A method for the detection of Dilong injection based on the determination of phenol

Abstract

The invention provides a method for detecting Dilong injection based on the determination of phenol, which uses liquid chromatography to separate the phenol in Dilong injection and then measures it at 270nm; the stationary phase of the chromatographic column used is octadecylsilane Bonded to silica gel, the elution method is gradient elution; the mobile phase includes mobile phase A and mobile phase B, wherein mobile phase A is 20 mM diammonium hydrogen phosphate, and mobile phase B is 40% acetonitrile. After separating phenol from Dilong Injection, the test result has a good linear relationship, high detection precision, good stability, good repeatability, good durability, simple operation, stable and reliable. According to the results of phenol determination, it can be judged whether the amount of phenol added in Dilong Injection meets the product standard, and then the quality of the finished product of Dilong Injection can be effectively controlled to ensure the safety of medication.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for detecting Dilong injection based on the determination of phenol. Background technique [0002] Dilong injection contains nucleosides, amino acids, proteins and polypeptides, lipids, enzymes and trace elements, etc. It has the effects of relieving asthma, relieving cough and lowering blood pressure, and can be used for coughing and wheezing caused by bronchial asthma. Phenol was added as a bacteriostatic agent. [0003] Hypoxanthine and nitrogen-containing compounds are the main active ingredients of Dilong Injection for relieving asthma and relieving cough. The content determination part of the current quality standard only includes nitrogen determination for total nitrogen, titration for amino nitrogen and thin-layer chromatography for valine content. [0004] As a bacteriostatic agent, phenol has certain toxicity and corrosiveness. The current quality standard d...

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Problems solved by technology

[0004] As a bacteriostatic agent, phenol has certain toxicity and corrosiveness. The current quality standard does not check and determine the content of phenol. The determination method of phenol in the fourth part of the "Chinese Pharmacopoeia" 2020 edition is redox titration and back titration. There are disadvantages such as cumbersome experimental operation, easy oxidation of phenol, and many interference factors.

Pan Yunzhi disclosed a method for the determination of phenol content in Dilong injection in "Reversed-Phase High Performance Liquid Chromatography Determination of Phenol Content in Dilong Injection" in Volume 32, No. 4, 2013 of "Medical Herald". Methanol-water (60:40) is the mobile phase. Although phenol has a good linear relationship within the concentration range, the average recovery rate is 99.46%, RSD=0.25% (n=9), but the nucleoside components cannot be completely separated under this condition. The result is less reliable

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