CN104434815A - Stable parecoxib sodium pharmaceutical composition for injection - Google Patents
Stable parecoxib sodium pharmaceutical composition for injection Download PDFInfo
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- CN104434815A CN104434815A CN201310412213.0A CN201310412213A CN104434815A CN 104434815 A CN104434815 A CN 104434815A CN 201310412213 A CN201310412213 A CN 201310412213A CN 104434815 A CN104434815 A CN 104434815A
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Abstract
The invention relates to a stable parecoxib sodium pharmaceutical composition for injection. The pharmaceutical composition specifically includes parecoxib sodium and injection additives. Disodium hydrogen phosphate and sodium calcium edentate are adopted as the buffering agent, and sodium hydroxide is taken as the pH regulator. The production process is feasible, the quality is stable and controllable, the skin irritation is small, and at the same time the composition is convenient for transportation and storage. The invention provides the reasonable preparation prescription and preparation technology for clinical medication, and industrialization is easy to realize.
Description
Technical field
The present invention relates to the medicine in field of medicaments, especially relate to a kind of Parecoxib sodium pharmaceutical composition of stable injection.
Technical background
Parecoxib is the prodrug of Valdecoxib, and Valdecoxib is the cox 2 inhibitor of high selectivity in clinical dosage scope.Rapid-action and the analgesic activity of Parecoxib Sodium is lasting, after the quiet note of Parecoxib Sodium 40mg single or intramuscular injection, occurs appreciable analgesic effect, produce the analgesic effect with clinical meaning, and reached maximum efficiency during 23-39 minute in 2 hours during 7-13 minute.The effect of the analgesic effect of Parecoxib 40mg and intramuscular injection ketorolac 60mg or quiet note 30mg is similar.After single-dose, the length of Parecoxib analgesic time is relevant with dosage and pain model, and scope is even longer at 6-12 hour.Parecoxib has the selectivity of height to COX-2, and only have faint selectivity to COX-1, therefore have good safety, its gastrointestinal ulceration incidence rate is significantly lower than traditional NSAIDs.Parecoxib is penetrated with cox 2 inhibitor as global first injection, analgesia effect is good, possess simultaneously and suppress super quick, eradicate the unique advantage of pain, agree with pentazocine pattern, promote pentazocine theory, meet clinical demand, be expected to become postoperative basic medication, make more patient enjoy painless surgical operation, thus more preferably select for Postoperative Analgesia After provides.
This product main component is Parecoxib Sodium, its chemistry N-[[4-(5-methyl-3-phenyl-4-isoxazolyl) phenyl] sulfonyl] propionamide sodium salt by name.
Molecular formula: C
19h
17n
2o
4sNa
Molecular weight: 392.41
Indication: for the short term therapy of postoperative pain.Before decision uses Selective COX-2 inhibitor, answer the overall risk of assess patient.
Specification: 40mg (in Parecoxib);
Usage and dosage: recommended dose is 40mg intravenous injection (IV) or intramuscular injection (IM) administration, within optionally interval 6-12 hour subsequently, give 20mg or 40mg, every day, accumulated dose was no more than 80mg.Directly can carry out rapid intravenous bolus injection, or by existing venous channel administration.Intramuscular injection should select deep part muscle slowly to inject.Be no more than 3 days the course for the treatment of.
The present invention is clinical the preparation composition and the preparing process that provide a kind of pharmaceutical composition of Parecoxib Sodium of injection.Using sodium hydrogen phosphate and calcium disodium edetate as excipient, and the pH stability of medicine is improved, pharmaceutical preparation is stablized, and in water, dissolubility is good, be convenient to storage, transport and carry, compared with external commercially available Parecoxib preparation of sodium, there is more excellent stability.And proved according to the injection obtained by this formula without hemolytic, blood vessel irritation and anaphylaxis by pharmacological evaluation, the requirement of Parecoxib sodium pharmaceutical composition to storage, lucifuge that prior art is produced has very strict requirement, change obviously through sunlight pH, all there is inconvenience in process of production.
