CN1293879C - Freeze-dried powder injection of pantoprazole sodium and its preparation - Google Patents
Freeze-dried powder injection of pantoprazole sodium and its preparation Download PDFInfo
- Publication number
- CN1293879C CN1293879C CNB2005100234698A CN200510023469A CN1293879C CN 1293879 C CN1293879 C CN 1293879C CN B2005100234698 A CNB2005100234698 A CN B2005100234698A CN 200510023469 A CN200510023469 A CN 200510023469A CN 1293879 C CN1293879 C CN 1293879C
- Authority
- CN
- China
- Prior art keywords
- sodium
- pantoprazole
- pantoprazole sodium
- freeze
- disodium edetate
- 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.)
- Active
Links
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 title claims abstract description 39
- 229960004048 pantoprazole sodium Drugs 0.000 title claims abstract description 39
- 239000007924 injection Substances 0.000 title claims abstract description 22
- 238000002347 injection Methods 0.000 title claims abstract description 22
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000000843 powder Substances 0.000 title claims description 18
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 17
- 239000002253 acid Substances 0.000 claims abstract description 15
- 150000001447 alkali salts Chemical class 0.000 claims abstract description 15
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims abstract 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 30
- 150000007529 inorganic bases Chemical class 0.000 claims description 14
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 claims description 12
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims description 12
- 229960005019 pantoprazole Drugs 0.000 claims description 12
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 12
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 10
- 229930195725 Mannitol Natural products 0.000 claims description 10
- 239000000594 mannitol Substances 0.000 claims description 10
- 235000010355 mannitol Nutrition 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 239000001509 sodium citrate Substances 0.000 claims description 8
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical group O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 8
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 6
- 229920002307 Dextran Polymers 0.000 claims description 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 5
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 5
- 239000008103 glucose Substances 0.000 claims description 5
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 4
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 4
- 235000019800 disodium phosphate Nutrition 0.000 claims description 4
- 238000007710 freezing Methods 0.000 claims description 4
- 230000008014 freezing Effects 0.000 claims description 4
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 239000001508 potassium citrate Substances 0.000 claims description 4
- 229960002635 potassium citrate Drugs 0.000 claims description 4
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 claims description 4
- 235000011082 potassium citrates Nutrition 0.000 claims description 4
- 235000017550 sodium carbonate Nutrition 0.000 claims description 4
- 235000011083 sodium citrates Nutrition 0.000 claims description 4
- 239000002585 base Substances 0.000 claims description 3
- 150000003839 salts Chemical class 0.000 claims description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 4
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 2
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 2
- 230000000694 effects Effects 0.000 abstract description 7
- 238000004108 freeze drying Methods 0.000 abstract description 6
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 239000000463 material Substances 0.000 abstract description 3
- 239000003513 alkali Substances 0.000 abstract 1
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 17
- 229940090044 injection Drugs 0.000 description 13
- 239000002671 adjuvant Substances 0.000 description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 7
- 238000002474 experimental method Methods 0.000 description 5
- 208000032843 Hemorrhage Diseases 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 239000008215 water for injection Substances 0.000 description 4
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 3
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 3
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 3
- 239000011575 calcium Substances 0.000 description 3
- 229910052791 calcium Inorganic materials 0.000 description 3
- 229910001424 calcium ion Inorganic materials 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- 210000004907 gland Anatomy 0.000 description 3
- 229910021645 metal ion Inorganic materials 0.000 description 3
- 238000012856 packing Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 208000007107 Stomach Ulcer Diseases 0.000 description 2
- 230000000536 complexating effect Effects 0.000 description 2
- 208000000718 duodenal ulcer Diseases 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 201000005917 gastric ulcer Diseases 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 235000015424 sodium Nutrition 0.000 description 2
