Objective: To develop the informatization management mode of rational use of the psychotropic drugs of category II in order to decrease adverse drug events and increase therapeutic efficacy Methods: To control the psychotropic drugs of category II abuse, we took the following measures with information technology, such as set the special prescription, define the maximum doses and days of single prescription, open special channel et al.. Results: several departments together put forward the effective intervention measures to prevent irrational prescriptions. Conclusion: The informatization management mode is adapted for the needs of hospital pharmaceutical practice with sufficient utilization of hospital information system's resource. It appears to be a rapid, scientific and practical system for monitoring and analyzing the clinical use of the psychotropic drugs of category II.

2008年1～2月,本院药物不良反应监测室连续收到3例奥美拉唑注射用来菌粉末在配制过程中出现变色的情况,现报道如下.

Objective An HPLC-MS/MS method was established for the determination of rupatadine fumarate in plasma. Methods The drug and internal standard(loratadine)in plasma were alkalified with sodium hydroxide,extracted with acetic ether-dichloromethane(4:1) and detected by HPLC-MS/MS. Results A good linearity of rupatadine fumarate in plasma was obtained from 0.05 to 13 μg·L-1,the minimum level of which was 0.05 μg·L-1 and the recovery rate was from 65.06% to 73.25%. Conclusion The method is sensitive,accurate and reliable,and could be used for determing drug concentration and pharmacokinetic of rupatadine fumarate.

目的研究加替沙星分散片(试验制剂)的人体相对生物利用度和生物等效性。方法用高效液相色谱(HPLC)法测定18例男性健康志愿者交叉口服加替沙星400 mg普通片(参比制剂)和分散片后的血药浓度,求算药动学参数并进行统计学评价。结果单剂量口服试验制剂和参比制剂后血浆中的加替沙星Cmax分别为(3.706±0.768)和(3.912±0.984)μg.mL-1;tmax分别为(0.806±0.349)和(1.306±0.598)h;浓度-时间曲线下面积[AUC(0-24)]分别为(17.721±4.030)和(18.064±3.129)μg.h.mL-1;AUC(0-inf)分别为(18.295±3.943)和(18.695±3.283)μg.h.mL-1;相对生物利用度为(99.62±21.62)%。结论加替沙星分散片与普通片具有生物学等效性。

OBJECTIVE To establish HPLC with fluorescence detection method for determination of tramadol Hydrochloride in plasma and to study the relative bioavailability following oral administration of reference tramadol Hydrochloride capsules and trial tramadol Hydrochloride Orally Disintegrating Tablets in healthy volunteers.METHODSHealthy volunteers were orally given 100 mg of either tramadol Hydrochloride in an open randomized cross-over test.The tramadol Hydrochloride concentration in plasma was determined by HPLC with Fluorescence detection method.RESULTSTwenty volunteers were randomLy divided into 2 groups.The parameters of the test and reference formulation:tmax,Cmax,t1/2,AUC0→24 were(2.2±0.8)h and(2.5±0.7)h;(284.8±161.4)μg·L-1 and(283.9±166.6)μg·L-1;(6.4±2.3)h and(6.3±3.2)h;(1 963.3±1 154.6)μg·h·L-1 and(1 991.6±1 296.1)μg·h·L-1,respectively.CONCLUSIONThe two preparation were equivalent.