Using online content uniformity measurements for rapid automated process development exemplified via an X-ray system

This paper addresses the relevance of automated content testing for the rapid automated process development (RAPD). Our previous work demonstrated that RAPD allowed a fast and efficient development of a continuous capsule-filling process. Target was the mean weight and the relative standard deviation of the weight. Likewise important are the content and the content uniformity. However, an implementation demands a certain level of automation. In general, technology is available that can detect active pharmaceutical ingredient (API) inside the capsules but the final application is linked to additional development and investment in machinery. To eliminate doubts regarding the benefits of an automated content check within the RAPD we present an application example. First, an X-ray system was used to detect barium sulfate accurately inside capsules. Second, a process was developed where barium sulfate was filled. The concentration of excipients was modified in the experiments, as well as the setting of the process parameter. The obtained model provided an explicit understanding of the process. Subsequently, the content uniformity model was compared to a model of the capsule weight relative standard deviation, confirming the benefits of an automated content check in the RAPD. Moreover, we presented another example illustrating the advantages of a connected continuous filling process, which permits evaluation of all process steps and their interactions (i.e. evaluation of the entire process).     

Opioid maintenance treatment: trajectories in and out of treatment

Problem: Although efficacy studies of opioid maintenance treatment (OMT) have shown evidence of treatment benefits, there is still need for studies on its effectiveness in natural clinical processes. This study investigates the development in health, substance use and social conditions of those who applied for OMT, including those denied access or discharged.

Method: First, persons assessed for admittance in 2005–2011 (n?=?127) were categorized into four trajectory groups based on whether they were admitted or denied (n?=?19), discharged (n?=?31), readmitted (n?=?21) or had been undergoing OMT without interruption (n?=?56). Second, 99 of these, the analytical sample, were interviewed at follow-up using (a) the Addiction Severity Index (ASI) for seven problem-areas and housing, and (b) self-rated change in 11 problem areas. The ASI was compared to baseline interviews after 55 months (mean). Third, outcomes within groups was studied in relation to alternative interventions.

Results: Within the analytical sample, those denied OMT showed no improvements at group level, those discharged had some improvements, more if readmitted than if not and those with uninterrupted OMT showed the most comprehensive improvements. Those outside OMT, denied and discharged, had considerable mortality risks related to ongoing drug use, especially in lack of well-planned alternative interventions.

Conclusion: Improvements strongly relate to access to OMT. This study underscores that access to OMT improves the situation in all areas investigated and decreases the risk for drug-related death. It underscores the importance of two major risk situations, i.e. being denied OMT and being discharged.     

基于响应面法优选美洲大蠊口腔原位温敏凝胶的制备研究

目的制备美洲大蠊Periplaneta americana口腔原位温敏凝胶。方法采用自由基聚合法首次以N-异丙基丙烯酰胺(NNIPAM)和甲基丙烯酸羟丙酯(HPMA)合成聚(N-异丙基丙烯酰胺-甲基丙烯酸羟丙酯)[P(NNIPAM-HPMA)]作为温敏材料;通过冷溶法制备美洲大蠊口腔原位温敏凝胶,采用Box-Behnken设计响应面法,以溶蚀时间、胶凝时间为评价指标,在固定美洲大蠊提取物用量基础上,对羟丙基甲基纤维素(HPMC)、聚乙烯吡咯烷酮(PVP K30)、P(NNIPAM-HPMA)的用量进行优选。结果通过原位聚合法合成了P(NNIPAM-HPMA)温敏材料;并用响应面法优选了可用于口腔的美洲大蠊原位温敏凝胶的处方,优选的处方为美洲大蠊提取物10%、HPMC 3.0%、PVP K30 9.5%、P(NNIPAM-HPMA) 10.0%,其溶蚀时间为2 h,胶凝时间8～9 s。结论优选得到美洲大蠊口腔原位温敏凝胶,为美洲大蠊提取物的口腔原位局部的临床应用奠定了科学依据。     

中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

医保投诉的影响因素及方案分析

目的分析医保投诉的影响因素及解决方案。方法选取2016年1月-2016年12月、2018年1月-2018年12月分别为对照阶段、观察阶段,分别采取常规医保管理、常规医保管理联合优化管理方案,在两个阶段内各随机选取医保支付医疗费用的患者3000例,设为对照组及观察组,分析投诉发生情况;在对照组及观察组内各随机选取患者300例,分析不同阶段服务质量。结果观察组投诉率低于对照组(P<0.05);观察组满意度评分高于对照组(P<0.05)。结论了解医保影响因素,并予以对症解决方案,能够降低医保投诉率,提升医院服务质量及患者满意度。     

Dry eye in chronic stroke patients with hemiplegia: A cross-sectional study

ABSTRACT

Objective: Dry eye is reported to be associated with several neurological diseases. The aim of this study is to evaluate the patients with hemiplegia after stroke for dry eye and compare their results with a control group.

Materials and methods: Forty-five patients with hemiplegia and 45 individuals as the control group were included in the study. Tear function tests (Schirmer and tear breakup time) and a dry eye questionnaire for dry eye symptoms (ocular surface disease index) were performed and the results of the two groups were compared.

Results: Schirmer test results were significantly lower in the post-stroke hemiplegia group compared to the control group (11.3 ± 8.2 mm and 20.6 ± 11.6 mm, respectively, p < .001). Tear breakup time results were significantly lower in the post-stroke hemiplegia group compared to the control group (7.9 ± 3.1 s and 12.1 ± 4.3 s, respectively, p < .001). Ocular surface disease index scores were not significantly different between hemiplegia and control groups (21.6 ± 20.0 and 19.8 ± 13.9, respectively, p = .635). Schirmer scores lower than 10 mm (60% and 30%, p < .001) and tear breakup time results lower than 10 s (65.6% and 28.9%, p < .001) were also higher in the hemiplegia group compared to control group.

Conclusion: We found lower Schirmer test and tear breakup time results and similar OSDI scores in hemiplegia patients compared to controls. Hemiplegia patients may have dry eye without typical symptoms. This should be taken into consideration in the follow-up and rehabilitation of post-stroke hemiplegia patients.