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Polyene phosphatidyl choline injection and method for preparing the same

A technology of polyene phosphatidylcholine and injection, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of poor stability, poor clarity, and the need for nitrogen. protection and other issues to achieve the effect of reducing the risk of medication, increasing stability and improving safety

Active Publication Date: 2008-04-02
SICHUAN HAISCO PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Polyene phosphatidylcholine is insoluble in water, and the clarity of the products currently on the market is poor, and can only be made into translucent dispersions; the stability is not good, the difference between batches of products is large, and the related substances are easy to exceed the standard after sterilization, which is difficult to achieve Quality Standard Requirements
Chinese patent application CN1961886A discloses a preparation method of polyene phosphatidylcholine injection, which mainly has the following disadvantages: 1. The preparation process is relatively complicated, and the whole preparation process needs nitrogen protection; 2. The prepared product also has Defects of the aforementioned marketed products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Taking the preparation of 10000ml polyene phosphatidylcholine injection as an example, 465g polyene phosphatidylcholine, 400g glycocholic acid, 200ml ethanol and 88g benzyl alcohol, 0.5g 2,6-di-tert-butyl p-cresol, 2g of tert-butyl-4-hydroxyanisole and 15g of vitamin E were ultrasonically dissolved, and the temperature of the solution was controlled below 40°C, then 80g of sodium hydroxide and water for injection with a total volume of 60% were added, stirred until it became a clear liquid, and 0.15 % of the needles were coarsely filtered with activated carbon, adjusted to pH 7.5-9.5, stirred evenly, added water to a sufficient amount, filtered through a 0.22 μm microporous membrane, and filled into 5ml ampoules after sampling and inspection of bacterial endotoxins , filled with nitrogen and sealed, sterilized at 105°C for 30 minutes.

Embodiment 2

[0038] Taking the preparation of 10000ml polyene phosphatidylcholine injection as an example, 465g polyene phosphatidylcholine, 150g Tween-80, 150ml propylene glycol, 88g benzyl alcohol, 1g 2,6-di-tert-butyl p-cresol, 1g tert-butyl-4-hydroxyanisole and 20g of vitamin E are ultrasonically dissolved, and the temperature of the solution is controlled below 40°C, then add 25g of sodium hydroxide and water for injection with a total volume of 60%, stir until it becomes a clear liquid, and add 0.15% Filter the needle with activated carbon, then add the remaining water for injection, stir evenly, add water to a sufficient amount, filter through a 0.22 μm microporous membrane, take a sample to check that the bacterial endotoxin is qualified, and fill it in a 5ml ampoule. Nitrogen filled and sealed, sterilized at 100°C for 30 minutes.

Embodiment 3

[0040] Taking the preparation of 10000ml polyene phosphatidylcholine injection as an example, 465g polyene phosphatidylcholine, 500g cholic acid, 500ml glycerin and 88g benzyl alcohol, 3g 2,6-di-tert-butyl p-cresol, 5g tert-butyl 4-hydroxyanisole and 10g of vitamin E were ultrasonically dissolved, and the temperature of the solution was controlled below 40°C, then 50g of sodium hydroxide and water for injection with a total volume of 60% were added, stirred until it became a clear liquid, and 0.15% of needle Roughly filter with activated carbon, then add the remaining water for injection, stir evenly, add water to a sufficient amount, filter with a 0.22 μm microporous membrane, take a sample to check that the bacterial endotoxin is qualified, fill it in a 5ml ampoule, and fill it with nitrogen Melt seal and sterilize at 105°C for 30 minutes.

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PUM

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Abstract

The invention discloses a polyene phosphatidyl choline injection and the preparation method. The components and the ratio (portion) of the polyene phosphatidyl choline injection of the invention is: 465 portion of polyene phosphatidyl choline injection, 88 portion of benzyl zlcohol, 50 to 800 portion of glycocholic acid, cholic acid or tween-80, 50 to 80 portion of alcohol, propanediol or glycerin, 15 to 200 portion of sodium hydroxide or sodium carbonate, 0.5 to 5 portion of 2,6-D-itert-butyl-p-cresol, 0.8 to 8 portion of Tertiary butyl-4-hydroxyl anisole, 3 to 25 portion of Vitamin E by weight. The polyene phosphatidyl choline injection of the invention has good clarity, high stability, simple preparation process and easy operation.

Description

technical field [0001] The invention relates to a polyene phosphatidylcholine injection and a preparation method thereof. Background technique [0002] Polyene phosphatidylcholine is a liver cell membrane protector, which has the functions of protecting liver sinusoidal endothelium and liver cell biofilm from damage, repairing membrane damage, promoting membrane regeneration, etc., and can reduce fatty infiltration and inflammatory response of liver cells, increase RNA and protein synthesis and glycogen content to promote liver cell regeneration, reduce the formation of connective tissue by inhibiting collagen production, reducing the ratio of collagen / DNA and liver hydroxyproline production, so as to achieve the treatment of acute and chronic hepatitis, liver cirrhosis, poisoning Metabolic liver disease, hepatic steatosis caused by various reasons, hepatic coma, secondary liver dysfunction and other liver diseases. [0003] Polyene phosphatidylcholine is insoluble in water...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/6615A61K9/08A61K47/18A61K47/34A61P1/16A61P31/14A61P31/20A61K47/26
Inventor 杨平鲁方平
Owner SICHUAN HAISCO PHARMA CO LTD
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