Lansoprazole for injection

A technology for lansoprazole and injection, applied in the field of pharmaceutical preparations

Pending Publication Date: 2021-07-06
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the above problems, one of the objects of the present invention is to provide a freeze-d

Method used

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  • Lansoprazole for injection
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  • Lansoprazole for injection

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0030] Preparation:

[0031] The preparation method of mannitol is:

[0032] 1) Non-filtration: Roose a messenger film production was filtered with a nanofiltration membrane to collect the nanofiltration membrane.

[0033] 2) Decolorizing, concentrated: Putting step 1) The obtained nanofiltration membrane clutter is discharged into activated carbon, and the solution is concentrated under vacuum to concentrate.

[0034] 3) Crystallization: The concentrate obtained from which step 2) obtained was concentrated, stirred, centrifuged, washing crystals, and natural mannitol crude.

[0035] 4) Recrystallization: The natural mannitol obtained by step 3) was heated with a low alcohol solution, recrystallized, centrifuged, dried, and natural mannitol boutique.

Example Embodiment

[0036] Example 1:

[0037] 1) Welney liquid

[0038] Weigh 10 parts by weight of Lan Solarazole, 40 parts by weight of mannitol, 5 parts by weight of sodium hydroxide, spare; 90% injection water (temperature: 30 ° C or less) in the liquid solution tank ), First adding the above known amount of mannitol, sodium hydroxide, stirring to dissolve; then add Lamovazole raw material, slowly stirring the sodium hydroxide solution to make the liquid The pH is maintained at 11.7 or more, and the drug solution is completely dissolved into a compound, and then the water is completed to a full amount, stir mix; the control fluid pH is between 10.8 to 11.5 (3 mg / ml of dilution after dilution 3 mg / ml) After 0.45 μM sterilization, the epiton was sampled, and after passing the intermediate detection, after passing, the liquid liquid was moved to the filling machine 100-level lamination under 0.22 μm secondary terminal sterilization to the chemical liquid bucket, for supply Filling.

[0039] 2) ...

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PUM

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Abstract

The invention discloses lansoprazole for injection, and particularly relates to lansoprazole for injection. The lansoprazole preparation for injection is a freeze-dried powder injection and is prepared from the following raw materials in parts by weight: 10-50 parts of lansoprazole, 40-80 parts of mannitol, 5-15 parts of meglumine and 1600-2400 ml of water for injection. The preparation process of the lansoprazole preparation for injection comprises the steps of liquid preparation, sterilization and filtration, filling and freeze drying, and the preparation process of mannitol comprises the steps of nanofiltration, decoloration and concentration, crystallization and recrystallization. The prepared lansoprazole for injection has less clarity and insoluble particles, can avoid the problems that the clarity of a solution is reduced and the insoluble particles are increased after the lansoprazole is stored for a period of time, can be matched with common diluting solvents such as 0.9% sodium chloride injection and 5% glucose injection, and has a wider clinical application range.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a kind of lansoprazole for injection. Background technique [0002] Lansoprazole chemical name: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]-sulfinyl]-1H-benzene And imidazole. [0003] 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 binds to the (H+ / K+)-ATPase base of the proton pump, inhibiting the activity of the enzyme and thereby inhibiting acid secretion. Lansoprazole is suitable for gastric ulcer, duodenal ulcer, reflux esophagitis, and Zollinger-Ellison syndrome (gastrinoma). [0004] But lansoprazole can not be taken orally, ca...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/10A61K47/18A61P1/04C07C29/76C07C31/26
CPCA61K9/19A61K9/0019A61K31/4439A61K47/10A61K47/18A61P1/04C07C29/76
Inventor 黄月娜王小芳王进宇潘淑华王寿春
Owner HAINAN JINRUI PHARMA
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