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Preparation method of ornithine aspartate injection

A technology for preparing ornithine aspartic acid and injection, which is applied in the field of medicine, can solve the problems of complex powder injection preparation process, high cost, and increased risk of adverse drug reactions, so as to ensure the sterilization effect and ensure the product quality. quality effect

Inactive Publication Date: 2018-11-30
安徽省金楠医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The powder injection preparation process is complicated, the cost is high, and it requires high skills for medical personnel
[0003] There are some impurities in the existing aspartate ornithine injection. The high content of impurities makes the quality of the injection difficult to control. At the same time, the high content of impurities will increase the risk of adverse drug reactions and reduce the safety of medication.

Method used

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  • Preparation method of ornithine aspartate injection

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Embodiment Construction

[0017] In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

[0018] A method for preparing ornithine aspartic acid injection, comprising the steps of:

[0019] S1. Cleaning and sterilization of low borosilicate glass ampoules: Remove the outer packaging of low borosilicate glass ampoules, put the ampoule into the bottle washing conveying tray, turn on the power, and transfer the injection bottle to the bottle washing machine, and use purified water, injection After cleaning with water, put it in a 250°C 100-level purification hot air circulation sterilization oven for 60 minutes, cool down, and enter the filling room for later use.

[0020] S2. Preparation of liquid medicine: P...

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Abstract

The invention discloses a preparation method of an ornithine aspartate injection. The preparation method comprises the following steps of S1, cleaning and sterilization of a low borosilicate glass ampoule, S2, preparation of liquid medicine, S3, filling, melt sealing and sterilization, and S4, sample inspection after the sterilization. Due to the use of medicinal charcoal and water for injection,the ornithine aspartate injection prepared by the preparation method does not produce harmful impurities, can further remove bacterial endotoxin, and then is sterilized and filtered through a filter membrane and a hundred-level laminar flow hood, and the sterilization effect and the product quality are ensured.

Description

technical field [0001] The invention belongs to the field of medicine, and more specifically relates to a method for preparing ornithine-aspartate injection. 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. Aspartic Acid Ornithine Injection is my country's first clinically used new drug with three effects of liver protection, detoxification and energy. Its main therapeutic ingredients are aspartic acid and ornithine. It is clinically used in acute, The treatment of chronic liver disease, including liver cirrhosis, fatty liver and elevated blood ammonia caused by hepatitis, is especially effective for hepatic encephalopathy. Currently commonly used dosage forms are powder injections, granules, and injections. Granules are particularly indicated for early loss of consciousness or neurological compli...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/04A61K31/205A61P1/16A61P25/00
CPCA61K9/0019A61K9/08A61K31/205A61K47/02A61P1/16A61P25/00
Inventor 胡惠平李杰杨红英陈贵霞
Owner 安徽省金楠医疗科技有限公司