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Quality control method of intestine astringe antidiarrheic preparation

A quality control method and technology of pharmaceutical preparations, applied in the direction of weighing by removing certain components, material analysis and measuring devices by observing the impact on chemical indicators, etc., can solve the problems of quantitative control of active ingredients in preparations, sensitivity And the accuracy is weak, the quality control method is too simple, etc., to achieve the effect of a reliable determination method

Inactive Publication Date: 2013-01-09
YUNNAN SHIPURUI BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0002] Astringent intestine antidiarrheal powder currently in circulation in the market is a Chinese patent medicine for treating diarrhea caused by spleen and stomach qi deficiency, acute and chronic enteritis, allergic enteritis, indigestion, intestinal dysfunction, etc. On page 643 of the Internal Medicine Spleen and Stomach Subvolume of "Compilation of National Standards of Chinese Patent Medicines", the quality control method in the quality standard is too simple and not specific, and it is difficult to effectively quantitatively control the active ingredients of the preparation
The ultraviolet spectrophotometric method of "petgenin" under its quality standard content determination item is slightly weak in sensitivity and accuracy, and the main active ingredients in the formula are not quantitatively controlled, so it cannot reflect Principles of controllable drug quality

Method used

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  • Quality control method of intestine astringe antidiarrheic preparation
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  • Quality control method of intestine astringe antidiarrheic preparation

Examples

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Effect test

Embodiment 1

[0040] A, high performance liquid chromatography is used to measure the content of petracenin in this preparation: take octadecyl bonded silica gel as filler; Be mobile phase with the methanol-water solution of 0.2:0.8 with the volume ratio; Detection wavelength is 275nm; The number of plates should not be less than 2000 according to the petracenin peak calculation; the preparation of the reference substance solution: take the petracenin reference substance, accurately weighed, add 99.5% methanol to make a solution containing 0.05mg per 1ml; the test solution Preparation: Take 0.5g of the content of the powder, and accurately weigh it as 0.5010 g , into a 50ml measuring bottle, add 99.5% methanol for ultrasonic treatment for 9min, let it cool, add 99.5% methanol to the mark, shake well, filter through a 0.40μm nylon filter membrane, and take the subsequent filtrate as the test solution; determination method: respectively Precisely draw 5 μl of each of the reference substance s...

Embodiment 2

[0044] A, high performance liquid chromatography is used to measure the content of petracenin in this preparation: take octadecyl bonded silica gel as filler; Be mobile phase with the methanol-water solution of 0.3:0.7 with the volume ratio; Detection wavelength is 275nm; The plate number should not be less than 2000 according to the petracenin peak calculation; the preparation of the reference substance solution: take the petracenin reference substance, weigh it accurately, add 99.0% methanol to make a solution containing 0.15mg per 1ml; the test solution Preparation: Take 1.0g of the tablet and finely grind the content, accurately weigh it as 1.0002g, put it into a 50ml measuring bottle, add 99.0% methanol for ultrasonic treatment for 11min, let it cool, add 99.0% methanol to the mark, shake well, pass through a 0.45μm polymer Tetrafluoroethylene filter membrane is filtered, and the subsequent filtrate is taken as need testing solution; Determination method: each 10 μ l of re...

Embodiment 3

[0048] A, high performance liquid chromatography measures the content of petracenin in this preparation: take octadecyl bonded silica gel as filler; Be mobile phase with the methanol-water solution of 0.25.:075 with volume ratio; Detection wavelength is 275nm; The number of theoretical plates should not be less than 2000 based on the petracenin peak; preparation of the reference substance solution: take an appropriate amount of the petracenin reference substance, weigh it accurately, add 99.9% methanol to make a solution containing 0.1mg per 1ml; the test substance Preparation of the solution: Take 1.5g of the contents in the capsule, accurately weigh 1.4999g, put it into a 50ml measuring bottle, add 99.9% methanol for ultrasonic treatment for 10min, let it cool, add 99.9% methanol to the mark, shake well, pass through 0.50 μm Filtrate with a nylon filter, and take the subsequent filtrate as the test solution; assay method: respectively accurately draw 8 μl of the reference sol...

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Abstract

The invention discloses a quality control method of intestine astringe antidiarrheic preparation. The intestine astringe antidiarrheic preparation consists of 7 to 18 parts by weight of featherleaf rodgersflower extract, 700 to 800 parts by weight of bentonite and auxiliary materials with appropriate quantity. The quality control method of the intestine astringe antidiarrheic preparation comprises the following steps of utilizing high-efficient liquid-phase chromatography to determine content of bergenin in the preparation; determining content of aluminum oxide in the intestine astringe antidiarrheic preparation; and determining content of silicon dioxide in the intestine astringe antidiarrheic preparation. The quality control method is characterized in that on the basis of the traditional standard, the main active component bergenin is quantitatively detected, and main active components such as aluminum oxide and silicon dioxide in the preparation are quantitatively detected. The method is operable, simple, feasible and capable of effectively controlling the quality of the intestine astringe antidiarrheic preparation.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine quality, and in particular relates to a quality control method of an astringent intestine antidiarrheal pharmaceutical preparation. Background technique [0002] Astringent intestine antidiarrheal powder currently in circulation in the market is a Chinese patent medicine for treating diarrhea caused by spleen and stomach qi deficiency, acute and chronic enteritis, allergic enteritis, indigestion, intestinal dysfunction, etc. On page 643 of the Internal Medicine Spleen and Stomach Volume of the "Compilation of National Standards of Chinese Patent Medicines", the quality control methods in the quality standards are too simple and not specific, making it difficult to effectively quantitatively control the active ingredients of the preparation. The ultraviolet spectrophotometric method of "petgenin" under its quality standard content determination item is slightly weak in sensitiv...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N21/78G01N5/04
Inventor 龙祥杨瑜王朝军何应心胡志祥
Owner YUNNAN SHIPURUI BIOLOGICAL ENG
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