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Production method for preventing bottle body yellowing and liquid turbidity of plastic bottled sodium chloride injection

The technology of a sodium chloride injection and a production method is applied in the directions of pharmaceutical formulations, sanitary equipment for toilets, active ingredients of alkaline/alkaline earth metal chlorides, etc., and can solve the problems of increasing labor and material costs and the like

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

[0023] The production method for preventing the plastic bottled sodium chloride injection from turning yellow and the liquid medicine from being turbid comprises the following steps:

[0024] 1) Weighing: prepare raw and auxiliary materials;

[0025] 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;

[0026] 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 fo...

Embodiment 2

[0033] The production method for preventing the plastic bottled sodium chloride injection from turning yellow and the liquid medicine from being turbid comprises the following steps:

[0034] 1) Weighing: prepare raw and auxiliary materials;

[0035] 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;

[0036]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 for...

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Abstract

The invention discloses a production method for preventing bottle body yellowing and liquid turbidity of a plastic bottled sodium chloride injection. The production method comprises the following steps: (1) reducing external force damages to a bottle preform and a bottle during production, and reducing film scraps and fiber attachment inside and outside a bottle body; (2) additionally providing a water outlet filter for a sterilizing cabinet, and reducing accumulation of the film scraps in a sterilizing pipeline and a heat exchanger; and (3) strengthening cleaning treatment of the sterilizing cabinet, reducing the attachment of yellowed film scraps after multiple times of high-temperature and high-heat treatment, cleaning the water outlet filter of the sterilizing cabinet every day, circularly cleaning the sterilizing cabinet by using 2% NaOH solution every week, and performing empty sterilization once. After implementing the steps, the problems of bottle body yellowing and in-bottle liquid turbidity for the polypropylene infusion bottled sodium chloride injection are solved, and the ratio of bottles with bottle body yellowing in-bottle liquid turbidity is almost zero.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production method for preventing the bottle body of plastic-packed sodium chloride injection from turning yellow and the liquid from being turbid. 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 elec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K33/14A61P3/12A61L2/18A61L2/26
Inventor 阮传明吕亚平陈兴华彭洪专陈早邦王敏
Owner GUANGXI YUYUAN PHARMA
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