CN103893767A - Ibuprofen medicine composition with stable quality - Google Patents
Ibuprofen medicine composition with stable quality Download PDFInfo
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- CN103893767A CN103893767A CN201310426181.XA CN201310426181A CN103893767A CN 103893767 A CN103893767 A CN 103893767A CN 201310426181 A CN201310426181 A CN 201310426181A CN 103893767 A CN103893767 A CN 103893767A
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Abstract
The invention discloses an ibuprofen medicine composition with stable quality. The ibuprofen medicine composition is prepared from ibuprofen and arginine. The ibuprofen medicine composition is characterized by comprising the following processes: taking 85% of prescribed injection water; adding prescribed arginine at the temperature of 85+/-2 DEG C; adding prescribed ibuprofen after agitating and dissolving, and agitating until completely dissolving; adding 0.1% of medicinal carbon to the solution; standing for 30 minutes after evenly agitating; carrying out suction filtration, supplying injection water to the full amount and evenly mixing; measuring the initial pH value, and adjusting the pH value range at 8.0+/-0.2 according to the initial pH value; refining, and bulking; carrying out hot-pressure sterilization at 121 DEG C for 30 minutes; inspecting by light, and warehousing, so as to prepare the product. The ibuprofen medicine composition is good in thermal stability, can be better applied to clinical use, and has more obvious advantages.
Description
Technical field
The present invention relates to the medicine in field of medicaments, especially relate to a kind of stay-in-grade ibuprofen medicinal composition and preparation method thereof.
Background technology
Since entering the nineties in 20th century, the OTC antipyretic analgesic market of developed country is acetaminophen, ibuprofen and three points of world of aspirin.U.S.'s OTC antipyretic analgesic market is by sales volume, and acetaminophen accounts for 45%, and aspirin accounts for 25%, and ibuprofen accounts for 25%, and other account for 5%, and up to the present the market structure still remains unchanged.In Europe, what account for market leading position is also these 3 medicines.In Britain and Spain, the sales volume of ibuprofen has exceeded acetaminophen.In the similar India of living standard and China, ibuprofen has become one of best-selling antipyretic analgesic, and its sales volume is just with annual 15%～20% speed increment.
China reaches more than 20 hundred million yuan containing the sales volume of the medicine of acetaminophen.It has become one of product that sales volume is leading.And ibuprofen market is subject to the particularly impact of India's product of external product, add the propaganda strength of ibuprofen inadequate; Domestic preparation is irritant to gastrointestinal tract, and some patients are reluctant to accept; Production scale is little, and cost is higher, be subject to simultaneously product at a low price the factor such as extruding and competition to affect market growth slow.
Antipyretics thing is divided into two kinds of traditional nonsteroidal antiinflammatory drug (COX-1 inhibitor) and unconventional nonsteroidal antiinflammatory drugs (cox 2 inhibitor and Nitric oxide releasing NSAID (non-steroidal anti-inflammatory drug)) according to the selectivity of inhibition to Cycloxygenase (COX).
Two kinds of hypotypes of Cycloxygenase are in the distribution difference of human body, and COX-1 extensively distributes in body, and COX-2 expresses in the time that body is subject to inflammation infringement, be therefore distributed in local inflammation tissue more.NSAID (non-steroidal anti-inflammatory drug) (NSAIDs) produces therapeutical effect in inflammation part by suppressing COX-2, and at whole body, has especially suppressed COX-1 and produced untoward reaction at gastrointestinal tract and kidney.Different NSAID (non-steroidal anti-inflammatory drug) is not quite similar to the selectivity of two kinds of COX hypotypes, has therefore caused their difference aspect curative effect and untoward reaction.The difference that causes clinically gastrointestinal side effect degree according to them, is roughly divided into three classes by traditional NSAIDs: the first kind is as ketoprofen, indomethacin, piroxicam; Equations of The Second Kind is as aspirin, naproxen; The 3rd class is as ibuprofen, diclofenac, Diflonid.Wherein first kind untoward reaction is the most serious, and Equations of The Second Kind takes second place, and the 3rd class is relatively the safest.
