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Method for testing amikacin sulfate injection

A technology of amikacin sulfate and test method, which is applied in the preparation of test samples, material analysis by observing the influence on chemical indicators, and analysis by chemical reaction of materials, etc. The problem of unstable results, etc., to achieve the effect of stable measurement results

Inactive Publication Date: 2014-12-24
SHANGHAI XINYI JINZHU PHARMA
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  • Summary
  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Amikacin Sulfate Injection is widely used clinically, and the dosage is relatively large. The current test methods all use the potency test method, and the test results are unstable.

Method used

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Examples

Experimental program
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Embodiment Construction

[0016] The testing method of amikacin sulfate injection of the present invention comprises the following steps:

[0017] Step 1: Add 50% water for injection into the concentrated preparation tank, add sodium bisulfite and sodium citrate, stir to dissolve, then add amikacin sulfate, stir to dissolve while adding;

[0018] Step 2, add medicinal charcoal to the above solution, stir evenly, and decarbonize with a Suzhou sand filter stick until it is clear, then filter into the dilute tank;

[0019] Step 3, add water for injection to the full amount, stir for 15 minutes to make it uniform;

[0020] Step 4, backfiltering with Suzhou sand filter stick and 0.38 μm polyethersulfone microporous membrane;

[0021] Step 5: Sampling for inspection of visible foreign matter; sampling to test the pH value of the intermediate; after all items are qualified, filter the medicinal liquid into the liquid storage tank and inject nitrogen gas;

[0022] Step 6, the medicinal liquid in the liquid s...

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Abstract

The invention discloses a method for testing an amikacin sulfate injection. The method comprises the following steps of 1, adding injection water with the mixing amount of 50 percent into a concentrated mixing tank, adding sodium hydrogen sulfite and sodium citrate for stirring and dissolving, and then adding amikacin sulfate while stirring and dissolving so as to obtain a mixture; 2, adding medical carbon into the mixture obtained in the step 1, and uniformly stirring; 3, adding the injection water to reach 100 percent, and stirring for 15 minutes; 4, performing return filtration through a Suzhou sand filtering stick and 0.38-micron polyether sulfone microfiltration membrane; 5, performing sampling so as to realize visible foreign matter checking; 6, filtering medicinal liquid in a liquid storage tank through a 0.22-micron polyether sulfone microfiltration membrane, sampling the medicinal liquid so as to realize visible foreign matter checking until visible foreign matters are qualified, and inputting the medicinal liquid into a seat bottle for encapsulation; 7, feeding nitrogen for encapsulation; and 8, checking whether gas leakage exists under a condition that the vacuum degree is -0.086MPa. A measurement result obtained by adopting the method for testing the amikacin sulfate injection is stable.

Description

technical field [0001] The invention relates to a test method, in particular to a test method for amikacin sulfate injection. Background technique [0002] Amikacin sulfate is an aminoglycoside antibiotic. This product is effective against most Enterobacteriaceae bacteria, such as Escherichia coli, Klebsiella, Enterobacter, Proteus, Shigella, Salmonella, Citrobacter, Serratia, etc. It has a good effect on Pseudomonas aeruginosa and some other Pseudomonas, Acinetobacter, Alcaligenes, etc.; it has a good effect on meningococcus, Neisseria gonorrhoeae, influenza bacillus, Yersinia Campylobacter fetus, Mycobacterium tuberculosis and certain mycobacteria also have good antibacterial effect. [0003] Amikacin sulfate injection is suitable for Pseudomonas aeruginosa and some other Pseudomonas, Escherichia coli, Proteus, Klebsiella, Enterobacter, Serratia, Acinetobacter Serious infections caused by sensitive Gram-negative bacilli and Staphylococcus (methicillin-sensitive strains)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/80G01N21/82G01N1/28
Inventor 雷治
Owner SHANGHAI XINYI JINZHU PHARMA
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