- 159000000000 sodium salts Chemical class 0.000 description 2
- OQUFOZNPBIIJTN-UHFFFAOYSA-N 2-hydroxypropane-1,2,3-tricarboxylic acid;sodium Chemical compound [Na].OC(=O)CC(O)(C(O)=O)CC(O)=O OQUFOZNPBIIJTN-UHFFFAOYSA-N 0.000 description 1
- 208000009304 Acute Kidney Injury Diseases 0.000 description 1
- 206010048962 Brain oedema Diseases 0.000 description 1
- 208000010412 Glaucoma Diseases 0.000 description 1
- 208000033626 Renal failure acute Diseases 0.000 description 1
- 201000011040 acute kidney failure Diseases 0.000 description 1
- 208000012998 acute renal failure Diseases 0.000 description 1
- 230000000767 anti-ulcer Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 208000006752 brain edema Diseases 0.000 description 1
- 239000002738 chelating agent Substances 0.000 description 1
- 238000010668 complexation reaction Methods 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 229960001484 edetic acid Drugs 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000008176 lyophilized powder Substances 0.000 description 1
- 238000005374 membrane filtration Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 229940026447 pantoprazole injection Drugs 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 229940126409 proton pump inhibitor Drugs 0.000 description 1
- 239000000612 proton pump inhibitor Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000008354 sodium chloride injection Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention discloses a pantoprazole sodium freeze-drying injection preparation which comprises the components: 1 portion by weight of pantoprazole sodium, 0 to 0.125 portion by weight of excipient, 0.075 to 0.125 portion by weight of weak acid strong alkali salt, 0.025 to 0.0375 portion of disodium edetate and a proper quantity of inorganic alkali. The prescription of the present invention is simple, and the present invention overcomes the side effect brought because excessive auxiliary materials are added, and is safely used by patients, and simultaneously the prepared preparation has better stability. The production cost of a product is lowered because the use quality of the auxiliary materials is reduced, and the present invention is more suitable for industrialized mass production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, more particularly relate to Pantoprazole Sodium Freezing Injectable Powder And Its Preparation Method.
Background technology
Pantoprazole Sodium (Pantoprazole Sodium), chemistry 5-difluoro-methoxy-2-[(3 by name, 4-dimethoxy-2-pyridine radicals)-methyl]-sulfinyl-1H-benzimidazole sodium salt.Pantoprazole Sodium is a proton pump inhibitor class antiulcerative.The injection Pantoprazole Sodium is mainly used in gastric ulcer, the duodenal ulcer emergency case is hemorrhage and prevent hemorrhage.Because it is all very sensitive to light, heat, oxygen, water etc., is suitable for injectable powder so be not suitable for making liquid drugs injection.
In document in the past, existing many relevant Pantoprazole Sodiums are made the report of lyophilized injectable powder, such as in Chinese patent " freeze-dried pantoprazole preparation and pantoprazole injection " (publication number CN1476335A, open day on February 18th, 2004), having disclosed " the aqueous solution lyophilization of Pantoprazole Sodium, ethylenediaminetetraacetic acid and/or its suitable salt and sodium hydroxide and/or sodium carbonate " made lyophilized formulations; But the preparation stability with the preparation of this technical scheme is bad, and when it is dissolved in the injection, intensive amount will descend in 2 to 4 hours, influenced drug effect.At Chinese patent " freeze-dried pantoprazole injectable powder and preparation method " (publication number CN1235018A, on November 17th, 1999 was disclosed) in disclosed a kind of method for preparing freeze-dried powder injection of pantoprazole sodium, its prescription is made up of Pantoprazole Sodium (1 part), lyophilized powder proppant (1-5 part), complexing of metal ion agent (0.05-2 part) and pH regulator agent.The used pharmaceutic adjuvant amount of this technical scheme is bigger, thereby brings some side effect.
Summary of the invention
The technical problem to be solved in the present invention is: provide a kind of side effect little, the freeze-dried powder injection of pantoprazole sodium of good stability.
The invention provides a kind of freeze-dried powder injection of pantoprazole sodium, count by weight, its composition comprises:
1 part of Pantoprazole Sodium (by pantoprazole)
Excipient 0--0.125 part
Weak acid strong alkali salt 0.075--0.125 part
Disodium edetate 0.025--0.0375 part
Inorganic base is an amount of;
In the present invention, excipient can be do not added, but, a spot of excipient can be added for the outward appearance that makes freeze-dried powder is more attractive in appearance.Excipient can be selected from mannitol, glucose, dextran etc.; Weak acid strong alkali salt can be selected from sodium citrate, sodium carbonate, potassium citrate, sodium hydrogen phosphate etc.; Inorganic base can be selected from sodium hydroxide, sodium bicarbonate, potassium hydroxide etc.
