CN102512418B - Pantoprazole sodium drug composition and preparation method thereof - Google Patents
Pantoprazole sodium drug composition and preparation method thereof Download PDFInfo
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- CN102512418B CN102512418B CN201110398553.3A CN201110398553A CN102512418B CN 102512418 B CN102512418 B CN 102512418B CN 201110398553 A CN201110398553 A CN 201110398553A CN 102512418 B CN102512418 B CN 102512418B
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Abstract
The invention provides a pantoprazole sodium drug composition and a preparation method thereof. The pantoprazole sodium drug composition is characterized by comprising the raw materials in parts by weight as follows: 1 part of pantoprazole sodium, 0.3-0.6 parts of sucrose, 0.005-0.05 parts of metal ion complexing agent and a proper amount of inorganic base. Meanwhile, the invention further provides a preparation method of a pantoprazole sodium freeze-dried powder injection.
Description
Technical field
The present invention relates to pharmaceutical composition of a kind of benzimidazole medicine and preparation method thereof, be specifically related to a kind of Pantoprazole sodium drug composition and preparation method thereof.
Background technology
Pantoprazole Sodium (Pantoprazole Sodium); chemistry 5-difluoro-methoxy-2-[(3 by name; 4-dimethoxy-2-pyridinyl)-methyl]-sulfinyl-1 H-benzimidazole sodium salt; it is a kind of proton pump inhibitor class antiulcerative; be applicable to duodenal ulcer, gastric ulcer AGML, the acutes hemorrhage of upper gastrointestinal tract such as plyability gastric ulcer.
In prior art, existing the relevant of freeze-dried powder injection of pantoprazole sodium reported for work, as used mannitol in CN101229138A, the ratio of its pantoprazole and mannitol is 1:2-5, and mannitol itself has pharmacological action, can improve plasma osmotic pressure, there is dehydration and diuresis, clinically for prophylaxis of acute renal failure and treatment cerebral edema, intracranial hypertension and other various edema, also can be used for treating glaucoma, to reduce intraocular pressure etc., so adding of mannitol may cause that patient produces new pharmacological action and even produces toxic and side effects clinically; And for example in CN1235018A, disclose a kind of technical scheme of injection Pantoprazole Sodium, comprised Pantoprazole Sodium, lyophilized powder proppant, complexing of metal ion agent and pH adjusting agent, parts by weight are 1 part of Pantoprazole Sodium; 1～5 part of lyophilized powder proppant; 0.05～2 part of complexing of metal ion agent.But the injection Pantoprazole Sodium that applicant prepares according to the embodiment recording in its description, not only lyophilizing appearance poor, formability is bad, so that product yield is low, cost increases, the poor stability of medicine especially can cause the clarity of oxidative degradation so that medicine undesirable in high temperature and long-term put procedure simultaneously.
Given this, the invention provides a kind of Pantoprazole sodium drug composition that is different from aforementioned prescription completely, have better stability and less side effect, the yield of product obviously improves simultaneously.
Summary of the invention
Pantoprazole sodium drug composition provided by the invention, pH value is 9.5-11.5, meter comprises by weight:
Wherein Pantoprazole Sodium is by pantoprazole, and pH value is 9.5-11.5.
Pantoprazole sodium drug composition provided by the invention, is preferably: also comprise sodium sulfite 0.01-0.05 weight portion.
Wherein, Pantoprazole Sodium is selected from pantoprazole sodium-hydrate or Pantoprazole Sodium times semihydrate; Complexing of metal ion agent is selected from disodium edetate or calcium disodium edetate or its combination; Inorganic base is selected from sodium hydroxide, potassium hydroxide or sodium bicarbonate etc.
Pantoprazole sodium drug composition provided by the invention, more preferably:
Pharmaceutical composition provided by the invention, can be pharmaceutically acceptable conventional formulation, is preferably freeze-dried powder.
