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A kind of production technology of glucose sodium chloride injection

A glucose sodium chloride and production process technology, which is applied in the field of glucose sodium chloride injection production technology, can solve the problem of affecting the production efficiency and quality safety of glucose sodium chloride injection, the residue of activated carbon particles and the high content of other particles, and the residue of activated carbon Particles cannot be completely removed and other problems, to achieve the effect of optimizing process production efficiency and finished product qualification rate, reducing bacterial endotoxin content, and good product stability

Active Publication Date: 2021-04-30
NANYANG LIXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Boiling water for injection can speed up the dissolution rate of glucose and tinidazole, but due to the high temperature and long retention time, more 5-HMF is produced by the degradation of glucose in a high temperature environment, and there are also residual particles of activated carbon that cannot be completely removed in the subsequent filtration process. Adding solution to adjust the pH is easy to introduce new impurities and particles, and at the same time make the electrolyte composition in the liquid medicine change, etc.
[0007] The existing production process has problems such as slow dissolution rate of raw materials, high content of activated carbon particles and other particles, and high glucose degradation product 5-HMF, which directly affects the production efficiency and quality safety of glucose sodium chloride injection.

Method used

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  • A kind of production technology of glucose sodium chloride injection
  • A kind of production technology of glucose sodium chloride injection
  • A kind of production technology of glucose sodium chloride injection

Examples

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Embodiment 1

[0042] A kind of glucose sodium chloride injection production technology, comprises the following steps:

[0043] Step 1. Weighing: Calculate the required amount of glucose, fructose, xylitol, and sodium chloride according to the total amount of preparation, and then accurately weigh, one person weighs and one person checks;

[0044] Step 2. Concentrated preparation: add 25% of the total amount of water for injection into the concentrated preparation tank, control the temperature at 80±5°C, pass nitrogen, put in glucose, fructose, xylitol, and sodium chloride, and pass nitrogen to keep warm Stir and circulate for 30 minutes, filter through the polysulfone cross-linked chitosan microfiltration membrane system, and check that the foreign matter in the liquid is qualified;

[0045] Step 3. Dilute dispensing: Rinse the concentrated dispensing tank and drug delivery pipeline with about 1000L of water for injection for three times. After the rinse water is filtered, send it to the d...

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Abstract

The invention discloses a production process of glucose sodium chloride injection. The method comprises the following steps: step 1, weighing; step 2, concentrated preparation; step 3, thin preparation; Bacteria; Step 6: Light inspection; Step 7: Packaging. The production process of glucose sodium chloride injection provided by the present invention, the production process of glucose sodium chloride injection provided by the present invention, through strict control of the quality of raw materials, adjustment and optimization of the process flow, the content of insoluble particles, heavy metals, and bacterial endotoxins in the product Significantly reduced, due to the use of nitrogen filled potting, the product has good stability, and no additional antioxidant is needed, which further improves the safety of the injection, and the production efficiency of the optimized process and the qualified rate of the finished product are both significantly improved.

Description

technical field [0001] The invention relates to the field of injection production, in particular to a production process for glucose sodium chloride injection. Background technique [0002] Glucose Sodium Chloride Injection is a preparation widely used clinically to regulate the electrolyte and acid-base balance of the human body. It is mainly used for the treatment of dehydration caused by hemorrhage, diarrhea, and vomiting. Glucose is one of the main sources of heat for the human body. Sodium and chlorine are important electrolytes in the body. They mainly exist in extracellular fluid and play a very important role in maintaining the normal volume and osmotic pressure of blood and extracellular fluid in the human body. [0003] Insoluble particles in injections refer to particulate impurities that are produced or mixed in through various channels during the production or use of drugs, with a particle size of 1-50 μm and invisible to the naked eye. Because it can flow with...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K33/14A61P3/12A61P7/08A61P7/04A61P1/12A61P1/08A61L2/04A61K31/7004
Inventor 李明虎
Owner NANYANG LIXIN PHARMA
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