仙茅药材的质量标准研究

目的:建立仙茅药材的质量标准。方法:采集31个不同产地的仙茅、购买11批市售仙茅药材,按2010年版《中国药典》(一部)要求对其中的浸出物、总灰分、酸不溶灰分、水分、重金属、仙茅苷等指标进行分析。结果:不同产地仙茅含量差异较大,以四川、云南的仙茅药材质量最好。市售11批药材中大部分批次的灰分和酸不溶灰分含量均符合药典标准;水溶性浸出物含量以28.0%～35.0%居多;醇溶性浸出物含量以云南、广西的含量最高,达14.66%;醚溶性浸出物含量以1.5%～2.0%居多。6个不同产地批次仙茅药材的重金属砷、铅、汞、铜的含量符合规定,镉的含量则远高于0.3mg·kg-1的标准规定。结论:所建标准可用于仙茅药材质量评价。     

Physico-chemical characterisation of PLGA nanoparticles after freeze-drying and storage

Nanoparticles represent promising carriers for controlled drug delivery. Particle size and size distribution of the particles are important parameters for the in vivo behaviour after intravenous injection and have to be characterised precisely. In the present study, the influence of lyophilisation on the storage stability of poly(d,l lactic-co-glycolic acid) (PLGA) nanoparticles, formulated with several cryoprotective agents, was evaluated. Nanoparticles were prepared by a high pressure solvent evaporation method and freeze-dried in the presence of 1%, 2%, and 3% (m/v) sucrose, trehalose, and mannitol, respectively. Additionally, to all samples containing 3% of the excipients, l-arginine hydrochloride was added in concentrations of 2.1% or 8.4% (m/V). Dynamic light scattering (DLS), analytical ultracentrifugation and transmission electron microscopy (TEM) were used for particle characterisation before and after freeze-drying and subsequent reconstitution. In addition, glass transition temperatures were determined by differential scanning calorimetry (DSC), and the residual moisture of the lyophilisates was analysed by Karl Fischer titration. It was demonstrated that 1% sucrose or 2% trehalose were suitable to maintain particle integrity after reconstitution of lyophilised PLGA nanoparticles. The storage stability study over 3 months showed notable changes in mean particle size, size distribution, and residual moisture content, depending on the composition of the formulation.     

An experimental set-up to test heatmoisture exchangers

Objectives The purpose of this study was to build an experimental set-up to assess continuously the humidification, heating and resistance properties of heat-moisture exchangers (HMEs) under clinical conditions.Design The experimental set-up consists of a patient model, measurement systems and a ventilator.Setting Surgical ICU, University Hospital of Rotterdam.Materials A clinically used HME.Measurements and results The air flow, pressure in the ventilation circuit, pressure difference over the HME, and partial water vapour pressure and temperature at each side of the HME were measured. The resistance, absolute humidity, humidification efficiency and temperature difference at the patient side of the HME were calculated. Measurements were performed during 24h. The temperature output, humidity output and lung mechanics of the patient model were similar to values found in mechanically ventilated patients The measurement system was in agreement with the ISO draft standard and was capable of measuring dynamic variation of water and heat exchange over the range of a clinically used ventilator setting.Conclusion The experimental setup described is reliable for evaluating HMEs and can also be used for future clinical evaluation of HMEs. The main advantages of this set-up over those described previously are: (i) measurements of dynamic variations of water and heat exchange; (ii) on-line measurements of expiratory, as well as inspiratory resistance.     

聚乙烯醇水凝胶含水率影响因素的初步研究

目的：研究影响聚乙烯醇（PVA）水凝胶含水率的相关因素。方法：将冷冻干燥后的PVA水凝胶浸泡于模拟体液（SBF）中再溶胀,观察不同分子量,不同循环次数,不同浓度PVA水凝胶随时间的再溶胀规律。结果：以PVA水凝胶的含水率为评价指标,在其他因素相同的条件下：不同分子量水凝胶的含水率：高分子量组＞中分子量组＞低分子量组,差异有显著性（P＜0．05）;冷冻循环1次的PVA水凝胶含水率47％,冷冻循环3次、5次、7次组含水率均大于80％,3组间无显著性差异（P＞0．05）;不同浓度PVA水凝胶的含水率测试结果为：10 wt％组＞15 wt％组＞20 wt％组＞25 wt％组,差异有显著性（P＜0．05）。结论：在本实验条件下,分子量高的PVA水凝胶的含水率较高,PVA浓度高的PVA水凝胶的含水率较低,经3～7次冷冻循环的PVA水凝胶具有高含水率。     

