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Lansoprazole freeze-dried powder injection for injection and preparation method thereof

A technology for freeze-dried powder injection and lansoprazole, which is applied in the field of lansoprazole freeze-dried powder injection for injection and its preparation, can solve the problem that the product compatibility stability is not good enough, the compatibility stability cannot be satisfied, the clinical application scope is limited and the Ease of use and other issues, to achieve a wide range of clinical use, to avoid the decline in clarity, and to achieve good effects of insoluble particles

Active Publication Date: 2015-04-22
江苏金丝利药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These solutions can solve the problems of clarity and insoluble particles of lansoprazole for injection to a certain extent, but the compatibility stability of the products prepared by it is still not good enough, and it can only be compatible with 0.9% sodium chloride injection clinically It cannot be used in conjunction with commonly used dilution solvents such as 5% glucose injection and sodium lactate Ringer injection, which limits the scope and ease of clinical use of this product
[0005] Chinese patent CN102961344 provides a solution to this problem. Glucose is added as a cosolvent, and lansoprazole for injection is prepared by dissolving with alkali and removing impurities by activated carbon at high temperature. The lansoprazole for injection prepared in this way azole, because the compatibility stability of glucose and 5% glucose injection is better, but it still cannot meet the problem of compatibility stability in sodium lactate Ringer injection

Method used

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  • Lansoprazole freeze-dried powder injection for injection and preparation method thereof
  • Lansoprazole freeze-dried powder injection for injection and preparation method thereof
  • Lansoprazole freeze-dried powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] prescription

[0016]

[0017] Get prescription quantity lansoprazole and put in pressure vessel, add the water for injection of total volume 80%, under the condition that relative pressure is 0.06MPa, heat and regulate water temperature to 105 ℃, stir 0.5 hour, obtain lansoprazole solution, then Add gac of 2% of the total mass of the solution and stir for 2.5 hours, filter with a 0.45 μm microporous membrane under heat preservation conditions, and add 5% sodium hydroxide solution to adjust the pH value to 11.5 at a temperature of 85° C. At room temperature, add the prescribed amount of mannitol and meglumine, and dilute to the full amount with water for injection. Under sterile conditions, filter with a 0.22 μm microporous membrane, fill in a vial, and put a rubber stopper on the vial halfway. , put the plate in the freeze dryer, turn on the freeze dryer, start the compressor, cool the plate layer, set the oil inlet temperature of the heat transfer oil to -40°C, and...

Embodiment 2

[0019] prescription

[0020]

[0021] Get prescription quantity lansoprazole and put in pressure vessel, add the water for injection of 90% of total volume, under the condition that relative pressure is 0.07MPa, heat and regulate water temperature to 110 ℃, stir for 0.5 hour, obtain lansoprazole solution, then add The activated carbon with 3% of the total mass of the solution was stirred for 1.5 hours, filtered with a 0.45 μm microporous membrane under the condition of heat preservation, and the obtained filtrate was adjusted to pH 11.0 by adding 1% sodium hydroxide solution under the condition of heat preservation at 85 ° C, and then lowered to room temperature , add the prescribed amount of mannitol and meglumine, and dilute to the full amount with water for injection. Under sterile conditions, filter it with a 0.22 μm microporous membrane, fill it into a vial, and put a rubber stopper on the vial halfway. Put the plate in the freeze dryer, turn on the freeze dryer, start...

Embodiment 3

[0023] prescription

[0024]

[0025]

[0026] Get prescription quantity lansoprazole and put in pressure vessel, add the water for injection of total volume 84%, under the condition that relative pressure is 0.065MPa, heat and regulate water temperature to 108 ℃, stir for 0.5 hour, obtain lansoprazole solution, then add Activated carbon with 2.6% of the total mass of the solution was stirred for 2.0 hours, filtered with a 0.45 μm microporous membrane under heat preservation conditions, and the obtained filtrate was adjusted to pH 11.3 by adding 0.5% sodium hydroxide solution at a temperature of 79 ° C, and then cooled to room temperature , add the prescribed amount of mannitol and meglumine, and dilute to the full amount with water for injection. Under sterile conditions, filter it with a 0.22 μm microporous membrane, fill it into a vial, and put a rubber stopper on the vial halfway. Put the plate in the freeze dryer, turn on the freeze dryer, start the compressor, cool...

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Abstract

The invention provides a preparation method of a lansoprazole freeze-dried powder injection for injection. The preparation method of the lansoprazole freeze-dried powder injection for injection is characterized by comprising the following steps: taking lansoprazole and adding the lansoprazole into a pressure container, adding injection water, heating and adjusting the temperature of the water to 105 DEG C-110 DEG C under pressurized condition, stirring for 0.5-1 hour to obtain a lansoprazole solution, then adding active carbon counting for 2%-3% of the total mass of the solution to stir for 1.5-2.5 hours, filtering by using a micro-pore filtration membrane with a pore diameter being 0.45 microns under the heat preservation condition to obtain a filtrate, adding alkali into the filtrate under the condition of the heat preservation temperature being 75 DEG C-85 DEG C and adjusting pH value to 11.0-11.5, cooling to the room temperature, adding a recipe amount of mannitol and meglumine and dropwise adding the injection water to reach the full dose, filtering by using a micro-pore filtration membrane with a pore diameter being 0.22 microns under the aseptic condition, filling and carrying out freeze-drying to obtain the lansoprazole freeze-dried powder injection for injection. The injection lansoprazole prepared by the method is relatively good in clarity and insoluble particle and can be used in match with common diluting solvents such as 0.9% sodium chloride injection, 5% glucose injection, sodium lactate injection and the like.

Description

technical field [0001] The invention relates to a lansoprazole freeze-dried powder for injection and a preparation process thereof, belonging to the field of medicines. Background technique [0002] Lansoprazole for injection is a new type of proton pump inhibitor drug, which is mainly used clinically to treat reflux esophagitis, gastric ulcer and duodenal ulcer. The existing prescription composition of lansoprazole for injection mainly includes the main component lansoprazole, freeze-dried excipients, pH regulator, etc., and the most mainstream prescription composition contains lansoprazole, mannitol, meglucosamine amine and sodium hydroxide, wherein mannitol is a freeze-drying excipient, meglumine is a stabilizer, and sodium hydroxide is a pH regulator. After Lansoprazole for Injection is stored for a period of time and used, it is prone to the problems of decreased solution clarity and increased insoluble particles, resulting in substandard product quality and drug safet...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61P1/04A61J3/02
Inventor 金幸汤磊王琰许洁杨应娜
Owner 江苏金丝利药业股份有限公司
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