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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-dried powder injection to solve the problems of solubility, stability and redissolution in aqueous solution.

Method used

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  • Lansoprazole for injection
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Examples

Experimental program
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Effect test

preparation example

[0031] The preparation method of mannitol is:

[0032] 1) Nanofiltration: The mogroside production waste liquid is subjected to nanofiltration with a nanofiltration membrane, and the nanofiltration membrane retentate is collected.

[0033] 2) Decolorization and concentration: putting activated carbon into the nanofiltration membrane retentate obtained in step 1) for decolorization, and concentrating the solution under reduced pressure in vacuo to obtain a concentrated solution.

[0034] 3) Crystallization: cool down the concentrated solution obtained in step 2), stir and crystallize, centrifugally filter, and wash the crystals to obtain crude natural mannitol.

[0035] 4) Recrystallization: heating and dissolving the crude natural mannitol obtained in step 3) with a low-carbon alcohol solution, recrystallizing, centrifuging, and drying to obtain fine natural mannitol.

Embodiment 1

[0037] 1) Dosing

[0038] Take by weighing 10 parts by weight of lansoprazole, 40 parts by weight of mannitol, 5 parts by weight of meglumine and sodium hydroxide, for subsequent use; add 90% water for injection (temperature: below 30 ℃) of dosing total amount in the liquid mixing tank ), first add the above-mentioned weighed mannitol, meglumine and sodium hydroxide, and stir to dissolve; then add the lansoprazole bulk drug, and slowly stir while adding dropwise 1mol / l sodium hydroxide solution to make the liquid Keep the pH value above 11.7 until the medicinal solution is completely dissolved into a clear solution, then add water for injection to the full amount, stir and mix well; control the pH value of the medicinal solution between 10.8 and 11.5 (the concentration of the diluted medicinal solution is 3mg / ml) The liquid medicine is sterilized and filtered at 0.45 μm, and samples are taken for intermediate detection. After passing the test, the liquid medicine is moved to t...

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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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