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Omeprazole sodium freeze-dried lipidosome preparation and preparation method thereof

A technology of omeprazole sodium and liposome preparation, which is applied in the field of freeze-dried liposome preparation of omeprazole sodium and its preparation, can solve problems such as poor stability, achieve stable product quality, improve therapeutic index, The effect of convenient clinical application

Inactive Publication Date: 2009-09-16
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] In view of the poor stability of the current omeprazole sodium solution, various problems of the existing liposome powder injections listed above

Method used

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  • Omeprazole sodium freeze-dried lipidosome preparation and preparation method thereof
  • Omeprazole sodium freeze-dried lipidosome preparation and preparation method thereof
  • Omeprazole sodium freeze-dried lipidosome preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1 The preparation of omeprazole sodium freeze-dried liposome preparation

[0041] Prescription (1000 bottles): Omeprazole Sodium 40g

[0042] Soy Lecithin 75g

[0043] Cholesterol 20g

[0044] Vitamin E 10g

[0045] Mannitol 40g

[0046] Preparation Process:

[0047] (1) Weigh 75g of soybean lecithin, 20g of cholesterol and 10g of vitamin E and dissolve them in 800ml of ethanol, heat and melt, add a phosphate buffer solution with a pH value of 7.8, heat to remove ethanol, transfer to a tissue masher, and stir at a high speed for 10 minutes, filter, sterilize, and sonicate for 10 minutes;

[0048] (2) In a sterile room, under 100-grade conditions, add 40 g of sterilized omeprazole sodium and 40 g of mannitol to dissolve, filter, and fill in vials;

[0049] (3) Pre-freeze at -35°C for 3 hours, then dry under reduced pressure and vacuum at -45°C to -5°C for 25 hours, and finally dry at 35°C for 5 hour...

Embodiment 2

[0051] Embodiment 2 The preparation of omeprazole sodium freeze-dried liposome preparation

[0052] Prescription (1000 bottles): Omeprazole Sodium 20g

[0053] Egg yolk lecithin 30g

[0054] Cholesterol 5g

[0055] Sodium bisulfite 7.5g

[0056] Mannitol 15g

[0057] Lactose 30g

[0058] Preparation Process:

[0059] (1) Take by weighing 20g egg yolk lecithin, 5g cholesterol and sodium bisulfite 7.5g and dissolve in the mixture of 500ml isopropanol and ethanol with a volume ratio of 5:1, heat and melt, add pH value 7.8 citrate buffer solution, Heat to evaporate isopropanol and ethanol, transfer to a tissue masher, stir at high speed for 30 minutes, filter, sterilize, and sonicate for 20 minutes;

[0060] (2) In a sterile room, under 100-grade conditions, add 20 g of sterilized omeprazole sodium, 15 g of mannitol and 30 g of lactose to dissolve, filter, and fill in vials;

[0061] (3) Pre-freeze at -45...

Embodiment 3

[0063] Embodiment 3 The preparation of omeprazole sodium freeze-dried liposome preparation

[0064] Prescription (1000 bottles): Omeprazole Sodium 20g

[0065] Hydrogenated egg yolk lecithin 10g

[0066] Ascorbyl Palmitate 15g

[0067] Sorbitol 10g

[0068] Trehalose 15g

[0069] Preparation Process:

[0070] (1) Weigh 10g of hydrogenated egg yolk lecithin and 15g of ascorbyl palmitate, dissolve them in 500ml of isopropanol and ethanol with a volume ratio of 5:1, heat and melt, add a pH value of 7.8 phosphate buffer solution, heat and evaporate to remove isopropanol Propanol and ethanol, transferred to a tissue masher, stirred at high speed for 20 minutes, filtered, sterilized, and ultrasonicated for 10 minutes;

[0071] (2) In a sterile room, under 100-grade conditions, add 20 g of sterilized omeprazole sodium, 10 g of sorbitol and 15 g of trehalose and dissolve, filter, and fill in vials;

[0072] (3) Pre-freeze a...

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Abstract

The invention relates an omeprazole sodium freeze-dried lipidosome preparation and a preparation method thereof. The omeprazole sodium freeze-dried lipidosome preparation is characterized by comprising the following components in portion by weight: 10 to 20 portions of omeprazole sodium, 10 to 40 portions of phospholipids, 0 to 10 portions of cholesterol, 0 to 10 portions of antioxidant, and 5 to 20 portions of cryoprotectant.

Description

technical field [0001] The invention relates to a liposome preparation, in particular to a freeze-dried liposome preparation of omeprazole sodium and a preparation method thereof. Background technique [0002] Omeprazole (Omeprazole) is a benzimidazole derivative synthesized for the first time in 1979 by Hassle Company in Sweden. It can specifically act on the parietal cells of the gastric mucosa and reduce the H in the parietal cells + , K + -ATPase activity inhibits gastric acid secretion. [0003] Omeprazole sodium has poor stability and is very sensitive to light, heat, oxygen, water, etc., especially under acidic conditions, its chemical structure can undergo destructive changes, discoloration and polymerization, and it is not suitable for making injections at all. Omeprazole Sodium for Injection has been marketed in China, the specification is 40mg (calculated as omeprazole), and it is equipped with a special solvent, which has the problems of inconvenient clinical ...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/4439A61K47/28A61K47/36A61P1/04
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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