The commercially available injection easing the pain only has opioid drug morphine and Pethidine and non-steroid antiinflammatory drug ketone to cough up sweet smell at present.Opioid drug can cause calmness, feels sick, vomiting, cognitive impairment and inhibition are breathed, and only eases the pain and can not play antiinflammation.Ketone is coughed up fragrant untoward reaction more seriously increase hemorrhage danger, gastrointestinal tract and kidney complication.And ibuprofen is little as the 3rd non-steroid antiphlogistic side effect, determined curative effect, in relieving the pain, also play antiinflammatory action, for doctor's medication and can not oral patient remove pain and bring down a fever new medical scheme is provided.
Ibuprofen is to go on the market in Britain nineteen sixty-eight the earliest, evident in efficacy due to antipyretic-antalgic aspect, and also toxicity is low, be better than aspirin and acetaminophen, thereby market expands rapidly.Due to the good curative effect of ibuprofen and have less untoward reaction, the U.S., Britain ratify to transfer it to nonprescription drugs with prescription drugs in succession.To early 1990s, the sales volume of world market Motrin has broken through 1,000,000,000 dollars of high pointes, is to break through the earliest the antipyretic analgesic product of 1,000,000,000 dollars.
Good antipyretic-antalgic effect has also driven the exploitation listing of numerous dosage forms, be peroral dosage form and local form of administration, as tablet, capsule, dry suspension, granule, drop, effervescent tablet, oral cavity disintegration tablet and ointment, gel, liniment, not yet there is injection type list marketing.And the injection market of U.S.'s treatment pain reaches approximately 6.79 hundred million dollars for 2008, this explanation ibuprofen kind also has huge market potential.
Ibuprofen has lighter untoward reaction and good antipyretic-antalgic effect, if injection can be developed listing, by the Gospel that is numerous pain and fever patient, external multinomial large-scale clinical trial all shown ibuprofen injection treatment light moderate pain or even severe pain and antipyretic aspect excellent results.Ibuprofen is well-known general medicine kind, and crude drug is cheap, and production cost is very low.Domestic pain market capacity is huge, and ibuprofen is that numerous doctor patients know in addition, and marketing is easy, can predict, and the exploitation listing of ibuprofen injection, brings considerable economic benefit and social benefit surely.
Common name: ibuprofen; English name: Ibuprofen; Chemical name: 4-isobutyl group-Alpha-Methyl phenylacetic acid; 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.
Structural formula:
The Yuan Yan producer of ibuprofen injection be Cumberland company of the U.S. (trade name:
specification: 4ml:400mg and 8ml:800mg; Dosage form: injection).In June, 2009 U.S.'s approval listing; 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; The usage and dosage of its injection: (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.
Application number is that the invention of CN201310140902.0 relates to a kind of ibuprofen compound, and the structural formula of described ibuprofen compound is as follows: the X-ray powder diffraction spectrogram that described ibuprofen compound uses Cu-K alpha ray to measure.The present invention also provides a kind of preparation method of described ibuprofen compound and the pharmaceutical composition containing described ibuprofen compound.Described ibuprofen medicinal composition is ibuprofen injection, ibuprofen sterile powder injection.Ibuprofen compound provided by the invention and drug regimen thereof compared with prior art, have better storage stability, have greatly improved patient's drug safety.
Application number is that the invention of CN201210555376.X consists of the following composition: arginine, ibuprofen and water for injection, and wherein the mol ratio of arginine and ibuprofen is 0.85～0.95:1; Ibuprofen shared weight/volume in injection is 10%, and arginine shared weight/volume in injection is 7.2～8.0%, and injection pH value is 7.5～8.5.The present invention creatively adopts minimum and minimum adjuvant to solve the stability difficult problem of ibuprofen injection, has been successfully prepared the ibuprofen injection of clinical use safety, good stability.
Application number is that the invention of CN201210337576.8 relates to field of pharmaceutical preparations, particularly brufen composition injection and preparation method thereof.This brufen composition preparation is made up of ibuprofen, arginine and water for injection; Described ibuprofen and described arginic mol ratio are 1:1～1.2.It dissolves soon, bioavailability is high, onset is rapid.Preparation method provided by the invention is simple to operate, easily controls, and is beneficial to industrialized great production.
