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Method for preparing sodium chloride and dextrose injection

A glucose sodium chloride and injection technology, which is applied in the field of preparation of glucose sodium chloride injection, can solve the problems of lower clarity, lower quality of injection, and lower content of 5-hydroxymethylfurfural, etc., so as to avoid glucose degradation The effect of reaction, excellent stability, and excellent sterilization effect

Pending Publication Date: 2019-03-22
江西润泽药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] The purpose of the present invention is to overcome the problem that the clarity of glucose sodium chloride injection that exists in the prior art reduces, and the high content of 5-hydroxymethylfurfural (5-HMF) causes the problem of the quality reduction of glucose sodium chloride injection, and provides A preparation method of glucose sodium chloride injection, the method adopts irradiation and / or microwave to sterilize the encapsulated glucose sodium chloride injection, without adopting the conventional damp heat sterilization method of raising the temperature of the liquid medicine , that is, it can realize the killing of bacteria in the sodium chloride injection, without reducing the clarity of the sodium chloride injection caused by the boiling of the drug solution, and at the same time reduce the content of 5-hydroxymethylfurfural in the injection, ensuring the quality of medicines

Method used

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  • Method for preparing sodium chloride and dextrose injection
  • Method for preparing sodium chloride and dextrose injection
  • Method for preparing sodium chloride and dextrose injection

Examples

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preparation example Construction

[0028] The present invention provides a kind of preparation method of glucose sodium chloride injection, wherein, described method comprises the following steps:

[0029] (a) Sodium chloride and glucose are dropped into the concentrated preparation tank that contains the water for injection of 60-70% configuration amount, stir until dissolving completely, add activated carbon I for injection, leave standstill after stirring 10-30min, filter, obtain concentrated dosing;

[0030] (b) Transfer the concentrated solution to the diluted formulation tank, add activated carbon II for injection, add water for injection to the configured volume into the diluted formulation tank, stir for 10-60 minutes after the adsorption reaction, and perform decarbonization treatment to obtain Medicinal solution: take a sample to detect the sodium chloride, glucose content and pH value of the medicinal solution, and the qualified medicinal solution is filtered through a 0.45 μm precision filter and a ...

Embodiment 1

[0061] (1) Accurately weigh raw materials;

[0062] (2) Add 70% water for injection, sodium chloride and glucose in the concentrated preparation tank, stir until fully dissolved, add activated carbon for injection 1, leave standstill after stirring for 30min, filter, and obtain concentrated dosing;

[0063] (3) Transfer the thick dosing solution to the dilute dosing tank, add activated carbon II for injection, add water for injection to the prepared volume in the dilute dosing tank, stir for adsorption reaction for 30 minutes, perform decarbonization treatment, and take samples to detect chlorination The content of sodium and glucose and the pH of the medicinal solution, the qualified medicinal solution is filtered through a 0.45 μm precision filter and a 0.2 μm sterilizing filter in sequence, and then canned. Wherein, the total consumption of activated carbon for injection is 0.06w / v%, the consumption ratio of activated carbon I for injection and activated carbon II for injec...

Embodiment 2

[0068] (1) Accurately weigh raw materials;

[0069] (2) Add 60% water for injection, sodium chloride and glucose in the concentrated preparation tank, stir until completely dissolved, add activated carbon I for injection, leave standstill after stirring for 10min, filter, and obtain concentrated dosing;

[0070] (3) Transfer the thick dosing solution to the dilute dosing tank, add activated carbon II for injection, add water for injection to the configured volume in the dilute dosing tank, stir for adsorption reaction for 40 minutes, then perform decarbonization treatment, and take samples to detect chlorination The sodium content and the pH of the medicinal solution, the qualified medicinal solution is filtered through a 0.45 μm precision filter and a 0.2 μm sterilizing filter in sequence, and then canned. Wherein, the total dosage of activated carbon for injection is 0.02w / v%, the dosage ratio of activated carbon for injection I and activated carbon for injection II is 1:2, ...

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Abstract

The invention relates to the technical field of medicinal preparation, and discloses a method for preparing a sodium chloride and dextrose injection. The method comprises the following steps: (a) adding sodium chloride and glucose into 60% to 70% configuration amount of water for injection to prepare a concentrated compound fluid; (b) adding the concentrated compound fluid into the water for injection until configuration amount, and carrying out potting to obtain potted liquid medicine; and (c) carrying out sterilization treatment on the potted liquid medicine, wherein the sterilization treatment comprises irradiation and / or microwave sterilization. According to the method, sterilization is carried out by using the sodium chloride and dextrose injection after irradiation and / or microwave potting, and killing of bacteria inside a sodium chloride injection can be realized without using a conventional moist heat sterilization method of increasing the temperature of the liquid medicine, the reduction of the clarity of the sodium chloride injection caused by boiling of the liquid medicine cannot be caused, and simultaneously, the content of 5-hydroxymethyl furfural inside the injectionis reduced, and the quality of the medicine is guaranteed.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of glucose sodium chloride injection. Background technique [0002] Critically ill patients often need fluid replacement therapy due to various reasons, while trauma or stress and other factors in critically ill patients put the body in a state of high decomposition, resulting in malnutrition, low immune function, and weakened resistance; glucose is one of the main sources of heat for the human body 1. Sodium and chlorine are important electrolytes in the body. They mainly exist in the extracellular fluid and play a very important role in maintaining the volume and osmotic pressure of normal blood and extracellular fluid in the human body. [0003] Although glucose itself has no direct biological toxicity, glucose will produce a large amount of toxic glucose degradation products (glucose degradation products.GDPs) during high-temperature s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/08A61P3/02A61L2/08A61L2/12A61K31/7004
CPCA61K9/0019A61K9/08A61K31/7004A61K33/14A61L2/0029A61L2/0064A61P3/02A61K2300/00
Inventor 眭荣春胡贤德曾华亮
Owner 江西润泽药业有限公司
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