Comparison of assays for determination of peptide content for lyophilized thymalfasin*

Abstract: Precise determination of the peptide content in drug substance samples depends highly upon the particular peptide compound and methodology used. Four independent methods were evaluated and compared to determine which would produce the best experimental precision for analysis of thymalfasin (thymosin α‐1). Four different methods were evaluated including elemental analysis (CHN), quantitative amino acid analysis (AAA), high‐performance liquid chromatography (HPLC), and Kjeldahl. This study demonstrates that the AAA method is highly variable in one laboratory while quite precise in another laboratory. Similarly, HPLC results depended on the laboratory conducting the study with more precise values obtained under cGMP. On the contrary, the CHN method yielded highly precise [i.e. <2% coefficient of variation (CV)] values. As precise knowledge of protein content is fundamental for the compounding of final pharmaceutical product of a specific potency, the CHN analysis is recommended for peptide content determination of the drug substance thymalfasin.     

The current role of photodynamic therapy in oesophageal dysplasia and cancer

Over the last 15 years photodynamic therapy (PDT) has become a viable treatment for pre-malignant and malignant disease of the oesophagus. Its initial use was in the palliation of oesophageal malignant obstruction bringing improved swallowing hence increasing nutritional intake and improving general quality of life. As the therapeutic boundaries of PDT have stretched, current studies look at the role of PDT in the treatment of pre-malignant dysplastic Barrett's epithelium and early malignancy as a curative mucosal ablative technique. As a curative treatment in early oesophageal cancer, PDT provides an alternative treatment to oesophagectomy for those more elderly or less medically fit patients.This paper reviews the uses of photodynamic therapy in oesophageal cancer with reference to the available publications on its use in the palliation of oesophageal cancer and treatment of early cancer and high grade dysplasia in Barrett's mucosa.     

Influence of moderate hypothermia on cerebral oxygenation in pigs with intracranial hypertension

BACKGROUND: Moderate hypothermia is one of the effective therapeutic methods for head injury in recent years, there are many mechanisms of moderate hypothermia for brain protection, and its influence on cerebral oxygenation is also one of them. OBJECTIVE: To observe the influence of moderate hypothermia on cerebral oxygenation of animals with acute intracranial hypertension, and further investigate the protective mechanism of moderate hypothermia. DESIGN: A randomized controlled trial. SETTING: Department of Neurosurgery, Renji Hospital affiliated to the Medical College of Shanghai Jiao Tong University. MATERIALS: Twenty healthy little pigs, either male or female, weighing 4.5–5.5 kg, were used. Neurotrend-typed multiparameter monitoring system (Diametrics Company, British); CMA/100 micro-injection pump (Carnegie Company, Sweden). METHODS: The experiment was conducted in the Changzheng Hospital affiliated to the Second Military Medical University of Chinese PLA in November, 2001. The pigs were randomized into two groups: the normothermia group (control group, n =10) and moderate hypothermia group (n =10). ① Bilateral femoral arteries were separated, one was connected to pressometer for monitoring mean arterial pressure (MEP), and the other for analysis of blood gases [including peripheral blood pH value, arterial partial pressure of carbon dioxide (PaCO2), arterial partial pressure of carbon dioxide (PaCO2), HCO3–]. ② Rectal temperature was monitored with mercurial thermometer. ③ Intracranial pressure was monitored using Camino optic ICP probe placed in the subdural space. ④ Neurotrend multiparameter monitoring sensor was inserted into the white matter for about 4 cm to determine cerebral perfusion pressure (CPP, CPP=MAP(ICP), brain tissue partial oxygen pressure (PO2), partial pressure of carbon dioxide (PCO2), HCO3– and brain temperature. The rectal temperature of animals in the moderate hypothermia group was lowered to 34 ℃ using ice bags, and the body temperature was maintained at 33–35 ℃ for 2 hours. The changes of the parameters were observed continuously, and the pigs in the normothermia group were not treated with cooling. MAIN OUTCOME MEASURES: ① MAP, ICP, rectal temperature, CCP; Indexes of cerebral oxygenation detected with Neurotrend-typed multiparameter monitoring system; ② Results of blood gases analysis in the moderate hypothermia group. RESULTS: All the 20 pigs were involved in the analysis of results. ① MAP, ICP, rectal temperature, CCP and indexes of cerebral oxygenation: In the moderate hypothermia group, the ICP after cooling was obviously lower than that before cooling [(3.31±1.19), (5.33±0.95) kPa, P < 0.05], CCP was higher, brain tissue PCO2 [(12.03±1.73), (10.59±2.01) kPa, P < 0.05], and brain tissue pH value was higher [(7.03±1.63), (9.40±1.30) kPa, P < 0.05], whereas the brain temperature was decreased as compared with that before cooling [(34.9±0.3), (37.2±0.2) ℃, P < 0.05]. ② Results of blood gases analysis in the moderate hypothermia group: There were no significant differences in the parameters of peripheral arterial blood gases analysis before and after cooling in the moderate hypothermia group (P > 0.05) CONCLUSION: Moderate hypothermia will not impair the cerebral oxygenation, and it can reduce brain tissue CO2 and decrease brain tissue acidosis.     

