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Method for preparing Polyene Phosphatidylcholine injection liquid

A technology for polyene phosphatidyl choline and injection is applied in the field of preparation of polyene phosphatidyl choline injection, and can solve the problems of high price, high relative difficulty and high cost

Inactive Publication Date: 2007-05-16
ZHEJIANG HAILISHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, as the main drug, the concentration required to dissolve is relatively high, and it is relatively difficult. At present, domestic polyene phosphatidylcholine injections mainly rely on imports, and the cost is high and expensive.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Preparation of Polyene Phosphatidylcholine Injection

[0020] Taking the preparation of 5000ml polyene phosphatidylcholine injection as an example, 232.5g polyene phosphatidylcholine, 69.8g sodium deoxycholate, 8g vitamin E and 45g benzyl alcohol 3 / 5 water for injection were stirred under a nitrogen stream until the mixture was formed. The homogeneous transparent colloidal dispersion system is coarsely filtered with a No. 3 vertical fusion filter under nitrogen flow. Then add the remaining water for injection, circulate and homogenize several times, add water to a sufficient amount, circulate and homogenize evenly. After filtering (sampling inspection) with a 0.22um microporous membrane, it is filled in a 5ml ampoule, filled with nitrogen, sealed by fusion, and sterilized at 100°C for 30 minutes.

Embodiment 2

[0021] Example 2 Preparation of Polyene Phosphatidylcholine Injection

[0022] Taking the preparation of 5000ml polyene phosphatidylcholine injection as an example, 232.5g polyene phosphatidylcholine, 69.8g sodium cholate, 45g benzyl alcohol, 8g vitamin E and 3 / 5 water for injection were stirred under a nitrogen stream until the mixture was formed. Uniform translucent colloidal dispersion system. Coarse filter with No. 3 vertical fusion filter under nitrogen flow. Then add the remaining water for injection, circulate and homogenize several times, add water to a sufficient amount, circulate and homogenize evenly. After filtering (sampling inspection) with a 0.22um microporous membrane, it is filled in a 5ml ampoule, filled with nitrogen, sealed by fusion, and sterilized at 100°C for 30 minutes.

Embodiment 3

[0023] Example 3 Preparation of Polyene Phosphatidylcholine Injection

[0024] Taking the preparation of 5000ml polyene phosphatidylcholine injection as an example, 232.5g polyene phosphatidylcholine, 58.8g sodium dehydrocholate, 40g benzyl alcohol, 8g vitamin E and 3 / 5 water for injection were stirred under nitrogen flow Until it becomes a uniform translucent colloidal dispersion, it is coarsely filtered with a No. 3 vertical fusing filter under nitrogen flow. Then add the remaining water for injection, circulate and homogenize several times, add water to a sufficient amount, circulate and homogenize evenly. After filtering (sampling inspection) with a 0.22um microporous membrane, it is filled in a 5ml ampoule, filled with nitrogen, sealed by fusion, and sterilized at 100°C for 30 minutes.

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PUM

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Abstract

The invention relates to a process for preparing polyene phosphatidyl choline injection, which consists of mixing polyene phosphatidyl choline, solubilizing agent and water for injection proportionally, charging right amount of preservative agent and anti-oxidizing agent, and mixing to colloid form dispersible system.

Description

technical field [0001] The invention relates to a preparation method of polyenoylcholine injection, which belongs to the technical field of medicine preparation. technical background [0002] Polyene Phosphatidylcholine Injection is a liver cell membrane protective agent for the treatment of various liver diseases. Its main component is natural polyene phosphatidylcholine, which contains a large amount of unsaturated fatty acids, mainly linoleic acid (accounting for about 70%), linolenic acid and oleic acid. Various liver diseases have damage to the ultrastructural structure of liver cell membranes and mitochondria, accompanied by loss of phospholipids, and insufficient cellular respiration and energy synthesis. Exogenous phospholipids are supplemented, and polyunsaturated phospholipids are introduced into the liver cell membrane structure to replace endogenous saturated phospholipids. , can enhance membrane fluidity and transmembrane transport system activity, and thus res...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/6615A61K9/08A61P1/16
Inventor 郑海辉
Owner ZHEJIANG HAILISHENG PHARM CO LTD
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