Polyene phosphatidyl choline injection, and preparation method thereof

A technology of polyene phosphatidyl choline and injection is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. The problems such as decrease, instability of polyene phosphatidylcholine, etc., achieve the effects of increased stability, simple prescription and process, and easy industrial production.

Inactive Publication Date: 2014-04-09
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Polyene phosphatidylcholine injection is a phospholipid drug. Like other phospholipids, it has the characteristics of thermal instability. Phospholipids will be hydrolyzed to varying degrees during high temperature sterilization and long-term storage, which will cause three major problems: 1. ) The content of the main drug polyene phosphatidylcholine decreased; 2) The generation of toxic substance lysophosphatidylcholine; 3) The hydrolysis of phospholipids caused the pH value of the product to decrease
However, the prescription of the above-mentioned injection is relatively complicated, which brings problems such as cost, safety and quality control, so it is still necessary to study a new prescription to solve the technical problem of instability of polyene phosphatidylcholine

Method used

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  • Polyene phosphatidyl choline injection, and preparation method thereof
  • Polyene phosphatidyl choline injection, and preparation method thereof
  • Polyene phosphatidyl choline injection, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Taking the preparation of 5L polyene phosphatidylcholine injection as an example, under nitrogen protection, 232.5 g of polyene phosphatidylcholine, 150 g of deoxycholic acid, 17.8 g of arginine, Sodium chloride 16g, benzyl alcohol 48.2g, sodium hydroxide 15g and riboflavin sodium phosphate 0.45g (calculated as riboflavin), stir well; add 0.1% activated carbon for adsorption for 30min, decarbonize; use sodium hydroxide solution or dilute Adjust the pH to 9.0 with hydrochloric acid solution; add water to the prepared amount; filter, subpackage and seal under nitrogen cover, sterilize at 121°C for 12 minutes, and pass the visual inspection to obtain the product.

Embodiment 2

[0034] Taking the preparation of 5L polyene phosphatidylcholine injection as an example, under nitrogen protection, 232.5 g of polyene phosphatidylcholine, 160 g of deoxycholic acid, 19.6 g of arginine, Sodium chloride 18g, benzyl alcohol 50g, sodium hydroxide 16.3g and riboflavin sodium phosphate 0.60g (calculated as riboflavin), stir well; add 0.1% activated carbon for adsorption for 30min, decarbonize; use sodium hydroxide solution or dilute Adjust the pH to 9.0 with hydrochloric acid solution; add water to the prepared amount; filter, subpackage and seal under nitrogen cover, sterilize at 121°C for 12 minutes, and pass the visual inspection to obtain the product.

Embodiment 3

[0036] Taking the preparation of 5L polyene phosphatidylcholine injection as an example, under the protection of nitrogen, add 232.5 g of polyene phosphatidylcholine, 140 g of deoxycholic acid, and tris to 70% of the prepared water for injection. 15g, sodium chloride 10g, benzyl alcohol 47.6g, sodium hydroxide 16.8g and riboflavin sodium phosphate 0.50g (calculated as riboflavin), stir well; add 0.1% activated carbon for 30min, decarbonize; solution or dilute hydrochloric acid solution to adjust the pH to 9.0; add water to the prepared volume; filter, subpackage and seal under nitrogen cover, sterilize at 121°C for 12 minutes, and pass the visual inspection to obtain the product.

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PUM

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Abstract

The invention belongs to the field of medicinal preparation, and specifically relates to a polyene phosphatidyl choline injection, and a preparation method thereof. The polyene phosphatidyl choline injection comprises polyene phosphatidyl choline, a solubilizer, an antiseptic, and a stabilizing agent; the solubilizer is selected from deoxycholic acid, deoxysodium cholate, dehydrocholic acid, sodium dehydrocholate, cholic acid, or sodium cholate; and the stabilizing agent is selected from amino acid, or a sodium salt thereof, or trometamol. Compared with a control group without the stabilizing agent, stability of the polyene phosphatidyl choline injection after high temperature sterilization and long-term storage is increased significantly, formula and preparation method are both simple, and the polyene phosphatidyl choline injection is convenient for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable polyene phosphatidylcholine injection and a preparation method thereof. Background technique [0002] Polyene phosphatidylcholine is a high-purity phosphatidylcholine extracted from soybean lecithin, which contains a large amount of unsaturated fatty acids, mainly linoleic acid (accounting for about 70%), linolenic acid and oleic acid. It contains a variety of unsaturated fatty acids, so it is called polyene phosphatidylcholine. Polyene phosphatidylcholine is an "essential" phospholipid that cannot be synthesized in the human body. It is a liver cell membrane protective agent and can treat a variety of acute and chronic liver diseases. Various liver diseases have damage to the ultrastructure of liver cell membranes and mitochondria, accompanied by loss of phospholipids and insufficient cellular respiration and energy synthesis. Supplementing exogen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/685A61K47/28A61K47/42A61P1/16
Inventor 程艳菊张勇
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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