目的:探讨品管圈(QCC)活动在精神病专科医院护理质量管理中的应用效果.方法:在精神病专科医院启动QCC,鼓励临床科室参与QCC,通过培训、推进会及专家指导等方式,严格按照QCC十大步骤,完成QCC并按完成情况进行专家评审.结果:本期QCC共启动护理质量管理品管圈14个,主题涉及患者安全防护5个、护理管理4个、差错预防2个、健康教育2个及服务满意度1个;通过专家评审共结题11个,结题率78.57％,平均目标达成率109.73％,平均目标进步率57.64％;在实施过程中,质量管理工具技术的掌握率和圈能力均明显提高,通过标准化圈成果得到很好应用,促进了护理质量管理水平.结论:在精神病专科医院护理质量管理中非常适合使用QCC,且具有良好的可行性和有效性.

目的探讨中、小剂量利培酮治疗精神分裂症患者的血药浓度、临床疗效及不良反应。方法将82例精神分裂症患者随机分为口服利培酮剂量2mg/d组和4mg/d组。采用RP-HPLC和LC-MS方法测定利培酮（RSP）和9-羟利培酮（9-OH-RSP）之和的血浆浓度。用阳性和阴性症状量表（PANSS）评定临床疗效,用不良反应症状量表（TESS）评定不良反应。结果4mg/d组（RSP+9-OH-RSP）血浓度均显著高于2mg/d组。2mg/d组第1周末PANSS平均减分率＜20%,其它各周末PANSS平均减分率＞20%,而4mg/d组各周末PANSS平均减分率＞20%.2mg/d组TESS评分明显低于4mg/d组。结论（RSP+9-OH-RSP）血浓度能较好地反映其临床效应。2mg/d和4mg/d利培酮治疗精神分裂症患者疗效相当,4mg/d利培酮治疗时起效更快,但易发生不良反应。

采用液相色谱—质谱联用技术测定60例精神分裂症患者利培酮(RSP)和9-羟利培酮(9-OH-RSP)之和的血浆浓度。用阳性和阴性症状量表(PANSS)评定临床疗效,用不良反应症状量表(TESS)评定副反应,对血药浓度与副反应进行相关分析。结果治疗后第8周末的PANSS总分与治疗前比较差异有统计学意义,血药浓度与副反应存在正相关。提示RSP+9-OH-RSP血药浓度与副反应密切相关,血药浓度的检测有助于预防副反应的发生。

AIM: To study the efficacy and side effects of both middle and low doses of risperidone in the treatment of first-episode schizophrenia, and to investigate the relationship between plasma concentration of RSP,9-OH-RSP and the efficacy or side effects occurred during RSP treatment. METHODS: Compared the patients treated with middle dosage of risperidone (groupB,40 cases)and the other 42 cases (groupA) that are treated with very low dosage of risperidone. RESULTS: Two groups were in statistical difference (P 0.05 ) by itself. But there were no significant difference between group A and group B (P 0.05 ). Group A took effect later than group B. Total scores of the treatment emergent symptom scale (TESS) were significantly lower in group A than in group B.The plasma concentration of 9-OH-RSP and the active moiety (RSP+9-OH-RSP) after one week's administration of risperidone were higher in group B than that in group A (P 0.05 ). CONCLUSION: This assay suggested that low dosage of risperidone is effective, safe and beneficial in the treatment of first-episode schizophrenia.

OBJECTIVE To evaluate the relationship between dose of risperidone and the steady plasma concentration of risperidone and 9-hydroxyrisperidone in schizophrenic patients.METHODS The steady plasma concentrations of risperidone and 9-hydroxyrisperidone were determined by HPLC-MS method and the relationship between total plasma concentration of risperidone and 9-hydroxyrisperidone and doses are evaluated.RESULTS The steady plasma concentration of RSP had a relationship with administered daily oral dose,r=0.766 8. A much better relationship existed between dialy dose of risperidone and the steady plasma concentration 9-hydroxyrisperidone (r=0.980 0) or the total active moiety,risperidone plus 9-hydroxyrisperidone concentrations(r=0.979 8).CONCLUSION The steady plasma concentrations of 9-hydroxyrisperidone or risperidone plus 9-hydroxyrisperidone were more related to the dialy dose of risperidone than that of risperidone. 9-hydroxyrisperidone has an important role in risperidone clinical application.