Preferred prescription is (meter by weight):
1 part of Pantoprazole Sodium (by pantoprazole)
0.125 part of excipient
0.125 part of weak acid strong alkali salt
0.0375 part of disodium edetate
Inorganic base is an amount of;
Wherein excipient can be selected from mannitol, glucose, dextran etc.; Weak acid strong alkali salt can be selected from sodium citrate, sodium carbonate, potassium citrate, sodium hydrogen phosphate etc.; Inorganic base can be selected from sodium hydroxide, sodium bicarbonate, potassium hydroxide etc.
Through experiment, the preferred mannitol of excipient of the present invention, weak acid strong alkali salt preferably citric acid sodium; Consider that pantoprazole is a sodium salt, and inorganic base addition can not be too many in prescription, so the preferred sodium hydroxide of inorganic base.
So preferred prescription is (meter by weight):
1 part of Pantoprazole Sodium (by pantoprazole);
0.125 part in mannitol;
0.125 part of sodium citrate;
0.0375 part of disodium edetate;
Sodium hydroxide is an amount of.
The present invention improves drug safety by to the selecting meticulously and to the strictness of each supplementary product consumption restriction, reduce the side effect that may produce the patient greatly because of the adjuvant addition of adjuvant, reaching medicinal standard simultaneously, further improves stability of drug.
Excipient is selected mannitol, glucose for use in the prior art, sodium chloride, dextran, and consumption is very big, with the ratio of weight and number of active component be 1 to 5 to 1.These materials are except as the pharmaceutic adjuvant, and itself also has its pharmacological action, can improve plasma osmotic pressure such as mannitol, produce dehydration, can be used for prophylaxis of acute renal failure and treatment glaucoma and cerebral edema etc. clinically.So should be in pharmaceutical preparation to add a spot of mannitol as far as possible.As a same reason, other adjuvants, as glucose, sodium chloride, dextran also all have its oneself pharmacological action, and human body should be taken in as far as possible less.The present invention is by the improvement to prescription, adds the adjuvant of minute quantity and reaches the preparation that meets medicinal standard.
In order to reduce the addition of adjuvant as far as possible, the present invention has carried out selecting to adjuvant meticulously, such as except disodium edetate, also can adopt other complexing of metal ion agent to come complexation of metal ions, but find through experiment, the amount that the use amount of other any metal chelating agents all will substantially exceed disodium edetate just can reach the effect of using disodium edetate, only needs trace to get final product and add disodium edetate.
In addition, can find by experiment, in prescription, add disodium edetate 0.025--0.0375 part, can improve its stability in 0.9% sodium chloride injection that membrane filtration water for injection is produced.If addition is too much, the calcium ion in the disodium edetate meeting chelating blood, patient's meeting so and the too much calcium that runs off.Consider the loss that is reduced in to greatest extent clinically calcium in the human body just, add 0.025--0.0375 part disodium edetate in the present invention, each consumption 40mg meter according to the injection Pantoprazole Sodium, wherein contain the 1--1.5mg disodium edetate, in theory can only chelating 0.105--0.158mg calcium ion, so its medication is safe, can not cause the side effect that calcium ion runs off.And the injection Pantoprazole Sodium is mainly used in gastric ulcer, the duodenal ulcer emergency case is hemorrhage and it is hemorrhage to prevent, and patient is very short service time, is about 3--5 days, and is little to the loss of calcium in the body.
Simultaneously, the present invention has also considered to make the stability problem behind the preparation fully.Contain weak acid strong alkali salt in prescription of the present invention, in the present invention, selecting weak acid strong alkali salt for use is not as the pH regulator agent, but use as stabilizing agent.Add weak acid strong alkali salt in the pantoprazole sodium freeze-drying powder pin, behind sodium citrate, can guarantee its stability in normal saline.Simultaneously, do not add inorganic base if only select disodium edetate for use, in the process of preparation, be easy to separate out pantoprazole.The present invention the time has selected disodium edetate and inorganic base for use simultaneously in preparation, can make the solution alkalize like this, can not separate out pantoprazole, considers that pantoprazole is a sodium salt, and inorganic base addition can not be too many in prescription, so inorganic base is good with sodium hydroxide.
