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Method for testing particle size and particle size distribution of linezolid raw medicine

A technology of linezolid and a testing method, which is applied in the field of testing the particle size and particle size distribution of linezolid bulk drugs, can solve the problems of difficulty in preparing samples, unsuitability, easy agglomeration and the like, and achieves simple, convenient and good reproducibility in the determination process. Effects of Sex and Precision

Inactive Publication Date: 2019-07-23
深圳万乐药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The bulk drug of linezolid is soluble in water, and the solid powder has high bulkiness and agglomeration. The dry laser diffraction method is not suitable for the powder of linezolid, which is difficult to disperse uniformly in the air. The powder of amine raw material is clogged on the filter screen of the inlet of the laser particle size tester, and accurate data cannot be obtained
However, because the linezolid bulk drug has certain water solubility, and it is easy to foam, agglomerate, and difficult to disperse in the process of dispersing in the aqueous solution, it is difficult to prepare suitable samples for testing by wet laser diffraction method, so it has not been used in Public report on effective test methods for particle size and particle size distribution of linezolid

Method used

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  • Method for testing particle size and particle size distribution of linezolid raw medicine
  • Method for testing particle size and particle size distribution of linezolid raw medicine
  • Method for testing particle size and particle size distribution of linezolid raw medicine

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Example 1 The particle size determination of linezolid bulk drug under different shading degrees

[0028] (1) Preparation before experiment:

[0029] Use the Malvern laser particle size analyzer, turn on the instrument, and warm up for half an hour. Run the particle size testing software, use the saturated solution of linezolid API to clean the pipeline of the instrument, and manually test the link in the software window to test the background of the instrument.

[0030] (2) Preparation of sample suspension: Take about 0.3g of linezolid API sample in a 100mL beaker, add 0.2ml of surfactant Tween-80 aqueous solution (W / V: 0.54g / 100ml) for wetting , and then add 50ml of saturated aqueous solution of linezolid bulk drug, and fully stir until a homogeneous suspension is obtained.

[0031] (3) Instrument parameter setting:

[0032] Injector: manual wet sampler with small capacity;

[0033] Sample refractive index: 1.60;

[0034] Sample absorbance: 0;

[0035] Dispersio...

Embodiment 2

[0045] Embodiment 2 intermediate precision experiment

[0046] The same batch of crude drug is carried out particle size distribution test by the method of the present invention by two analysts on the next day. The first analyst took 6 samples, each sample was tested 6 times in parallel, and the average and RSD of d(0.1), d(0.5), d(0.9) were counted; the second analyst performed the same batch of API samples For re-examination, 6 samples were taken in parallel and tested 6 times for each sample, and the average value and RSD of d(0.1), d(0.5), and d(0.9) were counted. Calculate the mean and RSD of d(0.1), d(0.5), d(0.9) for 6 samples each for two analysts, and the mean of d(0.1), d(0.5), d(0.9) for a total of 12 samples Value and RSD.

[0047] (1) Preparation before experiment:

[0048] Use the Malvern laser particle size analyzer, turn on the instrument, and warm up for half an hour. Run the particle size testing software, use the saturated aqueous solution of linezolid A...

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Abstract

The invention provides a method for testing the particle size and the particle size distribution of a linezolid raw medicine. The method has the advantages that the wet laser diffraction method is adopted for testing, and the raw medicine to be tested is prepared into a test suspension with a polysorbate-80 aqueous solution serving as a dispersant and a linezolid raw medicine saturated aqueous solution serving as a dispersion medium, so that the problems that solid powders of the linezolid raw medicine are bulked, are likely to be agglomerated, and have low possibility of dispersion and high possibility of foaming upon stirring in the dispersion medium are solved; and the testing process is simple and convenient, and experimental results are highly repeatable and precise, so that the method can be used for particle size testing in production and application processes of the linezolid raw medicine, and effective technical measures can be further provided for the product quality controlin the processes.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for testing the particle size and particle size distribution of a linezolid bulk drug. Background technique [0002] Antibiotics are the main drugs used in clinical anti-infection treatment, but the large-scale use of antibiotics has also increased the resistance of bacteria. With the intensification of bacterial drug resistance worldwide, especially the emergence of Gram-positive drug-resistant bacteria such as (MRSA, VRE, etc.), it has increased the difficulty of clinical anti-infection treatment. Therefore, research on bacterial drug resistance and The development of antibiotics against drug-resistant bacteria is becoming increasingly important. [0003] Linezolid is the first synthetic oxazolidine antibacterial drug, which is a bacterial protein synthesis inhibitor and is mainly used to treat infections caused by aerobic Gram-positive bacteria. Its...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N15/02
CPCG01N15/0205
Inventor 袁婉任思浩吴子强张蜜于玉根
Owner 深圳万乐药业有限公司
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