CN101947220A - Combined medicament of omeprazole sodium - Google Patents
Combined medicament of omeprazole sodium Download PDFInfo
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- CN101947220A CN101947220A CN2010102786472A CN201010278647A CN101947220A CN 101947220 A CN101947220 A CN 101947220A CN 2010102786472 A CN2010102786472 A CN 2010102786472A CN 201010278647 A CN201010278647 A CN 201010278647A CN 101947220 A CN101947220 A CN 101947220A
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Abstract
The invention discloses a combined medicament of omeprazole sodium and a method for preparing the same. The combined medicament of omeprazole sodium comprises the following medicinal ingredients in part by weight: 17.3 to 34.8 parts of omeprazole sodium, 8.7 to 13.0 parts of reduced glutathione and 43.5 to 52.2 parts of sodium glutamate. The combined medicament of omeprazole sodium provided by the invention has an effect of resisting medicament allergy, can relieve the effect and the adverse reaction of the meprazole sodium on damage to liver and has high medicament quality; and the preparation method has the advantages of energy conservation and environmental protection.
Description
The application is for enjoying China's patent priority application formerly.Formerly the application number of patent is 2010100004907, and the applying date is on 01 11st, 2010, and name is called a kind of composite medicament of omeprazole sodium and preparation method thereof.
Technical field
The present invention relates to a kind of composite medicament of omeprazole sodium and preparation technology thereof.
Background technology
Harmonization of the stomach duodenum mucosa has natural gastric acid and the erosive perfect mechanism of pepsin resisted, but when helicobacter pylori and nonsteroidal anti-inflammatory drug damage it, causes peptic ulcer disease to take place.Australia scholar Warren and Marshall disclose this cause of disease, and H is arranged
2The receptor antagonist medicine is treated effectively, after 22 years, and two people and obtain Nobel Prize in medicine in 2005.Have the proton pump inhibitor medicine to be used for the treatment of peptic ulcer disease the eighties in last century again, compares H
2The inhibitor for treating effect is more powerful and lasting.Omeprazole Sodium is exactly typically to represent medicine, is one of line choice drug of treatment peptic ulcer disease at present.But, the omeprazole sodium freeze-dried injection of prior art, still adopt the former technology of activated carbon desuperheating in the preparation production, cause the little effect particle of activated carbon, metal ion species all to remain in the medicinal liquid, when instiling, brings in the blood of human body in clean arteries and veins, bring the infringement of medicine, and the present invention discovers that the pyrogen in the activated carbon adsorption medicinal liquid is not thorough to health; The auxilliary excipient of the lyophilized injection of prior art for preparing adopts low molecular dextran-40, and this material has irritated effect to human body, makes the skeleton of excipient with mannitol, and mannitol is to the vascular stimulation untoward reaction; The group that the Omeprazole Sodium of prior art is not protected N heterocycle and band sulphur atom is being made, is being stored transportation, use and entering intravital oxidation and the untoward reaction of this medicine that peroxidating, photooxidation cause.
Summary of the invention
Easily cause allergic reaction after existing omeprazol sodium preparation is taken in order to overcome, untoward reaction and to problems such as liver injury reactions, the invention provides a kind of composite medicament of omeprazole sodium.
Composite medicament of omeprazole sodium provided by the invention comprises the active ingredient of following parts by weight:
Omeprazole Sodium 17.3～34.8
Reduced glutathion 8.7～13.0
Sodium glutamate 43.5～52.2.
The present invention also provides a kind of method for preparing above-mentioned composition of medicine, and step is as follows:
(1). getting weight is the water for injection of 50～125 times of described Omeprazole Sodium weight, stirs down, the Omeprazole Sodium of described amount, reduced glutathion and sodium glutamate dissolving fully, obtains the solution of medicine respectively.
