阅读说明：本技术 一种医疗器械快速灭菌剂及其制备方法 (Quick sterilizing agent for medical instruments and preparation method thereof ) 是由 蒋士龙 黄亚琴 汪婕 于 2020-11-25 设计创作，主要内容包括：本发明提供了一种医疗器械快速灭菌剂,它包括下列各重量百分数的组分：0.1--2%二氯异氰尿酸钠、5--15%硅酸钠、2--10%磷酸钠、0.5--5%氮化硼、1--5%络合剂、0.5--2%缓蚀剂、0.2—1%增强剂、0.1-2.5%稳定剂、0.1-2.55%渗透剂、余量为水；本发明还提供了一种所述医疗器械快速灭菌剂的制备方法,步骤包括：按所述各组分与含量将二氯异氰尿酸钠、硅酸钠、磷酸钠、氮化硼在60-70℃下加热混合1-3小时,冷却后加入稳定剂、渗透剂、EDTA-2Na、季戊四醇酯和偏硅酸钠,加水至100%,混匀即得灭菌剂。本发明对于医疗器械原液30分钟达到灭菌,5分钟达到消毒。本发明可杀灭肠道致病菌、化脓性球菌、致病性酵母菌、细菌芽胞、黑曲霉菌、龟分枝杆菌,并能灭活病毒,有着高效、速效、安全、简便、无腐蚀的优点。(The invention provides a quick sterilizing agent for medical instruments, which comprises the following components in percentage by weight: 0.1 to 2 percent of sodium dichloroisocyanurate, 5 to 15 percent of sodium silicate, 2 to 10 percent of sodium phosphate, 0.5 to 5 percent of boron nitride, 1 to 5 percent of complexing agent, 0.5 to 2 percent of corrosion inhibitor, 0.2 to 1 percent of reinforcing agent, 0.1 to 2.5 percent of stabilizing agent, 0.1 to 2.55 percent of penetrating agent and the balance of water; the invention also provides a preparation method of the medical apparatus rapid sterilizing agent, which comprises the following steps: heating and mixing sodium dichloroisocyanurate, sodium silicate, sodium phosphate and boron nitride at 60-70 ℃ for 1-3 hours according to the components and the content, cooling, adding a stabilizer, a penetrating agent, EDTA-2Na, pentaerythritol ester and sodium metasilicate, adding water to 100%, and uniformly mixing to obtain the sterilizing agent. The invention can sterilize the medical appliance stock solution within 30 minutes and sterilize the medical appliance stock solution within 5 minutes. The invention can kill intestinal pathogenic bacteria, pyogenic coccus, pathogenic saccharomycetes, bacterial spores, aspergillus niger and mycobacterium cheloni, can inactivate viruses, and has the advantages of high efficiency, quick effect, safety, simplicity and no corrosion.)

1. A rapid sterilant for medical devices, comprising: sodium dichloroisocyanurate, sodium silicate, sodium phosphate, boron nitride, a complexing agent, a corrosion inhibitor, a reinforcing agent, a stabilizing agent, a penetrating agent and deionized water; the weight percentages of the components are as follows:

0.1-2% of sodium dichloroisocyanurate;

5-15% of sodium silicate;

sodium phosphate, 2-10%;

0.5-5% of boron nitride;

1-5% of complexing agent;

0.5 to 2.0 percent of corrosion inhibitor;

0.1 to 2.5 percent of stabilizer;

0.2 to 1 percent of reinforcing agent;

0.1 to 2.5 percent of penetrating agent

Deionized water 90.5-55%.

2. The rapid sterilizing agent for medical instruments according to claim 1, wherein the complexing agent is one or more selected from sodium phosphate, sodium tripolyphosphate, sodium hexametaphosphate, boron nitride, sodium hydroxide and EDTA-2 Na.

3. The rapid sterilizing agent for medical instruments as claimed in claim 1, wherein the corrosion inhibitor is one or more selected from sodium silicate, sodium phosphate, boron nitride, pentaerythritol ester and sodium metasilicate.

4. The rapid sterilizing agent for medical devices as claimed in claim 1, wherein the stabilizer is one or more selected from the group consisting of sodium silicate, sodium phosphate, magnesium silicate, sodium hydroxide and borate.

