CN102920703B - Preparation method for lansoprazole for injection - Google Patents
Preparation method for lansoprazole for injection Download PDFInfo
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- CN102920703B CN102920703B CN 201110399277 CN201110399277A CN102920703B CN 102920703 B CN102920703 B CN 102920703B CN 201110399277 CN201110399277 CN 201110399277 CN 201110399277 A CN201110399277 A CN 201110399277A CN 102920703 B CN102920703 B CN 102920703B
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Abstract
The invention relates to a preparation method for lansoprazole for injection. The preparation method comprises the following steps: preparing 431 ml of a 0.2 N sodium hydroxide solution, weighing 30 g of micronized lansoprazole, adding the micronized lansoprazole to the prepared 0.2 N sodium hydroxide solution under nitrogen gas protection, and stirring until the micronized lansoprazole is completely dissolved; weighing 10 g of meglumine, adding 100 ml of medical injection water, and stirring until the meglumine is completely dissolved to obtain an intermediate solution 2; and weighing 60 g of mannitol and 2 g of disodium edentate, adding 800 ml of medical injection water, and stirring until the mannitol and the disodium edentate are completely dissolved to obtain an intermediate solution 3. A purpose of the present invention is to provide a preparation method for lansoprazole for injection, wherein the preparation method has characteristics of simple and safe operation, reasonable process conditions, low process cost, short production time, high production efficiency, no three waste pollution, equipment saving, energy saving, labor saving and field saving, and the produced drug liquid has a good clarity.
Description
Technical field
The present invention relates to a kind of preparation method of Lansoprazole for injecting.
Background technology
In the preparation method of existing Lansoprazole for injecting, it operates more complicated, and process costs is higher, and it is longer to produce the used time, and production efficiency is lower, device therefor, the energy, artificial and the place is more.In addition, the preparation method of existing Lansoprazole for injecting exists that lansoprazole is oxidized, can produce the problem such as a certain amount of precipitation in the medicinal liquid, causes the clarity of medicinal liquid relatively poor.
Summary of the invention
The object of the present invention is to provide a kind of simple to operate, safety, process conditions are reasonable, and process costs is low, produce used time weak point, production efficiency is high, three-waste free pollution, saving equipment, the energy, artificial and place, the preparation method of the better Lansoprazole for injecting of clarity of the medicinal liquid of producing.
The preparation method of Lansoprazole for injecting of the present invention comprises the steps:
The sodium hydroxide solution 431ml of A, preparation 0.2N, take by weighing micronized lansoprazole 30g, be under 8 ℃-12 ℃ the condition in temperature, in nitrogen protection, it joined and be stirred to micronized lansoprazole in the 0.2N sodium hydroxide solution of preparation and dissolve a solution in the middle of obtaining fully;
B, take by weighing the meglumine of 10g, add water for injection 100ml and be stirred to meglumine and dissolve two solution in the middle of obtaining fully;
C, the mannitol that takes by weighing 60g and 2g disodium edetate, adding water for injection 800ml is stirred to mannitol and disodium edetate dissolves fully, three solution in the middle of obtaining;
D, first middle two solution and middle three solution are mixed, in the mixed liquor of two solution and middle three solution, add again water for injection 1100ml in the middle of a middle solution being joined, can get pending medicinal liquid;
E, in the pending medicinal liquid that step D obtains, add 3 ‰ needle-use activated carbons, and stirred 15-25 minute, then medicinal liquid is carried out decarbonization filtering;
F, the medicinal liquid that step e is obtained adopt the microporous filter membrane of 0.45 μ m to carry out coarse filtration;
G, the medicinal liquid that step F is obtained adopt ultrafilter membrane to carry out ultrafiltration;
H, the medicinal liquid that step G is obtained adopt the microporous filter membrane of 0.22 μ m to carry out the degerming filtration;
I, medicinal liquid sampling and measuring lansoprazole content, clarity and acidity-basicity ph that step H is obtained are controlled at pH value between 10.4～12.0 with the sodium hydroxide solution of 0.2N;
After J, medicinal liquid sampling and measuring lansoprazole content, clarity and the acidity-basicity ph passed examination, medicinal liquid is sub-packed in the tubular injection bottle of 10ml specification, then every bottled 2.0ml utilizes plug to cover the entrance of tubular injection bottle with tamponade state not, and plug is lyophilization peritoneum plug;
K, the tubular injection bottle of medicinal liquid will be housed under subzero 30 ℃-subzero 38 ℃ of conditions, kept 3-5 hour, then be warming up to gradually subzero 6 ℃-subzero 10 ℃, under the condition of relative vacuum degree 10-15pa dry 9 hours, be warming up to gradually again 30 ℃-38 ℃, under the condition of relative vacuum degree 10-15pa dry 5-9 hour, then the tubular injection bottle that medicinal liquid is housed is carried out tamponade, rolls lid, lamp inspection, packing obtains Lansoprazole for injecting.
