CN102716069A - Injection liquid containing ibuprofen and preparation process of injection liquid - Google Patents
Injection liquid containing ibuprofen and preparation process of injection liquid Download PDFInfo
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- CN102716069A CN102716069A CN2012101878423A CN201210187842A CN102716069A CN 102716069 A CN102716069 A CN 102716069A CN 2012101878423 A CN2012101878423 A CN 2012101878423A CN 201210187842 A CN201210187842 A CN 201210187842A CN 102716069 A CN102716069 A CN 102716069A
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Abstract
The invention relates to a proportioning method of ibuprofen injection liquid, a preparation process and relevant substance limitation and belongs to the technical field of medicine. The medical auxiliary materials of the injection liquid are arginine, the injection liquid is prepared by mixing the ibuprofen and arginine according to a mol ratio, the total quantity of relevant substances in the injection liquid is lower than 0.5 percent, and in addition, the content of each kind of impurities is respectively lower than 0.1 percent. The pH value of the injection liquid is controlled in a range that the ibuprofen can be completely dissolved, and the crystal separation phenomenon cannot occur. The content of relevant substances of the injection liquid is strictly controlled in a certain range so that the adverse effect generated on human bodied is avoided to the furthest degree during the intravenous drip on patients, and the safety is higher. The ibuprofen injection liquid provided by the invention has the advantages that the preparation process is simple, the operation is easy, the efficiency is high, and products with stable quality can be prepared.
Description
Technical field
The present invention relates to a kind of matching method, preparation technology and related substance limit thereof of ibuprofen injection, belong to medical technical field.
Background technology
Ibuprofen is one type of nonsteroidal anti-inflammatory drug of having used for many years, is effective PG enzymatic synthesis inhibitor, has antiinflammatory preferably, analgesic and analgesic activity, and it is widely used in the pain that treatment of arthritis and various inflammation cause.Be specially adapted to treat rheumatic arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and neuritis etc.In addition, it is child's febrifuge of World Health Organization (WHO) and the unique common recommendation of U.S. FDA, is the first-selected febrifuge of child of generally acknowledging.
Ibuprofen goes on the market in Britain early than nineteen sixty-eight, because the antipyretic-antalgic aspect is evident in efficacy, and toxicity is low, is superior to aspirin and acetaminophen, thereby market enlarges rapidly.Since ibuprofen preferably curative effect with have less untoward reaction, in the later stage eighties 20th century, the U.S., Britain ratify to transfer it to OTC medicine in succession.
China began to produce ibuprofen in 1979, domestic existing listing dosage form is: ibuprofen tablet, ibuprofen dispersible tablet, ibuprofen-effervescent sheet, ibuprofen oral disintegrating tablets, ibuprofen soft gelatin capsule, ibuprofen syrup, ibuprofen chewable tablet, brufen soft capsule, ibuprofen modified release capsule and ibuprofen oral administration mixed suspension etc.
The appearance of ibuprofen intravenous fluid, can be can not be oral inpatient remove pain and bring down a fever, have very optimistic market prospect.
Ibuprofen is water-soluble hardly but be soluble in alkaline solution, and promptly dissolubility receives the influence of solution pH value.Describe in the description according to the Caldolor of FDA approval, this product design is 100mg/mL, need be diluted to concentration in use smaller or equal to 4mg/mL intravenous drip again.Its diluent is 5% glucose injection and 0.9% sodium chloride injection; The former pH value is 4.40, and the latter 5.50, all slant acidity; This just need not use under the situation of extra pH regulator agent as far as possible; Remove to control the pH value of injection behind the compatibility through the concentration of alkaline solution, it can be guaranteed in blood of human body is accepted scope, can not cause pH value to exceed after the certain limit ibuprofen simultaneously again and occur separating out phenomenon and influence product quality.
A kind of injection of forming by ibuprofen and arginine that relates among the patent CN01823764.9; This drug regimen composition formula is described as ibuprofen and arginic mol ratio is less than 1:1; But the experiment proof needs to use the pH regulator agent that pH value is controlled at more than 7.4; Be that ibuprofen in the ibuprofen injection dissolves fully, can not separate out.But still having injection stability hidden danger, there is possible potential safety hazard in its related substances meeting overrun even use.
