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OBJECTIVE: To establish a high performance liquid chromatography (HPLC) method to determine the contents of clindamycin phosphate and clindamycin in long-circulating autologous erythrocyte-based drug. METHODS: Clindamycin phosphate and clindamycin were determined by HPLC with Shimadzu Shim-pack VP-ODS chromatographic column (4.6 mm×250 mm, 5 μm) and Waters Symmetry C18 precolumn(3.9 mm×22 mm, 5 μm). The internal standard was nipagin ester. The mobile phase was composed of 0.062 5 mol•L-1 KH2PO4 and acetonitrile at 65∶35 (V/V) at a flow rate of 1.0 mL•min-1. The column temperature was maintained at 25 ℃ and the detection wavelength was set at 210 nm. RESULTS: The calibration curve of clindamycin phosphate showed good linearity in the range of 0.253-506 μg•mL-1, and the calibration curve of clindamycin showed good linearity in the range of 0.251-502 μg•mL-1. The average recovery was more than 98%. The test solution was stable at 4 ℃ and room temperature for 24 h, and the precision met requirements. CONCLUSION: The method is simple, specific, accurate and stable, which is suitable for the determination of clindamycin phosphate and clindamycin in long-circulating autologous erythrocyte-based drug.
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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.
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OBJECTIVE:To investigate the application of clindamycin phosphate for inpatients in a third grade class A hospital, and provide reference for the specication of its application. METHODS:Retrospective investigation was adopted to randomly obtain the medical information of inpatients who used Clindamycin phosphate for injection in a third grade class A hospital in May 2014, and its rationality was evaluated and analyzed by referred the instructions,relevant provisions and principles. RESULTS:Totally 205 patients used Clindamycin phosphate for injection,among which 174 were for the purpose of prevention medicine,31 cases for treatment purposes. There were reasonable use of 130 cases(63.4%);unreasonable prophylaxis of 71 cases(34.6%),unreason-able treatment of 4 cases(2.0%),it was mainly no indication of medicine,usage and dosage,treatment course and use of antibac-terial drugs. CONCLUSIONS:There still remains unreasonable phenomenon in the clinical application of the Clindamycin phos-phate for injection,the safe and effective clinical application can only be ensured if the drug regulatory system is improved and anti-bacterial drugs in clinical medicine guidelines is strictly enforced.
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Objective:To establish an HPLC method for the determination of clindamycin phosphate in compound phenytoin sodi-um ge1s. Methods:The HPLC analysis was carried out on a ZORBAX SB-C18 column(250 × 46 mm,5 μm)with 0. 1 mol·L-1 KH2PO4 solution(adjusting pH to 2. 5 with H3PO4 solution)-acetonitrile(75:25)as the mobile phase at the flow rate of 0. 8 ml· min-1 . The detection wavelength was 210 nm,the column temperature was 25℃ and the injection volume was 10μl. Results:The lin-ear range of clindamycin phosphate was 3. 00-18. 00 μg(r=0. 999 5). The average recovery was 101. 11%(RSD=0. 34%,n=6). Conclusion:The method is simple,sensitive and reproducible,and can be used in the determination of clindamycin phosphate in com-pound phenytoin sodium gels.
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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.
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OBJECTIVE:To study the pharmacokinetics and relative bioavailability of clindamycin phosphate capsules in healthy volunteers METHODS:A single oral dose of 300mg domestic clindamycin phosphate capsules or imported Dalacin C was given to 18 healthy male volunteers in an open randomized crossover study Clindamycin concentrations in plasma were determined by microbiologic assay The pharmacokinetic parmameters as well as relative bioavailability were calculated with 3p97 software and bioequivalence was analysed with NDST software RESULTS:The concentration-time curves of domestic clindamycin phosphate capsules or imported Dalacin C were well fitted for one-compartment open model The pharmacokinetic parameters of domestic and imported products were:Tmax(0 94?0 51) and(0 75?0 35)h;Cmax(3 86?0 62)?g/ml and (4 08?0 60)?g/ml;AUC0～12(14 88?3 64)?g/(ml?h)and(16 07?3 68)?g/(ml?h)respectively There were no significant differences in AUC0～12 and Cmax between two products CONCLUSION:The relative bioavailability of clindamycin phosphate capsules was(93 4?14 9)% compared with imported Dalacin C The results showed that the two formulations were bioequivalent