Related substances of venlafaxine hydrochloride and analysis and detection method of related substances

A technology for venlafaxine hydrochloride and a product, which is applied in the field of biopharmaceuticals, can solve problems such as insufficient research on venlafaxine hydrochloride, and achieve the effects of simple and easy preparation method, improved quality standards, and improved detection rate

Active Publication Date: 2016-08-24
ZHENJIANG GAOHAI BIOLOGICAL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the research on related substances of venlafaxine hydrochloride is not enough, further research is needed

Method used

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  • Related substances of venlafaxine hydrochloride and analysis and detection method of related substances
  • Related substances of venlafaxine hydrochloride and analysis and detection method of related substances
  • Related substances of venlafaxine hydrochloride and analysis and detection method of related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1: Preparation and structural confirmation of photodegradation products of venlafaxine hydrochloride

[0039] Get 50g of venlafaxine hydrochloride raw materials and evenly spread it in a petri dish, place it under a cool white fluorescent lamp for 20 hours of light, and the light intensity is 1,200,000 lux; The irradiation intensity of the fluorescent lamp is 200 Wh / m2, and it is taken out after the irradiation is finished. Then, the photodamaged sample was dissolved in an aqueous methanol solution with a methanol volume percentage concentration of 75%, stirred for 20 minutes, filtered with a suction filter funnel, collected the filtrate, and concentrated under reduced pressure to obtain 3.5 g of a concentrate; Dissolve, mix the sample with 4g of normal-phase silica gel with a particle size of 100-200 mesh, evaporate the solvent, use 80g of normal-phase silica gel with a particle size of 200-300 mesh as the separation silica gel for column chromatography, and us...

Embodiment 2

[0045] Example 2: Venlafaxine Hydrochloride Stability Test for Long-Term 6-Month Darkened and Not Lightened Sample Detection Analysis

[0046] Preparation of reference solution: Accurately weigh 2mg of photodegradable impurities in a 200ml volumetric flask, dissolve in acetonitrile to a constant volume, and use it as a photodegradable impurity stock solution; accurately measure 1ml of photodegradable impurity stock solution in a 20ml volumetric flask, and use liquid phase analysis The mobile phase of the initial ratio in the method was diluted to volume (about 0.5 μg / mL).

[0047]Preparation of the test solution: Take out venlafaxine hydrochloride raw materials that have been protected from light and not protected from light for 6 months from the stability test light box, and accurately weigh 20 mg respectively in a 20ml volumetric flask, and use the initial ratio in the liquid phase analysis method The mobile phase dissolves constant volume, respectively obtain long-term 6-mo...

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Abstract

The invention discloses related substances of venlafaxine hydrochloride and an analysis and detection method of the related substances. A new venlafaxine hydrochloride photodegradation product is found, and the structure of the degradation product is reported for the first time. The preparation method of the photodegradation product is simple and easy to implement and can be used for preparing the degradation product on a large scale. The degradation product can be quickly detected with a liquid-phase analysis method, the maximum absorption wavelength of the degradation product is taken as a detection wavelength, the detection rate of the degradation product is increased, and results are accurate and reliable. The photodegradation product can be used for checking the related substances of venlafaxine hydrochloride and preparations of venlafaxine hydrochloride, the quality standards of venlafaxine hydrochloride and preparations of venlafaxine hydrochloride are further improved, and the safety and the controllability are improved.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a photodegradation product of venlafaxine hydrochloride, a preparation method and an analysis and detection method of the photodegradation product. Background technique [0002] Venlafaxine hydrochloride is a reuptake inhibitor of three biogenic amines (serotonin, norepinephrine and dopamine), among which the reuptake inhibitory effect on serotonin is the strongest, and it has the strongest effect on norepinephrine reuptake. The inhibitory effect is also strong. Venlafaxine has no effect on muscarinic, nicotine, histamine and adrenergic receptors, and has no inhibitory effect on monoamine oxidase. [0003] Venlafaxine hydrochloride exerts dual antidepressant effects mainly by simultaneously blocking the reuptake of NE and 5-HT, increasing the concentration of NE and 5-HT, and only slightly inhibits the reuptake of dopamine (DA). It has almost no affinity for Mcholine receptors...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C217/74C07C213/08C07C213/10G01N30/02
CPCC07C213/08C07C213/10C07C217/74G01N30/02G01N2030/027
Inventor 潘立李义高李小彪赵阳
Owner ZHENJIANG GAOHAI BIOLOGICAL PHARMA CO LTD
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