alkaline auxiliary solvents in anhydride or the hydrate of sodium carbonate, sodium bicarbonate, sodium citrate, sodium citrate, sodium phosphate, dibastic sodium phosphate, sodium tartrate, sodium acetate.The invention still further relates to a kind of preparation method of ibuprofen injection.
A kind of ibuprofen injection of disclosure of the invention of application number CN200910102028.5 and preparation method thereof.Ibuprofen injection, comprise principal agent ibuprofen and pharmaceutically acceptable auxiliaries, described pharmaceutically acceptable auxiliaries comprises cyclodextrin or cyclodextrin derivative, water soluble excipient, each constituent content is ibuprofen 0.5% ~ 20%, cyclodextrin or cyclodextrin derivant 10% ~ 60% by weight percentage, water soluble excipient 1% ~ 40%, remains as water.The present invention has adopted cyclodextrin or the derivant take HP-β-CD as representative, and insoluble to become water solublity fabulous by water to make ibuprofen.And the stability of medicine is improved.These clathrates both can be made into the injection take water as solvent, also can be made into sterile injection powder.Greatly facilitate clinical administration, dosage is easily controlled, and has overcome the organic solvent and cosolvent, the solubilizing agent etc. that in existing insoluble and insoluble drug injection, generally adopt dangerous higher injection supplementary material and solvent simultaneously.
The ibuprofen injection that prior art is produced has very strict requirement to the requirement of storage, lucifuge, in use, preservation and transportation, all has inconvenience.Also added a large amount of other pharmaceutic adjuvants of non-injection stage, for the safety of clinical practice brings very big risk simultaneously.
The inventor is through studying for a long period of time, and unexpected discovery, applies special adjuvant, ibuprofen medicinal composition prepared by special process, light resistance is good, and good stability has not only successfully solved the problem of the poor dissolution of ibuprofen, easy to implement, can realize industrialization, remarkable in economical benefits.
Summary of the invention
The first object of the present invention is to provide a kind of ibuprofen medicinal composition of injection, and this ibuprofen injection is stablized light, to improving product yield, reduces costs, and realizes industrialization, is better applied to clinically, has more obvious advantage.
The second object of the present invention is the preparation method of the ibuprofen medicinal composition that injection of the present invention is provided, and the method is simple, and prepared ibuprofen medicinal composition is stable to light, good stability.
For realizing the first object of the present invention, the present invention adopts following technical scheme:
An ibuprofen medicinal composition for injection, the ibuprofen medicinal composition described in every 1000, its formula consists of:
Ibuprofen 400g
Arginine glutamic acid 576g
Water for injection adds to 4L.
Ibuprofen medicinal composition described in every 1000, its formula consists of:
Ibuprofen 800g
Arginine glutamic acid 1152g
Water for injection adds to 8L.
Ibuprofen medicinal composition of the present invention is adopted preparation with the following method:
Get recipe quantity water for injection 70%, temperature, at 70-80 ℃, adds the arginine glutamic acid of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add medicinal charcoal, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 7.7 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
In the present invention, the consumption of described medicinal charcoal is 0.1-0.2%.
In the present invention, described sterilizing is at 121 ℃ of pressure sterilizing 15-20 minute.
In the present invention, described sterilizing is 121 ℃ of pressure sterilizings 15 minutes.
For realizing the second object of the present invention, the present invention adopts following technical scheme:
The preparation method of ibuprofen medicinal composition of the present invention, wherein, the method comprises the steps:
Get recipe quantity water for injection 70%, temperature, at 70-80 ℃, adds the arginine glutamic acid of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; To 0.2% medicinal charcoal that adds amount of liquid medicine in above-mentioned solution, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 7.7 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
Below to the more detailed elaboration of the present invention:
One aspect of the present invention provides a kind of ibuprofen medicinal composition of injection, the ibuprofen medicinal composition described in every 1000, and its formula consists of:
Ibuprofen 400g
Arginine glutamic acid 576g
Water for injection adds to 4L.
One aspect of the present invention provides a kind of ibuprofen medicinal composition of injection, the ibuprofen medicinal composition described in every 1000, and its formula consists of:
Ibuprofen 800g
Arginine glutamic acid 1152g
Water for injection adds to 8L.
