Lansoprazole nano-particle frozen preparation for injection and preparation method thereof

A technology of lansoprazole and freeze-dried preparations, which is applied in the field of lansoprazole nanoparticle freeze-dried preparations for injection and its preparation, can solve the problems of submicron emulsion thermodynamic instability and emulsion droplet enlargement, and improve biological Utilization, increase absorption, effect of ensuring product quality

Active Publication Date: 2011-09-28
WUHAN PUSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN 101543474B provides a kind of with lansoprazole as active component, adds auxiliary materials such as sodium hydroxide, biodegradable polymer, emulsifier, skeleton agent, stabilizer, adopts double emulsion method to prepare submicron emulsion, further lyophilizes Made into lyophilized preparations for injection, but did not fundamentally solve the stability problem, because the submicroemulsion is thermodynamically unstable, and the emulsion droplets tend to increase during the preparation process and storage

Method used

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  • Lansoprazole nano-particle frozen preparation for injection and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0027] Formula: Lansoprazole 30g, dextran 10g, sodium sulfite 10g, hydroxypropyl-β-cyclodextrin 30g, polyethylene glycol-polylactic acid block copolymer 60g, mannitol 60g.

[0028] Preparation:

[0029] (1) Preparation: Routinely handle the pipes and containers used for dosing, and then wash them with water for injection; the vials and rubber stoppers should be roughly washed and then rinsed, then dried, sterilized, and cooled for later use.

[0030] (2) Dosing: First weigh the prescribed amount of dextran, solubilizer, and sodium sulfite into the dosing tank, add 80% of the prescribed amount of water for injection and stir to dissolve, then adjust the pH value with 10mol / L sodium hydroxide solution To 12.3; Add the prescribed amount of lansoprazole into the above liquid, stir to dissolve (if necessary, use 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution to adjust the pH value); add the prescribed amount under stirring The polyethylene glycol-polylactic ...

Embodiment 2

[0036] Formula: 30 g of lansoprazole, 5 g of dextran, 5 g of sodium sulfite, 20 g of hydroxypropyl-β-cyclodextrin, 50 g of polyethylene glycol-polylactic acid block copolymer, and 50 g of mannitol.

[0037] Preparation:

[0038] (1) Preparation: Routinely handle the pipes and containers used for dosing, and then wash them with water for injection; the vials and rubber stoppers should be roughly washed and then rinsed, then dried, sterilized, and cooled for later use.

[0039] (2) Dosing: First weigh the prescribed amount of dextran, solubilizer, and sodium sulfite into the dosing tank, add 80% of the prescribed amount of water for injection and stir to dissolve, then adjust the pH value with 10mol / L sodium hydroxide solution to 12; add the prescription amount of lansoprazole into the above liquid, stir to dissolve (if necessary, use 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution to adjust the pH value); add the prescription amount under stirring The pol...

Embodiment 3

[0045] Formula: 30 g of lansoprazole, 20 g of dextran, 20 g of sodium sulfite, 40 g of hydroxypropyl-β-cyclodextrin, 70 g of polyethylene glycol-polylactic acid block copolymer, and 70 g of mannitol.

[0046] Preparation:

[0047] (1) Preparation: Routinely handle the pipes and containers used for dosing, and then wash them with water for injection; the vials and rubber stoppers should be roughly washed and then rinsed, then dried, sterilized, and cooled for later use.

[0048] (2) Dosing: First weigh the prescribed amount of dextran, solubilizer, and sodium sulfite into the dosing tank, add 80% of the prescribed amount of water for injection and stir to dissolve, then adjust the pH value with 10mol / L sodium hydroxide solution to 13; another weighed prescription amount of lansoprazole, added to the above liquid, stirred to dissolve (if necessary, use 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution to adjust the pH value); add the prescription under stirri...

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Abstract

The invention discloses a lansoprazole nano-particle frozen preparation for injection capable of simultaneously improving the stability and dissolubility, and a preparation method thereof. The preparation comprises the following components in parts by weight: 20-40 parts of lansoprazole, 5-50 parts of dextran, 5-40 parts of sodium sulfite, 5-60 parts of solubilizer, 10-100 parts of nano-carrier material and 10-100 parts of freeze drying excipient. The preparation method comprises the steps of: adding the dextran, the solubilizer and the sodium sulfite into a liquid preparation tank, adding water for injection and stirring until dissolved, regulating the pH value, adding the lansoprazole and the nano-carrier material, continuing to stir evenly, adding the freeze drying excipient and stirring until dissolved, supplementing the water for injection to the full dose, decoloring, finely filtering, subpackaging and freeze drying to obtain the frozen preparation.

Description

technical field [0001] The invention relates to a proton pump inhibitor drug and a preparation method thereof, in particular to a lansoprazole nanoparticle freeze-dried preparation for injection and a preparation method thereof. Background technique [0002] Lansoprazole, chemical name: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl- 1H-benzimidazole]. Lansoprazole is an anti-acid and anti-ulcer drug. It is a second-generation proton pump inhibitor. It has the characteristics of unique mechanism of action, high specificity, strong anti-acid effect, and long duration. related to various digestive disorders. [0003] The mechanism of action of lansoprazole is the same as that of omeprazole, and it also works by inhibiting the best link of gastric acid secretion, H / K--ATPase (proton pump). However, lansoprazole does not directly inhibit H / K--ATPase, but is converted into biologically active sulfenic acid and sulfenamide forms of drugs in the acidic environ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/36A61K47/40A61P1/04
Inventor 刘浏陈葵祖徐林华梅媛王萍
Owner WUHAN PUSHENG PHARMA
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