CN103479605B - A kind of dilutable ibuprofen medicinal composition and preparation method thereof - Google Patents
A kind of dilutable ibuprofen medicinal composition and preparation method thereof Download PDFInfo
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- CN103479605B CN103479605B CN201210193959.2A CN201210193959A CN103479605B CN 103479605 B CN103479605 B CN 103479605B CN 201210193959 A CN201210193959 A CN 201210193959A CN 103479605 B CN103479605 B CN 103479605B
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Abstract
The invention discloses a kind of dilutable ibuprofen medicinal composition and preparation method thereof.The inventive method comprises the steps: the arginine of formula ratio, ibuprofen stirring and dissolving, filters deactivation charcoal, adding citric acid adjust ph, and add water stirring, filtration, fill, sterilizing and get final product.Preparation method of the present invention is simple, and safety and stability, can be used for large-scale production.
Description
Technical field
The present invention relates to a kind of dilutable ibuprofen medicinal composition and preparation method thereof.
Background technology
Ibuprofen is a kind of medicine with pain relieving, antiinflammatory and refrigeration function, and widely separately or be applied to the treatment of relevant disease with other drug compatibility.
Ibuprofen oral application easily causes gastrointestinal upset, as abdominal distention, dyspepsia, nausea,vomiting,diarrhea, can cause the bad or serious adverse reaction such as digestive tract ulcer, digestive tract hemorrhage time serious.Old friends study in formulation art for a long time, attempt its improvement opportunity.
The Motrin sold in the market mainly contains tablet, capsule, granule, suppository, emulsifiable paste and some slow releasing preparation.Because ibuprofen is almost insoluble in water, its difficulty preparing injection is very large, and the advantage of injection is irreplaceable, and clinical have specific demand to this.Prepare ibuprofen injection that a kind of stable Gong clinical safety uses for doctor and patient all tool be of great significance.
On June 11st, 2009, U.S. FDA have approved the application for quotation of the ibuprofen injection (Ibuprofen, Caldolor) of Cumberland company development.Cumberland company has its Patents ZL01823764.9 in China.Caldolor is the ibuprofen injection of first, whole world listing, said preparation specification is 400mg/4ml and 800mg/8ml, its usage is select suitable diluent, comprise 0.9% sodium chloride injection, 5% glucose injection or Ringer lactate solution, being diluted to final concentration is 4mg/ml or lower concentration posterior vein infusion.
Chinese patent CN200610170923.7 discloses a kind of infusion preparation of ibuprofen and preparation method thereof, but adds alcohol and some additives in its preparation, brings safety risks to clinical application.Therefore a kind of Motrin of safety and stability is badly in need of.
Chinese patent 201010134500.6 discloses a kind of ibuprofen injection and manufacture method thereof, and wherein containing ibuprofen and arginine, the mol ratio of arginine and ibuprofen is more than or equal to 1:1; Although this invention solves the problems of dissolution of ibuprofen, but not yet solve preparation when Clinical practice after compatibility the stability of solution or physiological adaption as the simulation preparation prepared by the embodiment 1,2 of this patent and glucose injection (pH value 3.8, Chinese Pharmacopoeia regulation glucose injection pH value is 3.2-5.5), there is opalescence (character is defective) in various degree in solution after sodium chloride injection (pH value 4.8, Chinese Pharmacopoeia specifies that sodium chloride injection pH value is 4.5-7.0) compatibility; Its pH value of simulation preparation prepared by the embodiment 3 of this patent up to 9.14, with pH value after glucose injection (pH value 3.8) compatibility be 8.54, with sodium chloride injection (pH value 4.8) compatibility after pH value be 8.60, have potential zest risk to human body.After it has been generally acknowledged that compatibility, the pH of medicinal liquid is good close to the at physiological ph of human body.
Summary of the invention
The object of the invention is open a kind of ibuprofen medicinal composition, and another object of the present invention is the preparation method of open said composition.