The present inventor is through studying for a long period of time, and unexpected discovery, applies special buffer agent, Parecoxib sodium pharmaceutical composition prepared by special process, light resistance is good, good stability, not only successfully solves the problem of the poor stability of Parecoxib Sodium, easy to implement, can industrialization be realized, remarkable in economical benefits.
summary of the invention:
The invention provides a kind of stabilizing pharmaceutical composition of injection Parecoxib Sodium, often prop up in this pharmaceutical composition containing Parecoxib 40mg.
The pharmaceutic adjuvant (injection additives) that injection Parecoxib sodium pharmaceutical composition of the present invention adopts comprises sodium hydrogen phosphate and calcium disodium edetate, sodium hydrate aqueous solution, and sodium hydroxide described here is as pH adjusting agent.
Sodium hydrogen phosphate of the present invention and calcium disodium edetate can as excipient, and sodium hydrogen phosphate also can be used as pH adjusting agent.
The pH scope of Parecoxib sodium pharmaceutical composition of the present invention is 7.5-8.0.
The invention reside in the Parecoxib sodium pharmaceutical composition providing a kind of injection, this injection Parecoxib sodium pharmaceutical composition is stablized light, to raising product yield, reduces costs, realizes industrialization, be better applied to clinical, have more obvious advantage.
The invention reside in the preparation method of the Parecoxib sodium pharmaceutical composition providing injection of the present invention, the method is simple, prepared Parecoxib sodium pharmaceutical composition good stability.
For realizing the first object of the present invention, the present invention adopts following technical scheme:
A Parecoxib sodium pharmaceutical composition for stable injection, containing Parecoxib Sodium and injection additives, is characterized in that the formula of the Parecoxib sodium pharmaceutical composition making 1000 bottles is composed as follows:
Parecoxib Sodium is in Parecoxib 20-40g
Sodium hydrogen phosphate 4-8g
Calcium disodium edetate 0.2-0.4g
Sodium hydroxide q. s
Water for injection adds to 2L
Preferably,
Parecoxib Sodium is in Parecoxib 40g
Sodium hydrogen phosphate 8g
Calcium disodium edetate 0.4g
Sodium hydroxide q. s
Water for injection adds to 2L
Parecoxib sodium pharmaceutical composition of the present invention is adopted and is prepared with the following method:
1) get recipe quantity 80% water for injection, the sodium hydrogen phosphate and the calcium disodium edetate that first add recipe quantity are stirred to dissolving, for subsequent use;
2) 1 is got) middle solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH to 7.5;
3) by 2) add the Parecoxib Sodium of recipe quantity in solution, be stirred to and dissolve completely;
4) 3 are got) solution, add 0.1% pin charcoal of this amount of solution, stir completely, place 20 minutes, filter, add to the full amount of water for injection, measure medicinal liquid original ph;
5) 4 are got) solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH scope 7.5-8.0;
6) adopt 0.45 μm and 0.22 μm of microporous filter membrane fine straining qualified to visible foreign matters;
7) Quality control of intermediates: detect Parecoxib sodium content, pH value, the test items such as visible foreign matters;
8) according to intermediates content, regulate loading amount, and confirm loading amount scope, carry out fill, half tamponade;
9) by point sample installed, load in freeze dryer, sample is refrigerated to-50 ~-40 DEG C, keep the freezing 3-4 hour of temperature, be evacuated to 2-8pa after freezing, slow homogeneous heating, to 0-5 DEG C, then stops heating up, keep the dry 10-20 hour of temperature, in 10-20 hour, be warming up to 20 ~ 25 DEG C again, then stop heating up, heat preservation and dryness 4-5 hour, tamponade, outlet;
10) sample outlet will be obtained, roll lid, obtain Parecoxib sodium pharmaceutical composition.
