WO2010057333A1

WO2010057333A1 - A stable activated glutaral disinfectant and its preparation method.

Info

Publication number: WO2010057333A1
Application number: PCT/CN2008/001896
Authority: WO
Inventors: 卞雪莲; 孙文胜; 张万国
Original assignee: 上海利康消毒高科技有限公司
Priority date: 2008-11-20
Filing date: 2008-11-20
Publication date: 2010-05-27

Abstract

The invention discloses a stable activated glutaral disinfectant and its preparation method. The stable activated glutaral disinfectant comprises (wt.%): glutaral (1-5), pentanediol (0.1-2.5), polyethylene glycol (3-8), non-ion surface activator (0.2-1), boracic acid (1-3), borax (0.5-1.5), antioxidant (0.1-1), corrosion inhibitor (0.5-2), and water (balance). The preparation method of the disinfectant is adding polyethylene glycol into water to stir and dissolve, adding boracic acid and borax to stir and dissolve, adding antioxidant and corrosion inhibitor to stir and dissolve, adding non-ion surface activator and mixing uniformly, and adding glutaral and pentanediol at last to stir and mix uniformly. The active constituent of glutaral of the disinfectant is in stable activated state, which don't need to be activated. It is convenient, long storage period, small volatilization of glutaral, and basically incorrodible to the stainless steel sheet, copper sheet, carbon steel sheet and aluminum sheet for use.

Description

Stable activated glutaraldehyde disinfectant and preparation method thereof

This invention relates to disinfectants, and more particularly to a stable activated glutaraldehyde disinfectant and a process for its preparation. Background technique

Glutaraldehyde is a typical disinfectant that can kill bacterial spores, fungal spores, mycobacteria, viruses (including hepatitis A, hepatitis B, and HIV). Since the 1960s,

'Glutaraldehyde has been widely used at home and abroad. Because of its broad spectrum, high efficiency, good water solubility, etc., it has been highly evaluated in applications, and is hailed as the third milestone in the history of chemical disinfectant development after formaldehyde and ethylene oxide. . Currently, glutaraldehyde is the preferred disinfectant recommended by the World Health Organization (WHO) for viral hepatitis. It is also a medical disinfectant recommended by the Chinese Ministry of Health. It is suitable for disinfection and sterilization of various surgical instruments, such as endoscopes, injection products, catheters, scalpels, etc.

Glutaraldehyde is stable under acidic conditions and is conducive to preservation, but the glutaraldehyde sterilization ability under acidic conditions is relatively weak. Under alkaline conditions, glutaraldehyde has the strongest sterilization activity, but has poor stability and is prone to polymerization and oxidation. At present, in clinical use, the glutaraldehyde disinfectant is mainly packaged in a binary or ternary package form, that is, the glutaraldehyde solution is separately packaged with the activator and the corrosion inhibitor, and the activator and the corrosion inhibitor are added to the glutaraldehyde solution before use. Temporary preparation in the middle. This aspect is inconvenient for clinical use. On the other hand, it also puts higher requirements on the preparation process. The activator and corrosion inhibitor must be completely dissolved in the glutaraldehyde solution and thoroughly mixed to form a uniform disinfectant. To ensure the disinfection effect.

In order to overcome the above disadvantages, the Applicant provides "a one-component activated glutaraldehyde disinfectant and a preparation method thereof" (Publication No.: CN101238816), in which a molecule of glutaraldehyde exists in an activated state without activation It can be used directly, which greatly increases the convenience of clinical use, and the properties of the product are relatively stable, but it still has certain corrosiveness to metals. Above, we provide a more effective activated glutaraldehyde disinfectant, a stable activated glutaraldehyde disinfectant, its active ingredient The dialdehyde molecule exists in a stable activation state and can be directly used without activation. It has the characteristics of convenient use, long storage period, less valeraldehyde molecular volatilization, and stainless steel sheet, copper sheet, carbon steel sheet and aluminum sheet. Basically non-corrosive. Summary of the invention

The invention aims to solve the defects that the existing glutaraldehyde needs to be temporarily prepared during use, and provides a stable activated glutaraldehyde disinfectant with superior performance and a preparation method thereof. The invention adopts a scientific formula to make the molecules of the active component glutaraldehyde in the disinfectant exist in a stable activated state, and the glutaraldehyde molecule has less volatilization into the air, has less air pollution to the environment, is convenient to use, and has very good properties. Stable, storage period can be more than 2 years, and there is almost no corrosion on stainless steel sheets, copper sheets, carbon steel sheets and aluminum sheets.

