Preparation And Security Test Of Doxycycline Hydrochloride Oral Solution

Through the investigation and understanding of the existing dosage form of doxycycline hydrochloride,with practice,determined by orthogonal test,selecting the best formula to prepare Doxycycline Hydrochlorideoral solution,and a series of stability tests,in vitro antibacterial tests and acute toxicity test have been done for determining the stability,security and antibacterial effects of its oral dosage form,which provides reference for its clinical use.The main study of this paper includes the following five parts:Part I:Preparation of doxycycline hydrochloride oral solutionAccording to the physicochemical properties of doxycycline hydrochloride and its own characteristics to select the appropriate solubilizing agents,metal complexing agents, antioxidants and other accessories.By pre-experiment and single factor test,generally determining the composition of the prescription.Through orthogonal test to determine the optimal ratio of the amount of materials and the optimal formula.The oral formulation preparation process is simple, the resulting preparation is a pale clear liquid,without visible things in clarityexamination,in the end,confirming the pH between 4.0-5.0,which conforms with thepharmacopoeia on oral solution regulations.PartⅡ:The establishment of content analysis methodof doxycycline hydrochlorideoral solution By HPLC, measuring the content of doxycycline at 280 nm. comparingwith ultravioletspectrophotometry,HPLC has the higher the precision,the better recovery rate and reproducibility and more reliable in measurement results.Part III:Stability test of doxycycline hydrochloride By high-lights irradiation test,high and low temperature tests and accelerated test,investigating stability of the sample of Doxycycline Hydrochloride Oral Solution,The results showed that doxycycline hydrochlorideis sensitive to light,and insensitive in the changes of temperature and humidity,thereforekeeping in dark place for save.Part IV:Antibacterial test of doxycycline hydrochlorideoral solution Throughvitro antibacterial test on four common pathogens of livestock diseases including E. coli,Staphylococcus aureus,Streptococcus agalactiae,Salmonella.MIC was determined by tube dilution method.The results showed thatthe MIC and MBC ofdoxycycline hydrochloride to these four kinds of bacteria is between 2-32μg/mL,the MBC is between 4-64μg/mL,the antimicrobial activity and the bactericidal effect is good.Part V:doxycycline hydrochloride Acute oral toxicity test According to the acute toxicity tests to do safety evaluation on doxycycline hydrochloride,the results showed that the LD50 of doxycycline hydrochloride on mouse is 1274.5mg/mL,which showed its good safety and a low-toxicity drugs that can be used safely in clinical.