CN102961344A - Lansoprazole lyophilized powder injection and preparation method thereof - Google Patents
Lansoprazole lyophilized powder injection and preparation method thereof Download PDFInfo
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- CN102961344A CN102961344A CN 201210426380 CN201210426380A CN102961344A CN 102961344 A CN102961344 A CN 102961344A CN 201210426380 CN201210426380 CN 201210426380 CN 201210426380 A CN201210426380 A CN 201210426380A CN 102961344 A CN102961344 A CN 102961344A
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- lansoprazole
- injection
- sodium hydroxide
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Abstract
The invention discloses a lansoprazole lyophilized powder injection and a preparation method thereof. The lansoprazole lyophilized powder injection is prepared from lansoprazole, glucose, mannitol and sodium hydroxide, and overcomes the shortcomings of low main drug content and high impurity of the existing lansoprazole. The invention has simple preparation process, and the obtained lansoprazole for injection has good stability, high safety, and great value in development and utilization in clinics.
Description
Technical field
The invention belongs to medical technical field.Relate to a kind of proton pump inhibitor class medicine, be a kind of lansoprazole freeze-dried injection for injection in particular, the lansoprazole freeze-dried injection for injection of this invention preparation can be used for treating reflux esophagitis, gastric ulcer, duodenal ulcer etc. clinically.
Background technology
Lansoprazole (lansoprazole) is in the world second proton pump inhibitor antiulcerative that omeprazole (Omerpazole) is developed by Wu Tian company afterwards.Put on market in 1992, get permission listing in the U.S. in June, 2004.The lansoprazole construction features is the substituted benzimidazole chemical compound that imports fluorine element in the side chain, because the importing of fluorine element, thereby so that showing, lansoprazole has higher bioavailability and stronger proton pump inhibitory action.
Lansoprazole is by suppressing gastric mucosa parietal cell proton pump, reach to suppress H
+, K
+The activity of-ATP enzyme, thereby constantly gastric acid inhibitory and pepsic secretion.According to the in recent years result of study demonstration of peptic ulcer, lansoprazole is at the omeprazole that obviously is better than at present clinical extensive employing aspect the treatment duodenal ulcer.It is reliable for effect that lansoprazole presses down acid, and safety coefficient is large, is a kind of proton pump inhibitor of new generation with wide future.
Common lansoprazole dosage form is tablet, capsule etc. in the market, and few freeze-dried powder is also arranged.The inventor finds that in actual production process visible foreign matters and the rear crystallize that redissolves are the thorny problems that affects lansoprazole stability and dissolubility.Disclosed many documents have the report for this respect now, and the patent record was arranged in the past, can solve the stability of preparation and the problem of dissolubility by interpolation cosolvent meglumine, Polyethylene Glycol, and solubility are good.But the problem that in middle trial production process, still has visible foreign matters.The Lansoprazole for injecting that the present invention obtains on the basis of a large amount of experiments, impurity is few, and good stability is safe, even room temperature is preserved, quality is also reliable.
Summary of the invention
In order to overcome the defects of prior art, a kind of stable Lansoprazole for injecting is provided, the inventor selects glucose can guarantee that as cosolvent preparation visible foreign matters and particulate matter meet the Lansoprazole composition of injection requirement by a large amount of tests.
A kind of Lansoprazole freeze-dried powder for injection pin of the present invention and preparation method thereof is characterized in that, described freeze-dried powder component is: lansoprazole, glucose, mannitol, sodium hydroxide, its three's ratio is 3～7.5:3～7.5:1:2.
Lansoprazole freeze-dried powder for injection pin of the present invention, the preferred ratio of each component is 4:4:1:2.