Prescription of the present invention has been reduced to minimum limit through repeatedly experiment with the addition of adjuvant in the prescription.But reach Clinical Application by experiment and confirm that this prescription that contains the adjuvant of minute quantity has good stability, significant change (seeing following table for details) does not take place in color, clarity and content in 4 hours:
| The transfusion title | Standards of pharmacopoeia (pH) | Time | The transfusion pH value | Color | Clarity | Changes of contents (labelled amount meter %) | |
| Before the preparation | After the preparation | ||||||
| 0.9% sodium chloride | 4.5--7.0 | 0 | 6.10 | 9.18 | No significant change | No significant change | 97.6 |
| 1 | 9.15 | No significant change | No significant change | 98.3 | |||
| 2 | 9.15 | No significant change | No significant change | 97.4 | |||
| 3 | 9.13 | No significant change | No significant change | 96.6 | |||
| 4 | 9.10 | No significant change | No significant change | 96.2 | |||
Prescription of the present invention is simple, has overcome because of adjuvant adds the side effect that too much brings, and the patient uses safer; The preparation that is made into simultaneously has better stability.Also the minimizing because of supplementary product consumption reduces production cost of products, is more suitable for industrialized great production.
The present invention also provides a kind of method for preparing freeze-dried powder injection of pantoprazole sodium, may further comprise the steps: take by weighing weak acid strong alkali salt and disodium edetate dissolves with water for injection by recipe quantity, with about inorganic adjusting PH with base to 10.0～10.5, the Pantoprazole Sodium that adds recipe quantity again, add or do not add excipient according to circumstances, continue to add the injection water to prescribed volume, after the coarse filtration with 0.2 μ micropore non-velum filteration, to clarity of solution qualified after, measure content, calculate the about 2ml of every bottled amount, press the freeze-dry process lyophilization after the fill, gland, sealing back packing.
Through check, every index of the freeze-dried powder injection of pantoprazole sodium for preparing with preparation technology of the present invention all meets the requirements.
The specific embodiment
Below in conjunction with embodiment the present invention is done a concrete description.
Embodiment 1
Take by weighing sodium citrate 5.0g, disodium edetate 1.5g dissolves with water for injection, transfer pH to 10.0 with an amount of 1% sodium hydroxide, add 40.0g Pantoprazole Sodium and 5.0g mannitol again, continue to add the injection water to prescribed volume, after the coarse filtration with 0.2 μ micropore non-velum filteration, to clarity of solution qualified after, measure content, calculate the about 2ml of every bottled amount, be distributed into 1000 bottles, press the freeze-dry process lyophilization after the fill, gland, sealing back packing.Every bottle contains Pantoprazole Sodium 40mg.Through check, indicating content is 97.8%, and moisture content is less than 6.0%, and clarity and clarity are all up to specification.
Embodiment 2
Weighing sodium carbonate 3.0g, disodium edetate 1g dissolves with water for injection, transfer pH to 10.4 with an amount of sodium bicarbonate, add the 40.0g Pantoprazole Sodium again, continue to add the injection water to prescribed volume, after the coarse filtration with 0.2 μ micropore non-velum filteration, to clarity of solution qualified after, measure content, calculate the about 2ml of every bottled amount, be distributed into 1000 bottles, press the freeze-dry process lyophilization after the fill, gland, sealing back packing.Every bottle contains Pantoprazole Sodium 40mg.Through check, every index all meets the requirements.
Claims (4)
1. a freeze-dried powder injection of pantoprazole sodium is counted by weight, comprises following component:
1 part of Pantoprazole Sodium
Excipient 0--0.125 part
Weak acid strong alkali salt 0.075--0.125 part
Disodium edetate 0.025--0.0375 part
Inorganic base is an amount of
Wherein Pantoprazole Sodium is by pantoprazole; Excipient is mannitol or glucose or dextran; Weak acid strong alkali salt is sodium citrate or sodium carbonate or potassium citrate or sodium hydrogen phosphate; Inorganic base is sodium hydroxide or sodium bicarbonate or potassium hydroxide;
The preparation method of wherein said freeze-dried powder injection of pantoprazole sodium may further comprise the steps: with weak acid strong alkali salt and disodium edetate dissolving, with inorganic adjusting PH with base to 10.0～10.5; Add Pantoprazole Sodium and excipient, add the injection water, filter to prescribed volume, fill, freezing.
