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A detection method and purity analysis method of rhpth protein or rhpth protein preparation

A protein preparation and detection method technology, which is applied in the field of medical testing and drug analysis, can solve the problems of the specificity, detection limit, durability and precision of the detection method of rhPTH content and purity, and achieve great application value and improve the specificity. sexual effect

Active Publication Date: 2020-05-15
BEIJING GENETECH PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] As the rhPTH product is in the development stage, the specificity, detection limit, durability and precision of the current detection method for rhPTH content and purity are not enough, and further improvement is needed

Method used

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  • A detection method and purity analysis method of rhpth protein or rhpth protein preparation
  • A detection method and purity analysis method of rhpth protein or rhpth protein preparation
  • A detection method and purity analysis method of rhpth protein or rhpth protein preparation

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Embodiment 1

[0039] This embodiment provides a detection method for rhPTH protein or rhPTH protein preparation, and the specific detection steps are as follows:

[0040] 1.1 Configure the rhPTH protein or rhPTH protein preparation to be tested as a test mother solution, and the concentration of the test mother solution is 2 mg / mL;

[0041] 1.2 Dilute the test mother solution into the test solution of rhPTH protein or rhPTH protein preparation; the concentration of the test solution is 0.2mg / mL;

[0042] 1.3 The mobile phase includes mobile phase A and mobile phase B. Mobile phase A is mainly prepared by mixing acetonitrile solution and sodium sulfate solution at a volume ratio of 8:92. The pH of mobile phase A is 1.9, and mobile phase B is mainly made of acetonitrile solution. It is prepared by mixing with sodium sulfate solution according to the volume ratio of 45:55, and the pH value of mobile phase B is 2.5;

[0043] 1.4 Select the C18 column as the reversed-phase chromatographic colum...

Embodiment 2

[0047] This embodiment provides a detection method for rhPTH protein or rhPTH protein preparation, and the specific detection steps are as follows:

[0048] 1.1 Configure the rhPTH protein or rhPTH protein preparation to be tested as a test mother solution, and the concentration of the test mother solution is 3 mg / mL;

[0049] 1.2 Dilute the test mother solution into the test solution of rhPTH protein or rhPTH protein preparation; the concentration of the test solution is 0.3mg / mL;

[0050]1.3 The mobile phase includes mobile phase A and mobile phase B. Mobile phase A is mainly prepared by mixing acetonitrile solution and sodium sulfate solution at a volume ratio of 15:85. The pH of mobile phase A is 2.5, and mobile phase B is mainly made of acetonitrile solution. It is prepared by mixing with sodium sulfate solution according to the volume ratio of 55:45, and the pH value of mobile phase B is 1.9;

[0051] 1.4 Select the C8 column as the reversed-phase chromatographic column...

Embodiment 3

[0055] This embodiment provides a detection method for rhPTH protein or rhPTH protein preparation, and the specific detection steps are as follows:

[0056] 1.1 Configure the rhPTH protein or rhPTH protein preparation to be tested as a test mother solution, and the concentration of the test mother solution is 2.5mg / mL;

[0057] 1.2 Dilute the test mother solution into the test solution of rhPTH protein or rhPTH protein preparation; the concentration of the test solution is 0.25mg / mL;

[0058] 1.3 The mobile phase includes mobile phase A and mobile phase B. Mobile phase A is mainly prepared by mixing acetonitrile solution and sodium sulfate solution at a volume ratio of 10:90. The pH of mobile phase A is 2.3, and mobile phase B is mainly made of acetonitrile solution. It is prepared by mixing with sodium sulfate solution according to the volume ratio of 50:50, and the pH value of mobile phase B is 2.3;

[0059] 1.4 Select the C18 column as the reversed-phase chromatographic co...

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Abstract

The invention provides a detection method and a purity analysis method of rhPTH (Recombinant Human Parathyroid Hormone) protein or an rhPTH protein preparation, and belongs to the fields of medical examinations and pharmaceutical analysis. The detection method of the rhPTH protein or the rhPTH protein preparation, which is provided by the invention, through optimizing conditions of proportion of mobile phases, concentration of a sample, detection time, detection wavelength, column temperature and the like, is used for further improving the detection specificity, a detection limit and durability, and the detection method can also have a more accurate detection result and good and reliable detection data when being adopted to carry out purity analysis, and has higher practical application value.

Description

technical field [0001] The invention relates to the field of medical testing and drug analysis, in particular to a detection method and purity analysis method of rhPTH protein or rhPTH protein preparation. Background technique [0002] In the process of drug development, the detection method of protein content and purity is an important evaluation parameter for drug screening and quality control. The reliability of the test results can be used to guide drug screening and product quality control. [0003] Human parathyroid hormone is one of the important hormones to maintain blood calcium balance in the body. Its basic physiological function is to increase the number of osteoblasts to promote bone resorption and growth. rhPTH is the active fragment of human endogenous parathyroid hormone. One injection can increase the accumulation of new bone on the surface of cancellous and cortical bone by stimulating the activity of osteoblasts. [0004] Since the rhPTH product is in th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 刘月峰苏迪李静樊欣迎闻亚磊蔡杨柳
Owner BEIJING GENETECH PHARML
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