Injection inosine and preparation method thereof

A technology for injection and water for injection, which is applied in the field of medicine, can solve the problems of high risk of clinical use, fluctuation of shelf life of freeze-dried powder, unstable quality of finished products, etc., to avoid the introduction of other substances, high clarity, and stable quality Effect

Active Publication Date: 2021-09-17
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Inosine for injection is generally a white or off-white loose block or powder. The existing inosine for injection is mainly stored in the form of freeze-dried powder, but due to the nature of inosine itself and the limitations of the preparation process, the finished product is generally There is a problem of unstable quality; therefore, the shelf life of the existing freeze-dried inosine powder for injection often has a large fluctuation range, and the risk of clinical use is relatively high

Method used

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  • Injection inosine and preparation method thereof
  • Injection inosine and preparation method thereof
  • Injection inosine and preparation method thereof

Examples

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Effect test

Embodiment 1

[0024] This embodiment provides a kind of inosine for injection, which is freeze-dried powder injection, each 0.2g, and its specific preparation method is as follows:

[0025] Dissolve NaCl in water for injection to prepare a solution with a concentration of 0.005mol / L, measure the pH of the solution to be 7.08, and set aside;

[0026] Add 200g of inosine to 4L of dissolving solution at a temperature of 10°C, keep the temperature constant during the dissolving process, then stir and slowly add 4g of sodium hydroxide until the inosine is completely dissolved to obtain a clear solution, and measure the pH of the clear solution Value is 12.46 (the initial pH of clarified liquid is in 11.5-13.1 and gets final product);

[0027] Add dropwise dilute hydrochloric acid with a concentration of 0.01mol / L to the clarified liquid to adjust the pH of the clarified liquid to between 8.0-9.0;

[0028] Add 250g of mannitol to the clarified liquid, stir until it is completely dissolved; after...

Embodiment 2

[0032] This embodiment provides a kind of inosine for injection, which is freeze-dried powder injection, each 0.2g, and its specific preparation method is as follows:

[0033] Dissolve NaCl in water for injection to prepare a solution with a concentration of 0.01mol / L, measure the pH of the solution to be 7.06, and set aside;

[0034] Add 200g of inosine to 4L of dissolving solution at a temperature of 20°C, keep the temperature constant during the dissolving process, then stir and slowly add 4g of sodium hydroxide until the inosine is completely dissolved to obtain a clear solution, and measure the pH of the clear solution The value is 12.33;

[0035] Add dropwise dilute hydrochloric acid with a concentration of 0.01mol / L to the clarified liquid to adjust the pH of the clarified liquid to between 8.0-9.0;

[0036] Add 250g of mannitol to the clarified liquid, stir until it is completely dissolved; after decolorization and impurity removal, filter, fill, and freeze-dry to obt...

Embodiment 3

[0039] This embodiment provides a kind of inosine for injection, which is freeze-dried powder injection, each 0.2g, and its specific preparation method is as follows:

[0040] Dissolve NaCl in water for injection to prepare a solution with a concentration of 0.05mol / L, measure the pH of the solution to be 7.02, and set aside;

[0041] Add 200g of inosine to 4L of dissolving solution at a temperature of 40°C, keep the temperature constant during the dissolving process, then stir and slowly add 4g of sodium hydroxide until the inosine is completely dissolved to obtain a clear solution, and measure the pH of the clear solution The value is 12.35;

[0042] Add dropwise dilute hydrochloric acid with a concentration of 0.01mol / L to the clarified liquid to adjust the pH of the clarified liquid to between 8.0-9.0;

[0043] Add 250g of mannitol to the clarified liquid, stir until it is completely dissolved; after decolorization and impurity removal, filter, fill, and freeze-dry to obt...

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Abstract

The invention relates to injection inosine and a preparation method thereof. The preparation method of the injection inosine comprises the following steps that the inosine is added into a dissolving solution which is prepared from metal salt and water for injection and has a pH value of 7.0-8.0, then sodium hydroxide is added, and a clear solution is obtained after the inosine is completely dissolved; the pH value of the clear solution is adjusted to 8.0-9.0; mannitol is added into the clear solution, and stirring is carried out until the mannitol is dissolved; and filtering, filling and freeze-drying are carried out to obtain the injection inosine. The preparation method is simple to operate, and the injection inosine which is stable in quality and safer in clinical application can be prepared. The injection inosine is prepared from the following raw materials: inosine, metal salt, sodium hydroxide, diluted hydrochloric acid, mannitol and water for injection, the raw materials do not contain components prone to causing adverse reaction, and the injection inosine has the advantage of stable quality.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to inosine for injection and a preparation method thereof. Background technique [0002] Inosine for injection has the effect of improving the body's metabolism. It is used in the adjuvant treatment of leukopenia and thrombocytopenia caused by various reasons, heart failure, angina pectoris, hepatitis, etc., and can also be used in the adjuvant treatment of optic atrophy and central retinitis. treat. [0003] The main component of inosine for injection is inosine, which is a nucleoside compound formed by combining hypoxanthine and ribose; inosine is a normal component of the human body and is the precursor of adenine, which can directly enter the body cells through the cell membrane It participates in nucleic acid metabolism, energy metabolism and protein synthesis in the body, and can increase the activity of coenzyme A and pyruvate oxidase, so that cells can perform normal metab...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7076A61K47/26A61K47/02A61P1/16A61P7/00A61P9/04A61P9/10A61P27/02
CPCA61K31/7076A61K9/19A61K9/0019A61K47/26A61K47/02A61P7/00A61P9/04A61P9/10A61P1/16A61P27/02
Inventor 符永红林方育肖汉文林小雪唐雄肇
Owner HAINAN GENERAL & KANGLI PHARMA
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