The present invention also provides a kind of preparation method of freeze-dried powder injection of pantoprazole sodium, it is characterized by: by recipe quantity, take sucrose and complexing of metal ion agent is dissolved with water for injection, or by recipe quantity, take sucrose, complexing of metal ion agent and sodium sulfite and dissolve with water for injection, with inorganic adjusting PH with base to 9.5-11.5, the Pantoprazole Sodium that adds again recipe quantity, continue to inject water to prescribed volume, after coarse filtration with 0.2 μ m filtering with microporous membrane, after qualified to clarity of solution, measure content, after fill, press freeze-dry process lyophilization, jump a queue, roll lid, obtain.In prior art, often by perusal solution colour, clarity of solution, investigate the quality of the pharmaceutical preparations, however these evaluation indexes be affected by human factors greatly, and sensitivity is low, subjective factors is larger on the judgement impact of final result.In order to reduce this subjective error as far as possible, the present invention is except adopting the detections such as solution colour, clarity, also adopt the method for ultraviolet detection to evaluate the preparation of difference prescription, improved the sensitivity that preparation detects, can evaluate exactly the quality of different prescriptions.
The injection pantoprazole sodium freeze-drying product outward appearance comparison of test example 1 different dosage of sucroses
Material: Pantoprazole Sodium times semihydrate: import lot number: ACCH002763, Dr.Reddy ' s Laboratories Ltd..
Method and result:
According to table 1 prescription, taking sodium sulfite, disodium edetate, sucrose dissolves with water for injection, with appropriate 1mol/L sodium hydroxide, regulate pH to 11.5, add again Pantoprazole Sodium 3.38g (counting 3.00g with pantoprazole), inject water to prescribed volume, after coarse filtration, with 0.2 μ m filtering with microporous membrane, after qualified to clarity of solution, measure content, every bottled amount 2ml, every bottle of specification is 60mg, 50 bottles of each prescription fills, after fill, press freeze-dry process lyophilization, roll lid, obtain freeze-dried powder.
Table 1: the injection pantoprazole sodium freeze-drying product outward appearance of different sucrose prescriptions
Conclusion:
As seen from the results in Table 1, when sucrose and pantoprazole ratio are 0.3-0.6:1, dried frozen aquatic products outward appearance is better, and product yield is high; When sucrose and pantoprazole ratio are less than 0.3:1, because sucrose concentration is less, cannot play good supporting role, dried frozen aquatic products formability is poor; When sucrose and pantoprazole ratio are during higher than 0.6:1, because sucrose concentration is difficult for more greatly lyophilizing, not only lyophilisation condition is harsh, and energy consumption is very big, and lyophilization cycle is long, and dried frozen aquatic products product is from wall, and formability is poor, and outward appearance is inhomogeneous; Therefore, when sucrose and pantoprazole ratio are during lower than 0.3:1 or higher than 0.6:1, all there will be a large amount of waste products in freeze-drying prods, cause yield to reduce, cost increases.
The injection Pantoprazole Sodium stability comparison of the different sodium sulfite consumptions of test example 2
Material: Pantoprazole Sodium times semihydrate: import lot number: ACCH002763, Dr.Reddy ' s Laboratories Ltd..
Method and result:
According to table 2 prescription, take sodium sulfite, disodium edetate, water for injection 35ml dissolving for sucrose, with appropriate 0.2mol/ml sodium hydroxide, regulate pH to 11.5, then add Pantoprazole Sodium 1.69g (counting 1.50g with pantoprazole), inject water to prescribed volume, after coarse filtration, with 0.2 μ m filtering with microporous membrane, qualified to clarity of solution after, measure content, every bottled amount 2ml, every bottle of specification is 60mg, presses freeze-dry process lyophilization after fill, roll lid, obtain freeze-dried powder.
