Method for detecting mixing uniformity of hydroxychloroquine sulfate particles

A technology of hydroxychloroquine sulfate and mixing uniformity, which is applied in the field of detecting the mixing uniformity of hydroxychloroquine sulfate particles, can solve the problems that are not conducive to improving production efficiency and cannot measure the detection results, and achieve fast and accurate mixing uniformity of hydroxychloroquine sulfate particles , high safety factor, fast and accurate detection effect

Pending Publication Date: 2021-12-17
SHANGAI PHARMA GRP CO LTD +2
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The problem to be solved by the present invention is to overcome the method for detecting the mixing uniformity of hydroxychloroquine sulfate particles in the prior art, which cannot efficiently, accurately and safely measure the detection results, which is not conducive to improving production efficiency, and provides a method for detecting hydroxychloroquine sulfate Method for Particle Mixing Uniformity

Method used

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  • Method for detecting mixing uniformity of hydroxychloroquine sulfate particles
  • Method for detecting mixing uniformity of hydroxychloroquine sulfate particles
  • Method for detecting mixing uniformity of hydroxychloroquine sulfate particles

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Embodiment 1

[0040] The detection method of embodiment 1 hydroxychloroquine sulfate particle mixing uniformity

[0041] (1) Add the hydroxychloroquine sulfate granules in the three-dimensional mixing tank, start the three-dimensional mixing tank, make the hydroxychloroquine sulfate particles fully contact with the inner wall of the three-dimensional mixing tank; then add magnesium stearate to avoid sticking the magnesium stearate on the three-dimensional mixing tank The inner wall; get the mixture, the batch is PAT190806-3.

[0042] (2) The near-infrared spectrometer is set on the sampling window of the three-dimensional mixing tank, and when the three-dimensional mixing tank is started, the near-infrared spectrometer and the three-dimensional mixing tank rotate synchronously.

[0043] The collection of near-infrared spectra of the mixture during the mixing process can be controlled by the Result-Operation software. After opening the software, start to collect the background spectrum, and...

Embodiment 2

[0047] The detection method of embodiment 2 hydroxychloroquine sulfate particles mixing uniformity

[0048] The compound batch among the embodiment 2 is PAT190806-5, and others are all the same as embodiment 1. Among them, the wavelength range is 5862-6059cm -1 The SD value line graph of the characteristic peak area is as follows Figure 5 shown.

[0049] At the 9th data point, the SD value was below 0.02, and it was determined that the hydroxychloroquine sulfate particles had been mixed evenly when mixing for 84s.

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Abstract

The invention discloses a method for detecting mixing uniformity of hydroxychloroquine sulfate particles. The method comprises the following steps of: acquiring a near infrared spectrum of a mixture in a mixing process, wherein the mixture comprises hydroxychloroquine sulfate particles and magnesium stearate; and calculating a standard deviation value of a collected near infrared spectrum peak area by adopting a moving window standard deviation method. The method for detecting the mixing uniformity of the hydroxychloroquine sulfate particles, disclosed by the invention, is relatively high in accuracy and safety coefficient; and when the detection method is applied to industrial production, the mixing uniformity of the hydroxychloroquine sulfate particles can be rapidly and accurately detected, and the end point of the mixing time can be efficiently and conveniently monitored.

Description

technical field [0001] The invention relates to a method for detecting the mixing uniformity of hydroxychloroquine sulfate particles. Background technique [0002] Hydroxychloroquine sulfate is a commonly used drug in the clinical treatment of rheumatoid arthritis and systemic lupus erythematosus. The production process of hydroxychloroquine sulfate solid preparation includes initial mixing process and final mixing process. Usually, primary mixing is the process of wet granulating the hydroxychloroquine sulfate bulk drug to obtain hydroxychloroquine sulfate granules; final mixing is to mix the prepared hydroxychloroquine sulfate granules with fillers, disintegrants, solid binders, lubricants, etc. The process of mixing agents and compatibilizers. Among them, the mixing time is very critical to achieve the purpose of uniform mixing, and it is an important quality control point for hydroxychloroquine sulfate solid preparations [0003] At present, the method for detecting t...

Claims

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Application Information

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IPC IPC(8): G01N21/3563G01N21/359G01N1/38
CPCG01N21/3563G01N21/359G01N1/38G01N2021/3572G01N2001/386
Inventor 柯樱朱振明陆峰张烁阳王薇青
Owner SHANGAI PHARMA GRP CO LTD
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