2. freeze-dried powder injection of pantoprazole sodium according to claim 1 is counted by weight, comprises following component:
1 part of Pantoprazole Sodium
0.125 part of excipient
0.125 part of weak acid strong alkali salt
0.0375 part of disodium edetate
Inorganic base is an amount of
Salt is sodium citrate or sodium carbonate or potassium citrate or sodium hydrogen phosphate; Inorganic base is sodium hydroxide or sodium bicarbonate or potassium hydroxide.
3. freeze-dried powder injection of pantoprazole sodium according to claim 1 and 2 is counted by weight, comprises following component:
1 part of Pantoprazole Sodium
0.125 part in mannitol
0.125 part of sodium citrate
0.0375 part of disodium edetate
Sodium hydroxide is an amount of
Wherein Pantoprazole Sodium is by pantoprazole.
4. a method for preparing the described freeze-dried powder injection of pantoprazole sodium of claim 1 may further comprise the steps: with weak acid strong alkali salt and disodium edetate dissolving, with inorganic adjusting PH with base to 10.0～10.5; Add Pantoprazole Sodium and excipient, add the injection water, filter to prescribed volume, fill, freezing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100234698A CN1293879C (en) | 2005-01-20 | 2005-01-20 | Freeze-dried powder injection of pantoprazole sodium and its preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100234698A CN1293879C (en) | 2005-01-20 | 2005-01-20 | Freeze-dried powder injection of pantoprazole sodium and its preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1679563A CN1679563A (en) | 2005-10-12 |
| CN1293879C true CN1293879C (en) | 2007-01-10 |
Family
ID=35066581
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100234698A Active CN1293879C (en) | 2005-01-20 | 2005-01-20 | Freeze-dried powder injection of pantoprazole sodium and its preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1293879C (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101961309B (en) * | 2010-09-15 | 2012-06-27 | 河南辅仁怀庆堂制药有限公司 | Process for preparing pantoprazole sodium for injection |
| CN102000034B (en) * | 2010-10-13 | 2011-12-21 | 江苏奥赛康药业股份有限公司 | S-pantoprazole sodium composite for injection and preparation method thereof |
| CN102225063B (en) * | 2011-05-10 | 2012-10-10 | 江苏奥赛康药业股份有限公司 | Pantoprazole sodium composition for injection |
| CN103271882A (en) * | 2013-05-30 | 2013-09-04 | 瑞阳制药有限公司 | Small-volume pantoprazole sodium freeze-dried powder injection and preparation method and production device thereof |
| CN103301125A (en) * | 2013-06-27 | 2013-09-18 | 海南卫康制药(潜山)有限公司 | Levorotatory pantoprazole sodium composition for injection |
| CN103622921A (en) * | 2013-08-30 | 2014-03-12 | 浙江金华康恩贝生物制药有限公司 | Pantoprazole sodium freeze-dried powder injection used for injection and preparation method thereof |
| CN103550173A (en) * | 2013-10-15 | 2014-02-05 | 海南卫康制药(潜山)有限公司 | Pantoprazole sodium composition freeze-dried powder injection for injection |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1235018A (en) * | 1999-04-22 | 1999-11-17 | 沈阳东宇药业有限公司 | Preparation of freeze-dried pantoprazole injection and preparing method thereof |
| CN1476335A (en) * | 2000-11-22 | 2004-02-18 | ��̹��ҽҩ��˾ | Freeze-dried pantoprazole preparation and pantoprazole injection |
| WO2004080440A1 (en) * | 2003-03-11 | 2004-09-23 | Korea United Pharm, Inc. | Process for the preparing of hardcapsule formulation containing lansoprazole |
-
2005
- 2005-01-20 CN CNB2005100234698A patent/CN1293879C/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1235018A (en) * | 1999-04-22 | 1999-11-17 | 沈阳东宇药业有限公司 | Preparation of freeze-dried pantoprazole injection and preparing method thereof |
| CN1476335A (en) * | 2000-11-22 | 2004-02-18 | ��̹��ҽҩ��˾ | Freeze-dried pantoprazole preparation and pantoprazole injection |
| WO2004080440A1 (en) * | 2003-03-11 | 2004-09-23 | Korea United Pharm, Inc. | Process for the preparing of hardcapsule formulation containing lansoprazole |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1679563A (en) | 2005-10-12 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1293879C (en) | Freeze-dried powder injection of pantoprazole sodium and its preparation | |
