| Objective:Dextroranrezole sodium enteric-coated tablets are novel proton pump inhibitors and are a right-handed isomer of rabeprazole sodium in the treatment of peptic ulcer with higher safety,better efficacy and smaller side effects have received more and more attention.The paper studied the quality standards and stability of the product and developed the quality standards of this product.Methods:1,In order to control the quality of dexamethasone sodium enteric-coated tablets,the effects of dexamethasone sodium on the physicochemical properties and enteric-coated tablets were studied by high performance liquid chromatography,uv spectrophotometer and gas chromatography method to identify the establishment of the identification of the goods,the relevant substances,content uniformity,release,acid resistance,determination of the content and the determination of residual solvents and other methods.A column of CHIRALPAK IC(250 x 4.6 mm,5 ?m)filled with silica gel-bonded cellulose-three as a filler was used as a column for the mobile phase;With n-hexane,ethanol and diethylamine in a ratio of 300: 700:1;Column temperature: 35 ?;The wavelength at 285 nm was measured.The relevant substances,acid resistance and content use the same chromatographic column: C18(4.6 x 250 mm,5 microns);Column temperature: 30 ?;Mobile phase: 45% phosphoric acid solution(neutral,concentration of 0.05 mol/L)and55% methanol;Liquid flow rate: 1.0 mL / min;Measurement wavelength: 290 nm;Solvent: 40% sodium hydroxide solution(concentration 0.05 mol / L)and 60% methanol;Sample concentration: 1.0 g / L;Injection volume: 10 ?L.Measurement of uniformity is based on the Chinese Pharmacopoeia 2015 edition of the four general rules 0401 spectrophotometric method for determination,according to external standard method to calculate the content,absorbance measurement position is the wavelength of 290 nm.Release rate according to the Chinese Pharmacopoeia 2015 edition of the four general rules 0931 dissolution test method,according to the method of pharmacopoeia operation,the use of 700 mL hydrochloric acid solution(concentration 0.1 mol / L)as the medium,the speed set to 6000 rpm per hour.Residual solvent test to take a uniform increase in temperature,the initial temperature of 45 ?,for 6 minutes,and then the rate of 20 degrees Celsius per minute temperature will rise to 150 ?,for 5 minutes,then the rate of 30 degrees Celsius per minute will raised to 250 ? for 3 minutes.The temperature of the sample inlet was220 ?;The headspace condition was carried out at 90 ? for 30 minutes;The injection volume was 1 mL.2,Refer to the requirements of the relevant criteria of drug stability,the paper of traits,related substances,release,content as a test factor,carried out the impact factor test,accelerated test and long-term test.The influencing factors were carried out under three conditions: temperature 60 ?,light intensity(4000-5000)Lx,humidity 85%-95%;Inspection time: 0,5,10 day.Accelerated test conditions:(38-42)?,humidity 70%-80%;Inspection time: 0,1,2,3,6 month.Long-term test conditions:(28-32)?,relative humidity 60%-70%;Inspection time: 0,3,6,9,12,18,24,36 month.Results:1,The requirements of the corresponding standards were met for each project measured in the rabeprazole sodium enteric-coated tablets.2,The stability test results are this product is more sensitive to high temperature environment,in the storage,transportation and other processes should be kept cool.Conclusion:1,The quality control of the inspection items of the test indicators are consistent with the reference preparation,in line with the guiding principles of quality standards.2,According to the results of stability studies,the rabeprazole sodium enteric-coated tablets of the package material to meet the product placed in the process of quality control requirements,more sensitive to high temperature,storage needs to be dark,put in the shade. |
PDF Full Text Request