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Heparin sodium production process elution monitoring method

A technology of heparin sodium and eluent, which is applied in the direction of phase influence characteristic measurement, etc., can solve the problems of time-consuming and laborious manual operation, failure to monitor the whole process of elution, drug running, etc., so as to avoid production accidents, save manpower and material resources, and avoid The effect of cumbersome steps

Active Publication Date: 2016-01-06
山东万邦赛诺康生化制药股份有限公司
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Problems solved by technology

[0002] At present, during the production of heparin sodium in the workshop, the monitoring of the progress of the elution process is done by workers measuring the concentration of the eluted salt solution to complete the monitoring of the process completion. This method cannot monitor the progress of the elution. The monitoring of the whole process of elution is prone to running out of drugs, and manual operation is time-consuming and laborious

Method used

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  • Heparin sodium production process elution monitoring method
  • Heparin sodium production process elution monitoring method
  • Heparin sodium production process elution monitoring method

Examples

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Embodiment

[0022] Real-time monitoring of the elution process of heparin sodium using the differential detection monitoring system (RI-201H):

[0023] A. First prepare 2.7% and 12% saline solution (w / w) with purified water and injection grade sodium chloride, among which 1200L of 2.7% saline solution and 1000L of 12% saline solution. Take 1000ml of 12% saline solution for ultrasonic dissolution for 30min and filter it with suction as a standard solution for differential detection to calibrate the baseline.

[0024] B. Heparin sodium elution process steps at room temperature: use 12% (w / w) NaCl solution 1000L to elute the elution column, and when the increase in the refractive index of the C column effluent reaches 4.3%, let it stand for 2 hours , and then start elution, collect the eluent into the glass reactor 3 and then use 1200L of 2.7% (w / w) NaCl solution to squeeze the resin column, when the refractive index of the outlet effluent of the eluting column is less than 4.0 %, stop coll...

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Abstract

The invention relates to a heparin sodium production process elution monitoring method. The method comprises the following steps: 1, sampling a salt solution from which resin is to be eluted as a base line of a standard solution calibration differential detector; 2, manually measuring the concentration of the salt solution obtained after elution for completing monitoring over the process completeness, and meanwhile utilizing differential detection for detecting the refractive index of the solution; 3, correlating obtained differential detection refraction value data with the salt concentration, obtained through conventional manual detection, of the elution solution, and building a mathematic model; 4, verifying monitoring capability of the mathematic model. By means of the method, the elution progress can be monitored in real time, and compared with manual inspection used in existing production, the operation is simpler, more convenient, faster and more efficient.

Description

technical field [0001] The invention relates to a method for monitoring the eluent by using a differential detector in the production process of heparin sodium, so as to achieve the purpose of monitoring the elution process. Background technique [0002] At present, during the production of heparin sodium in the workshop, the monitoring of the progress of the elution process is done by workers measuring the concentration of the eluted salt solution to complete the monitoring of the process completion. This method cannot monitor the progress of the elution. The monitoring of the whole process of elution is prone to drug running, and manual operation is time-consuming and laborious. [0003] Therefore, it is very beneficial and necessary to develop a simple and convenient monitoring system that can monitor the elution progress in real time for the production of heparin sodium. Contents of the invention [0004] A method for monitoring elution in the production process of he...

Claims

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Application Information

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IPC IPC(8): G01N21/41
Inventor 孟凡政郑会武刘清凉
Owner 山东万邦赛诺康生化制药股份有限公司
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