盐酸曲马多与盐酸甲氧氯普胺在静脉镇痛泵中配伍的稳定性考察

目的：考察盐酸曲马多注射液与盐酸甲氧氯普胺注射液在静脉镇痛泵中的配伍稳定性。方法：在室温条件下,观察与测定盐酸曲马多注射液与盐酸甲氧氯普胺注射液在静脉镇痛泵中配伍后的外观、不溶性微粒及pH值变化,并用高效液相色谱法测定配伍液中二者的含量变化。结果：室温72h内,盐酸曲马多与盐酸甲氧氯普胺在静脉镇痛泵（0．9％氯化钠注射液）中混合后的外观、pH、不溶性微粒、含量均无明显变化。结论：在室温条件下,盐酸曲马多注射液与盐酸甲氧氯普胺注射液在静脉镇痛泵中混合后72h内均保持稳定。     

异甘草酸镁注射液与 5%葡萄糖注射液、10%果糖注射液配伍的稳定性

目的：考察异甘草酸镁注射液与5％葡萄糖注射液、10％果糖注射液2种输液配伍的稳定性.方法：将异甘草酸镁注射液与5％葡萄糖注射液、10％果糖注射液按临床常用的浓度配伍,室温下放置8h,分别于0、2、4、6、8h取样,用高效液相色谱法测定异甘草酸镁的含量,用酸度计测定pH值,用光阻法测定其不溶性微粒.结果：异甘草酸镁注射液与上述2种注射液配伍后,8h内的pH值、含量两项指标的变化在《中华人民共和国药典》（2010年版）规定的范围之内,但不溶性微粒指标较大,不符合相关规定.结论：异甘草酸镁注射液与5％葡萄糖注射液、10％果糖注射液配伍后,含量与pH值符合《中华人民共和国药典》（2010年版）规定,但不溶性微粒指标不符合规定,建议临床不配伍使用.     

抗肿瘤药物配制后稳定性探讨

检索中英文数据库,查阅有关文献,综述临床常用静脉用抗肿瘤药物配制后稳定的条件及时间,为临床安全用药提供参考。     

六味千骨巴布剂的稳定性考察

考察六味千骨巴布剂的稳定性。方法：用HPLC法测定六味千骨巴布剂中柚皮苷的含量,并考察性状、鉴别、舍膏量、赋形性、黏附性、微生物限度等其他指标。结果：六味千骨巴布剂样品在加速试验及长期试验中,考察前后各项检查指标均无明显变化。结论：六味千骨巴布剂在室温条件下稳定性较好。本品的工艺及包装等设计合理,符合制剂稳定的要求。     

薄膜包衣对西罗莫司滴丸溶出度及稳定性的影响研究

目的：探讨薄膜包衣对西罗莫司（SRL）滴丸溶出度及稳定性的影响,以证实薄膜包衣的作用及合理性。方法：选用欧巴代为SRL滴丸的包衣材料进行包衣;对其体外释药及稳定性进行考察,并与未包衣的SRL滴丸进行比较。结果：与未包衣滴丸相比,在相同时间内,薄膜包衣SRL滴丸的体外释药量明显降低（P〈0.05）,而稳态释药速率并无显著影响（P〉0.05）;高湿条件下（75%±5%）包衣SRL滴丸的吸湿性显著下降,在强光环境中（4 500 lx±500 lx）,包衣SRL滴丸的稳定性也较好,而在高温条件下（40℃±2℃）,稳定性无显著提高。结论：欧巴代薄膜包衣可明显提高SRL滴丸的稳定性,而对其药物溶出无显著性影响。     

Biomechanical comparison of stability of tibiotalocalcaneal arthrodesis with two different intramedullary retrograde nails