The present invention is implemented as follows:

A stable activated glutaraldehyde disinfectant comprising the following components wt%:

Glutaraldehyde: 1-5;

Pentylene glycol: 0.1-2.5;

Polyethylene glycol: 3-8;

Nonionic surfactant: 0.2-1;

Boric acid: 1-3;

Borax: 0.5-1.5; 'Antioxidant: thiopolyol, 0.1-1;

Corrosion inhibitor: 0.5-2;

Water: Balance.

The disinfectant, the ratio of the glutaraldehyde to the pentanediol in the weight ratio of the components is 1: 0.1-0.5.

The disinfectant, the nonionic surfactant is one or more of a fatty alcohol polyoxyethylene ether, an alkylphenol ethoxylate and a polyoxyethylene sorbitan ester.

The disinfectant, the polyethylene glycol has a molecular weight of 200 to 8,000.

The disinfectant, the antioxidant is selected from one or more of thioglycerol, thiosorbitol and thioglucose. The disinfectant, the corrosion inhibitor is sodium hexametaphosphate and/or potassium metaphosphate.

The method for preparing a stable activated glutaraldehyde disinfectant is as follows: according to the components and content, adding polyethylene glycol to water and stirring and dissolving, adding boric acid and borax to dissolve and dissolve, adding antioxidant, inhibiting corrosion The agent is stirred and dissolved, and then mixed with a nonionic surfactant, and finally pentanediol and glutaraldehyde are added, and the mixture is stirred and uniformly, that is, the disinfectant is obtained.

The invention has a stable activated glutaraldehyde disinfectant, and uses glutaraldehyde as a bactericide, and is combined with pentanediol, polyethylene glycol, nonionic surfactant, boric acid, borax, antioxidant, corrosion inhibitor and water. A pro-aqueous solution prepared. The instability of glutaraldehyde is mainly manifested in the polymerization and oxidation of aldehyde groups in its molecule. The present invention uses a hydrophilic polymer compound polyethylene glycol, and a polyethylene glycol molecule is dispersed around the glutaraldehyde molecule, which can effectively reduce collision between molecules of glutaraldehyde. The pentanediol molecule has a similar molecular chain structure with the glutaraldehyde molecule, and is arranged around the glutaraldehyde molecule. The hydroxyl group can block the polymerization of the aldehyde group between the glutaraldehyde molecules, and the pentanediol has an auxiliary antioxidant effect. The thiopolyol has excellent reducibility, and its use as an antioxidant can effectively inhibit oxidation of the glutaraldehyde molecule. The present invention inhibits the polymerization and oxidation of glutaraldehyde molecules by the combined action of the above components, thereby greatly improving the stability of glutaraldehyde. Nonionic surfactants can reduce surface tension, increase the penetration of glutaraldehyde molecules, and help enhance the bactericidal ability of glutaraldehyde. The buffer system consisting of boric acid and borax stabilizes the pH of the solution in the near-neutral range, while boric acid and borax have an auxiliary anti-corrosion effect. The sodium hexametaphosphate or potassium metaphosphate is used as a corrosion inhibitor to complex with the metal ions released from the metal surface, and the insoluble salt formed is closely covered on the metal surface in a gelled precipitation state to form a protective film, which effectively retards the corrosion of the metal. process.

The disinfectant of the invention adopts the scientific formula to exert the comprehensive effect of the above components, so that the glutaraldehyde molecule is always in a stable activation state, the bactericidal action is strong, and the speed of killing the bacterial spores is fast. The glutaraldehyde molecule in the disinfectant of the invention is effectively protected and pulled, and the property is very stable, and the effective period is much more than two years; the glutaraldehyde molecule escapes less in the solution, and the degree of air pollution to the environment is small. The disinfectant of the invention is a one-dimensional package, which does not need to be prepared before use and is convenient to use. The disinfectant of the invention has minimal corrosion to metal, and has no corrosion to stainless steel sheets, copper sheets, carbon steel sheets and aluminum sheets. detailed description

Hereinafter, the present invention will be further described in conjunction with specific embodiments: Example 1

Add 50 g of polyethylene glycol 3000 to 873.6 g of water and stir to dissolve. Add 20 g of boric acid, 10 g of borax to stir and dissolve, add 5 g of thioglycerol, 10 g of sodium hexametaphosphate, stir and dissolve, add 5 g of fatty alcohol. The oxyethylene ether (Aeo-9) was uniformly mixed, and finally 4.4 g of pentanediol and 22 g of glutaraldehyde were added, and the mixture was stirred and mixed to obtain the disinfectant.

In this example, the disinfectant glutaraldehyde content was 22000 mg/L, and the average killing logarithm of B. subtilis black mutant spores was 5.00. The results of the field test of the medical device sterilization simulation showed that the disinfectant of the present invention was used for 14 hours after continuous use for 34 hours of B. subtilis spore dyeing on the dentate dentate portion, and was aseptically grown after repeated tests. The minimum acceptable concentration of the disinfectant energy test of the present invention is a glutaraldehyde content of 2000 mg/L.

