Production method for sodium chloride injection

A technology of sodium chloride injection and production method, which is applied in the direction of active ingredients of alkali/alkaline earth metal chlorides, pharmaceutical formulas, and devices for making medicines into special physical or ingestible forms, and can solve problems such as increasing manpower and material costs , to achieve the effect of stable quality

Inactive Publication Date: 2016-12-14
GUANGXI YUYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the existing technology, drugs such as sodium chloride injection are generally produced according to the process steps suggested by the State Food Administration or Pharmacopoeia and other guidance documents. If a drug manufacturer changes the production process for a product that has received approval, it needs to Resubmitting for approval will increase the cost of manpower and material resources

Method used

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  • Production method for sodium chloride injection
  • Production method for sodium chloride injection
  • Production method for sodium chloride injection

Examples

Experimental program
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Effect test

Embodiment 1

[0027] A production method of sodium chloride injection, comprising the steps of:

[0028] 1) Weighing: prepare raw and auxiliary materials;

[0029] 2) Concentrated preparation: inject 300L of water for injection into the concentrated preparation tank, start stirring, put sodium chloride into the concentrated preparation tank to fully dissolve the sodium chloride, add 0.02% (w / v) of activated carbon, and clean the carbon adjustment barrel with water for injection There is no carbon stain on the mixing spoon, add the cleaning water to the concentrated tank, boil the liquid medicine and keep it boiling for 10 minutes, and cool the liquid medicine temperature to 70-75°C;

[0030] 3) Dilute formulation: add 2 / 3 of the prepared water to the dilute formulation tank, start stirring, decarbonize and filter the thick formulation through a titanium rod, and then send it to the dilute formulation tank, rinse the concentrated formulation tank 3 times, rinse Put the lotion into the dilut...

Embodiment 2

[0037] A production method of sodium chloride injection, comprising the steps of:

[0038] 1) Weighing: prepare raw and auxiliary materials;

[0039] 2) Concentrated preparation: inject 300L of water for injection into the concentrated preparation tank, start stirring, put sodium chloride into the concentrated preparation tank to fully dissolve the sodium chloride, add 0.02% (w / v) of activated carbon, and clean the carbon adjustment barrel with water for injection There is no carbon stain on the mixing spoon, add the cleaning water to the concentrated tank, boil the liquid medicine and keep it boiling for 10 minutes, and cool the liquid medicine temperature to 70-75°C;

[0040] 3) Dilute formulation: add 2 / 3 of the prepared water to the dilute formulation tank, start stirring, decarbonize and filter the thick formulation through a titanium rod, and then send it to the dilute formulation tank, rinse the concentrated formulation tank 3 times, rinse Put the lotion into the dilute ...

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Abstract

The invention discloses a production method for a sodium chloride injection. By the research on the influence of the pH value on visible foreign matters in the sodium chloride injection in a dilution procedure, a result shows that the quality of the sodium chloride injection is stabler when the pH value is between 5.30 and 6.10.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production method of sodium chloride injection. Background technique [0002] Sodium chloride injection, the main ingredient and its chemical name are: sodium chloride, molecular formula: NaCl molecular weight: 58.44. It is a colorless clear liquid; the taste is slightly salty. For dehydration caused by various reasons, including hypotonic, isotonic and hypertonic dehydration; hypertonic non-ketotic diabetic coma, application of isotonic or hypotonic sodium chloride can correct dehydration and hypertonicity state; hypochloremic metabolic alkalosis; external use of normal saline to wash eyes, wash wounds, etc.; also used in obstetric water sacs to induce labor. [0003] Sodium chloride is an electrolyte replacement drug. Sodium and chlorine are important electrolytes in the body, mainly present in extracellular fluid, and play a very important role in main...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K9/08A61P3/12A61J3/00
CPCA61K33/14A61J3/00A61K9/0019A61K9/08
Inventor 阮莹乐杨家雄陈兴华彭洪专陈早邦王敏
Owner GUANGXI YUYUAN PHARMA
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