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Content determination method for montmorillonite preparation

A determination method, montmorillonite technology, applied in the direction of removing a certain component weighing, aluminum/calcium/magnesium active ingredients, digestive system, etc., can solve inaccurate content determination, supernatant can not be clarified, lost, etc. problem, to achieve the effect of accurate content determination

Active Publication Date: 2013-05-01
SHANDONG SBOND PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The deficiency of montmorillonite content determination method in the existing quality standard of montmorillonite powder is inaccurate, reason is that montmorillonite is a natural nano-scale material, has dispersibility in water, can be dispersed into colloidal state, and most particles can reach Below 2um, some particles can reach the nanometer level. When measuring the content, put it in a centrifuge tube, add 30ml of 50% ethanol, shake well, and centrifuge. Some extremely fine particles cannot be completely precipitated, and the supernatant cannot be clarified. Discard the upper When the clear liquid is discarded, the content is transferred to the evaporating dish with constant weight, which is the content after the loss of some extremely fine particles, resulting in inaccurate content determination; take montmorillonite powder, put it in a beaker, add water, and stir Evenly, filter with No. 3 vertical melting glass crucible, some extremely fine particles can pass through the vertical melting glass crucible, the residue in the crucible is the residue after losing some of the fine particles, resulting in inaccurate content determination

Method used

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  • Content determination method for montmorillonite preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Weigh 0.2364g of montmorillonite powder with a marked amount of 3g / bag, put it in a centrifuge tube, add 20ml of 50% ethanol, add 1 drop of 10% sodium chloride solution, shake fully, and centrifuge (3000 rpm) For 25 minutes, discard the supernatant, repeat twice, transfer the contents to an evaporating dish with constant weight, evaporate to dryness, and dry to constant weight at 105°C to obtain 0.1828g of montmorillonite. The stone content is 96.9% of the labeled amount.

Embodiment 2

[0050] Measure 10ml of the montmorillonite suspension with a marked amount of 10%, put it in a centrifuge tube, add 50ml of water, add 20% ammonium chloride, 2 drops of the solution, shake fully, and centrifuge (5000 rpm) for 15 minutes , discard the supernatant, repeat 1 time, transfer the content to an evaporating dish with constant weight, evaporate to dryness, and dry to constant weight at 105°C to obtain 0.9814g of montmorillonite. Calculate the content of montmorillonite in the test sample It is 98.1% of the labeled amount.

Embodiment 3

[0052] Take the montmorillonite dispersible tablet whose marked amount is 1g / sheet, grind it finely, weigh 0.5177g, put it in a centrifuge tube, add 30ml of 50% ethanol, add 2 drops of 15% magnesium chloride solution, after fully shaking, centrifuge (4000 RPM) for 20 minutes, discard the supernatant, repeat twice, transfer the content to an evaporating dish with constant weight, evaporate to dryness, and dry to constant weight at 105°C to obtain montmorillonite 0.4263g, calculated as The content of montmorillonite in the product is 103.2% of the marked amount.

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Abstract

The invention relates to a content determination method for montmorillonite preparation. The content determination method is characterized in that montmorillonite powder is precisely weighed, the quantity of sampled montmorillonite powder is recorded, the sampled montmorillonite powder is placed in a centrifugal tube, 50% of ethanol or ethanol lower than 50% or water is added in the sampled montmorillonite powder by 20ml to 50ml, further, 10% to 20% of water-solubility salt liquor is also added in the sampled montmorillonite powder by one to two drops, after mixture of the sampled montmorillonite powder, 50% of ethanol or ethanol lower than 50% or water and 10% to 20% of water-solubility salt liquor is sufficiently shaken by 3000-5000 turns per fractional centrifugation for 10 minutes to 25 minutes, supernatant fluid is removed, the step is repeated by once to twice, then contents are transferred to an evaporation vessel with the constant weight, are evaporated and are dried at the temperature of 105 DEG C so that the weight of the contents is constant, and the weight of montmorillonite in tested substances is measured. The content determination method has the advantages that during centrifugation, the supernatant fluid is clear, loss of the montmorillonite is avoided when the supernatant fluid is removed, and accordingly, the content determination method is more accurate compared with an existing method.

Description

field of invention [0001] The invention relates to a method for determining the content of a montmorillonite preparation, which belongs to the technical field of pharmaceutical standard methods. Background technique [0002] Montmorillonite is a drug that has been proved to be effective in treating diarrhea with few toxic and side effects. According to the existing quality standard of montmorillonite powder, it should be 95.0-105.0% of the marked amount when calculated as a dry product, and there are basically two methods for determining the content: [0003] Standard number: WS-408(X-352)-99 montmorillonite powder standard, the determination method of montmorillonite content is: take 0.2g of this product, weigh it accurately, put it in a beaker, add 25mL of water, stir well, and use Filter the No. 3 vertical melting glass crucible with constant weight, wash the beaker with appropriate amount of water, put the lotion into the vertical melting glass crucible and filter, dry ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N5/04A61K33/06A61P1/12
Inventor 张为胜李诗标周长征牛凤菊许翠萍苑学明
Owner SHANDONG SBOND PHARMA