CN102657622A - Preparation process of freeze-dry powder injection containing esomeprazole sodium - Google Patents
Preparation process of freeze-dry powder injection containing esomeprazole sodium Download PDFInfo
- Publication number
- CN102657622A CN102657622A CN2012101521863A CN201210152186A CN102657622A CN 102657622 A CN102657622 A CN 102657622A CN 2012101521863 A CN2012101521863 A CN 2012101521863A CN 201210152186 A CN201210152186 A CN 201210152186A CN 102657622 A CN102657622 A CN 102657622A
- Authority
- CN
- China
- Prior art keywords
- sodium
- esomeprazole sodium
- esomeprazole
- injection
- freeze
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a preparation process of a freeze-dry powder injection containing esomeprazole sodium, and also provides the esomeprazole sodium for injection, which has the advantages of safe quality and high stability. The preparation process comprises the following steps of: dissolving the esomeprazole sodium, an excipient, a metal ion complexing agent, an antioxidant and the like in injection water; adding a pH value adjusting agent to adjust the pH of mixed solution; adding medicinal carbon to decolorize; filtering; canning the filtrate; partially plugging; performing freeze-drying; pressing a plug under vacuum; rolling a cover; performing lamp inspection; and packaging to obtain a finished product. The preparation process is rational in prescription design; the defects of instability of the esomeprazole sodium upon heating and poor clarity of solution after redissolution are effectively overcome; and a prepared product has the advantages of high stability, high redissolution and the like and is suitable for industrial production.
Description
Technical field
The invention belongs to technical field of medicine, relate to a kind of preparation technology who contains the lyophilized injectable powder of esomeprazole sodium, the present invention provides the injection esomeprazole sodium of a kind of quality safety, good stability simultaneously.
Background technology
Esomeprazole (Esomeprazole) is the S-optical isomer of omeprazole, is global first isomer proton pump inhibitor (PPI), suppresses the parietal cell proton pump through specificity and reduces gastric acid secretion.Confirm through a large amount of clinical experiments and drug research: it keeps gastric pH>time of 4 is longer, but sour efficient is higher, and curative effect is superior to preceding two generation PPI, and individual variation is little.Owing to have metabolic advantage; Esomeprazole has higher bioavailability and more consistent pharmacokinetics than omeprazole; The medicine that arrives proton pump is increased; Press down sour effect and be superior to other PPI, be widely used in clinical treatment GERD, upper gastrointestinal hemorrhage, stress ulcer, duodenal ulcer, eradicate helicobacter pylori (HP), Zhuo-relevant diseases such as Emhorn syndrome at present.
CN102319223A discloses a kind of esomeprazole lyophilized formulations and preparation method thereof, and its prescription is C
17H
18N
3NaO
3S0.5 H
2O40g (in esomeprazole), trehalose or sorbitol 12g, disodium edetate 1.2g, the 0.1mol/L sodium hydroxide solution is an amount of, and water for injection adds to 5000nl, processes 1000 bottles altogether.The solid content of dosing is on the low side in this prescription, be prone to phenomenons such as pre-freeze is unreal, spray bottle, atrophy, crystallize in the freezing dry process, and the fill loading amount is the 5ml/ bottle in this technology, causes the lyophilization cycle long partially, and production cost is higher, is unfavorable for large-scale production.
CN102357082A has announced lyophilized injectable powder of a kind of esomeprazole sodium and preparation method thereof, and its prescription is 1 part in esomeprazole sodium, 1 ~ 3 part in mannitol, and 0.025 ~ 0.075 part of calcium disodium edetate, sodium hydroxide or sodium carbonate are an amount of, and pH value is adjusted to 11 ~ 12.This patent sample is taked nitrogen protection in the preparation process, production cost is high, and security risk is big; Formulation samples redissolution back had metachromatism in 2 ~ 4 hours; The clarity of solution is relatively poor after redissolving, and pH value changes greatly, and lacks the long term test data of the stability test of formulation samples in this patent.
