Sodium bicarbonate Ringer's injection and preparation method thereof

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...

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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 under acidic conditions (pH3~5). Stronger, there will be desorption in the alkaline solution, which will increase the impurities in the solution and affect the quality of the preparation; Chinese application CN201510881456.8 also needs to introduce carbon dioxide at the end of the process to adjust the pH value, although the carbon dioxide addition process is relatively simple, further research It is found that the product produced by this process has poor stability and the insoluble particles increase rapidly; the Chinese application CN201711005695.2 also needs to inject carbon dioxide at the end of the process. Further research found that the product produced by this process has poor stability and the insoluble particles increase rapidly; China's application CN201710052371.8 also requires the introduction of carbon dioxide at the end of the process. Further research found that the product produced by this process has poor stability and the insoluble particles increase rapidly

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