Among the patent CN201010293328.9 prescription of being made up of ibuprofen and cosolvent (arginine) is advised that ibuprofen and arginic mol ratio are 1:1.001-2; This prescription can guarantee that ibuprofen can not separated out under suitable pH value; But must use the pH regulator agent to reduce pH value and accept scope to reach blood of human body; And big as the required quantitative change of the arginine of pharmaceutic adjuvant, cost also uprises thereupon.In addition, the content of related substance inspection is still low inadequately for injection under this pharmaceutical composition proportioning.
Therefore, this area still needs a kind ofly not only to have solved the water miscible problem of ibuprofen, but also can the related substance of injection be reduced to ibuprofen injection prescription and the preparation technology who minimizes and reduce the industry cost.
Summary of the invention
The object of the invention is to remedy the deficiency of above set forth to existing ibuprofen injection and patent thereof, provides a kind of and can significantly improve product quality and stability, higher ibuprofen injection prescription and the preparation technology thereof of safety.Prove that through experimentation the present invention can effectively solve the solubility of ibuprofen, avoid separating out, reducing the content of related substance in the injection, reduce the industry cost.
According to technical scheme provided by the invention, a kind of injection that contains ibuprofen, composition is following: comprise ibuprofen, arginine and injection; Wherein ibuprofen and arginine mol ratio are 1.0:0.9 ~ 1.1; Ibuprofen shared mass/volume percentage ratio in injection is 10%, and arginine shared mass/volume percentage ratio in injection is 7.6% ~ 9.3%; The injection pH value is 7.0 ~ 8.0.
Said ibuprofen and arginine mol ratio are 1:1.
Said arginine shared mass/volume percentage ratio in injection is 8.444%.
A kind of preparation technology who contains the injection of ibuprofen, preparation process is following:
(1) washing of ampoule: get the neutral density glass ampoule, in ampoule, pour into deionized water earlier, 100 ℃ were boiled 25 ~ 35 minutes, and water dumping while hot with fresh water for injection lavation for several times, placed 160 ~ 170 ℃ of baking ovens 2 ~ 4 hours immediately, and taking-up is put cold, subsequent use;
(2) dosing: get arginine 303.99mg ~ 371.55mg earlier, add water for injection 2.4mL ~ 3.6mL that supersound process is crossed, stir and make its dissolving, add the 400.00mg ibuprofen again, the ultrasonic agitation dissolving; Supersonic frequency is 50 ~ 100Hz, and dissolution time is 15 ~ 30 minutes; Using pH regulator agent regulator solution pH value is 7.0 ~ 8.0, and restock water for injection 1.6mL ~ 0.4mL stirs, and adds that to account for total liquor capacity mass ratio be 0 ~ 0.5% needle-use activated carbon again, stirs 20 ~ 40 minutes down in 50 ~ 60 ℃; Utilize defecator and 0.22 ~ 0.45 μ m microporous filter to the clear of filtrating the gained medicinal liquid, get final ibuprofen filtrating;
(3) fill and post processing: final ibuprofen filtrating Chinese medicine content, pH value that determination step (2) obtains, according to calculating the loading amount fill; Being about to final ibuprofen filtrates by the labelled amount fill in 5mL or 10mL ampoule; After the fill with ampoule fusion sealing;
(4) sterilization and quality inspection: with the wet-hot steam sterilization 8min ~ 20min under 96 ~ 121 ℃ of conditions of the ibuprofen injection behind the sealing by fusing in the step (3); To its leak detection, lamp inspection, the packing warehouse-in promptly gets the product ibuprofen injection.
Content of impurities is smaller or equal to 0.5% of gross mass in the said product ibuprofen injection;
Wherein, the content of impurity 4-isobutyl acetophenone is smaller or equal to 0.1%; The benzoic content of impurity 4-isobutyl group is smaller or equal to 0.1%; The content of impurity 2-(3-isobutyl phenenyl) propanoic acid is smaller or equal to 0.1%; The content of impurity 2-(4-butyl phenyl) propanoic acid is smaller or equal to 0.1%; The content of impurity 3-(4-isobutyl phenenyl) propanoic acid is smaller or equal to 0.1%; Impurity 7-(2-aminomethyl phenyl)-1-[4-(2-methyl-propyl) phenyl]-1,2,3,4-tetralin-1, the content of 4-dicarboxylic acids is smaller or equal to 0.1%; The content of impurity 2-(4-isobutyryl phenyl) propanoic acid is smaller or equal to 0.1%; The content of impurity 2-(4-ethylphenyl) propanoic acid is smaller or equal to 0.1%.
All charge into nitrogen protection in the said step (3) before and after the ampoule filling medicinal liquid.
