目的:观察痰热清注射液用于辅助治疗儿童支原体肺炎疗效.方法:将54例儿童支原体肺炎患者随机分为两组治疗,对照组(26例)单用阿奇霉素常规治疗,治疗组(28例)在常规治疗的基础上加用痰热清注射液,检测两组治疗前后末梢血白细胞总数或中性与淋巴细胞比例改变及观察X线胸片变化,观察两组治疗效果.结果:治疗组总有效率92.85%,疗效明显优于对照组(P＜0.05),且退热、止咳、肺部炎症吸收和末梢血白细胞恢复正常时间均明显短于对照组(P＜0.05).结论:痰热清注射液协同阿奇霉素用于治疗儿童支原体肺炎疗效确切.

目的:探讨临床药师在老年病科防范用药错误中的作用和工作方法.方法:针对老年病科容易发生用药错误的环节,结合临床病例,开展防范用药错误的实践工作.结果:临床药师在老年病科通过与医师、护士的沟通交流以及开展用药监护、患者教盲等工作可以减少患者的用药错误.结论:临床药师在用药错误的防范中起着重要作用,在老年病科配备临床药师对防范老年患者用药错误、促进安全用药尤为重要.

目的 探讨骨炎宁颗粒的制备方法及其临床疗效.方法 按处方制备成颗粒剂,对其进行定性、定量检测,观察其外观与稳定性,并用于治疗骨髓炎患者以观察临床效果.结果 骨炎宁颗粒性质稳定；薄层色谱中,供试品溶液色谱在与对照药材色谱相应位置上出现相同颜色的斑点,阴性对照无干扰；绿原酸含量为4.45～4.50 mg;临床有效率(97.3％)优于对照组(82.9％)(P＜0.05).结论 骨炎宁制备工艺可行,质量可控制,临床疗效比较满意.

Objective:To evaluate the relative bioavailability and bioequivalence of domestic levofloxacin hydrochloride tablets in healthy male volunteers.Method:A single oral dose of 200 mg levofloxacin hydrochloride test and reference tablets were given to 20 male healthy volunteers in a randomized crossover design.Serum levofloxacin concentrations were determined by reversed-phase high performance liquid chromatography(HPLC) method.The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations.Result:The main pharmacokinetic parameters of levofloxacin hydrochloride test and reference tablets were as the follows:t_(1/2) of(7.37±0.88) and(7.39±0.96) h,t_(max)of(1.13±0.30) and (1.06±0.24) h.C_(max) of(2.08±0.42) and(2.03±0.35) mg·L~(-1),and AUC_(0-24) of(13.17±2.32) and(13.73±2.89) mg·h·L~(-1),respectively.The relative bioavailability of the test tablets was(97.7±16.7)%.Conclusion:The two preparations of levofloxacin hydrochloride are bioequivalent.

OBJECTIVE To establish an HPLC method for the determination of 6-methylmercaptopurine ribonucleotides(6-MMPR) in human red blood cells (RBC).METHODS The RBC samples were deproteinated by 70% perchloric acid.6-MMPR were hydrolyzed to 6-methylmercaptopurine(6-MMP) by heating the sample for 45 min at 100 ℃.Separation was achieved by Hypersil GOLD C18column(4.6 mm×250 mm,5 μm) with UV detection at 290 nm.The mobile phase consisted of 0.02 mol·L-1 potassium phosphate buffer(pH 3.3): acetonitrile(95∶5).RESULTS The calibration curve was linear over the range of 80.91~3 236.36 pmol·(8×108)-1 RBC (r2=0.998 5) and the limit of quantitation was 80.91 pmol·(8×108)-1 RBC.The intra-and inter-day coefficients of variation were less than 2.09% and 5.61%,respectively.The mean analytical recoveries were 100.27%-110.79%,and the mean extraction recoveries were more than 70%.CONCLUSION This method is simple,rapid,sensitive and specific,and it enables quantitation of 6-MMPR in RBC from patients under AZA therapy.

