Study on the related properties of compound phthalaldehyde disinfectant

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Objective To observe the germicidal efficacy and toxicity of a compound phthalaldehyde disinfectant. Methods Carrier immersion quantitative germicidal test and animal toxicity test were used to observe the related properties of the compound phthalaldehyde disinfectant. Results The compound phthalaldehyde disinfectant contained 5800ms/L phthalaldehyde and 4080ms/L benzalkonium bromide. The spores of Bacillus subtilis var. noir on the simulated endoscopic carrier were acted on with its stock solution for 45min, and the kill value was> 3.00. The disinfectant on mice acute oral toxicity LD. The value is greater than 5000 ms/kg (body weight), and the micronucleus test result for mouse bone marrow polychromatic erythrocytes is negative. Conclusion The compound phthalaldehyde disinfectant has good germicidal efficacy and belongs to non-toxic substance.
O-phthalaldehyde (OPA), is an important pharmaceutical chemical Interbody, previously mainly used for amine alkaloids, fluorometer histamine determination Reagents and pharmaceutical testing. Since 1994 Alfa et al. In the disinfection of endoscopes and found that it has a good disinfection effect, foreign countries on Many studies have been carried out on the disinfection of OPA, which has been developed It is a new type of efficient disinfectant and has passed FDA certification. o-phthalaldehyde has the same bactericidal effect as glutaraldehyde and has Use the characteristics of low concentration, low irritation, light odor and low corrosion. Ben In this paper, a compound consisting of phthalaldehyde and benzalkonium bromide is studied. venom, its simulated field disinfection effect and use safety were Experimental observation. The results are reported below.
1 Materials and methods
1 ]
1.1 test material
The compound phthalaldehyde disinfectant used in the test was developed by a domestic enterprise. The active ingredient phthalaldehyde content is 5800mg/L, supplemented 4080mg/L benzalkonium bromide, colorless transparent solution, slightly gas Taste, shaking with foam. The test indicator strain was Bacillus subtilis var. niger (ATCC9372). Spores, which are preserved in this laboratory and prepared into bacterial spore suspension for preparation. Use. The bacteria carrier for laboratory sterilization test is 10mm diameter circle. Shaped stainless steel sheet, ready for use after sterilization; The simulated bacteria carrier is polytetrafluoroethylene. Ene tube, and PTFE tube as a simulated endoscopic pipe for the present. Field simulation disinfection test.
1.2 Stability Test Method
5 groups, each group of l0, half male and half female. Set 1250, 2,500, 5000 mg/kg (body weight) three dose groups, another positive control group (CP,40 ms/kg) and negative control group (distilled water). Press
20 ml/kg dosage, the use of oral gavage. Using 30h dyeing Poisonous method, that is, the interval between the two poisons is 24h, 6h after the second poisoning. Dead animals, direct smear of thoracic bone marrow, methanol fixation, Giemsa staining
Color. Count 1000 polychromatic erythrocytes (PCE) per mouse The number of present micronucleus cells was calculated and polychromatic erythrocytes (PCE) and positive The ratio of stained red blood cells (NCE). Calculate the micronucleus cell rate (‰ ), using the card The square test is statistically processed.
2 Results
2.1 stability test results
The sealed package of the compound phthalaldehyde disinfectant solution was tested by 37 ~ C After 90 days of storage, the decrease rate of o-phthalaldehyde content was 3.45%. character The effective storage period of the disinfectant is 2 years. 2.2 neutralizer qualification test results
The test results show that with 10g/L glycine 5g/L phosphorus Lipid 20g/L Tween 80 0.03mol/L phosphate buffer (PBS) solution as a neutralizing agent, can effectively neutralize the disinfectant stock solution Killing effect on spores of Bacillus subtilis var. niger, and the neutralizer And the neutralization product had no effect on the growth and reproduction of Bacillus subtilis black variant spores (Table 1).
2.3 germicidal test results The test results show that the test temperature of 20 ~ C, the compound benzene two Formaldehyde disinfectant stock solution on the carrier of Bacillus subtilis black variant spores. With 45min, the average killing logarithm value is> 3.O0; Acting for 22.5min, The average kill-to-kill value was 2.99, and the positive control group was recovered on average. The number of bacteria is 5.98.
Simulation field test results of 2.4 endoscope cleaning and disinfecting machine The compound phthalaldehyde disinfectant solution was used to simulate the endoscopic body. Spore action of Bacillus subtilis black variant on medium carrier for 45min, each time The elimination of the test values are> 3.00, to meet the disinfection requirements. (Table 2).

2.5 Medical Device Simulation Field Test Results The hemostatic forceps was stained with the original solution of the compound phthalaldehyde disinfectant. The infected Bacillus subtilis black var. spores acted for 60min, killing on average For the value> 3.00, to achieve the qualified requirements of disinfection.
2.6 continuous service test results In the disinfection solution repeatedly placed medical devices, continuous use for 7 days After sampling the liquid on the haemostatic forceps on the contaminated shoots of Bacillus subtilis var. Spore action for 60min, continuous detection of 3O carrier average killing logarithm value All> 3.00, to meet the disinfection requirements.
2.7 Toxicity Test Results
2.7.1 Results of acute oral toxicity test Within two weeks after exposure, try No obvious symptoms of poisoning and death were found in the animals. End of test The animals were sacrificed for gross dissection and no abnormal changes were found. The compound Acute oral toxicity of orthophthalaldehyde disinfectant in male and female mice LD5o value> 5000 mg/kg (body weight).
2.7.2 Results of a complete skin irritation test
Compound with test substance After the original solution of the orthophthalaldehyde disinfectant was applied to the skin of the rabbits, 3 homes Rabbit skin did not appear erythema, edema and other inflammatory reactions, acute skin The excitation index is 0. Irritation evaluation is non-irritating.
2.7.3 Bone marrow polychromatic erythrocyte micronucleus test results Each test There was no significant difference in the micronucleus rate between the group and the negative control group. (P>0.05), while the positive control group was significantly higher than the negative control group (P<0.01)。
3 Discussions
The experimental results show that the compound orthophthalaldehyde disinfectant solution Spores of Bacillus subtilis var. niger can be eliminated after 45min Poison requirements, the results are slightly better than Song Jiangnan's report, continuous use. 7d can still meet the disinfection requirements, belongs to the non-toxic material, storage performance Stable. Endoscopic cleaning and disinfecting machine simulation field test shows that the compound One cycle of o-phthalaldehyde disinfectant is sufficient to disinfect endoscopes. requirements.


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