度洛西汀与氟西汀治疗抑郁症对照研究

目的：以氟西汀为对照,研究度洛西汀对抑郁症的疗效和不良反应。方法：将50例符合CCMD-3抑郁症诊断标准的抑郁症患者随机分为两组,应用度洛西汀和氟西汀各25例进行随机对照研究,治疗时间为6周。用汉密尔顿抑郁量表（HAMD）评定疗效及副反应量表（TESS）评定不良反应。结果：度洛西汀较氟西汀疗效相当,但度洛西汀起效快。结论：度洛西汀对抑郁症的疗效确切、较氟西汀对抑郁症的疗效起效快,尤其改善抑郁症患者的躯体症状效果明显,不良反应轻,依从性好。     

文拉法辛与氟西汀治疗抑郁症疗效的比较

目的：分析比较文拉法辛与氟西汀治疗抑郁症的疗效。方法：选取90例抑郁症患者随机平分为两组,实验组口服文拉法辛30~220mg/次,2次/d;对照组口服氟西汀20mg/次,1次/d。均以6周为1个疗程,观察比较其疗效及不良反应。结果：两组患者在服药治疗后的病情严重程度、副反应及HAMD评分比较无显著差异（P〈0.05）。结论：文拉法辛与氟西汀对于治疗抑郁症疗效相当,但文拉法辛起效更快。     

帕罗西汀与氟西汀治疗老年抑郁症对照研究

目的:比较帕罗西汀和氟西汀对老年抑郁症的疗效和不良反应。方法:将60例老年抑郁症患者随机分为帕罗西汀组和氟西汀组,分别给予帕罗西汀和氟西汀治疗,疗程6周。采用汉密尔顿抑郁量表(HAMD)及不良反应量表(TESS)评定疗效和不良反应。结果:帕罗西汀组和氟西汀总显效率分别为83.2%和76.6%,二者疗效相仿。HAMD评分帕罗西汀组治疗2周即显著下降,氟西汀组治疗4周时显著下降。帕罗西汀组副反应较少,而氟西汀组常见的不良反应为恶心、口干、失眠、兴奋等。结论:帕罗西汀是一种安全、有效的抗抑郁药物,适合用于老年抑郁症患者。     

盐酸氟西汀与阿米替林治疗抑郁症临床对照观察

为探讨国产氟西汀的临床疗效及不良反应，笔者用国产盐酸氟西汀与阿米替林(均为常州第四制药厂生产)对治疗抑郁症的疗效、不良反应进行了临床对照观察，报道如下。     

50例氟西汀治疗精神分裂症后抑郁临床分析

目的:探讨氟西汀治疗精神分裂症后抑郁的临床疗效。方法:选取2013年1月~2013年6月来我院接受治疗并符合CCMD-3抑郁诊断标准的患者50例,在服用了常规药物治疗却没有得到很好效果的前提下服用氟西汀,剂量控制在20~40mg,每天早上坚持口服,持续6周,并采用BPRS、HAMD、PANSS、SANS对患者进行药物疗效和相应副作用的评定。结果:经过治疗以后患者的情况有所好转,HAMD值下降。结论:氟西汀对治疗精神分裂症后抑郁病状的疗效良好,不良反应较轻,值得在临床上广泛推荐和使用。     

氟西汀治疗抑郁症42例

氟西汀是一种新型5-羟色胺再摄取抑制剂,对抑郁症疗效,副作用轻微,但起效较慢及部分起效,近年来不少学者将非典型抗精神病药作为治疗抑郁症的增效剂,为探讨启维合用氟西汀对老年期抑郁症的疗效及安全性,我们将其与单独使用氟西汀进行了对照研究,     