A kind of Lansoprazole freeze-dried powder for injection pin of the present invention and preparation method thereof is characterized in that the method comprises the steps:
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2), the lansoprazole, glucose, the mannitol that take by weighing recipe quantity is dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and be stirred to entirely molten;
(3), add medicine liquid volume 1 ‰ (m/v) active carbon, about 80 ℃ stirrings of constant temperature 30 minutes;
(4), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(5), the intermediate pick test, determine the fill loading amount according to survey content;
(6), cillin bottle and plug are processed (by the rule of operation operation);
(7), fill, partly jump a queue;
(8), the semi-finished product that install are put into the freeze dryer drying;
(9), tamponade, outlet, Zha Gai, semi-finished product pick test;
(10), pack warehouse-in.
Lansoprazole freeze-dried powder for injection pin preparation method of the present invention is characterized in that pH value is 11-12.5.
Lansoprazole freeze-dried powder for injection pin preparation method of the present invention, preferred PH is 11-11.5.
The Lansoprazole for injecting of the present invention program's gained has the following advantages:
1, preparation component of the present invention is simple, and impurity is few, and drug content is high, and is safe;
2, this product is freeze-dried powder, absorbs soon, and is remarkable for disease serious patient's effect;
3, this product preparation raw material is easy to get, and becomes to produce cost low;
4, this product good stability, even room temperature is preserved, quality is also reliable.
The specific embodiment
Below enforcement only for more detailed description the present invention, but do not limit in any form the present invention.
Be guarantee test result's concordance, the embodiment of the invention has been used identical raw material, adjuvant, cillin bottle and plug, and has adopted one freeze drying process to prepare Lansoprazole for injecting.
The lansoprazole of reference examples 1 preparation injection
Prescription:
Lansoprazole 40g
Glucose 40g
Mannitol 10g
Sodium hydroxide 20g
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2) lansoprazole, glucose, the mannitol that take by weighing recipe quantity are dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and are stirred to entirely molten;
(3), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(4), the intermediate pick test, determine the fill loading amount according to survey content;
(5), cillin bottle and plug are processed (by the rule of operation operation);
(6), fill, partly jump a queue;
(7), the semi-finished product that install are put into the freeze dryer drying;
(8), tamponade, outlet, Zha Gai, semi-finished product pick test;
(9), pack warehouse-in.
The lansoprazole of reference examples 2 preparation injections
Prescription:
Lansoprazole 40g
Glucose 50g
Mannitol 10g
Sodium hydroxide 20g
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2) lansoprazole, glucose, the mannitol that take by weighing recipe quantity are dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and are stirred to entirely molten;
(3), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(4), the intermediate pick test, determine the fill loading amount according to survey content;
(5), cillin bottle and plug are processed (by the rule of operation operation);
(6), fill, partly jump a queue;
(7), the semi-finished product that install are put into the freeze dryer drying;
(8), tamponade, outlet, Zha Gai, semi-finished product pick test;
(9), pack warehouse-in.
The lansoprazole of reference examples 3 preparation injections
Prescription:
Lansoprazole 40g
Glucose 60g
Mannitol 10g
Sodium hydroxide 20g
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2) lansoprazole, glucose, the mannitol that take by weighing recipe quantity are dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and are stirred to entirely molten;
(3), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(4), the intermediate pick test, determine the fill loading amount according to survey content;
(5), cillin bottle and plug are processed (by the rule of operation operation);
(6), fill, partly jump a queue;
(7), the semi-finished product that install are put into the freeze dryer drying;
(8), tamponade, outlet, Zha Gai, semi-finished product pick test;
(9), pack warehouse-in.
The lansoprazole of reference examples 4 preparation injections
Prescription:
Lansoprazole 40g
Glucose 70g
Mannitol 10g
Sodium hydroxide 20g
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2) lansoprazole, glucose, the mannitol that take by weighing recipe quantity are dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and are stirred to entirely molten;
(3), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(4), the intermediate pick test, determine the fill loading amount according to survey content;
(5), cillin bottle and plug are processed (by the rule of operation operation);
(6), fill, partly jump a queue;
(7), the semi-finished product that install are put into the freeze dryer drying;
(8), tamponade, outlet, Zha Gai, semi-finished product pick test;
(9), pack warehouse-in.
