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Method used for germicidal treatment of catgut suture

A technology for sterilization treatment and sutures, applied in chemistry and other fields, can solve problems affecting product appearance, low sterilization dose, and difficulty in mastering, and achieve significant social and economic benefits

Inactive Publication Date: 2010-01-13
梁金平
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is not suitable to use ethylene oxide gas to sterilize the intestinal suture with maintenance fluid in the packaging bag.
cobalt 60 Irradiation sterilization not only requires too much investment in one-time equipment, but also its dosage is related to the state of the initial bacteria of the product, which is often difficult to master
cobalt 60 It is difficult to achieve complete sterilization when the sterilization dose is low, and the high dose will make the suture yellow and affect the appearance of the product; moreover, it will cause greater damage to the suture and greatly reduce its tensile strength

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1: 1.1 g of hydrogen peroxide, 0.5 g of benzoic acid, 70.0 g of isopropanol, 15.0 g of ethanol, and 1.0 g of sodium benzoate were added to 100 mL of pure water.

[0018] Wind the prepared sheep intestine suture thread into a coil and put it into a 3cm×6.5cm product small packaging bag, add about 1.5mL of the composition disinfectant prepared according to the formula in Example 1 with a dropper, seal it, and put it into the product packaging bag In, then sealed, put into the outer package, spray code. After the product is stored at room temperature for 1 week, the sutures are taken out for inspection of the product's appearance, wire diameter, tensile strength, sterility test and other standard indicators of the product's factory inspection.

[0019] According to the method and steps described in the 2002 edition of "Disinfection Technical Specifications", with the formula of Example 1, Bacillus subtilis var. niger spores were selected as indicator bacteria, and ...

Embodiment 2

[0021] Example 2: 0.6g hydrogen peroxide, 0.5g benzoic acid, 25.0g isopropanol, 60.0g ethanol, 0.7g sodium benzoate, add pure water to 100mL.

[0022] Wind the prepared sheep intestine suture thread into a coil and put it into a 3cm×6.5cm product small packaging bag, add about 1.5mL of the composition disinfectant prepared according to the formula in Example 2 with a dropper, and seal it. Following steps are with embodiment 1.

[0023] According to the method and steps described in the 2002 edition of "Disinfection Technical Specifications", with the formula of Example 2, Bacillus subtilis var. niger spores were selected as the indicator bacteria, and stainless steel sheets and sheep intestine suture coils were used as the bacteria carrier to carry out the carrier qualitative sterilization test. And on-site simulated sterilization test; the results can completely kill the spores infected on the carrier for 10 hours respectively, which meets the sterility requirements.

[0024...

Embodiment 3

[0025] Example 3: 1.8 hydrogen peroxide, 1.5 g benzoic acid, 45.0 g isopropanol, 41.0 g ethanol, 1.8 g sodium benzoate, add pure water to 100 mL.

[0026] Wind the prepared sheep intestine suture thread into a coil and put it into a 3cm×6.5cm product small packaging bag, add about 1.5mL of the composition disinfectant prepared according to the formula of Example 3 with a dropper, and seal it. Following steps are with embodiment 1.

[0027] According to the method and steps described in the 2002 edition of "Disinfection Technical Specifications", with the formula of Example 3, Bacillus subtilis var. niger spores were selected as indicator bacteria, and stainless steel sheets and sheep intestine suture coils were used as carriers for bacterial contamination, and the carrier qualitative sterilization test was carried out. And on-site simulated sterilization test; the results can completely kill the spores infected on the carrier for 7 hours respectively, which meets the sterility...

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Abstract

The invention provides a method used for the germicidal treatment of a catgut suture. The method is characterized in that the method applies a hydrogen peroxide composition disinfector with no toxicity, high efficiency and low corrosiveness to substitute maintenance liquid added into the original suture and enables the suture to be soaked in the hydrogen peroxide composition disinfector for a long time, so that the suture can reach an aseptic requirement, and main performance indexes of the product, such as diameter, tensile strength and the like of the suture are free from the obvious influence of the hydrogen peroxide composition disinfector. After the germicidal treatment is carried out on batch catgut suture products with different specifications by adopting the method, samples are delivered to an authoritative surveillance detection mechanism of medical appliances for detecting. The result is that all the 16 detected technical indexes of the appearance, the suture diameter, the tensile strength, the aseptic test and the like of a product conform to the requirements of the absorbable surgical sutures YY1116-2002. By the experimental observation of the storage period of the product after the germicidal treatment by using the method for as long as one year, each detected index of the product conforms to the national standard requirements of products.

Description

technical field [0001] The invention relates to a sterilization treatment method for surgical suture products, in particular to the application of a low-concentration hydrogen peroxide composition disinfectant in the sterilization treatment technology for sheep intestine suture products. Background technique [0002] The relevant national standards stipulate that all kinds of surgical suture products must meet strict sterility requirements, and the products must pass the sterility inspection before leaving the factory. The sterilization treatment of surgical suture products mainly uses ethylene oxide gas and cobalt 60 Irradiation sterilization, in the long use process, it is found that the two sterilization treatment methods have their disadvantages. The amount of residual drug in the suture after ethylene oxide gas sterilization is relatively large, which is often difficult to control to reach the standard limit of national products. Because the packaging of sheep intesti...

Claims

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Application Information

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IPC IPC(8): A61L2/18A61L101/22A61L101/36A61L101/34
Inventor 梁金平梁健张旭胡志锋梁琼洪倩陈和周张冬生
Owner 梁金平
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