Example 2

Add 40g of polyethylene glycol 1500 to 909.5g of water and stir to dissolve, add 15g of boric acid, 5g of borax to stir and dissolve, add 2g of thiosorbitol, 5g of sodium hexametaphosphate, stir and dissolve, add 2.5g of polyoxygen The ethylene sorbitan ester (Tween-80) was uniformly mixed, and finally 6 g of pentanediol and 15 g of glutaraldehyde were added, and the mixture was stirred and mixed to obtain the disinfectant.

In this example, the disinfectant glutaraldehyde content was 15000 mg/L, and the average killing logarithm of the B. subtilis black mutant spores was 3.63. The results of the field test of the medical device sterilization simulation showed that the disinfectant of the present invention was applied to the black variabilis spores of the dentate dentate for 14 hours after continuous use for 14 hours, and was aseptically grown after repeated tests. The minimum acceptable concentration of the disinfectant energy test of the present invention is glutaraldehyde content of 2000 mg/L.

Example 3

Add 30 g of polyethylene glycol 6000 to 927 g of water and stir to dissolve. P 15 g of boric acid and 7 g of borax are stirred and dissolved. Add 3 g of glucosamine and 5 g of potassium metaphosphate to stir and dissolve, then add 2 g of alkylphenol. The polyoxyethylene ether (TX-10) was uniformly mixed, and finally, 1 g of pentanediol and 10 g of glutaraldehyde were added, and the mixture was stirred and mixed to obtain the disinfectant.

In this example, the glutaraldehyde content of the disinfectant was 10000 mg/L, and the average killing logarithm of the B. subtilis var. The results of the field test of the medical device sterilization simulation showed that the disinfectant of the present invention was used for 14 hours after continuous use for the Bacillus subtilis spore buds stained on the dentate dentate for 10 hours, and was aseptically grown after repeated tests. Disinfectant energy test of the invention The minimum acceptable concentration is glutaraldehyde content of 2000 mg / L.

Example 4

Add 50g of polyethylene glycol 400 to 885g of water and stir to dissolve, add 10g of boric acid, 5g of borax to stir and dissolve, add 5g of thiosorbitol, 15g of potassium metaphosphate and stir to dissolve, then add 4g of polyoxyethylene The sorbitan ester (Tween-80) was uniformly mixed, and finally 6 g of pentanediol and 20 g of glutaraldehyde were added, and the mixture was stirred and mixed to obtain the disinfectant.

In this example, the glutaraldehyde content of the disinfectant was 20000 mg/L, and the average killing logarithm of the B. subtilis var. The field test results of the medical device sterilization simulation showed that the disinfectant of the present invention was applied to the B. subtilis spore buds infected with the dentate dentate for 5 hours after continuous use for 14 hours, and was aseptically grown after repeated tests. The minimum acceptable concentration of the disinfectant energy test of the present invention is glutaraldehyde content of 2000 m _g / L.

Example 5

Add 80 g of polyethylene glycol 1000 to 826.5 g of water and stir to dissolve. Add 20 g of boric acid and 8 g of borax to stir and dissolve. Add 7 g of thiosorbitol, 15 g of sodium hexametaphosphate, stir and dissolve, and add 6 g of fatty alcohol. The polyoxyethylene ether (Aeo-9) was uniformly mixed, and finally, 12.5 g of pentanediol and 25 g of glutaraldehyde were added, and the mixture was stirred and mixed to obtain the disinfectant.

In this example, the disinfectant glutaraldehyde content was 25000 mg/L, and the average killing logarithm of B. subtilis black mutant spores was 5.00. The results of the field test of the medical device sterilization simulation showed that the disinfectant of the present invention was used for 14 hours after continuous use for 34 hours of B. subtilis spore dyeing on the dentate dentate portion, and was aseptically grown after repeated tests. The minimum acceptable concentration of the disinfectant energy test of the present invention is a glutaraldehyde content of 2000 mg/L.