The present invention seeks to be achieved through the following technical solutions:
Ibuprofen medicinal composition raw material of the present invention consists of:
Ibuprofen 10-200 weight portion
Arginine 8.5-202 weight portion
Citric acid 0.1-20 weight portion
Water for injection adds to 1000 parts by volume
Ibuprofen medicinal composition raw material composition of the present invention is preferably:
Ibuprofen 100 weight portion
Arginine 92 weight portion
Citric acid 4.0 weight portion
Water for injection adds to 1000 parts by volume
Ibuprofen medicinal composition raw material composition of the present invention is preferably:
Ibuprofen 100 weight portion
Arginine 88 weight portion
Citric acid 2.5 weight portion
Water for injection adds to 1000 parts by volume
Ibuprofen medicinal composition raw material composition of the present invention is preferably:
Ibuprofen 100 weight portion
Arginine 100 weight portion
Citric acid 3.2 weight portion
Water for injection adds to 1000 parts by volume
The preparation method of ibuprofen medicinal composition of the present invention comprises the steps:
1, in material-compound tank, add the water for injection of 2/3 cumulative volume, be heated to 60-100 DEG C, add the arginine of formula ratio, be stirred to and dissolve completely;
2, add the ibuprofen of formula ratio, be stirred to and dissolve completely;
3, the active carbon of cumulative volume 0.1%g/ml is added wherein, stir and maintain the temperature at 60-100 DEG C, absorption 10-30 minute;
4, excessively active carbon is filtered;
5, water for injection is added to nearly 1000 parts by volume, stir, by 10% citric acid adjust ph to 8.0-8.5, inject water to 1000 parts by volume, stir, measure semi-finished product content, should be the 97-103% of labelled amount, after qualified, the microporous filter membrane through≤0.22 μ filters, fill, add butyl rubber plug, roll lid;
6, through 115 DEG C-125 DEG C, 8-30 minute pressure sterilizing, checks visible foreign matters, rejects defective work, to obtain final product.
The preparation method of ibuprofen medicinal composition of the present invention is preferably as follows step:
1, in material-compound tank, add the water for injection of 2/3 cumulative volume, be heated to 80 DEG C, add the arginine of formula ratio, be stirred to and dissolve completely;
2, add the ibuprofen of formula ratio, be stirred to and dissolve completely;
3, the active carbon of cumulative volume 0.1%g/ml is added wherein, stir and maintain the temperature at 80 DEG C, adsorb 20 minutes;
4, excessively active carbon is filtered;
5, water for injection is added to nearly 1000 parts by volume, stir, by 10% citric acid adjust ph to 8.0-8.5, add to the full amount of water for injection and stir, measure semi-finished product content, should be the 97-103% of labelled amount, after qualified, microporous filter membrane through≤0.22 μ filters, and fill, adds butyl rubber plug, rolls lid;
6, through 121 DEG C, 12 minutes pressure sterilizings, check visible foreign matters, reject defective work, to obtain final product.
Foregoing invention citric acid can by malic acid, tartaric acid, and aspartic acid substitutes.
Described weight portion and the relation of parts by volume are the relations of g/ml.
The invention provides the ibuprofen medicinal composition that a kind of stable diluted posterior vein gives, have pain relieving, antiinflammatory and refrigeration function, preparation method is simple, and safety and stability, can be used for large-scale production.
Experimental example and embodiment are used for further illustrating but are not limited to the present invention below.
Experimental example 1: with the Caldolor(ibuprofen injection of Cumberland company of the U.S.) compatibility stability compare
(1) with glucose injection compatibility
The Caldolor(ibuprofen injection of brufen composition prepared by Example 1 and Cumberland company of the U.S.) each 10ml adds in 250ml glucose injection respectively, and it the results are shown in Table 1 to detect index of correlation in 0.5 hour, 4 hours.
