ABSTRACT
OBJECTIVE:To provide reference for the instructions of domestic Clindamycin phosphate injection. METHODS:The contents in the instructions of domestic Clindamycin phosphate injection approved the listing from Jan. 2006 to Dec. 2015 were statistically investigated according to Regulation for Drug Package Inserts and Label Management and Regulatory Guidelines for Chemicals and Biologicals,and the items with great differences in different approval number were analyzed comparatively. RE-SULTS:The labeling rate of clinical experiment in the collected 25 instructions of domestic Clindamycin phosphate injection was 0,the labeling rate of validity was 44%,the labeling rate of use for elderly patients was 68%,the labeling rate of overdosage was 76%,and the labeling rate of others was 100%. The items with great differences were mainly special populations,usage and dos-age,adverse reactions,validity,storage conditions and precautions. CONCLUSIONS:There are great differences in instructions of domestic Clindamycin phosphate injection,some items are inaccurate,incomplete and lack of scientificity,which may result in ir-rational drug use in patients and increase the risk of medication. It is suggested that the domestic enterprises should modify and per-fect the contents of the instructions of domestic Clindamycin phosphate injections referring to the instructions of foreign brand name drug;and the drug regulatory department should strengthen the monitoring of drug instructions.
ABSTRACT
OBJECTIVE:To establish HPLC method for the content determination of bacteriostatic agent benzyl alcohol in Clindamycin phosphate injection.METHODS:The determination was performed on CAPCELL PAK C8 column using potassium dihydrogen phosphate solution-acetonitrile(775:225)as mobile phase at flow rate of 1.0 mL?min-1.The detection wavelength was set at 210 nm.RESULT:The linear range of benzyl alcohol was 4.175～41.75 ?g?mL-1(r=0.999 9)with an average recovery of 100.5%(n=9),RSD=0.09%.CONCLUSION:The method is accurate and reproducible for the content determination of benzyl alcohol in Clindamycin phosphate injection.