酪酸梭菌活菌散与制霉菌素片联用治疗婴幼儿鹅口疮的疗效观察

目的观察和评价酪酸梭菌活菌散与制霉菌素片联用治疗婴幼儿鹅口疮的临床疗效。方法将97例鹅口疮患儿随机分为观察组和对照组,观察组47例,在涂抹制霉菌素片的基础上服用酪酸梭菌活菌散,0.5g/次,3次/d,疗程28 d,对照组50例,单独制霉菌素片,观察复发率和不良反应。结果观察组的总复发率为8.5%,显著低于对照组的30%(P<0.05)。结论酪酸梭菌活菌散与制霉菌素片联用治疗婴幼儿鹅口疮预防复发疗效显著,且未见不良反应,值得临床推广应用。     

苯磺酸左旋氨氯地平在治疗老年轻中度高血压中的作用

目的:观察探讨苯磺酸左旋氨氯地平治疗老年轻中度高血压患者的临床疗效和安全性。方法:160例老年轻中度高血压患者随机分为研究组与对照组,研究组给予苯磺酸左旋氨氯地平;对照组给予苯磺酸氨氯地平,治疗过程中进行24h血压监测,总治疗8周为一疗程。结果:研究组4周末和8周末的总有效率分别为78.75%和96.25%,显著高于对照组的53.75%和86.25%,差异有统计学意义(P<0.05)。治疗前后两组的舒张压和收缩压均有明显降低,其中研究组收缩压平均下降(29.0±3.2)mmHg,舒张压平均下降(15.3±2.3)mmHg,对照组则分别下降(18.5±2.8)mmHg和(9.0±2.5)mmHg,差异具有统计学意义(P<0.05)。治疗8周末的24h、白昼和夜间的收缩压和舒张压均有明显降低,差异有统计学意义(P<0.05),但治疗组下降更明显,与对照组比较差异有统计学意义(P<0.05)。治疗后两组的脉压均有明显降低,差异具有统计学意义(P<0.05),但研究组下降更明显。结论:苯磺酸左旋氨氯地平治疗老年轻中度高血压临床疗效好,不良反应少,且对心脏具有保护功能。     

Micellar‐based spectrofluorimetric method for the selective determination of ledipasvir in the presence of sofosbuvir: application to dosage forms and human plasma

A fast, low‐cost, sensitive, and selective spectrofluorimetric method for the determination of ledipasvir was developed and validated. The method is based on an enhancement in the native fluorescence intensity of ledipasvir by 500% of its original value by the formation of hydrogen bonds between the cited drug and Tween‐20 in the micellar system (pH = 5.0). All fluorescence measurements were carried out at 425 nm and 340 nm for emission and excitation wavelengths, respectively. A linear relationship between the concentration of ledipasvir and the observed fluorescence intensity was achieved in the range of 0.1–2.0 μg ml^?1 with 0.028, 0.084 μg ml^?1, for detection and quantitation limits, respectively. The acquired selectivity and sensitivity using the proposed method facilitate the analysis of ledipasvir in spiked human plasma with sufficient percentage recovery (95.36–99.30%). The proposed method was developed and validated according to International Council for Harmonisation (ICH) guidelines. Moreover, the cited drug was successfully determined in its pharmaceutical dosage form using the proposed method. In addition, the validity of the proposed results was statistically confirmed using Student's t‐test, variance ratio F‐test, and interval hypothesis test.     

Validated spectrofluorimetric determination of two pharmaceutical antihypertensive mixtures containing amlodipine besylate together with either candesartan cilexetil or telmisartan

Amlodipine besylate (AML) is available in fixed‐dose combination tablets with either candesartan cilexetil (CAN) or telmisartan (TEL). This work describes a simple, selective and sensitive spectrofluorimetric method for analysis of AML/CAN and AML/TEL binary mixtures without prior separation. The method involves measurement of the native fluorescence of AML at excitation and emission wavelengths of 367 and 454 nm, respectively, in water without interference from either of the two drugs. By contrast, the intrinsic fluorescence of CAN was measured at excitation and emission wavelengths of 265 and 392 nm, respectively, in ethanol, while TEL was measured at 366 nm in 0.05 M sodium hydroxide solution using 294 nm as the excitation wavelength. The proposed spectrofluorimetric procedure was validated with respect to linearity, ranges, precision, accuracy, selectivity, robustness, detection and quantification limits. Regression analysis showed a good correlation between fluorescence intensity and concentration over the ranges 0.1–1.4, 0.025–0.25 and 0.0025–0.05 µg/mL for AML, CAN and TEL, respectively. Limits of detection were 0.034, 0.0063 and 0.0007 µg/mL for AML, CAN and TEL, respectively. The proposed method was successfully applied for the analysis of several synthetic binary mixtures of different ratios and laboratory‐prepared tablets with good recoveries, and no interference from common pharmaceutical additives was observed. Copyright © 2014 John Wiley & Sons, Ltd.     

