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Ornithine aspartate pharmaceutical composition for injection

A technology of ornithine aspartate and a composition, which is applied in the field of medicines in the field of medicine, can solve problems such as inconvenience in use, storage and transportation, and achieve the effects of reducing market risk, good stability and no allergic reaction.

Inactive Publication Date: 2014-03-26
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] The aspartate ornithine pharmaceutical composition produced by the prior art has very strict requirements on storage and light protection, and is inconvenient in use, storage and transportation

Method used

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  • Ornithine aspartate pharmaceutical composition for injection
  • Ornithine aspartate pharmaceutical composition for injection
  • Ornithine aspartate pharmaceutical composition for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0061] The described ornithine-aspartic acid pharmaceutical composition of every 1000 bottles, its formula consists of:

[0062]

[0063] Preparation process: Take 70% of the prescribed amount of water for injection, at a temperature of 50-60°C, add the prescribed amount of mannitol and anhydrous sodium bicarbonate, stir and dissolve; measure the initial pH value, and oxidize it with 4% hydroxide according to the initial pH value Adjust the pH range of sodium solution to 6.2-7.2; add the prescribed amount of ornithine aspartate, and stir until it is completely dissolved; add 0.1% medicinal charcoal, and stir for 30 minutes at 50-60°C; filter with suction and add Water for injection to the full amount, mix evenly, measure the pH value; fine filter; Vacuum, heat up to -8°C within 3 hours, maintain -8°C for 12-18 hours, heat up to 40°C in 3 hours, maintain 40°C for 3-8 hours, press the plug and cover; lamp inspection; storage; and the aspartic acid ornithine pharmaceutical co...

Embodiment 2

[0065] The described ornithine-aspartic acid pharmaceutical composition of every 1000 bottles, its formula consists of:

[0066]

[0067] Preparation process: with embodiment 1.

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Abstract

The invention belongs to the technical field of medicine, and discloses an ornithine aspartate pharmaceutical composition for injection. The ornithine aspartate injection consists of ornithine aspartate, mannitol and anhydrous sodium carbonate; a preparation method of the ornithine aspartate pharmaceutical composition comprises the following steps: fetching water for injection of the prescribed amount, adding the mannitol and the anhydrous sodium carbonate, and stirring for dissolution; adjusting the pH value to 6.2-7.2; adding the ornithine aspartate and stirring till complete dissolution; adding medicinal carbon, and stirring; performing suction filtration, supplementing the water for injection till full dose, and mixing uniformly; and performing fine filtration, filling, freeze-drying, light inspection and warehousing to obtain the ornithine aspartate pharmaceutical composition. The ornithine aspartate pharmaceutical composition has good stability and is mainly used for treating hepatic encephalopathy and chronic hepatitis B related diseases.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to an ornithine-aspartate pharmaceutical composition for injection and a preparation method thereof. Background technique [0002] Ornithine aspartate was first used clinically in Germany in the 1970s. It was included in the German Pharmacopoeia in 1991 and was approved by the US FDA for the treatment of hepatic encephalopathy. With the accumulation of clinical application experience, a wider application of ornithine-aspartate in the treatment of liver diseases has been gradually discovered. It is clinically used in the treatment of hepatic encephalopathy—one of the serious complications of end-stage liver disease; in the treatment of chronic hepatitis B; in the treatment of liver cancer patients during and after surgery, especially effective for hepatic encephalopathy. [0003] Ornithine Aspartate [0004] Chemical name: (S)-2,5-diaminovaleric acid (s)-2-aminosuccinate, the s...

Claims

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Application Information

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IPC IPC(8): A61K31/205A61K47/26A61K47/04A61K9/19A61P1/16
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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