Objective To explore the relationship between serum concentration and clinical efficacy of quetiapine in the treatment of patients with schizophrenia. Methods The subjects were 70 inpatients with Positive and Negative Symptom Scale (PANSS) score of at least 60 before treatment. They were treated with quetiapine for 8 weeks, with the dosage range of 250 mg to 600 mg daily. The clinical efficacy and side effects were assessed with the PANSS and Treatment Emergent Symptom Scale before and at the 1st, 2nd, 4th and 8th weekend of treatment. The blood samples were gotten at the 1st, 2nd, 4th and 8th weekend of treatment, and the serum concentration of quetiapine was determined with high performance liquid chroma-tography. Results The serum concentration had significant positive correlation with the dose of quetiapine (r = 0. 248-0. 347 , P 0. 05-0. 01) . The responsive rate in patients with serum concentration of over 250 μg/L was 75%. The serum concentration in responsive patients was (320 ± 142) μg/L, significant higher than that in non-responsive patients (251± 109)μg/L The serum concentration was positively correlated to the reduction of PANSS score (r = 0. 343 - 0. 499, P0. 05-0.01). The lowest mean effective dosage was 344 mg per day. Conclusion Quetiapine is effective for schizophrenia and the clinical efficacy is related to its serum concentration. The lowest appropriate serum concentration of quetiapine is 250 μg/L It is of significance for monitoring serum concentration of quetiapine in treatment of schizophrenia.

OBJECTIVE To establish a RP-HPLC method for the determination of quetiapine fumarate concentration in patients with schizophrenia,and to study the relationship between serum concentration and clinical response. METHODS A HPLC method was used to determine quetiapine fumarate concentration.Blood samples were collected in 76 schizophrenia inpatients before or at the end of 2,4,6 weeks of quetiapine fumarate treatment and the therapeutic efficacy was measured by BPRS.RESULTS The standard curve was linear over the range of 50～500 ng.mL~-1 of quetiapine fumarate in serum (r=0.985 0). The serum concentrations were proportionally increased with daily dose in the range of 50～450 mg,but no significant correlation between dose and age/sex was discovered.The optimal therapeutic concentration was estimated from 126 to 350 ng.mL~-1 . CONCLUSION The assay was simple, precise and usable for therapeutic quetiapine fumarate monitoring.The optimal concentration window was suggetted as 126～350 ng.mL~-1 .

To establish a method for determination of serum concentrations of quetiapine fumarate in patients with schizophrenia of different doses and to study its relationship with clinical response. METHODS: A HPLC method was used to determine serum concentrations of quetiapine fumarate in 76 patients with schizophrenia before or after 2, 4, 6-week treatment and its therapeutic efficacies were measured by BPRS. RESULTS: The standard curve was linear within the concentration range of 0.05-0.5 mg*L-1 of quetiapine fumarate in serum (r=0.9850). The serum concentrations of quetiapine fumarate were proportionally increased with the daily dose of 50-450 mg, but there was no significant correlation with age and sex. The optimal range estimated was 0.126-0.350 mg*L-1. CONCLUSION: The assay is simple, precise and suitable for therapeutic monitoring of quetiapine fumarate and the optimal concentration window is 0.126-0.350 mg*L-1 in treatment of patients with schizophrenia.

目的:进行双氯酚酸钾颗粒与双氯酚酸钾片单剂双交叉生物等效性研究.方法:男性健康志愿者18名自身交叉单剂量口服双氯酚酸钾颗粒与双氯酚酸钾片50mg,采用高效液相色谱法测定双氯酚酸钾经-时血药浓度,计算其药代动力学参数与相对生物利用度.结果:双氯酚酸钾颗粒与双氯酚酸钾片主要药代动力学参数T1/2(β)分别为(3.022±0.698)h和(2.980±0.744)h,Tpeak分别为(0.972±0.188)h和(1.000±0.000)h,Cmax分别为(1.57±0.211)μg/ml和(1.664±0.243)μg/ml,AUC0～12分别为(4.115±0.422)μg/(ml·h)和(4.217±0.293)μg/(ml·h),AUC0～∞分别为(4.59±0.330)μg/(ml·h)和(4.639±0.383)μg/(ml·h).两药各药代动力学参数间均无统计学差异,双氯酚酸钾颗粒相对生物利用度(F)为(99.47±9.79)%.结论:双氯酚酸钾颗粒与双氯酚酸钾片具有生物等效性.

