维脑路通片压片工段工艺质量回顾分析

目的：通过维脑路通片压片工段工艺质量回顾分析,保证药品质量的安全生产要求。维脑路通是芦丁经羟乙基化半合成的产物,对抗5-羟色胺、缓激肽引起的血管损伤,增加毛细血管抵抗力,能降低毛细血管的通透性和脆性,并有抑制血小板凝集、防止血栓形成的作用,降低毛细血管通透性,可防止血管通透性升高引起的水肿。对急性缺血性脑损伤有显著的保护作用。适用于脑血栓形成和脑栓塞所致的偏瘫、失语以及心肌梗死前综合征、动脉硬化等。维脑路通是临床上治疗闭塞性脑血管病的常用药物。根据2010年修订的《药品生产质量管理规范》第二百六十六条要求,企业至少应当对关键中间控制点及成品的检验结果进行回顾分析。方法：是通过联系跟踪95批次的产品,进行片重的分析。结果：是平均偏差SD=0.000467,平均数average=0.125679,相对平均偏差RSD=0.003716,RSD（％）=0.3716,RSD<3％,符合方法学要求。结论：是验证工厂使用的压片机的性能符合GMP的要求,达到了阶段性的压片工段的质量管理要求。     

北豆根分散片的工艺研究

目的试制北豆根分散片。方法在崩解时限、溶出度等多项质量指标控制下,对北豆根分散片的处方、工艺条件等进行验证。结果选择羧甲基淀粉钠、交联聚乙烯吡咯烷酮、微晶纤维素,用2号筛网制粒,崩解时间70 s以内,分散均匀,稳定性好。结论该处方合理。     

健脾消胀片对大鼠胃酸含量、胃蛋白酶活力及胃肠电活动影响

目的探讨健脾消胀片对大鼠胃酸含量、胃蛋白酶活力及胃肠电活动的影响。方法结扎大鼠幽门与十二指肠结合部造模,测大鼠胃酸含量和胃蛋白酶活力;用EGEG-8D胃肠电图仪记录5 min大鼠胃电图,测量频率和幅值,以观察健脾消胀片对大鼠胃窦电活动、小肠电活动的影响。结果大、中剂量健脾消胀片组可使大鼠胃酸含量显著升高,大剂量健脾消胀片组可使大鼠胃蛋白酶活性显著升高,中剂量健脾消胀片组可使大鼠胃蛋白酶活性明显升高;大、中剂量健脾消胀片组可使大鼠胃窦电活动频率显著升高,小剂量健脾消胀片组可使大鼠胃窦电活动频率明显升高,大、中、小剂量健脾消胀片组可使大鼠胃窦电活动幅值显著升高;大、中、小剂量健脾消胀片组可使大鼠小肠电活动频率和幅值均显著升高。结论健脾消胀片具有消食和胃的临床意义。     

Prediction of oral disintegration time of fast disintegrating tablets using texture analyzer and computational optimization

One of the promising approaches to predict in vivo disintegration time of orally disintegrating tablets (ODT) is the use of texture analyzer instrument. Once the method is able to provide good in vitro in vivo correlation (IVIVC) in the case of different tablets, it might be able to predict the oral disintegration time of similar products. However, there are many tablet parameters that influence the in vivo and the in vitro disintegration time of ODT products. Therefore, the measured in vitro and in vivo disintegration times can occasionally differ, even if they coincide in most cases of the investigated products and the in vivo disintegration times may also change if the aimed patient group is suffering from a special illness. If the method is no longer able to provide good IVIVC, then the modification of a single instrumental parameter may not be successful and the in vitro method must be re-set in a complex manner in order to provide satisfactory results. In the present experiment, an optimization process was developed based on texture analysis measurements using five different tablets in order to predict their in vivo disintegration times, and the optimized texture analysis method was evaluated using independent tablets.     

复合陶瓷人工全踝关节的研制及临床应用

本文介绍了研制的复合陶瓷人工踝关节,并讨论了踝关节生物力学特点,假体设计的生物力学依据和临床应用效果及其设计依据。     

分散片的处方和工艺

分析了分散片的处方和工艺特点,及其在药物溶出度和生物利用度方面的优越性。     

桂利嗪分散片溶出度测定的研究

采用紫外分光光度法对桂利嗉分散片溶出度进行了测定。结果显示 ,本品 3批 3 min平均溶出量均超过标示量的 80 % ,提示该方法用于桂利嗪分散片的溶出度的测定快速简便、结果满意。     

海风藤挥发油的β-环糊精包合工艺研究

目的：优选出海风藤挥发油β-环糊精包合最佳工艺。方法：以挥发油包合率、包合物收率为指标,采用正交试验优选海风藤挥发油β-环糊精包合的最佳工艺条件。结果：最佳包合工艺条件为包合比为1：10,包合温度60℃,包合时间2h。结论采用优选的包合工艺条件制备的包合物包合率及收率较高。     

颞浅动脉旁皮下注射复方樟柳碱治疗视神经挫伤的疗效分析

目的探讨复方樟柳碱颞浅动脉旁皮下注射治疗视神经挫伤的疗效。方法20例（22只眼）视神经挫伤患者为治疗组,采用复方樟柳碱2ml患侧颞浅动脉旁皮下注射,每日1次,每疗程14d,3个疗程。另18例（20只眼）视神经挫伤患者为对照组,除不加用复方樟柳碱外,其他用药同治疗组疗效观察指标为视力、视野。结果治疗组总有效率为86％,对照组为45％．两组比较具有显著的统计学差异（P〈0．05）。结论颞浅动脉旁皮下注射复方樟柳碱注射液治疗视神经挫伤有明显疗效,且毒副作用小,安全性高,值得临床推广应用。     

A Comprehensive Study on the Rejuvenation Efficiency of Compound Rejuvenators for the Characterization of the Bituminous Binder,Mortar, and Mixture

This study aims to comprehensively investigate the rejuvenation efficiency of various self-developed compound rejuvenators on the physical, mechanical, and aging properties of aged bitumen, asphalt mortar, and mixture. The results revealed that the restoration capacity of vacuum distilled-oil rejuvenators on high-and-low temperature performance-grade of aged bitumen is more significant. In contrast, an aromatic-oil based rejuvenator is good at enhancing low-temperature grade and aging resistance. Moreover, the temperature and time of the curing conditions for mixing recycling of asphalt mixture were optimized as 150 °C and 120 min. Furthermore, the sufficient anti-rutting, structural stability, and moisture resistance of recycled asphalt mixture affirmed the rejuvenation efficiency of compound rejuvenators.