氟西汀、多潘立酮联合阿米替林治疗功能性消化不良

目的：研究氟西汀、多潘立酮、小剂量阿米替林联合用药治疗功能性消化不良（functional dyspesia,FD）的临床疗效。方法：146例符合罗马Ⅲ诊断标准并伴有焦虑,睡眠障碍的患者随机分为治疗组（n=74）和对照组（n=72）。治疗组口服氟西汀片20mgQd（早餐时顿服）,多潘立酮片10mgTid,阿米替林6．25mgQn。对照组口服多潘立酮片10mgTid并按症状对症处理。疗程8周,应用症状变化评定疗效标准及汉密尔顿焦虑量表（HAMA）于治疗前及治疗8周后进行疗效评定。结果：治疗组和对照组症状缓解总有效率为分别为94．6％、59．8％;两组有明显差异（P〈0．05）;治疗组在治疗8周后的HAMA总分显著低于对照组（P〈0．05）。结论：氟西汀、多潘立酮、小剂量阿米替林治疗FD疗效确切。     

文拉法辛与氟西汀治疗抑郁症临床疗效对比

目的:比较文拉法辛和氟西汀治疗抑郁症的临床疗效。方法:将2009年6月—2010年10月我院收治的62例抑郁症患者随机分为文拉法辛组和氟西汀组,并分别给予文拉法辛或氟西汀治疗,对比观察两组临床效果。结果:文拉法辛组治疗第1周起HAMD评分明显低于治疗前,且差异显著(P<0.01),氟西汀组治疗第3周起HAMD评分明显低于治疗前,且差异显著(P<0.01);文拉法辛组有效率为83.9%,氟西汀组有效率为80.6%,组间差异无统计学意义(P>0.05)。结论:文拉法辛治疗抑郁症比氟西汀起效快,但临床疗效相当,均可推广为临床一线用药。     

舍曲林、氟西汀和帕罗西汀治疗抑郁症的对照观察

 目的：了解舍曲林、氟西汀和帕罗西汀治疗抑郁症的作用和不良反应的差异。方法：采用随机双盲的原则进行治疗， 采用汉密尔顿抑郁量表（HAMD）、汉密尔顿焦虑量表（HAMA）、不良反应量表(TESS)进行评定。结果：71例患者完成试验，3种药物组治疗后HAMD、HAMA评分均较治疗前有明显下降，治疗前后3种药物之间的HAMA、HAMD的评分无差异，3种药物均未发现明显的不良反应。结论：3种药物的疗效可靠，它们的疗效和不良反应无明显差异。     

LC-MS法检验减肥类产品中非法添加的氟西汀

目的建立液相色谱-质谱联用(LC-MS)法测定减肥类产品中非法添加的氟西汀。方法质谱定性分析采用Shimadzu Shim-pack XR-ODS色谱柱(100 mm×2.0 mm,2.2μm);流动相为甲醇-0.01 mol/L乙酸铵(含0.1%乙酸),梯度洗脱;体积流量0.3 m L/min。液相色谱定量分析采用Inertsil ODS-SP C18色谱柱(4.6 mm×150 mm,5μm);流动相为甲醇-乙腈-0.8%三乙胺溶液(磷酸调p H至5.8)(5∶35∶60);检测波长226 nm;体积流量1.0 m L/min。结果在72批样品中,有2批(均为平衡素)非法添加了氟西汀。结论该方法快速、准确、灵敏度高,可用于检验非法添加的氟西汀。     

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??OBJECTIVE To develop a LC-MS method for simultaneously quantifying four anti-tuberculosis drugs [isoniazid(INH)??pyrazinamide(PZA)?? ethambutol(EMB) and rifampicin(RIF)] in human cerebrospinal fluid and to help guide the clinical medication. METHODS The drugs in cerebrospinal fluid were extracted by acetonitrile precipitation, and separated on ZORBAX Bonus-RP column(2.1 mm??150 mm,3.5 ??m) with the mobile phase of aqueous solution(containing 0.1% formic acid)-acetonitrile(containing 0.1% formic acid)(80??20) at a flow rate of 0.25 mL??min^-1. Multiple reaction monitoring(MRM) mode was performed combined with electrospray ionization source operating in the positive ionization mode. RESULTS The liner calibration curves of INH??PZA??EMB and RIF were obtained in the concentration range of 20-5 000(r=0.998 6), 120-30 000(r=0.997 7), 20-5 000(r=0.999 4), 60-15 000(r=0.996 2)ng??mL^-1, respectively. The intra-and inter-day precision was less than 15% and the absolute recovery was above 75%. This method was successfully applied to analyze the drugs in cerebrospinal fluid from six clinical samples. CONCLUSION The method is rapid, simple, sensitive and accurate, and proved to be suitable for clinical therapeutic drug monitoring.     