According to the disinfectant disclosed in the publication No. CN101238816, according to the ratio of the above various examples, a control group with the same concentration of glutaraldehyde was arranged, and the accelerated stability test of the disinfectant was carried out, and the specific method was as follows: After 3 months in the °C incubator, the glutaraldehyde content was measured before and after standing, and the percentage decrease of glutaraldehyde content after 3 months was calculated. The results of accelerated test of disinfectant stability are shown in Table 1. Table 1 Percentage reduction (%) of glutaraldehyde content in disinfectant (placed at 37 ° C for 3 months)

Similarly, the disinfectant-induced metal corrosion test is carried out by using the disinfectant invented by the public number CN101238816. The specific test method is as follows: test stainless steel sheet, copper sheet, carbon steel sheet, aluminum sheet, and clean and degrease the metal sheet. Polishing and removing the oxide layer on the metal surface, rinsing and drying, then immersing in the disinfectant separately, weighing the metal sheet before and after soaking, and observing the surface morphology of the metal sheet. Calculate the metal corrosion rate according to the following formula:

Metal corrosion rate (R) = 8.76 X 10 ⁷ X (M-Mt ) I (SX t XD)

In the formula, R is the corrosion rate (mm/a), M is the mass of the sheet before the test (g), Mt is the mass of the sheet after the test (g), S is the surface area of the sheet (cm ² ), and t is the soaking time. (h), D is the density of the metal material (kg/m ³ ).

See Table 2 and Table 3 for the corrosion test results of the two groups of disinfectants on metals.

Corrosion rate of metal to disinfectant of the present invention (mm/a)

Corrosion rate of metal to disinfectant (mm/a) of the publication No. CN101238816 Stainless steel sheet copper sheet Carbon steel sheet Aluminum sheet Example 1 0.0063 0.0054 0.0097 0.0307 Example 2 0.0051 0.0072 0.0090 0.0300 Example 3 0.0069 0.0077 0.0099 0.0282 Example 4 0.0064 0.0069 0.0089 0.0293 Example 5 0.0054 0.0074 0.0102 0.0287 Average 0.0060 0.0069 0.0095 0.0294 The above results show that the disinfectant sample of the present invention has a stability test at 37 ° C for 3 months, and the rate of decrease of glutaraldehyde content is < 4%, and the publication number CN101238816 Compared with the disinfectant of the invention, the stability of the product is obviously improved, and the storage period can be more than 2 years. The metal corrosion test results show that the disinfectant of the invention has no corrosion to the stainless steel sheet, the copper sheet, the carbon steel sheet and the aluminum sheet, and the corrosion rate of the disinfectant to the metal is much lower than that of the disinfectant disclosed in the publication No. CN101238816.

In summary, the disinfectant of the present invention is a mono-package, and glutaraldehyde is always present in a stable activation state during storage and use, so that the preparation step before use is not required, and it has the characteristics of being convenient to use and convenient to use. The disinfectant of the present invention is very stable in nature and can be used for more than 2 years. The disinfectant of the present invention has little corrosiveness to metals, and is substantially non-corrosive to stainless steel sheets, copper sheets, carbon steel sheets, and aluminum sheets. The disinfectant of the invention also has the characteristics that the amount of glutaraldehyde molecules in the solution is small and the degree of air pollution in the environment is small. The disinfectant of the invention has the quick-acting and high-efficiency bactericidal ability, and has a good killing effect on the bacterial propagule, the bacterial spore, the virus, the Mycobacterium tuberculosis and the fungus. The disinfectant of the invention is suitable for disinfecting and sterilizing various surgical instruments, such as endoscopes, injection articles, catheters, scalpels, and the like.

Claims

Rights request

A stable activated glutaraldehyde disinfectant characterized in that it comprises the following components wt% _: glutaraldehyde: 1-5;

Pentyl glycol: 0.1-2.5;

Polyethylene glycol: 3-8;

Nonionic surfactant: 0.2-1;

Boric acid: 1-3;

Borax: 0.5-1.5;

Antioxidant: thiopolyol 0.1-1;

Corrosion inhibitor: 0.5-2;

Water - balance.

The disinfectant according to claim 1, wherein the ratio of glutaraldehyde to pentanediol in the weight ratio of the components is 1: 0.1-0.5.

The disinfectant according to claim 1, wherein the nonionic surfactant is one of a fatty alcohol polyoxyethylene ether, an alkylphenol ethoxylate, and a polyoxyethylene sorbitan ester. Kind or several.

The disinfectant according to claim 1, wherein the polyethylene glycol has a molecular weight of 200 to 8,000.

The disinfectant according to claim 1, wherein the antioxidant is one or more selected from the group consisting of thioglycerol, thiosorbitol, and thioglucose.

The disinfectant according to claim 1, wherein the corrosion inhibitor is sodium hexametaphosphate and/or potassium metaphosphate. ·

7. A method for preparing a disinfectant according to any one of claims 1 to 6 wherein: according to said component and content, polyethylene glycol is added to water to stir and dissolve, boric acid and borax are added to stir and dissolve, and an antioxidant is added. The corrosion inhibitor is stirred and dissolved, and then mixed with a nonionic surfactant. Finally, pentanediol and glutaric acid are added, and the mixture is stirred and mixed uniformly to obtain the disinfectant.