5. The medical instrument rapid sterilizing agent according to claim 1, wherein the reinforcing agent and the penetrating agent are one or more of sodium phosphate, benzotriazole, sodium nitrite and polyphosphate.

6. A preparation method of a medical apparatus rapid sterilizing agent is characterized by comprising the following steps:

step 1: heating and mixing 0.1-2% of sodium dichloroisocyanurate, 5-15% of sodium silicate, 2-10% of sodium phosphate and 0.5-5% of boron nitride according to the content of each component to prepare a solution;

step 2: after the solution in the step 1 is cooled, adding 0.1-2.5% of stabilizer, 0.1-2.5% of penetrating agent, 1-5% of complexing agent, 0.5-2.0% of corrosion inhibitor and 0.2-1% of reinforcing agent;

and step 3: adding 90.5-55% water until the total weight percentage of the solution reaches 100%, and mixing uniformly to obtain the sterilizing agent.

7. The method for preparing the rapid sterilizing agent for the medical devices as claimed in claim 6, wherein in the step 1, the components are mixed and heated at the temperature of: 60-70 ℃, heating time: 1-3 hours.

8. The method as claimed in claim 6, wherein in step 2, the reagents are added and then stirred uniformly.

9. The preparation method of the rapid sterilizing agent for the medical instruments as claimed in claim 6, wherein after the main components are uniformly mixed, deionized water is added to make the whole weight percentage of the solution reach 100%, and the solution is uniformly stirred.

Technical Field

The invention relates to a complex chlorine sterilizing agent, in particular to a quick sterilizing agent for medical instruments and a preparation method thereof.

Background

For the sterilization of medical instruments, the traditional chemical disinfection and sterilization agents such as glutaraldehyde, o-phthalaldehyde, peracetic acid and the like have long sterilization time, large smell and corrosiveness and are obviously limited in the using process. The glutaraldehyde disinfectant has drug resistance to mycobacterium bisecting, the o-phthalaldehyde disinfectant cannot achieve a sterilization effect when the using concentration is low, and the peracetic acid disinfectant has low stability and is corroded.

Complexing chlorine: the process of combining molecules or ions with metal ions to form new stable ionic groups is called complexation, and generally refers to compounds containing complex chloride ions.

The sterilization mechanism of the complex chlorine is as follows: HOCl molecules are continuously released into the solution and keep dynamic balance, the HOCl molecules are small and uncharged, can easily penetrate through cell membranes of microorganisms to enter the solution, nascent state [ O ] and [ Cl ] are released, the oxidation effect and the chlorination effect are strong, amino acids in the microorganisms can be decomposed, the amino acid chains are broken, and the proteins lose functions, so that the microorganisms can be rapidly killed.

In the prior art, most of disinfectant has certain corrosivity, the disinfection speed is not ideal, and the ideal disinfection effect on medical instruments is difficult to achieve in the using process.

Disclosure of Invention

Aiming at the defects of the prior art, the sterilization solution can kill intestinal pathogenic bacteria, pyogenic coccus, pathogenic yeast, bacterial spores, aspergillus niger and mycobacterium cheloniae, and can inactivate viruses. Not only has high efficiency, broad spectrum, quick sterilization and long-term sterilization effect, but also has good safety, simple and convenient and quick use and no corrosion. Is suitable for high-level disinfection and sterilization of various medical instruments, endoscopes and the like in medical and health institutions.

In order to achieve the purpose, the technical scheme provided by the invention is as follows:

a rapid sterilant for medical devices, comprising: sodium dichloroisocyanurate, sodium silicate, sodium phosphate, boron nitride, a complexing agent, a corrosion inhibitor, a reinforcing agent, a stabilizing agent, a penetrating agent and deionized water; the weight percentages of the components are as follows:

0.1-2% of sodium dichloroisocyanurate;

5-15% of sodium silicate;

sodium phosphate, 2-10%;

0.5-5% of boron nitride;

1-5% of complexing agent;

0.5 to 2.0 percent of corrosion inhibitor;

0.1 to 2.5 percent of stabilizer;

0.2 to 1 percent of reinforcing agent;

0.1 to 2.5 percent of penetrating agent

Deionized water 90.5-55%.

