| Potassium persulfate compound salt powder referred to as KMPS powder is a very safe and effective solid disinfectant.It has sold well at home and abroad for more than 30 years.However,due to technology monopoly and administrative protection,there has been no similar product listed in China for a long time.The application of KMPS powder are affected because the powder is easy to absorb moisture,high bags,poor liquidity,and not easy to sink to the bottom,which is caused by the large specific surface area of powder.Granule is safer and more convenient than powder at clinical application due to its better granular fluidity,smaller specific surface area and better stability.According to the "Classification and data Requirements of Registration for Veterinary disinfectant",a comprehensive study of KMPS particles had been conducted,including pharmacy,clinical trials,and other studies.The research had shown that KMPS granules are safe,effective,and controlled quality.It is summarized as follows:1 Prescription process research The prescription of KMPS granules was studied by single factor selection and orthogonal test.The stability of KMPS granules under different conditions was investigated through the verification of different processes,then the small and medium trial prescription techniques were finally determined.KMPS granules were prescribed as potassium persulfate compound salt 55%,sodium dodecyl benzene sulfonate 10%,sodium hexametaphosphate 20.9%,sodium chloride 2%,sulfamic acid 8.0%,TX-10 4%,amaranth red indicator 0.1%.Separate the acid and base components and mix them after granulating.In terms of trial production,the production process of this product was relatively easy to master,the product yield can reach more than 95 %,and the quality of the product was relatively stable during the production process.It was proved that the production process was stable and reliable and can be used in large production.2 Quality study The product characteristics,identification,inspection and content determination of KMPS granules were studied,and the draft quality standards and draft instructions were developed.A systematic quality control method was formed through the quality study of three batches of pilot products.This method had the characteristics of strong specificity,high sensitivity,good repeatability,and simple operation.It can be used for quality inspection and control of KMPS granules.3 Stability study of drug According to the "Guiding Principles for the Stability Test of Veterinary Medicines",an appendix to the 2015 edition of the "People's Republic of China Veterinary Pharmacopoeia",moreover,in accordance with the "Technical guidelines for the Study of the Stability of Veterinary Chemical Drugs",the impact factors test,accelerated test,and long-term test were conducted.The results showed that the characteristic,p H value,and solubility were basically unchanged,under the simulated market condition that the KMPS granules were placed accelerated for 6months and long-term for 24 months.Although the content of characterisistic was slightly reduced,all the traits were all within the prescribed range,and complied with the draft quality standard of KMPS granules.The results showed that the KMPS particles were stable and can be stably placed for at least 2 years.4 Clinical trials and evaluations4.1 Germicidal efficacy test of KMPS granules at laboratory In order to verify the sterilization effect of KMPS particles,suspension quantitative sterilization test was used to study.The KMPS granules diluted as 1:200can kill E.coli or Staphylococcus aureus when interacting at room temperature for 2min.The germicidal rate of KMPS granules diluted as 1:400 can reach 100 percent when interacting at room temperature for 30 min.The germicidal rate of KMPS granules diluted as 1:600 and 1:800 can reach 90 percent when interacting at room temperature for 10 min.The experimental results showed that the germicidal efficiency of KMPS granules are basically the same as virkon,and have a good bactericidal effect.4.2 KMPS granules resistance to organic interference sterilization experiment The dose required to kill bacterial propagators in suspensions containing organic interference was determined in the laboratory to verify that the sterilization dose was actually not subject to organic interference.The test results showed that the sterilization effect of the KMPS granules diluted as 1:200 is not disturbed by organic matter,and it was also not disturbed by organic matter when diluting as 1:400 and interacting 30 min.The bactericidal effect of the KMPS granules was better than that of Wei Ke and self-made KMPS powder by using the same dilution.4.3 Study on the effect of KMPS granules on surface disinfection of specific bacteria The surface disinfection effect of KMPS particles on specific bacteria was tested.The results showed that at the same concentration,the surface disinfection effect of KMPS particles and KMPS powder on specific bacteria was similar.The surface field disinfection effect of KMPS granules and KMPS powder on Gram-negative bacteria was better than that of Gram-positive bacteria.The recommended concentration of surface disinfection for E.coli and Pasteurium multikilling was diluted as 1:400.For the surface disinfection of Staphylococcus aureus and Streptococcus,the concentration should be selected at 1:200.The concentration for Field disinfection of Bacillus thuringiensis should be selected at1:200.4.4 Study on on-site disinfection effect of KMPS granules The on-site disinfection effect test of KMPS granules was carried out.The results showed that the sterilization rate of KMPS particles on the ground of livestock and poultry houses can reach more than 99 %,when disinfection for 10 min by using the high concentration of KMPS granules solution diluted as 1:100,or disinfection for 30 min by using the the middle concentration of KMPS granules solution diluted as 1:200,or disinfection for 30 min by using the control disinfectant KMPS powder solution diluted as 1:200.The sterilization rate of KMPS particles on the air of livestock and poultry houses can reach more than 99 %,when disinfection for 10 min by using the high concentration solution diluted as 1:100 and the middle concentration diluted as 1:200 of KMPS granules,as well as disinfection for 10 min by using the control disinfectant KMPS powder solution diluted as 1:200. |
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