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.     

Endodontic treatment of a hypertaurodontic mandibular left second molar in a patient with many taurodonts combined with multiple pulp stones

Taurodontism is a rare embryologic anomaly of teeth, defined by an apical displacement of the furcation of roots and enlarged pulp chambers. Taurodontism has been classified as hypo‐, meso‐ or hypertaurodontism according to the severity of the anomaly. The aim of this case report was to illustrate a clinical case with multiple bilateral taurodonts and to describe the endodontic management of the hypertaurodontic mandibular left second molar with a C‐shaped canal and extensive dental pulp calcifications. A healthy 20‐year‐old male patient was referred for the endodontic treatment of his lower left second molar. Cone beam computed tomography revealed a C‐shaped root canal configuration and several dental pulp calcifications in this tooth. The endodontic treatment was performed in two appointments under an operating dental microscope. A panoramic radiograph, made during the 18 months follow‐up appointment, revealed nine other taurodontic molars, most of them associated with dental pulp calcifications.     

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。     

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。     

Human parotid proline-rich proteins: correlation of genetic polymorphisms to dental caries

Parotid saliva contains a variety of proline-rich proteins. This study found that, among 306 children between the ages of 5 to 15 years, there is a significant increase in the decayed-missing-filled tooth surface (DMFS) score of the permanent teeth with age in children with the specific proline-rich protein phenotypes Pa and Pr. However, the increase in DMFS score of the permanent teeth of children was significantly greater in children with Pa+ and Pr22 than in those with the other phenotypes (Pa- or Pr11 and Pr12). The previously established close correlation between the Pa and Pr phenotypes and the genetic variants of salivary peroxidase (a powerful antibacterial system in the oral cavity) may provide an explanation for the relationship of certain proline-rich protein phenotypes to dental caries.     

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     

Treatment time analysis for extensive amalgam restorations

The treatment times for the fabrication of Extensive Amalgam Restorations (EAR) as recorded in a longitudinal clinical trial at the Dental School in Nijmegen were analyzed. 269 EAR's with different retention methods were made on molars by three operators. A mean total treatment time of 60 min was found. The factor operator had a significant influence on all treatment phases resulting in a 26% difference in total treatment time between operators. Also significant influences were found in some treatment phases for the factor retention, side location of the tooth and extension of the restoration. The results of this study with regard to treatment times must be considered from the perspective of the quality of the care provided.     

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。