Application number is that the invention of CN201210276621.3 has supplied a kind of pharmaceutical composition that contains ibuprofen.The invention provides a kind of new pharmaceutical composition that contains ibuprofen injection and the preparation method of preparation thereof; Pharmaceutical composition of the present invention is suitable for large production; The good stability of pharmaceutical composition of the present invention, with occurring without opalescence or turbid phenomenon after normal saline or the dilution of 5% glucose injection.
Application number is that CN201210215458.X relates to a kind of ibuprofen injection, injection is made up of active component ibuprofen, cosolvent arginine, its feature is: in this injection, ibuprofen, arginine mol ratio are 1: 1～1: 1.2, and use ammonia and hydrochloric acid as pH value regulator simultaneously, in ibuprofen and arginic solution, adding ammonia adjust pH is 7.8～9.0, its particulate matter has obvious minimizing, and has solved the compatibility consistency problem of injection and sodium chloride and glucose injection; Be 7.0～8.0 with hydrochloric acid solution readjustment pH value again, make the pH value of medicinal liquid identical with blood of human body pH value or close, improve compliance and the comfort level of patient's medication.
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.
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.
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.
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.
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 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.
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 taking 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 taking 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.
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.
The ibuprofen injection that prior art is produced has very strict requirement to the requirement of storage, lucifuge, in use, preservation and transport, 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 stay-in-grade ibuprofen medicinal composition, and this ibuprofen medicinal composition is to Heat stability is good, steady quality.
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, to improving product yield, reduces costs, and realizes industrialization, is better applied to clinically, has more obvious advantage.
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 bottles, its formula consists of:
Ibuprofen 400g
Arginine 600g
Water for injection adds to 4L.
Ibuprofen medicinal composition described in every 1000 bottles, its formula consists of:
Ibuprofen 800g
Arginine 1200g
Water for injection adds to 8L.
For realizing the second object of the present invention, the preparation method of ibuprofen medicinal composition of the present invention, wherein, the method comprises the steps:
Get recipe quantity water for injection 85%, temperature, at 85 ± 2 DEG C, adds the arginine of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add 0.1% medicinal charcoal, after stirring, place 30 minutes; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 8.0 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; 121 DEG C of pressure sterilizings 30 minutes; 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 600g
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 1200g
Water for injection adds to 8L.
Traditional ibuprofen injection, poor heat stability, related substance is along with sample is placed increase gradually, and quality cannot ensure.
In the present invention, in the stability study process to ibuprofen injection light, after finding to select the suitable recipe quantity of arginine to dissolve completely, then dissolve ibuprofen, regulate pH=8.0, can effectively improve said preparation to hot stability, 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 problem to poor heat stability, 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 to thermally-stabilised, and related substance is controlled, and quality is good.
Preparation method provided by the present invention comprises: get recipe quantity water for injection 85%, temperature, at 85 ± 2 DEG C, adds the arginine of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add 0.1% medicinal charcoal, after stirring, place 30 minutes; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 8.0 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; 121 DEG C of pressure sterilizings 30 minutes; 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.
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 0.1%, and adsorption time is at 30 minutes, and adsorption temp is at 40-50 DEG C, best results.
In preparation method of the present invention, described sterilizing is 121 DEG C of pressure sterilizings 30 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, 121 DEG C of pressure sterilizings 30 minutes, and 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) new ibuprofen injection provided by the present invention is by the excessive arginine that adds, then by pH regulator to 8.0, the formulation products of making after sterilization time extends, improves greatly to heat stability, and related substance is substantially unchanged, steady quality.
3) preparation method the method for new ibuprofen medicinal composition provided by the present invention is simple, and prepared ibuprofen injection is to thermally-stabilised, and related substance is controlled, and quality is good.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail
Embodiment 1
Ibuprofen medicinal composition described in every 1000 bottles, its formula consists of:
Ibuprofen 400g
Arginine 600g
Water for injection adds to 4L.
Preparation technology: get recipe quantity water for injection 85%, temperature, at 85 ± 2 DEG C, adds the arginine of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add 0.1% medicinal charcoal, after stirring, place 30 minutes; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 8.0 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; 121 DEG C of pressure sterilizings 30 minutes; Lamp inspection; Warehouse-in; Get product.