目的:建立富马酸喹硫平片含量测定的反相高效液相色谱法.方法:采用Hypersil ODS-C18(250mm×4.6mm,5μm)色谱柱,以甲醇-0.5%三乙胺(78∶22,冰醋酸调pH至7～8)为流动相,流速1 mL·min-1,检测波长254nm,柱温室温,进样量10μL .考察了流动相不同配比、不同pH对富马酸喹硫平色谱行为的影响.结果:富马酸喹硫平与片剂辅料及其他杂质可完全分离;在10～100μg*mL-1浓度范围内线性关系良好(r=0.9986),平均回收率99.7%,RSD=1.5%.结论:该方法操作简便,结果准确,专属性强,可用于富马酸喹硫平片的含量测定.

OBJECTIVE：To develop a method for the determination of eperisone hydrochloride by high performance liquid chromatography(HPLC).METHOD:C18 column as the stationary phase and methanol-water-triethylamine(80∶19.5∶0.5,V/V,adjusted to pH 7.5 with glacial acetic acid) as the mobile phase were adopted.The detection was performed at 254nm.Eperisone hydrochloride tablets were disssolved in methanol,supersonic-vibrated and filtered.Tolperisone was used as internal standard.RESULTS:The standard curve was linear in the range of 0.4～1.6mg/ml with the excellent correlation coefficient of 0.9999.The average recovery was 98.4%(RSD=1.2%,n=15).Three batches of eperison hydrochloride tablets were analyzed and the labelled contents were 97.8%,98.3% and 98.9% respectively.CONCLUSION:The method was simple,sensitive,rapid and suitable for the quantitative anylysis of the preparation.

目前,临床上已广泛应用氯氮平治疗精神分裂症,对氯氮平血液浓度的测定方法,国外报道的有放射免疫法和气相色谱法;1998年国内报道了上海用高效液相色谱法测定血液中氯氮平浓度的方法.根据我院现有的仪器、设备及其它实验条件,参照上述文献建立了自己的测定方法,并用于临床血浓度检测,现将测定结果报告如下: 1.实验材料 1.1 仪器与试剂:Beckman 126恒流泵,166可调波长检测器,IBM-XT微机处理仪及监视器记录仪.氯氮平(上海十九制药厂提供)、安定(济南第三制药厂提供)、甲醇(优级纯)、三乙胺、醋酸及乙醚均为化学纯.

OBJECTIV: To simultaneously determine the concentrations of risperidone and its main active metabolite 9-hydroxyrisperidone in serum of 16 psychotic patients. METHODS:Hypersil ODS-C 18 colunm was used as the stationary phase and a solution composed of methanol-water-triethylamine (73:36.5 :0.5,v/v, was adjusted to pH 8 with glacial acetic acid ) as the mobile phase with a flow rate of 1 .0 ml·min-1. The detection was performed at UV 280mm. RESULTS: The standard curve was linear within the concentration range of 10-100μg.L-1 of risperidone and 9-hydroxyrisperidone in serum (r=0.9950 and 0.9935). The recoveries of risperidone and 9-hydroxyrisperidone was between 98.3% to 102. 1%.The relative standard deviations for the within-day and the between-days variation were 6.71 %. The risperidone and 9-hydroxyrisperidone serum concentrations of 16 psychotic patients were in the range of 10.9-38.8μg.L-1 and 11 .5-49.7 μg.L-1 respectively within the dose of 2-5mg a day. CONCLUSION: The assay method is simple, precise and usable for therapeutic risperidone monitoring and its pharmacokinetic studies. The concentration risperidon and its active metabolite 9-hydroxyrisperidon were proportionally increased within the dose of 2-5mg risperidone.

First order derivative UV spectrophotometry was applied for determination of risperidone tablets. It had good linearity between amplitude values (D) and concentrations (C) in 5～40 μg/ml in methanol solution, and the average recovery was 99.91% with RSD 0. 05 %.