(2). with molecular cut off is the solution that the membrane ultrafiltration step (1) of 8000D obtains, and filtrate is the membrane ultrafiltration of 1500D with molecular cut off, and filtrate is regulated pH value 7.2～7.6 with 8% sodium hydroxide solution.
(3). the solution that step (2) obtains was 121 ℃ of moist heat sterilizations 20 minutes.
(4). the solution after the sterilization, be cooled to 20～22 ℃, the sodium hydroxide solution with 8% is regulated pH to 7.2～7.6, with the membrane filtration of 0.22 μ m, obtains the composition of medicine medicinal liquid.
(5). the content of each active ingredient in the composition of medicine medicinal liquid that determination step (4) obtains.
(6). described composition of medicine medicinal liquid is made acceptable forms on the pharmaceutics:
A, press the Omeprazole Sodium dosage that pharmaceutics allows, the composition of medicine medicinal liquid that above-mentioned steps (4) makes is aseptic subpackaged, make the Omeprazole Sodium composite medicinal injection;
B, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in cillin bottle, put into the freeze drying box of lyophilization unit, lyophilization routinely makes residual moisture in the composition of medicine solid≤2%.Tamponade, roll lid, make the lyophilized injection of omeprazole sodium composite medicine;
C, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in 316L rustless steel pallet, and lyophilization makes moisture in the composition of medicine solid≤2%.The drug form preparation such as oral formulations, spray for preparing composite medicament of omeprazole sodium according to a conventional method.
The present invention can realize following technique effect:
1. composition of medicine provided by the invention is higher than the medicine of omeprazol sodium preparation of the prior art and other treatment gastric ulcer to the therapeutic effect of gastric ulcer.
2. replace the low molecular dextran-40 of prior art to make excipient with sodium glutamate, avoided the anaphylaxis of low molecular dextran-40, sodium glutamate and reduced glutathion compound action also can alleviate the effect of Omeprazole Sodium to hepar damnification.
With reduced glutathion as Reducing agent, have protective effect, can eliminate the untoward reaction that Omeprazole Sodium brings owing to photooxidation, oxidation, peroxidating in external and body.
4. adopt molecular cut off 8000D and 1500D membrane ultrafiltration technology of molecular cut off depyrogenation, replace traditional active carbon depyrogenation technology, greatly improved the interior quality of medicine, and energy-conserving and environment-protective.
5. the composition of medicine medicinal liquid of above-mentioned steps (4) preparation, the solid after the lyophilization is the dispersed system that is molecularity, makes corresponding preparation, the uniformity of dosage units of each composition mix than traditional coating and high-speed stirred wet mixing technology high more than 20%.
The specific embodiment
The invention will be further described with specific embodiment below, can be implemented so that those skilled in the art can better understand the present invention also, but illustrated embodiment is not as a limitation of the invention.
Embodiment 1
The omeprazole sodium composite medicine that present embodiment provides comprises the active ingredient of following parts by weight:
Omeprazole Sodium: 17.3
Reduced glutathion 8.7
Sodium glutamate 43.5
The preparation method of combinations thereof medicine is as follows:
(1). getting weight is the water for injection of 50～125 times of described Omeprazole Sodium weight, stirs down, the Omeprazole Sodium of described amount, reduced glutathion and sodium glutamate dissolving fully, obtains the solution of medicine respectively.
(2). with molecular cut off is the solution that the membrane ultrafiltration step (1) of 8000D obtains, and filtrate is the membrane ultrafiltration of 1500D with molecular cut off, and filtrate is regulated pH value 7.2～7.6 with 8% sodium hydroxide solution.
(3). the solution that step (2) obtains was 121 ℃ of moist heat sterilizations 20 minutes.
(4). the solution after the sterilization, be cooled to 20～22 ℃, the sodium hydroxide solution with 8% is regulated pH to 7.2～7.6, with the membrane filtration of 0.22 μ m, obtains the composition of medicine medicinal liquid.
