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Rapid measurement method of drug dissolution rate

A rapid determination and dissolution technology, applied in the direction of measuring devices, material analysis by electromagnetic means, instruments, etc., to achieve the effects of improved sensitivity, simple operation and shortened time

Inactive Publication Date: 2017-02-01
NAT INST FOR FOOD & DRUG CONTROL
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  • Application Information

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Problems solved by technology

The important thing is that the paper itself has the process of separating samples, can effectively eliminate interference, and can directly detect samples. At present, this method has been successfully applied to the rapid, direct qualitative and quantitative analysis of drugs in blood samples, but there is no paper A report on the application of spray ionization to the determination of drug dissolution

Method used

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  • Rapid measurement method of drug dissolution rate
  • Rapid measurement method of drug dissolution rate

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Embodiment 1

[0026] A kind of rapid determination method of drug dissolution rate is carried out according to the following steps (the overall flow chart of drug dissolution rate determination is as follows figure 1 shown):

[0027] Preparation of Standard Solutions: Phosphate buffer containing 0.05M potassium phosphate and adjusted to pH 6.8 with phosphoric acid unless otherwise stated. All stock solutions (enalapril maleate, quinapril HCl, benazepril HCl) were prepared in phosphate buffered saline. Prepare a series of calibrator solutions for the calibration curve at concentrations ranging from 0.01 μg / mL to 160 μg / mL by diluting the corresponding stock solutions with phosphate buffered saline. Deuterated internal standards or internal standards of structurally similar compounds were prepared in phosphate buffer at a concentration of 100 μg / mL.

[0028] Sample solution preparation: using 900 ml of phosphate buffer (pH=6.8) as the dissolution medium, the dissolution experiment was carri...

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Abstract

The invention discloses a rapid measurement method of a drug dissolution rate. A paper spray mass spectrometry MRM mode is used as a quantitative mode, and is used for measurement of the drug dissolution rate. Measurement of the dissolution rate comprises the steps of: firstly, shearing qualitative filter paper into a triangle; mixing dissolution liquid with corresponding internal standard solution according to a volume ratio of 1 to (0.1 to 10); dropping the obtained mixed solution on the triangle paper piece; carrying out air-drying; applying an external voltage of 3 to 5kv to the sample paper piece; dropping a spray solvent acetonitrile onto the paper piece to carry out spray detection. The invention provides mass spectrometry, so that for tolerance of involatile buffer salt, dissolution liquid of a drug can be directly analyzed without suffering from the pre-treatment process, and thus, a new method is provided for rapid measurement of the drug dissolution rate.

Description

technical field [0001] The invention relates to a drug detection method, in particular to a rapid determination method for drug dissolution. Background technique [0002] Mass spectrometry (MS) technology has the characteristics of fast analysis speed, strong specificity and high sensitivity. In recent years, with the continuous innovation and improvement of ionization technology and mass analyzer, mass spectrometry has become one of the fastest growing analytical techniques. The innovation of ionization technology has been promoting the "leapfrogging" development of mass spectrometry. The development of new open ionization (Ambient ionization, AI) technology has become the frontier and research direction of mass spectrometry. Direct analysis of samples , rapid analysis of the surface of objects and other aspects have made major breakthroughs, which has greatly promoted the development of mass spectrometry in real-time, surface, in situ, and high-throughput analysis. [00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N27/62
CPCG01N27/62
Inventor 刘阳何兰刘宁庾莉菊刘静
Owner NAT INST FOR FOOD & DRUG CONTROL
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