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Preparation method of sodium chloride injection

A technology of sodium chloride injection and sodium chloride, which is applied in the fields of pharmaceutical formulations, drug delivery, and inorganic non-active ingredients. It can solve the problems of reduced clarity and quality, and achieve excellent clarity and excellent sterilization effect. Effect

Inactive Publication Date: 2019-03-29
江西润泽药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a kind of preparation method of sodium chloride injection in order to overcome the problem that the clarity of sodium chloride injection existing in the prior art is reduced, and quality is reduced

Method used

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  • Preparation method of sodium chloride injection
  • Preparation method of sodium chloride injection
  • Preparation method of sodium chloride injection

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Experimental program
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Effect test

preparation example Construction

[0027] The invention provides a preparation method of sodium chloride injection, comprising:

[0028] (a) in the concentrated dispensing tank, sodium chloride is added in the water for injection of 60-70% configuration amount, stirred to dissolve completely, then add activated carbon for injection I, obtain concentrated dispensing liquid;

[0029] The temperature of the concentrated medicinal solution is controlled to be 40-50° C., and after stirring for 10-60 min to carry out the adsorption reaction, the concentrated medicinal solution is filtered until the concentrated medicinal solution is clear to obtain the concentrated medicinal solution;

[0030] (b) transferring the concentrated solution to the dilute preparation tank, adding water for injection into the dilute preparation tank to the configured amount, then adding activated carbon II for injection, stirring for adsorption reaction for 10-60min, and then carrying out decarbonization treatment to obtain dilute solution;...

Embodiment 1

[0058] (1) Weighing: accurately weigh the raw materials;

[0059] (2) Concentrated preparation: in the concentrated preparation tank, add sodium chloride to 70% of the water for injection of the configured amount, stir until completely dissolved, add activated carbon I for injection, control the temperature of the medicinal solution to be 50 ° C, and stir to carry out the adsorption reaction for 60min, Filter until the medicinal liquid is clarified to obtain a concentrated solution;

[0060] (3) Diluted preparation potting: transfer the concentrated preparation solution to the dilute preparation tank, add water for injection to the dilute preparation tank to the configured amount, add activated carbon II for injection, stir to carry out adsorption reaction for 30min, and then carry out decarbonization treatment , Sampling to detect the content of sodium chloride and the pH of the liquid, and the qualified liquid is filtered through a 0.45μm precision filter and a 0.2μm sterili...

Embodiment 2

[0065] (1) Weighing: accurately weigh the raw materials;

[0066] (2) Concentrated preparation: in the concentrated preparation tank, add sodium chloride to 60% of the water for injection, stir until completely dissolved, add activated carbon I for injection, control the temperature of the medicinal solution to be 40 ° C, and stir to carry out the adsorption reaction for 50 min, Filter until the medicinal liquid is clarified to obtain a concentrated solution;

[0067] (3) dilute preparation and encapsulation: transfer the concentrated preparation to the dilute preparation tank, add activated carbon II for injection, stir to carry out adsorption reaction for 40min, carry out decarbonization treatment, and sample to detect the content of sodium chloride and the concentration of the medicinal solution. pH, the qualified liquid is filtered through a 0.45μm precision filter and a 0.2μm sterilizing filter for potting. Wherein, the total dosage of activated carbon for injection is 0...

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Abstract

The present invention relates to the technical field of medicinal preparations and discloses a production method of a sodium chloride injection. The production method comprises the following steps: (a) sodium chloride is added into water for injection at a 60-70% preparation amount to prepare concentration prepared medicinal liquid in a concentration preparation tank; (b) the concentration prepared liquid is added into the water for injection to a preparation amount, and filling is conducted to obtain filled medicinal liquid; and (c) the filled medicinal liquid is sterilized to obtain a sterilized sodium chloride injection; wherein the sterilization is as follows: the filled medicinal liquid is placed in an irradiation device for a radiation sterilization treatment, irradiation time is 10-40 min, and radiation dose is 20-70 kGy. The method uses the radiation method to sterilize the filled sodium chloride injection, does not need a conventional sterilization method by increasing temperature of the medicinal liquid, can realize killing of bacteria in the sodium chloride injection, ensures quality of medicines, and does not produce clarity decrease of the sodium chloride injection caused by boiling-out of the medicinal liquid, etc.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation 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 and clear liquid; the taste is slightly salty. For dehydration from various causes, including hypotonic, isotonic and hypertonic; hypertonic nonketotic diabetic coma, isotonic or hypotonic sodium chloride can be used to correct dehydration and hypertonicity low chloride metabolic alkalosis; external use of normal saline to flush eyes, wash wounds, etc.; also used in obstetric water bladder induction of labor. [0003] Sodium chloride is an electrolyte replacement drug. Sodium and chloride are important electrolytes in the body, mainly present in extracellular fluid, and play a very important role in maintaining normal blo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61L2/08
CPCA61K9/0019A61K9/08A61K47/02A61L2/0029
Inventor 胡贤德廖年生李海荣
Owner 江西润泽药业有限公司