The standby ibuprofen injection of table 1. embodiment 1 brufen composition, the Cumberland Inc. of the U.S. of preparing compares with glucose injection compatibility
Result: the ibuprofen injection that Cumberland Inc. of the U.S. is standby and glucose injection compatibility instability, character undesirable (generation opalescence), particulate matter exceeds standard (with reference to Chinese Pharmacopoeia to the regulation of the intravenous fluid of 100ml or more than 100ml: the microgranule containing more than 10 μm and 10 μm in every 1ml must not cross 25,3 must not be crossed containing the microgranules of more than 25 μm and 25 μm), do not meet clinical application requirement; Brufen composition prepared by embodiment 1 and glucose injection compatibility are stablized, and indices meets clinical application requirement.
(2) with sodium chloride injection compatibility
The Caldolor(ibuprofen injection of brufen composition prepared by Example 1 and Cumberland company of the U.S.) each 10ml adds in 250ml sodium chloride injection respectively, and it the results are shown in Table 2 to detect index of correlation in 0.5 hour, 4 hours.
The standby ibuprofen injection of table 2. embodiment 1 brufen composition, the Cumberland Inc. of the U.S. of preparing compares with sodium chloride injection compatibility
Result: Caldolor and sodium chloride injection compatibility instability, character undesirable (generation opalescence), particulate matter exceeds standard (with reference to Chinese Pharmacopoeia to the regulation of the intravenous fluid of 100ml or more than 100ml: the microgranule containing more than 10 μm and 10 μm in every 1ml must not cross 25,3 must not be crossed containing the microgranules of more than 25 μm and 25 μm), do not meet clinical application requirement; Embodiment 1 is stablized with sodium chloride injection compatibility, and indices meets clinical application requirement.
Conclusion: commercial samples (Caldolor of Cumberland company) compatibility stability is poor, does not meet clinical application requirement.The indices of the every compatibility mechanism of brufen composition prepared by the present invention all meets clinical requirement, has good clinical drug safety.
Experimental example 2: brufen composition prepared by embodiment 1 and simulation sample 1(10% ibuprofen aqueous solution, its arginine: the mol ratio of ibuprofen is 1:1) compatibility stability compare
(1) with glucose injection compatibility
Get the brufen composition prepared by embodiment 1 to add respectively in 250ml glucose injection with each 10ml of simulation sample 1, and it the results are shown in Table 3 to detect index of correlation in 0.5 hour, 4 hours.
Table 3. embodiment 1, simulation sample 1 compare with glucose injection compatibility
Result: simulation sample 1 is unstable with glucose injection compatibility, and character undesirable (generation opalescence), does not meet clinical application requirement; The brufen composition prepared by embodiment 1 and glucose injection compatibility are stablized, and indices meets clinical application requirement.
(2) with sodium chloride injection compatibility
Get the brufen composition prepared by embodiment 1 and simulation sample 1 each 10ml to add respectively in 250ml sodium chloride injection and to detect index of correlation in 0.5 hour, 4 hours it the results are shown in Table 4.
Table 4. embodiment 1, simulation sample 1 compare with sodium chloride injection compatibility
Result shows: produce opalescence, less stable after simulation sample 1 and sodium chloride injection compatibility; By embodiment 1 prepare brufen composition and sodium chloride injection compatibility stability good, indices meets clinical application requirement.
Conclusion: after simulation sample compatibility, character is understable, and Clinical practice exists security risks; After pharmaceutical composition of the present invention and sodium chloride injection, glucose injection compatibility, indices is stablized, and meets clinical application requirement.
Experimental example 3: brufen composition prepared by embodiment 1 and simulation sample 2(10% ibuprofen aqueous solution, its arginine: the mol ratio of ibuprofen is 1.1:1) compatibility compare
Brufen composition, simulation sample 2(10% ibuprofen aqueous solution prepared by Example 1, its arginine: the mol ratio of ibuprofen is 1.1:1) each 10ml adds the change of comparing pH value before and after compatibility in 250ml sodium chloride injection respectively, carry out muscle irritation test by after embodiment 1 and simulation sample 2 and sodium chloride injection compatibility further, the results are shown in Table 5.
