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Method for preparing kitasamycin tartrate injection

The technology of guitarmycin and injection is applied in the field of preparation of macrolide drug guitarmycin tartrate injection, which can solve the problems of large chance of contamination, need to be prepared, complicated process and the like

Inactive Publication Date: 2006-08-23
刘小清
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compared with the solution dosage form, the powder injection has some disadvantages, for example; (1) the process is complicated, and the chance of bacterial contamination is large; (2) it needs to be prepared during use, it is inconvenient, and it is difficult to find problems such as the clarity of the solution
[0005] Therefore, if the shortcoming of the unstable structure of kitasamycin can be solved, a fast, safe, effective and more convenient kitasamycin tartrate solution injection will be provided, which will bring great benefits to patients and society.
Kitamycin Injection solves the unstable shortcomings of the first-generation macrolide drugs recognized at home and abroad during high-temperature sterilization and long-term storage, which marks a breakthrough in the stability of the drug. There is no report of this process in literature at home and abroad

Method used

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Examples

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example 1

[0019] Example 1: Preparation of small volume kitasamycin tartrate injection

[0020] prescription:

[0021] Kitamycin Tartrate 200g

[0022] Ethanol 500ml

[0023] Propylene glycol 500ml

[0024] Appropriate amount of PH regulator

[0025] Total 1000ml

[0026] A total of 1000 bottles

[0027] In a 10,000-level clean area, take kitasamycin tartrate, ethanol and propylene glycol and mix and dissolve according to the prescription. Adjust the PH to 6.5-7.5 with a PH regulator, add activated carbon at 0.03% of the liquid volume, decolorize at room temperature for 30 minutes, and send the activated carbon into a 100-level clean area after coarse filtration of activated carbon, and fine filter through a 0.22um microporous membrane. Take an appropriate amount of the fine filtrate and submit it for inspection. After passing the inspection, calculate the filling volume, subpackage, sterilize, light check, and pa...

example 2

[0028] Example 2: Preparation of Large Volume Kitamycin Tartrate Injection

[0029] prescription:

[0030] Kitamycin Tartrate 200g

[0031] Ethanol 1000ml

[0032] Propylene glycol 1000ml

[0033] Tween 200g

[0034] Appropriate amount of PH regulator

[0035] Add water for injection to 100000ml

[0036] A total of 1000 bottles

[0037] In a 10,000-level clean area, take kitasamycin tartrate, ethanol, propylene glycol and 30% water for injection to mix and dissolve according to the prescription. Adjust the PH to 6.5-7.5 with a PH regulator, add activated carbon at 0.05% of the liquid volume, decolorize at room temperature for 30 minutes, filter the activated carbon roughly and send it to a 100-level clean area, and filter it through a 0.22um microporous membrane. Add water for injection to the full amount, adjust the pH value, take a proper amount of fine filtrate and submit it for inspection, calculate the filling volum...

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PUM

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Abstract

The present invention solves the difficult problem of microlide medicine kitasamycin tartrate in unstable structure, and provides preparation process of kitasamycin tartrate injection. The kitasamycin tartrate injection consists of kitasamycin tartrate or kitasamycin as main medicine component, solvent for injection, pH stabilizer, chemical structure stabilizer, metal ion complexing agent, isosmotic regulator and other auxiliary components. The kitasamycin tartrate injection has high stability, high safety and effectiveness, simplified clinical use and other advantages.

Description

technical field [0001] The invention relates to a preparation method of macrolide drug kitasamycin tartrate injection. Background technique [0002] Kitasamycin (kitasamycin) is the first generation of macrolides - 16-membered ring macrolides. The mechanism of action and antibacterial spectrum are similar to erythromycin, but it has strong antibacterial effect on Gram-positive bacteria, and has effects on staphylococcus, hemolytic streptococcus, pneumococcus, diphtheria bacillus, tetanus bacillus, anthrax bacillus, etc. . It also has antibacterial effect on Gram-negative bacteria such as Neisseria gonorrhoeae and Bacillus pertussis. Some erythromycin-resistant Staphylococcus aureus are still sensitive to kitasamycin, and they are also quite active against Leptospira, Rickettsia, and Mycoplasma. [0003] At present, the kitasamycins that are marketed at home and abroad are all kitasamycin tartrate powder injections, and their pH value is 3.0 to 5.0. composition of the mix...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K9/08A61P31/04
Inventor 刘小清
Owner 刘小清
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