The preparation method of Lansoprazole for injecting of the present invention, the temperature of the sodium hydroxide solution of preparation 0.2N is 10 ℃ in the described steps A; The tubular injection bottle of medicinal liquid will be housed in the described step K under subzero 35 ℃ of conditions, kept 4 hours, and then be warming up to gradually subzero 8 ℃, drying is 9 hours under the condition of relative vacuum degree 13.3pa, be warming up to gradually 35 ℃, drying is 7 hours under the condition of relative vacuum degree 13.3pa again.
The preparation method of Lansoprazole for injecting of the present invention; it adopts unique processing step, adopts micronized lansoprazole, can improve dissolution velocity; reduce the activity duration; increase work efficiency, owing to be in nitrogen protection, to dissolve lansoprazole, can prevent that lansoprazole is oxidized; improve the quality of product; and adopt ultrafilter membrane to carry out ultrafiltration, and medicinal liquid can not produce precipitation after the ultrafiltration, and clarity is better.Therefore, the preparation method of Lansoprazole for injecting of the present invention has simple to operate, safety, and process conditions are reasonable, process costs is low, produces used time weak point, and production efficiency is high, three-waste free pollution, saving equipment, the energy, artificial and place, the better characteristics of the clarity of the medicinal liquid of producing.
The below is described further the preparation method of Lansoprazole for injecting of the present invention.
The specific embodiment
Embodiment 1
The preparation method of Lansoprazole for injecting of the present invention comprises the steps:
The sodium hydroxide solution 431ml of A, preparation 0.2N, the sodium hydroxide solution 431ml of 0.2mol/L namely, take by weighing micronized lansoprazole 30g, be under 8 ℃-12 ℃ the condition in temperature, in nitrogen protection, it is joined and be stirred to micronized lansoprazole in the 0.2N sodium hydroxide solution of preparation and dissolve a solution in the middle of obtaining fully; Adopt micronized lansoprazole can improve dissolution velocity, reduce the activity duration, increase work efficiency; In nitrogen protection, dissolve lansoprazole, can prevent that lansoprazole is oxidized, improve the quality of product;
B, take by weighing the meglumine of 10g, add water for injection 100ml and be stirred to meglumine and dissolve two solution in the middle of obtaining fully;
C, the mannitol that takes by weighing 60g and 2g disodium edetate, adding water for injection 800ml is stirred to mannitol and disodium edetate dissolves fully, three solution in the middle of obtaining;
D, first middle two solution and middle three solution are mixed, in the mixed liquor of two solution and middle three solution, add again water for injection 1100ml in the middle of a middle solution being joined, can get pending medicinal liquid;
E, in the pending medicinal liquid that step D obtains, add 3 ‰ needle-use activated carbons, and stirred 15-25 minute, then medicinal liquid is carried out decarbonization filtering;
F, the medicinal liquid that step e is obtained adopt the microporous filter membrane of 0.45 μ m to carry out coarse filtration;
G, the medicinal liquid that step F is obtained adopt ultrafilter membrane to carry out ultrafiltration; Medicinal liquid can not produce precipitation after the ultrafiltration, and clarity is better;
H, the medicinal liquid that step G is obtained adopt the microporous filter membrane of 0.22 μ m to carry out the degerming filtration;
I, medicinal liquid sampling and measuring lansoprazole content, clarity and acidity-basicity ph that step H is obtained are controlled at pH value between 10.4～12.0 with the sodium hydroxide solution of 0.2N;
After J, medicinal liquid sampling and measuring lansoprazole content, clarity and the acidity-basicity ph passed examination, medicinal liquid is sub-packed in the tubular injection bottle of 10ml specification, then every bottled 2.0ml utilizes plug to cover the entrance of tubular injection bottle with tamponade state not, and plug is lyophilization peritoneum plug;
K, the tubular injection bottle of medicinal liquid will be housed under subzero 30 ℃-subzero 38 ℃ of conditions, kept 3-5 hour, then be warming up to gradually subzero 6 ℃-subzero 10 ℃, drying is 9 hours under the condition of relative vacuum degree 10-15pa, is warming up to gradually 30 ℃-38 ℃ again, under the condition of relative vacuum degree 10-15pa dry 5-9 hour, then the tubular injection bottle that medicinal liquid is housed is carried out tamponade, roll lid, lamp inspection, packing obtains Lansoprazole for injecting.
The temperature of the sodium hydroxide solution of preparation 0.2N is preferably 10 ℃ among the above-mentioned steps A; The tubular injection bottle of medicinal liquid preferably will be housed among the above-mentioned steps K under subzero 35 ℃ of conditions, kept 4 hours, and then be warming up to gradually subzero 8 ℃, drying is 9 hours under the condition of relative vacuum degree 13.3pa, be warming up to gradually 35 ℃, drying is 7 hours under the condition of relative vacuum degree 13.3pa again.
Embodiment recited above is described preferred implementation of the present invention; be not that scope of the present invention is limited; design under the spiritual prerequisite not breaking away from the present invention; various distortion and improvement that the common engineers and technicians in this area make technical solution of the present invention all should fall in the definite protection domain of claims of the present invention.
