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Sub-micro emulsion frozen preparation of pantoprazole sodium prepared by using multiple emulsion method

A technology for pantoprazole sodium and freeze-dried preparations, applied in the field of submicroemulsion freeze-dried preparations of pantoprazole sodium, can solve the problems of short validity period, difficult to achieve long-term storage and the like, achieve stable product quality and reduce drug side effects , the effect of improving the therapeutic index

Inactive Publication Date: 2009-10-07
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After the pantoprazole sodium submicron emulsion preparation is further lyophilized, it is convenient for its long-term storage, and after reconstitution with water, it is beneficial for injection administration, which effectively solves the problem that the known pantoprazole sodium preparation is difficult to achieve long-term storage and has a short period of validity. quality requirements

Method used

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  • Sub-micro emulsion frozen preparation of pantoprazole sodium prepared by using multiple emulsion method
  • Sub-micro emulsion frozen preparation of pantoprazole sodium prepared by using multiple emulsion method
  • Sub-micro emulsion frozen preparation of pantoprazole sodium prepared by using multiple emulsion method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The preparation of embodiment 1 pantoprazole sodium submicron emulsion lyophilized preparation

[0039] Formula: Pantoprazole Sodium 20g

[0040] Polylactic acid 66g

[0041] Polyvinyl alcohol 30g

[0042] Mannitol 120g

[0043] Povidone K30 50g

[0044] Preparation Process

[0045] (1) 20g pantoprazole sodium is dissolved in 500ml water, 66g polylactic acid is dissolved in 200ml dichloromethane, both mixing and stirring 30min, rotating speed 200r / min, make W / O type emulsion;

[0046] (2) Dissolve 50g of povidone K30 and 120g of mannitol in 1000ml of water, add the solution to the above-mentioned W / O emulsion, stir at room temperature for 30min, and rotate at 600r / min to make a W / O / W type double emulsion;

[0047] (3) Add the above-mentioned W / O / W type double emulsion into the aqueous solution of 30g polyvinyl alcohol, stir at room temperature for 30min, and rotate at 800r / min, evaporate dichloromethane under reduced pressure, separate by high-speed...

Embodiment 2

[0050] The preparation of embodiment 2 pantoprazole sodium submicron emulsion preparation

[0051] Formula: Pantoprazole Sodium 40g

[0052] Poly(lactic-co-glycolic acid) 100g

[0053] Poloxamer 188 80g

[0054] Trehalose 110g

[0055] Dextran 40 30g

[0056] Preparation Process

[0057] (1) Dissolve 40g of pantoprazole sodium in 1000ml of water, dissolve 100g of polylactic acid-glycolic acid copolymer in 500ml of isopropanol, mix and stir for 15min at a speed of 400r / min to make a W / O emulsion ;

[0058] (2) Dissolve 30g of dextran 40 and 110g of trehalose in 600ml of water, add the solution to the above-mentioned W / O emulsion, stir at room temperature for 40min, and rotate at 800r / min to make a W / O / W double emulsion;

[0059] (3) Add the above-mentioned W / O / W type double emulsion into 40g of poloxamer 188 aqueous solution, stir at room temperature for 60min, rotate at 500r / min, distill off isopropanol under reduced pressure, centrifuge at high s...

Embodiment 3

[0062] The preparation of embodiment 3 pantoprazole sodium submicron emulsion preparation

[0063] Recipe: Pantoprazole Sodium 60g

[0064] Polyethylene glycol-polylactic acid copolymer 200g

[0065] Cholesterol 40g

[0066] Lecithin 60g

[0067] Lactose 250g

[0068] Povidone K15 80g

[0069] Preparation Process

[0070] (1) Dissolve 60g of pantoprazole sodium in 1200ml of water, dissolve 200g of polyethylene glycol-polylactic acid copolymer in 800ml of acetonitrile, mix and stir the two for 20min at a speed of 800r / min, and make a W / O emulsion ;

[0071] (2) Dissolve 80g of povidone K15 and 250g of lactose in 1000ml of water, add the solution to the above-mentioned W / O emulsion, stir at room temperature for 35min, and rotate at 200r / min to make W / O / W double emulsion;

[0072] (3) Add the above-mentioned W / O / W type double emulsion into an aqueous solution of 40g cholesterol and 60g lecithin, stir at room temperature for 50min, and rotate a...

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Abstract

The invention provides a sub-micro emulsion frozen preparation of pantoprazole sodium and a preparation method thereof. The sub-micro emulsion frozen preparation of pantoprazole sodium is prepared mainly with the following components according to portions by weight: 1-10 portions of pantoprazole sodium, 5-50 portions of biodegradable polymer, 1-20 portions of emulsifying agent, 5-40 portions of skeleton supporting agent and 1-20 portions of stabilizing agent.

Description

technical field [0001] The invention relates to a submicron emulsion freeze-dried preparation of pantoprazole sodium, in particular to a method for preparing the pantoprazole sodium submicroemulsion preparation. Background technique [0002] Pantoprazole sodium, its chemical name is: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)-methyl]-sulfinyl-1H-benzo Imidazole sodium salt monohydrate, the structural formula is: [0003] [0004] Pantoprazole is a proton pump inhibitor that interacts with H in gastric parietal cells + -K + -Covalent binding of two sites of the ATPase system inhibits the final step of gastric acid production in a dose-dependent manner and inhibits both basal and stimulated gastric acid secretion. It is suitable for acute upper gastrointestinal bleeding such as duodenal ulcer, gastric ulcer, acute gastric mucosal lesions, and compound gastric ulcer. [0005] Pantoprazole sodium is an alkaline drug, which is sensitive to light, heat, oxygen, water, e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/107A61K31/4439A61K47/42A61K47/36A61K47/34A61K47/32A61P1/04A61K47/24A61K47/26A61K47/28
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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