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Preparation method of lansoprazole freeze-dried powder injection for injection

A technology for freeze-dried powder injection and lansoprazole, applied in the field of drug production, can solve the problems of inability to meet the compatibility stability, product compatibility stability is not good enough, limited clinical use range and ease of use, etc., and achieve a wide clinical use range. , to avoid the decrease of clarity, good effect of insoluble particles

Active Publication Date: 2014-09-03
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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  • Preparation method of lansoprazole freeze-dried powder injection for injection
  • Preparation method of lansoprazole freeze-dried powder injection for injection
  • Preparation method of lansoprazole freeze-dried powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] prescription

[0016]

[0017] Take the prescription amount of lansoprazole and place it in a pressure vessel, add 80% of the total volume of water for injection, under the condition of a relative pressure of 0.06MPa, heat and adjust the water temperature to 105°C, stir for 0.5 hours to obtain a lansoprazole solution, and then Add activated carbon with 2% of the total mass of the solution and stir for 2.5 hours, filter with a 0.45μm microporous membrane under insulation, and adjust the pH to 11.5 by adding 5% sodium hydroxide solution to the filtrate under insulation at 85°C. At room temperature, add the prescribed amount of mannitol and meglumine, and dilute to the full volume with water for injection. Under aseptic conditions, filter with a 0.22μm microporous membrane and fill it in a vial with a rubber stopper. , Put the plate into the freeze dryer, turn on the freeze dryer, start the compressor, cool the slab, set the heat transfer oil inlet temperature to -40 ℃, and k...

Embodiment 2

[0019] prescription

[0020]

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

Embodiment 3

[0023] prescription

[0024]

[0025]

[0026] Take the prescription amount of lansoprazole and place it in a pressure vessel, add 84% of the total volume of water for injection, heat and adjust the water temperature to 108°C under the condition of a relative pressure of 0.065MPa, stir for 0.5 hours to obtain a lansoprazole solution, and then add it The total mass of the solution is 2.6% activated carbon, stirred for 2.0 hours, filtered with a 0.45μm microporous membrane under the insulation condition, and the filtrate obtained is adjusted to pH 11.3 with 0.5% sodium hydroxide solution under the insulation condition at 79°C, and then lowered to room temperature , Add the prescribed amount of mannitol and meglumine, and dilute to the full volume with water for injection, under sterile conditions, filter with a 0.22μm microporous membrane, fill it in a vial, add a rubber stopper to the vial, Put the plate into the freeze dryer, turn on the freeze dryer, start the compressor, cool t...

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PUM

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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 preparation process of lansoprazole freeze-dried powder injection for injection, which belongs to the technical field of medicine production. Background technique [0002] Lansoprazole for injection is a new type of proton pump inhibitor drugs, 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 ingredient lansoprazole, freeze-dried excipients, pH regulators, etc. The most mainstream prescription composition contains lansoprazole, mannitol, and meglumine Amine and sodium hydroxide, of which mannitol is a lyophilized excipient, meglumine is a stabilizer, and sodium hydroxide is a pH regulator. Lansoprazole for injection after being stored for a period of time is prone to problems such as decreased solution clarity and increased insoluble particles, resulting in unqualified product quality and dru...

Claims

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Application Information

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Patent Type & Authority Applications(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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