(5). the content of each active ingredient in the composition of medicine medicinal liquid that determination step (4) obtains.
(6). described composition of medicine medicinal liquid is made acceptable forms on the pharmaceutics:
A, press the Omeprazole Sodium dosage that pharmaceutics allows, the aseptic subpackaged Omeprazole Sodium composite medicinal injection of making of composition of medicine medicinal liquid that above-mentioned steps (4) is made;
B, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in cillin bottle, put into the freeze drying box of lyophilization unit, lyophilization routinely makes residual moisture in the composition of medicine solid≤2%.Tamponade, roll lid, make the lyophilized injection of omeprazole sodium composite medicine;
C, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in 316L rustless steel pallet, and lyophilization makes moisture in the composition of medicine solid≤2%.The drug form preparation such as oral formulations, spray for preparing composite medicament of omeprazole sodium according to a conventional method.
The pharmacodynamics demonstration test:
1. animal is selected:
Rat commonly used, 10 every group, body weight 200-250g, health, male or female is indicated kind system and the quality certification number of animal.
2. model and method:
2.1. acetic acid burns the type gastric ulcer model
Experimental animal rat, the male and female dual-purpose, random packet, fasting is 24 hours before the experiment, freely drinks water, and under etherization opens the abdominal cavity, the glass tubing of internal diameter 5mm, long 30mm vertically is positioned on the body of stomach serosal surface, ice acetic acid 0.2ml in tube chamber dipped in out glacial acetic acid with cotton swab after 1.5 minutes, the suture operation otch.Postoperative rat normal diet was set up matched group and administration group in second day at random.Successive administration 15 days.Dissect and take out stomach, measure the ulcer area, compare between each group.
2.2. pyloric ligation ulcers gastric ulcer model (making negative control)
Rat, male and female dual-purpose, random packet, the experiment before fasting 36-72 hour, freely drink water, with ether with Animal Anesthesia, open the abdominal cavity, the ligation pylorus, postoperative was dissected and is got stomach in 18 hours, injected 1% formalin 8ml in gastral cavity, stomach is immersed in 1% formalin solution, after 10 minutes, cut off stomach along greater gastric curvature, the preceding stomach ulcer surface of counting is long-pending to be 43～47mm
2
The result is as follows:
Embodiment 2:
The omeprazole sodium composite medicine that present embodiment provides, the active ingredient that comprises following parts by weight becomes:
Omeprazole Sodium: 34.8
Reduced glutathion 13.0
Sodium glutamate 52.2
The preparation method of above-mentioned omeprazole sodium composite medicine is:
(1). getting weight is the water for injection of 50～125 times of described Omeprazole Sodium weight, stirs down, the Omeprazole Sodium of described amount, reduced glutathion and sodium glutamate dissolving fully, obtains the solution of medicine respectively.
(2). with molecular cut off is the solution that the membrane ultrafiltration step (1) of 8000D obtains, and filtrate is the membrane ultrafiltration of 1500D with molecular cut off, and filtrate is regulated pH value to 7.2～7.6 with 8% sodium hydroxide solution.
(3). the solution that step (2) obtains was 121 ℃ of moist heat sterilizations 20 minutes.
(4). the solution after the sterilization, be cooled to 20～22 ℃, the sodium hydroxide solution with 8% is regulated pH to 7.2～7.6, with the membrane filtration of 0.22 μ m, obtains the composition of medicine medicinal liquid.
(5). the content of each active ingredient in the composition of medicine medicinal liquid that determination step (4) obtains.
(6). described composition of medicine medicinal liquid is made acceptable forms on the pharmaceutics:
A, press the Omeprazole Sodium dosage that pharmaceutics allows, the aseptic subpackaged Omeprazole Sodium composite medicinal injection of making of composition of medicine medicinal liquid that above-mentioned steps (4) is made;
B, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in cillin bottle, put into the freeze drying box of lyophilization unit, lyophilization routinely makes residual moisture in the composition of medicine solid≤2%.Tamponade, roll lid, make the lyophilized injection of omeprazole sodium composite medicine;
C, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in 316L rustless steel pallet, and lyophilization makes moisture in the composition of medicine solid≤2%.The drug form preparation such as oral formulations, spray for preparing composite medicament of omeprazole sodium according to a conventional method.