Below to the more detailed elaboration of the present invention:
One aspect of the present invention provides a kind of Parecoxib sodium pharmaceutical composition of injection, the Parecoxib sodium pharmaceutical composition described in every 1000, and its formula consists of:
Parecoxib Sodium is in Parecoxib 40g
Sodium hydrogen phosphate 8g
Calcium disodium edetate 0.4g
Sodium hydroxide q. s
Water for injection adds to 2L.
The present inventor finds through a large amount of experimental studies, and when Parecoxib sodium pharmaceutical composition is above-mentioned formula, described injection the best in quality, stability is best.
Another aspect of the present invention provides the preparation method of injection Parecoxib sodium pharmaceutical composition of the present invention, and the method is simple, prepared injection Parecoxib sodium pharmaceutical composition good stability.
Preparation method provided by the present invention comprises:
1) get recipe quantity 80% water for injection, the sodium hydrogen phosphate and the calcium disodium edetate that first add recipe quantity are stirred to dissolving, for subsequent use;
2) 1 is got) middle solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH to 7.5;
3) by 2) add the Parecoxib Sodium of recipe quantity in solution, be stirred to and dissolve completely;
4) 3 are got) solution, add 0.1% pin charcoal of this amount of solution, stir completely, place 20 minutes, filter, add to the full amount of water for injection, measure medicinal liquid original ph;
5) 4 are got) solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH scope 7.5-8.0;
6) adopt 0.45 μm and 0.22 μm of microporous filter membrane fine straining qualified to visible foreign matters;
7) Quality control of intermediates: detect Parecoxib sodium content, pH value, the test items such as visible foreign matters;
8) according to intermediates content, regulate loading amount, and confirm loading amount scope, carry out fill, half tamponade;
9) by point sample installed, load in freeze dryer, sample is refrigerated to-50 ~-40 DEG C, keep the freezing 3-4 hour of temperature, be evacuated to 2-8pa after freezing, slow homogeneous heating, to 0-5 DEG C, then stops heating up, keep the dry 10-20 hour of temperature, in 10-20 hour, be warming up to 20 ~ 25 DEG C again, then stop heating up, heat preservation and dryness 4-5 hour, tamponade, outlet;
10) sample outlet will be obtained, roll lid, obtain Parecoxib sodium pharmaceutical composition.
The injection Parecoxib sodium pharmaceutical composition obtained according to the inventive method, through industrial amplification production machine study on the stability, proves that product is stablized, through pharmacology, toxicological test, solution is non-stimulated to blood vessel, without anaphylaxis, also without haemolysis, to human body fanout free region.
Compared with prior art, tool of the present invention has the following advantages:
1) injection Parecoxib sodium pharmaceutical composition provided by the present invention is for improving the yield of this product, reducing the market risk of product, and being better applied to clinical treatment has very large help.
2) new Parecoxib composition of sodium provided by the present invention is through industrialized great production and study on the stability, and prove constant product quality, through pharmacology, toxicological test, solution is non-stimulated to blood vessel, without anaphylaxis, also without haemolysis, to human body fanout free region.
3) preparation method of new Parecoxib composition of sodium provided by the present invention, the method is simple, and prepared injection Parecoxib sodium pharmaceutical composition is stablized light, good stability.
4) the present invention is through repeatedly groping, and optimizes preparation process, is the deciding factor that its preparation stability is significantly better than commercial samples.
5) grope through repetition test in preparation, have found crucial cooling time and the temperature range of this medicament freeze-drying technique more applicable, especially have employed the method for gradient cooling, improve product quality, improve product appearance, make it fuller, more easily molten.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail
Embodiment 1
The formula of the Parecoxib sodium pharmaceutical composition described in every 1000 consists of:
Parecoxib Sodium is in Parecoxib 40g
Sodium hydrogen phosphate 8g
Calcium disodium edetate 0.4g
Sodium hydroxide q. s
Water for injection adds to 2L.