Table 2: the injection Pantoprazole Sodium prescription of different sodium sulfite consumptions
| Prescription | 1 | 2 | 3 | 4 | 5 | 6 |
| Pantoprazole Sodium (g) | 1.69 | 1.69 | 1.69 | 1.69 | 1.69 | 1.69 |
| Sucrose (g) | 0.675 | 0.675 | 0.675 | 0.675 | 0.675 | 0.675 |
| Disodium edetate (g) | 0.0375 | 0.0375 | 0.0375 | 0.0375 | 0.0375 | 0.0375 |
| Sodium sulfite (g) | 0 | 0.0075 | 0.015 | 0.030 | 0.075 | 0.15 |
Temperatures involved factorial experiments:
Get respectively 1～No. 6 dried frozen aquatic products of above-mentioned prescription and put at 60 ℃ and place 10 days, respectively at 0,5, sampling in 10 days, is configured to the solution of 30mg/ml, carries out UV scanning, the results are shown in accompanying drawing 1,2,3;
Conclusion:
Hot test result shows, along with extend standing time, pantoprazole sodium solution ultraviolet scanning spectrum figure changes, at 300nm～500nm, particularly between 350nm～380nm, absorbance increases, illustrate that product reduces with extending stability standing time, sodium sulfite consumption is different, uv absorption changes different, increase along with sodium sulfite content, the variation of ultraviolet absorptivity reduces, illustrate that the higher preparation stability of sodium sulfite content is better, but collateral security preparation stability and reduce under the prerequisite of supplementary product consumption as far as possible and screen, sodium sulfite consumption is 0.01 to 0.05 part.
The injection Pantoprazole Sodium stability comparison of test example 3 different prescriptions
Material: Pantoprazole Sodium times semihydrate: import lot number: ACCH002763, Dr.Reddy ' s Laboratories Ltd..
Method and result:
Prescription 1: Pantoprazole Sodium 1.69g, sucrose 0.675g, disodium edetate 0.056g, sodium sulfite 0.075g;
Prescription 2: Pantoprazole Sodium 1.69g, mannitol 5.25g, sodium citrate 0.188g;
Prescription 3: Pantoprazole Sodium 1.69g, glucose 5.625g, disodium edetate 0.15g, sodium hydrogen phosphate is appropriate.
According to above-mentioned prescription, take corresponding adjuvant respectively, with water for injection 35ml, dissolve, with appropriate 0.2mol/ml sodium hydroxide, regulate pH to 11.5, the Pantoprazole Sodium 1.69g (in pantoprazole 1.50g) that adds again recipe quantity, inject water to prescribed volume, filtration, fill, lyophilizing, obtain.
Temperatures involved factorial experiments:
1) get respectively 1～No. 3 dried frozen aquatic products of above-mentioned prescription and put at 60 ℃ and place 10 days, respectively at 0,5, sampling in 10 days, is configured to the solution of 30mg/ml, carries out UV scanning, the results are shown in accompanying drawing 4～6;
2) get respectively 1～No. 3 dried frozen aquatic products of above-mentioned prescription and put at 60 ℃ and place 10 days, respectively at 0,5, sampling in 10 days detects clarity, and result 1 dried frozen aquatic products of writing out a prescription is all qualified; 2 dried frozen aquatic products, 1 of the sampling in 5 days of writing out a prescription is defective, and 2 of samplings in 10 days are defective; 3 dried frozen aquatic products 5 days, the 10 days sampling of writing out a prescription all have 2 defective.
Conclusion:
By UV scanning collection of illustrative plates and clarity, checked, all proof prescription 1 is write out a prescription 2,3 stable.
Test example 4: different prescription pantoprazole sodium freeze-drying powder pin study on the stability
Material: Pantoprazole Sodium times semihydrate: import lot number: ACCH002763, Dr.Reddy ' s Laboratories Ltd..
