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Analysis method of roflumilast bulk drug

A technology of roflumilast and analytical methods, applied in material separation, analytical materials, measuring devices, etc., can solve problems such as specificity, poor repeatability, and inability to quantitatively and comprehensively detect active ingredients, and achieve strong specificity and accuracy. , high sensitivity and good reproducibility

Pending Publication Date: 2020-08-28
山东希尔康泰药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing analytical methods for roflumilast raw materials are poor in specificity and repeatability, and cannot quantitatively and comprehensively detect its active ingredients

Method used

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  • Analysis method of roflumilast bulk drug
  • Analysis method of roflumilast bulk drug
  • Analysis method of roflumilast bulk drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0034] The analysis method of the roflumilast bulk drug described in this example includes: a specificity test.

[0035] The specificity test methods include: 1) non-destructive test; 2) raw material acid damage test; 3) raw material alkali damage test; 4) raw material oxidation damage test; 5) raw material high temperature damage test; 6) light damage test; 7) Sunlight damage test.

[0036] Described specificity test method comprises:

[0037] 1) Undestructive experiment: Precisely measure 10ml of the mother liquid of roflumilast raw material drug, put it in a 50ml colorless and transparent measuring bottle, add solvent [acetonitrile: water (1:1)] to dilute to the mark, shake well, and measure the above 20 µl of the sample was injected into the liquid chromatograph, and the chromatogram was recorded;

[0038] 2) Raw material acid destruction test: Precisely measure 10ml of the mother liquid of roflumilast raw material, put it in a 50ml measuring bottle, add 2ml of 0.1mol / L ...

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Abstract

The invention discloses an analysis method of a roflumilast bulk drug. The analysis method comprises carrying out a specificity test; the specificity test method comprises the following steps: 1) carrying out an undamaged experiment; 2) performing a raw material acid damage experiment; 3) carrying out a raw material alkali damage experiment; 4) performing raw material oxidative damage experiment;5) performing a raw material high-temperature damage experiment; 6) carrying out an illumination damage test; 7) performing a sunlight damage test. The method has the beneficial effects that the content determination is carried out through a specificity test and specific high performance liquid chromatography conditions; the method is high in specificity and accuracy, capable of comprehensively reflecting chemical components of the product, high in sensitivity, good in reproducibility, easy to operate and capable of more objectively, comprehensively and sensitively reflecting the quality change condition of the product, so that the medicine quality is integrally controlled, and comprehensive monitoring of the medicine quality is achieved.

Description

technical field [0001] The invention relates to the technical field of crude drug analysis, in particular to a method for analyzing the crude drug of roflumilast. Background technique [0002] Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor and a new drug for the treatment of COPD. It is used to treat symptoms of bronchitis-associated cough and excess mucus in patients with severe COPD. Roflumilast is mainly expressed in inflammatory cells associated with asthma, including eosinophils, neutrophils and mast cells. The drug can specifically act on a certain enzyme involved in smooth muscle contraction, prevent cAMP from degrading, thereby blocking the pro-inflammatory response signal transmission, has anti-inflammatory activity, and has achieved good results in the clinical treatment of asthma and chronic obstructive pulmonary disease Efficacy. Roflumilast can also significantly delay the deterioration of respiratory symptoms, while greatly improving the quality of l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/74
Inventor 张存国广国良王贺
Owner 山东希尔康泰药业有限公司
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