Adopt needle-use activated carbon to filter in the step of preparation process of the present invention and can remove bacterial endotoxin, and guarantee the sample solution clear.Adopt defecator to cooperate the micropore fine straining, can raise the efficiency, guarantee product quality.Can guarantee the aseptic level of product with 0.22 ~ 0.45 μ m microporous filter.Inflated with nitrogen can effectively be removed residual oxygen content in the ampoule before the fill, reduces the probability that related substance produces.
The present invention has following advantage: the present invention is controlled at one with the injection pH value dissolves completely in the scope ibuprofen, crystal promptly can not take place separate out phenomenon.The content of injection related substance is strict controlled in the certain limit, when making it to patient's intravenous drip, as much as possible avoids to property human body is produced untoward reaction, safety is higher.Ibuprofen injection preparation technology described in the present invention is simple, easy to operate, efficient is high, can make stay-in-grade product.
Description of drawings
Fig. 1 is that principal agent ibuprofen and 7 kinds of impurity mix the appearance liquid chromatogram.
Fig. 2 is a 4-isobutyl acetophenone liquid chromatogram.
Fig. 3 is a 4-isobutyl-benzene formic acid liquid chromatogram.
Fig. 4 is 2-(3-isobutyl phenenyl) propanoic acid liquid chromatogram.
Fig. 5 is 2-(4-butyl phenyl) propanoic acid liquid chromatogram.
Fig. 6 is 7-(2-aminomethyl phenyl)-1-[4-(2-methyl-propyl) phenyl]-1,2,3,4-tetralin-1,4-dicarboxylic acids liquid chromatogram.
Fig. 7 is 2-(4-isobutyryl phenyl) propanoic acid liquid chromatogram.
Fig. 8 is 2-(4-ethylphenyl) propanoic acid liquid chromatogram.
Fig. 9 is ibuprofen injection sample (embodiment 1 and a 2) blank solvent liquid chromatogram.
Figure 10 is the ibuprofen injection sample liquid chromatogram of embodiment 1 preparation.
Figure 11 is the ibuprofen injection sample liquid chromatogram of embodiment 2 preparations.
The specific embodiment
Below in conjunction with embodiment the present invention is described in further detail, but be not to be limitation of the present invention, the equal replacement of every any this area of doing according to the disclosure of invention all belongs to protection scope of the present invention.
Embodiment 1
Per 200 ibuprofen injections contain following ingredients: ibuprofen 80.000g (0.388mol); Arginine 67.551g (0.388mol); Water for injection 800mL.
The preparation technology who contains the injection of ibuprofen
(1) washing of ampoule: get neutral density glass ampoule (specification 5mL), with pouring into deionized water in the ampoule earlier, 100 ℃ were boiled 30 minutes, and water dumping while hot with fresh water for injection lavation twice, placed 160 ℃ of baking ovens 2 hours immediately, and taking-up is put cold, subsequent use.
(2) dosing: get the recipe quantity arginine earlier, add supersound process and cross water for injection 700mL, stir and make dissolving; Add the recipe quantity ibuprofen again; The ultrasonic agitation dissolving, surveying pH value is 7.8 ~ 8.0, restock water for injection is to full dose; Stir, add 0.1% (w/v) needle-use activated carbon and stir 30min down for 55 ℃.Earlier medicinal liquid is filtered with buchner funnel, reuse core defecator and 0.22 μ m filtering with microporous membrane take off charcoal, filtrate at last that it is clear and bright to be filtered to filtrating through G4 glass incipient fusion filter, ibuprofen filtrating.
(3) fill and post processing: final ibuprofen filtrating Chinese medicine content, pH value that determination step (2) obtains, according to calculating the loading amount fill; Being about to final ibuprofen filtrates by the labelled amount fill in 5mL or 10mL ampoule; After the fill with ampoule fusion sealing;
(4) sterilization and quality inspection: with the wet-hot steam sterilization 8min ~ 20min under 96 ~ 121 ℃ of conditions of the ibuprofen injection behind the sealing by fusing in the step (3); To its leak detection, lamp inspection, the packing warehouse-in promptly gets the product ibuprofen injection.
Embodiment 2
Per 200 ibuprofen injections contain following ingredients: ibuprofen 160.000g (0.776mol); Arginine 135.108g (0.776mol); Water for injection 1600mL.
The preparation technology who contains the injection of ibuprofen:
(1) washing of ampoule: get neutral density glass ampoule (specification 10mL), with pouring into deionized water in the ampoule earlier, 100 ℃ were boiled 30 minutes, and water dumping while hot with fresh water for injection lavation twice, placed 160 ℃ of baking ovens 2 hours immediately, and taking-up is put cold, subsequent use.
