Method for detecting montmorillonite preparation

A quality inspection method and montmorillonite technology, which can be used in testing pharmaceutical preparations, measuring devices, material inspection products, etc.

Inactive Publication Date: 2012-01-18
JINAN KANGZHONG PHARMA TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the prior art, there is no quality detection method for smectite nasal cavity administration preparations, which cannot effectively guarantee product quality in production and use, and thus cannot guarantee the efficacy of medicines

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiment 1 Montmorillonite nasal drop test

[0049] (1) Appearance inspection Take the sample and shake it well, pour it into a test tube, observe with normal vision, it is a white thick liquid with no visible impurities. The results are in compliance.

[0050] (2) Smectite content Take the sample and shake it up, take 10ml of it and transfer it into a centrifuge tube, add 10ml of ethanol, mix well, centrifuge at 3000 rpm for 15 minutes, discard the supernatant, add 10ml of 50% ethanol, shake well, 3000 Spin / centrifuge for 15 minutes, discard the supernatant, transfer the contents to an evaporating dish dried at 105°C for 48 hours, evaporate to dryness, dry at 105°C for 48 hours, weigh, and calculate the amount of montmorillonite nasal drops per 100ml Containing montmorillonite is 3g.

[0051] (3) pH value Take an appropriate amount of the sample and transfer it into a centrifuge tube, centrifuge at 3000 rpm for 15 minutes, take the supernatant, test it with a pH me...

Embodiment 2

[0060] Embodiment 2 Assay of montmorillonite nasal spray

[0061] (1) Appearance inspection Shake the sample well, pour it into a test tube, observe with normal vision or corrected vision, it is a white thick liquid with no visible impurities; the results meet the regulations.

[0062] (2) Smectite content Take the sample and shake it up, take 10ml of it and transfer it into a centrifuge tube, add 10ml of ethanol, mix well, centrifuge at 3000 rpm for 15 minutes, discard the supernatant, add 10ml of 50% ethanol, shake well, 3000 Spin / centrifuge for 15 minutes, discard the supernatant, transfer the contents to an evaporating dish dried at 105°C for 48 hours, evaporate to dryness, dry at 105°C for 48 hours, weigh, and calculate the amount per 100ml of montmorillonite nasal spray 10g containing montmorillonite.

[0063] (3) pH value Take an appropriate amount of the sample and transfer it into a centrifuge tube, centrifuge at 3000 rpm for 15 minutes, take the supernatant, test it...

Embodiment 3

[0072] Example 3 Gel assay for montmorillonite nasal cavity

[0073] (1) Appearance inspection Shake the sample well, pour it into a test tube, observe with normal vision or corrected vision, it is a white thick liquid with no visible impurities; the results meet the regulations.

[0074] (2) Smectite content Take the sample and shake it up, take 10ml of it and transfer it into a centrifuge tube, add 10ml of ethanol, mix well, centrifuge at 3000 rpm for 15 minutes, discard the supernatant, add 10ml of 50% ethanol, shake well, 3000 Spin / centrifuge for 15 minutes, discard the supernatant, transfer the contents to an evaporating dish dried at 105°C for 48 hours, evaporate to dryness, dry at 105°C for 48 hours, weigh, and calculate the amount of coagulation per 100ml of montmorillonite nasal cavity. The glue contains 30g of montmorillonite.

[0075] (3) pH value Take an appropriate amount of the sample and transfer it into a centrifuge tube, centrifuge at 3000 rpm for 15 minutes,...

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PUM

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Abstract

The invention relates to a method for detecting the quality of a montmorillonite nasal cavity administration preparation. The method comprises the following steps of: measuring appearance and content; measuring a pH value, an osmotic pressure ratio and a sedimentation volume ratio; identifying silicate and aluminum salt; detecting an X-ray diffraction map, granularity and microorganism limits, and the like. By the method, the quality of a montmorillonite nasal cavity administration preparation product is effectively ensured in the producing and using process, so that the safety and the effectiveness of the method are further ensured.

Description

field of invention [0001] The invention relates to a detection method of a smectite preparation, in particular to a detection method of a smectite preparation for nasal administration, and belongs to the technical field of medicines. Background technique [0002] Montmorillonite is a typical 2:1 layered silicate mineral containing crystal water, which has many excellent properties such as high dispersion, suspension, swelling, cohesiveness, adsorption, and cation exchange. Montmorillonite can adsorb various pathogens and toxins, and has a long history of medicinal use. [0003] The montmorillonite powder has definite curative effect in treating diarrhea, and has little toxic and side effects. Smectite powder is an oral preparation, and its standard is not suitable for the detection of smectite nasal administration preparations, and the standard of smectite powder has certain defects. [0004] Invention patent 200910308592.2 discloses the application of montmorillonite in t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N5/04G01N13/04G01N31/02G01N23/20G01N15/02G01N33/15
Inventor 郭美莹冯立娟许翠萍牛凤菊张为胜李诗标
Owner JINAN KANGZHONG PHARMA TECH DEV
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