| Based on the treatment of dairy cow hysteritis,the effervescent tablets with polyhexamethylene biguanide(PHMB)as disinfectant ingredient were developed,and the quality evaluation and performance study were carried out.The following conclusions were drawn:The surfactant was selected dodecyl dimethyl betaine(BS-12).The carrier material was light magnesium carbonate.The mass ratio of BS-12 to light magnesium carbonate is1:1.The surface tension value of modified light megnesium carbonate was measured.It is found that when the content of it is 500 mg/L,the surface tension value is lowest.Through single factor screening and orthogonal test,the optimum formula was made on that the content of polyhexamethylene biguanide hydrochloride was determined to be50%,the content of modified light megnesium carbonate was 5%,the content of borneol was 2%,the content of disintegrator was 2%,the content of acid source was 14%,the content of alkali source was 12%,the content of superfine boric acid was 2%,and the content of anhydrous magnesium sulfate was 13%.The polyhexamethylene biguanide hydrochloride treatment,mixing sequence and time of each component and the way of pressing were explained.The preparation of powder and the temperature and humidity of tablet pressing were investigated.It should be carried out at room temperature and under40% relative humidity.Through the quality test of this product,it was found that all the indexes met the requirements of the Chinese Veterinary Pharmacopoeia.An ultraviolet spectrophotometric method was established to determine the content of polyhexamethylene biguanide in the product.The results showed that the maximum absorption peak was detected at 232 nm wavelength without the influence of impurity peak.The peak shape was good.The standard curve equation was Y = 0.0387 X + 0.0321,and there was a good linear relationship between 5 mg/L and 50 mg/L(r = 0.9999),the recovery rate was between 99% and 102%,the relative standard deviation within 2%,that meet the requirements.The product has good bactericidal performance.The neutralizer was determined to be6 g/L sodium thiosulfate+10 g/L histidine+3 g/L lecithin+30 g/L Tween 80.When the product dissolves into polyhexamethylene biguanide at a concentration of 125 mg/L,it acted on E.coli for 10 min,killing the logarithm value is more than 5;for the Staphylococcus aureus for 10 min,and the bactericidal logarithm value is above 5.It was found that there was no erythema or swelling in the skin of rabbits by single administration of complete skin irritation test,multiple administration complete skin irritation test and single administration of damaged skin irritation test.It was concluded that the effervescent tablet had no irritating effect on the skin.The product through the stability test,it was found that temperature and light had no effect on its various indicators,but humidity had a great impact on its indicators.Therefore,in the process of storage and transportation,the sealed moisture insulation packaging was chosen.After the product was sealed moisture insulation packaging,after that,accelerated test and long-term experimental investigation were carried out.It was found that all indicators had no obvious change.It was explained that after sealed moisture insulation packaging,the sealed moisture insulation packaging was applied to the product.Humidity has been well controlled;through long-term experiments,the tentative validity period of this effervescent tablet is 12 months,but in order to get the exact validity period,we still need to keep samples for observation and complete the detection of this product for 18 months,24 months and 36 months. |
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