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Production method for preventing turbidity of plastic-bottle sodium chloride injection

The technology of a sodium chloride injection and a production method is applied in directions such as pharmaceutical formulations, active ingredients of alkaline/alkaline earth metal chlorides, and drug delivery, which can solve problems such as increasing labor and material costs, and achieve a reduction in the probability of pollution and impact resistance. Strong and stable effect

Inactive Publication Date: 2016-02-03
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] A production method for preventing turbidity of plastic bottled sodium chloride injection liquid, comprising the steps of:

[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 formulation tank, rinse the concentrated formulation ta...

Embodiment 2

[0033] A production method for preventing turbidity of plastic bottled sodium chloride injection liquid, comprising the steps of:

[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 formulation tank, rinse the concentrated formulation ta...

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Abstract

The invention discloses a production method for preventing turbidity of plastic-bottle sodium chloride injection. The production method includes 1) reducing damage caused by external force during production of bottle blanks and bottles and reducing membrane scraps and fiber attachments inside and outside bottle bodies; 2) increasing a sterilization cabinet drainage outlet filtering device to reduce accumulation of the membrane scraps in a sterilization pipeline and a heat exchanger; 3) strengthening sterilization cabinet washing treatment to reduce attachments of yellowing membrane scraps subjected to multi-time high temperature and high heat, wherein the sterilization cabinet drainage outlet filtering device is washed every day, and the sterilization cabinet is washed circularly by a 2% NaOH solution and is subjected to non-load sterilization once every week. According to the production method, the problem of turbidity of the sodium chloride injection in polypropylene infusion bottles is solved, and the turbidity rate of the sodium chloride injection in the bottle bodies is nearly zero.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production method for preventing turbidity of sodium chloride injection in plastic bottles. 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 f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K33/14A61P3/12
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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