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??OBJECTIVE To establish a UPLC-MS/MS method for the determination of ropivacaine and sufentanil plasma concentration in neonate and maternal. METHODS Ropivacaine and sufentanil were extracted from plasma by ethyl acetate and ethyl ether (1??1,V/V), and determined by LC-MS/MS using bupivacaine as the internal standard. Separation was carried on Waters BEH C₁₈ column (2.1 mm??50 mm, 1.7 ??m) with a mobile phase of 0.1% formic acid acetonitrile -0.1% formic acid water. The flow rate was 0.35 mL??min^-1 and column temperature was maitained at 45 ??. ESI source was applied and operated in positive ion mode. Quantitative determination was performed using multiple reaction monitoring (MRM) of m/z 275.2??m/z 126.0 for ropivacaine, and m/z 387.1??m/z 238.1 for sufentanil. RESULTS There were good linearity of ropivacaine (0.25-202.0 ng??mL^-1) and sufentanil (0.165-133.6 ng??mL^-1), and the correlation coefficient (r²) were greater than 0.995. The extraction recovery for ropivacaine and sufentanil were more than 71.62%, while the intra-day precision (RSD) were lower than 13.86%. CONCLUSION The method is accurate and high sensitive, providing a good analysis mean for monitoring neonate and maternal blood concentration of ropivacaine and sufentanil.     

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??OBJECTIVE To establish a high performance size exclusion chromatography(HPSEC) method for the separation and analysis of polymers in cefotaxime sodium and cefotaxime sodium for injection, and determine the structures of the impurities by LC-MS. METHODS HPSEC was performed by using Sepax SRT SEC-150(7.8 mm??300 mm, 5 ??m)column. The mobile phase was 0.1 mol??L^-1 disodium hydrogen phosphate and 0.1 mol??L^-1 phosphate buffer solution. The flow rate was 0.8 mL??min^-1, the detection wavelength was set at 235 nm, the injection volume was 10 ??L, and the column temperature was maintained at 35 ??. The concentration of polymers was quantified by external standard method. The LC-MS/MSⁿ system conditions were as following: the mobile phase was 20 mmol??L^-1 amonium acetate, the flow rate was 0.8 mL??min^-1, ESI source with positive and negative ion scan was utilized, the scanning range was m/z 200-1 600, and the post-column diversion ratio was 1??4. RESULTS Eight impurity peaks were obtained in total; the resolutions were all greater than 1.5. The linear range of cefotaxime was 1-100 ??g??mL^-1(r=1.000 0). The RSD repeatability was 1.2%(n=6). The limit of detection was 0.2 ??g and the limit of quantitation was 0.4 ??g. Three polymers were identified by LC-MS. CONCLUSION The HPSEC method can be used for the quantitative and qualitative analyses of individual polymer impurities. It is also sensitive for the control of polymers in cefotaxime.     

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??OBJECTIVE To establish a determination method of trace hydroxylamine in rasagiline mesylate by ion chromatography with on line SPE. METHODS First, the sample was injected and hydroxylamine was transferred to the analytical column, and the matrix of rasagiline mesylate was trapped on the SPE column, IonPac CG12A. Second, the IonPac CG12A column was washed with acetonitrile and equipped with MSA solution of the same concentration as eluent. RESULTS The liner calibration curve was obtained over the range of 0.04-3.75 ??g??mL^-1 with a correlation coefficient (r²) of 0.999 9. And the detection limit of hydroxylamine was 0.02 ??g??mL^-1. The method was applied to detect trace hydroxylamine in rasagiline mesylate samples successfully. The spiked recoveries were 94%-103%. CONCLUSION The method has high automation degree, selectivity and sensitivity for trace hydroxylamine analysis     

