Development of a predictive in vitro dissolution for clarithromycin granular suspension based on in vitro-in vivo correlations

The objective of this study was to evaluate the in vitro behavior of different clarithromycin granular suspensions based on a developed in vitro-in vivo correlation model, using one reference and two test formulations. In vitro release rate data were obtained for each product using the USP apparatus II, operated at 50?rpm under different pH conditions. The dissolution efficiency was used to analyze the dissolution data. In vivo study was performed on six healthy male volunteers under fasting condition. Correlation was made between in vitro release and in vivo absorption. A linear model was developed using percent absorbed data versus percent dissolved data from the three products. Dissolution condition of 0.1N HCl for 1?h and then phosphate buffer at pH 6.8 was found to be the most discriminating dissolution method. Rate of absorption for the reference as estimated by Wagner-Nelson deconvolution was correlated with in vitro release with a correlation coefficient of 0.99. The in vivo results for the two test products were compared to the predicted values using the reference model with a correlation coefficient of 0.94. Furthermore, multiple level C correlations were obtained for some pharmacokinetic parameters with the corresponding in vitro kinetic parameters with correlation coefficients exceeding 0.90. Moreover, the interpretation of the in vitro and in vivo data with reference to formulations was discussed.     

出血性胃炎的临床治疗方案分析与疗效观察

目的：探究出血性胃炎的临床治疗方案及效果。方法：将2012年9月至2014年12月期间收治的80例出血性胃炎患者随机分为观察组及对照组，每组40例，对照组给予单纯奥美拉唑治疗，观察组在此基础上运用硫糖铝，比较两组临床疗效、住院治疗时间、复发率。结果：观察组治疗总临床治疗有效率为95.0%，显著高于对照组（77.5%）；观察组患者平均住院治疗时间为（7.13±2.05）d，对照组为（13.25±3.51）d，两组比较差异具有统计学意义（P＜0.05）；观察组复发率为2.5%，对照组为17.5%，差异具有统计学意义（P＜0.05）。结论：采用奥美拉唑联合硫糖铝治疗出血性胃炎，临床治疗效果明显，复发率低，并显著减少患者住院治疗时间，减轻患者负担。     

Observation of the morphology and calcium content of vestibular otoconia in rats after simulated weightlessness

Conclusions

Reduction in bone formation may have been the main reason for the lower calcium content of the otoconia after simulated weightlessness in rats. The head-ward distribution of blood volume may explain the morphological changes observed in the middle and inner ears.

Objective

To observe morphological changes in the vestibular organs and measure the calcium content of otoconia in rats after simulated weightlessness.

Material and methods

We used a tail suspension model of simulated weightlessness and then investigated changes in the vestibular organs using scanning electron microscopy and X-ray microanalysis.

Results

In comparison to untreated rats, the vestibular otoconia of the rats subjected to simulated weightlessness were small, irregularly shaped or fissured, and were arranged loosely and out of order. In addition, the calcium content of the otoconia was markedly decreased.     

悬吊运动训练系统对不随意运动型脑瘫的康复效果分析

目的 分析悬吊运动训练系统对不随意运动型脑瘫的康复效果,为临床治疗提供科学依据。方法 选取2015年8月-2017年8月荆州市妇幼保健院收治的42例不随意运动型脑瘫患儿为研究对象,采用数字随机法均分为观察组与对照组,各21例,对照组患儿接受常规康复治疗,观察组患儿在常规康复治疗基础上运用悬吊运动训练系统,连续康复治疗3个月。采用Berg平衡量表(BBS)、粗大运动功能评分(GMFM)评价两组患儿平衡及粗大运动功能,记录步长、步宽以及10 m最大步行速度(MWS)评价步行能力,并比较不同年龄、粗大运动功能分级系统(GMFCS)分级对步行能力的影响。结果 两组患儿治疗前GMFM 评分、BBS评分差异无统计学意义(P>0.05),治疗后均显著增加,且治疗后观察组均显著高于对照组,差异有统计学意义(t=4.767、3.543,P＜0.01);两组治疗前步行能力相关评分差异无统计学意义(P>0.05),治疗后步宽显著降低,步长、MWS显著增加,且治疗后观察组步长、MWS显著高于对照组,步宽显著低于对照组(t=4.767、3.985、4.221,P＜0.001);治疗后不同年龄及GMFCS分级患儿步宽、步长、MWS比较,差异具有统计学意义(年龄:t=3.986、2.878、2.986,P＜0.001;GMFCS分级:t=4.043、4.173、3.875,P＜0.001)。结论 在常规康复治疗的基础上加用悬吊运动训练系统能提升不随意运动型脑瘫患儿粗大运动及平衡能力,降低步行宽度,提升步速及步长,也能显著提升其康复效果,同时患儿年龄及GMFCS分级影响治疗效果。     

血管内皮生长因子对尾吊大鼠后肢胫骨骨丢失的影响

目的探究血管内皮生长因子(vascular endothelial growth factor,VEGF)对废用性骨丢失的影响。方法建立尾吊大鼠的动物模型,并随机平均分为尾吊盐水组、尾吊VEGF组、对照盐水组、对照VEGF组。实验过程中,每周两次对大鼠右腓肠肌注射VEGF或者等量的生理盐水,4周后通过micro-CT对大鼠胫骨近端进行扫描,以松质骨和皮质骨骨密度(bone mineral density,BMD)、骨体积分数(BV/TV)、骨小梁数量(Tb.N)、骨小梁间距(Tb.Sp)和结构模型指数(SMI)等松质骨微结构参数以及皮质骨厚度作为评价指标,探讨VEGF对尾吊大鼠后肢胫骨骨丢失的影响。结果与对照组大鼠相比,尾吊组大鼠松质骨表观BMD、BV/TV、Tb.N以及皮质骨厚度均显著降低,Tb.Sp与SMI显著升高,尾吊会造成大鼠的骨丢失,而注射VEGF能够缓解尾吊大鼠松质骨的骨丢失。结论血供的改变可能与骨重建之间存在着一定的联系,改善血供有助于对抗废用性的骨丢失。