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Valnemulin hydrochloride freeze-dried powder injection and preparation method thereof

A technology of warnemulin hydrochloride and freeze-dried powder injection, which is applied in the field of warnemulin hydrochloride freeze-dried powder injection and its preparation, and can solve problems such as unseen technical solutions

Active Publication Date: 2018-10-12
四川通达动物保健科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the use of freeze-drying method, the freeze-dried powder injection can improve its stability and efficacy for heat-sensitive drugs, which is consistent with the characteristics and medication requirements of warnemulin hydrochloride, but there is no relevant technical solution yet

Method used

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  • Valnemulin hydrochloride freeze-dried powder injection and preparation method thereof
  • Valnemulin hydrochloride freeze-dried powder injection and preparation method thereof
  • Valnemulin hydrochloride freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] S1. Under a sterile environment, accurately weigh 0.1 g of warnemulin hydrochloride (calculated as warnemulin) and 0.9 g of mannitol, place it in a clean preparation container, add 4 ml of water for injection, and stir until completely dissolved , adjust the pH value to about 4.5, add water for injection to 5ml, stir evenly, and perform sterilizing filtration with a 0.22 μm microporous filter membrane. After the filtrate is checked for clarity, the freeze-dried stock solution is obtained;

[0031] S2. Fill the freeze-dried stock solution into a 10ml control glass bottle, half-stopper it, and move it into a freeze-drying machine; the freeze-drying process is as follows: the liquid medicine is quickly frozen to -40°C for 3 hours, vacuumed to below 10Pa, and then Biochemical drying, temperature -12°C, time 10 hours, then analytical drying, temperature 25°C, duration 8 hours, full stoppering, capping, to obtain lyophilized powder injection of warnemulin hydrochloride (warnem...

Embodiment 2

[0033] The difference from Example 1 is that: Weigh 0.5 g of warnemulin hydrochloride (calculated as warnemulin) and 0.5 g of mannitol (the mass and fraction ratio of warnemulin to mannitol is 1:1).

Embodiment 3

[0035] The difference from Example 1 is that: Weigh 0.9 g of warnemulin hydrochloride (calculated as warnemulin) and 0.1 g of mannitol (the mass and fraction ratio of warnemulin to mannitol is 9:1).

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PUM

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Abstract

The invention discloses a valnemulin hydrochloride freeze-dried powder injection and a preparation method thereof. The preparation method comprises the following steps: dissolving the proportioned valnemulin raw powder and excipient by adopting injection water, removing the heat source, obtaining the valnemulin hydrochloride freeze-dried stock solution, pre-freezing, subliming drying, parsing drying, obtaining the freeze-dried powder, plugging, rolling a cover, inspecting, and obtaining a valnemulin hydrochloride freeze-dried powder injection finished product. The finished product appearance is in a white loose block shape, can be rapidly dissolved into clear liquid after the injection water is added, and is good in re-solubility. When the valnemulin hydrochloride freeze-dried powder injection is stored for six months under the condition of 40 plus or minus 2 DEG C and RH75 percent plus or minus 5 percent, the quality is stable. The valnemulin hydrochloride freeze-dried powder injection is simple, easy, stable and reliable in process, accurate in administration dosage of a dosage form, and suitable for the industrialized production.

Description

technical field [0001] The invention relates to a warnemulin hydrochloride freeze-dried powder injection and a preparation method thereof, belonging to the technical field of veterinary antibacterial drug preparations. Background technique [0002] Warnimulin hydrochloride is a new type of veterinary antibacterial drug, which has a wide range of antibacterial properties and low drug resistance. Mycoplasma, bacteria and spirochetes such as Staphylococcus aureus, Actinobacillus, Pasteurella, Brachyspira hyodysenteriae and colon pili-like spirochetes have good antibacterial activity. At present, the drug has been approved by the European Union for the prevention and treatment of swine dysentery caused by Brachyspira hyodysenteriae infection and porcine enzootic pneumonia caused by Mycoplasma pneumoniae infection. [0003] The existing warnemulin hydrochloride veterinary preparations are mainly premixed dosage forms, and there are many influencing factors, high cost and poor ec...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K31/22A61P31/04
CPCA61K9/0019A61K9/19A61K31/22A61K47/26A61P31/04
Inventor 侯东
Owner 四川通达动物保健科技有限公司
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