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Method for detecting particle size distribution of progesterone in progesterone soft capsule content

A particle size distribution and detection method technology, applied in the field of analysis and detection, can solve the problems of difficult separation of oil and progesterone particles, difficulty in ensuring that the particle size of progesterone does not change, and unsuitable testing.

Pending Publication Date: 2022-05-24
湖南醇健制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, progesterone is suspended in the oil of the soft capsule content, and it is very difficult to separate the oil and progesterone particles, so the dry laser diffraction method is not suitable for the test of the particle size distribution of progesterone in the content (suspension) of the progesterone soft capsule. suitable
Wet laser diffraction test is because the oil in the content (suspension) of progesterone soft capsules will affect the test results, and it is difficult to ensure that the particle size of progesterone does not change during the dispersion process, so it is very difficult to choose a suitable dispersant. Failed to test the distribution of progesterone in the content (suspension) of progesterone soft capsules

Method used

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  • Method for detecting particle size distribution of progesterone in progesterone soft capsule content
  • Method for detecting particle size distribution of progesterone in progesterone soft capsule content
  • Method for detecting particle size distribution of progesterone in progesterone soft capsule content

Examples

Experimental program
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Effect test

Embodiment 1

[0042]The test method for the particle size distribution of the progesterone soft capsule content sample with batch number 21081501 is as follows: use a Bettersize2600 intelligent laser particle sizer from Dandong Bettersize Instrument Co., Ltd., turn on the instrument, and preheat for half an hour. Run the particle size test software, use light liquid paraffin to clean the instrument pipeline, pour saturated light liquid paraffin into the detector after draining, and set the circulation speed to 2000rpm. Adjust the instrument alignment in the software window and test the instrument background. Take 0.5g of the content of the progesterone soft capsule and put it in a 50ml beaker, dilute it to 10ml with saturated light liquid paraffin, stir to disperse, ultrasonic frequency 36kHz, ultrasonic time 3mim to configure the test sample. Add the test product dropwise to the sample cell until the refractive index is about 12%, click the test button in the software to test the sample, a...

Embodiment 2

[0045] The particle size distribution of the progesterone soft capsule content sample with batch number 21081501 is tested as follows: Use a Bettersize2600 intelligent laser particle size analyzer from Dandong Bettersize Instrument Co., Ltd., turn on the instrument, and warm up for half an hour. Run the particle size test software, use light liquid paraffin to clean the instrument pipeline, pour saturated light liquid paraffin into the detector after draining, and set the circulation speed to 2000rpm. Adjust the instrument alignment in the software window and test the instrument background. Take 0.3g of the content of the progesterone soft capsule and put it in a 50ml beaker, dilute it to 10ml with saturated light liquid paraffin, stir to disperse, ultrasonic frequency 36kHz, ultrasonic time 3mim to configure the test sample. Add the test product dropwise to the sample cell until the refractive index is about 12%, click the test button in the software to test the sample, and t...

Embodiment 3

[0048] The particle size distribution of the progesterone soft capsule content sample with batch number 21081501 is tested as follows: Use a Bettersize2600 intelligent laser particle size analyzer from Dandong Bettersize Instrument Co., Ltd., turn on the instrument, and warm up for half an hour. Run the particle size test software, use light liquid paraffin to clean the instrument pipeline, pour saturated light liquid paraffin into the detector after draining, and set the circulation speed to 2000rpm. Adjust the instrument alignment in the software window and test the instrument background. Take 0.5g of the content of the progesterone soft capsule and put it in a 50ml beaker, dilute it to 10ml with saturated light liquid paraffin, stir to disperse, ultrasonic frequency 36kHz, ultrasonic time 3mim to configure the test sample. Add the test product dropwise into the sample cell until the refractive index is about 15%, click the test button in the software to test the sample, and...

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Abstract

The invention discloses a method for detecting the particle size distribution of progesterone in progesterone soft capsule content, which comprises the following steps: adding the progesterone soft capsule content into a saturated light liquid paraffin solution, ultrasonically dispersing uniformly, and testing the particle size through a laser particle size detection instrument to obtain the particle size distribution of the progesterone soft capsule content. Compared with an existing microscope image analysis method, the method has the advantages that the number of detected samples is larger, detection equipment is relatively cheap, and the precision and the applicability are better; the measuring instrument is wide in use, the experimental result is visual and efficient, the relative standard deviation of multiple measurement results of D10 and D90 particle sizes is not larger than 5%, the relative standard deviation of multiple measurement results of D50 particle sizes is not larger than 3%, and the requirement for repeatability of detection results of a laser particle analyzer in Chinese pharmacopoeia is met.

Description

technical field [0001] The present application relates to the technical field of analysis and detection, in particular to a method for detecting the particle size distribution of progesterone in the contents of a progesterone soft capsule. Background technique [0002] Progesterone soft capsule is a kind of high-efficiency drug used to treat dysfunction caused by progesterone deficiency and to assist in pregnancy, and the market demand is large. The content of progesterone soft capsule is an oil suspension, and the particle size and particle size distribution of progesterone in the oil are important quality control indicators of progesterone soft capsule. [0003] The testing method for the particle size and particle size distribution of the contents of progesterone soft capsules is currently only the microscope image analysis method. Because of the inherent defects of microscopy, this method has the defects of small number of observed particles (only 1000-2000 particles) a...

Claims

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Application Information

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IPC IPC(8): G01N15/02
CPCG01N15/0205
Inventor 徐宽邓键杨劲午陈胤林吴四清
Owner 湖南醇健制药科技有限公司
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