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??OBJECTIVE To establish limited sampling strategy to estimate area under the curve (AUC) of HSCT patients who had received busulfan (Bu) intravenous infusion. METHODS Plasma samples were collected at certain time points from 22 HSCT patients who had received busulfan intravenous infusion. The LC-MS/MS method was used to measure blood concentration of busulfan. The classical method was used to calculate pharmacokinetic parameters. To estimate AUC_0-6, measured blood concentration data was used to build a multiple linear regression model which was subsequently validated. Consistency between results produced by the traditional method and the proposed LSS respectively was assessed by the intraclass correlation coefficient (ICC) and Bland-Altman (BA) analysis. RESULTS It is shown that model based on concentrations on two sampling time points (2 and 5 h) is able to predict AUC_0-6accurately (adjusted r²=0.917. MPE=0.2%, RMSE=4.48%). The 95% confidence interval of ICC is 0.914-0.984 while the limit of agreement in the BA is -0.9-8.8. Results produced by limited sampling strategy are nearly consistent with AUC_0-6 produced by the classical method. CONCLUSION The proposed limited sampling strategy to estimate AUC_0-6 based on C₂ and C₅ can be used to busulfan blood concentration monitoring in clinical practice.     

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??OBJECTIVE To establish a rapid and sensitive method for the determination of vitamin K homologue in human plasma using HPLC-fluorescence detection. METHODS With salting-out assisted liquid/liquid extraction, the fluorescence derivatization reaction of vitamin K homologues was proposed by ethanolic SnCl₂ in acidic medium. An AQ-C₁₈ column was used as the chromatographic column with a mobile phase of a mixture of methanol-water(98??2) at a flow rate of 1 mL??min^-1,the fluorescence detector was set at ??ex/??em=248 nm/418 nm, and the column temperature was maintained at 30 ??. RESULTS The calibration curves of vitamin K1(VK1) and vitamin K2 (VK2) were as followed:Y_a=2.944??_a+0.023(r=0.999 8,1.000-50.036 ng??mL^-1),Y_b=1.195??_b+2.653(r=0.999 7,5.006-100.124 ng??mL^-1), respectively. Their precision RSD, stability RSD, repeatability RSD and freezing-thawing test RSD were all less than 10%.CONCLUSION The method is simple, sensitive and accurate, which can be used for the assay of endogenous vitamin K homologue in human plasma.     

超高效液相色谱-电化学检测法测定女贞子中的3种成分

目的 建立超高效液相色谱-电化学检测法同时测定女贞子中羟基酪醇、红景天苷和酪醇3种成分的方法。方法 取女贞子药材粉末0.1 g经20 mL甲醇超声提取30 min,提取液再经0.22 μm滤膜过滤后上样进行色谱分离。以 ACQUITY UPLC HSS T3 柱(2.1 mm×100 mm,1.8 μm)为固定相,25 mmol·L^-1乙酸铵溶液(pH 3.6)-甲醇=88∶12(V/V)为流动相。电化学检测器检测,库伦检测池第一通道电压为350 mV,第二通道为550 mV。结果 羟基酪醇、红景天苷和酪醇的质量浓度在0.1~10、1~50和0.1~8 mg·L^-1内与其峰面积呈线性关系(r²>0.999 0),平均加标回收率分别为101.52%、102.15%和101.92%,相对标准偏差分别为3.64%、3.87%和4.54%。结论 使用超高效液相色谱-电化学检测法测定3种成分不仅灵敏度高,而且分析时间大大缩短,适合于女贞子中3种苯乙醇类化合物的测定。     