Esomeprazole stable sodium property is poor, and is all very sensitive to light, heat, oxygen, water etc., and especially under acid condition, its chemical constitution can take place by destructive the variation, variable color and polymerism occur.Research worker of the present invention, is found can obtain the lyophilized injectable powder that clarity is good, stability is strong, drug content is high, its related substances is low through changing prescription and method for preparing through long term test research in order to overcome the above-mentioned defective of esomeprazole sodium.
Summary of the invention
The present invention aims to provide the preparation technology of the lyophilized injectable powder that contains esomeprazole sodium that a kind of clarity is good, stability is strong, drug content is high, its related substances is low, and this technology is fit to large-scale production, can satisfy the requirement of field of medicaments.
1, processing technology of the present invention may further comprise the steps:
(1) excipient, metal ion chelation agent and the antioxidant that take by weighing recipe quantity dissolve in the water for injection of cumulative volume 80%, stir the full back of dissolving and add recipe quantity esomeprazole sodium, stir and make dissolving fully;
(2) add recipe quantity medicinal charcoal, stirring and adsorbing, decarbonization filtering;
(3) add the pH value regulator and regulate medicinal liquid pH, benefit adds to the full amount of water for injection, aseptic filtration;
(4) with the sterile liquid medicine fill in low Pyrex control bottle, the false add plug;
(5) sample is put into freeze dryer, lyophilization;
(6) after lyophilizing finished, lid was rolled in the vacuum tamponade, lamp inspection;
(7) examine entirely qualified after, the packing promptly get.
The above excipient is one or more mixture in glycine, mannitol, glucose, maltose alcohol, alanine, dextran, the glucosan, preferred mannitol, and amount of excipient accounts for 50% ~ 90% of total solid amount.
The above antioxidant is one or more mixture in sodium sulfite, anhydrous sodium sulfite, sodium pyrosulfite, sodium thiosulfate, the ascorbic acid, preferred anhydrous sodium sulfite, and the antioxidant consumption accounts for 0.5% ~ 5.0% of total solid amount.
The above metal ion chelation agent is one or more mixture in ethylenediaminetetraacetic acid, disodiumedetate, the calcio-disodium edetate, preferred calcio-disodium edetate, and the metal ion chelation agent consumption accounts for 0.1 ~ 5.0% of total solid amount.
The above pH value regulator is one or more mixture in sodium hydroxide, sodium hydrogen phosphate, sodium dihydrogen phosphate, sodium bicarbonate, the sodium carbonate.
The consumption of the above medicinal charcoal is 0.05 ~ 0.5% (m/v), and the stirring and adsorbing temperature is 18 ℃ ~ 85 ℃, and adsorption time is 10min ~ 40min.
The above medicinal liquid pH value is adjusted to 10.0 ~ 10.9.
The above freeze drying process is for putting into sample freeze drying box earlier pre-freeze 3 ~ 4 hours fast below-40 ℃; Open vacuum pump then; Through being warming up under-10 ℃ ~ 0 ℃ condition reduced vacuum in 10 ~ 12 hours dry 6 ~ 10 hours, be warming up to 25 ℃ ~ 30 ℃ dryings at last more than 4 hours then.
Advantage of the present invention: the present invention writes out a prescription reasonable in design, adds that whole process of preparation does not need towards the nitrogen protection behind the micro-antioxidant, simple and safe operation, and relative cost is lower.The injection esomeprazole sodium of the inventive method preparation, quality is loose, and solubility is good, and clarity is good, and stability is strong, and water content is low, and drug content is high, and its related substances is low.It is poor that the present invention has overcome esomeprazole stable sodium property, to defective such as light, heat, oxygen, water etc. are all very sensitive.Injection esomeprazole sodium market prospect is fine, is fit to large-scale production.
The specific embodiment
Following enforcement can illustrate in greater detail the present invention, but does not limit the present invention in any form.
