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A kind of preparation method of netilmicin sulfate freeze-dried powder for injection

A technology of netilmicin sulfate and freeze-dried powder, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, and devices for making drugs into special physical or ingestible forms, which can solve the problem of shelf life fluctuations and preservation Problems such as short time limit and insufficient precision can achieve the effect of improving shelf life, drug stability and quality improvement

Active Publication Date: 2016-05-11
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, some manufacturers directly produce netilmicin sulfate injection for use, but because the preservation of the injection is difficult and the shelf life is short, it is often prepared in the form of freeze-dried powder and stored for use when needed. The preparation method of the netilmicin sulfate freeze-dried powder for injection is not accurate enough due to the control of parameters, and the quality of the finished product is unstable for a long time, and the shelf life therefore has a large fluctuation range, and, in terms of precision control, the conventional preparation method is due to There is a phenomenon that the precision is not high enough

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment

[0028] According to the method provided by the invention, the following operations are carried out, wherein the consumption of each component is netilmicin sulfate 150g, sodium sulfite 6g, water for injection 1800g, activated carbon configuration amount 0.1% (w / w):

[0029] a. Weigh 70% water for injection of the prepared amount and add it to the liquid mixing tank and cool to room temperature.

[0030] b. Add the approved dosage of netilmicin sulfate and sodium sulfite, stir until completely dissolved, and add water for injection to the full amount.

[0031] c. Add 0.1% (w / w) activated carbon in the preparation amount, and stir for 30 minutes to obtain medicinal solution A.

[0032] d. Filter and decarbonize medicinal solution A through a 0.45 μm microporous filter element, and then fine filter through a 0.22 μm microporous membrane to obtain medicinal solution B. Sample the obtained medicinal solution B for inspection, and pass the medicinal solution B It is sent to the liq...

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Abstract

The invention provides a preparation method of netilmicin sulfate freeze-dried powder for injection. The quality of the obtained netilmicin sulfate freeze-dried powder is greatly improved through the adjustment of process steps such as the adjustment of medicine adding sequences as well as the precise control over temperatures, time, pressures and other parameters, the multilayer control of filtration and the like. Thus, the storage life of the netilmicin sulfate freeze-dried powder is prolonged; the process is more normalized. As a result, the preparation method is suitable for being popularized.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a preparation method of netilmicin sulfate freeze-dried powder for injection. Background technique [0002] The mechanism of action of netilmicin sulfate injection is to bind to the 30S subunit of bacterial ribosomes and inhibit the synthesis of bacterial proteins. Indicated for the treatment of serious infections caused by sensitive Gram-negative bacilli such as Pseudomonas aeruginosa, Proteus (indole positive and negative), Escherichia coli, Klebsiella, Enterobacter, Serratia Neonatal sepsis, septicemia, central nervous system infection (including meningitis), urinary tract infection, respiratory tract infection, gastrointestinal tract infection, peritonitis, biliary tract infection, skin or Bone infection, otitis media, sinusitis, soft tissue infection, listeriosis, etc. At present, some manufacturers directly produce netilmicin sulfate injection for use, but because the preservation...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7036A61P31/04A61J3/02A61L2/07
Inventor 王志涛林密林小雪
Owner HAINAN GENERAL & KANGLI PHARMA