Preparation technology comprises:
1) get recipe quantity 80% water for injection, the sodium hydrogen phosphate and the calcium disodium edetate that first add recipe quantity are stirred to dissolving, for subsequent use;
2) 1 is got) middle solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH to 7.5;
3) by 2) add the Parecoxib Sodium of recipe quantity in solution, be stirred to and dissolve completely;
4) 3 are got) solution, add 0.1% pin charcoal of this amount of solution, stir completely, place 20 minutes, filter, add to the full amount of water for injection, measure medicinal liquid original ph;
5) 4 are got) solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH scope 7.5-8.0;
6) adopt 0.45 μm and 0.22 μm of microporous filter membrane fine straining qualified to visible foreign matters;
7) Quality control of intermediates: detect Parecoxib sodium content, pH value, the test items such as visible foreign matters;
8) according to intermediates content, regulate loading amount, and confirm loading amount scope, carry out fill, half tamponade;
9) by point sample installed, load in freeze dryer, sample is refrigerated to-50 ~-40 DEG C, keep the freezing 3-4 hour of temperature, be evacuated to 2-8pa after freezing, slow homogeneous heating, to 0-5 DEG C, then stops heating up, keep the dry 10-20 hour of temperature, in 10-20 hour, be warming up to 20 ~ 25 DEG C again, then stop heating up, heat preservation and dryness 4-5 hour, tamponade, outlet;
10) sample outlet will be obtained, roll lid, obtain Parecoxib sodium pharmaceutical composition.
For determining the feasibility of this prescription, also to carry out a large amount of groping test, the existing representational part had is listed below:
Test example 1
According to the correlational study of the conclusion to prescription analysis in listing product description, principal agent physicochemical property and influence factor's result of the test and adjuvant, the following prescription of our Preliminary design:
Illumination prescription 1-prescription 5 being placed in 4500LX ± 500LX is placed 24 hours hours, checks its character, pH value and related substance respectively at 0 hour, 24 hours.The results are shown in following table:
Above result of the test shows, prescription 1 is most preferably, all comparatively stable at illumination prescription 1 related substance after 24 hours, pH value.
Test example 2
Prescription 1 medicinal liquid is placed 8 hours under 25 DEG C, 40 DEG C, 50 DEG C conditions, in sampling in 0,2,4,8 hour, measures, investigate solution character, pH and related substance situation of change.
The stability test result of prescription 1
From testing above, Parecoxib sodium solution is more stable under uniform temperature state in 8 hours.With reference to the injection Parecoxib Sodium that Yuan Yan producer Pharmacia & Upjohn Company produces, commodity are called special resistance to description and European Drug Administration provides the relevant research and development information of this product known, the dissolubility of Parecoxib Sodium has the dependent feature of pH, therefore the stability of reply Parecoxib Sodium under condition of different pH is investigated, and selects suitable pH value range.
Test example 3
Reference inlet port standard and European Union's research and development information, investigation Parecoxib Sodium is the stability state between 7.0-8.5 at pH.Parecoxib sodium solution by the preparation of following prescription, and investigate its under different pH in the comparative result of steadiness.
According to physicochemical property, available data, formulate prescribed regimen, as following table:
1) get recipe quantity 80% water for injection, the sodium hydrogen phosphate and the calcium disodium edetate that first add recipe quantity are stirred to dissolving, for subsequent use;
2) 1 is got) middle solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH to be 7.5;
3) by 2) add the Parecoxib Sodium of recipe quantity in solution, be stirred to and dissolve completely;
4) 3 are got) solution, add 0.1% pin charcoal of this amount of solution, stir completely, place 15 minutes, filter, add to the full amount of water for injection, measure medicinal liquid original ph;
5) 4 are got) solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH scope 7.0 ~ 8.5;
Place 8 hours under illumination 4500lx ± 500lx condition, carry out the mensuration of index of correlation, investigate result as follows:
Above result of the test shows, pH value is between 7.5-8.5, and related substance is without significant change, and character is colourless clear liquid, but the pH of pH8.5 group changes greatly, therefore determine that its pH scope is 7.5-8.0, namely select prescription 1 to carry out next step and optimize.