Embodiment 1
Prescription: (specification: 40mg)
Esomeprazole sodium 100g (in esomeprazole)
Mannitol 400g
Anhydrous sodium sulfite 10g
Calcio-disodium edetate 5g
Water for injection adds to 5000ml
Prepare 2500
Method for preparing:
Taking by weighing recipe quantity mannitol, anhydrous sodium sulfite, calcio-disodium edetate dissolves in the new system water for injection of cumulative volume 80%; The full back adding recipe quantity esomeprazole sodium that dissolves is stirred to complete dissolving; Add the 10g medicinal charcoal; Be heated to 60 ℃, constant temperature stirring and adsorbing 20 minutes is with the titanium rod decarbonization filtering of 0.8 μ m.Regulate filtrating pH to 10.6 with the 1mol/L sodium hydroxide solution, add to the full amount of water for injection.Through 0.45 μ m, 0.22 μ m two-stage accurate filter aseptic filtration, filtrating is done the intermediate inspection.Sterile filling after qualified, loading amount is controlled at 2.0ml ~ 2.1ml/ and props up, the false add plug.Sample is put into freeze dryer carry out lyophilization: earlier-42 ℃ of quick pre-freezes 3 hours, the open vacuum pump was warming up to 0 ℃ of reduced vacuum dry 6 hours through 10 hours then then, was warming up to 30 ℃ of dryings at last 4 hours.Behind dry the end, the vacuum tamponade, outlet rolls lid, lamp inspection, pack after the assay was approved said injection esomeprazole sodium.
Embodiment 2
Prescription: (specification: 40mg)
Esomeprazole sodium 100g (in esomeprazole)
Mannitol 400g
Sodium sulfite 15g
Calcio-disodium edetate 5g
Water for injection adds to 5000ml
Prepare 2500
Method for preparing:
Taking by weighing recipe quantity mannitol, sodium sulfite, calcio-disodium edetate dissolves in the new system water for injection of cumulative volume 80%; The full back adding recipe quantity esomeprazole sodium that dissolves is stirred to complete dissolving; Add the 12g medicinal charcoal, stirring and adsorbing 30 minutes is with the titanium rod decarbonization filtering of 0.8 μ m.Regulate filtrating pH to 10.6 with the 1mol/L sodium hydroxide solution, add to the full amount of water for injection.Through 0.45 μ m, 0.22 μ m two-stage accurate filter aseptic filtration, filtrating is done the intermediate inspection.Sterile filling after qualified, loading amount is controlled at 2.0ml ~ 2.1ml/ and props up, the false add plug.Sample is put into freeze dryer carry out lyophilization: earlier-40 ℃ of quick pre-freezes 4 hours, the open vacuum pump was warming up to 0 ℃ of reduced vacuum dry 6 hours through 10 hours then then, was warming up to 28 ℃ of dryings at last 4 hours.Behind dry the end, the vacuum tamponade, outlet rolls lid, lamp inspection, pack after the assay was approved said injection esomeprazole sodium.
Embodiment 3
Prescription: (specification: 40mg)
Esomeprazole sodium 100g (in esomeprazole)
Mannitol 300g
Sodium pyrosulfite 15g
Calcio-disodium edetate 5g
Water for injection adds to 5000ml
Prepare 2500
Method for preparing:
Taking by weighing recipe quantity mannitol, sodium pyrosulfite, calcio-disodium edetate dissolves in the new system water for injection of cumulative volume 80%; The full back adding recipe quantity esomeprazole sodium that dissolves is stirred to complete dissolving; Add the 8g medicinal charcoal, stirring and adsorbing 40 minutes is with the titanium rod decarbonization filtering of 0.8 μ m.Regulate filtrating pH to 10.8 with the 0.5mol/L sodium hydroxide solution, add to the full amount of water for injection.Through 0.45 μ m, 0.22 μ m two-stage accurate filter aseptic filtration, filtrating is done the intermediate inspection.Sterile filling after qualified, loading amount is controlled at 2.0ml ~ 2.1ml/ and props up, the false add plug.Sample is put into freeze dryer carry out lyophilization: earlier-45 ℃ of quick pre-freezes 3 hours, the open vacuum pump was warming up to-5 ℃ of reduced vacuum dry 6 hours through 12 hours then then, was warming up to 28 ℃ of dryings at last 4 hours.Behind dry the end, the vacuum tamponade, outlet rolls lid, lamp inspection, pack after the assay was approved said injection esomeprazole sodium.
