Pharmaceutical And Bactericidal Activity In Vitro Research On Adduct Sodium Sulphate-Hydrogen Peroxide-Sodium Chloride

Adduct sodium sulphate-hydrogen peroxide-sodium chloride(ASPC), a new type of inorganic crystal compound, was prepared by anhydrous sodium sulfate、30% solution hydrogen peroxide and sodium chloride. It had bactericidal properties of liquid hydrogen peroxide, but also avoided the nature shortcomings of liquid, such as unstable, unsafe, inconvenient to transport and store. On the basis of relevant literature the subject carried out a further research on the preparation method of this adduct and then stduied its physicochemical properties, stability, and a preliminary research of its sterilization effect. The specific contents are as follows:1 Synthesis of adduct sodium sulphate-hydrogen peroxide-sodium chloride ASPC was prepared with anhydrous sodium sulfate,30% hydrogen peroxide and sodium chloride as raw materials. Firstly single factor experimental was designed to examine the impact, which is caused by the ratio of raw materials, reaction temperature, reaction time and drying temperature, over the product yield and its ratio of hydrogen peroxide and accordingly determine the level of each factor in the orthogonal experiment. Meanwhile, primary and secondary order of the affection factors and optimal test conditions was obtained by using L9 (34) orthogonal table to analyze the four factors and three levels. The results showed that the order of factors from the most important to the least should be the raw material ratio, reaction temperature, reaction time, drying temperature. The optimal experimental condition was adding 32 g sodium sulfate,4 g sodium chloride in 100 ml of 30% hydrogen peroxide solution. The reaction time was 30 min. The reaction temperature was 25℃. In this case, the product contained a higher ratio of hydrogen peroxide reaching 9.70% or more. A high quality ASPC can be obtained.2 Quality and stability research of adduct sodium sulphate-hydrogen peroxide-sodium chloride To evaluate the quality and stability of ASPC and to inspect its appearance, solubility, hygroscopicity in accordance with relevant provisions of the Veterinary Pharmacopoeia of the People’s Republic of China(2010). At the same time the pH, loss on drying, heavy metals, iron salts, arsenic salt content and the analuse method by measuring the ratio of hydrogen peroxide in the adduct was checked. The adduct stability by impact factor test and accelerated test were studied. The result showed that the product was a white crystalline powder with no special smell and it absorbed moist slightly. The product was easily dissolved in water, hydrochloric, sodium hydroxide solution and was almost insoluble in ethanol and in chloroform. It had no sharp melting point. Its aqueous solution had a pH of 5.0 to 6.0. It had a weight loss of less than 5.0% on drying. Its heavy metal and iron salt content were both less than 5 mg·kg-1 and no gutzeit had been detected. By testing the hydrogen peroxide content it proved to have a good precision and the recovery test showed the average recovery and RSD were 98.9% and 0.23% respectively. There was a level decline in the high-temperature and strong light test, which showed that the product was unstable in high temperature and strong light conditions In humidity conditions, the product appearance, pH, dissolubility content showed no significant changes. In accelerated test, the change in appearance and solubility was not obvious, and pH was increased whereas the content of the hydrogen peroxide in the sample decreases by about 2%. Under the same condition, compared with liquid hydrogen peroxide the liquid volume was reduced, and the content was decreased by 20% or so. The initial draft quality standard of the ASPC was established.3 Sterilization in vitro tset of adduct sodium sulphate-hydrogen peroxide-sodium chloride To examine the sterilization efficacy of ASPC, suspension quantitative germicidal test was carried out under laboratory conditions. The sample solution of three concentrations 10.8,5.4,2.7 g·L-1 were tested for their role in the killing of E. coli, Staphylococcus aureus and Bacillus cereus. Simulated field and field trials were carried out to test the bactericidal effect and sterilization rate of high, medium, low dose and drug control group at different times. The results showed that under laboratory conditions, using the test solution of hydrogen peroxide 10.8g·L-1, the 10 min average sterilization rate of E. coli and Staphylococcus aureus was over 99.9%. And with the test solution of hydrogen peroxide 5.4 g·L-1, the 20 min average sterilization rate of E. coli and Staphylococcus aureus was over 99.9%, solution of hydrogen peroxide 2.7g·L-1, only after 60 min the sterilization rate of Staphylococcus aureus can achieved a qualified level. In simulated field test, to make sterilization rate of E. coli to be over 99.9%, it took the high-dose group 20 min, the middle dose group and drug control group 30 min, and the low-dose group 60min. For staphylococcus aureus and bacillus cereus, all groups required 60min to achieve the qualified disinfection. As to bacillus cereus, it took all the three concentrations 60min to thoroughly kill it. In field trials test first 30 mins, the sterilization rate of the high-dose group was significantly higher than that of the low-dose group and drug control group, when the disinfection was longer than 1 h, the sterilization rates of high, medium-dose group and drug control group were almost 100% (greater than 99.9%).ASPC had good bactericidal effect.