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Sodium glycerophosphate injection and its manufacturing method and application

A technology of sodium glycerophosphate and injection, which can be applied in the directions of active ingredients of phosphorus compounds, metabolic diseases, drug combinations, etc., and can solve problems such as increasing infusion infection and increasing patient infusion volume.

Inactive Publication Date: 2004-08-04
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This increases the patient's infusion volume and increases the chance of infusion infection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0031] Sodium glycerophosphate (anhydrous): 200g, concentrated hydrochloric acid: 4ml, water for injection: 947g

[0032] a. Add 650g of water for injection at 20°C into the preparation tank, and add 3.5ml of concentrated hydrochloric acid under stirring;

[0033] B, continue to stir, dissolve 200g sodium glycerophosphate (anhydrous);

[0034] c. After the liquid medicine is clarified, add 35°C water for injection to 1.000Kg, and continue to stir;

[0035] d. Add 1M hydrochloric acid to adjust the pH, and the pH should be 7.2 at 25°C;

[0036] e. Add 35°C water for injection to 1.100kg;

[0037] f. The liquid medicine is filtered through 15μm, 35μm and 0.22μm filters to the receiving container in sequence,

[0038] g. Under 100-level laminar flow protection, the liquid medicine automatic filling machine pours into a 10ml sterile ampoule and seals it, and the filled ampoule is protected from light;

[0039] h. Put the filled ampoule in a rotating sterilizer to sterilize, th...

example 2

[0041] Sodium glycerophosphate (anhydrous): 208g, concentrated hydrochloric acid: 4ml, water for injection: 939g

[0042] a. Add 700g of water for injection at 20°C to the preparation tank, and add 4ml of concentrated hydrochloric acid under stirring;

[0043] B, continue to stir, dissolve 208g sodium glycerophosphate (anhydrous);

[0044] c. After the liquid medicine is clarified, add water for injection at 35°C to 1.111Kg, and continue stirring;

[0045] d. Add 1M hydrochloric acid to adjust the pH, and the pH should be 7.2 at 25°C;

[0046] e. Add 38°C water for injection to 1.147kg;

[0047] f. The liquid medicine is filtered through 15μm, 35μm and 0.22μm filters to the receiving container in sequence,

[0048]g. Under 100-level laminar flow protection, the liquid medicine automatic filling machine pours into a 10ml sterile ampoule and seals it, and the filled ampoule is protected from light;

[0049] h. Put the filled ampoule in a rotating sterilizer to sterilize, the...

example 3

[0051] Sodium glycerophosphate (anhydrous): 216g, concentrated hydrochloric acid: 4ml, water for injection: 931g

[0052] a. Add 750g of 30°C water for injection into the preparation tank, and add 4.5ml of concentrated hydrochloric acid under stirring;

[0053] B, continue to stir, dissolve 216g sodium glycerophosphate (anhydrous);

[0054] c. After the liquid medicine is clarified, add water for injection at 40°C to 1.150Kg, and continue stirring;

[0055] d. Add 1M hydrochloric acid to adjust the pH, and the pH should be 7.6 at 25°C;

[0056] e. Add 40°C water for injection to 1.300kg;

[0057] f. The liquid medicine is filtered through 15μm, 35μm and 0.22μm filters to the receiving container in sequence;

[0058] g. Under 100-level laminar flow protection, the liquid medicine automatic filling machine pours into a 10ml sterile ampoule and seals it, and the filled ampoule is protected from light;

[0059] h. Place the filled ampoules in a rotating sterilizer for steriliz...

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Abstract

A sodium glycerylphosphate injection is prepared from anhydrous sodium glycerylphosphate, hydrochloric acid and the water for injection through adding concentrated hydrochloric acid to the water for injection at 20-30 deg.C, while stirring, dissolving anhydrous sodium glycerylphosphate in it while stirring, adding the water for injection while stirring, adding hydrochloric acid to regulate pH=7.2-7.6, and adding the water for injection at 35-40 deg.C. Before it is applied, it must be mixed with compound amino acid or glucose injection. The finished injection must be applied within 24 hr.

Description

technical field [0001] The invention belongs to a phosphorus injection sourced from organic phosphorus. Background technique [0002] Phosphorus is one of the indispensable elements of the human body, and it is of great significance to maintain the normal physiological functions of the human body. It participates in the formation of bones and teeth, participates in the phosphorylation reaction in sugar metabolism, constitutes phospholipids in membrane components, and is one of the important components of intracellular RNA, DNA and many coenzymes. Phosphorus deficiency does not occur in the human body under normal circumstances, but in patients with diseases such as severe malnutrition or long-term parenteral nutrition, due to the reduction of phosphorus absorption function, the increase of phosphorus metabolism requirements and insufficient phosphorus intake, phosphorus deficiency occurs more common. Therefore, it is necessary to supplement phosphorus preparations clinical...

Claims

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Application Information

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IPC IPC(8): A61K31/66A61P3/02
Inventor 马涛
Owner 费森尤斯卡比华瑞制药有限公司
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