Method and result:
By table 3 prescription, take sodium sulfite, disodium edetate, sucrose respectively and dissolve with water for injection, with appropriate 1mol/L sodium hydroxide adjusting pH to 11.5, then add Pantoprazole Sodium 676.7g (in pantoprazole 600.0g), inject water to prescribed volume, after coarse filtration, with 0.2 μ m filtering with microporous membrane, qualified to clarity of solution after, measure content, every bottled amount 2ml, every bottle of specification is 60mg, presses freeze-dry process lyophilization after fill, roll lid, obtain freeze-dried powder.
Table 3: the injection Pantoprazole Sodium list of ingredients of respectively writing out a prescription
3, get the freeze-dried powder preparing respectively according to above-mentioned prescription and carry out temperatures involved factor and long-term stable experiment:
1) hot test:
Get the freeze-dried powder preparing respectively according to above-mentioned prescription and be placed under 60 ℃ of conditions and place 10 days, respectively at sampling in 0 day, 5 days, 10 days, detect, 30 bottles of every sub-samplings, the results are shown in Table 4,5,6.
Table 4: 0 day testing result of above-mentioned 3 kinds of prescriptions
| Prescription | Outward appearance | Clarity | Have or not vacuum |
| 1 | White loose block | All clarify colourless | All there is vacuum |
| 2 | White loose block | All clarify colourless | All there is vacuum |
| 3 | White loose block | All clarify colourless | All there is vacuum |
| 4 | White loose block | All clarify colourless | All there is vacuum |
| 5 | White loose block | All clarify colourless | All there is vacuum |
| 6 | White loose block | All clarify colourless | All there is vacuum |
| 7 | White loose block | All clarify colourless | All there is vacuum |
| 8 | White loose block | All clarify colourless | All there is vacuum |
| 9 | White loose block | All clarify colourless | All there is vacuum |
Table 5: above-mentioned 3 kinds of prescription high temperature (60 ℃) are placed 5 days result of the tests
Table 6: above-mentioned 3 kinds of prescription high temperature (60 ℃) are placed 10 days result of the tests
Hot test result shows: write out a prescription 3 at hot conditions stability inferior extreme difference, and after 5 days high temperature, the equal atrophy carbonization of all samples in prescription 3; And contrast therewith, in prescription 2, without significant change, in prescription 1, all samples is after high temperature test in 10 days, and sample is unchanged, and outward appearance is white; Clarity testing result shows to write out a prescription, and sample is through high temperature all clarifications in 5 days in 1,2, and after 10 days high temperature, clarity is all qualified, is less than 0.5
#turbidity standard.Explanation is for hot test, and prescription 3 is least stable, and prescription 1,2 is very stable, and to add prescription 1 stability of EDTA and sodium sulfite best.Detect finding, in hot test process, in prescription 3, to occur that atrophy reddens or the sample of carbonization still has vacuum, due to prove and not rolling and leak gas in the process of lid, can be the less stable of prescription itself thus certainly.
2) long-term stable experiment:
Get the freeze-dried powder preparing respectively according to above-mentioned prescription and carry out long-term stable experiment, the results are shown in Table 7 and 8:
Long-term stable experiment result shows, adopt sucrose to add the stability of disodium edetate prescription better whole, especially with sucrose, add the prescription stability of disodium edetate and sodium sulfite best: through 24 months long-time stability, 1～No. 6 sample appearance of writing out a prescription has no significant change, up to specification, write out a prescription 7～No. 9 along with extend standing time, color becomes lightpink; 1～No. 6 sample clarity of writing out a prescription is all qualified, writes out a prescription 7～No. 9 along with extend standing time, engenders clarity failed test sample.
Table 7: the testing result of relevant outward appearance in long-term stable experiment
Table 8: the testing result of relevant clarity in long-term stable experiment
The present invention has removed mannitol, has avoided causing clinically that patient produces new pharmacological action and even produces toxic and side effects.