治疗药物血药浓度监测(TDM)已经广泛应用,并为个体化治疗方案的制定提供了更具体的数据支持,然而,更进一步分析常规治疗方案下,不同生物个体血药浓度产生差异的原因,以及同一个体不同疾病时期或变更用药方案所导致的治疗药物疗效的差异,应是临床药师参与临床药物治疗的重要工作内容之一.

目的:综述绿茶的药理作用和临床应用研究进展.方法:查阅最近几年国内外相关文献及研究资料,并对其分析,归纳,总结.结果:绿茶作为一种非发酵茶,比红茶和乌龙茶含有更多的茶多酚.研究表明茶多酚具有抗氧化,抗肿瘤、抗炎、降血压、血脂和血糖,降低心脑血管疾病危险因子等药理作用.2006年FDA批准了绿茶提取物外制剂Veregen用于临床,并已在美国上市;而最近研究报道绿茶提取物治疗慢性淋巴细胞性白血病具有很好的疗效.结论:绿茶研究将具有非常好的临床应用前景.

Objective To evaluate the relative bioavailability and bioequivalence of azathioprine tablets in healthy volunteers.Methods A single oral dose of 100 mg azathioprine test and reference tablets were given to 20 male healthy volunteers in a randomized crossover study.Plasma metabolite 6-mercaptopurine of azathioprine was determined by RP-HPLC.The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations.Results The concentration-time curves were fitted to a one-compartment open model.The main pharmacokinetic parameters of azathioprine test and reference tablets were as follows: t1/2 were(1.30±0.25) and(1.30±0.34) h;tmax were(1.25±0.16) and(1.24±0.21) h;Cmax were(48.44±17.09) and(52.32±24.37) μg·L-1;AUC0-twere(89.49±19.25) and(91.90±25.31) μg·h·L-1;AUC0-∞were(96.11±19.74) and(98.36±24.66) μg·h·L-1,respectively.The relative bioavailability of F0-t and F0-∞were(99.62±15.29)% and(99.39±13.59)%,respectively.Conclusion The two azathiprine preparations are bioequivalent.

Objective To set up the way for determining cefaclor plasma levels and study pharmacokinetics and bioequivalence of those in Chinese healthy volunteers. Methods A single oral dose of 500 mg test or reference of cefaclor dispersible tablets was given to each volunteer according to an open randomized crossover design.The concentrations of cefaclor in plasma were determined by HPLC method.The pharmacokinetic parameters were calculated and bioequivalence was evaluated. Results A linear calibration curve for assay of cefaclor in plasma was obtained in the range of 0.150 4～24.060 0 mg·L-1 with the limit of quantitation of 0.150 4 mg·L-1 and the absolute recoveries was at least 80%.The main pharmacokinetic parameters of test and reference of cefaclor dispersible tablets were as follows: Cmax(12.882±2.494)and(12.578±3.143) mg·L-1;tmax(0.615±0.165)and(0.663±0.345) h;t1/2(0.824±0.164)and(0.808±0.175) h;AUC0→t(16.039±2.666)and(15.367±2.776) mg·h·L-1;AUC0→∞(16.301±2.729)and(15.646±2.874) mg·h·L-1.The relative bioavailability of the test tablets was(105.6±13.8)%. Conclusion The established HPLC technique is specific,accurate and sensitive.The result shows that the two formulations are bioequivalent in human by ANOVA,and both bilateral and monolateral t test.

目的:探讨临床药师在房颤患者个体化抗凝治疗方案的制订与用药监护中的工作要点.方法:参与1例老年非瓣膜病房颤患者缺血性脑卒中二级预防的华法林抗凝治疗用药方案的制订与用药监护.结果:确定符合患者特点的抗凝强度,避免不良反应发生的策略,提高其长期抗凝治疗和国际标准化比值(INR)监测的依从性.结论:个体化用药方案的设计与分析及用药监护是临床药师开展"以病人为中心"药学服务工作的切入点.

