钛酸四丁酯增韧改性聚乳酸/淀粉共混材料

制备了钛酸四丁酯[Ti(OBu)4]增韧改性的聚乳酸(PLA)/淀粉共混材料,测试了材料的加工流变性能、力学性能、共混形态、结晶性能及疏水性能和降解性能。结果表明:当mTi(OBu)4∶mPLA=0.20时,共混材料的冲击强度提高了40.9%,而弯曲强度下降了59.2%;FT-IR和SEM显示钛酸四丁酯的化学架桥作用增加了共混材料中聚乳酸与淀粉的相容,其吸水率随钛酸四丁酯含量的增加而减少,掩埋150 d后质量下降5%~8%。     

改善莫索尼定片含量均匀度的制备工艺研究

目的　解决小剂量药物莫索尼定片含量均匀度不符合规定的问题。方法　先将PVP、L -HPC、乳糖混合均匀 ,莫索尼定以 60 %乙醇溶解后加入 ,利用苋菜红帮助判断制粒过程是否混合均匀。结果　莫索尼定片含量均匀度符合规定。结论　制备工艺可行     

再论人类专业护理活动的产生

本文尝试以新的理论视角，讨论原始人类活动是人类护理和医疗活动的共同起源、人类护理－医疗活动耦联与融合等问题。阐述人类专业护理活动的产生过程、机制和原因。最后指出专业护理明显地是基于性别文化原则的社会分工的产物。     

An assessment of dose-uniformity of samples delivered from paediatric oral droppers

BACKGROUND AND OBJECTIVES: To assess the accuracy and precision of delivery from containers containing oral drops, both under optimal laboratory conditions and during use by volunteers using a variety of real pharmaceutical products and specially prepared fluids. METHODS: The effects of the physical properties (viscosity, surface tension, fluid density) of fluids and the angle of a dropper upon the accuracy and precision of dispensing were investigated under standard laboratory conditions. Dose delivery was then assessed using a number of volunteers who were either given no instructions on the use of containers or were instructed to hold the droppers vertically. RESULTS: Viscosity, surface tension, fluid density and residual volume had little or no effect upon the volume of liquid delivered by a dropper clamped in the vertical position. However, when the angle of the dropper was moved towards 45 degrees from the vertical, the volume dispensed declined and became more variable to a point where the requirements of the European Pharmacopoeia were no longer fulfilled. This finding applied to a variety of products. When volunteers used the same droppers manually, the mean volumes dispensed were lower than when the droppers were vertically clamped and the variability was greater. It appeared that these problems were associated with volunteers failing to hold the dropper vertically and the precision and accuracy were indeed increased if the volunteers were instructed as to how the dropper should be held. The results from volunteers were more precise and accurate with the most viscous of the fluids tested and it was speculated that this may have been because the volunteers could more easily use the droppers vertically as there was less fear of dispensing too many drops. CONCLUSIONS: The key factor in achieving satisfactory dispensing from droppers is to ensure that the dropper is held vertically and this should form the basis of instructions to patients. Formulators should consider increasing the viscosity of prepared dropper solutions to reduce further errors in dose.     

Development of mini-tablets with 1mm and 2mm diameter

The feasibility of formulating mini-tablets with 1 mm diameter on a rotary-die press in comparison to mini-tablets of 2 mm was investigated. To gain insight into the production of 1 mm mini-tablets, three model drugs of different compression characteristics were chosen, namely quinine hydrochloride, ibuprofen and spray-dried gentian extract. A high drug load in combination with robust and reproducible mechanical properties was requested. Depending on the individual drug substance, mini-tablets were produced by direct compression or after roll-compaction/dry granulation. The tensile strength, mass, and their variation coefficients were determined to assess the mechanical properties of the tablets. The content uniformity and the dissolution behavior of selected batches were analyzed.For the first time 1 mm mini-tablets could be successfully produced by direct compression (90% quinine hydrochloride; 90% dried gentian extract) and after roll compaction (70% ibuprofen). Depending on the applied compression pressure, 1 mm mini-tablets with quinine hydrochloride exhibited robust mechanical properties (e.g. median tensile strength of 2.02 N/mm²) with equal or lower variance of distribution compared to the 2 mm compacts. With respect to content uniformity of dosage forms, 1 mm mini-tablets containing 80% quinine hydrochloride met the requirements of the European Pharmacopeia (AV = 6.8).     

