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Verification method for glutaraldehyde processed animal source biological material in in-vitro cells

A technology of animal origin and biological materials, which is applied in the direction of biochemical equipment and methods, microbial measurement/inspection, etc., can solve the problems of cumbersome proportioning, poor neutralization effect, and the influence of indicating cell growth, etc., and achieve simple and convenient operation, The effect of low cost and good application prospects

Inactive Publication Date: 2018-11-06
苏州良辰生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the high concentration of sodium thiosulfate and sodium sulfite will also affect the growth of indicator cells, and the ratio of glutaraldehyde to it is also cumbersome, which may easily cause problems such as poor neutralization effect

Method used

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  • Verification method for glutaraldehyde processed animal source biological material in in-vitro cells
  • Verification method for glutaraldehyde processed animal source biological material in in-vitro cells

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A method for verifying animal-derived biological materials treated with glutaraldehyde in in vitro cells, comprising the following steps:

[0028] Step (1), bovine pericardial material is placed in the glutaraldehyde disinfectant of 50mL, and glutaraldehyde disinfectant is the phosphate buffer solution that is 24% glutaraldehyde aqueous solution and pH value 7.2 by mass concentration according to volume ratio is 1 :39 is prepared, the mass concentration of glutaraldehyde in the glutaraldehyde disinfectant is 0.6%, and then placed in 2~8 ℃ of refrigerators to soak for 1d;

[0029] Step (2), take out the soaked bovine pericardium material, hang and drain until no liquid drops drop, add in 10mL medium containing neutralizing agent, the mass concentration of glycine in the medium is 0.6%, the mass concentration of arginine The concentration is 0.2%;

[0030] Step (3), shredding the bovine pericardium material, controlling the homogenization speed to be 20,000 rpm, and th...

Embodiment 2

[0033] A method for verifying animal-derived biological materials treated with glutaraldehyde in in vitro cells, comprising the following steps:

[0034] Step (1), the pig corium material is placed in the glutaraldehyde disinfectant of 30mL and soaks 16h in 20 ℃ of constant temperature incubators, and glutaraldehyde disinfectant is the glutaraldehyde aqueous solution that mass concentration is 24% and pH value is 7.2 The phosphate buffer solution is prepared according to the volume ratio of 1:49, and the mass concentration of glutaraldehyde in the glutaraldehyde disinfectant is 0.5%;

[0035] Step (2), take out the soaked pig dermis, hang and drain until there is no dripping, add 10mL in the medium containing neutralizing agent, the mass concentration of glycine in the medium is 0.5%, and the arginine in the medium The mass concentration is 0.2%;

[0036] Step (3), shredding the pig leather material, controlling the homogenization speed to 20,000 rpm, and the homogenization t...

Embodiment 3

[0039] A method for verifying animal-derived biological materials treated with glutaraldehyde in in vitro cells, comprising the following steps:

[0040] Step (1), the bovine jugular vein valved pipeline material is placed in the glutaraldehyde disinfectant of 50mL and soaked for 2d, and the glutaraldehyde disinfectant consists of a glutaraldehyde aqueous solution with a mass concentration of 24% and a phosphate buffer with a pH value of 7.2 The liquid is prepared according to the volume ratio of 1:39, and the mass concentration of glutaraldehyde in the glutaraldehyde disinfectant is 0.625%;

[0041] Step (2), take out the soaked bovine jugular vein valved pipeline material, hang it in the air and drain until there is no drop, add 10mL of medium containing neutralizing agent, the mass concentration of glycine in the medium is 0.6%, and cultivate The mass concentration of arginine in the base is 0.3%;

[0042] Step (3), shredding the bovine jugular vein valved pipeline material,...

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Abstract

The invention discloses a verification method for a glutaraldehyde processed animal source biological material in in-vitro cells. The verification method comprises the following steps: step (1) putting the animal source biological material into a glutaraldehyde disinfectant to be soaked; step (2) taking the soaked animal source biological material to be drained, adding a culture medium containinga neutralizer, shearing and homogenizing and taking a sample from homogenate suspension; step (3) diluting the sample, adding to a 96-hole culture plate which indicator cells are planted on, putting the culture plate into an incubator to be cultured and observing a cell growth condition under a microscope. The verification method disclosed by the invention has the advantages of simpleness and convenience in operation and low cost; as biological materials from animals all need to be verified by viral inactivation, the glutaraldehyde self is a good viral inactivator, and the neutralizer in the verification method disclosed by the invention can neutralize excessive glutaraldehyde, the verification method disclosed by the invention has a good application prospect in viral inactivation processverification.

Description

technical field [0001] The invention relates to a method for verifying animal-derived biological materials treated with glutaraldehyde in in vitro cells. Background technique [0002] Biogenic materials composed of mammalian extracellular matrix are widely used in surgical wound repair, tissue reconstruction, and tissue engineering scaffold materials due to their good biocompatibility. Medical devices composed of animal-derived biological materials are called animal-derived medical devices. The range and types of materials derived from animals in medical devices are very wide, and are applicable to all medical devices made of or derived from non-living animal tissues (except medical devices for in vitro diagnostics). These materials can constitute the main components of devices (such as bovine / pig heart valves, bovine pericardium, sheep gut sutures, bone substitutes for stomatology or plastic surgery, chitosan surgical anti-adhesion films, etc.), coatings for products or i...

Claims

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Application Information

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IPC IPC(8): C12Q1/02
CPCC12Q1/02
Inventor 吴娟缪汝娉
Owner 苏州良辰生物医药科技有限公司