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Polyene phosphatidyl choline intravenous preparation and preparation method thereof

A polyene phosphatidylcholine and preparation technology, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of drug liquid pollution, high blood sugar side effects, and unseen content reports and other problems, to achieve the effect of convenient clinical use, safe clinical application and avoiding side effects

Inactive Publication Date: 2012-05-16
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

[0008] One is the cumbersome operation of intravenous injection that needs to be diluted before use, which is easy to cause contamination of the drug solution
[0009] Second, when glucose solution is used as a diluent for water injection, insulin is required for its metabolism and utilization. Although it can provide heat for patients with liver disease on the one hand, it can also cause side effects of hyperglycemia on the other hand.
[0012] In a word, according to the search results of related patents and prior art documents, there is no report of the same content of the present invention

Method used

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  • Polyene phosphatidyl choline intravenous preparation and preparation method thereof
  • Polyene phosphatidyl choline intravenous preparation and preparation method thereof
  • Polyene phosphatidyl choline intravenous preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1 (specification 100ml: 232.5mg)

[0020] Put 250 g of polyene phosphatidylcholine and 500 g of sodium cholate in a high-speed tissue masher, add 60,000 ml of water for injection, and stir under nitrogen flow until a uniform translucent colloidal dispersion system is formed. Add activated carbon for adsorption for 15 minutes, and use a No. 3 vertical fusion filter for coarse filtration under nitrogen flow. Add 5000g of xylitol and 20000ml of water for injection, circulate and homogenize several times, add water to a sufficient amount of 100000ml, circulate and homogenize evenly. After passing through a 0.22 μm microporous membrane filter (sampling inspection), filling, filling with nitrogen, fusion sealing, sterilizing at 121° C. for 15 minutes. Inspection, packaging.

Embodiment 2

[0021] Embodiment 2 (specification 250ml: 465.0mg)

[0022] Put 250 g of polyene phosphatidylcholine and 350 g of sodium cholate in a high-speed tissue masher, add 150,000 ml of water for injection, and stir under nitrogen flow until a uniform translucent colloidal dispersion system is formed. Add activated carbon for adsorption for 15 minutes, and use a No. 3 vertical fusion filter for coarse filtration under nitrogen flow. Add 12500g of xylitol and 50000ml of water for injection, circulate and homogenize several times, add water to a sufficient amount of 250000ml, circulate and homogenize evenly. After passing through a 0.22 μm microporous membrane filter (sampling inspection), filling, filling with nitrogen, fusion sealing, sterilizing at 121° C. for 15 minutes. Inspection, packaging.

Embodiment 3

[0023] Embodiment 3 (specification 500ml: 1162.5mg)

[0024] Put 250 g of polyene phosphatidylcholine and 250 g of sodium cholate in a high-speed tissue masher, add 300,000 ml of water for injection, and stir under nitrogen flow until a uniform translucent colloidal dispersion system is formed. Add activated carbon for adsorption for 15 minutes, and use a No. 3 vertical fusion filter for coarse filtration under nitrogen flow. Add 25,000g of xylitol and 125,000ml of water for injection, circulate and homogenize several times, add water to a sufficient amount of 500,000ml, and circulate and homogenize evenly. After passing through a 0.22 μm microporous membrane filter (sampling inspection), filling, filling with nitrogen, fusion sealing, sterilizing at 121° C. for 15 minutes. Inspection, packaging.

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Abstract

The invention relates to a polyene phosphatidyl choline intravenous preparation (comprising infusion and freeze-drying) and a preparation method thereof. The raw materials of the polyene phosphatidyl choline intravenous preparation comprise polyene phosphatidyl choline, sodium cholate and xylitol which can accept the adjustment osmotic pressure. The process comprises the following steps: preparing a colloidal dispersion system from the polyene phosphatidyl choline and the sodium cholate according to the prescription under the conditions required by the process; carrying out active carbon decoloration on the colloidal dispersion system, then carrying out rough filtration on the obtained product under the condition of adding nitrogen, adding the xylitol according to the prescription into the obtained solution to prepare concentrated solution for later use; and adding water for injection to make up to volume, and preparing the infusion by the processing procedures of filtering, filling, adding the stopper, pressing the cover, sterilizing, detecting leakage and the like, or preparing the freeze-drying preparation by the processing procedures of filtering, filling, freeze-drying, adding the stopper, pressing the cover and sterilizing. The prepared infusion solution finished product has convenient clinical use, better stability on low temperature storage or clinical use, no turbidity or emulsification phenomenon, and better safety performance.

Description

technical field [0001] The invention relates to an intravenous preparation (transfusion and freeze-drying) with polyene phosphatidylcholine as the main raw material, especially a polyene phosphatidylcholine xylitol injection and a preparation method thereof. Background technique [0002] Polyene Phosphatidylcholine is a further extract of soybean extract - soybean phospholipids, which is chemically consistent with important endogenous phospholipids. [0003] Modern pharmacological studies have shown that polyene phosphatidylcholine can reduce fat infiltration of liver cells; reduce inflammation; promote liver cell regeneration by increasing RNA and protein synthesis and glycogen content; inhibit collagen production and reduce collagen / DNA ratio and liver hydroxyproline to reduce connective tissue formation; polyene phosphatidylcholine can protect liver sinusoidal endothelial cells and liver cell biofilm from damage, repair membrane damage, and promote membrane regeneration. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K9/19A61K47/28A61K31/685A61P1/16
Inventor 安英张玲玲张慧英
Owner 北京瑞伊人科技发展有限公司
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