鼠曲草TLC鉴别及质量检查项目研究

目的建立简单快捷的鼠曲草药材质量控制方法和标准。方法通过对3个不同产地的鼠曲草药材进行TLC鉴别、水溶性浸出物、醇溶性浸出物、水分以及灰分测定的研究,建立其质量控制标准。结果确定了鼠曲草TLC鉴别、水分、灰分和水溶性浸出物、醇溶性浸出物的测定方法,制定了其质量控制标准。结论研究结果表明本研究制定的鼠曲草药材质量控制标准,可为山东省以及其他地区使用和检验提供依据。     

湿润疗法治疗63例老年病人褥疮的临床体会

目的：总结湿润疗法治疗老年病人并发褥疮的临床经验。方法：对1994年以来老年病人并发褥疮的临床资料进行回顾性调查分析。调查内容包括原发病、褥疮患病病史、创面个数、分布部位、褥疮分期、治疗方法及愈合情况等。结果：一、二期褥疮14例21个创面，治疗3周愈合；其余49例病人的121个创面中，属于三期创面73个，最长愈合时间75d；48个四期创面于150d愈合，未行植皮手术治疗。     

Factors affecting the measurement of bone impedance

Factors which affect the measurement of the electrical properties of bone were examined. Environmental conditions such as the pH of the preserving solution and time of exposure of the sample to air, which controls the moisture content of the specimen, significantly affected the bone impedance. A change in pH of ×2 from the neutral solution (pH=7) caused a change in the resistance R. conductance β and capacitance C values of 70 per cent, 125 per cent and 190 per cent respectively. A 5 min exposure to air increased the resistance by 92 per cent and reduced the capacitance by 35 per cent of their original values. A loss of 8 per cent moisture content by weight resulted in 400 per cent increase in R and 65 per cent decrease in C. Significant errors were introduced in the measurement of bone impedance owing to stray and wiring capacitances; these were avoided by using a differential impedance measurement technique. Further, it is shown that it is essential to measure the phase angle while measuring the bone impedance. Finally, it is illustrated that when normalising for different sized bone specimens, both the resistive component and capacitive component have to be considered while computing the impedance per unit volume.     

润口液药理作用及刺激性的研究

润口液是一种用于解除生理性、病理性口干的制剂。实验研究结果表明，润口液具有促进唾液分泌，保持口腔湿润的功能，并且无毒、无刺激性。     

Evaluation of a novel sugar coating method for moisture protective tablets

A novel method of manufacturing one-step dry-coated (OSDRC) tablets, which we recently invented, was used to produce sugar-coated tablets protected from moisture without the need for a conventional complicated sugar coating process. Amorphous sucrose was selected for the outer layer of the OSDRC tablets as sugar-coated layer. The isothermal crystallization behavior and characteristics such as water vapor permeability, tensile strength, and disintegration time of compressed amorphous sucrose were investigated. Water vapor adsorption measurements showed the crystallization behavior of amorphous tablets to be similar to that of amorphous powder, although it was affected by compression pressure. We found that the crystallized amorphous sucrose after compression at 200 MPa was moisture protective, and the water vapor permeability coefficient was decreased to 1/2000 or less compared with a tablet prepared with a lactose-microcrystalline cellulose (MCC) mixture, hydroxypropylmethylcellulose (HPMC), and sucrose crystal. The water vapor permeability and physicochemical characteristics were influenced by the amorphous content or additive content. It was confirmed that a new sugar-coated tablet using amorphous sucrose and OSDRC technology was moisture protective, therefore, it was concluded that the novel sugar coating method was very useful to obtain a moisture protective tablet.     

Hyphenation of Raman spectroscopy with gravimetric analysis to interrogate water-solid interactions in pharmaceutical systems

A moisture sorption gravimetric analyzer has been combined with a Raman spectrometer to better understand the various modes of water-solid interactions relevant to pharmaceutical systems. A commercial automated moisture sorption balance was modified to allow non-contact monitoring of the sample properties by interfacing a Raman probe with the sample holder. This hybrid instrument allows for gravimetric and spectroscopic changes to be monitored simultaneously. The utility of this instrument was demonstrated by investigating different types of water-solid interactions including stoichiometric and non-stoichiometric hydrate formation, deliquescence, amorphous-crystalline transformation, and capillary condensation. In each of the model systems, sulfaguanidine, cromolyn sodium, ranitidine HCl, amorphous sucrose and silica gel, spectroscopic changes were observed during the time course of the moisture sorption profile. Analysis of spectroscopic data provided information about the origin of the observed changes in moisture content as a function of relative humidity. Furthermore, multivariate data analysis techniques were employed as a means of processing the spectroscopic data. Principle components analysis was found to be useful to aid in data processing, handling and interpretation of the spectral changes that occurred during the time course of the moisture sorption profile.