A Proposal for an Alternative Approach to Particle Size Method Development During Early-Stage Small Molecule Pharmaceutical Development

Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation conforms to the true value. Defining a “true” value for the size of a particle can be challenging as the output of its measurement will differ because of variations in measurement approaches, instrumental differences and calculation methods. Consequently, for “real” particles, a universal “true” value does not exist and accuracy is therefore not a definable characteristic. Accordingly, precision is then a measure of the ability to reproducibly achieve a measurement of unknown relevance.This article proposes, in place of accuracy, a means to define the “appropriateness” of a measurement in line with the critical quality attributes (CQA) of the material being characterized. The decision as to whether the measurement is correct should involve a link to the CQA; that is, correlation should be demonstrated, without which the measured particle size cannot be defined as a critical material attribute.Correspondingly, methods should also be able to provide sufficient precision to demonstrate discrimination relating to variation in the CQA. The benefits and challenges of this approach are discussed.     

脂蛋白残粒RLP-c检测的临床意义

目的 探讨脂蛋白残粒RLP-c作为新的脂质指标的临床意义。方法 采用免疫分离法测定正常对照组(NC)、冠心病组(CHD)和2型糖尿病组(T2DM)的RLP-c水平,并比较RLP-c与其他脂质指标的相关性。结果 CHD组和T2DM组RLP-c水平明显高于NC组(P<0.01),其水平与甘油三脂(TG)和极低密度脂蛋白胆固醇(VLDL-c)高度相关(P<0.01)。结论 RLP-c可用于对动脉粥样硬化的危险性评估。     

咀嚼槟榔习惯与牙体磨损关系的临床研究

目的 :探讨长期咀嚼槟榔与牙体磨损的关系。方法 :对长期咀嚼槟榔的 6 4例患者的咀嚼槟榔时间、频率及其牙体牙合面磨损、曲面体层片进行分析。结果 :所有患者后牙牙合面出现不同程度的磨损 ,且咀嚼槟榔时间越长 ,牙合面磨损越严重 (P <0 .0 1) ;咀嚼频率越高 ,牙合面磨损加重 (P <0 .0 1) ,磨损严重者可伴根尖周炎症及牙槽骨不同程度吸收。结论 :长期咀嚼槟榔可导致牙体牙合面不同程度磨损。     

静脉输液加药后的微粒变化

本文对我院急诊病人常用的供静脉给药的22种药物、42组配伍情况,制成静脉加药输液,在超净工作台条件下,用KF—4型微粒计数器,测定了168次微粒数,结果显示输液加药后微粒虽有增加,但均在药典规定范围内。输液中加1种、2种、3种药物后所产生的微粒数分别为x_1=5.52(n_1=16);x_2=8.17(n_2=18)、x_3=10.25(n_3=8),经统计处理,三组间无显著差异(P<0.05)。本文对产生微粒的药物、注射器、操作环境等因素进行了分析。     

无皂乳液聚合法合成均一性聚苯乙烯微球

研究了聚苯乙烯微球的合成过程中，离子强度、聚合时间对粒径的影响及其稳定性，实验结果表明：适当改变离子强度、聚合时间可以得到不同粒径的聚苯乙烯微球，且粒子稳定性较好。     

高频等离子体化学气相淀积法制备TiO2超细粒子

利用ＴｉＣｌ４＋Ｏ２体系，在高频等离子体化学气相淀积反应器中合成了纯度高、粒度细的ＴｉＯ２粒子。考察了工艺条件对ＴｉＯ２粒子物性的影响；探讨了ＴｉＯ２粒子晶型控制的方法，金红石型质量分数可通过工艺条件控制；探讨了ＴｉＯ２粒子晶型控制的方法。金红石型质量分数可通过工艺条件控制，减少ＴｉＯ２单体浓度可提高金红石型质量分数；也可通过在原料ＴｉＣｌ４中添加ＡｌＣｌ３等晶型转化剂，使可转化为单一金红石型Ｔｉ     

Characteristic modifications of the breathing pattern of mice to evaluate the effects of airborne chemicals on the respiratory tract

A system was developed for exposure of unanesthetized mice to airborne chemicals and for continuous measurement of their breathing pattern prior to, during and following exposure. By measuring inspiratory and expiratory airflows (VI and VE), and integration with time to yield tidal volume (VT), we obtained characteristic modifications to the normal breathing pattern. These permitted recognition that a specific portion of the respiratory tract was affected by the selected airborne chemicals. Following recognition, we also quantitated the degree of effect using one specific measurement in each case. An effect on the upper respiratory tract, induced by the sensory irritant, 2-chlorobenzylchloride, was quantitated by measuring a decrease in respiratory frequency. An effect on the conducting airways, induced by the airway constrictor, carbamylcholine, was quantitated by a decrease in VE at the mid-point of VT. An effect at the alveolar level, induced either by the vagal nerve ending stimulant, propranolol, or by the pulmonary irritant, machining fluid G, was quantitated by an increase in the length of a pause induced at the end of expiration. The system is easy to construct and operate and can be used to rapidly evaluate the effects of airborne chemicals on the respiratory tract.     

湿性皮肤再生技术在皮肤擦伤的应用

目的:探导湿性皮肤再生技术治疗皮肤擦伤的疗效。方法:自2000年1月-2005年10月,治疗头面部、躯干和四肢急性皮肤擦伤共353例,其中采用湿润烧伤膏和暴露疗法治疗(新法组)185例,按传统疗法清创治疗(传统组)168例。结果:新法组7天内痊愈116例,占62．7％;14天内痊愈59例,占3713％;总有效率100％。传统组7天内痊愈82例,占48．8％;14天内痊愈58例,占34．5％;另外28例,占16．7％,发生不同程度的创面感染,痂下积脓,需作再次清创,碘伏湿敷或改用MEBO治疗,创面延期愈合,愈后瘢痕增生明显。结论:湿润烧伤膏和暴露疗法治疗皮肤擦伤与传统疗法比较,具有缩短创面愈合时间,愈后不留瘢痕等优点。     

接枝环氧树脂水分散液的合成、分离与表征

控制不同的反应条件,采用甲基丙烯酸、苯乙烯与环氧树脂在丙二醇丁醚/正丁醇溶剂中接枝共聚,合成了粒径在87～104nm范围的环氧树脂水分散液。通过环己烷/乙醇和丙酮两步萃取,对接枝共聚产物进行分离,用FTIR表征,并估算了接枝共聚物的组成。实验结果表明,所制备的粒径为纳米级的环氧树脂水分散液,具有良好的机械稳定性、冻融稳定性及贮存稳定性。ξ电位测定表明,产物在pH>8的条件下更为稳定。     

棉织布与无纺布尘埃粒子数及抗渗液性能比较研究

目的比较棉织布与无纺布制作的手术衣和手术洞巾等在手术铺巾时空气中的尘埃粒子数及术中抗渗液性能，为有效控制外科切口感染和预防医患交叉感染提供参考。方法将棉织布与无纺布制作的手术布类各备15包，包内内容均相同，经灭菌处理。应用尘埃粒子计数仪测定两组铺巾时、铺巾后及收巾时空气中的尘埃粒子数，同时在手术过程中观察其抗渗液性能。结果无纺布组在铺巾时、铺巾后及收巾时产生的尘埃粒子数显著少于棉织布组（P〈0．05，P〈0．01）；其抗渗液率为100％，而棉织布组为0。结论无纺布抗渗液性能优，可减少手术环境中的尘埃粒子数，从而控制外科切口感染；其阻隔防护效能对患者和医护人员具有双重保护作用。