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Compound electrolyte injection composition and preparation method thereof

A compound electrolyte and composition technology, which is applied in drug combination, drug delivery, pharmaceutical formulation, etc., to achieve the effect of precise and stable pH control

Inactive Publication Date: 2014-06-25
北京金康驰医药投资有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, the preparation method needs to be further improved in terms of effectively removing impurities such as organic impurities, pyrogens and pigments, and improving product stability.

Method used

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  • Compound electrolyte injection composition and preparation method thereof
  • Compound electrolyte injection composition and preparation method thereof
  • Compound electrolyte injection composition and preparation method thereof

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Effect test

Embodiment Construction

[0018] The following examples are used to illustrate the present invention, but they cannot be used to limit the scope of the present invention.

[0019] 1. Experiment on the effect of sterilization operation on pH value:

[0020] According to the standard of injection, the pH of this product should be between 4.0 and 8.0. The sample solution was prepared according to the prescription ratio, and the pH value was adjusted appropriately, and the change of pH after sterilization was investigated. The results are shown in Table 1.

[0021] Table 1: pH change results

[0022]

[0023] Conclusion: From the test results, it can be seen that the pH of the solutions of different pHs will decrease after sterilization, and the range of the decrease is about 0.14-0.25 pH.

[0024] 2. The effect of membrane filtration on the pH value of the solution at different water temperatures

[0025] The sample solution was prepared according to the prescription ratio, passed through 0.45 μm an...

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Abstract

The invention relates to a preparation method of compound electrolyte injection and a compound electrolyte injection composition. The preparation method comprises the following steps of: adding water for injection of which the quantity is 50% as heavy as the quantity of the prescription quantity in a concentrated preparation tank, weighing sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride of which the quantity is equal to the quantity of the prescription quantity and putting into a liquid preparation tank, dissolving in a stirring way, adding 0.1% (g / ml) of active carbon for injection, adsorbing for 15min in a stewing way, removing carbon into a dilute preparation tank in a filtering way, additively adding water for injection to be near to be full dose, evenly stirring, adjusting pH to be within the range from 7.0 to 7.6 by 0.1mol / L of sodium hydroxide, finely filtering by filters with 0.45mum and 0.22mum after an intermediate is detected to be qualified, carrying out light detection till no foreign matters are visible, carrying out split charging according to 500ml of each bag, sterilizing for 15min in a hot-press way under 121 DEG C, printing after the products are detected to be qualified under light, packing, and storing. Every 1000mL of the compound electrolyte injection composition prepared by the preparation method comprises 5.26g of sodium chloride, 5.02g of sodium gluconate, 3.68g of sodium acetate, 0.37g of potassium chloride and 0.30g of magnesium chloride; and the pH value is 6.8-7.4. The toxins, the insoluble particles and the heavy metals in the composition bacterium completely meet the requirements of injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for preparing a compound electrolyte injection and a compound electrolyte injection composition prepared by the method. Background technique [0002] Disorders of water and electrolyte metabolism are very common in clinical practice. Diseases of many organ systems, some systemic pathological processes, such as liver cirrhosis, diabetes, pulmonary heart disease, burns and post-operation, etc., can cause or be accompanied by water and electrolyte metabolism disorders; some changes in the external environment, some Iatrogenic factors such as improper use of drugs can also often lead to disturbance of water and electrolyte metabolism. If it is not corrected in time, the disturbance of water and electrolyte metabolism itself can cause corresponding obstacles to the physiological functions of various organ systems in the whole body, especially the cardiovascular sys...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K33/14A61K9/08A61P3/12A61K31/19A61K31/191
Inventor 余美荣刘向荣
Owner 北京金康驰医药投资有限公司
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