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Lansoprazole lyophilized powder for injection and preparation method

A technology of freeze-dried powder injection and lansoprazole, which is applied in the field of medicine and can solve problems such as increasing adverse reactions

Inactive Publication Date: 2012-11-21
HUBEI HOPE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This prescription process has similar problems with the Japanese patent JP 2005200409 (A), and the increased sodium bisulfite will also increase the adverse reactions in clinical use

Method used

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  • Lansoprazole lyophilized powder for injection and preparation method
  • Lansoprazole lyophilized powder for injection and preparation method
  • Lansoprazole lyophilized powder for injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Take by weighing 3.5 parts of sodium hydroxide, first add water for injection to dissolve and make a solution of about 1% (g / ml); take by weighing 30 parts of lansoprazole, add lansoprazole in the above-mentioned sodium hydroxide solution under stirring , stir to make the solution clear, and take by weighing 70 parts of mannitol and 100 parts of tromethamine respectively in addition, join in the lansoprazole solution, stir and make dissolving, supplement water for injection to 2000 parts, add 5 parts of activated carbon, stir for 30 minutes, Filtration to remove charcoal, the liquid medicine is finely filtered through a 0.45μm microporous membrane until it is clear, and the content and pH value are determined to be 10.9 (adjusted with 0.1mol / L sodium hydroxide or hydrochloric acid solution if necessary), and then passed through the second stage The combined filtration system of 0.22μm microporous membrane performs sterile filtration on the liquid medicine. Under aseptic...

Embodiment 2

[0099] Take by weighing 3.3 parts of sodium hydroxide, first add water for injection to dissolve and make a solution of about 1% (g / ml); take by weighing 30 parts of lansoprazole, add lansoprazole in the above-mentioned sodium hydroxide solution under stirring , stirred to make the solution clear, and another 200 parts of trometamol was weighed, added to the lansoprazole solution, stirred to dissolve, supplemented with water for injection to 2000 parts, added 10 parts of activated carbon, stirred for 30 minutes, filtered to remove carbon, and the medicine The liquid is finely filtered through a 0.45μm microporous membrane until it is clear, and the content and pH value are determined to be 10.5 (adjusted with 0.1mol / L sodium hydroxide or hydrochloric acid solution if necessary), and then passed through a secondary 0.22μm micropore The combined filtration system of the filter membrane performs sterile filtration on the liquid medicine. Under aseptic conditions, the above-mentio...

Embodiment 3

[0102] Take by weighing 4.5 parts of sodium hydroxide, first add water for injection to dissolve and make a solution of about 1% (g / ml); take by weighing 30 parts of lansoprazole, add lansoprazole in the above-mentioned sodium hydroxide solution under stirring , stir to make the solution clear, and take by weighing 160 parts of mannitol and 10 parts of tromethamine respectively in addition, join in the lansoprazole solution, stir and make dissolving, supplement water for injection to 2000 parts, add 1 part of activated carbon, stir for 30 minutes, Filtration to remove charcoal, the liquid medicine is finely filtered through a 0.45 μm microporous membrane until it is clear, and the content and pH value are determined to be 12 (adjust with 0.1mol / L sodium hydroxide or hydrochloric acid solution if necessary), and then pass through the secondary The combined filtration system of 0.22μm microporous membrane performs sterile filtration on the liquid medicine. Under aseptic conditio...

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Abstract

The invention discloses lansoprazole lyophilized powder for injection and a preparation method. The powder is prepared from the following raw materials: lansoprazole, solubilizer and a stabilizing agent. The preparation method comprises the following steps: (a) preparation of a lansoprazole sterile solution, which comprises the steps of weighing sodium hydroxide, dissolving in water for injection, stirring, adding activated carbon and filtering out carbon to prepare the sterile solution; and (b) preparation of the lansoprazole lyophilized powder for injection, which comprises the steps of: (1) subpackaging: subpackaging the sterile solution into sterilized penicillin bottles in an aseptic condition; (2) pre-freezing: balancing the subpackaged medicinal solution in a lyophilizer and cooling so that the liquor medicine is solidified into solid state; (3) lyophilisation: vacuumizing by using a vapor condenser, heating and controlling the temperature of the medicament; (4) re-drying: controlling the temperature of the medicament and drying under the condition of heat insulation; and (5) plugging and capping after lyophilisation is completed. The lansoprazole lyophilized powder has good effect and few insoluble particles, can be compatible with more injections in clinical application without generating precipitates. The lansoprazole lyophilized powder can be used for treating reflux esophagitis, gastric ulcer and duodenal ulcer.

Description

technical field [0001] The invention belongs to the technical field of medicine. More specifically relate to a kind of lansoprazole freeze-dried powder injection, also relate to a kind of preparation method of lansoprazole freeze-dried powder injection simultaneously, the injection lansoprazole freeze-dried powder injection prepared by this invention is clinically available For the treatment of reflux esophagitis, gastric ulcer, duodenal ulcer, etc. Background technique [0002] Lansoprazole (Lansoprazole) is the second proton pump inhibitor anti-ulcer drug after omeprazole. It is structurally similar to omeprazole. Due to the introduction of fluorine atoms, its chemical stability and therapeutic effect are superior to omeprazole. After the product enters the parietal cells from the blood, it is activated under acidic conditions and interacts with the proton pump (H + / K + )-ATPase base-building binding, inhibiting enzyme activity and thus inhibiting acid secretion. Mai...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19
Inventor 刘万忠刘伟华刘萍萍
Owner HUBEI HOPE PHARMA