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 other particles, and the residue of activated carbon Particles cannot be completely removed, so as to prevent dust particles and sedimentation bacteria from entering the liquid medicine, reduce the content of particles and endotoxins, and prevent sugars from being oxidized

Active Publication Date: 2019-06-04
NANYANG LIXIN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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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  • Production technology of glucose sodium chloride injection
  • Production technology of glucose sodium chloride injection
  • Production technology of glucose sodium chloride injection

Examples

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Embodiment 1

[0042] A production process for glucose and sodium chloride injection, comprising 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 weighing and one person reviewing;

[0044] Step 2. Concentrated preparation: add 25% water for injection to the concentrated preparation tank, control the temperature at 80±5 °C, pass nitrogen, put glucose, fructose, xylitol and sodium chloride into it, pass nitrogen insulation conditions Under the stirring cycle for 30 minutes, it was filtered through the polysulfone cross-linked chitosan microfiltration membrane system, and the foreign matter in the liquid was checked to be qualified;

[0045] Step 3. Dilute preparation: rinse the concentrated preparation tank and the drug delivery pipeline three times with about 1000L water for injection, the flushing water is filtered and sent to the...

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Abstract

The invention discloses a production technology of glucose sodium chloride injection. The method comprises the following steps of step I, performing weighing; step II, performing thick blending; stepIII, performing thin blending; step IV, performing washing, stuffing and sealing; step V, performing sterilization; step VI, performing lamp inspection; and step VII, performing packing. According tothe production technology of glucose sodium chloride injection provided by the invention, the quality of the raw materials is strictly controlled, the technological process is adjusted and optimized,and the content of insoluble granules, heavy metal, and bacterial endotoxin in products is obviously reduced. Because nitrogen filling for encapsulation is adopted, the products are good in stability,antioxidants do not need to be added, the safety of the injection is further improved, and the production efficiency of an optimized technology and the qualified rate of finished products are both obviously increased.

Description

technical field [0001] The invention relates to the field of injection production, in particular to a production process for glucose and sodium chloride injection. Background technique [0002] Glucose and Sodium Chloride Injection is widely used clinically to adjust the electrolyte and acid-base balance of human body. It is mainly used for the treatment of dehydration caused by massive bleeding, diarrhea and vomiting. Glucose is one of the main sources of heat in the human body. Sodium and chlorine are important electrolytes in the body, mainly present 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 particulates in injections refer to particulate impurities generated or mixed in by various means during the production or use of medicines, with particle sizes ranging from 1 to 50 μm and invisible to the naked eye. Because it can flow with the bl...

Claims

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Application Information

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