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High performance liquid chromatography for testing content of component in composite polygonum cuspidatum ammonia sensitive tablet

A technology of high-performance liquid chromatography and component content, which is applied in the field of high-performance liquid chromatography for determining the component content of Compound Polygonum cuspidatum Ammin Tablets, and can solve problems such as the inability to ensure the safety and effectiveness of drugs

Active Publication Date: 2018-11-20
广西壮族自治区食品药品检验所
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its prescription consists of 296.3mg of Senecio dry paste, 1158mg of Polygonum cuspidatum dry paste, 100mg of acetaminophen, and 0.7mg of chlorpheniramine maleate in each tablet. Aminophenol is used for content determination, and the other three components have neither content detection methods nor unlimited regulations, which cannot ensure the safety and effectiveness of the drug
After investigation, there is no research report on the content determination of other components in Compound Polygonum cuspidatum Ammin Tablets

Method used

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  • High performance liquid chromatography for testing content of component in composite polygonum cuspidatum ammonia sensitive tablet
  • High performance liquid chromatography for testing content of component in composite polygonum cuspidatum ammonia sensitive tablet
  • High performance liquid chromatography for testing content of component in composite polygonum cuspidatum ammonia sensitive tablet

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Embodiment Construction

[0015] 1. Instruments and reagents

[0016] 1.1 Instruments Waters e2695 liquid chromatograph (with PDA detector); Milli-Q deionized water generator (Milli-Q company); Mettler-Toledo XS205DU electronic balance.

[0017] 1.2 Reagent acetaminophen; chlorpheniramine maleate; chlorogenic acid; Polydatin reference substances were purchased from China National Institutes for Food and Drug Control. Methanol and acetonitrile were chromatographic pure reagents, water was ultrapure water, and other reagents For analytical purity. The 6 batches of Compound Polygonum cuspidatum Ammonia-sensitive Tablets are all from manufacturer A (each tablet contains Senecio dry paste 23 mg, Polygonum cuspidatum dry paste 55 mg, acetaminophen 100 mg, and chlorpheniramine maleate 0.7 mg).

[0018] 2. Methods and results

[0019] 2.1 Chromatographic conditions Chromatographic column: Kromasil 100-5C 18 (5μm, 250×4.6mm); mobile phase: A: acetonitrile, B: 0.1% phosphoric acid solution, gradient elution p...

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Abstract

The invention discloses a high performance liquid chromatography for testing contents of components in a composite polygonum cuspidatum ammonia sensitive tablet. According to the high performance liquid chromatography, a 50% methanol solution is adopted for ultrasonic extraction, an acetonitrile-0.1% phosphoric acid solution is adopted as a mobile phase, Kromasil 100-5 C18 chromatographic column separation is carried out, and ultraviolet detection wavelengths are 222nm and 326nm. A high performance liquid chromatography-ultraviolet spectrum double-wavelength method is implemented, contents oftwo chemical components, namely p-acetaminophen and chlorpheniramine maleate, a main component chlorogenic acid of a dry groundsel ointment, a main component polydatin in a dry polygonum cuspidatum can be detected, and the method has the characteristics of being rapid in pretreatment, good in separation of the four components from other components, and good in accuracy. By adopting high performance liquid chromatography, references for evaluating and controlling quality of composite polygonum cuspidatum ammonia sensitive tablets can be provided.

Description

technical field [0001] The invention belongs to the technical field of component content detection of compound polygonum cuspidatum and ammonia-sensitive tablets, and in particular relates to a high-performance liquid chromatography method for determining the component content of compound polygonum cuspidatum and ammonia-sensitive tablets. Background technique [0002] Compound Polygonum cuspidatum Ammin Tablets is an over-the-counter cold medicine compounded by Chinese and Western medicines. It is used for headache, fever, runny nose, pharyngitis, etc. caused by colds. Its prescription consists of 296.3mg of Senecio dry paste, 1158mg of Polygonum cuspidatum dry paste, 100mg of acetaminophen, and 0.7mg of chlorpheniramine maleate in each tablet. The content of aminophenol is measured, and the other three components have no content detection method and unlimited regulations, which cannot ensure the safety and effectiveness of the drug. After investigation, there is no resear...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/02G01N30/74
CPCG01N30/02G01N30/06G01N30/74
Inventor 邓鸣卢日刚朱健萍李智明杨娜曾庆花
Owner 广西壮族自治区食品药品检验所
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