Claims (1)
1. the preparation method of Lansoprazole for injecting is characterized in that comprising the steps:
The sodium hydroxide solution 431ml of A, preparation 0.2N, take by weighing micronized lansoprazole 30g, be under 8 ℃-12 ℃ the condition in temperature, in nitrogen protection, it joined and be stirred to micronized lansoprazole in the 0.2N sodium hydroxide solution of preparation and dissolve a solution in the middle of obtaining fully;
The temperature of the sodium hydroxide solution of preparation 0.2N is 10 ℃ in the described steps A;
B, take by weighing the meglumine of 10g, add medical used injection water 100ml and be stirred to meglumine and dissolve two solution in the middle of obtaining fully;
C, the mannitol that takes by weighing 60g and 2g disodium edetate, adding medical used injection water 800ml is stirred to mannitol and disodium edetate dissolves fully, three solution in the middle of obtaining;
D, first middle two solution and middle three solution are mixed, in the mixed liquor of two solution and middle three solution, add again medical used injection water 1100ml in the middle of a middle solution being joined, can get pending medicinal liquid;
E, in the pending medicinal liquid that step D obtains, add 3 ‰ needle-use activated carbons, and stirred 15-25 minute, then medicinal liquid is carried out decarbonization filtering;
F, the medicinal liquid that step e is obtained adopt the microporous filter membrane of 0.45 μ m to carry out coarse filtration;
G, the medicinal liquid that step F is obtained adopt ultrafilter membrane to carry out ultrafiltration;
H, the medicinal liquid that step G is obtained adopt the microporous filter membrane of 0.22 μ m to carry out the degerming filtration;
I, medicinal liquid sampling and measuring lansoprazole content, clarity and acidity-basicity ph that step H is obtained, the sodium hydroxide solution of 0.2N is regulated pH value is controlled between 10.4～12.0;
After J, medicinal liquid sampling and measuring lansoprazole content, clarity and the acidity-basicity ph passed examination, medicinal liquid is sub-packed in the tubular injection bottle of 10ml specification, then every bottled 2.0ml utilizes plug to cover the entrance of tubular injection bottle with tamponade state not, and plug is lyophilization peritoneum plug;
K, the tubular injection bottle of medicinal liquid will be housed under subzero 30 ℃-subzero 38 ℃ of conditions, kept 3-5 hour, then be warming up to gradually subzero 6 ℃-subzero 10 ℃, drying is 9 hours under the condition of relative vacuum degree 10-15pa, be warming up to gradually again 30 ℃-38 ℃, under the condition of relative vacuum degree 10-15pa dry 5-9 hour;
The tubular injection bottle of medicinal liquid will be housed in the described step K under subzero 35 ℃ of conditions, kept 4 hours, and then be warming up to gradually subzero 8 ℃, drying is 9 hours under the condition of relative vacuum degree 13.3pa, be warming up to gradually 35 ℃, drying is 7 hours under the condition of relative vacuum degree 13.3pa again;
Then the tubular injection bottle that medicinal liquid is housed is carried out tamponade, roll lid, lamp inspection, packing obtains Lansoprazole for injecting.
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| CN 201110399277 CN102920703B (en) | 2011-12-06 | 2011-12-06 | Preparation method for lansoprazole for injection |
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| CN 201110399277 CN102920703B (en) | 2011-12-06 | 2011-12-06 | Preparation method for lansoprazole for injection |
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| CN102920703B true CN102920703B (en) | 2013-05-29 |
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| CN103271884B (en) * | 2013-06-28 | 2015-12-09 | 悦康药业集团有限公司 | Lansoprazole composition and preparation method thereof |
| CN112353766A (en) * | 2020-10-27 | 2021-02-12 | 马鞍山丰原制药有限公司 | Lansoprazole lyophilized preparation and preparation method thereof |
| CN113069421A (en) * | 2021-03-29 | 2021-07-06 | 海南锦瑞制药有限公司 | Lansoprazole for injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1709248A (en) * | 2005-06-02 | 2005-12-21 | 江苏奥赛康药业有限公司 | Lansoprazole lyophilized powder injection and its preparing method |
| CN101057846A (en) * | 2006-04-17 | 2007-10-24 | 上海秀新臣邦医药科技有限公司 | Lansoprazole for injecting and its preparation method |
| CN100506213C (en) * | 2008-01-18 | 2009-07-01 | 山东罗欣药业股份有限公司 | Lansoprazole freeze-dried powder for injection and preparing method thereof |
| CN101502493A (en) * | 2009-03-23 | 2009-08-12 | 悦康药业集团有限公司 | Method for preparing lansoprazole freeze-dried injection for injection |
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Address after: 100176 No. 6, Hongda Middle Road, Beijing economic and Technological Development Zone, Beijing Patentee after: Yuekang Pharmaceutical Group Co., Ltd. Address before: 100176 No. 6, Hongda Middle Road, Beijing economic and Technological Development Zone, Beijing Patentee before: YOUCARE PHARMACEUTICAL GROUP CO., LTD. |
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