HPLC-UV测定五更清肠溶片中补骨脂素的含量

目的建立五更清肠溶片中补骨脂素的含量测定方法。方法HypersilODS C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(45∶55),检测波长为246 nm。结果补骨脂素在12.5~125μg.m l-1范围内,浓度与峰面积值呈良好线性关系,r=0.9996,平均加样回收率为98.12%,RSD=1.8%。结论本方法简便,重复性好,可用于五更清肠溶片的质量控制。     

塞克硝唑阴道泡腾片人体药代动力学研究

目的:研究塞克硝唑阴道泡腾片人体内的药代动力学特征。方法:单次给药分别应用250、500、750 mg,多次给药应用500 mg,连用7 d,采用HPLC测定血浆中塞克硝唑的浓度。用DAS软件计算其药代动力学参数。结果:健康已婚女性受试者单次使用塞克硝唑阴道泡腾片250、5007、50 mg后的T1/2β分别为18.84、15.25、21.86 h,与文献报道基本一致;Tmax分别为12.22、14.00、18.00 h,Cmax分别为3.58、5.42、8.00 mg.L-1,AUC分别为103.52、190.992、96.92 mg.h-1.L-1,与口服制剂相比,吸收较慢,峰浓度较低,吸收量较少,提示本药全身作用较小,不良反应也较少,局部残留较多有利于发挥治疗作用。多次使用塞克硝唑500 mg后的T1/2β=22.74 h、Cmax=14.30 mg.L-1、Tmax=1 1.60 h、AUC=520.14 mg.h-1.L-1,Cmax和AUC与单次给药相比明显增大,说明该药因半衰期较长,长期用药有一定的蓄积,多次连续用药应引起注意。结论:本试验提供了塞克硝唑阴道泡腾片体内血药浓度的HPLC测定方法及药动学参数,为其临床应用和合理用药提供了参考和依据。     

左旋泮托拉唑钠肠溶片的制备及其稳定性考察

目的：制备左旋泮托拉唑钠肠溶片并考察其稳定性。方法：以3因素3水平（碳酸钠的含量0,5％，10％；黏合剂的种类MC，HPMC和PVP；浓度2％，5％，8％）的正交试验设计进行片芯处方筛选，并参考中国药典2000年版附录考察了制剂的稳定性。结果：确定了以聚乙烯吡咯烷酮（PVP）为黏合剂、10％碳酸钠为稳定剂的处方，恒温加速试验及长期留样试验6个月，含量及有关物质未见明显改变。结论：本法制备肠溶片的处方工艺简便，易于控制和操作。     

高效液相色谱法测定二维钙赖氨酸片中维生素B_1含量

目的探讨二维钙赖氨酸片中维生素B1(VitB1)的含量测定方法。方法高效液相色谱法。色谱柱为GeminiC18柱(250mm×4.6mm,5μm),流动相为内含5mmol/L庚烷磺酸钠、以磷酸调节pH值至3.5的乙腈-水-三乙胺(16∶84∶0.3)溶液,检测波长为245nm,流速为1.0mL/min。结果VitB1线性范围是0.05～0.25μg,r=0.99999,平均回收率为98.99%,RSD=0.65%。结论方法灵敏快速,结果准确,重现性好,可用于该制剂的质量控制。     

益心丹片的质量标准研究

目的 :制定益心丹片的质量标准。方法 :用薄层色谱法鉴别何首乌、丹参、人参、赤芍。结果 :其定性方法简便、准确、专属性强、重现性好。结论 :可供制定质量标准用     

Validated high-throughput HPLC assay for nimesulide using a short monolithic column

High samples analysis rate is a key demand in modern pharmaceutical analysis, especially during new product development and validation of industrial-scale manufacturing process. The present study reports a validated HPLC assay for the dissolution studies of nimesulide-containing tablets (Lizepat 100 mg/tab, Cosmopharm Ltd., Korinthos, Greece). Using a 50 mm x 4.6 mm i.d. monolithic column (Chromolith, Merck) and acetonitrile-phosphate buffer (pH 7.0; 10 mM) (34:66, v/v) as the mobile phase, the separation cycle was completed in 60s at a flow rate of 4.0 ml min(-1). The assay was validated in terms of selectivity against potential impurities of the active ingredient, detection and quantification limits, linearity, accuracy and inter-/intra-day precision. Results from the application of the HPLC method to the accelerated and long-term dissolution stability control of Lizepat tablets (Lot 005) are reported.     

Pharmacokinetics of enteric-coated mycophenolate sodium in stable pediatric renal transplant recipients

This study aims to characterize the pharmacokinetics of mycophenolic acid (MPA) and its glucuronide metabolite (mycophenolic acid 7-O-glucuronide, MPAG) following single oral administration of enteric-coated mycophenolate sodium (EC-MPS, myfortic) at an approximate dose level of 450 mg/m(2) body surface area (BSA) to 25 stable renal transplant recipients (aged 5-16 yr), and to evaluate the safety and tolerability of EC-MPS in this pediatric population. Patients had been maintained on a cyclosporine emulsion, Neoral-based immunosuppressive regimen for at least 3 months and had received their first or second renal transplant more than 6 months prior to entry into the study. After a brief lag phase (t(lag) 0.75 h), MPA was rapidly absorbed (t(max) 2.5 h) and rapidly converted to MPAG (t(max) 3.25 h), with relatively high plasma concentrations of MPAG (C(max) 67.7 microg/mL) compared with MPA (C(max) 36.3 microg/mL). The elimination half-life for MPAG was slightly longer than for MPA (approximately 13 h vs. 8.5 h), and the apparent oral clearance of MPA was approximately 0.2 L/h/kg. The pharmacokinetics of MPA or MPAG were not affected by age, body weight or BSA, within the study population. The pharmacokinetic results for pediatric patients are comparable with those obtained previously in adults, although exposure based on AUC(0-infinity) was approximately 23% higher, and this finding may be a result of dosing on the basis of BSA, rather than body weight. The recommended dose of EC-MPS in pediatric patients is 400-450 mg/m(2) twice daily or, alternatively, approximately 10-14 mg/kg twice daily when used in combination with cyclosporine microemulsion.