Table 5. embodiment 1, simulation sample 2 compare with pH value before and after sodium chloride injection compatibility
Conclusion: from pH value comparative result before and after table 5 embodiment 1, simulation sample 2 and sodium chloride injection compatibility, after embodiment 1 and sodium chloride injection compatibility, the pH value of medicinal liquid is closer to Human Physiology pH value, and therefore can reduce the zest of medicine to human body, its safety in utilization is higher.Illustrate that adding citric acid has the effect significantly improving drug use safety.
Experimental example 4: simulation sample 3(10% ibuprofen aqueous solution, its arginine: the mol ratio of ibuprofen is 1.1:1, add dilute hydrochloric acid and regulate pH to 8.0-8.5), simulation sample 4(10% ibuprofen aqueous solution, its arginine: the mol ratio of ibuprofen is 1.1:1, add dilute sulfuric acid regulate pH8.0-8.5) compatibility mechanism
Delivery is intended sample 3,4 each 10ml and is added the 250ml sodium chloride injection of different pH value and the change of comparing character before and after compatibility in 250ml glucose injection respectively, the results are shown in Table 6, table 7.
Character change after sample 3,4 and sodium chloride injection compatibility simulated by table 6.
Character change after sample 3,4 and glucose injection compatibility simulated by table 7.
Conclusion: from simulating sample 3,4 and pH value and Character change result after different pH value sodium chloride injection and glucose injection compatibility in table 6,7, when add in medicine hydrochloric acid or sulphuric acid adjust can make compatibility after the pH value of medicinal liquid controlled, but, there is certain safety risks in the opalescence with there will be after lower injection compatibility in various degree.
Experimental example 5: the compatibility mechanism of the simulation preparation of the lower embodiment 1,2,3,4 of Chinese patent 201010134500.6 and muscle irritation test
With reference to embodiment 1,2,3,4 method under Chinese patent 201010134500.6 description item, preparation simulation sample 1#, 2#, 3#, 4#;
Delivery is intended sample 1#, 3#, 4# each 10ml and 2# and is simulated sample 100ml and add the 250ml sodium chloride injection of different pH value and the change of comparing character before and after compatibility in 250ml glucose injection respectively, the results are shown in Table 8, table 9.
Character change after sample 1#, 2#, 3#, 4# and sodium chloride injection compatibility simulated by table 8.
Character change after sample 1#, 2#, 3#, 4# and glucose injection compatibility simulated by table 9.
Following embodiment all can realize the effect of above-mentioned experimental example.
Embodiment 1:
1. in material-compound tank, add the water for injection of about 2/3 cumulative volume, be heated to 80 DEG C, add 9.2kg arginine, be stirred to and dissolve completely;
2. add 10kg ibuprofen, be stirred to and dissolve completely;
3. according to the ratio of 0.1%g/ml, active carbon is added wherein, stir and maintain the temperature at 80 DEG C of absorption 20min;
4. cross and filter active carbon;
5. add water for injection to nearly 100 liters, stir, by 10% citric acid adjust ph to 8.0-8.5, inject water to 100 liters to stir, measure semi-finished product content and should be 103% of labelled amount, the microporous filter membrane through≤0.22 μ filters, fill is in 5ml control glass bottle, and loading amount 4ml/ bottle, adds butyl rubber plug, roll lid, sterilizing, leak detection, check visible foreign matters, reject defective work, packaging, to obtain final product.
Embodiment 2:
1. in material-compound tank, add the water for injection of about 2/3 cumulative volume, be heated to 80 DEG C, add 9.2kg arginine, be stirred to and dissolve completely;
2. add 10kg ibuprofen, be stirred to and dissolve completely;
3. according to the ratio of 0.1%g/ml, active carbon is added wherein, stir and maintain the temperature at 80 DEG C of absorption 20min;
4. cross and filter active carbon;
5. add water for injection to nearly 1000 liters, stir, by 10% malic acid adjust ph to 8.0-8.5, inject water to 1000 liters, stir, measure semi-finished product content, after qualified, the microporous filter membrane through≤0.22 μ filters, and fill is in 5ml control glass bottle, add butyl rubber plug, roll lid, sterilizing, leak detection, checks visible foreign matters, rejects defective work, packaging, to obtain final product.