OBJECTIVE To study the preparation method and the character of immunoliposome loading polypeptide with ATWLPPR as ligand linked on the Surface.METHODS Use reverse-phase evaporation method to prepare blank liposome.To prepare blank immunoliposome,oligopeptide ATWLPPR was covalently linked to the blank liposome using DSPE-PEG-COOH as spacer.And PEDF was loaded into the blank immunoliposome by pH gradient methods.HPLC was used to determine ligand binding efficiency.PEDF kit was used to indirectly determine the envelop efficiency of PEDF immunoliposome.Using corresponding methods to analyze the appearance,the mean diameter,the surface charge,and the in vitro stability of the immunoliposome.RESULTS PEDF loading immunoliposome with ATWLPPR linked on the surface was successfully prepared.The average ligand binding efficiency was 59.85%.The average envelop efficiency was 74.6%.The mean diameter was 357.5 nm.The average surface charge was-46.6 mV.The 24 h leakage of PEDF in vitro was 0.99%.CONCLUSION The pH gradient method was tried,and the polypeptide loading immunoliposome was prepared successfully,and the pharmaceutical character was stable.This experiment settled a fundation for the objective of using novel method to active targeting deliver PEDF to retina choroidal neovascularization.

Objective To study the relative boiavailability of two specifications of amoxycillin dispersible tablets with the reference one and to evaluate the bioequivalence in healthy volunteers. Methods The 3 formulations in 3 periods with double 33 Latin square test were adopted. 24 healthy volunteers were orally given with 1 g of either amoxycillin dispersible tablets in an open randomized cross-over test. The plasma amoxycillin concentration was determined within 8 h administration by HPLC. The data were processed by DAS pharmacokinetic program, which were calculated to evaluate the bioequivalence between tested formulations and reference formulation. Results The pharmacokinetics markers of amoxycillin dispersible tablets were as follows: tmax were (1.68±0.56) h,(1.65±0.54) h,(1.79±0.61) h, t1/2kewere (1.19±0.34) h,(1.16±0.31) h,(1.10±0.15) h;Cmax were (12.42±3.01) μg·mL-1,(11.85±3.40) μg·mL-1, (11.16±3.07) μg·mL-1, AUC0-8h were (33.83±7.81) μg·mL-1·h,(32.38±7.62) μg·mL-1·h,(31.37±7.25)μg·mL-1·h, AUC0-∞ were (35.10±7.72) μg·mL-1·h, (33.63±7.87)μg·mL-1·h,(32.50±7.32)μg·mL-1·h, respectively. The relative bioavailability of two tested formulations were (110.2±21.9)%, (106.0±25.3)% , respectively. The results show that there were no significant differences in parameters tmax, Cmax, AUC0-8 h and AUC0-∞ between tested formulations and reference formulation (P>0.05). Conclusion Three formulations of amoxycillin dispersible tablets are bioequivalent.

目的了解院内药品不良反应(ADR)发生规律和特点,促进临床合理用药。方法采用回顾性研究方法,对同济医学院附属协和医院2004年～2007年446例ADR报告进行汇总统计分析。结果446例ADR中,抗菌药物引起的ADR居首位,占81.61%;ADR临床表现以皮肤及附件损伤最为常见,占总例数的50.83%;严重的ADR占14.13%;由静脉给药引起的ADR最多,占95.96%。结论应继续加强药品不良反应监测工作,以减少和避免不良反应的发生,促进合理用药和保障用药安全。

OBJECTIVE To evaluate the relative bioavailability and bioequivalence of tamoxifen citrate capsules in healthy volunteers.METHODS A single oral dose of 40 mg tamoxifen citrate test and reference preparations were given to 20 male healthy volunteers in a randomized crossover design.Tamoxifen concentrations in plasma were determined by LC/MS/MS.The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations.RESULTS The main pharmacokinetic parameters of tamoxifen citrate test and reference preparations were as follow: t1/ 2 were(53.5±14.4) h and(51.7±8.9) h;tmax were(3.9±0.9) h and(4.0±1.1) h;Cmax were(108.1±19.8) μg·L-1 and(101.3±16.5) μg·L-1;AUC0-72 were(3 073.7±439.1) μg·h·L-1 and(3 148.8±373.7) μg·h·L-1;AUC0-∞ were(5 074.8±1 082.2) μg·h·L-1 and(5 121.2±902.0) μg·h·L-1,respectively.The differences of the major pharmacokinetic parameters between test and reference preparations were not significant.The relative bioavailability of test preparation was(97.9±10.8) %.CONCLUSION The statistical analysis of the results shows that the two preparations are bioequivalent.

