Objective To investigate the effect of early postoperative enteral nutrition support on the balance of free amino acid spectrum in plasma for patients with cardiac valve replacement during perioperative period. Methods (Forty-seven) patients undergoing cardiac valve replacement were divided into two groups randomly, the routine diet group and the Nutrison Fibre group. The levels of free amino acids in plasma were measured with pre-column derivatization of high-performance liquid chromatography. Results During perioperative period most free amino acids in plasma decreased significantly in the routine diet group (Plt;0.05). Despite some free amino acids in plasma decreased significantly in the Nutrison Fibre group(Plt;0.05), all free amino acids in plasma returned to (Pgt;05) or were higher than the preoperative levels in the postoperative sixth day (Plt;0.05). At the same postoperative points, most free amino acids in plasma in the Nutrison Fibre group were higher than that of the routine diet group (Plt;0.05). Conclusions The levels of free amino acids in plasma decrease significantly in patients with cardiac valve replacement after operation. Early postoperative Nutrison Fibre enteral nutrition support is helpful for keeping the balance of free amino acids in plasma for patients with cardiac valve replacement.
Objective To compare the systematic and lung pharmacokinetic parameters of moxifloxacin hydrochloride and explore a feasible tool to monitor drug concentration and evaluate therapeutic efficacy of respiratory fluoroquinolones. Methods Ten adult patients with community-acquired pneumonia or acute exacerbation of chronic bronchitis were enrolled.The subjects received a single dose of oral moxifloxacin hydrochloride 400 mg. Serum specimens were sampled at 0，1，2，3，4，8，24 h and sputum specimens were collected 0，1，2，4，8，20，24 h after administration，respectively.The serum and sputum concentrations of moxifloxacin hydrochloride were assayed by means of high-performance liquid chromatography. Standard pharmacokinetic parameters including peak concentrations(Cmax) and area under the concentration-time curve (AUC0-24 h) were assessed. Results Serum C(max) was（5.95±1.35）mg/L at 2 hours and serum AUC0-24 h was (58.72±8.11）mg·h-1·L-1 while sputum Cmax and AUC0-24 h were （16.18±6.47）mg/L at 3 hours and （138.04±78.29）mg·h-1·L-1 respectively，which were significantly higher than those in serum. Conclusion Oral administration of moxifloxacin hydrochloride to patients with respiratory infections results in rapid penetration into lung and maintain a one-fold drug concentration compared to blood concentration within 24 hours.Sputum drug concentration analysis demonstrates a superior pharmacokinetic profile of moxifloxacin in respiratory tract.
