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Method for checking granularity of montmorillonite

An inspection method, the technology of montmorillonite, applied in the field of medicine, can solve the problems that the curative effect of montmorillonite cannot be guaranteed, the test results cannot be obtained, and the test steps are cumbersome.

Inactive Publication Date: 2012-08-15
JINAN KANGZHONG PHARMA TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 2. "Inspection according to law" does not stipulate the method of dispersion
"Inspect according to law" which dispersion medium and dispersion method to use to disperse montmorillonite can reflect the particle size and particle size distribution of montmorillonite when it is taken orally, and truly reflect the particle size and particle size distribution of montmorillonite after oral administration. It is obvious to the technicians that the technicians in the field cannot obtain consistent results according to their own understanding, cannot control the quality of the product, and cannot guarantee the curative effect of montmorillonite
[0013] 3. The laser diffraction particle size analyzers currently on the market are generally equipped with ultrasonic and stirring devices, "stir at a speed of 3000 rpm for 15 minutes", and then check according to the law. The inspection steps are cumbersome and inconvenient to operate
It is stipulated to take "take about 0.12g of this product". Sometimes the particle size of samples from different manufacturers and different batches of the same manufacturer varies greatly, and the particle size of different manufacturers of the products currently on sale varies by more than 4 times, so some samples of the specified sampling amount will exceed the laser diffraction. Due to the suitable shading range of the particle size analyzer detector, accurate detection results cannot be obtained

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Take an appropriate amount of sample, and check the particle size and particle size distribution of the sample according to the third method of "Chinese Pharmacopoeia" 2010 edition two appendix IX E, and adopt the stirring and dispersing method to check the particle size and particle size distribution of the tested sample. The results are: d(0.1) 0.14 μm, d(0.5) 0.18 μm, d(0.9) 0.28 μm, D[4,3] 6.91 μm.

Embodiment 2

[0034] Take an appropriate amount of sample, put it into the laser diffraction particle size analyzer sample cylinder filled with water, turn on the instrument stirring device, when the dispersion is in a stable state, reach 8% of the shading range of the laser diffraction particle size analyzer detector, and start testing, the result is : d(0.1) 1.12 μm, d(0.5) 2.92 μm, d(0.9) 7.04 μm, D[4,3] 3.63 μm.

Embodiment 3

[0036] Take an appropriate amount of sample, put it into the laser diffraction particle size analyzer sample cylinder filled with water, turn on the instrument stirring device, when the dispersion is in a stable state, reach 20% of the shading range of the laser diffraction particle size analyzer detector, start detection, the result Yes: d(0.1) 2.40 μm, d(0.5) 6.15 μm, d(0.9) 17.84 μm, D[4,3] 8.53 μm.

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Abstract

The invention relates to a method for checking granularity of montmorillonite, comprising the following steps of: placing a proper amount of samples into a laser diffraction granulometer sample tube filled with water; opening a stirring device; and checking when a dispersoid is in a stable state. The method is used for checking the actual granularity of the montmorillonite, is very indispensable to quality control and curative effect assurance of pharmaceutical montmorillonite, is simple in steps and convenient for operation.

Description

technical field [0001] The invention relates to a method for inspecting the quality of medicines, in particular to a method for inspecting the particle size of montmorillonite, which belongs to the technical field of medicine. Background technique [0002] Montmorillonite is used in the medical field to treat diarrhea, and is also used as a pharmaceutical excipient in other medicines. [0003] Drug quality is the guarantee of drug safety and effectiveness. Whether the inspection method of drug quality can truly reflect the quality of drugs is also related to the safety and effectiveness of drugs. [0004] There are serious defects in the existing "National Standard for Montmorillonite" particle size inspection method. [0005] For example, "Montmorillonite (WS1-(X-1 65)-2004Z)" stipulates: "Take 10g of this product, add 500ml of water, and stir vigorously for 15 minutes (the speed is not lower than 5000 rpm); another 45μm pore size medicine sieve Dry at 105°C for 3 hours a...

Claims

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Application Information

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IPC IPC(8): G01N15/02
Inventor 李诗标张为胜张梅雪郭美莹苏静冯立娟赵建东
Owner JINAN KANGZHONG PHARMA TECH DEV
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