Preparation technology for sodium chloride injection packaged in plastic bottles

A technology for sodium chloride injection and preparation process, which is applied in the field of preparation of sodium chloride injection in plastic bottles, and can solve the problems of increasing labor and material costs and the like

Inactive Publication Date: 2015-12-16
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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The preparation technology of plastic bottled sodium chloride injection comprises the steps:

[0026] 1) Weighing: prepare raw and auxiliary materials;

[0027] 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;

[0028] 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 lot...

Embodiment 2

[0036] The preparation technology of plastic bottled sodium chloride injection comprises the steps:

[0037] 1) Weighing: prepare raw and auxiliary materials;

[0038] 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;

[0039] 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 lot...

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PUM

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Abstract

The invention discloses a preparation technology for sodium chloride injection packaged in plastic bottles. The preparation technology includes the following measures that external force damage to bottle preforms and the bottles in the production process is reduced, and film scraps and fibers adhering to the insides and the outsides of bottle bodies are reduced; a filtering device is additionally arranged on a drain outlet of a sterilization cabinet, and accumulation of the film scraps in a sterilization pipeline and a heat exchanger is reduced; sterilization cabinet cleaning is enhanced, adhesion of yellowed film scraps after repeated high-temperature and high-heat treatment is reduced, the filtering device on the drain outlet of the sterilization cabinet is washed every day, and the sterilization cabinet is washed circularly with 2% NaOH solution each weak and carries out no-load sterilization once. After the measures are executed, the problem that liquid medicine in bottle bodies of the sodium chloride injection packaged in the polypropylene infusion bottles is turbid is solved, and the ratio of turbid liquid medicine in the bottle bodies is almost zero. By adjusting the formula, a new polypropylene material, a first-level recovered polypropylene granule material and thermoplastic elastomers are evenly mixed by the weight ratio of 1:1:1 and manufactured into hanging rings, the product quality is ensured while production cost is reduced, and the hanging rings will not break off.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation process of plastic bottled 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 impo...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K33/14A61J1/05
Inventor 阮莹乐丁永强吕亚平陈兴华陈早邦王敏
Owner GUANGXI YUYUAN PHARMA
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