The complexing agent is composed of one or more of sodium phosphate, sodium tripolyphosphate, sodium hexametaphosphate, boron nitride, sodium hydroxide and EDTA-2 Na.

The corrosion inhibitor is one or more of sodium silicate, sodium phosphate, boron nitride, pentaerythritol ester and sodium metasilicate.

The stabilizer is one or more of sodium silicate, sodium phosphate, magnesium silicate, sodium hydroxide and borate.

The reinforcing agent and the penetrating agent are one or more of sodium phosphate, benzotriazole, sodium nitrite and polyphosphate.

A preparation method of a medical device rapid sterilizing agent comprises the following steps:

step 1: heating and mixing 0.1-2% of sodium dichloroisocyanurate, 5-15% of sodium silicate, 2-10% of sodium phosphate and 0.5-5% of boron nitride according to the content of each component to prepare a solution;

step 2: after the solution in the step 1 is cooled, 0.1-2.5% of stabilizer, 0.1-2.5% of penetrating agent, 1-5% of complexing agent, 0.5-2.0% of corrosion inhibitor and 0.2-1% of reinforcing agent are added.

And step 3: adding 90.5-55% water until the total weight percentage of the solution reaches 100%, and mixing uniformly to obtain the sterilizing agent.

In the step 1, the components are mixed and heated, and the heating temperature is as follows: 60-70 ℃, heating time: 1-3 hours.

In the step 2, after each reagent is added, the reagent needs to be uniformly stirred.

After the main components are uniformly mixed, deionized water is added to ensure that the whole weight percentage of the solution reaches 100 percent, and the solution is uniformly stirred.

The quick sterilizing agent for the medical instruments is convenient to use, and can sterilize the stock solution of the medical instruments within 30 minutes and sterilize the stock solution of the medical instruments within 5 minutes. The complex chlorine sterilization liquid can kill intestinal pathogenic bacteria, pyogenic coccus, pathogenic yeast, bacterial spores, aspergillus niger and mycobacterium cheloni, and can inactivate viruses. Not only has high efficiency, broad spectrum, quick sterilization and long-term sterilization effect, but also has good safety, simple and convenient and quick use and no corrosion. Is suitable for high-level disinfection and sterilization of various medical instruments, endoscopes and the like in medical and health institutions.

Detailed Description

The present invention will be described in further detail with reference to the following examples in order to clarify technical problems, technical solutions, implementation processes and performance displays.

Example 1

As a possible embodiment, the quick sterilizing agent for the medical apparatus consists of sodium dichloroisocyanurate, a complexing agent, a corrosion inhibitor, an enhancer, a stabilizer, a penetrating agent, sodium silicate, sodium phosphate and water.

The weight percentage of each component is as follows:

sodium dichloroisocyanurate, 0.1%;

5% of sodium silicate;

sodium phosphate, 2%;

5% of boron nitride;

3% of complexing agent;

1% of corrosion inhibitor;

0.2% of reinforcing agent;

0.5 percent of stabilizer;

2% of penetrant;

deionized water, 81.2%.

Wherein the complexing agent is composed of one or more of sodium phosphate, sodium tripolyphosphate, sodium hexametaphosphate, boron nitride, sodium hydroxide and EDTA-2 Na;

wherein, the corrosion inhibitor is one or more of sodium silicate, sodium phosphate, boron nitride, pentaerythritol ester and sodium metasilicate;

wherein the stabilizer is one or more of sodium silicate, sodium phosphate, boron nitride, magnesium silicate, sodium hydroxide and borate;

wherein the reinforcing agent and the penetrating agent are one or more of sodium phosphate, benzotriazole, sodium nitrite and polyphosphate.

As a possible embodiment, the preparation procedure of example 1 includes:

step 1: heating and mixing 0.1% of sodium dichloroisocyanurate, 5% of sodium silicate, 2% of sodium phosphate and 5% of boron nitride according to the content of the components to prepare a solution;

step 2: after the solution in the step 1 is cooled, 0.5% of stabilizing agent, 2% of penetrating agent, 3% of complexing agent, 1% of corrosion inhibitor and 0.2% of reinforcing agent are added.

