A method for screening and quantitative analysis of preservative components in compound licorice tablets

A compound licorice tablet and a determination method are applied in the field of screening and quantitative analysis of preservative components in compound licorice tablets, and can solve the problems that the preservative components cannot be well separated, and the degree of separation cannot meet the analysis requirements.

Active Publication Date: 2021-07-27
潍坊市检验检测中心
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Using this method to detect compound licorice tablets, the results show that the chromatographic peaks of the components in the test product cannot be well separated from preservative components such as sodium benzoate and sorbic acid, and the resolution cannot meet the analysis requirements

Method used

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  • A method for screening and quantitative analysis of preservative components in compound licorice tablets
  • A method for screening and quantitative analysis of preservative components in compound licorice tablets
  • A method for screening and quantitative analysis of preservative components in compound licorice tablets

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Instruments and reagents

[0035] Agilent1260 Ⅱ high performance liquid chromatography (preparation of quaternary pump, online degasser, DAD detector, automatic sampler, Open LAB CDS 2.X chemical workstation), XS205DU electronic analytical balance (Mettler Toledo company), ultrasonic instrument.

[0036] Methanol, acetonitrile, ethanol, and formic acid are chromatographically pure, potassium dihydrogen phosphate is analytically pure, and water is ultrapure water. Reference substances sodium benzoate (100433-201702, 99.7%), potassium sorbate (calculated as sorbic acid, 101075-201602, 99.7%), methylparaben (100278-201705, 100%), ethylparaben (100847- 201604, 99.9%), propylparaben (100444-201804, 99.60%), and butylparaben (190010-201001, 99.70%) were purchased from China National Institute for Food and Drug Control. Compound licorice tablets came from 6 different batches of 3 different manufacturers.

[0037] 2. Analysis method

[0038] 1. Preparation of diluent

[...

Embodiment 2

[0068] Embodiment two: the investigation of different solvents to positive sample extraction effect

[0069] 1. Preparation of positive samples

[0070] According to the prescription ratio of Compound Licorice Tablets, a certain amount of potassium sorbate (calculated as sorbic acid), methylparaben, ethylparaben, propylparaben, and butylparaben was added respectively to prepare a preservative containing the Known positive samples (containing sodium benzoate, potassium sorbate (calculated as sorbic acid), methylparaben, ethylparaben, propylparaben, and butylparaben are 2.02mg / tablet, 0.45mg / tablet, 0.075 mg / tablet, 0.076 mg / tablet, 0.074 mg / tablet, 0.075mg / tablet).

[0071] 2. Other conditions are the same as in Example 1, and the extraction effects of different solvent dilutions on positive samples are investigated respectively, as shown in Tables 4.1-4.4.

[0072] Table 4.1 Extraction effect of methanol

[0073]

[0074] Table 4.2 Extraction effect of ethanol

[0075] ...

Embodiment 3

[0081] Embodiment three: in chromatographic conditions, the selection of detection wavelength

[0082] Other conditions are the same as embodiment one, and reference substance solution is carried out chromatographic analysis, adopts DAD detector, obtains the ultraviolet light absorption spectrum of each compound, and wherein the maximum absorption wavelength of benzoic acid is 224nm, sorbic acid, methylparaben, ethylparaben Esters, propylparaben, and butylparaben all have the maximum absorption at 254nm wavelength. Considering the interference of each component of Compound Licorice Tablets and the detection sensitivity of the analyte, the final selection of methylparaben, ethylparaben, and propylparaben The detection wavelength of ester and butylparaben is 254nm, and the detection wavelength of sodium benzoate and sorbic acid is 240nm.

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Abstract

The invention provides a method for screening and quantitative analysis of preservative components in compound licorice tablets, comprising the following steps: (1) preparation of the test solution: take 10 tablets of compound licorice, accurately weighed, ground into fine powder, Then accurately weigh about 1 piece, put it in a 50mL measuring bottle, add an appropriate amount of diluent, ultrasonically, let it cool, dilute to the mark with diluent, shake well, filter through a 0.45μm microporous membrane, and take the subsequent filtrate as The test solution; (2) Preparation of reference solution: Weigh sodium benzoate, potassium sorbate (calculated as sorbic acid), methyl paraben, ethyl paraben, propyl paraben, and butyl paraben, Add diluent to dissolve, and prepare reference solution with different concentrations; (3) Determination by reversed-phase high-performance liquid chromatography. This method not only realizes the content determination of sodium benzoate in the prescription of compound licorice tablets, but also can screen and quantitatively analyze whether sorbic acid and paraben preservatives are illegally added.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a detection method for screening and quantitatively analyzing preservative components in compound licorice tablets. Background technique [0002] Compound Licorice Tablets is a compound preparation with good antitussive and expectorant effects. Its quality standards are recorded in the "Chinese Pharmacopoeia" 2020 Edition, Part Two. The prescriptions include licorice extract powder, opium powder or poppy fruit extract powder, star anise oil, camphor, sodium benzoate, etc. Modern pharmacological studies have shown that licorice extract is a protective antitussive and expectorant, poppy fruit extract powder has a strong antitussive effect, star anise oil and camphor are highly volatile, can stimulate the smooth muscle of the respiratory tract, and promote the discharge of sputum , Play the role of reducing phlegm; sodium benzoate is a preservative. [0003] Most of the ing...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 张筱隋海山齐衍超魏丽杰
Owner 潍坊市检验检测中心
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