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A kind of real-time monitoring method of clevidipine butyrate crude drug synthesis process

A technology of clevidipine butyrate and clevidipine butyrate, which is applied in the field of medical analysis, can solve problems such as insufficient real-time detection, and achieve the effects of short sample prediction time, strong model prediction ability, and accurate results

Active Publication Date: 2017-08-01
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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Problems solved by technology

However, the application of Raman spectroscopy to the real-time detection of the drug synthesis process is not enough

Method used

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  • A kind of real-time monitoring method of clevidipine butyrate crude drug synthesis process
  • A kind of real-time monitoring method of clevidipine butyrate crude drug synthesis process
  • A kind of real-time monitoring method of clevidipine butyrate crude drug synthesis process

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Embodiment Construction

[0050] The specific implementation manners of the present invention will be described below in conjunction with the accompanying drawings.

[0051] The synthetic route of the clevidipine butyrate involved in this embodiment is as follows: Figure 6 As shown, the reaction takes clevidipine acid and chloromethyl butyrate as reactants, with any one of acetonitrile, tetrahydrofuran, acetone and dimethylformamide as solvent, and esterifies butyric acid under the catalysis of potassium carbonate Clevidipine. Taking acetonitrile as the reaction solvent as an example below, the real-time monitoring method of the synthesis process of the clevidipine butyrate bulk drug of the present application is described in detail. .

[0052] The instruments and reagents involved in this embodiment are as follows:

[0053] Instruments: portable Raman spectrometer detection spectrometer (i-Raman; B&W Tek; USA); high performance liquid chromatography (Aglient 1260 series).

[0054] Reagents: clevi...

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Abstract

The invention provides a real-time monitoring method for a clevidipine butyrate crude drug synthesis process. A Raman spectrum analysis technique is adopted, a model curve which can predict concentrations of a product clevidipine butyrate and a reactant chloromethyl butyrate in a synthesis reaction process is provided, and reaction degree and good and poor technological parameters can be judged. According to the technical scheme of the invention, operation is easy, detection is rapid, quantities of reactants and products in synthesized reaction solution can be evaluated in a few minutes, results are accurate, application range is wide, concentrations, which are predicted according to the model curve provided by the invention, of reactant and product components are close to concentrate data obtained by adopting high performance liquid chromatography, and the real-time monitoring method for the clevidipine butyrate crude drug synthesis process is not restricted to the clevidipine butyrate crude drug and also can be applicable to real-time monitoring of a synthesis process of other crude drugs.

Description

technical field [0001] The invention belongs to the technical field of medical analysis, and in particular relates to a real-time monitoring method for the synthesis process of clevidipine butyrate crude drug. Background technique [0002] In the process of drug synthesis, the optimization of process parameters can directly affect the quality of raw materials and play a decisive role in the quality of raw materials. Bad process parameters have a great impact on the reaction results, not only directly affecting the concentration of the final product, but also It is also possible to introduce a lot of process impurities, affecting the quality of the drug. At present, the commonly used analytical methods for analyzing the concentration of components in the synthesis process of raw materials are high performance liquid chromatography (HPLC), thin layer chromatography (TLC), gas chromatography (GC), etc. Samples at different time points are then concentrated for testing, so they...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/65
Inventor 陆峰刘艳华陈辉柳艳张军东沈国兵宋志勇
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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