Traditional ibuprofen injection, photostability is poor, poorly soluble, and quality cannot guarantee.
In the present invention, in the stability study process to ibuprofen injection light, after finding to select the suitable recipe quantity of arginine glutamic acid to dissolve completely, then dissolve ibuprofen, can effectively improve the stability of said preparation to light, related substance is unchanged.Through the screening of test recipe and the summary of test data of tens of times, optimize its recipe quantity, not only solve the poor problem of photostability, and constant product quality.
The inventor finds through a large amount of experimental study, when ibuprofen medicinal composition is above-mentioned formula, and described injection the best in quality, stability is best.
Another aspect of the present invention provides the preparation method of ibuprofen injection of the present invention, and the method is simple, and prepared ibuprofen injection is stable to light, good stability.
Preparation method provided by the present invention comprises: get recipe quantity water for injection 70%, temperature, at 70-80 ℃, adds the arginine glutamic acid of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; To 0.2% medicinal charcoal that adds amount of liquid medicine in above-mentioned solution, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 7.7 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
The ibuprofen injection making according to the inventive method is through industrial amplification production machine study on the stability, proves that product is stable, and through pharmacology, toxicological test, solution is non-stimulated to blood vessel, without anaphylaxis, also without haemolysis, to human body without injury.
In preparation method of the present invention, the consumption of described medicinal charcoal is 0.1-0.2%.
Add appropriate medicinal charcoal can improve the clarity of solution, can adsorb again thermal source, pigment, medicinal charcoal there is no absorption to ibuprofen, and the inventor adopts UV-VIS spectrophotometry to measure the content of ibuprofen, has investigated medicinal charcoal, temperature, the impact of adsorption time on determination of ibuprofen in injection.Result shows, medicinal charcoal consumption is at 0.1-0.2%, and adsorption time is at 30 minutes, and adsorption temp is at 40-50 ℃, best results.
In preparation method of the present invention, described sterilizing is at 121 ℃ of pressure sterilizing 15-20 minute, is preferably 121 ℃ of pressure sterilizings 15 minutes.
Product of the present invention is the sterile water solution of ibuprofen, and sterilising conditions is very crucial, should reach sterilization effect, can not destroy again solution, and the inventor investigates sterilising conditions, refers to test example.Result shows, at 121 ℃ of pressure sterilizing 15-20 minute, and wherein 121 ℃ of pressure sterilizings 15 minutes, best results.
Compared with prior art, tool of the present invention has the following advantages:
1) new ibuprofen injection provided by the present invention has thoroughly solved the indissoluble problem of ibuprofen.
2) ibuprofen injection provided by the present invention is for improving the yield of this product, the market risk of reduction product, and being better applied to clinical treatment has very large help.
3) new brufen composition provided by the present invention, through industrialized great production and study on the stability, proves constant product quality, and through pharmacology, toxicological test, solution is non-stimulated to blood vessel, without anaphylaxis, also without haemolysis, to human body without injury.
4) preparation method of new brufen composition provided by the present invention, the method is simple, and prepared ibuprofen injection is stable to light, good stability.
The specific embodiment
Below in conjunction with embodiment, the present invention is described in further detail
embodiment 1
Ibuprofen medicinal composition described in every 1000, its formula consists of:
Ibuprofen 400g
Arginine glutamic acid 576g
Water for injection adds to 4L.
Preparation technology: get recipe quantity water for injection 70%, temperature, at 70-80 ℃, adds the arginine glutamic acid of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; To 0.2% medicinal charcoal that adds amount of liquid medicine in above-mentioned solution, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 7.7 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
embodiment 2
Ibuprofen medicinal composition described in every 1000, its formula consists of:
Ibuprofen 800g
Arginine glutamic acid 1152g
Water for injection adds to 8L.
Preparation technology: with embodiment 1.
comparing embodiment 1
Embodiment 2 arginine are cosolvent, in prescription, are 1.03:1 with the mol ratio of ibuprofen.
