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Preparation method of metronidazole freeze dried powder injection

A technology of freeze-dried powder injection and metronidazole, which is applied in the field of chemical preparations, can solve problems such as the unqualified rate of clarity, poor product stability, and impact on clinical application, and achieve a strong killing effect on trichomonas, increased stability, and Effect of Clarity Improvement

Inactive Publication Date: 2006-09-13
巴里莫尔制药(通化)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the freeze-dried powder injection of metronidazole in the domestic market is produced by many companies, all of which are prepared by traditional techniques. The products have poor stability, strong irritation, poor solubility, high failure rate of clarity, and unsatisfactory curative effect. Problems such as stability can not be solved all the time, which affects clinical application

Method used

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  • Preparation method of metronidazole freeze dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A) Take 60% fresh water for injection at 80°C, avoid light, add metronidazole in the prescription, fully stir and dissolve, place it at room temperature, seal it in shading, refrigerate at 10°C for 48 hours, and use an ultrafiltration membrane with a molecular weight cut-off of 30,000 Ultrafiltration to obtain ultrafiltrate I.

[0024] B) Take fresh water for injection with a preparation amount of 30% at 90°C, add disodium edetate in the prescription to dissolve, place it at room temperature, refrigerate at 10°C for 48 hours, and ultrafilter with an ultrafiltration membrane with a molecular weight cut-off of 30,000 to obtain ultrafiltration Filtrate II.

[0025] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 6.0. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.45 μm filter membrane, and filled in vials under dark conditions. After freeze-drying, crimping and ...

Embodiment 2

[0027] A) Take 65% of fresh water for injection at 85°C, avoid light, add metronidazole in the prescription, fully stir and dissolve, place it at room temperature, seal it in shading, refrigerate at 8°C for 36 hours, and use an ultrafiltration membrane with a molecular weight cut-off of 20,000 Ultrafiltration to obtain ultrafiltrate I.

[0028] B) Take fresh water for injection with a preparation amount of 10% at 85°C, add disodium edetate in the prescription to dissolve, place it at room temperature, refrigerate at 8°C for 36 hours, and ultrafilter with an ultrafiltration membrane with a molecular weight cut-off of 20,000 to obtain ultra- Filtrate II.

[0029] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 5.8. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.45 μm filter membrane, and filled in vials under dark conditions. After freeze-drying, crimping and packagin...

Embodiment 3

[0031] A) Take 50% fresh water for injection at 90°C, avoid light, add metronidazole in the prescription, fully stir to dissolve, place it at room temperature, seal it in shading, refrigerate at 2°C for 12 hours, and use an ultrafiltration membrane with a molecular weight cut-off of 10,000 Ultrafiltration to obtain ultrafiltrate I.

[0032] B) Take fresh water for injection with a preparation amount of 15% at 90°C, add disodium edetate in the prescription to dissolve, place it at room temperature, refrigerate at 2°C for 12 hours, and ultrafilter it with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain ultrafiltration. Filtrate II.

[0033] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 6.2. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.45 μm filter membrane, and filled in vials under dark conditions. After freeze-drying, crimping and...

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Abstract

A freeze-dried powder injection of metronidazole for treating anaerobe infection, Trichomonas vaginalis and amebiasis is prepared from metronidazole through depositing in water, cold storage, ultrafiltration, further preparing in dark condition and N2 atmosphere, pouring in containers, freeze drying and sealing.

Description

technical field [0001] The present invention relates to a preparation method of metronidazole freeze-dried powder injection, specifically, relates to a kind of freeze-dried powder injection mainly composed of metronidazole, which is processed by water sinking, refrigeration and ultrafiltration technology, and then subjected to Prepared in the dark, filled, freeze-dried, capped and packaged to make a freeze-dried powder injection finished product, which belongs to the field of chemical preparations. The product can be injected intravenously, and has a strong antibacterial effect on most anaerobic bacteria, and has a strong effect on killing trichomonas, and also has a killing effect on amoeba in the intestinal tract and tissues. Aerobic infection, vaginal trichomoniasis, intestinal and parenteral amoebiasis (amoebiasis liver abscess, pleural amoebiasis, etc.). Background technique [0002] Metronidazole, also known as metronidazole, has decades of clinical application histor...

Claims

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Application Information

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IPC IPC(8): A61K31/4164A61K9/19A61P31/04A61P31/10
CPCY02A50/30
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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