ABSTRACT
OBJECTIVE:To predict the shelf life of compound sodium citrate injection by initial average rate stability test. METHODS: The initial average rate stability test was performed at 7 different temperatures to investigate the relationship between the initial average rate (V0) of the glucose degradation reaction and Kelvin's temperature (1/T), and the activation energy of reaction, the drug reaction velocity constant and shelf life were computed as well. RESULTS: The regression equation was lgV0=18.15—6 774.6?1/T(r=—0.937 5), the reaction activation energy was 31.0Kcal?mol-1, the drug reaction velocity constant at 20℃ was 1.1?10-5h-1, and the shelf life was 1.09 years. CONCLUSION: The method is simple and it can accurately predicate the shelf life of compound sodium citrate injection.
ABSTRACT
OBJECTIVE:To investigate the feasibility and accuracy of the current preparative method of CRRT displacement liquid in hospital preparation manufacturing laboratory.METHODS:The electrolytes in 8 CRRT displacement liquid samples were determined and the RSD values were calculated by comparison with theoretic value;the effects of ionic concentration and volume of raw material on the preparing results as well as the RSD of volume error were investigated.RESULTS:The RSD between theoretical and practical ionic concentrations was lower than 4.14%.The maximum change of ionic concentration caused by concentration of solution was 5.32 mmol?L-1;The maximum volume change caused by volume loading was 62 mL and the displacement liquid ionic concentration lower than theoretical value was 0.4 mmol?L-1.The RSD of volume difference was 2.46%.CONCLUSION:The preparing results of CRRT displacement liquid by the preparative method adopted in our hospital can meet the clinical standard on this preparation.