坦洛辛缓释片治疗混合痔切除术后尿潴留的疗效观察

目的探讨坦洛辛缓释片对混合痔切除术后尿潴留的预防效果。方法将102例混合痔患者随机分为观察组和对照组,两组患者均接受硬膜外麻醉下混合痔外剥内扎术。观察组于术后30min口服坦洛辛缓释片0.2mg,对照组术前、术后均未使用坦洛辛缓释片和其他预防尿潴留的药物,比较两组麻醉时间、术后第1次排尿时间、第1次排尿伴随症状和尿潴留发生情况。结果观察组第1次排尿时间短于对照组,第1次排尿伴随症状、尿潴留发生率低于对照组,差异均具有统计学意义(P0.05)。结论坦洛辛缓释片在缩短第1次排尿时间和减少第1次排尿伴随症状、尿潴留发生率有一定疗效。     

孟鲁斯特钠咀嚼片在健康人体内药动学和生物等效性

目的:研究两种(仿制新药与市售)孟鲁司特钠咀嚼片在人体内生物等效性。方法:采用单中心、随机、开放、双周期自身交叉试验设计,20名健康男性志愿者分2周期分别口服受试制剂和参比制剂各10 mg,HPLC法测定血浆中孟鲁司特钠咀嚼片的浓度,用DAS2.1.1软件计算人体药动学参数并进行生物等效性评价。结果:受试制剂和参比制剂两药的主要药代动力学参数AUC0-t分别为(17.94±6.19)μg h/ml和(17.37±4.73)μg h/ml,AUC0-∞分别为(18.26±6.16)μg h/ml和(17.64±4.66)μg h/ml,Cmax分别为(5.58±1.95)μg/ml和(5.54±1.65)μg/ml,Tmax分别为(2.03±0.97)h和(1.93±0.69)h,t1/2分别为(1.20±0.17)h和(1.19±0.13)h。受试制剂的平均相对生物利用度为(101.5±6.56)%。结论:受试制剂和参比制剂具有生物等效性。     

合欢解郁汤联合草酸艾司西酞普兰片治疗老年抑郁症患者疗效及对hs-CRP影响

摘要 目的：探究合欢解郁汤联合草酸艾司西酞普兰片在治疗老年抑郁症患者中的疗效,并分析治疗对患者超敏C反应蛋白（hs-CRP）水平的影响。方法：选择2021年2月至2022年1月在我院接受治疗的80例老年抑郁症患者为研究对象,将其均分为实验组与对照组（各40例）,对照组患者接受常规草酸艾司西酞普兰片治疗,实验组患者在对照组基础上加用合欢解郁汤治疗,对比两组患者治疗效果,治疗前后汉密尔顿抑郁量表（HAMD）、匹兹堡睡眠质量指数（PSQI）、自杀意念自评量表（SIOSS）、白细胞介素-6（IL-6）、hs-CRP水平,并记录对比两组患者治疗中不良反应发生率。结果：（1）实验组患者治疗有效率为97.50 %,对照组为85.00 %,两组比较差异明显（P<0.05）;（2）治疗前两组患者HAMD及PSQI评分差异不大,治疗后实验组患者上述量表评分均低于对照组（P<0.05）;（3）治疗前两组患者SIOSS量表各维度评分差异不大（P>0.05）,治疗后实验组患者绝望因子、乐观因子、睡眠因子和掩饰因子得分均低于对照组（P<0.05）;（4）治疗前两组患者IL-6和hs-CRP水平差异不大（P>0.05）,治疗后实验组IL-6和hs-CRP水平均低于对照组（P<0.05）;（5）两组患者不良反应发生率差异不大（P>0.05）。结论：合欢解郁汤联合草酸艾司西酞普兰片对老年抑郁症具有较好疗效,能改善抑郁症状,降低其自杀风险以及炎症因子水平,同时治疗安全性较高。     

Preparation and Evaluation of Self-nanoemulsifying Tablets of Carvedilol

The purpose of this study was to combine the advantages of self-nanoemulsifying drug delivery systems and tablets as a conventional dosage form emphasizing the excipients’ effect on the development of a new dosage form. Systems composed of HCO-40, Transcutol® HP, and medium-chain triglyceride were prepared. Essential properties of the prepared systems regarding carvedilol solubility, a model drug, and self-emulsification time were determined. In order to optimize self-nanoemulsifying drug delivery systems (SNEDDS), formulation dispersion–drug precipitation test was performed in the absence and presence of cellulosic polymers. Furthermore, SNEDDS was loaded onto liquisolid powders. P-glycoprotein (P-gp) activity of the selected SNEDDS was tested using HCT-116 cells. Carvedilol showed acceptable solubility in the selected excipients. It also demonstrated improvement in the stability upon dilution with aqueous media in the presence of cellulosic polymers. Use of granulated silicon dioxide improved the physical properties of liquisolid powders containing SNEDDS. It improved the compressibility of the selected powders and the tested SNEDDS showed marked P-gp inhibition activity. Prepared self-nanoemulsifying tablet produced acceptable properties of immediate-release dosage forms and expected to increase the bioavailability of carvedilol.