Embodiment 2
Ibuprofen medicinal composition described in every 1000 bottles, its formula consists of:
Ibuprofen 800g
Arginine 1200g
Water for injection adds to 8L.
Preparation technology: with embodiment 1.
Test example 1
The Study on influencing factors of crude drug
First investigate the Dependent Stability test of raw material under formulation concentrations, be further preparation process screening and optimizing process conditions, by raw material, remove medicinal composite film packaging, precision samples, put in measuring bottle, be mixed with the solution of 100mg/ml, adjust pH in 8.0 left and right, under 60 DEG C of high temperature, strong illumination condition, place 6 hours, in sampling in 0,1,3,6 hour, measure, investigate solution character and related substance and pH value.
Result shows: material solution was 60 DEG C of high temperature, strong illumination, placement 10 hours, and single largest impurity and total impurities obviously increase, and illustrate that this solution is all unstable to light, heat.
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 unstable.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 85%, temperature, at 85 DEG C, adds respectively the arginine stirring and dissolving of recipe quantity, and visual observations adds ibuprofen after dissolving, and is stirred to visual observations and dissolves;
4,, to 0.1% medicinal charcoal that adds medicine liquid volume in 3, after stirring, place 30 minutes;
5,4 are adopted and carry out sucking filtration, and add 10%% 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 μ m and 0.22 μ m filter membrane fine straining qualified to visible foreign matters;
7, fill: the loading amount difference fill that medicinal liquid is pressed to 4ml/ bottle is in vial;
8, sterilizing: 121 DEG C of pressure sterilizings 30 minutes.
Prescription 1 is carried out to the mensuration of index of correlation to prescription 3, investigate result as follows
Result shows, all less after the maximum single impurity levels of prescription 2 and the sterilizing of total impurities amount, is better than writing out a prescription 1.
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 0,0.1,0.2g, in every group, in 40 DEG C 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 ensureing 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 DEG C 30 minutes, 121 DEG C 20 minutes, 121 DEG C 30 minutes, observe after sterilizing drug content result following table in solution:
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 DEG C 30 minutes, F0>12, reaches sterilization effect, on solution content almost without affecting.
Claims (2)
1. a stay-in-grade ibuprofen medicinal composition, is characterized in that, the ibuprofen medicinal composition described in it, and every 1000 bottles of its formulas consist of:
Ibuprofen 400-800g
Arginine 600-1200g
Water for injection adds to 4-8L.
2. the preparation method of ibuprofen medicinal composition according to claim 1, is characterized in that, the method comprises the steps: to get recipe quantity water for injection 85%, and temperature, at 85 ± 2 DEG C, adds the arginine of recipe quantity, after stirring and dissolving; Add the ibuprofen of recipe quantity, be stirred to and dissolve completely; In above-mentioned solution, add 0.1% medicinal charcoal, after stirring, place 30 minutes; Sucking filtration, adds water for injection to full dose, mix homogeneously; Record original ph, according to original ph, regulate pH value scope 8.0 ± 0.2 with 4% sodium hydroxide solution and 10% hydrochloric acid solution; Fine straining; Fill; 121 DEG C of pressure sterilizings 30 minutes; Lamp inspection; Warehouse-in; Get product.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107233307A (en) * | 2017-07-03 | 2017-10-10 | 华润双鹤利民药业（济南）有限公司 | A kind of ibuprofen injection and preparation method thereof |
| CN114588107A (en) * | 2022-04-06 | 2022-06-07 | 河北一品生物医药有限公司 | Ibuprofen lysine salt injection and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN103027890A (en) * | 2011-09-29 | 2013-04-10 | 天津市汉康医药生物技术有限公司 | Ibuprofen medicine composition for injection |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN103027890A (en) * | 2011-09-29 | 2013-04-10 | 天津市汉康医药生物技术有限公司 | Ibuprofen medicine composition for injection |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107233307A (en) * | 2017-07-03 | 2017-10-10 | 华润双鹤利民药业（济南）有限公司 | A kind of ibuprofen injection and preparation method thereof |
| CN114588107A (en) * | 2022-04-06 | 2022-06-07 | 河北一品生物医药有限公司 | Ibuprofen lysine salt injection and preparation method thereof |
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Application publication date: 20140702 |