The lansoprazole of reference examples 5 preparation injections
Prescription:
Lansoprazole 40g
Glucose 75g
Mannitol 10g
Sodium hydroxide 20g
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2) lansoprazole, glucose, the mannitol that take by weighing recipe quantity are dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and are stirred to entirely molten;
(3), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(4), the intermediate pick test, determine the fill loading amount according to survey content;
(5), cillin bottle and plug are processed (by the rule of operation operation);
(6), fill, partly jump a queue;
(7), the semi-finished product that install are put into the freeze dryer drying;
(8), tamponade, outlet, Zha Gai, semi-finished product pick test;
(9), pack warehouse-in.
The lansoprazole of reference examples 6 preparation injections
Prescription:
Lansoprazole 40g
Glucose 75g
Mannitol 10g
Sodium hydroxide 20g
Water for injection adds to 1000ml
Add medicine liquid volume 1 ‰ (m/v) active carbon, about 80 ℃ stirrings of constant temperature 30 minutes;
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2) lansoprazole, glucose, the mannitol that take by weighing recipe quantity are dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and are stirred to entirely molten;
(3), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(4), the intermediate pick test, determine the fill loading amount according to survey content;
(5), cillin bottle and plug are processed (by the rule of operation operation);
(6), fill, partly jump a queue;
(7), the semi-finished product that install are put into the freeze dryer drying;
(8), tamponade, outlet, Zha Gai, semi-finished product pick test;
(9), pack warehouse-in.
Claims (5)
1. Lansoprazole freeze-dried powder for injection pin and preparation method thereof is characterized in that, described freeze-dried powder component is: lansoprazole, glucose, mannitol, sodium hydroxide, its three's ratio is 3～7.5:3～7.5:1:2.
2. Lansoprazole freeze-dried powder for injection pin according to claim 1, the preferred ratio of each component is 4:4:1:2.
3. a kind of Lansoprazole freeze-dried powder for injection pin according to claim 1 and preparation method thereof is characterized in that the method comprises the steps:
(1), take by weighing the water for injection that the recipe quantity sodium hydroxide dissolves in new system, the sodium hydroxide solution that is mixed with about 2% is for subsequent use;
(2), the lansoprazole, glucose, the mannitol that take by weighing recipe quantity is dissolved in the new system water for injection of full dose 80%, add above-mentioned sodium hydroxide solution and be stirred to entirely molten;
(3), add medicine liquid volume 1 ‰ (m/v) active carbon, about 80 ℃ stirrings of constant temperature 30 minutes;
(4), coarse filtration, filter out active carbon with husky filter stick; Fine straining filters with 0.22 μ m accurate filter;
(5), the intermediate pick test, determine the fill loading amount according to survey content;
(6), cillin bottle and plug are processed (by the rule of operation operation);
(7), fill, partly jump a queue;
(8), the semi-finished product that install are put into the freeze dryer drying;
(9), tamponade, outlet, Zha Gai, semi-finished product pick test;
(10), pack warehouse-in.
4. Lansoprazole freeze-dried powder for injection pin preparation method according to claim 3 is characterized in that pH value is 11-12.5.
5. Lansoprazole freeze-dried powder for injection pin preparation method according to claim 3, preferred PH is 11-11.5.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210426380 CN102961344A (en) | 2012-10-31 | 2012-10-31 | Lansoprazole lyophilized powder injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210426380 CN102961344A (en) | 2012-10-31 | 2012-10-31 | Lansoprazole lyophilized powder injection and preparation method thereof |
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| CN102961344A true CN102961344A (en) | 2013-03-13 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103230373A (en) * | 2013-04-12 | 2013-08-07 | 沈阳双鼎制药有限公司 | Dexlansoprazole freeze-drying powder for injection and preparation method thereof |
-
2012
- 2012-10-31 CN CN 201210426380 patent/CN102961344A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103230373A (en) * | 2013-04-12 | 2013-08-07 | 沈阳双鼎制药有限公司 | Dexlansoprazole freeze-drying powder for injection and preparation method thereof |
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Application publication date: 20130313 |