And step 3: adding 81.2% of water until the total weight percentage of the solution reaches 100%, and uniformly mixing to obtain the sterilizing agent.

In the step 1, the components are mixed and heated, and the heating temperature is as follows: 60-70 ℃.

In the step 2, after each reagent is added, the reagent needs to be uniformly stirred.

Wherein, after the main components are uniformly mixed, deionized water is added to ensure that the whole weight percentage of the solution reaches 100 percent, and the solution is uniformly stirred.

According to the inspection report of the Jiangsu province disease prevention control center:

1) for the present example 1, for the detection of the degree of metal corrosion:

and (4) conclusion: the embodiment basically has no corrosion to the stainless steel sheet and the copper sheet, slightly corrodes the aluminum sheet and severely corrodes the carbon steel sheet.

2) For this example 1, the killing effect on Bacillus subtilis var niger spores:

for this example 1, qualitative sterilization effect on Bacillus subtilis var niger spores:

and (4) conclusion: and (3) at the test temperature of 20 ℃, the stock solution of the sample acts for 15min, 30min and 45min to sterilize the bacillus subtilis var niger on the stainless steel sheet to be qualified.

3) For this example 1, results of the mouse acute oral toxicity test:

and (5) concluding that the test sample belongs to a non-toxic grade.

4) For this example 1, the micronucleus test was performed on mouse bone marrow pleochromophilia erythrocytes

And (4) conclusion: example 1 test samples were devoid of micronucleus effects on mouse bone marrow pleochromocytes.

Example 2

As a possible embodiment, the quick sterilizing agent for the medical apparatus consists of sodium dichloroisocyanurate, a complexing agent, a corrosion inhibitor, an enhancer, a stabilizer, a penetrating agent, sodium silicate, sodium phosphate and water.

The weight percentage of each component is as follows:

sodium dichloroisocyanurate, 2%;

10% of sodium silicate;

8% of sodium phosphate;

2% of boron nitride;

5% of complexing agent;

0.5 percent of corrosion inhibitor;

0.5 percent of reinforcing agent;

1.0% of a stabilizer;

1.0% of penetrant;

deionized water, 70%.

Wherein the complexing agent is composed of one or more of sodium phosphate, sodium tripolyphosphate, sodium hexametaphosphate, boron nitride, sodium hydroxide and EDTA-2 Na;

wherein, the corrosion inhibitor is one or more of sodium silicate, sodium phosphate, boron nitride, pentaerythritol ester and sodium metasilicate;

wherein the stabilizer is one or more of sodium silicate, sodium phosphate, boron nitride, magnesium silicate, sodium hydroxide and borate;

wherein the reinforcing agent and the penetrating agent are one or more of sodium phosphate, benzotriazole, sodium nitrite and polyphosphate.

As a possible embodiment, the preparation procedure of example 2 includes:

step 1: heating and mixing 2% of sodium dichloroisocyanurate, 10% of sodium silicate, 8% of sodium phosphate and 2% of boron nitride according to the content of the components to prepare a solution;

step 2: and (3) after the solution in the step (1) is cooled, adding 1% of stabilizer, 1% of penetrating agent, 5% of complexing agent, 0.5% of corrosion inhibitor and 0.5% of reinforcing agent.

And step 3: adding 70% deionized water until the weight percentage of the total components of the solution reaches 100%, and uniformly mixing to obtain the sterilizing agent.

In the step 1, the components are mixed and heated, and the heating temperature is as follows: 60-70 ℃.

In the step 2, after each reagent is added, the reagent needs to be uniformly stirred.

Wherein, after the main components are uniformly mixed, deionized water is added to ensure that the whole weight percentage of the solution reaches 100 percent, and the solution is uniformly stirred.

According to the inspection report of the Jiangsu province disease prevention control center:

1) for the present example 2, for the detection of the metal corrosion degree:

and (4) conclusion: the embodiment basically has no corrosion to the stainless steel sheet and the copper sheet, slightly corrodes the aluminum sheet and severely corrodes the carbon steel sheet.

