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Lansoprazole-contained freeze-dried powder injection

A technology of lansoprazole and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection containing lansoprazole to achieve the effects of enhancing stability, increasing solubility and reducing degradation

Active Publication Date: 2010-11-03
CHANGZHOU NO 4 PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In summary, on the basis of a large number of experiments, the present invention has developed a kind of freeze-dried powder injection containing lansoprazole, solved the deficiency of the lansoprazole powder injection existing in the art at present, is lansoprazole Freeze-dried powder preparations have opened up a new situation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] prescription:

[0044] Raw material name dosage

[0045] Lansoprazole 30g

[0046] Mannitol 100g

[0047] Macrogol 600 45ml

[0048] Appropriate amount of sodium hydroxide

[0049]

[0050] Makes 1000 bottles

[0051] Preparation process: Weigh the prescribed amount of lansoprazole, add it to an appropriate amount of water for injection and stir evenly, add an appropriate amount of sodium hydroxide solution to adjust the pH value of the solution to 11.0, stir until the lansoprazole is completely dissolved, add the prescribed amount of polyethylene glycol Glycol 600, mannitol, stir to dissolve completely, add activated carbon to absorb for 30 minutes, filter to remove carbon, add water for injection to 800ml, perform fine filtration with a 0.22um microporous membrane until the clarity is qualified, intermediate sampling , after passing the test, quantitatively fill in vials, half-press the rubber stopper, put into a lyophilizer, and...

Embodiment 2

[0053] prescription:

[0054] Raw material name dosage

[0055] Lansoprazole 30g

[0056] Mannitol 50g

[0057] Polyethylene glycol 800 60ml

[0058] Disodium hydrogen phosphate appropriate amount

[0059]

[0060] Makes 1000 bottles

[0061] Preparation process: Weigh the prescription amount of lansoprazole, add it to an appropriate amount of water for injection and stir evenly, add an appropriate amount of sodium hydroxide solution to adjust the pH value of the solution to 10.5, stir until the lansoprazole is completely dissolved, add the prescription amount of polyethylene glycol Glycol 800, mannitol, stir to dissolve completely, add activated carbon to absorb for 20 minutes, filter to remove carbon, add water for injection to 1000ml, use 0.45um microporous membrane for fine filtration until the clarity is qualified, intermediate sampling , after passing the test, quantitatively fill in vials, half-press the rubber stopper, put into a lyoph...

Embodiment 3

[0063] prescription:

[0064] Raw material name dosage

[0065] Lansoprazole 30g

[0066] Glucose 15g

[0067] Macrogol 1000 9g

[0068] Appropriate amount of sodium hydroxide

[0069]

[0070] Makes 1000 bottles

[0071] Preparation process: Weigh the prescription amount of lansoprazole, add it to an appropriate amount of water for injection and stir evenly, add an appropriate amount of sodium hydroxide solution to adjust the pH value of the solution to 12.0, stir until the lansoprazole is completely dissolved, add the prescription amount of polyethylene glycol Glycol 1000, glucose, stir to dissolve completely, add activated carbon to absorb for 30 minutes, filter to remove carbon, add water for injection to 1300ml, perform fine filtration with a 0.22um microporous membrane until the clarity is qualified, intermediate sampling, After passing the test, it is quantitatively filled in vials, half-pressed with rubber stoppers, loaded into a freez...

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PUM

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Abstract

The invention provides a lansoprazole-contained freeze-dried powder injection and a preparation method thereof, wherein the freeze-dried powder injection comprises 1 part of lansoprazole, 0.05-50 parts of excipient and 0.1-10 parts of polyethylene glycol; the preparation method of the freeze-dried powder injection comprises the following steps of: weighing the lansoprazole, adding into water for injection, adding a pH regulator for regulating the pH value of a solution to be 10-12.5, stirring until the lansoprazole in the solution is completely dissolved, adding the polyethylene glycol and the excipient, adding the water for injection until reaching the whole volume, quantitatively filling into a cillin bottle, and carrying out freeze-drying; and the freeze-dried powder injection can simultaneously solve the problem of stability and solubility puzzling the preparation and has good redissolution property.

Description

technical field [0001] The invention provides a freeze-dried powder injection, especially a freeze-dried powder injection containing lansoprazole. Background technique [0002] Lansoprazole is a substituted benzimidazole compound anti-ulcer drug, which belongs to the proton pump inhibitor. It can continuously inhibit the activity of gastric acid and pepsin by inhibiting the proton pump of gastric mucosa parietal cells, that is, inhibiting the activity of H+, K+-ATPase. secretion. According to the research results of peptic ulcer in recent years, lansoprazole is obviously better than omeprazole, which is widely used in clinical practice, in the treatment of duodenal ulcer (DU). Lansoprazole has reliable acid-suppressing effects and a large safety factor, and is a promising new generation of proton pump inhibitors. Only oral preparations are listed on the domestic market at present. Injections have the advantages of quick onset and are not affected by the gastrointestinal e...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61K47/34A61P1/04A61K47/10
Inventor 姚俊华
Owner CHANGZHOU NO 4 PHARMA FACTORY
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