Method for determining trace imatinib in blood sample and application thereof to zero phase clinical trial

A technology of tinib meter and medicinal salt, which can be applied to the application of the method in drug zero-phase clinical trial research and the field of drug determination, which can solve problems such as great difference and difficulty in measuring blood drug concentration.

Inactive Publication Date: 2015-04-01
BEIJING SHIJITAN HOSPITAL CAPITAL MEDICAL UNIVERSTY
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Problems solved by technology

According to the general norms of phase zero clinical trials of drugs, in this phase zero clinical trial of drugs, the dose of the subject once a day is 4mg. After taking this very low dose, the drug dose in the subject's body fluids such as plasma will Lower, directly caused the problem of difficul...

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  • Method for determining trace imatinib in blood sample and application thereof to zero phase clinical trial
  • Method for determining trace imatinib in blood sample and application thereof to zero phase clinical trial
  • Method for determining trace imatinib in blood sample and application thereof to zero phase clinical trial

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Embodiment Construction

[0086] The present invention can be further described by the following examples, however, the scope of the present invention is not limited to the following examples. Those skilled in the art can understand that various changes and modifications can be made in the present invention without departing from the spirit and scope of the present invention. The present invention provides general and / or specific descriptions of the materials and test methods used in the tests. While many of the materials and methods of manipulation which are employed for the purposes of the invention are well known in the art, the invention has been described here in as much detail as possible.

[0087] In the further description below, if not specified, the imatinib or its pharmaceutically acceptable salt used is imatinib mesylate, and the imatinib mesylate preparation used is a commercially available capsule H20100238. In the following, when the internal standard is used, unless otherwise specifie...

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Abstract

The invention relates to a method for determining trace imatinib in a blood sample and application to zero phase clinical trial, in particular, the invention relates to a method for determining imatinib or pharmaceutical salts of the imatinib in a biological sample. The method adopts the high performance liquid chromatography-tandem mass spectrum for determination and comprises the following steps and the testing conditions: treatment of a tested sample, determination of the sample, and determining a liquid chromatogram condition and a mass spectrum condition and the like. The invention also relates to application of imatinib or pharmaceutical salts of the imatinib to zero phase clinical trial and application of the method to pharmacokinetics experimental study of imatinib or pharmaceutical salts. The result shows that the detection method with the above characteristics can be beneficially used for detecting the concentration of imatinib or pharmaceutical salts of the imatinib such as mesylate in the biological sample such as blood plasma in the medicine zero phase clinical trial. The chemical structure of imatinib mesylate is shown in the description.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for determining a drug, in particular to a method for determining a drug in a biological sample such as blood plasma, and more particularly to a method for targeting a very small amount of anticancer drug Imam in a biological sample such as blood plasma. Determination method of tinib and its pharmaceutically acceptable salts. The invention also relates to the application of the method in phase zero clinical trial research of medicines. Background technique [0002] Imatinib Mesylate (Imatinib Mesylate) is a selective tyrosine kinase inhibitor developed by Novartis, Switzerland. The inhibitor targets the abnormal protein Bcr-Abl with tyrosine kinase activity produced by Ph chromosome positive (Philadelphia chromosome positive, Ph+) chronic myeloid leukemia (CML). It was approved by FDA in May 2001 for the treatment of chronic myelogenous leukemia. In February 2002, FDA f...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 王兴河周保利陈刚王进漆璐王泽娟金辉
Owner BEIJING SHIJITAN HOSPITAL CAPITAL MEDICAL UNIVERSTY
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