Method for evaluating biological security of solubilizing auxiliary materials

A technology of biosafety and excipients, applied in biochemical equipment and methods, measurement/inspection of microorganisms, thermal development of materials, etc., can solve problems that have not been reported, and achieve simple operation, low interference, and standardization of detection Effect

Inactive Publication Date: 2010-06-02
THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, Tetrahymena thermophila has become an ideal material for biological and pharmacological research,

Method used

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  • Method for evaluating biological security of solubilizing auxiliary materials
  • Method for evaluating biological security of solubilizing auxiliary materials
  • Method for evaluating biological security of solubilizing auxiliary materials

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1. Preparation of test article

[0043] Take 5 kinds of solubilizing excipients, 0.5mg, 1.0mg, 2.0mg, 3.0mg, 4.0mg of each excipient, weigh them accurately, add 1mL of distilled water to dissolve, and prepare the concentrations of 0.5mg / mL, 1.0mg / mL, 2.0mg / mL, 3.0mg / mL, 4.0mg / mL solutions of various solubilizing excipients. Under sterile conditions, filter with a 0.22 μm filter membrane and store at 4°C for later use.

[0044] 2. Measurement method

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PUM

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Abstract

The invention relates to a method for evaluating the biological security of solubilizing auxiliary materials. In the method, tetrahymena thermophile is taken as a model, a microcalorimetry is combined, the influence on the growth metabolism of the tetrahymena thermophile from the solubilizing auxiliary materials is inspected, and the biological security of the solubilizing auxiliary materials is evaluated. By carrying out information analysis on a thermal activity spectrum with integral characteristics and adopting characteristic parameters that reflect different growth metabolism stages, the invention inspects the influence on the growth metabolism of the tetrahymena thermophile from the solubilizing auxiliary materials totally, objectively and quantitively, evaluates the biological security of the solubilizing auxiliary materials, is simple in operation and is beneficial to the detection normalization.

Description

technical field [0001] The invention relates to a method for evaluating the biological safety of solubilizing auxiliary materials, belonging to the field of pharmaceutical auxiliary materials. Specifically, the present invention uses Tetrahymena thermophila as a biological model, combined with microcalorimetry, to investigate the effect of solubilizing excipients on the growth and metabolism of Tetrahymena thermophila, thereby evaluating the biological safety of solubilizing excipients. Background technique [0002] Most of the solubilizing excipients are a kind of non-ionic surfactants, which have both hydrophilic groups and lipophilic groups in their structure, and can form micelles or reverse micelles in the solution. Applied in drug-soluble liquid preparations. With the improvement and improvement of modern liquid preparations and the emergence of new modern dosage forms, the status of solubilizing excipients is becoming more and more important. However, there are toxi...

Claims

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Application Information

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IPC IPC(8): C12Q1/02G01N25/48
Inventor 鄢丹张少锋肖小河杨明
Owner THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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