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Preparation method of inosine and composition injection thereof

A technology of inosine injection and composition, which is applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of drug safety for patients, loss of production enterprises, yellowing of color, etc. problem, to achieve the effect of ensuring stability

Active Publication Date: 2016-02-03
FUZHOU NEPTUNUS FUYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although inosine sodium chloride injection has been listed in the 2010 edition of the "Chinese Pharmacopoeia", it is often found that individual batches of products still have oxidation phenomena such as yellowing and yellowing within the validity period. This uncertain quality problem has not only caused the production Enterprises have caused great losses; and it is very likely to cause drug safety to clinical patients

Method used

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  • Preparation method of inosine and composition injection thereof
  • Preparation method of inosine and composition injection thereof
  • Preparation method of inosine and composition injection thereof

Examples

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Effect test

Embodiment 1

[0073] Accurately weigh the raw and auxiliary materials of each formula with the unit of 1 million ml of water for injection: inosine 6kg, sodium chloride 9kg, glycine 2kg; medicinal activated carbon 0.1kg.

[0074] The preparation process comprises the following steps:

[0075] (1) Take 0.1kg of medicinal activated carbon and make a paste with water for injection.

[0076] (2) Inject 500,000 ml of water for injection into the concentrated preparation tank, add inosine, sodium chloride, and glycine raw materials to stir and dissolve, adjust the pH to 6.5-7.0 with 10% sodium hydroxide solution, and add the adjusted wet medicinal activated carbon Heat to 96°C for 15 minutes.

[0077] (3) After the preparation is completed, the liquid medicine is refluxed and filtered, and the concentrated medicine is filtered using a titanium sintered rod with a pore size not greater than 15 μm for decarburization.

[0078] (4) Use a small beaker to collect the medicinal liquid at the return p...

Embodiment 2

[0087] Accurately weigh the raw and auxiliary materials of each formula with the unit of 1 million ml of water for injection: inosine 6kg, sodium chloride 9kg, glycine 1.5kg; medicinal activated carbon 0.1kg.

[0088] The preparation process comprises the following steps:

[0089] (1) Take 0.1kg of medicinal activated carbon and make a paste with water for injection.

[0090] (2) Inject 500,000 ml of water for injection into the concentrated preparation tank, add inosine, sodium chloride, and glycine raw materials to stir and dissolve, adjust the pH to 6.5-7.0 with 10% sodium hydroxide solution, and add the adjusted wet medicinal activated carbon Heat to 97°C for 15 minutes.

[0091] (3) After the preparation is completed, the liquid medicine is refluxed and filtered, and the concentrated medicine is filtered using a titanium sintered rod with a pore size not greater than 15 μm for decarburization.

[0092] (4) Use a small beaker to collect the medicinal liquid at the return...

Embodiment 3

[0101] Accurately weigh the raw and auxiliary materials of each formula with the unit of 1 million ml of water for injection: inosine 6kg, sodium chloride 9kg, glycine 2.5kg; medicinal activated carbon 0.1kg.

[0102] The preparation process comprises the following steps:

[0103] (1) Take 0.1kg of medicinal activated carbon and make a paste with water for injection.

[0104] (2) Inject 500,000 ml of water for injection into the concentrated preparation tank, add inosine, sodium chloride, and glycine raw materials to stir and dissolve, adjust the pH to 6.5-7.0 with 10% sodium hydroxide solution, and add the adjusted wet medicinal activated carbon Heat to 95°C for 15 minutes.

[0105] (3) After the preparation is completed, the liquid medicine is refluxed and filtered, and the concentrated medicine is filtered using a titanium sintered rod with a pore size not greater than 15 μm for decarburization.

[0106] (4) Use a small beaker to collect the medicinal liquid at the return...

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Abstract

The invention discloses a preparation method of inosine and a composition injection thereof. The injection is composed of raw materials of inosine and sodium chloride, and accessories of glycine and water for injection. 100ml of the composition contains 0.6 wt% of inosine, 0.9 wt% of sodium chloride and 0.15-0.25wt% of glycine. The injection is a large volume injection prepared from inosine and pharmaceutically acceptable accessories and has stable quality; and the injection is used for auxiliary treatment of leukopenia, thrombocytopenia, heart failure, angina pectoris and hepatitis caused by various reasons, and can also be used for auxiliary treatment of optic atrophy and central retinitis. The invention also involves preparation of a composition injection containing polygeline and inosine; the composition injection is a large volume injection prepared from polygeline, inosine and pharmaceutically acceptable excipients and has stable quality; and the composition injection is used for acute normovolemic hemodilution, improves microcirculation and prevents the occurrence of ischemic and hypoxic injury of tissues.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to the preparation of inosine and its composition injection. Background technique [0002] Inosine. Chemical name: 9-D-ribosehypoxanthine, molecular formula: C 10 h 12 N 4 o 5 , molecular weight: 268.23, chemical structural formula: [0003] [0004] Inosine is a subadenosine nucleoside compound, which is a normal component of the human body and a precursor of adenine. It can directly enter the body cells through the cell membrane and participate in nucleic acid metabolism, energy metabolism and protein synthesis in the body. [0005] Inosine can activate the pyruvate oxidase system, increase the activity of coenzyme A, activate liver function, and make the tissue cells in the low-energy and hypoxic state continue to metabolize, which is helpful for the recovery of damaged liver cell function. And participate in human energy metabolism and protein synthesi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/708A61K38/01A61P3/00A61P1/16A61P7/00A61P9/04A61P9/10A61P25/02A61P27/02A61J3/00A61K47/18
Inventor 俞宁
Owner FUZHOU NEPTUNUS FUYAO PHARMA
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