The pharmacodynamics demonstration test:
1. animal is selected:
Rat commonly used, 10 every group, body weight 200-250g, health, male or female is indicated kind system and the quality certification number of animal.
2. model and method:
2.1. acetic acid burns the type gastric ulcer model
Experimental animal rat, the male and female dual-purpose, random packet, fasting is 24 hours before the experiment, freely drinks water, and under etherization opens the abdominal cavity, the glass tubing of internal diameter 5mm, long 30mm vertically is positioned on the body of stomach serosal surface, ice acetic acid 0.2ml in tube chamber dipped in out glacial acetic acid with cotton swab after 1.5 minutes, the suture operation otch.Postoperative rat normal diet was set up matched group and administration group in second day at random.Successive administration 15 days.Dissect and take out stomach, measure the ulcer area, compare between each group.
2.2. pyloric ligation ulcers gastric ulcer model (making negative control)
Rat, male and female dual-purpose, random packet, the experiment before fasting 36-72 hour, freely drink water, with ether with Animal Anesthesia, open the abdominal cavity, the ligation pylorus, postoperative was dissected and is got stomach in 18 hours, injected 1% formalin 8ml in gastral cavity, stomach is immersed in 1% formalin solution, after 10 minutes, cut off stomach along greater gastric curvature, the preceding stomach ulcer surface of counting is long-pending to be 43～47mm
2
The result is as follows:
Embodiment 3:
The omeprazole sodium composite medicine that present embodiment provides comprises the active ingredient of following parts by weight:
Omeprazole Sodium: 29.1
Reduced glutathion 10.2
Sodium glutamate 46.3
The preparation method of above-mentioned omeprazole sodium composite medicine is:
(1). getting weight is the water for injection of 50～125 times of described Omeprazole Sodium weight, stirs down, the Omeprazole Sodium of described amount, reduced glutathion and sodium glutamate dissolving fully, obtains the solution of medicine respectively.
(2). with molecular cut off is the solution that the membrane ultrafiltration step (1) of 8000D obtains, and filtrate is the membrane ultrafiltration of 1500D with molecular cut off, and filtrate is regulated pH value 7.2～7.6 with 8% sodium hydroxide solution.
(3). the solution that step (2) obtains was 121 ℃ of moist heat sterilizations 20 minutes.
(4). the solution after the sterilization, be cooled to 20～22 ℃, the sodium hydroxide solution with 8% is regulated pH to 7.2～7.6, with the membrane filtration of 0.22 μ m, obtains the composition of medicine medicinal liquid.
(5). the content of each active ingredient in the composition of medicine medicinal liquid that determination step (4) obtains.
(6). described composition of medicine medicinal liquid is made acceptable forms on the pharmaceutics:
A, press the Omeprazole Sodium dosage that pharmaceutics allows, the aseptic subpackaged Omeprazole Sodium composite medicinal injection of making of composition of medicine medicinal liquid that above-mentioned steps (4) is made;
B, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in cillin bottle, put into the freeze drying box of lyophilization unit, lyophilization routinely makes residual moisture in the composition of medicine solid≤2%.Tamponade, roll lid, make the lyophilized injection of omeprazole sodium composite medicine;
C, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in 316L rustless steel pallet, and lyophilization makes moisture in the composition of medicine solid≤2%.The drug form preparation such as oral formulations, spray for preparing composite medicament of omeprazole sodium according to a conventional method.
The pharmacodynamics demonstration test:
1. animal is selected:
Rat commonly used, 10 every group, body weight 200-250g, health, male or female is indicated kind system and the quality certification number of animal.