Embodiment 3:
1. in material-compound tank, add the water for injection of about 2/3 cumulative volume, be heated to 80 DEG C, add 9.2kg arginine, be stirred to and dissolve completely;
2. add 10kg ibuprofen, be stirred to and dissolve completely;
3. according to the ratio of 0.1%g/ml, active carbon is added wherein, stir and maintain the temperature at 80 DEG C of absorption 20min;
4. cross and filter active carbon;
5. add water for injection to nearly 100 liters, stir, with asparagine acid for adjusting pH value to 8.0-8.5, inject water to 100 liters, stir, measure semi-finished product content, after qualified, the microporous filter membrane through≤0.22 μ filters, and fill is in 5ml control glass bottle, loading amount 4ml/ bottle, adds butyl rubber plug, rolls lid, sterilizing, leak detection, checks visible foreign matters, reject defective work, packaging, to obtain final product.
Embodiment 4
1. in material-compound tank, add the water for injection of about 2/3 cumulative volume, be heated to 80 DEG C, add 9.2kg arginine, be stirred to and dissolve completely;
2. add 10kg ibuprofen, be stirred to and dissolve completely;
3. according to the ratio of 0.1%g/ml, active carbon is added wherein, stir and maintain the temperature at 80 DEG C of absorption 20min;
4. cross and filter active carbon;
5. add water for injection to nearly 100 liters, stir, by 10% tartaric acid adjust ph to 8.0-8.5, inject water to 100 liters, stir, measure semi-finished product content, should be 103% of labelled amount, the microporous filter membrane through≤0.22 μ filters, and fill is in 5ml control glass bottle, loading amount 4ml/ bottle, adds butyl rubber plug, rolls lid, sterilizing, leak detection, checks visible foreign matters, reject defective work, packaging, to obtain final product.
Embodiment 5
1. in material-compound tank, add the water for injection of about 2/3 cumulative volume, be heated to 80 DEG C, add 9.2kg arginine, be stirred to and dissolve completely;
2. add 10kg ibuprofen, be stirred to and dissolve completely;
3. the active carbon of 100g is added wherein, stir and maintain the temperature at 80 DEG C of absorption 20min;
4. cross and filter active carbon;
5. add water for injection to 100 liter, stir, by 10% malic acid adjust ph to 8.0-8.5, inject water to 100 liters to stir, measure semi-finished product content and should be 103% of labelled amount, the microporous filter membrane through≤0.22 μ filters, fill is in 5ml control glass bottle, and loading amount 4ml/ bottle, adds butyl rubber plug, roll lid, sterilizing, leak detection, check visible foreign matters, reject defective work, packaging, to obtain final product.
Embodiment 6:
1. in material-compound tank, add the water for injection of about 2/3 cumulative volume, be heated to 80 DEG C, add 9.2kg arginine, be stirred to and dissolve completely;
2. add 10kg dexibuprofen, be stirred to and dissolve completely;
3. according to the ratio of 0.1%g/ml, active carbon is added wherein, stir and maintain the temperature at 80 DEG C of absorption 20min;
4. cross and filter active carbon;
5. add water for injection to nearly 100 liters, stir, by 10% citric acid adjust ph to 8.0-8.5, inject water to 100 liters to stir, measure semi-finished product content and should be 100% of labelled amount, the microporous filter membrane through≤0.22 μ filters, fill is in 5ml control glass bottle, and loading amount 4ml/ bottle, adds butyl rubber plug, roll lid, sterilizing, leak detection, check visible foreign matters, reject defective work, packaging, to obtain final product.
