Sodium bicarbonate Ringer's injection and preparation method thereof

A technology of Ringer's injection and sodium bicarbonate, which is applied in the field of medicine, can solve problems such as poor product stability, increased safety risks, and precipitation of Ringer's solution, and achieve the effect of low insoluble particle number

Active Publication Date: 2019-10-15
WUHAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sodium bicarbonate has a very good effect on correcting acidosis and maintaining the acid-base balance in the body. It should be the best choice for buffering tissue acidosis. To be developed and used in conjunction with sodium bicarbonate, it is necessary to solve the problem that sodium bicarbonate will cause precipitation of Ringer's solution
[0004] In order to solve this problem, many methods have been tried in the prior art, but these methods are relatively complex and difficult to control the product quality, especially because the insoluble particles produced by the precipitation problem increase rapidly, which increases the safety risk of medication, for example: China application The process of CN201510064578.8 requires multiple feeds of sodium dioxide gas, and the feed rate of carbon dioxide needs to be strictly controlled. At the same time, activated carbon is used in the process to remove pyrogens and impurities. Usually, activated carbon has an adsorption effect un

Method used

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  • Sodium bicarbonate Ringer's injection and preparation method thereof
  • Sodium bicarbonate Ringer's injection and preparation method thereof
  • Sodium bicarbonate Ringer's injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Sodium Bicarbonate Ringer's Injection was prepared using the following steps:

[0031] 1. Add 65L of water for injection into the preparation tank, add citric acid, sodium chloride, potassium chloride, calcium chloride dihydrate, and magnesium chloride hexahydrate in turn according to the prescription amount and stir to dissolve;

[0032] 2. Adjust the temperature of the solution in the preparation tank in step 1 to 38°C, add the prescribed amount of L-malic acid and stir to dissolve, then add the prescribed amount of sodium bicarbonate and stir to dissolve, add water for injection to 100L;

[0033] 3. Measure the pH value and content of the preparation tank solution in step 2, filter it with a 0.22 μm filter membrane, fill it according to the 500ml specification, and sterilize it at 121° C. for 15 minutes after filling to obtain Sodium Bicarbonate Ringer Injection.

[0034] Wherein: the specific prescription of described sodium bicarbonate Ringer's injection is:

[00...

Embodiment 2

[0050] Sodium Bicarbonate Ringer's Injection was prepared using the following steps:

[0051] 1. Add 65L of water for injection into the preparation tank, add citric acid, sodium chloride, potassium chloride, calcium chloride dihydrate, and magnesium chloride hexahydrate in turn according to the prescription amount and stir to dissolve;

[0052] 2. Adjust the temperature of the solution in the preparation tank in step 1 to 38°C, add the prescribed amount of L-malic acid and stir to dissolve, then add the prescribed amount of sodium bicarbonate and stir to dissolve, add water for injection to 100L;

[0053] 3. Measure the pH value and content of the solution in the preparation tank in step 2, filter it with a 0.22 μm membrane, fill it into 200 bottles according to the 500ml specification, and sterilize it at 121° C. for 15 minutes after filling to obtain Sodium Bicarbonate Ringer Injection.

[0054] Wherein: the specific prescription of the sodium bicarbonate Ringer injection i...

Embodiment 3～4

[0063] The preparation method is the same as that of Example 2, except that in step 2, the temperature of the solution in the preparation tank is adjusted to 39°C and 40°C respectively.

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Abstract

The invention relates to a sodium bicarbonate Ringer's injection and a preparation method thereof. Effective components of each 1000ml of the sodium bicarbonate Ringer's injection comprise 5.84 g of sodium chloride, 0.30 g of potassium chloride, 0.22 g of calcium chloride dehydrate, 0.20 g of magnesium chloride hexahydrate, 2.35 g of sodium bicarbonate, citric acid and L-malic acid. The sodium bicarbonate Ringer's injection obtained by the method has good stability, is not easy to generate precipitate, has a small number of insoluble particles and is stable, and the safety of medication is greatly improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to sodium bicarbonate Ringer injection and a preparation method thereof. Background technique [0002] In 1882, Sydney Ringer, in experiments with frog hearts, found that hearts perfused with tap water functioned better than distilled water, and he believed that electrolytes in the water played an important role. Based on this discovery, Ringer invented a compound sodium chloride injection containing electrolytes such as sodium, potassium, chloride, and calcium, and named it "Ringer's solution" or "Ringer's solution". In the early 1930s, Alexis Hartmann added lactic acid to Ringer's solution to treat acidosis. Lactated Ringer's solution came out, also known as "Hartmann's solution"; Successful intoxication and good solution stability, lactated Ringer's solution and 5% dextrose lactated Ringer's solution rapidly gained popularity. Because the formation of lactic acid b...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K9/08A61K47/12A61P7/08A61K33/06A61K33/00
CPCA61K9/0019A61K9/08A61K33/00A61K33/06A61K33/14A61K47/12A61P7/08A61K2300/00
Inventor 胡汉昆林嫚婷吴东方苏亚霞但菊开张觅吴建华刘亮田银刘薇芝
Owner WUHAN UNIV
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