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Ornidazole injection and preparation technology thereof

A technology of ornidazole injection and injection, which is applied in the field of pharmaceutical preparations and can solve problems such as irritation to the human body and unsatisfactory test results.

Inactive Publication Date: 2013-04-17
SHANXI PUDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some of these substances added are irritating to the human body, some are active substances, and some test results are not ideal

Method used

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  • Ornidazole injection and preparation technology thereof
  • Ornidazole injection and preparation technology thereof
  • Ornidazole injection and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1: Preparation of Ornidazole Injection (5ml:0.25g)

[0051] Ornidazole

2.5kg

Propylene Glycol

35L

Water for Injection

add to

50L

production

10000 pieces

[0052] A. Measure the prescribed amount of propylene glycol and place it in the liquid mixing tank, heat it to 80°C, and add the prescribed amount of ornidazole raw material while stirring to completely dissolve;

[0053] B. add water for injection, mix homogeneously with the above-mentioned ornidazole-propylene glycol solution, water to 80% of prescription quantity, get ornidazole solution;

[0054] C. Measure an appropriate amount of concentrated hydrochloric acid, dilute with water for injection to make a hydrochloric acid solution to adjust the pH value of the ornidazole solution to 3.4;

[0055] D. Add 0.1% (W / V) activated carbon for needles, stir and adsorb at 80°C for 15 minutes, and decarbonize while hot with a Φ1.0μm microporo...

Embodiment 2

[0060] Example 2: Preparation of Ornidazole Injection (5ml:0.25g)

[0061] Ornidazole

[0062] The preparation process is the same as in Example 1.

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PUM

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Abstract

The invention provides an ornidazole injection which comprises ornidazole, propylene glycol and water for injection, wherein the ornidazole can be well dissolved when the volume of the propylene glycol is 60%-70% of that of the injection. According to a preparation technology for the ornidazole injection, oxygen in the solution can be completely removed by utilizing carbon dioxide gas, and the saturated carbon dioxide gas in the injection can be used for not only reducing the oxidized by-product of the ornidazole injection, but also improving the heat stability of the ornidazole injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ornidazole injection and a preparation process. Background technique [0002] Ornidazole (ONZ), chemical name: 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole. Ornidazole is a third-generation nitroimidazole antibiotic, which is used for anaerobic infection, as well as protozoan and trichomonad infection. For the treatment of bacterial infections caused by Bacteroides fragilis, Bacteroides diteri, Bacteroides ovale, Bacteroides polymorpha, Bacteroides vulgaris, Clostridium, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori, Bacteroides melanin, A variety of infectious diseases caused by sensitive anaerobic bacteria such as Fusobacterium, CO2 Phagocytosis, and Bacteroides gingivalis; treatment of severe amoebic diseases in the digestive system, such as amoebic dysentery, amoebic liver abscess, etc. [0003] Ornidazole injection is the main ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4164A61K47/10A61P31/04A61P33/02
CPCY02A50/30
Inventor 李立忠王勇解晓荣李润宝苏志强姚荷云闫洁胡成伟
Owner SHANXI PUDE PHARMA CO LTD
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