Objective To select the optimum condition for the spray granulation of guyanning granules. Methods The newly-fluid-bed-spray-drier-granulation technique was adopted with the temperature of exit and entry(A),blast pressure(B)and condensed solution(C) as inspecting factors,three levels of each factors,the content of caffeotannic acid in semi-finished guyanning granules as inspecting markers by the orthogonal experiment. Results The temperature of exit and entry was most notable(P<0.01) among three factors.However,blast pressure and extracting technique was of little importance. Conclusion The optimum spraying granulation technique of guyanning granules is A1B3C3,which is that A: 90-100/50-60 ℃,B:-1 800 Pa.

Objective To optimumize the conditions for preparing guyanning granules and investigate effects of which on erythrocytic immune function in rats. Methods The process was studied by orthogonal experimental design,the newly-fluid-bed-spray-drier-granulation technique was adopted and relative density of extractions,temperature of entry and blast pressure were used as inspecting factors,three levels of each factors and water content of the end and semi-end products as inspecting markers.Suppurative osteomyelitis was established in rats.WBC,rosette of C3b receptor,red cell immune and serum Lysozgme content were evaluated. Results The relative density of extractions and blast pressure were the more important factors than temperature of entry(P0.05).The optimum technique for spraying dry of guyanning granules was as follows: the relative density of extractions 1:1.20,temperature of entry 90-100/50-60 ℃,blast pressure-1 800 Pa.It was found that guyanning was more effective in respect of immune process than(P0.01)the model and penicillin(P0.05). Conclusion The optimum technique is reliable and it indicattes that guyanning granules has potent antiinflammatory and immune enhancement effects.

目的建立消炎止痛颗粒质量标准。方法采用薄层色谱(TLC)法对处方中的皂角刺、天花粉、大血藤、地榆等4种药材进行定性鉴别;采用高效液相色谱(HPLC)法测定消炎止痛颗粒中芍药苷的含量。结果薄层鉴别斑点清晰,阴性对照无干扰,消炎止痛颗粒中芍药苷与其他组分良好分离,芍药苷浓度线性范围在0.06~0.96μg,r=0.999 9,样品加样回收率为98.5%,RSD=1.61%(n=6)。结论该方法简便可行,重复性好,为消炎止痛颗粒的质量控制提供了参考。

Objective To establish a standard for the quality control of FufangChuanji Tablets.Methods Rhizome Cibotii,Radix Dipsaci and Herba Lycopodti were identified by TLC,and the content of paeoniae was determined by HPLC.Results There was a good linear relationship within a range of 0.2048～1.024μg for Paeoniflorin,correlation coefficient r=0.9993,the average recovery was 99.05%(n=6),RSD=1.13%,(n=6).Conclusion This method is simple,feasible and reproducible and can be used for quality control of FufangChuanji Tablets.

OBJECTIVE An HPLC with gradient elution method was established for the determination of silymarin SMEDDS. METHODS Separation and determination were performed on a Symmetry C18 column (3.9 mm×150 mm,5 μm).The mixed solvent of A (phosphoric acid-water=0.5∶100) and B (menthol-water-phosphoric acid=80∶20∶0.5) as the mobile phase (gradient elution);the detection wavelength was 288 nm;the column temperature was 40 ℃. RESULTS The linear range was 0.293 7-0.881 1 μg (r=0.999 6). The precision was 99.30%,the average recovery was 99.88%,and the RSD was 0.699%(n=9).CONCLUSION The method is accurate and reproducible. It can be used for the quality control of silymarin SMEDDS.