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Production process of sodium chloride injections filled in plastic bottles

A technology of sodium chloride injection and production process, which is applied to the active ingredients of alkali/alkaline earth metal chlorides, packaging, and packaged food, and can solve the problems of increasing manpower and material costs

Inactive Publication Date: 2015-12-23
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] A production process of plastic bottled sodium chloride injection, comprising the steps of:

[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 loti...

Embodiment 2

[0036] A production process of plastic bottled sodium chloride injection, comprising the steps of:

[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 loti...

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PUM

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Abstract

The invention discloses a production process of sodium chloride injections filled in plastic bottles. The problem that bodies of polypropylene infusion bottles filled with sodium chloride injections turn yellow is solved and the rate of yellowing bottles is nearly zero after implementing the following measures: (1) reducing damages, caused by external forces, of preforms and bottles in the production process and reducing adhesion of film chips and fibers inside and outside the bottle bodies; (2) adding a sterilization cabinet outfall filter device to reduce accumulation of the film chips in sterilization pipelines and heat exchangers; and (3) reinforcing sterilization cabinet cleaning treatment to reduce adhesion of the film chips which turn yellow after multiple times of high-temperature heating, wherein the sterilization cabinet outfall filter device is cleaned every day, a sterilization cabinet is circularly cleaned by adopting a 2% NaOH solution every week, and no-load sterilization is carried out once. Rings are manufactured after adjusting a formula and uniformly mixing polypropylene new materials, recovered first-class polypropylene granules and thermoplastic rubber in a weight ratio of 1 to 1 to 1, so that the product quality is ensured while the production cost is reduced, and the rings can not be broken off.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production 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 impor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K33/14A61J1/05C08L23/12C08L101/00
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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