Embodiment 4
Prescription: (specification: 20mg)
Esomeprazole sodium 50g (in esomeprazole)
Mannitol 400g
Sodium sulfite 10g
Calcio-disodium edetate 5g
Water for injection adds to 5000ml
Prepare 2500
Method for preparing:
Taking by weighing recipe quantity mannitol, sodium sulfite, calcio-disodium edetate dissolves in the new system water for injection of cumulative volume 80%; The full back adding recipe quantity esomeprazole sodium that dissolves is stirred to complete dissolving; Add the 4g medicinal charcoal; Be warming up to 60 ℃, constant temperature stirring and adsorbing 25 minutes is with the titanium rod decarbonization filtering of 0.8 μ m.Regulate filtrating pH to 10.5 with the 1mol/L sodium hydroxide solution, add to the full amount of water for injection.Through 0.45 μ m, 0.22 μ m two-stage accurate filter aseptic filtration, filtrating is done the intermediate inspection.Sterile filling after qualified, loading amount is controlled at 2.0ml ~ 2.1ml/ and props up, the false add plug.Sample is put into freeze dryer carry out lyophilization: earlier-43 ℃ of quick pre-freezes 3 hours, the open vacuum pump was warming up to-5 ℃ of reduced vacuum dry 8 hours through 10 hours then then, was warming up to 28 ℃ of dryings at last 4 hours.Behind dry the end, the vacuum tamponade, outlet rolls lid, lamp inspection, pack after the assay was approved said injection esomeprazole sodium.
Embodiment 5
Prescription: (specification: 40mg)
Esomeprazole sodium 100g (in esomeprazole)
Gentran 40 0g
Anhydrous sodium sodium bisulfate 10g
Calcio-disodium edetate 5g
Water for injection adds to 5000ml
Prepare 2500
Method for preparing:
Taking by weighing recipe quantity glucosan, anhydrous sodium sulfite, calcio-disodium edetate dissolves in the new system water for injection of cumulative volume 80%; The full back adding recipe quantity esomeprazole sodium that dissolves is stirred to complete dissolving; Add the 10g medicinal charcoal, stirring at room absorption 25 minutes is with the titanium rod decarbonization filtering of 0.8 μ m.Regulate filtrating pH to 10.8 with the 1mol/L sodium hydroxide solution, add to the full amount of water for injection.Through 0.45 μ m, 0.22 μ m two-stage accurate filter aseptic filtration, filtrating is done the intermediate inspection.Sterile filling after qualified, loading amount is controlled at 2.0ml ~ 2.1ml/ and props up, the false add plug.Sample is put into freeze dryer carry out lyophilization: earlier-40 ℃ of quick pre-freezes 3 hours, the open vacuum pump was warming up to 0 ℃ of reduced vacuum dry 6 hours through 10 hours then then, was warming up to 30 ℃ of dryings at last 4 hours.Behind dry the end, the vacuum tamponade, outlet rolls lid, lamp inspection, pack after the assay was approved said injection esomeprazole sodium.
Test Example 1
This Test Example relates to the investigation of pH value, color and clarity
Get the prepared injection esomeprazole sodium sample of embodiment 1,2,3, investigate the clarity of its pH value, color and solution respectively.
PH value is measured: 1 bottle of sample thief, add 0.9% sodium chloride solution 5.2ml, and jolting makes dissolving, measures (two appendix VI of Chinese Pharmacopoeia version in 2010 H) in accordance with the law.
Colour measurement: sample thief and yellow standard color solution (two appendix IX of Chinese Pharmacopoeia version in 2010 A, first method) are relatively.
Clarity is measured: 1 bottle of sample thief, add 0.9% sodium chloride solution 5.2ml, and jolting makes dissolving, and solution should be clarified, and as showing muddy, compares with No. 1 turbidity standard (two appendix IX of Chinese Pharmacopoeia version in 2010 B).Result such as following table 1.