BackgroundThe aim of the study was to compare the initial construct stability of two retrograde intramedullary nail systems for tibiotalocalcaneal arthrodesis (TTCF) (A3, Small Bone Innovations; HAN, Synthes) in a biomechanical cadaver study.MethodsNine pairs of human cadaver bones were instrumented with two different retrograde nail systems. One tibia from each pair was randomized to either rod. The bone mineral density was determined via tomography to ensure the characteristics in each pair of tibiae were similar. All tests were performed in load-control. Displacements and forces were acquired by the sensors of the machine at a rate of 64 Hz. Specimens were tested in a stepwise progression starting with six times ±125N with a frequency of 1 Hz for 250 cycles each step was performed (1500 cycles). The maximum load was then increased to ±250N for another 14 steps or until specimen failure occurred (up to 3500 cycles).ResultsAverage bone mineral density was 67.4 mgHA/ccm and did not differ significantly between groups (t-test, p = .28). Under cyclic loading, the range of motion (dorsiflexion/plantarflexion) at 250N was significantly lower for the HAN-group with 7.2 ± 2.3 mm compared to the A3-group with 11.8 ± 2.9 mm (t-test, p < 0.01). Failure was registered for the HAN after 4571 ± 1134 cycles and after 2344 ± 1195 cycles for the A3 (t-test, p = .031). Bone mineral density significantly correlated with the number of cycles to failure in both groups (Spearman-Rho, r > .69, p < 0.01).ConclusionsThe high specimen age and low bone density simulates an osteoporotic bone situation. The HAN with only lateral distal bend but two calcaneal locking screws showed higher stability (higher number of cycles to failure and lower motion such as dorsiflexion/plantarflexion during cyclic loading) than the A3 with additional distal dorsal bend but only one calcaneal locking screw. Both constructs showed sufficient stability compared with earlier data from a similar test model.Clinical relevanceThe data suggest that both implants allow for sufficient primary stability for TTCF in osteoporotic and consequently also in non-osteoporotic bone.Level of evidenceNot applicable, experimental basic science study.     

聚乙二醇对盐酸伊立替康脂质体体外释放及在不同稀释介质中稳定性的影响

目的:考察不同聚乙二醇含量对盐酸伊立替康脂质体体外释放特性及在不同稀释介质中稳定性的影响。方法:采用乙二胺四乙酸铵梯度法,以聚乙二醇2000含量分别为0、8、14、20、26 mg/ml的聚乙二醇2000-二硬脂酰磷脂酰乙醇胺(m PEG2000-DSPE)制备盐酸伊立替康脂质体,测定其包封率和粒径,评价其体外24 h内的累积释放度和在生理氯化钠溶液与5%葡萄糖注射液中的稳定性。结果:随着m PEG2000-DSPE含量的增加,盐酸伊立替康脂质体体外24 h累积释放度逐渐减小;以生理氯化钠溶液及5%葡萄糖注射液稀释后,随着m PEG2000-DSPE含量的增加,盐酸伊立替康脂质体的包封率和粒径变化均减小;当聚乙二醇2000质量浓度增加至20、26 mg/ml时,脂质体包封率和粒径基本不再变化。结论:m PEG2000-DSPE的加入可减慢盐酸伊立替康脂质体的体外释放,提高其在不同稀释介质中的稳定性。     

丙泊酚中/长链脂肪乳注射液与小剂量盐酸利多卡因注射液的配伍稳定性考察

目的:考察丙泊酚中/长链脂肪乳注射液与小剂量盐酸利多卡因注射液的配伍稳定性。方法:分别将盐酸利多卡因注射液0.25、0.5、1 ml(含盐酸利多卡因5、10、20 mg)加入丙泊酚中/长链脂肪乳注射液20 ml中,考察6 h内配伍溶液的外观、pH值以及两种药物的含量变化。结果:丙泊酚中/长链脂肪乳注射液中加入盐酸利多卡因注射液,6 h内利多卡因与丙泊酚含量变化均<3%,外观、pH值均无显著变化。结论:丙泊酚与小剂量的利多卡因配伍后6h内含量、外观、pH值稳定。     

注射用硫酸头孢噻利与5种输液的配伍稳定性

目的：考察注射用硫酸头孢噻利与5种输液的配伍稳定性。方法在30℃下,将注射用硫酸头孢噻利分别与5％葡萄糖注射液、果糖注射液、果糖氯化钠注射液、转化糖注射液和木糖醇注射液配伍,在6h内考察配伍液的外观,pH值,采用高效液相色谱法测定硫酸头孢噻利的含量。结果硫酸头孢噻利与5种输液在6h内含量、pH值及外观均无明显变化。结论硫酸头孢噻利与5种输液在30℃,6h内配伍稳定。     

口捷爽复方泡腾片稳定性考察

目的考察口捷爽复方泡腾片的稳定性,并初步确定其有效期。方法观察并测定复方泡腾片在强光、高温及高湿度等环境下的性状、崩解时限、重量差异、发泡量、酸度、含量等指标的变化。结果加速试验与长期试验中各项考察指标均无明显变化,符合药品质量标准的相关规定。结论口捷爽复方泡腾片在加速试验和长期试验条件下稳定,可初步预测该制剂的有效期1年。