(2) dosing: get the recipe quantity arginine earlier, add supersound process and cross water for injection 1400mL, stir and make dissolving; Add the recipe quantity ibuprofen again, the ultrasonic agitation dissolving, surveying pH value is 7.8 ~ 8.0; Restock water for injection is to full dose; Stir, (w/v, quality: volume) needle-use activated carbon stirs 40min down for 60 ℃ to add 0.2%.Earlier medicinal liquid is filtered with buchner funnel, reuse core defecator and 0.22 μ m filtering with microporous membrane take off charcoal, filtrate at last that it is clear and bright to be filtered to filtrating through G4 glass incipient fusion filter, ibuprofen filtrating.
(3) fill and post processing: final ibuprofen filtrating Chinese medicine content, pH value that determination step (2) obtains, according to calculating the loading amount fill; Being about to final ibuprofen filtrates by the labelled amount fill in 5mL or 10mL ampoule; After the fill with ampoule fusion sealing;
(4) sterilization and quality inspection: with the wet-hot steam sterilization 8min ~ 20min under 96 ~ 121 ℃ of conditions of the ibuprofen injection behind the sealing by fusing in the step (3); To its leak detection, lamp inspection, the packing warehouse-in promptly gets the product ibuprofen injection.
1 pair of related substance standard substance of application implementation example position analysis:
Embodiment 1 is carried out the analysis of related substance with routine 2 ibuprofen injections.
Chromatographic condition
Chromatographic column: Galaksil EF-C 18-H 5um, 4.6 * 150mm
Mobile phase: A: pure water (phosphoric acid adjust pH to 2.5 ~ 3.5): acetonitrile=50 ~ 72:50 ~ 28; B: pure acetonitrile
Adopt gradient elution method, gradient condition is following:
Detect wavelength: 214nm
Flow velocity: 2mL/min
Column temperature: 20 ~ 30 ℃
Sample size: 20 μ L
1, the location of related substance standard substance
The preparation of test liquid: it is an amount of that precision is measured each related substance standard substance respectively, adds mobile phase A and process the solution that every 1mL contains 0.25mg, as need testing solution.By above chromatographic condition sample introduction, all related substances are all accomplished the location, and separating degree is better, and are up to specification, also do not influence the peak that of principal agent ibuprofen, see that Fig. 1 to Fig. 8 and table 1 are to table 8.
Table 1 principal agent ibuprofen and 7 kinds of impurity mix appearance liquid chromatogram test result
Table 2 4-isobutyl acetophenone liquid chromatogram test result.
Table 3 4-isobutyl-benzene formic acid liquid chromatogram test result.
Table 4 2-(3-isobutyl phenenyl) propanoic acid liquid chromatogram test result.
Table 5 2-(4-butyl phenyl) propanoic acid liquid chromatogram test result.
Table 7 2-(4-isobutyryl phenyl) propanoic acid liquid chromatogram test result.
Table 8 2-(4-ethylphenyl) propanoic acid liquid chromatogram test result.
2, the detection of ibuprofen related substance
The preparation of test liquid: it is an amount of with embodiment 2 ibuprofen that precision is measured embodiment 1 respectively, adds mobile phase A and process the solution that every 1mL contains 4mg, as need testing solution.By above chromatographic condition sample introduction, the data result of related substance is respectively 0.067% and 0.083%, sees Figure 10 and Figure 11 and table 10,11.Fig. 9 is ibuprofen injection sample (embodiment 1 and a 2) blank solvent liquid chromatogram.
The ibuprofen injection sample liquid chromatogram test result of table 10 embodiment 1 preparation.
The ibuprofen injection sample liquid chromatogram test result of table 11 embodiment 2 preparations.
Claims (6)
1. an injection that contains ibuprofen is characterized in that composition is following: comprise ibuprofen, arginine and injection; Wherein ibuprofen and arginine mol ratio are 1.0:0.9 ~ 1.1; Ibuprofen shared mass/volume percentage ratio in injection is 10%, and arginine shared mass/volume percentage ratio in injection is 7.6% ~ 9.3%; The injection pH value is 7.0 ~ 8.0.
2. contain the injection of ibuprofen according to claim 1, it is characterized in that: said ibuprofen and arginine mol ratio are 1:1.