Ibuprofen 40g
Arginine 34.8g
Water for injection adds to 4000ml
________________________________________
Make altogether 1000 (or 500)
Method for making: take recipe quantity arginine, add 3200ml water for injection, stirring makes entirely molten.Then add recipe quantity ibuprofen, gradation progressively adds, and limit edged stirs.Add rear continuation to stir 20 minutes, make entirely molten.Surveying medicinal liquid pH value is 7.7 ~ 8.5.With 0.15%(w/v) needle-use activated carbon, adsorbs decarbonization filtering 15 minutes; Benefit injects water to 4000ml.Continue to use 0.22um filtering with microporous membrane, the clear and bright filtrate of gained is carried out to the inspection of semifinished product.The semi-finished product medicinal liquid being up to the standards is carried out to fill.Every fill 4ml or 8ml.Sealing, sterilizing.After product inspection is qualified, preserve.
test example 1
the Study on influencing factors of crude drug
Raw material, remove medicinal composite film packaging, precision samples, put in measuring bottle, be mixed with the solution of 100mg/ml, adjust pH in 7.7 left and right, under 40 ℃ ± 2 ℃ high temperature, 80 ℃ ± 2 ℃ high temperature, illumination 4500lx ± 500lx condition, place 6 hours, in sampling in 0,1,3,6 hour, measure, investigate solution character and related substance and pH value.
Above result of the test shows: material solution (100mg/ml) at 40 ℃ of high temperature, 80 ℃ of high temperature, place 6 hours, each testing result is all comparatively stable, under 20 ℃ of illumination conditions, places and maximumly singly assortedly measures defectively in 6 hours, illustrates that this solution is to photo-labile.
test example 2
In test example 1 research process, find, need to add suitable basic auxiliary, just can make ibuprofen dissolve completely, in stability of solution investigation process, ibuprofen solution is to photo-labile.Still consider to add suitable adjuvant, carry out prescription screening and optimization.
Preparation technology:
1, prepare: configuration 10% sodium hydroxide solution and 10% hydrochloric acid solution are appropriate, for subsequent use.According to recipe quantity, raw material is carried out to the pure actual inventory that calculates;
2, weigh: check after actual inventory through double, weigh according to actual inventory;
3, get recipe quantity water for injection 70%, temperature, at 75 ℃ ± 5 ℃, adds respectively arginine, glutamic acid, the arginine glutamic acid stirring and dissolving of recipe quantity, and visual observations adds ibuprofen after dissolving, and is stirred to visual observations and dissolves;
4, to 0.2% medicinal charcoal that adds medicine liquid volume in 3, stir 15 minutes;
5,4 are adopted and carry out sucking filtration, and add 10%-20% water for injection and rinse charcoal layer, add water for injection to full dose, mix and blend 5 minutes;
6, fine straining: by medicinal liquid adopt 0.45 m and 0.22 m filter membrane fine straining qualified to visible foreign matters;
7, fill: the loading amount difference fill that medicinal liquid is propped up by 4.2ml/ is in vial;
8, sterilizing: 121 ℃ of pressure sterilizings 15 minutes.
Prescription 1 is carried out to the mensuration of index of correlation to prescription 3, investigates result as follows:
Above result of the test shows, all less after prescription 3 maximum single impurity levels and the sterilizing of total impurities amount, is better than writing out a prescription 1 and prescription 2.
test example 3
This test example is to investigate medicinal charcoal consumption, temperature, the impact of adsorption time on determination of ibuprofen in injection.
The preparation of 1 ibuprofen sample solution: precision takes ibuprofen 100g and is placed in 2000ml volumetric flask, dilute with water scale, shakes up, and measures content, adds a certain amount of pyrogen, as reserve liquid.
