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Method for inspecting preservatives in spleen-tonifying oral liquid

An inspection method and preservative technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve good reproducibility, high precision, and good stability

Pending Publication Date: 2019-06-07
广西壮族自治区食品药品检验所
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In order to ensure the safety of the medicine, it is necessary to establish a simple and reliable detection method to control the amount and type of preservatives in the medicine, but there is no relevant report on the detection method of the preservatives in Qipi Oral Liquid

Method used

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  • Method for inspecting preservatives in spleen-tonifying oral liquid
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  • Method for inspecting preservatives in spleen-tonifying oral liquid

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Embodiment 1

[0030] Embodiment 1, specific content is as follows:

[0031] 1. Instruments and reagents

[0032] Agilent, 1260 HPLC detector DAD;

[0033] Benzoic acid (including test use, batch number: 100419-201703, content 99.9%, China Inspection Institute); potassium sorbate (including test use, batch number: 101075-201602, content 99.7%, China Inspection Institute); p-Hydroxybenzoic acid methyl Ester (including test use, batch number: 100278-201705, China Inspection Institute); ethyl p-hydroxybenzoate (including test use, batch number: 21228, Dr.Ehrenstorfer GmbH); propyl p-hydroxybenzoate (including test use, batch number : 100444-201804, content 99.6%, China Inspection Institute); isopropyl p-hydroxybenzoate (including test use, batch number: 51990039, Shanghai Anpu); butyl p-hydroxybenzoate (including test use, batch number: 110792- 200503, China Inspection Institute); isobutyl p-hydroxybenzoate (including test use, batch number: 41110, content 99.7%, Dr. Ehrenstorfer GmbH); aceto...

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Abstract

The invention discloses a method for inspecting preservatives in spleen-tonifying oral liquid. On the basis of the high performance liquid chromatography, eight kinds of preservatives including benzoic acid, potassium sorbate, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, isopropyl p-hydroxybenzoate, propyl p-hydroxybenzoate, isobutyl 4-hydroxybenzoate, and butyl p-hydroxybenzoate in spleen-tonifying oral liquid can be measured simultaneously to check whether the types of the added preservatives and contents meet requirements. According to the disclosed method, the examination of the experimental conditions and the methodological verification are carried out; the precision, reproducibility, stability, and recovery rate are high; the measurement result is accurate; and the use of the preservatives in the spleen-tonifying oral liquid can be controlled effectively.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine testing, in particular to a method for checking preservatives in Qipi oral liquid. Background technique [0002] The prescription of Qipi oral liquid in the 2015 edition of "Chinese Pharmacopoeia" indicates that the preservative potassium sorbate added to 1000mL of oral liquid is 1.5g; It shall not exceed 0.3% (of which potassium salt and sodium salt are calculated as acid), and parabens shall not exceed 0.05%. The addition of preservatives can inhibit the growth of bacteria and prolong the shelf life of pharmaceuticals. However, the preservatives currently used are mainly synthetic chemical reagents, and long-term excessive intake will endanger human health. Among them, benzoic acid, potassium sorbate, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, isopropyl p-hydroxybenzoate, propyl p-hydroxybenzoate, isobutyl p-hydroxybenzoate, p-hydroxybenzoic acid Butyl esters are t...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
Inventor 张涛朱雪妍燕霞白桂昌林敬开罗永强朱韬
Owner 广西壮族自治区食品药品检验所
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