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Freeze-dried metronidazole powder injection and preparation method thereof

A technology of freeze-dried powder injection and metronidazole, which is applied in the field of medicine, can solve the problems of increasing insoluble particles, long reconstitution time, and difficulty in compounding, etc., achieve high long-term stability, reduce insoluble particles, and shorten reconstitution time Effect

Inactive Publication Date: 2017-07-11
北京圣传创世科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] It can be seen that the main metronidazole freeze-dried powder injections at present include metronidazole disodium phosphate powder injections (with few auxiliary materials) and metronidazole and edetate disodium. However, although the current metronidazole freeze-dried powder injections To a certain extent, it reduces the adverse effects of nitrite and iron ions, but the powder injection also brings a series of new problems such as the increase of insoluble particles, long reconstitution time, difficulty in reconstitution or instability after reconstitution.

Method used

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  • Freeze-dried metronidazole powder injection and preparation method thereof
  • Freeze-dried metronidazole powder injection and preparation method thereof
  • Freeze-dried metronidazole powder injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0033] Example 1: Screening and optimization of freeze-dried powder prescription

[0034] The metronidazole medicinal solution was prepared respectively according to the prescription in Table 1, and then freeze-dried to obtain a freeze-dried powder injection. The freeze-drying process is as follows: pre-freezing stage: keep warm at -40°C for 3 hours, and then vacuumize; primary sublimation: the temperature rises to -30°C for 4 hours, then the temperature rises to -20°C for 4 hours, and then the temperature rises to 0°C Keep it for 6 hours; secondary drying: the temperature rises to 30°C and keeps it for 6 hours. Then the appearance, reconstitution time, clarity after reconstitution and insoluble particle inspection of the lyophilized powder were detected respectively.

[0035] Appearance and clarity: visually inspect the appearance. Dissolve the powder injection in 100mL of sodium chloride injection and then inspect it. With reference to the second part of the "Chinese Pharm...

Embodiment 2

[0044] prescription:

[0045]

[0046] Preparation method: Take 85% of the prescription amount of water for injection, slowly add the prescription amount of metronidazole and polyvinylpyrrolidone into the water for injection, stir and dissolve at a temperature of 40-50°C, and then continue to add sorbitol and glutamic acid to stir and dissolve , and then make up the rest of the water for injection to prepare the intermediate drug solution, and then freeze-dry to obtain the freeze-dried powder injection after filtering through the filter membrane. ; Primary sublimation: temperature rises to -30°C for 4 hours, then temperature rises to -20°C for 4 hours, then temperature rises to 0°C for 6 hours; secondary drying: temperature rises to 30°C for 6 hours.

Embodiment 3

[0048] prescription:

[0049]

[0050] Preparation method: Take 85% of the prescription amount of water for injection, slowly add the prescription amount of metronidazole and polyvinylpyrrolidone into the water for injection, stir and dissolve at 50°C, then continue to add sorbitol and glutamic acid to stir and dissolve, and then put Make up the rest of the water for injection to prepare the intermediate drug solution, and then filter the membrane and freeze-dry to make the freeze-dried powder injection. The freeze-drying process is as follows: pre-freezing stage: keep at -45°C for 4 hours, vacuumize; once sublimated : The temperature is raised to -30°C for 4 hours, then the temperature is raised to -15°C for 5 hours, then the temperature is raised to 0°C for 5 hours; secondary drying: the temperature is raised to 28°C for 7 hours.

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Abstract

The invention relates to a metronidazole freeze-dried powder preparation for injection and a preparation method thereof, which comprises metronidazole, glutamic acid, sorbitol and polyvinylpyrrolidone. It can effectively reduce nitrite and iron ions in metronidazole injection, avoid infusion pain, phlebitis, and side effects such as dizziness, chest tightness, and diarrhea caused by impurities such as nitrite. Dry powder injection has the advantages of short reconstitution time, less insoluble particles, easy reconstitution, and improved stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a metronidazole freeze-dried powder preparation for injection and a preparation method thereof. Background technique [0002] Metronidazole is a nitroimidazole derivative with broad-spectrum anti-anaerobic and antiprotozoal effects. It is mainly used clinically to prevent and treat infections caused by anaerobic bacteria, such as respiratory tract, digestive tract, abdominal cavity and pelvic pus infection, skin and soft tissue, etc. site infection and endocarditis, sepsis and meningitis caused by Bacteroides fragilis, in addition, it is also widely used in oral anaerobic infection. At present, the Pharmacopoeia has included metronidazole tablets, metronidazole vaginal effervescent tablets, metronidazole suppositories, metronidazole capsules, metronidazole gel, metronidazole injection, metronidazole glucose injection, metronidazole Sodium chloride injection and other varieties....

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4164A61K47/32A61P31/10A61P31/04A61P33/02
CPCA61K9/19A61K9/0019A61K31/4164A61K47/32
Inventor 朱孝云
Owner 北京圣传创世科技发展有限公司
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