The present invention writes out a prescription simply, supplementary product consumption seldom, patient uses safer, and product yield increases, and production cost reduces, simultaneously by the invention provides the preparation of writing out a prescription and making, lyophilizing outward appearance is good, and drug quality is stable, especially in high temperature and long-term put procedure, does not occur oxidative degradation phenomenon, product clarity all meets the requirements, and has better stability.
Accompanying drawing explanation
Fig. 1 is that 60 ℃ of different prescription pantoprazole sodium freeze-drying powder pin high temperature are placed 0 day ultraviolet scanning spectrum figure:
The ultraviolet scanning spectrum of curve 1 representative prescription 1;
The ultraviolet scanning spectrum of curve 2 representative prescriptions 2;
The ultraviolet scanning spectrum of curve 3 representative prescriptions 3;
The ultraviolet scanning spectrum of curve 4 representative prescriptions 4;
The ultraviolet scanning spectrum of curve 5 representative prescriptions 5;
The ultraviolet scanning spectrum of curve 6 representative prescriptions 6.
Fig. 2 is that 60 ℃ of different prescription pantoprazole sodium freeze-drying powder pin high temperature are placed 5 days ultraviolet scanning spectrum figure:
The ultraviolet scanning spectrum of curve 1 representative prescription 1;
The ultraviolet scanning spectrum of curve 2 representative prescriptions 2;
The ultraviolet scanning spectrum of curve 3 representative prescriptions 3;
The ultraviolet scanning spectrum of curve 4 representative prescriptions 4;
The ultraviolet scanning spectrum of curve 5 representative prescriptions 5;
The ultraviolet scanning spectrum of curve 6 representative prescriptions 6.
Fig. 3 is that 60 ℃ of different prescription pantoprazole sodium freeze-drying powder pin high temperature are placed 10 days ultraviolet scanning spectrum figure:
The ultraviolet scanning spectrum of curve 1 representative prescription 1;
The ultraviolet scanning spectrum of curve 2 representative prescriptions 2;
The ultraviolet scanning spectrum of curve 3 representative prescriptions 3;
The ultraviolet scanning spectrum of curve 4 representative prescriptions 4;
The ultraviolet scanning spectrum of curve 5 representative prescriptions 5;
The ultraviolet scanning spectrum of curve 6 representative prescriptions 6.
Fig. 4 is that 60 ℃ of different prescription pantoprazole sodium freeze-drying powder pin high temperature are placed 0 day ultraviolet scanning spectrum figure:
The ultraviolet scanning spectrum of curve 1 representative prescription 1;
The ultraviolet scanning spectrum of curve 2 representative prescriptions 2;
The ultraviolet scanning spectrum of curve 3 representative prescriptions 3.
Fig. 5 is that 60 ℃ of different prescription pantoprazole sodium freeze-drying powder pin high temperature are placed 5 days ultraviolet scanning spectrum figure:
The ultraviolet scanning spectrum of curve 1 representative prescription 1;
The ultraviolet scanning spectrum of curve 2 representative prescriptions 2;
The ultraviolet scanning spectrum of curve 3 representative prescriptions 3.
Fig. 6 is that 60 ℃ of different prescription pantoprazole sodium freeze-drying powder pin high temperature are placed 10 days ultraviolet scanning spectrum figure:
The ultraviolet scanning spectrum of curve 1 representative prescription 1;
The ultraviolet scanning spectrum of curve 2 representative prescriptions 2;
The ultraviolet scanning spectrum of curve 3 representative prescriptions 3.
The specific embodiment
Embodiment 1
Take sodium sulfite 3g, disodium edetate 2.4g, sucrose 36g dissolves with water for injection, with appropriate 1mol/L sodium hydroxide, regulate pH to 10, then add pantoprazole sodium-hydrate 60g (in pantoprazole), inject water to prescribed volume, after coarse filtration with 0.2 μ m filtering with microporous membrane, after qualified to clarity of solution, measure content, calculate every bottled amount 2ml, be distributed into 1000 bottles, after fill, press freeze-dry process lyophilization, roll lid, obtain freeze-dried powder.Through check, indices all meets the requirements.
