Glycerin fructose sodium chloride injection and preparation process thereof

A sodium chloride injection and sodium chloride technology, applied in the direction of active ingredients of alkali/alkaline earth metal chlorides, active ingredients of hydroxyl compounds, medical preparations containing active ingredients, etc., to solve safety problems and eliminate clinical safety hazards Effect

Active Publication Date: 2015-06-03
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the high quality requirements of this variety, the limit requirements of 5-hydroxymethylfurfural are extremely strict. In practice, a certain amount of antioxidants and auxiliary materials are used to solve this problem, which will bring certain safety problems of auxiliary materials. ;At the same time,...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0015] Conditions: stirring for 30 minutes. (5-Hydroxymethylfurfural is abbreviated as 5-HMF.)

[0016] Table 1 Selection of preparation temperature

[0017] condition

[0018] The test results in Table 1 show that low temperature is beneficial to the stability of fructose.

experiment example 2

[0020] Conditions: ultrafiltration tests 1, 2, and 3 were evaluated and verified by ultrafiltration membrane filtration; activated carbon 1 and 2 were evaluated and verified by adding activated carbon and then filtered with a 0.22um microporous membrane.

[0021] Table 2 Comparative test of ultrafiltration and activated carbon process

[0022] condition

Ultrafiltration test 1

Ultrafiltration test 2

Ultrafiltration test 3

Activated carbon 1

Activated carbon 2

endotoxin

Compliance

Compliance

Compliance

Compliance

Compliance

[0023] The test results in Table 2 show that ultrafiltration can remove the heat source in the injection, and can achieve the same effect as adding activated carbon.

[0024] All embodiments of the present invention can achieve the effects of the above experimental examples.

Embodiment 1

[0026] Add 540ml of water for injection to the preparation tank at a temperature of about 45°C, add 100g of glycerin and 9g of sodium chloride, stir to dissolve, filter into the dilution tank; add 50g of sterile fructose for injection to dissolve, add to the preparation volume of 1000ml, and measure the content And conform to the regulations, filter with 0.22um microporous membrane and ultrafiltration membrane, refill, sterilize, light check, pack and get final product.

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PUM

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Abstract

The invention discloses a glycerin fructose sodium chloride injection and a preparation process thereof. The glycerin fructose sodium chloride injection is prepared by the following step: preparing 50-150 parts of glycerinum, 5-15 parts of sodium chloride and 10-100 parts of fructose for injection at a low temperature and carrying out ultrafiltration, wherein low temperature refers to the temperature at 30-60 DEG C. According to the glycerin fructose sodium chloride injection, a new technology is used. By adopting a new low-temperature preparation and ultrafiltration technology, no auxiliaries and active carbon are added in the preparation process, so that the problem that fructose is unstable (5-hydroxymethylfurfural is generated) and the problem on safety of residues of active carbon are solved, and the clinical potential safety hazards are eliminated.

Description

[0001] This application is the application number 201110220697.X submitted on August 3, 2011, and it is called a divisional application of glycerol fructose sodium chloride injection and its preparation process. technical field [0002] The invention relates to an injection and a preparation process thereof, in particular to a glycerol fructose sodium chloride injection and a preparation process thereof. Background technique [0003] Glycerin Fructose Sodium Chloride Injection is clinically a drug for lowering intracranial pressure, with definite curative effect, and has been well received by doctors and patients. However, due to the high quality requirements of this variety, the limit requirements of 5-hydroxymethylfurfural are extremely strict. In practice, a certain amount of antioxidants and auxiliary materials are used to solve this problem, which will bring certain safety problems of auxiliary materials. At the same time, for the requirements of intravenous administrat...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K9/08A61P25/00A61K31/7004A61K31/047
Inventor 欧苏梁隆程志鹏
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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