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Polyene phosphatidylcholine freeze-dried preparation injection and its preparing method

A technology of polyene phosphatidylcholine and freeze-drying agent is applied in freeze-drying transportation, digestive system, powder transportation and other directions, can solve the problems of low storage temperature, inconvenient storage, inconvenient transportation and packaging, etc. The product quality is stable and reliable, and the method is simple and easy to implement.

Inactive Publication Date: 2006-08-23
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The storage temperature of polyene phosphatidylcholine injection is low, and it is required to be below 8°C, which is inconvenient for storage, and inconvenient for transportation and packaging

Method used

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  • Polyene phosphatidylcholine freeze-dried preparation injection and its preparing method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Dissolve 50g deoxycholic acid in 700ml water for injection, stir until homogeneous, adjust pH to 8.5 with 2mol / L NaOH solution, add 46.5g polyene phosphatidylcholine, 0.8g benzyl alcohol, 2g sodium bisulfite, 5g Mannitol, stir to dissolve, adjust pH to 8.5 with 2mol / L NaOH solution, add water to make up to 1000ml, add 0.2g activated carbon, stir and let it stand for about 30 minutes, filter, fill, and freeze-dry by a method known in the art to obtain .

Embodiment 2

[0019] Dissolve 50g deoxycholic acid in 700ml water for injection, stir until homogeneous, adjust pH to 7.5 with 2mol / L NaOH solution, add 46.5g polyene phosphatidylcholine, 0.8g benzyl alcohol, 0.2g BHT, 5g sorbitol , stir to dissolve, adjust the pH to 7.5 with 2mol / L NaOH solution, add water to make up to 1000ml, add 0.2g of activated carbon, stir and let it stand for about 30 minutes, filter, fill, and freeze-dry by methods known in the art.

Embodiment 3

[0021] Dissolve 25g of deoxycholic acid in 700ml of water for injection, stir until homogeneous, adjust the pH to 9.5 with 2mol / L NaOH solution, add 46.5g of polyene phosphatidylcholine, 0.8g of benzyl alcohol, 2g of sodium bisulfite, and 5g of manna Alcohol, stir to dissolve, adjust the pH to 9.5 with 2mol / L NaOH solution; add water to make up to 1000ml, add 0.2g of activated carbon, stir and let it stand for about 30 minutes, filter, fill, and freeze-dry by methods known in the art.

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Abstract

The present invention discloses freeze dried polyene phosphatidylchline preparation for injection and its preparation process. The freeze dried polyene phosphatidylchline preparation contains polyene phosphatidylchline in 30-60 wt% and medicinal supplementary material 40-70 wt%. The test on stability shows that the preparation of the present invention has excellent stability and high storage temperature up to 25deg.c. The present invention has simple and practical preparation process and stable and reliable product.

Description

technical field [0001] The invention relates to a polyene phosphatidylcholine preparation, in particular to a polyene phosphatidylcholine preparation for injection and a preparation method thereof. Background technique [0002] Polyene Phosphatidylcholine (Polyene Phosphatidylcholine) is a highly purified 1,2-dilinoleoylphosphatidylcholine extracted from soybeans, also known as essential phospholipids (EPL). Imported by Lipoid Company, the product quality meets the standards for injection. Polyene phosphatidylcholine is a major component of cell membranes and is chemically identical to important endogenous phospholipids. It mainly enters into liver cells, and combines with liver cell membranes and organelle membranes with complete molecules, regulates the shape and function of cell membranes, repairs the damaged liver cell membrane structure, increases the fluidity and stability of membranes, and corrects the extracellular activity of enzymes. Escape, maintain the activity...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/6615A61K9/19A61P1/16
Inventor 张旭龙泉李静贾琳
Owner YAOPHARMA CO LTD
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