Preparation process of polyene phosphatidylcholine injection

A technology of polyene phosphatidylcholine and injection, which is applied in the directions of active ingredients of phosphorus compounds, digestive system, drug combination, etc., can solve the problems of high price, relatively high difficulty and high cost

Inactive Publication Date: 2005-04-06
北京瑞伊人科技发展有限公司 +1
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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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  • Preparation process of polyene phosphatidylcholine injection
  • Preparation process of polyene phosphatidylcholine injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Taking the preparation of 5000ml polyene phosphatidylcholine injection as an example, 232.5g polyene phosphatidylcholine, 500g sodium deoxycholate and 3 / 5 water for injection were stirred under nitrogen flow until a uniform translucent colloidal dispersion system was formed . Add 5g of activated carbon for adsorption for 20min, and use a No. 3 vertical fusion filter for coarse filtration under nitrogen flow. Then add 45g of benzyl alcohol and the remaining water for injection, circulate and homogenize several times, add water to a sufficient amount, circulate and homogenize evenly. After passing through a 0.45 μm microporous membrane filter (sampling inspection), it is filled in a 5ml ampoule, flushed with nitrogen, sealed by fusing, and sterilized at 121°C for 15 minutes.

Embodiment 2

[0033] Taking the preparation of 5000ml polyene phosphatidylcholine injection as an example, 232.5g polyene phosphatidylcholine, 420g sodium dehydrocholate and 3 / 5 water for injection were stirred under nitrogen flow until uniform translucent colloidal dispersion system. Add 2.5g of activated carbon for adsorption for 15min, and use a No. 3 vertical fusion filter for coarse filtration under nitrogen flow. Then add 40g of benzyl alcohol and the remaining water for injection, circulate and homogenize several times, add water to a sufficient amount, circulate and homogenize evenly. After passing through a 0.45 μm microporous membrane filter (sampling inspection), it is filled in a 5ml ampoule, flushed with nitrogen, sealed by fusing, and sterilized at 121°C for 15 minutes.

Embodiment 3

[0035] Taking the preparation of 5000ml polyene phosphatidylcholine injection as an example, 232.5g polyene phosphatidylcholine, 580g sodium cholate and 3 / 5 water for injection were stirred under nitrogen flow until a uniform translucent colloidal dispersion system was formed. Add 10 g of activated carbon for adsorption for 25 minutes, and use a No. 3 vertical fusion filter for coarse filtration under nitrogen flow. Then add 47.5g of benzyl alcohol and the remaining water for injection, circulate and homogenize several times, add water to a sufficient amount, circulate and homogenize evenly. After passing through a 0.45 μm microporous membrane filter (sampling inspection), it is filled in a 5ml ampoule, flushed with nitrogen, sealed by fusing, and sterilized at 121°C for 15 minutes.

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PUM

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Abstract

The invention discloses a method for preparing polyene phosphatidyl choline injection, including mixing polyene phosphatidyl choline, solubilizer, and injection water in proportion, stirring them into a colloidal dispersive system, adding in activated carbon to absorb, and adding proper antiseptic. It is a low-cost, simple-technique preparing method.

Description

technical field [0001] The invention relates to a preparation method of polyene phosphatidylcholine 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, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/66A61P1/16
Inventor 张志宏王卓睿庄大伟
Owner 北京瑞伊人科技发展有限公司
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