目的 采用高效液相色谱-质谱联用法研究盐酸多奈哌齐口腔崩解片的人体药物代谢动力学，并评价其生物等效性。 方法 2009年9月－11月对22例健康男性受试志愿者单次交叉口服盐酸多奈哌齐口腔崩解片（试验制剂）和盐酸多奈哌齐普通片（参比制剂），测定给药后不同时间点血浆中多奈哌齐经时血药浓度，采用DAS 2.0软件进行药物代谢动力学参数计算和生物等效性评价。 结果 受试者单次口服试验制剂与参比制剂后，达峰时间分别为（2.95 ± 1.16）、（3.19 ± 0.98） h，峰浓度分别为（9.98 ± 2.93）、（9.13 ± 2.05） ng/mL，药时曲线下面积（0-t）分别为（470.76± 142.64）、（446.57 ± 137.30）ng/mL·h；药时曲线下面积（0-∞）分别为（517.74 ± 169.79）、（489.47 ± 162.13）ng/mL·h。试验制剂与参比制剂的生物等效性结果为104.7%，其90%置信区间为（98.4%，111.4%）。结论 盐酸多奈哌齐口腔崩解片与普通片生物等效。
目的 研究高效液相色谱-质谱联用法（HPLC-MS/MS）测定血浆中二亚油酰磷脂酰胆碱（DLPC）浓度测定的方法。 方法 2010年11月－2011年1月，7例受试者，3例服用多烯磷脂酰胆碱软胶囊（试验制剂），3例服用多烯磷脂酰胆碱胶囊（参比制剂），1例未服药；采集服药者血浆，对各种检测方法、样品预处理条件进行考核；用建立的方法对6例服药者和1例未服药者血浆DLPC浓度进行测定。 结果 最终建立的方法为：采用API 3000型HPLC-MS/MS液质联用系统，多反应离子检测模式，正离子扫描，大气压化学电离源，色谱柱为Ultimate CN分析柱（50.0 mm × 4.6 mm，5 ?m），流动相为甲醇︰水︰甲酸（80︰20︰0.05，V/V/V），流速为0.5 mL/min，格列齐特作为内标。受试者口服多烯磷脂酰胆碱软胶囊试验制剂与参比制剂后，DLPC血浆浓度水平均未见明显的变化规律。未服药者血浆DLPC浓度也有较高浓度水平。 结论 所建立的HPLC-MS/MS法，未能用于多烯磷脂酰胆碱软胶囊生物等效性评价。
目的 采用高效液相色谱法测定受试者口服埃索美拉唑肠溶胶囊与埃索美拉唑镁肠溶片后血药浓度，评价埃索美拉唑肠溶胶囊的生物等效性。 方法 2009年9月－10月，36例健康男性受试者单次交叉口服埃索美拉唑肠溶胶囊（试验制剂）和埃索美拉唑镁肠溶片（参比制剂），测定给药后不同时间点血浆中埃索美拉唑经时血药浓度，采用DAS 2.0软件进行药物代谢动力学参数计算和生物等效性评价。 结果 受试者单次口服试验制剂与参比制剂后，达峰时间分别为（2.19 ± 0.96）、（2.43 ± 0.92） h，峰浓度分别为（1 748.86 ± 615.81）、（1 442.92 ± 476.41） μg/L，药时曲线下面积（AUC）0-t分别为（3 927.14 ± 1 839.10）、（3 878.79 ± 1 734.84） μg/L·h，AUC0-∞分别为（3 998.36 ± 1 866.22）、（3 918.31 ± 1 773.44） μg/L·h。试验制剂与参比制剂的生物等效性为94.0%，其90%CI为（82.3%，107.2%）。 结论 埃索美拉唑肠溶胶囊与埃索美拉唑镁肠溶片生物等效。
目的 采用高效液相色谱-质谱联用法（HPLC-MS/MS）研究普罗布考片的人体药物代谢动力学变化规律。 方法 2010年10月－11月，24例健康男性受试者单次口服普罗布考片0.5 g，采用HPLC-MS/MS法测定给药后不同时间点血浆中普罗布考的经时血药浓度，采用DAS 2.0软件进行药动学参数计算。 结果 受试者单次口服普罗布考片，达峰时间为（11.50 ± 6.66）h，峰浓度为（2 894.72 ± 1 320.53）ng/mL，药-时曲线下面积（AUC）0-t为（238 876.96 ± 131 873.67） ng/mL· h，AUC0-∞为（259 989.08 ± 146 112.88）ng/mL· h，半衰期为（278.52 ± 164.72） h。结论 普罗布考片体内过程符合二室模型，单次口服具有较好的安全性。
【摘要】 目的 评价麻敏维C缓释胶囊（每粒含盐酸伪麻黄碱90 mg和马来酸氯苯那敏4 mg）在人体的生物等效性。 方法 于2006年6月采用随机交叉自身前后对照试验设计，26例受试者分别单次和多次空腹口服麻敏维C缓释胶囊（试验制剂）和复方盐酸伪麻黄碱缓释胶囊（参比制剂），与不同时间点取血样，采用液-质联用（HPLC/MS）法测定人血浆中盐酸伪麻黄碱和马来酸氯苯那敏的浓度，以DAS软件计算药物代谢动力学参数，并进行生物等效性评价。 结果 单次给药后，两组分的主要药物代谢动力学参数无统计学意义（Pgt;0.05）。试验制剂中马来酸氯苯那敏和盐酸伪麻黄碱生物利用度分别为104.31%和109.19%。多次给药后，两组分的主要药物代谢动力学参数无统计学意义（Pgt;0.05）。试验制剂的马来酸氯苯那敏和盐酸伪麻黄碱的生物利用度分别为103.58%和99.37%。 结论 麻敏维C缓释胶囊和复方盐酸伪麻黄碱缓释胶囊具有生物等效性。【Abstract】 Objective To investigate the bioequivalence of delayed-release capsule of ephedrine-chlorphenamine-vitamin C. Methods In June 2006, 26 healthy volunteers were administrated with delayed-release capsule of ephedrine-chlorphenamine-vitamin C or delayed-release capsule of ephedrine-chlorphenamine in a randomized and two-way crossover design with single or multiple dosage. The plasma concentrations were determined by HPLC/MS method. The pharmacokinetic parameters and bioequivalence were calculated by DAS software. Results After single dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 104.31% in chlorphenamine and 109.19% in ephedrine, respectively. After multiple dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 103.58% in chlorphenamine and 99.37% in ephedrine, respectively. Conclusion Delayed-release capsule of ephedrine-chlophenamine-vitamin C is equivalent to the reference preparation.