The impact of 2 different time different amounts medicinal charcoal on ibuprofen absorption: add respectively medicinal charcoal 0,0.05,0.1,0.2g, in every group, in 40 ℃ of thermostat water baths, heat 15,30 minutes respectively, be cooled to room temperature, get subsequent filtrate according to measuring trap containing under quantifier, calculate content, detect pyrogen, the results are shown in Table:
Medicinal charcoal different amounts and the impact of different mixing time on determination of ibuprofen and pyrogen
From showing, can find out, the consumption of medicinal charcoal is 0.2%, and the content of ibuprofen obviously declines, adsorption time is longer, and content declines more obvious, therefore in preparation process, is guaranteeing the quality of the pharmaceutical preparations in the situation that, select medicinal charcoal consumption 0.1%, adsorption time was at 30 minutes.
test example 4
This test example is to investigate the impact of temperature on ibuprofen injection content under sterilising conditions:
This product is the sterile water solution of ibuprofen, sterilising conditions is very crucial, should reach sterilization effect, can not destroy again solution, the inventor investigates sterilising conditions, after the ibuprofen solution of prescription preparation certain volume, be packaged in ampoule bottle respectively at 115 ℃ 30 minutes, 121 ℃ 20 minutes, 121 ℃ 15 minutes
,121 ℃ of sterilizings in 20 minutes, drug content result following table in solution after observation sterilizing:
The impact of sterilising conditions on ibuprofen injection content
As can be seen from the above tests: sterilising temp condition is little on this product impact, selects 121 ℃ 15 minutes, F0>12, reaches sterilization effect, on solution content almost without affecting.
test example 5
The accelerated test of ibuprofen injection
Prepare three batches of ibuprofen injections (lot number is respectively HK1006001, HK1006002, HK1006003) according to commercially available back according to the method for the embodiment of the present invention 1, at 40 ℃ ± 2 ℃, the condition of RH75% ± 5% is placed 6 months, during this time respectively at the 1st, sampling in 2,3,6 months, according to stability inspection item detect, and with 0 day data comparison.
1, investigation project
High spot reviews: character, pH value, visible foreign matters, osmotic pressure molar density, related substance and content.
2, test data sees the following form
Accelerated test result
Above conclusion (of pressure testing) can be found out: this product long term test with under accelerated test condition, place 6 months every detection indexs no significant difference compared with 0 month, good stability.
comparative test example 1
The calorstat 10 days that comparative test example 1 and embodiment 1 is placed in respectively to the illumination of 4500LX ± 500LX, 60 ℃ ± 2 ℃ of high temperature, checked its character, pH value and related substance respectively at 0 day, 10 days.The results are shown in following table:
Known according to result of the test, embodiment 1 and comparative example 1 place 10 days in the calorstat of the illumination of 4500LX ± 500LX, 60 ℃ ± 2 ℃ of high temperature, embodiment 1 is under different condition, each check item has no significant change, comparative example is all comparatively responsive to light, heat, related substance, pH obviously increases trend, and the present invention has obvious quality stability.
Claims (6)
1. an ibuprofen medicinal composition for injection, is characterized in that the formula of every 1000 pharmaceutical compositions consists of:
Ibuprofen 400g
Arginine glutamic acid 576g
Water for injection adds to 4L.
2. an ibuprofen medicinal composition for injection, is characterized in that the formula of every 1000 pharmaceutical compositions consists of:
Ibuprofen 800g
Arginine glutamic acid 1152g
Water for injection adds to 8L.
3. the preparation method of ibuprofen medicinal composition according to claim 1 and 2, is characterized in that, the method comprises the steps:
Get recipe quantity water for injection 70%, temperature, at 70-80 ℃, adds the arginine glutamic acid of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add medicinal charcoal, after stirring, place; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 7.7 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; Sterilizing; Lamp inspection; Warehouse-in; Get product.
4. preparation method according to claim 3, is characterized in that, the consumption of described medicinal charcoal is 0.1-0.2%.
5. preparation method according to claim 3, is characterized in that, described sterilizing is at 121 ℃ of pressure sterilizing 15-20 minute.
6. preparation method according to claim 5, is characterized in that, described sterilizing is 121 ℃ of pressure sterilizings 15 minutes.
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| CN101156842A (en) * | 2007-09-29 | 2008-04-09 | 北京和为康医药科技有限公司 | Pharmaceutical preparation containing arginine glutamic acid |
| CN101966147A (en) * | 2010-09-27 | 2011-02-09 | 四川阳光润禾药业有限公司 | Ibuprofen injection composite and preparation method thereof |
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| CN101966147A (en) * | 2010-09-27 | 2011-02-09 | 四川阳光润禾药业有限公司 | Ibuprofen injection composite and preparation method thereof |
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