Table 1 sample appearance, pH value, color and clarity testing result
Test Example 2
This Test Example relates to study on the stability
(1) influence factor's test
Get embodiment 1 prepared injection esomeprazole sodium sample and carry out illumination (illumination 4500lx), high temperature (60 ℃), low temperature (4 ℃) test respectively, placed continuously 10 days, in the 0th, 5,10 days difference pick test.The result sees table 2.
Table 2 influence factor result of the test
(2) accelerated test
It is 75% thermostatic container that the sample of embodiment 1,2,3 is placed relative humidity (RH), and constant temperature was placed 6 months continuously in 40 ℃ of baking ovens, the pick test respectively at the 0th, 1,2,3, during June.Each lot sample article character is white lyophilizing block as a result, and moisture, the inspection of aseptic, bacterial endotoxin are all qualified, and other indexs are seen table 3.
Table 3 accelerated test is investigated the result
(3) the room temperature investigation that keeps sample
1,2,3 three groups of sample room temperatures of instance are placed, respectively at the 0th, 3,6,9,12,18 month pick test.Each lot sample article character is white lyophilizing block as a result, and moisture, the inspection of aseptic, bacterial endotoxin are all qualified, and other indexs are seen table 4.
The table 4 room temperature investigation result that keeps sample
Investigate through accelerated test and long-time stability, the result shows having good stability of product injection esomeprazole sodium freeze-dried powder injection of the present invention, reliable in quality, but long term store is more than 2 years.Injection esomeprazole sodium freeze-dried powder injection prescription of the present invention is simple, and technology is reasonable, can satisfy the demand of big production.
Claims (10)
1. a preparation technology who contains the lyophilized injectable powder of esomeprazole sodium is characterized in that comprising medicinal liquid preparation, pre-freeze stage, pre-freeze constant temperature stage, drying bu sublimation stage and the drying stage again that heats up.
2. the preparation technology of injection esomeprazole sodium according to claim 1 is characterized in that described injection esomeprazole sodium specification counts 10mg, 20mg and 40mg with esomeprazole.
3. the preparation technology of injection esomeprazole sodium according to claim 1 is characterized in that the said medicinal liquid preparation stage comprises following steps:
(1) excipient, metal ion chelation agent and the antioxidant that take by weighing recipe quantity dissolve in the water for injection of cumulative volume 80%, stir the full back of dissolving and add recipe quantity esomeprazole sodium, stir and make dissolving fully;
(2) add recipe quantity medicinal charcoal, stirring and adsorbing, decarbonization filtering;
(3) add the pH value regulator and regulate the medicinal liquid pH value, benefit adds to the full amount of water for injection, aseptic filtration, with the sterile liquid medicine fill in low Pyrex control bottle, the false add plug;
(4) sample is put into freeze dryer, lyophilization;
(5) after lyophilizing finished, lid was rolled in the vacuum tamponade, lamp inspection;
(6) examine entirely qualified after, the packing promptly get.
4. a kind of method for preparing that contains the lyophilized injectable powder of esomeprazole sodium according to claim 1; It is characterized in that said excipient is one or more mixture in glycine, mannitol, glucose, maltose alcohol, alanine, dextran, the glucosan; Preferred mannitol, amount of excipient accounts for 50% ~ 90% of total solid amount.
5. the described a kind of method for preparing that contains the lyophilized injectable powder of esomeprazole sodium of claim 1; It is characterized in that: said antioxidant is one or more mixture in sodium sulfite, anhydrous sodium sulfite, sodium pyrosulfite, sodium thiosulfate, the ascorbic acid; Preferred anhydrous sodium sulfite, the antioxidant consumption accounts for 0.2% ~ 5.0% of total solid amount.
6. a kind of method for preparing that contains the lyophilized injectable powder of esomeprazole sodium according to claim 1; It is characterized in that said metal ion chelation agent is one or more mixture in ethylenediaminetetraacetic acid, disodiumedetate, the calcio-disodium edetate, the metal ion chelation agent consumption accounts for 0.1% ~ 5.0% of total solid amount.
7. a kind of method for preparing that contains the lyophilized injectable powder of esomeprazole sodium according to claim 1 is characterized in that said pH value regulator is one or more mixture in sodium hydroxide, sodium hydrogen phosphate, sodium dihydrogen phosphate, sodium bicarbonate, the sodium carbonate.