2. model and method:
2.1. acetic acid burns the type gastric ulcer model
Experimental animal rat, the male and female dual-purpose, random packet, fasting is 24 hours before the experiment, freely drinks water, and under etherization opens the abdominal cavity, the glass tubing of internal diameter 5mm, long 30mm vertically is positioned on the body of stomach serosal surface, ice acetic acid 0.2ml in tube chamber dipped in out glacial acetic acid with cotton swab after 1.5 minutes, the suture operation otch.The postoperative normal diet was set up matched group and administration group in second day at random.Successive administration 15 days.Dissect and take out stomach, measure the ulcer area, compare between each group.
2.2. pyloric ligation ulcers gastric ulcer model (making negative control)
Rat, male and female dual-purpose, random packet, the experiment before fasting 36-72 hour, freely drink water, with ether with Animal Anesthesia, open the abdominal cavity, the ligation pylorus, postoperative was dissected and is got stomach in 18 hours, injected 1% formalin 8ml in gastral cavity, stomach is immersed in 1% formalin solution, after 10 minutes, cut off stomach along greater gastric curvature, the preceding stomach ulcer surface of counting is long-pending to be 43～47mm
2
The result is as follows:
Embodiment 4:
The omeprazole sodium composite medicine that present embodiment provides comprises the active ingredient of following parts by weight:
Omeprazole Sodium: 34.8
Reduced glutathion 8.7
Sodium glutamate 52.2
The preparation method of above-mentioned omeprazole sodium composite medicine is:
(1). getting weight is the water for injection of 50～125 times of described Omeprazole Sodium weight, stirs down, the Omeprazole Sodium of described amount, reduced glutathion and sodium glutamate dissolving fully, obtains the solution of medicine respectively.
(2). with molecular cut off is the solution that the membrane ultrafiltration step (1) of 8000D obtains, and filtrate is the membrane ultrafiltration of 1500D with molecular cut off, gets filtrate and regulates pH value to 7.2～7.6 with 8% sodium hydroxide solution.
(3). the solution that step (2) obtains was 121 ℃ of moist heat sterilizations 20 minutes.
(4). the solution after the sterilization, be cooled to 20～22 ℃, the sodium hydroxide solution with 8% is regulated pH to 7.2～7.6, with the membrane filtration of 0.22 μ m, obtains the composition of medicine medicinal liquid.
(5). the content of each active ingredient in the composition of medicine medicinal liquid that determination step (4) obtains.
(6). described composition of medicine medicinal liquid is made acceptable forms on the pharmaceutics:
A, press the Omeprazole Sodium dosage that pharmaceutics allows, the aseptic subpackaged Omeprazole Sodium composite medicinal injection of making of composition of medicine medicinal liquid that above-mentioned steps (4) is made;
B, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in cillin bottle, put into the freeze drying box of lyophilization unit, lyophilization routinely makes residual moisture in the composition of medicine solid≤2%.Tamponade, roll lid, make the lyophilized injection of omeprazole sodium composite medicine;
C, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in 316L rustless steel pallet, and lyophilization makes moisture in the composition of medicine solid≤2%.The drug form preparation such as oral formulations, spray for preparing composite medicament of omeprazole sodium according to a conventional method.
The pharmacodynamics demonstration test:
1. animal is selected:
Rat commonly used, 10 every group, body weight 200-250g, health, male or female is indicated kind system and the quality certification number of animal.
2. model and method:
2.1. acetic acid burns the type gastric ulcer model
Experimental animal rat, the male and female dual-purpose, random packet, fasting is 24 hours before the experiment, freely drinks water, and under etherization opens the abdominal cavity, the glass tubing of internal diameter 5mm, long 30mm vertically is positioned on the body of stomach serosal surface, ice acetic acid 0.2ml in tube chamber dipped in out glacial acetic acid with cotton swab after 1.5 minutes, the suture operation otch.The postoperative normal diet was set up matched group and administration group in second day at random.Successive administration 15 days.Dissect and take out stomach, measure the ulcer area, compare between each group.
