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Morpholine-nidazole injection and preparation method thereof

A technology of morpholinidazole and injection, which is applied in the direction of medical formula, medical preparations containing active ingredients, packaged food, etc., can solve problems such as poor stability, and achieve simple and easy preparation methods, low drug toxicity, good clinical safety

Pending Publication Date: 2020-12-29
JIANGSU HANSOH PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to solve the above problems, the present invention provides a morpholinidazole injection and a preparation method thereof, which can solve the problems of obvious photodegradation and poor stability of the aqueous solution of the crude drug

Method used

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  • Morpholine-nidazole injection and preparation method thereof
  • Morpholine-nidazole injection and preparation method thereof
  • Morpholine-nidazole injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0058] Experimental example 1 Comparison experiment of light stability of different pH intermediate medicinal liquids

Embodiment 1

[0060] Weigh 900mg of sodium chloride and dissolve it in 70% prescription water for injection, stir until completely dissolved; add 500mg of morpholinidazole, stir until completely dissolved; use 2M hydrochloric acid to adjust the pH to 4.0, then dilute to 100mL Afterwards, stir and mix evenly, and the liquid medicine after constant volume is sterilized and filtered through a filter element, then filled into a soft bag, and sterilized at 121°C for 15 minutes.

Embodiment 2

[0062] Weigh 900 mg of sodium chloride and dissolve it in 70% prescription water for injection, stir until completely dissolved; add 500 mg of morpholinidazole, stir until completely dissolved; use 2M hydrochloric acid to adjust the pH to 6.0, then dilute to 100 mL Afterwards, stir and mix evenly, and the liquid medicine after constant volume is sterilized and filtered through a filter element, then filled into a soft bag, and sterilized at 121°C for 15 minutes.

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PUM

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a morpholine-nidazole injection and a preparation method thereof. The morpholine-nidazole injection provided by theinvention contains morinidazole, a pH regulator and sodium chloride, and the pH regulator is used for regulating the pH value to 6.0-8.0. The morpholine-nidazole injection is good in stability, high in clinical safety, simple and feasible in preparation method, low in production cost, high in production efficiency and beneficial for process amplification production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a morphinidazole injection and a preparation method thereof. Background technique [0002] Nitroimidazole antibacterial drugs, the traditional drugs sold in the market mainly include metronidazole, ornidazole, secnidazole, etc., especially metronidazole as a fungicide, has a wide spectrum of anti-anaerobic bacteria, and is effective against Bacteroides fragilis, Eubacterium, Clostridium perfringens was highly sensitive, moderately sensitive to Peptococcus, Peptostreptococcus, and Previo melanogenum, and less sensitive to non-spore-forming Gram-positive bacilli. [0003] Morpholinidazole (formula I), as a third-generation nitroimidazole derivative, is a Class 1.1 new drug developed by Hansoh. The drug has low toxicity, good activity, anti-anaerobic bacteria, anti-trichomonas, and anti-amoeba, and is especially suitable for the following infections in adults ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K31/4164A61P31/04A61P33/02A61P15/00A61P1/00A61J1/10A61J1/14
CPCA61K9/08A61K9/0019A61K47/02A61K31/4164A61P31/04A61P33/02A61P15/00A61P1/00A61J1/10A61J1/14A61J1/1468
Inventor 董礼于婷崔畅畅杨宝海
Owner JIANGSU HANSOH PHARMA CO LTD
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