8. the preparation technology of injection esomeprazole sodium according to claim 3 is characterized in that, the consumption of the said medicinal charcoal of step (2) is 0.05% ~ 0.5% (m/v), and the stirring and adsorbing temperature is 18 ℃ ~ 85 ℃, and adsorption time is 10min ~ 40min.
9. a kind of method for preparing that contains the lyophilized injectable powder of esomeprazole sodium according to claim 3 is characterized in that, the said medicinal liquid pH value of step (3) is adjusted to 10.0 ~ 10.9.
10. a kind of method for preparing that contains the lyophilized injectable powder of esomeprazole sodium according to claim 3; It is characterized in that; The said freeze drying process of step (4) is for putting into sample freeze drying box earlier pre-freeze 3 ~ 4 hours fast below-40 ℃; Open vacuum pump then through being warming up under-10 ℃ ~ 0 ℃ condition reduced vacuum in 10 ~ 12 hours dry 6 ~ 10 hours, is warming up to 25 ℃ ~ 30 ℃ dryings more than 4 hours then at last.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012101521863A CN102657622A (en) | 2012-05-17 | 2012-05-17 | Preparation process of freeze-dry powder injection containing esomeprazole sodium |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012101521863A CN102657622A (en) | 2012-05-17 | 2012-05-17 | Preparation process of freeze-dry powder injection containing esomeprazole sodium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102657622A true CN102657622A (en) | 2012-09-12 |
Family
ID=46767294
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012101521863A Pending CN102657622A (en) | 2012-05-17 | 2012-05-17 | Preparation process of freeze-dry powder injection containing esomeprazole sodium |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102657622A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070834A (en) * | 2013-01-16 | 2013-05-01 | 青岛正大海尔制药有限公司 | Lyophilized powder containing esomeprazole |
| CN104546743A (en) * | 2014-12-29 | 2015-04-29 | 成都通德药业有限公司 | Packaging composition of proton pump inhibitor drug for injection and preparation method of packaging composition |
| CN104666255A (en) * | 2015-03-23 | 2015-06-03 | 山东北大高科华泰制药有限公司 | Omeprazole sodium freeze drying powder injection pharmaceutical composition for injection |
| CN105055339A (en) * | 2015-07-31 | 2015-11-18 | 苏州汇和药业有限公司 | Injection esomeprazole composition and method for preparing same |
| CN111973562A (en) * | 2020-09-04 | 2020-11-24 | 四川制药制剂有限公司 | Esomeprazole sodium for injection and preparation method thereof |
| CN112007000A (en) * | 2020-09-18 | 2020-12-01 | 开封康诺药业有限公司 | Espressole sodium freeze-dried powder injection and preparation method thereof |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5877192A (en) * | 1993-05-28 | 1999-03-02 | Astra Aktiebolag | Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole |
| US6143771A (en) * | 1993-05-28 | 2000-11-07 | Astrazeneca Ab | Compounds |
| CN101513387A (en) * | 2008-11-20 | 2009-08-26 | 李铁军 | Esomeprazole magnesium injection liquid |
| CN102319223A (en) * | 2011-09-21 | 2012-01-18 | 石药集团欧意药业有限公司 | Esomeprazole freeze-dried preparation and preparation method thereof |
| CN102357082A (en) * | 2011-11-01 | 2012-02-22 | 南京新港医药有限公司 | Esomeprazole sodium freeze-dried powder injection and preparation method thereof |
| CN102512378A (en) * | 2011-12-09 | 2012-06-27 | 天津市汉康医药生物技术有限公司 | Stable and safe oxiracetam pharmaceutical composition for injection |
-
2012
- 2012-05-17 CN CN2012101521863A patent/CN102657622A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5877192A (en) * | 1993-05-28 | 1999-03-02 | Astra Aktiebolag | Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole |
| US6143771A (en) * | 1993-05-28 | 2000-11-07 | Astrazeneca Ab | Compounds |
| CN101513387A (en) * | 2008-11-20 | 2009-08-26 | 李铁军 | Esomeprazole magnesium injection liquid |