眼底动脉硬化与血压、血糖、血脂的多元分析与评估

目的探讨眼底动脉硬化与血压、血脂、血糖的相关性，评估中风危险度。方法对2004年5月至2008年10月就诊的患者335例，作为观察组，并与无症状的健康体检者180例作对照，动态检测眼底动脉硬化、血压、血糖、血脂的异常变化，并做综合量化评估。结果脑血管疾病与眼底动脉硬化、血压、血糖、血脂等因素密切相关。结论眼底动脉硬化、血糖、血脂、血压异常的量化评分，能够预估中风，以便采取预防性治疗。     

厄贝沙坦治疗高血压患者的临床效果观察

目的：观察厄贝沙坦治疗高血压患者的临床效果。方法：选择2007年1月～2009年1月来本院就诊的高血压患者200例，随机分为两组，厄贝沙坦组100例，采用厄贝沙坦治疗4周；对照组100例采用依那普利治疗，观察患者用药前后动态血压、心脏功能变化，并评价临床疗效。结果：厄贝沙坦组患者治疗总有效率为97％，均未出现明显不良反应：与对照组比较．差异有统计学意义，P〈0．05。厄贝沙坦组治疗后24h、白昼和夜间平均收缩压和舒张压与治疗前比较，差异有统计学意义，P〈0．05；用药后血压晨峰也显著降低，与治疗前比较，差异有统计学意义，P〈0．05：但与对照组间比较，差异无统计学意义，P〉0．05。结论：厄贝沙坦治疗高血压疗效满意，安全性较高，还可降低患者的心脑血管意外的风险。     

When work strain transcends psychological boundaries: an inquiry into the relationship between time pressure,irritation, work–family conflict and psychosomatic complaints

Against the theoretical background of the effort–recovery model and the action regulation theory, the author presents a cross‐sectional questionnaire study testing hypotheses about the relationship between work‐related time pressure, cognitive and emotional irritation, work–family conflict and psychosomatic complaints. Subjects were 576 female home care nurses. Results of a path analysis show that the relation of time pressure and psychosomatic complaints is partially mediated by experiencing a work–family conflict; also the relation of time pressure and work–family conflict is partially mediated by cognitive and emotional irritation. It is argued that cognitive and emotional irritation are fruitful concepts for a more comprehensive understanding of the relationship between work stressors and the development of strain‐based work–family conflict. Implications for the prevention of work–family conflict are outlined. Copyright © 2008 John Wiley & Sons, Ltd.     

HPLC法测定滑膜炎颗粒中原儿茶醛的含量

目的建立滑膜炎颗粒剂中原儿茶醛的含量测定方法质量。方法采用高效液相色谱法对方中原儿茶醛进行含量测定。结果高效液相色谱法测定结果表明原儿茶醛在0．1005～1．005μg范围内呈线性关系，平均加样回收率为99．22％；RSD为0．72％。结论本法简便，重现性好、结果可靠，可作为控制滑膜炎颗粒剂的质量方法。     

聚环氧氯丙烷／液晶复合富氧膜的研究

研究了聚环氧氯丙烷(PECHCH)/N(4-乙氧基苄叉)4-丁基苯胺(EBBA)复合膜对氧气和氮气的透过性和选择性。用示差扫描量热计(DSC)、解偏振光强仪(DLI和偏光显微镜考察了复合膜的形态结构。结果表明,当PECH/EBBA复合膜处于液晶的向列相转变温度时,有较高的气体透过性和选择性。发现只有复合膜中EBBA含量在30wt％以上,PECH和EBBA呈非均相混合时,才有较明显的富氧效果。当EBBA含量达50wt%时,氧氮分离系数α=3.78。     

中药高臀位灌肠治疗慢性肾功能衰竭疗效观察

目的 观察中药高臀位灌肠治疗慢性肾功能衰竭(chronic renal failure,CRF)的临床疗效.方法 将100例CRF患者随机分为两组,治疗组70例采用中药高臀化灌肠治疗,对照组30例口服活性炭治疗.结果 治疗组总有效率为88.6%,对照组总有效率为50.0%.结论 中药高臀位灌肠治疗CRF有效.     

葡立胶囊与抗骨增生胶囊联用治疗颈椎病的临床研究

目的 了解、观察葡立胶囊与抗骨增生胶囊联用治疗颈椎病对血清SOD含量及疼痛功能评分的影响。方法 对一组神经根型颈椎病患者，用葡立胶囊与抗骨增生胶囊联合应用治疗3个月，测定血清SOD含量及疼痛功能评分变化。结果 颈椎病患者治疗组血清SOD含量与治疗前相比明显升高，疼痛功能评分治疗前相比明显降低。结论 葡立胶囊与抗骨增生胶囊联合应用可明显缓解症状，提高血清SOD活力，延缓颈椎间盘退变，对治疗颈椎病有明显疗效。