Preparation And Quality Control Of Compound Metronidazole Dispersible Tablet

In this study, metronidazole and oxytetracycline hydrochloride were used as the maindrugs, and appropriate auxiliary materials were selected to make dispersible tablets.And thenwe set up quality control method. The orthogonal experiment was used to screen prescriptionof the drug and conduct the selection of the granulation size. The quality inspection ofdispersible tablets of the compound metronidazole includes the check of character, the weightdifference, the hardness, pH, disintegration time and uniform dispersion. The dispersibletablet of compound metronidazole is prepared and the content of metronidazole andoxytetracycline hydrochloride is determined by UV spectrophotometry, which was establishedto calculate the recovery rate and precision. We investigated the safety of compoundmetronidazole by acute toxicity test. The optimized formula of compound metronidazole (in onepiece) was composed of metronidazole20%, oxytetracycline hydrochloride10%,Carboxymethyl starch sodium(CMS-Na)15%, starch25%and microcrystallinecellulose(MCC)25%; The quality inspection of dispersible tablets of the compoundmetronidazole was conformed to the request of the tablet in China Drug Standard; the contentof metronidazole and oxytetracycline hydrochloride is determined by UV spectrophotometry,and the recovery is high and the precision is good. The median lethal dose (LD50) ofcompound metronidazole was2940mg/kg, so it belonged to low mammalian toxicity drug.Compound metronidazole dispersible tablets have fast disintegration speed,convenient use,simple preparation process, high stability and good compliance and then can be used forveterinary clinical.