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Process for preparing anti-interference horseshoe crab agent

A preparation process and technology of limulus reagents are applied in the field of preparation of anti-interference limulus reagents, which can solve problems such as unreachable, and achieve the effects of protecting limulus resources, ensuring the safety of people's lives and properties, and improving the economic benefits of enterprises.

Inactive Publication Date: 2007-07-25
丁友玲
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to foreign reports, when the test sample contains interfering substances, the dilution method is often used, but some drugs (such as polysaccharides) cannot achieve the purpose with the dilution method

Method used

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  • Process for preparing anti-interference horseshoe crab agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] The process steps in Example 1 include the step of separating and extracting blood cells from Limulus whole blood. Its next steps:

[0015] A. Preparation of P-type anti-jamming Limulus reagent semi-finished products: using affinity chromatography, using the sterile pyrogen-free affinity chromatography column prepared by gel Dextransulfate Sepharose CL-6B and the equipment for collecting and separating components, Limulus blood cells Each factor such as C factor, B factor, G factor, anti-endotoxin factor, procoagulase and other components were separated. Discard the G factor and the anti-endotoxin factor, and collect the remaining components, which is the semi-finished product of the P-type anti-jamming LAL reagent.

[0016] B. Removing pyrogens for aliphatic dihydric alcohols: that is, using a special depyrogenation gel to remove pyrogens from aliphatic dihydric alcohols by column elution.

[0017] C. Dissolve the prepared aliphatic dihydric alcohols with pyrogen-fre...

Embodiment 2

[0018] The process steps in Example 2 include the step of separating and extracting blood cells from Limulus whole blood. The next steps are

[0019] A. Preparation of P-type anti-jamming Limulus reagent semi-finished products: using affinity chromatography, using the sterile pyrogen-free affinity chromatography column prepared by gel Dextransulfate Sepharose CL-6B and the equipment for collecting and separating components, Limulus blood cells Each factor such as C factor, B factor, G factor, anti-endotoxin factor, procoagulase and other components were separated. Discard the G factor and the anti-endotoxin factor, and collect the remaining components, which is the semi-finished product of the P-type anti-jamming LAL reagent.

[0020] B. Removing pyrogens for aliphatic dihydric alcohols: that is, using a special depyrogenation gel to remove pyrogens from aliphatic dihydric alcohols by column elution.

[0021] C. Dissolve the prepared aliphatic diols with pyrogen-free water t...

Embodiment 3

[0022] The process steps in Example 3 include the step of separating and extracting blood cells from Limulus whole blood. Its next steps:

[0023] A. Preparation of P-type anti-jamming Limulus reagent semi-finished products: using affinity chromatography, using the sterile pyrogen-free affinity chromatography column prepared by gel Dextransulfate Sepharose CL-6B and the equipment for collecting and separating components, Limulus blood cells Each factor such as C factor, B factor, G factor, anti-endotoxin factor, procoagulase and other components were separated. Discard the G factor and the anti-endotoxin factor, and collect the remaining components, which is the semi-finished product of the P-type anti-jamming LAL reagent.

[0024] B. Removing pyrogens for aliphatic dihydric alcohols: that is, using a special depyrogenation gel to remove pyrogens from aliphatic dihydric alcohols by column elution.

[0025] C. Dissolve the prepared aliphatic dihydric alcohols with pyrogen-fre...

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Abstract

The anti-interference limulus reagent preparing process includes the step of separating Limulus blood to extract blood cell, and features the subsequent steps of: A. preparing type-P anti-interference Limulus reagent semi-product; B. eluting in column with special pyretogen gel to eliminate pyretogen of aliphatic diols; C. dissolving the prepared aliphatic diols in no-pyretogen water to prepare 100 mg / ml solution, adding prepared aliphatic diol solution into type-P anti-interference Limulus reagent semi-product to obtain aliphatic diol content of 0.2 %, eddy mixing for 30 min, letting stand over night at -18 deg.c, eddy mixing for one other 30 min, adding 1-10 % activating agent for sensitivity reaching 0.03-0.5 EU / ml, filling into ampule or Schering bottle, freeze drying at -40 deg.c, and sealing at 25 deg.c.

Description

technical field [0001] The invention belongs to a preparation process of an anti-interference limulus reagent. Background technique [0002] Limulus reagent was successfully developed in my country in 1982 and has been used in the pharmaceutical industry for 21 years, but it was only used in injections (mainly five large infusions) that did not interfere with the Limulus test. The 2000 edition of the Chinese Pharmacopoeia added 167 varieties of drugs that must be tested for their pyrogens with the limulus reagent, including chemicals, biological products, and antibiotics. These drugs have varying degrees of interference with the limulus test. According to foreign reports, when the test sample contains interfering substances, the dilution method is often used, but some drugs (such as polysaccharides) cannot achieve the purpose with the dilution method. Contents of the invention [0003] The purpose of the present invention is to provide a novel anti-interference LAL reagen...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/579
Inventor 丁友玲
Owner 丁友玲
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