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Glycerin fructose sodium chloride injection and preparation method thereof

A technology of sodium chloride injection and sodium chloride, which is applied in the fields of active ingredients of alkali/alkaline earth metal chlorides, blood diseases, and pharmaceutical formulations, and can solve problems such as hidden dangers of drug use, rising content, and exceeding safety limits for patients, and achieve guaranteed The effect of product quality

Inactive Publication Date: 2017-05-31
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventor carried out tests according to the prescription and preparation process disclosed in the existing literature and found that the existing prescription and process can ensure that the content of 5-hydroxymethylfurfural is within the safety limit required by the standard, but it was found by the stability inspection experiment that With the passage of time, the content of 5-hydroxymethylfurfural in glycerol fructose increased significantly, and exceeded the safety limit, which brought huge hidden dangers to patients.

Method used

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  • Glycerin fructose sodium chloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Prescription: Take 0.1kg of glycerin, 0.05kg of fructose, 0.009kg of sodium chloride, 0.0006kg of activated carbon, 0.0003kg of calcium sodium edetate, appropriate amount of citric acid, and add water for injection to 1L.

[0022] Preparation process: Weigh the raw materials and auxiliary materials according to the prescription and reserve; put glycerin and sodium chloride in a beaker, add water for injection to make the concentration of sodium chloride 4%, stir and dissolve with a glass rod, add 0.03% (W / V) Activated carbon, boil for 14 minutes, let it cool to 80℃, filter with 0.22μm microporous membrane, transfer to another beaker, add water for injection to 2L, stir evenly with a glass rod, turn on nitrogen, adjust the nitrogen pressure gauge to 0.1bar, take a sample to check the content of glycerin and sodium chloride; put calcium sodium edetate into a beaker, stir to dissolve, add fructose at 40℃, stir to dissolve with a glass rod, add 0.03% (W / V) activated carbon , U...

Embodiment 2

[0024] Prescription: Take 0.21kg of glycerin, 0.1kg of fructose, 0.018kg of sodium chloride, 0.0012kg of activated carbon, 0.0006kg of calcium sodium edetate, appropriate amount of citric acid, and add water for injection to 2L.

[0025] Preparation process: Weigh the raw materials and auxiliary materials according to the prescription and reserve; put glycerin and sodium chloride in a beaker, add water for injection to make the concentration of sodium chloride 4%, stir and dissolve with a glass rod, add 0.03% (W / V) Activated carbon, boil for 14 minutes, let it cool to 80℃, filter with 0.22μm microporous membrane, transfer to another beaker, add water for injection to 2L, stir evenly with a glass rod, turn on nitrogen, adjust the nitrogen pressure gauge to 0.1bar, take a sample to check the content of glycerin and sodium chloride; put calcium sodium edetate into a beaker, stir to dissolve, add fructose at 40℃, stir to dissolve with a glass rod, add 0.03% (W / V) activated carbon , U...

Embodiment 3

[0027] Prescription: Take 0.3 kg of glycerin, 0.15 kg of fructose, 0.027 kg of sodium chloride, 0.0012 kg of activated carbon, 0.0006 kg of calcium sodium edetate, appropriate amount of citric acid, and add water for injection to 3L.

[0028] Preparation process: Weigh the raw materials and auxiliary materials according to the prescription and reserve; put glycerin and sodium chloride in a beaker, add water for injection to make the concentration of sodium chloride 4%, stir and dissolve with a glass rod, add 0.03% (W / V) Activated carbon, boil for 14 minutes, let cool to 80°C, filter with 0.22μm microporous membrane, transfer to another beaker, add water for injection to 2L, stir evenly with a glass rod, turn on nitrogen, adjust the nitrogen pressure gauge to 0.1bar, take a sample to check the content of glycerin and sodium chloride; put calcium sodium edetate into a beaker, stir to dissolve, add fructose at 40℃, stir to dissolve with a glass rod, add 0.03% (W / V) activated carbon ...

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Abstract

The invention relates to a glycerin fructose sodium chloride injection and a preparation method thereof. The glycerin fructose sodium chloride injection is prepared from glycerin, fructose, sodium chloride, activated carbon, sodium calcium edetate and citric acid, wherein the glycerin content accounts for 10% of the total content, the fructose content 5%, the sodium chloride content 0.9%, the activated carbon content 0.06% and the sodium calcium edetate content 0.03%. According to the formula and preparation method of the injection, the content of 5-hydroxymethylfurfural can be effectively controlled, the stability is good, and the product quality is guaranteed.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a glycerol fructose sodium chloride injection and a preparation method. Background technique [0002] Glycerol and Fructose Sodium Chloride Injection was approved for marketing in my country in 1993 for acute and chronic intracranial pressure increase, cerebral edema and other diseases caused by cerebrovascular disease, brain injury, brain tumor, intracranial inflammation and other reasons. In the course of the research, the prepared samples were measured at 284nm wavelength in accordance with the provisions of "Glycerol Fructose Sodium Chloride Injection" in the 2010 edition of the Chinese Pharmacopoeia, to investigate the influence of various factors on the main quality of the prepared fructose injection Indicator 5-hydroxymethyl furfural (5-HMF) and the effect of color. [0003] 5-Hydroxymethylfurfural is produced by the dehydration of fructose under weak acidity and high te...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/08A61K47/18A61K47/12A61P7/10A61K31/047A61K31/7004
CPCA61K33/14A61K9/0019A61K9/08A61K31/047A61K31/7004A61K47/12A61K47/183A61K2300/00
Inventor 徐飞王亚平李赛梅杨禄鹏
Owner SHANDONG QIDU PHARMA
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