3) For this example 2, the killing effect on Bacillus subtilis var niger spores:

for this example 2, qualitative sterilization effect on Bacillus subtilis var niger spores:

and (4) conclusion: and (3) at the test temperature of 20 ℃, the stock solution of the sample acts for 15min, 30min and 45min to sterilize the bacillus subtilis var niger on the stainless steel sheet to be qualified.

3) For this example 2, mice acute oral toxicity test results:

and (5) concluding that the test sample belongs to a non-toxic grade.

4) For this example 2, the micronucleus test was performed on mouse bone marrow pleochromophilia erythrocytes

And (4) conclusion: example 2 the test samples had no micronucleus effect on mouse bone marrow pleochromocytes.

Example 3

As a possible embodiment, the quick sterilizing agent for the medical apparatus consists of sodium dichloroisocyanurate, a complexing agent, a corrosion inhibitor, an enhancer, a stabilizer, a penetrating agent, sodium silicate, sodium phosphate and water.

The weight percentage of each component is as follows:

1% of sodium dichloroisocyanurate;

15% of sodium silicate;

5% of sodium phosphate;

2.5 percent of boron nitride;

1% of complexing agent;

2% of corrosion inhibitor;

1% of reinforcing agent;

2.5 percent of stabilizer;

2.5% of penetrant;

deionized water, 67.5%.

Wherein the complexing agent is composed of one or more of sodium phosphate, sodium tripolyphosphate, sodium hexametaphosphate, boron nitride, sodium hydroxide and EDTA-2 Na;

wherein, the corrosion inhibitor is one or more of sodium silicate, sodium phosphate, boron nitride, pentaerythritol ester and sodium metasilicate;

wherein the stabilizer is one or more of sodium silicate, sodium phosphate, boron nitride, magnesium silicate, sodium hydroxide and borate;

wherein the reinforcing agent and the penetrating agent are one or more of sodium phosphate, benzotriazole, sodium nitrite and polyphosphate.

As a possible embodiment, the preparation procedure of example 3 includes:

step 1: heating and mixing 1% of sodium dichloroisocyanurate, 15% of sodium silicate, 5% of sodium phosphate and 2.5% of boron nitride according to the content of the components to prepare a solution;

step 2: after the solution in the step 1 is cooled, 2.5% of stabilizing agent, 2.5% of penetrating agent, 1% of complexing agent, 2% of corrosion inhibitor and 1% of reinforcing agent are added.

And step 3: adding 67.5 percent of deionized water until the weight percentage of the total components of the solution reaches 100 percent, and uniformly mixing to obtain the sterilizing agent.

In the step 1, the components are mixed and heated, and the heating temperature is as follows: 60-70 ℃.

In the step 2, after each reagent is added, the reagent needs to be uniformly stirred.

Wherein, after the main components are uniformly mixed, deionized water is added to ensure that the whole weight percentage of the solution reaches 100 percent, and the solution is uniformly stirred.

According to the inspection report of the Jiangsu province disease prevention control center:

1) for the present example 3, the detection of the degree of corrosion of the metal

And (4) conclusion: the embodiment basically has no corrosion to the stainless steel sheet and the copper sheet, slightly corrodes the aluminum sheet and severely corrodes the carbon steel sheet.

2) For this example 3, the killing effect against bacillus subtilis var niger spores:

qualitative sterilization effect on black variant spores of bacillus subtilis:

and (4) conclusion: and (3) at the test temperature of 20 ℃, the stock solution of the sample acts for 15min, 30min and 45min to sterilize the bacillus subtilis var niger on the stainless steel sheet to be qualified.

3) For this example 3, results of the mouse acute oral toxicity test:

sex	Dosage (mg/kg. bw)	Animal number (only)	Number of dead animals	Mortality (%)
					Female	5000	10	0	0
Male sex	5000	10	0	0

And (5) concluding that the test sample belongs to a non-toxic grade.

4) For example 3, the mouse bone marrow pleochromocytogenic micronucleus test

And (4) conclusion: example 3 the test samples had no micronucleus effect on mouse bone marrow pleochromocytes.

Having described embodiments of the present disclosure, the foregoing description is intended to be exemplary, not exhaustive, and not limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terms used herein were chosen in order to best explain the principles of the embodiments, the practical application, or technical improvements to the techniques in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.