Embodiment 2
Take sodium sulfite 1.2g, disodium edetate 1.0g, sucrose 18g dissolves with water for injection, with appropriate 1mol/L sodium hydroxide, regulate pH to 11.5, then add Pantoprazole Sodium times semihydrate 40g (in pantoprazole), inject water to prescribed volume, after coarse filtration with 0.2 μ m filtering with microporous membrane, after qualified to clarity of solution, measure content, calculate every bottled amount 2ml, be distributed into 1000 bottles, after fill, press freeze-dry process lyophilization, roll lid, obtain freeze-dried powder.Through check, indices all meets the requirements.
Embodiment 3
Take sodium sulfite 1.6g, calcium disodium edetate 0.8g, sucrose 40g dissolves with water for injection, with appropriate 1mol/L sodium hydroxide, regulate pH to 11, then add pantoprazole sodium-hydrate 80g (in pantoprazole), inject water to prescribed volume, after coarse filtration with 0.2 μ m filtering with microporous membrane, after qualified to clarity of solution, measure content, calculate every bottled amount 2ml, be distributed into 1000 bottles, after fill, press freeze-dry process lyophilization, roll lid, obtain freeze-dried powder.Through check, indices all meets the requirements.
Embodiment 4
Take disodium edetate 1.2g, calcium disodium edetate 1.2g, sucrose 18g dissolves with water for injection, with appropriate 1mol/L sodium hydroxide, regulate pH to 10.5, then add Pantoprazole Sodium times semihydrate 60g (in pantoprazole), inject water to prescribed volume, after coarse filtration with 0.2 μ m filtering with microporous membrane, after qualified to clarity of solution, measure content, calculate every bottled amount 2ml, be distributed into 1000 bottles, after fill, press freeze-dry process lyophilization, roll lid, obtain freeze-dried powder.Through check, indices all meets the requirements.
Claims (3)
1. a Pantoprazole sodium drug composition lyophilized injectable powder, counts by weight, composed of the following components:
Wherein Pantoprazole Sodium is by pantoprazole, and pH value is 9.5～11.5.
2. Pantoprazole sodium drug composition lyophilized injectable powder according to claim 1, is characterized by: complexing of metal ion agent is selected from disodium edetate, calcium disodium edetate or its combination, and inorganic base is selected from sodium hydroxide, potassium hydroxide or sodium bicarbonate.
3. Pantoprazole sodium drug composition lyophilized injectable powder according to claim 2, is characterized by: meter by weight, composed of the following components:
Wherein Pantoprazole Sodium is by pantoprazole, and pH value is 9.5～11.5.
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| CN102846559B (en) * | 2012-09-20 | 2014-07-09 | 浙江亚太药业股份有限公司 | Pantoprazole sodium freeze-dry preparation and preparation method thereof |
| CN104910136B (en) * | 2015-06-18 | 2016-04-06 | 海南灵康制药有限公司 | A kind of compound of pantoprazole sodium and preparation thereof adopting particle process crystal product molecule to assemble to prepare with form optimisation technique |
| EP3694322A1 (en) | 2017-10-09 | 2020-08-19 | Terumo BCT Biotechnologies, LLC | Lyophilization container and method of using same |
| EP3938742A1 (en) | 2019-03-14 | 2022-01-19 | Terumo BCT Biotechnologies, LLC | Multi-part lyophilization container and method of use |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1996017607A1 (en) * | 1993-07-17 | 1996-06-13 | Byk Gulden Lomberg Chemische Fabrik Gmbh | Method of producing a pantoprazol lyophilisate |
| 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 |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1996017607A1 (en) * | 1993-07-17 | 1996-06-13 | Byk Gulden Lomberg Chemische Fabrik Gmbh | Method of producing a pantoprazol lyophilisate |
| 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 |
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