Claims (7)
1. an ibuprofen medicinal composition, is characterized in that said composition raw material consists of:
The preparation method of said composition comprises the steps:
A, in material-compound tank, add the water for injection of 2/3 cumulative volume, be heated to 60-100 DEG C, add the arginine of formula ratio, be stirred to and dissolve completely;
B, add the ibuprofen of formula ratio, be stirred to and dissolve completely;
C, the active carbon of cumulative volume 0.1%g/ml is added wherein, stir and maintain the temperature at 60-100 DEG C, absorption 10-30 minute;
D, mistake filter active carbon;
E, add water for injection to nearly 1000 parts by volume, stir, the concentration adding formula ratio is 10% citric acid, injects water to 1000 parts by volume, stir, measure semi-finished product content, pH value, after qualified, microporous filter membrane through≤0.22 μ filters, and fill, adds butyl rubber plug, rolls lid;
F, through 115 DEG C-125 DEG C, 8-30 minute pressure sterilizing, check visible foreign matters, reject defective work, to obtain final product.
2. ibuprofen medicinal composition as claimed in claim 1, is characterized in that
The preparation method of said composition comprises the steps:
A, in material-compound tank, add the water for injection of 2/3 cumulative volume, be heated to 80 DEG C, add the arginine of formula ratio, be stirred to and dissolve completely;
B, add the ibuprofen of formula ratio, be stirred to and dissolve completely;
C, the active carbon of cumulative volume 0.1%g/ml is added wherein, stir and maintain the temperature at 80 DEG C, adsorbing 20 minutes;
D, mistake filter active carbon;
E, add water for injection to nearly 1000 parts by volume, stir, the concentration adding formula ratio is 10% citric acid, add to the full amount of water for injection and stir, measure semi-finished product content, pH value, after qualified, microporous filter membrane through≤0.22 μ filters, and fill, adds butyl rubber plug, rolls lid;
F, through 121 DEG C, 12 minutes pressure sterilizings, check visible foreign matters, reject defective work, to obtain final product.
3. an ibuprofen medicinal composition, is characterized in that said composition raw material consists of:
4. the ibuprofen medicinal composition as described in claim arbitrary in claim 1-3, is characterized in that said composition raw material consists of:
5. the ibuprofen medicinal composition as described in claim arbitrary in claim 1-3, is characterized in that said composition raw material consists of:
6. the ibuprofen medicinal composition as described in claim arbitrary in claim 1-3, is characterized in that said composition raw material consists of:
7. the ibuprofen medicinal composition as described in claim arbitrary in claim 1-3, is characterized in that described ibuprofen comprises the optical isomer of ibuprofen.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101810568A (en) * | 2010-03-29 | 2010-08-25 | 南京泛太化工医药研究所 | Injection containing ibuprofen and preparation method thereof |
| CN101991549A (en) * | 2010-10-26 | 2011-03-30 | 武汉朗济科技发展有限公司 | Antipyretic, analgesic and anti-inflammatory medicinal composition |
| CN102100686A (en) * | 2009-12-21 | 2011-06-22 | 北京润德康医药技术有限公司 | Medicinal composition containing ibuprofen and arginine and preparation method and application thereof |
| CN102370615A (en) * | 2010-08-19 | 2012-03-14 | 四川科伦药物研究有限公司 | Ibuprofen injection preparation and preparation method thereof |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100686A (en) * | 2009-12-21 | 2011-06-22 | 北京润德康医药技术有限公司 | Medicinal composition containing ibuprofen and arginine and preparation method and application thereof |
| CN101810568A (en) * | 2010-03-29 | 2010-08-25 | 南京泛太化工医药研究所 | Injection containing ibuprofen and preparation method thereof |
| CN102370615A (en) * | 2010-08-19 | 2012-03-14 | 四川科伦药物研究有限公司 | Ibuprofen injection preparation and preparation method thereof |
| CN101991549A (en) * | 2010-10-26 | 2011-03-30 | 武汉朗济科技发展有限公司 | Antipyretic, analgesic and anti-inflammatory medicinal composition |
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