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??OBJECTIVE To develop a highly sensitive and specific LC-MS/MS method to explore the pharmacokinetic properties of araloside A. METHODS Araloside A was administered in a dose of 50 mg??kg^-1 via gastric in fusion and 5 mg??kg^-1 by intravenous injection in rats.Araloside A was analyzed by a validated LC-MS/MS method in plasma after intravenous and intragastric administration. The pharmacokinetic parameters were evaluated by software DAS 3.0. RESULTS The RESULTS of pharmacokinetic study showed that the linear range of araloside A was good in 1.0-10 000.0 ??g??L^-1(r>0.994 8). The specificity, precision and accuracy, matrix effect and extraction recovery rate and stability all meet the requirements. The main pharmacokinetic parameters for intragastric administration with araloside A 50 mg??kg^-1 and intravenous injection of araloside A 5 mg??kg^-1 were as follows:t_1/2 was(8.65??3.22) and(2.00??0.21)h, AUC_0-t was(277.14??101.00) and (21 194.59??4 385.13)ng??h??L^-1, MRT_0-t was (7.88??0.64) and (1.21??0.11)h, Vd/F was (2 229.99??1 013.97) and (0.71??0.20)L??kg^-1, CL/F was(149.11??62.28) and (0.24??0.05) L??h^-1??kg^-1, respectively; ??_max was (32.68??10.74) ??g??L^-1 for intragastric administration and t_max reached(1.21??0.70) h, oral bioavailability of araloside A was about 0.14%. CONCLUSION The LC-MS/MS method established is specific and sensitive, and can be successfully applied in basic pharmacokinetic study of araloside A in rat plasma.     

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??OBJECTIVE To investigate the pharmacokinetics of mycophenolate mofetil in patients with myasthenia gravis, and evaluate the correlation between plasma concentration and AUC. METHODS Eight myasthenia gravis patients older than 18 years old with normal liver and renal function were included in this study. Blood samples were collected at 0, 1, 2, 3, 4, 6, 8, 10 h after the patients were continuously given oral mycophenolate mofetil 2 g??d ^-1for one week. Plasma concentrations of mycophenolate mofetil were determined by HPLC method and data analysis was done by WinNonlin program. RESULTS The main pharmacokinetic parameters of mycophenolate mofetil were as follows??_max was (11.39??3.23) ??g??mL^-1,t_max was (1.5??0.8) h,AUC_{0-12 h} was (38.71??11.23) ??g??h??mL^-1. The ??₂ had the best correlation with AUC (r²=0.80) followed by ??₀ and ??₄ (r²=0.75). CONCLUSION The pharmacokinetics of mycophenolate mofetil has great inter-individual differences, but without significant difference with those in healthy volunteers and transplant patients. The ??₀ can be used for routine therapeutic drug monitoring because of convenience and feasibility.     

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??OBJECTIVE To establish an HPLC method for simultaneous determination of ginsenoside Rg₁, Re, Rb₁ and jujuboside A, B in Renshen Jianpi Pellets (RSJPW). METHODS The determination was conducted on an Eclipse XDB C₁₈ column (4.6 mm??250 mm, 5 ??m) with the mobile phase of acetonitrile (A)-water (B) gradiently eluted at the following flow rates:0-90 min, 1.0 mL??min^-1; 90-130 min, 1.0-0.5 mL??min^-1; 130-140 min, 0.5 mL??min^-1. And the column temperature was maintained at 35 ??; the detection wavelength was set at 203 nm. RESULTS The calibration curves of ginsenoside Rg₁, Re, Rb₁ and jujuboside A, B were in good linearity over 0.32-2.24 ??g (r=0.998 2), 0.16-1.12 ??g (r=0.995 3), 0.32-2.24 ??g (r=0.999 6), 0.16-1.12 ??g (r=0.991 5), 0.08-0.56 ??g (r=0.999 6). The corresponding average recovery rates were 97.18%, 97.62%, 98.79%, 98.48%, 94.51%; the standard deviations were 1.10%, 0.98%, 0.34%, 1.09%, 1.88%, respectively. CONCLUSION The established HPLC method is accurate, reliable and reproducible, which can be used as a reference for the quality control of RSJPW.