Test example 4
Injection Parecoxib Sodium charging sequence is screened
According to documentation & info and pre-stage test, the dissolubility of Parecoxib Sodium has pH dependency, consider water for injection pH wider range, its charging sequence may be dissolved principal agent and be produced different impacts, therefore prepare by the proportioning of prescription 1, select different dosing modes, select best charging sequence to dissolve situation.
According to physicochemical property, available data, formulate prescribed regimen, as following table:
Investigation result is as follows:
By above result of the test, charging sequence 3 is conducive to the dissolving of Parecoxib Sodium most, considers, and selects charging sequence 3 to be optimal sequence.
Test example 5
The selection of charcoal consumption of injection Parecoxib sodium pharmaceutical composition prescription pin
Pin charcoal has the features such as decolouring, attracts bacteria, pyrogen and impurity, its absorption pyrogen multiplex, antibacterial in the production of injection.The general consumption of pin charcoal is 0.05-0.3%, and the content of medicine can be made when consumption is excessive to reduce, and need carry out the screening of application quantity according to product difference.According to available data, formulate prescribed regimen, as following table:
1) get recipe quantity 90% water for injection, the sodium hydrogen phosphate and the calcium disodium edetate that first add recipe quantity are stirred to dissolving, for subsequent use;
2) 1 is got) middle solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH to 7.5;
3) by 2) add the Parecoxib Sodium of recipe quantity in solution, be stirred to and dissolve completely;
4) 3 are got) solution, select not commensurability injection active carbon (0.05%, 0.1%, 0.2%W/V) respectively, stir completely, places 20 minutes, filter, add to the full amount of water for injection, mensuration medicinal liquid original ph;
5) 4 are got) solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH scope 7.5 ~ 8.0;
Investigate active carbon to the impact of medicament contg, result of the test is in Table:
The content detection result of method 1-method 3
Above result of the test shows: adopt 0.1% pin charcoal to adsorb, the solution quality obtained conforms with the regulations, so we select the medicinal charcoal of 0.1%.
Test example 6
The research of injection Parecoxib Sodium prescription lyophilisation condition
Lyophilisation condition screens
Freeze-drying process comprises pre-freeze, sublimation drying and parsing-desiccation three phases.Below by investigating pre-freeze stage, sublimation drying stage respectively and resolving drying stage different technical parameters to choose targets optimised processs such as preparations shaping, redissolution times.
Evaluate from outward appearance, redissolution time aspect above-mentioned three kinds of technique products obtained therefroms, result is as follows:
by above craft screening, we determine the best freeze-dry process of this product: sample is refrigerated to-50 ~-40 DEG C, keep the freezing 3-4 hour of temperature, be evacuated to 2-8pa after freezing, slow homogeneous heating, to 0-5 DEG C, then stops heating up, keep the dry 10-20 hour of temperature, in 10-20 hour, be warming up to 20 ~ 25 DEG C again, then stop heating up, heat preservation and dryness 4-5 hour.
Compare with the influence factor contrasting medicine:
Contrast medicine and embodiment 1 are compared, according to preparation technology in embodiment 1, through lyophilization, make finished product, be placed in the calorstat 10 days of the illumination of 4500LX ± 500LX, 60 DEG C ± 2 DEG C high temperature, 92.5% high humidity respectively, respectively at 0 day, 10 days its character, basicity and related substance checked and to compare with commercial samples, the results are shown in following table:
Make by oneself and the influence factor's testing result contrasting medicine
According to result of the test, embodiment 1 is under the environment of illumination, high temperature, high humidity, and each check item has no significant change, and commercial samples is unstable, and therefore the present invention has obvious quality stability.
Claims (4)
1. the Parecoxib sodium pharmaceutical composition of a stable injection, it is characterized in that containing the treatment Parecoxib Sodium of effective dose, sodium hydrogen phosphate and calcium disodium edetate, wherein the weight ratio of Parecoxib Sodium, sodium hydrogen phosphate and calcium disodium edetate three is 1:0.2:0.01.