| KR101529093B1 (en) | Latanoprost-containing aqueous pharmaceutical composition | |
| PL198132B1 (en) | Moxifloxacin formulation containing common salt | |
| KR20150108430A (en) | Argatroban formulation comprising an acid as solubilizer | |
| JP6388475B2 (en) | Peritoneal dialysis solution containing glucose polymer | |
| KR20130033465A (en) | Medical solution, method for producing and use thereof | |
| KR20090095668A (en) | A forsythoside injection and preparation thereof | |
| CN101810588B (en) | Pantoprazole sodium freeze-drying medicinal composition for injection and preparation method thereof | |
| EP2243477A1 (en) | Paracetamol for parenteral application | |
| US8946161B2 (en) | Method of treatment using stable liquid formulation of G-CSF | |
| JP6629877B2 (en) | Pharmaceutical composition for nasal mucosal administration | |
| CN104840418A (en) | Fasudil hydrochloride injection composition and preparation method thereof | |
| CN1732972A (en) | Dextran for injection and method for preparing the same | |
| CN113730344B (en) | Naproxen preparation for injection and application thereof | |
| CN1663615A (en) | Fructose injection of antibiotic medicine | |
| WO2003068247A1 (en) | Eye installation based on iodine anions | |
| CN105769756A (en) | Sitafloxacin fumarate injection and preparation method thereof | |
| CN1857311A (en) | Blood replacement base solution for blood purification treatment | |
| CN103191054A (en) | Heparin sodium tube sealing injection and preparation method thereof | |
| CN103768011A (en) | Fudosteine injection and preparation method thereof | |
| CN1626081A (en) | Ropivacaine freeze-dried powder and injection preparation in use for injection and preparation method | |
| JP5019923B2 (en) | Pranoprofen-containing pharmaceutical composition | |
| CN1557302A (en) | Carbazochrome Sodium Sulfonate infusion and its preparation method | |
| CN1270702C (en) | Intravenous injection liquid of coenzyme Q10, and its prepn. method | |
| CN1813674A (en) | Sodium vitamin C formulation for intravenous administration and its preparing method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Zhongmei Huadong Pharmaceutical Co., Ltd., Hangzhou Assignor: Hangzhou Huadong Medicine Group Biological Engineering Research Institute Co., Ltd. Contract fulfillment period: 2008.7.5 to 2018.7.5 contract change Contract record no.: 2008330000425 Denomination of invention: Pantoprazole sodium freeze dried injection and preparation method thereof Granted publication date: 20070110 License type: Exclusive license Record date: 2008.9.10 |
|
| LIC | Patent licence contract for exploitation submitted for record |
Free format text: EXCLUSIVE LICENCE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.7.5 TO 2018.7.5 Name of requester: ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. HANGZHO Effective date: 20080910 |
|
| C56 | Change in the name or address of the patentee |
Owner name: NEW DRUG RESEARCH INSTITUTE CO., LTD. OF HANGZHOU Free format text: FORMER NAME: BIOENGINEERING INST. CO., LTD., HANGZHOU EAST-CHINA MEDICINE GROUP |
|
| CP01 | Change in the name or title of a patent holder |
Address after: Hangzhou City, Zhejiang province Gongshu District 310011 Moganshan Road No. 866 Patentee after: HANGZHOU HUADONG MEDICINE GROUP NEW MEDICINE RESEARCH INSTITUTE CO., LTD. Address before: Hangzhou City, Zhejiang province Gongshu District 310011 Moganshan Road No. 866 Patentee before: Hangzhou Huadong Medicine Group Biological Engineering Research Institute Co., Ltd. |
|
| DD01 | Delivery of document by public notice | ||
| DD01 | Delivery of document by public notice |
Addressee: Wang Qiong Document name: Notification of Passing Examination on Formalities |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20170213 Address after: Hangzhou City, Zhejiang province Gongshu District 310011 Moganshan Road No. 866 Patentee after: HANGZHOU HUADONG MEDICINE GROUP NEW MEDICINE RESEARCH INSTITUTE CO., LTD. Patentee after: Zhongmei Huadong Pharmaceutical Co., Ltd., Hangzhou Address before: Hangzhou City, Zhejiang province Gongshu District 310011 Moganshan Road No. 866 Patentee before: HANGZHOU HUADONG MEDICINE GROUP NEW MEDICINE RESEARCH INSTITUTE CO., LTD. |