2.2. pyloric ligation ulcers gastric ulcer model (making negative control)
Rat, male and female dual-purpose, random packet, the experiment before fasting 36-72 hour, freely drink water, with ether with Animal Anesthesia, open the abdominal cavity, the ligation pylorus, postoperative was dissected and is got stomach in 18 hours, injected 1% formalin 8ml in gastral cavity, stomach is immersed in 1% formalin solution, after 10 minutes, cut off stomach along greater gastric curvature, the preceding stomach ulcer surface of counting is long-pending to be 43～47mm
2
The result is as follows:
Embodiment 5:
The omeprazole sodium composite medicine that present embodiment provides comprises the active ingredient of following parts by weight:
Omeprazole Sodium: 17.3
Reduced glutathion 13.0
Sodium glutamate 43.5
The preparation method of above-mentioned omeprazole sodium composite medicine is:
(1). getting weight is the water for injection of 50～125 times of described Omeprazole Sodium weight, stirs down, the Omeprazole Sodium of described amount, reduced glutathion and sodium glutamate dissolving fully, obtains the solution of medicine respectively.
(2). with molecular cut off is the solution that the membrane ultrafiltration step (1) of 8000D obtains, and filtrate is the membrane ultrafiltration of 1500D with molecular cut off, gets filtrate and regulates pH value to 7.2～7.6 with 8% sodium hydroxide solution.
(3). the solution that step (2) obtains was 121 ℃ of moist heat sterilizations 20 minutes.
(4). the solution after the sterilization, be cooled to 20～22 ℃, the sodium hydroxide solution with 8% is regulated pH to 7.2～7.6, with the membrane filtration of 0.22 μ m, obtains the composition of medicine medicinal liquid.
(5). the content of each active ingredient in the composition of medicine medicinal liquid that determination step (4) obtains.
(6). described composition of medicine medicinal liquid is made acceptable forms on the pharmaceutics:
A, press the Omeprazole Sodium dosage that pharmaceutics allows, the aseptic subpackaged Omeprazole Sodium composite medicinal injection of making of composition of medicine medicinal liquid that above-mentioned steps (4) is made;
B, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in cillin bottle, put into the freeze drying box of lyophilization unit, lyophilization routinely makes residual moisture in the composition of medicine solid≤2%.Tamponade, roll lid, make the lyophilized injection of omeprazole sodium composite medicine;
C, by the Omeprazole Sodium dosage that allows on the pharmaceutics, the composition of medicine medicinal liquid of above-mentioned steps (4) preparation is aseptic subpackaged in 316L rustless steel pallet, and lyophilization makes moisture in the composition of medicine solid≤2%.The drug form preparation such as oral formulations, spray for preparing composite medicament of omeprazole sodium according to a conventional method.
The pharmacodynamics demonstration test:
1. animal is selected:
Rat commonly used, 10 every group, body weight 200-250g, health, male or female is indicated kind system and the quality certification number of animal.
2. model and method:
2.1. acetic acid burns the type gastric ulcer model
Experimental animal rat, the male and female dual-purpose, random packet, fasting is 24 hours before the experiment, freely drinks water, and under etherization opens the abdominal cavity, the glass tubing of internal diameter 5mm, long 30mm vertically is positioned on the body of stomach serosal surface, ice acetic acid 0.2ml in tube chamber dipped in out glacial acetic acid with cotton swab after 1.5 minutes, the suture operation otch.Postoperative rat normal diet was set up matched group and administration group in second day at random.Successive administration 15 days.Dissect and take out stomach, measure the ulcer area, compare between each group.