| CN102319223A (en) * | 2011-09-21 | 2012-01-18 | 石药集团欧意药业有限公司 | Esomeprazole freeze-dried preparation and preparation method thereof |
| CN102357082A (en) * | 2011-11-01 | 2012-02-22 | 南京新港医药有限公司 | Esomeprazole sodium freeze-dried powder injection and preparation method thereof |
| CN102512378A (en) * | 2011-12-09 | 2012-06-27 | 天津市汉康医药生物技术有限公司 | Stable and safe oxiracetam pharmaceutical composition for injection |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070834A (en) * | 2013-01-16 | 2013-05-01 | 青岛正大海尔制药有限公司 | Lyophilized powder containing esomeprazole |
| CN104546743A (en) * | 2014-12-29 | 2015-04-29 | 成都通德药业有限公司 | Packaging composition of proton pump inhibitor drug for injection and preparation method of packaging composition |
| CN104666255A (en) * | 2015-03-23 | 2015-06-03 | 山东北大高科华泰制药有限公司 | Omeprazole sodium freeze drying powder injection pharmaceutical composition for injection |
| CN105055339A (en) * | 2015-07-31 | 2015-11-18 | 苏州汇和药业有限公司 | Injection esomeprazole composition and method for preparing same |
| CN111973562A (en) * | 2020-09-04 | 2020-11-24 | 四川制药制剂有限公司 | Esomeprazole sodium for injection and preparation method thereof |
| CN112007000A (en) * | 2020-09-18 | 2020-12-01 | 开封康诺药业有限公司 | Espressole sodium freeze-dried powder injection and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102657622A (en) | Preparation process of freeze-dry powder injection containing esomeprazole sodium | |
| CN102274195B (en) | Oxiracetam freeze-dried powder preparation and preparation method thereof | |
| CN102085190A (en) | Pantoprazole sodium freeze-dried powder injection and preparation method thereof | |
| CN100496463C (en) | Omeprazole sodium freeze-dried powder injection and preparing method thereof | |
| CN103254174B (en) | Lansoprazole compound and pharmaceutical composition thereof | |
| CN102038651B (en) | Ropivacaine mesylate freeze-dried powder injection | |
| CN104257615A (en) | Dezocine freeze-dried pharmaceutical composition and preparation method thereof | |
| CN102552175B (en) | A kind of injection fludarabine phosphate lyophilized formulations and preparation method thereof | |
| CN102973524A (en) | Esomeprazole sodium lyophilized powder injection and preparation method thereof | |
| CN102319223B (en) | Esomeprazole freeze-dried preparation and preparation method thereof | |
| CN102743342B (en) | Sodium fusidate lyophilized composition for injection | |
| CN102670524B (en) | Pantoprazole sodium freeze-dried preparation for injection and preparation method thereof | |
| CN102512382B (en) | Esomeprazole sodium pharmaceutical composition for injection | |
| CN110960493B (en) | Parecoxib sodium freeze-dried preparation and preparation method thereof | |
| CN103565754A (en) | Calcium folinate composition for injection and preparation method thereof | |
| CN102813631B (en) | Method for preparing phentolamine mesilate freeze-drying powder injection | |
| CN112076162A (en) | Piperacillin sodium tazobactam sodium probenecid three-part freeze-dried preparation for injection | |
| CN109394706A (en) | A kind of Lansoprazole freeze-dried powder for injection and preparation method thereof | |
| CN102949354B (en) | Sodium rabeprazole composition for injection | |
| CN101317851A (en) | Freeze drying prescription containing glycyrrhizin and preparation method thereof | |
| CN103463636A (en) | Pantoprazole sodium medicine composition for injection | |
| CN103239416A (en) | Injection composition with isosorbide mononitrate and preparation method for injection composition | |
| CN101313895B (en) | Lansoprazole freeze-dried injection | |
| CN102512381A (en) | Lansoprazole medicine composition used for injection | |
| CN103565747A (en) | Esomeprazole composition and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20120912 |