2., according to the Parecoxib sodium pharmaceutical composition described in claim 1, it is characterized in that the formula of the Parecoxib sodium pharmaceutical composition making 1000 bottles is composed as follows:
Parecoxib Sodium is in Parecoxib 20-40g
Sodium hydrogen phosphate 4-8g
Calcium disodium edetate 0.2-0.4g
Sodium hydroxide q. s
Water for injection adds to 2L.
3. Parecoxib sodium pharmaceutical composition according to claim 1 and 2, is characterized in that the formula of the Parecoxib sodium pharmaceutical composition making 1000 bottles is composed as follows:
Parecoxib Sodium is in Parecoxib 40g
Sodium hydrogen phosphate 8g
Calcium disodium edetate 0.4g
Sodium hydroxide q. s
Water for injection adds to 2L.
4. the preparation method of the Parecoxib sodium pharmaceutical composition described in claim 1 or 2, is characterized in that the method comprises following process:
1) get recipe quantity 80% water for injection, the sodium hydrogen phosphate and the calcium disodium edetate that first add recipe quantity are stirred to dissolving, for subsequent use;
2) 1 is got) middle solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH to 7.5;
3) by 2) add the Parecoxib Sodium of recipe quantity in solution, be stirred to and dissolve completely;
4) 3 are got) solution, add 0.1% pin charcoal of this amount of solution, stir completely, place 20 minutes, filter, add to the full amount of water for injection, measure medicinal liquid original ph;
5) 4 are got) solution, add 0.1mol/L sodium hydrate aqueous solution, adjust pH scope 7.5-8.0;
6) adopt 0.45 μm and 0.22 μm of microporous filter membrane fine straining qualified to visible foreign matters;
7) Quality control of intermediates: detect Parecoxib sodium content, pH value, the test items such as visible foreign matters;
8) according to intermediates content, regulate loading amount, and confirm loading amount scope, carry out fill, half tamponade;
9) by point sample installed, load in freeze dryer, sample is refrigerated to-50 ~-40 DEG C, keep the freezing 3-4 hour of temperature, be evacuated to 2-8pa after freezing, slow homogeneous heating, to 0-5 DEG C, then stops heating up, keep the dry 10-20 hour of temperature, in 10-20 hour, be warming up to 20 ~ 25 DEG C again, then stop heating up, heat preservation and dryness 4-5 hour, tamponade, outlet;
10) sample outlet will be obtained, roll lid, obtain Parecoxib sodium pharmaceutical composition.
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| CN201310412213.0A CN104434815A (en) | 2013-09-12 | 2013-09-12 | Stable parecoxib sodium pharmaceutical composition for injection |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105616362A (en) * | 2016-02-16 | 2016-06-01 | 成都苑东生物制药股份有限公司 | Parecoxib sodium pharmaceutical composition for injection and preparation method thereof |
| CN116421569A (en) * | 2023-06-15 | 2023-07-14 | 四川尚锐生物医药有限公司 | Parafaxib sodium pharmaceutical composition for injection and preparation method thereof |
-
2013
- 2013-09-12 CN CN201310412213.0A patent/CN104434815A/en not_active Withdrawn
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105616362A (en) * | 2016-02-16 | 2016-06-01 | 成都苑东生物制药股份有限公司 | Parecoxib sodium pharmaceutical composition for injection and preparation method thereof |
| CN116421569A (en) * | 2023-06-15 | 2023-07-14 | 四川尚锐生物医药有限公司 | Parafaxib sodium pharmaceutical composition for injection and preparation method thereof |
| CN116421569B (en) * | 2023-06-15 | 2023-09-05 | 四川尚锐生物医药有限公司 | Parafaxib sodium pharmaceutical composition for injection and preparation method thereof |
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Application publication date: 20150325 |