2.2. pyloric ligation ulcers gastric ulcer model (making negative control)
Rat, male and female dual-purpose, random packet, the experiment before fasting 36-72 hour, freely drink water, with ether with Animal Anesthesia, open the abdominal cavity, the ligation pylorus, postoperative was dissected and is got stomach in 18 hours, injected 1% formalin 8ml in gastral cavity, stomach is immersed in 1% formalin solution, after 10 minutes, cut off stomach along greater gastric curvature, the preceding stomach ulcer surface of counting is long-pending to be 43～47mm
2
The result is as follows:
The above embodiment is the preferred embodiment that proves absolutely that the present invention lifts, and protection scope of the present invention is not limited thereto.Being equal to that those skilled in the art are done on basis of the present invention substitutes or conversion, all within protection scope of the present invention.Protection scope of the present invention is as the criterion with claims.
Claims (4)
1. a composite medicament of omeprazole sodium is characterized in that, comprises the active ingredient of following parts by weight:
Omeprazole Sodium 17.3～34.8
Reduced glutathion 8.7～13.0
Sodium glutamate 43.5～52.2.
2. prepare the method for the described composition of medicine of claim 1, it is characterized in that, step is as follows:
(1). getting weight is the water for injection of 50～125 times of described Omeprazole Sodium weight, stirs down, the Omeprazole Sodium of described amount, reduced glutathion and sodium glutamate dissolving fully, obtains the solution of medicine respectively;
(2). with molecular cut off is the solution that the membrane ultrafiltration step (1) of 8000D obtains, and filtrate is the membrane ultrafiltration of 1500D with molecular cut off, and filtrate is regulated pH value to 7.2～7.6 with 8% sodium hydroxide solution;
(3). the solution that step (2) obtains was 121 ℃ of moist heat sterilizations 20 minutes;
(4). the solution after the sterilization, be cooled to 20～22 ℃, the sodium hydroxide solution with 8% is regulated pH value to 7.2～7.6, with the membrane filtration of 0.22 μ m, obtains the composition of medicine medicinal liquid;
(5). the content of each active ingredient in the composition of medicine medicinal liquid that determination step (4) obtains;
(6). described composition of medicine medicinal liquid is made acceptable forms on the pharmaceutics.
3. method according to claim 2 is characterized in that, acceptable forms is injection, lyophilized injection, oral formulations, spray on the described pharmaceutics.
4. the medicine of the treatment gastric ulcer of the described composition of medicine of claim 1 preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102786472A CN101947220A (en) | 2010-01-11 | 2010-09-13 | Combined medicament of omeprazole sodium |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010000490.7 | 2010-01-11 | ||
| CN201010000490A CN101766614A (en) | 2010-01-11 | 2010-01-11 | Omeprazole sodium combined medicament and preparation method thereof |
| CN2010102786472A CN101947220A (en) | 2010-01-11 | 2010-09-13 | Combined medicament of omeprazole sodium |
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| Publication Number | Publication Date |
|---|---|
| CN101947220A true CN101947220A (en) | 2011-01-19 |
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| CN2010102786472A Pending CN101947220A (en) | 2010-01-11 | 2010-09-13 | Combined medicament of omeprazole sodium |
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| CN102091070A (en) * | 2010-12-27 | 2011-06-15 | 吴赣英 | Rabeprazole sodium combined medicament and preparation process thereof |
| CN102058593A (en) * | 2010-12-27 | 2011-05-18 | 吴赣英 | Combination medicament of ilaprazole sodium and preparation process thereof |
| CN103059000A (en) * | 2013-01-29 | 2013-04-24 | 黄明芳 | Novel omeprazole compound and pharmaceutical composition thereof |
| CN107773529B (en) * | 2016-08-24 | 2020-06-16 | 华仁药业股份有限公司 | Esomeprazole sodium and sodium chloride injection and preparation method thereof |
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| CN101766614A (en) | 2010-07-07 |
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Application publication date: 20110119 |