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Micronized tinidazole powder injection

A technology of tinidazole powder and tinidazole, which is applied in the field of medicine, can solve the problems of uneven freeze-dried powder, poor clarity, and low product purity, and achieve improved bioavailability, water solubility, and clinical efficacy Effect

Inactive Publication Date: 2015-03-11
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the routinely used preparation of sterile powder for injection such as freeze-dried powder injection has the following disadvantages: the freeze-dried powder is uneven, the color is poor, there is a difference in pure loading, there is a problem in clarity, the prepared product has low purity, and the stability of the substance The sex problem has not been completely solved, and it is still not easy to store for a long time, etc., and the process of freeze-dried powder injection is more complicated and the cost is higher
[0009] Ordinary aseptic subpackaged preparations for injection have large particle size, slow reconstitution, and poor clarity after reconstitution, and the filling volume varies greatly during the subpackaging process

Method used

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  • Micronized tinidazole powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0037] The preparation of the micronized injection tinidazole powder preparation of embodiment 2

[0038] (1) 100g of tinidazole, 300g of polyethylene glycol 400, 600g of mannitol, and 20g of citric acid were mixed and dissolved, and freeze-dried in a large plate to obtain sterile powder of tinidazole for injection;

[0039] (2) Pre-crushing the sterile powder of tinidazole for injection with a fluid energy mill using collision technology to make coarse particles with a particle size of 70 μm;

[0040] (3) Use the CWJ-30 ultrafine pulverizer to ultrafinely pulverize the above coarse particles and pulverize them into 2-10μm fine powder;

[0041]Grinding conditions: the air temperature after freeze-drying is 5°C, the water content is 0.5%, the pressure when injected into the ultrafine pulverizer is 1.2MPa, the working pressure of the ultrafine pulverizer is 1.0MPa, the internal working temperature is 3°C, and the pulverization time is 120min.

[0042] (4) Subpackaging under as...

Embodiment 3

[0043] The preparation of the micronized injection tinidazole powder preparation of embodiment 3

[0044] (1) 100g of tinidazole, 400g of propylene glycol, 700g of mannitol, and 20g of citric acid were mixed and dissolved, and freeze-dried in a large plate to obtain sterile powder of tinidazole for injection;

[0045] (2) The fluid energy mill using collision technology pre-crushed the sterile powder of tinidazole for injection to make coarse particles with a particle size of 100 μm;

[0046] (3) Use the CWJ-30 ultrafine pulverizer to ultrafinely pulverize the above coarse particles and pulverize them into 2-10μm fine powder;

[0047] Grinding conditions: the air temperature after freeze-drying is 8°C, the water content is 0.4%, the pressure when injected into the ultrafine pulverizer is 1.0MPa, the working pressure of the ultrafine pulverizer is 1.2MPa, the internal working temperature is 6°C, and the pulverization time is 150min.

[0048] (4) Subpackaging under aseptic con...

Embodiment 4

[0049] The preparation of the micronized injection tinidazole powder preparation of embodiment 4

[0050] (1) 100 g of tinidazole was pre-crushed aseptic tinidazole powder for injection using a fluid energy mill with collision technology to make coarse particles with a particle size of 120 μm;

[0051] (2) Use the CWJ-30 ultrafine pulverizer to ultrafinely pulverize the above coarse particles and pulverize them into 2-10μm fine powder;

[0052] Grinding conditions: the air temperature after freeze-drying is 7°C, the water content is 0.7%, the pressure when injected into the ultrafine pulverizer is 0.9MPa, the working pressure of the ultrafine pulverizer is 1.3MPa, the internal working temperature is 4°C, and the pulverization time is 70min.

[0053] (3) Mix and dissolve micronized tinidazole, 200g polyethylene glycol 400, 300g propylene glycol, 800g mannitol, and 20g citric acid, freeze-dry in a large plate, and obtain tinidazole sterile powder for injection;

[0054] (4) Su...

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Abstract

The invention relates to a micronized tinidazole powder injection, which is prepared by the following steps: firstly, carrying out large-tray freeze-dried aseptic treatment on tinidazole and auxiliary materials, then micronizing by adopting a superfine grinding technology, so as to prepare fine powder, and carrying out aseptic packaging; or firstly, micronizing the tinidazole by adopting the superfine grinding technology, so as to prepare fine powder, carrying out large-tray freeze-dried aseptic treatment on the fine powder and the auxiliary materials, and carrying out aseptic packaging. By adopting the micronized tinidazole powder injection prepared by adopting the superfine grinding technology, the water solubility of the tinidazole is improved, the bioavailability is improved, and the clinical treatment effect of a medicament preparation is improved.

Description

technical field [0001] The invention relates to a tinidazole powder injection preparation, in particular to a micronized tinidazole powder injection preparation prepared by superfine pulverization technology, and belongs to the technical field of medicine. Background technique [0002] Tinidazole has high activity against protozoa and anaerobic bacteria. It has antibacterial activity against Bacteroides such as Bacteroides fragilis, Fusobacterium, Clostridium, Peptococcus, Peptostreptococcus, Veillonella and Gardnerella, and the concentration of 2-4mg / L can inhibit most of the anorexia Aerobic bacteria; microaerophilic bacteria and Helicobacter pylori are sensitive to it; the MIC against Trichomonas vaginalis is similar to that of metronidazole, and its metabolites have stronger activity against Gardnerella than tinidazole. [0003] The mechanism of action of tinidazole has not been fully elucidated, and the nitroreductase of anaerobic bacteria plays an important role in th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4164A61P33/02A61P31/04
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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