3. contain the injection of ibuprofen according to claim 1, it is characterized in that: said arginine shared mass/volume percentage ratio in injection is 8.444%.
4. preparation technology who contains the injection of ibuprofen is characterized in that preparation process is following:
(1) washing of ampoule: get the neutral density glass ampoule, in ampoule, pour into deionized water earlier, 100 ℃ were boiled 25 ~ 35 minutes, and water dumping while hot with fresh water for injection lavation for several times, placed 160 ~ 170 ℃ of baking ovens 2 ~ 4 hours immediately, and taking-up is put cold, subsequent use;
(2) dosing: get arginine 303.99mg ~ 371.55mg earlier, add water for injection 2.4mL ~ 3.6mL that supersound process is crossed, stir and make its dissolving, add the 400.00mg ibuprofen again, the ultrasonic agitation dissolving; Supersonic frequency is 50 ~ 100Hz, and dissolution time is 15 ~ 30 minutes; Using pH regulator agent regulator solution pH value is 7.0 ~ 8.0, and restock water for injection 1.6mL ~ 0.4mL stirs, and adds that to account for total liquor capacity mass ratio be 0 ~ 0.5% needle-use activated carbon again, stirs 20 ~ 40 minutes down in 50 ~ 60 ℃; Utilize defecator and 0.22 ~ 0.45 μ m microporous filter to the clear of filtrating the gained medicinal liquid, get final ibuprofen filtrating;
(3) fill and post processing: final ibuprofen filtrating Chinese medicine content, pH value that determination step (2) obtains, according to calculating the loading amount fill; Being about to final ibuprofen filtrates by the labelled amount fill in 5mL or 10mL ampoule; After the fill with ampoule fusion sealing;
(4) sterilization and quality inspection: with the wet-hot steam sterilization 8min ~ 20min under 96 ~ 121 ℃ of conditions of the ibuprofen injection behind the sealing by fusing in the step (3); To its leak detection, lamp inspection, the packing warehouse-in promptly gets the product ibuprofen injection.
5. contain the injection of ibuprofen according to claim 1, it is characterized in that: content of impurities is smaller or equal to 0.5% of gross mass in the said product ibuprofen injection;
Wherein, the content of impurity 4-isobutyl acetophenone is smaller or equal to 0.1%; The benzoic content of impurity 4-isobutyl group is smaller or equal to 0.1%; The content of impurity 2-(3-isobutyl phenenyl) propanoic acid is smaller or equal to 0.1%; The content of impurity 2-(4-butyl phenyl) propanoic acid is smaller or equal to 0.1%; The content of impurity 3-(4-isobutyl phenenyl) propanoic acid is smaller or equal to 0.1%; Impurity 7-(2-aminomethyl phenyl)-1-[4-(2-methyl-propyl) phenyl]-1,2,3,4-tetralin-1, the content of 4-dicarboxylic acids is smaller or equal to 0.1%; The content of impurity 2-(4-isobutyryl phenyl) propanoic acid is smaller or equal to 0.1%; The content of impurity 2-(4-ethylphenyl) propanoic acid is smaller or equal to 0.1%.
6. like the said preparation technology who contains the injection of ibuprofen of claim 2, it is characterized in that: all charge into nitrogen protection in the said step (3) before and after the ampoule filling medicinal liquid.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040734A (en) * | 2012-12-20 | 2013-04-17 | 蚌埠丰原涂山制药有限公司 | High-stability ibuprofen injection and preparation method thereof |
| CN108158980A (en) * | 2016-12-07 | 2018-06-15 | 浙江普利药业有限公司 | Arginine Ibuprofen parenteral solution and preparation method thereof |
| CN109521117A (en) * | 2018-12-07 | 2019-03-26 | 成都倍特药业有限公司 | A kind of detection method of the ibuprofen injection in relation to substance |
Citations (1)
| 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 |
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- 2012-06-07 CN CN2012101878423A patent/CN102716069A/en active Pending
Patent Citations (1)
| 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 |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040734A (en) * | 2012-12-20 | 2013-04-17 | 蚌埠丰原涂山制药有限公司 | High-stability ibuprofen injection and preparation method thereof |
| CN108158980A (en) * | 2016-12-07 | 2018-06-15 | 浙江普利药业有限公司 | Arginine Ibuprofen parenteral solution and preparation method thereof |
| CN109521117A (en) * | 2018-12-07 | 2019-03-26 | 成都倍特药业有限公司 | A kind of detection method of the ibuprofen injection in relation to substance |
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Application publication date: 20121010 |