Enteric polymers as acidifiers for the pH-independent sustained delivery of a weakly basic drug salt from coated pellets

Weakly basic drugs and their salts exhibit a decrease in aqueous solubility at higher pH, which can result in pH-dependent or even incomplete release of these drugs from extended release formulations. The objective of this study was to evaluate strategies to set-off the very strong pH-dependent solubility (solubility: 80 mg/ml at pH 2 and 0.02 mg/ml at pH 7.5, factor 4000) of a mesylate salt of weakly basic model drug (pK_a 6.5), in order to obtain pH-independent extended drug release. Three approaches for pH-independent release were investigated: (1) organic acid addition in the core, (2) enteric polymer addition to the extended release coating and (3) an enteric polymer subcoating below the extended release coating. The layering of aspartic acid onto drug cores as well as the coating of drug cores with an ethylcellulose/Eudragit L (enteric polymer) blend were not effective to avoid the formation of the free base at pH 7.5 and thus failed to significantly improve the completeness of the release compared to standard ethylcellulose/hydroxypropyl cellulose (EC/HPC)-coated drug pellets. Interestingly, the incorporation of an enteric polymer layer underneath the EC/HPC coating decreased the free base formation at pH 7.5 and thus resulted in a more complete release of up to 90% of the drug loading over 18 h. The release enhancing effect was attributed to an extended acidification through the enteric polymer layer. Flexible release patterns with approximately pH-independent characteristics were successfully achieved.     

HPLC法测定复方氨酚那敏颗粒中马来酸氯苯那敏含量均匀度

目的:用高效液相色谱法测定复方氨酚那敏颗粒中马来酸氯苯那敏的含量均匀度。方法:采用十八烷基硅烷键合硅胶柱(4.6mm×150mm,5μm),检测波长210nm,乙腈-0.3%十二烷基硫酸钠溶液-磷酸(60:40:0.02)(用三乙胺调节pH值至3.3±0.1)为流动相,流速为1.0ml/ml,进样量20μl,以外标法测定含量。结果:马来酸氯苯那敏在浓度0.01601～0.08005mg/ml范围内线性关系良好,方法的回收率结果良好,平均回收率97.62%,RSD为1.02%。复方氨酚那敏颗粒中马来酸氯苯那敏含量均匀度符合要求。结论:方法准确,重复性好,可用于测定复方氨酚那敏颗粒中马来酸氯苯那敏含量均匀度。     

提高他克莫司胶囊含量均一性的工艺研究

目的研究提高他克莫司胶囊含量均一性的工艺。方法在普通湿法制粒机增设弯管式定位加料系统控制加料位置和流速、选用合适的辅料与工艺参数制得他克莫司胶囊,用HPLC测定含量。结果他克莫司胶囊含量均一性良好,中间体粉末RSD<2.0%,含量均匀度A+1.80S<15,溶出度>85%。结论使用弯管定位加料,选用乳糖G200及合适的工艺参数,制备的他克莫司胶囊含量均一,适合产业化生产。     

Rapid quantitative analysis of magnesium stearate in pharmaceutical powders and solid dosage forms by atomic absorption: Method development and application in product manufacturing

The distribution of magnesium stearate (MgSt) in tablet granule has a significant impact on the compression process. A rapid quantitative method for evaluating magnesium stearate content by atomic absorption was established. The MgSt was extracted from the granule in 0.1 mol/L nitric acid and the resulting free magnesium ion quantitated by atomic absorption. The total analysis time was significantly shortened in comparison to the previously used sample ignition method.