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Cleaning method of disinfectant containing guanidine compound on the surface of medical equipment

A technology of guanidine compounds and medical equipment, which is applied in the cleaning field of disinfectants, can solve the problems of high cytotoxicity and complicated cleaning steps, and achieve the effect of improving the cleaning effect, optimizing the elution rate, and removing it simply, quickly and efficiently

Active Publication Date: 2021-09-24
WUHAN RUIFA MEDICAL DEVICES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, previous studies have shown that medical devices containing guanidine compounds still have high cytotoxicity (Grade 3 toxicity) when rinsed with saline
Patent CN100548388 discloses a preservative for medical equipment. In this scheme, neutral buffer, acidic eluent and neutral buffer are used to wash in sequence, and the composition of the eluent, that is, the cleaning steps are more complicated

Method used

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  • Cleaning method of disinfectant containing guanidine compound on the surface of medical equipment
  • Cleaning method of disinfectant containing guanidine compound on the surface of medical equipment
  • Cleaning method of disinfectant containing guanidine compound on the surface of medical equipment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Prepare a solution with the following composition as a cleaning solution for hemoperfusion disinfectant:

[0036] 2.58g sodium citrate, 58.44g sodium chloride, 10g ammonium chloride, 12g ammonium sulfate;

[0037] Adjust the pH of the solution to 2.5 and make up to 1 L.

[0038]A solution of polyhexamethylene biguanide hydrochloride with a concentration of 0.04 wt% was prepared as a disinfectant and antiseptic for the perfusion device. First use 2.5 L of this disinfectant to clean the hemoperfusion device with a column volume of 250 ml containing protein as a ligand, then fill the perfusion device with this solution, and place the perfusion device at 4° C. for a period of time. Then use 2.5L of the cleaning solution prepared above to clean the hemoperfusion device, and the flow direction of the cleaning solution is from bottom to top. Each 250ml cleaning solution was used as one elution volume for one wash, and the results of detecting the content of polyhexamethylene...

Embodiment 2-8 and comparative example 1-3

[0047] Compared with Example 1, the cleaning methods for the perfusate provided in Examples 2-8 and Comparative Examples 1-3 are different in that the formula of the cleaning solution is shown in Table 3, and the rest of the experimental steps are basically the same as in Example 1. All in the table are the mass of solute contained in 1L cleaning solution, and the pH value of the cleaning solution is 2.5.

[0048] Table 3 Embodiment 2-8 and the content of the guanidine compounds in the blood after the composition of the cleaning solution of Table 3 and Comparative Example 1-3 and 10 elution volumes

[0049]

[0050]

[0051] As can be seen from Table 3, compared with the cleaning solution of Comparative Example 1-3, the cleaning solution of Example 2-8 can elute most of the active ingredients of the disinfectant, and the effect is much better than that of Comparative Example 1-3 cleaning solution. In Examples 2-8, after hemoperfusion is used, the content of active ingre...

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Abstract

The invention provides a method for cleaning a disinfectant containing guanidine compounds on the surface of medical equipment. An acid salt with a pH value of 1.8-4.0 composed of citrate with a concentration of 1-10g / L, sodium chloride with a concentration of 30-100g / L, ammonium chloride and ammonium sulfate with a concentration of 3-12g / L The solution cleans guanidine compounds from the surface of medical devices that have proteins bound as ligands. The invention adopts ammonium salt of strong acid and weak base, which is acidic in aqueous solution, and adding an appropriate amount of ammonium salt is helpful for the neutralization and adsorption of guanidine compounds. Sodium citrate is a salt of weak acid and strong base, which is alkaline in aqueous solution, so the content of citrate can be reduced accordingly. The invention has better cleaning and removal effect on guanidine compounds, can realize the effect of residual traces of guanidine compounds on the surface of medical equipment, and will not negatively affect the function of medical equipment containing protein.

Description

technical field [0001] The invention relates to the technical field of medical equipment cleaning, in particular to a cleaning method of a disinfectant containing guanidine compounds on the surface of medical equipment. Background technique [0002] Most of the three types of medical devices are in contact with human blood, tissues or body fluids, especially medical devices used in extracorporeal blood circulation, such as dialyzers, filters, perfusion devices, etc. These medical devices are kept strictly sterile when human blood or body fluids come into contact with these medical devices and are to be reintroduced into the human body. Generally, these medical devices are kept sterile by moist heat sterilization or radiation sterilization. However, in some specific cases, some medical devices cannot be sterilized by existing sterilization methods, because sterilization will damage the function of such medical devices, such as hemoperfusion devices containing proteins. [0...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C11D9/38C11D9/40C11D9/26C11D9/60B08B3/08
CPCB08B3/08C11D7/10C11D7/265C11D11/0023
Inventor 王朦周琦张磊王业富
Owner WUHAN RUIFA MEDICAL DEVICES CO LTD