Quality inspection of Ricosi preparation

A quality inspection method and Likejun's technology, applied in chemical instruments and methods, measuring devices, material separation, etc., can solve the problems of operator hazard, cumbersome method operation, etc., and achieve the effect of strong specificity

Active Publication Date: 2007-02-28
JIANGSU JIBEIER PHARMA
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

At present, Likejun tablets (10mg / tablet and 20mg / tablet two specifications) are used clinically, but due to the particularity of the original drug of Likejun, the content determination method in its quality testing method has been using the chemical titration method. , has its limitations, the method is cumbersome to operate, and uses chemical reagents that are more harmful to operators

Method used

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  • Quality inspection of Ricosi preparation

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Effect test

Embodiment Construction

[0018] The quality detection method of the Likejun preparation of the present invention is to take Likejun or mix Likejun with suitable auxiliary materials or mix Likejun with suitable auxiliary materials and then granulate to make various Likejun solid preparations, which can be obtained . Each preparation unit of Li Kejun contains 5-80mg of Li Kejun (former name: Lixuesheng).

[0019] The quality detection method of Likejun preparation of the present invention comprises the following work:

[0020] (1) Chromatographic conditions: use octadecylsilane bonded silica gel as filler; wherein the mobile phase of chromatographic conditions is made up of water-acetonitrile-glacial acetic acid; its optimal proportion is water-acetonitrile-glacial acetic acid (56:44 : 0.3). The detection wavelength is 210nm.

[0021] (2) Preparation of the test solution: take an appropriate amount of Likejun preparation, grind it finely, weigh it accurately, make 100 μg / ml with acetonitrile or mobil...

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Abstract

A method for detecting quality of Likejun preparation includes preparing chromatogram conditions by using silica gel as loading agent and using water - acetonitrile - glacial acetic acid as flowing phase as well as using wavelength of 210 nm as detection wavelength, preparing test solution by putting proper amount of Likejun preparation into acetonitrile of 100 micron g / ml, preparing control solution by putting proper amount of likejun control matter into acetonitrile of 100 micron g / ml, carrying out determination as injecting 10 - 20 micron l of each prepared solution into liquid phase chromatograph, calculating and determining Likejun content in sample.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and discloses a quality detection method for Likejun preparations. Background technique [0002] Likejun (former name: Lixuesheng) has a chemical name: 2-(α-phenyl-α-ethoxycarbonyl-methyl)thiazolidine-4-carboxylic acid, which is a white blood cell-increasing drug. The structural formula is as follows: [0003] [0004] Molecular formula: C 14 h 17 o 4 NS [0005] Molecular weight: 295.36 [0006] Likejun is used to prevent and treat leukopenia and thrombocytopenia caused by various reasons. It is mainly used clinically for the treatment of leukopenia and thrombocytopenia caused by tumor radiotherapy and chemotherapy, and endocrine disorders treatment drugs. At present, Likejun tablets (10mg / tablet and 20mg / tablet two specifications) are used clinically, but due to the particularity of the original drug of Likejun, the content determination method in its quality testing method h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02B01J20/281
Inventor 郑修文张正行杭太俊张宏业
Owner JIANGSU JIBEIER PHARMA
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