Application of disaccharides alone and in combination,for the improvement of stability and particle properties of spray-freeze dried IgG

Purpose: Spray-freeze drying (SFD) is a recently applied method to develop pharmaceutical powders. This study aimed to analyze the competence of Trehalose, Mannitol, Lactose, and Sorbitol instability and aerosolization of Immunoglobulin G (IgG) via SFD.

Methods: Induced soluble aggregates were quantified at 0 and 3?months, and 45?°C using size-exclusion chromatography. Conformation and thermogravimetric assessments were done by Fourier transform infrared spectroscopy and differential scanning calorimetry. Laser light scattering was performed to determine the particle sizes. Aerodynamic features were characterized by twin stage impinger and scanning electron microscopy.

Results: Although sugars/polyols preferably stabilized IgG following the process, storage stabilization was achieved in Trehalose, Trehalose-Lactose, Lactose, and Trehalose-Mannitol-based powders with soluble aggregates <5%. The conformation of antibody was preserved with β sheet content from 66.28% to 76.37%. Particle sizes ranged from 5.23 to 8.12?µm. Mannitol exhibited the best aerodynamic behavior, fine particle fraction (FPF: 70%) but high degree of protein aggregation during storage.

Conclusions: SFD could favorably stabilize antibody using Trehalose and its combination with Lactose and Mannitol, and also, Lactose alone. Sorbitol disturbed IgG powder recovery. Incorporation of other types of excipient is required for efficient respiratory delivery of IgG molecules.     

喷雾(冰冻)干燥法制备钠、锂快离子导体

对两种性能较好的快离子导体Na_3Zr_2Si_2P_3O_(12)(Nasicon)和Li_(1.8)Ti_(1.2)·Cr_(0.8)P_3O_(12)用喷雾干燥法和冰冻干燥法制备粉料和陶瓷烧结,并对样品进行了X射线衍射分析,形貌和显微结构观察以及阻抗谱测量等。实验结果表明:两种方法制备的粉料具有颗粒细,均匀性好,合成温度低等优点。在300℃时,两种样品的电阻半分别为10.05 Ω.cm和94.8 Ω.cm。激活能分别为0.25 eV和0.27ev。     

葛根汤颗粒喷雾干燥工艺条件试验研究

目的：优选葛根汤颗粒啧雾干燥的最佳工艺条件。方法：应用正交设计法，以每小时药粉产率及有效成分含量为考察指标，对影响葛根汤喷雾干燥过程的因素进行考察。结果：正交试验法设计的三个因素中，浸膏的相对密度影响显著，入塔风温影响较显著。结论：颗粒最佳工艺条件为：入塔风温：170℃，气流量：700L／h，浸膏相对密度：1．22，在此条件下，葛根汤颗粒有效成分中葛根素及芍药苷的含量明显高于原湿法制粒制剂。     

病毒唑雾化吸入治疗上呼吸道感染临床疗效观察

选择89年2月至90年2月175例上呼吸道感染患儿,分为病毒唑雾化吸入组(61例).病毒唑全身给药组(53例)和对照组(61例).平均退热时间分别为30.01±.11,31.89±9.28,40.57±16.94小时.病毒唑组与对照组有非常显著性差异(p<0.01)但两病毒唑治疗组之间无显著性差异,并发现发病时间在一天内接受治疗者,退热时间明显短于超过一天之病例,且发病两天后治疗者与对照组已无显著差异(p<0.05).病毒唑全身用药组和对照组共有4例发展为支气管炎和肺炎,而雾化吸入组无,说明该治疗方法可以阻止病毒感染蔓延至下呼吸道.     

热风和微波真空联合干燥甘蓝试验

对甘蓝进行热风和微波真空联合干燥试验,目的是缩短热风干燥时间,提高产品质量.结果表明:联合干燥缩短了干燥时间约48.33%,提高了产品的营养成分保存率、叶绿素保存率;微波真空干燥使产品质构疏松.     

Haarkrankheit oder hitze-(brand)-einwirkung?

Zusammenfassung Ein 4 Tage nach einem offensichtlich durch Brandstiftung erfolgten Dachstuhlbrand einer Kirche untersuchter Tatverdächtiger wies in einem umschriebenen Bezirk stumpfe Haarenden auf. Typische Haarspitzenveränderungen durch Hitzeeinwirkung waren makroskopisch und lupenmikroskopisch nicht sicher erkennbar. Mikroskopisch konnte jedoch die Diagnose eindeutig gestellt werden. Auffällige spindelförmige Haarveränderungen, die zunächst ebenfalls als hitzebedingt oder durch krankhafte Haarveränderungen hervorgerufen angesehen wurden, erwiesen sich als Artefakte durch Aufsprühen eines Haarfestigers.Auszugsweise auf der Tagung der Deutschen Gesellschaft für Rechtsmedizin in St. Gallen im September 1986 vorgetragen     

一种有效提高小丸微波干燥能力及质量的装置

介绍一种能提高小丸微波干燥能力,避免小丸干燥开裂、过火等现象,可以提高小丸微波干燥均匀度的装置。     

Claudin‐7 Expressed on Lateral Membrane of Rat Epididymal Epithelium does not Form Aberrant Tight Junction Strands

Claudins are integral membrane proteins at tight junctions (TJs) and form TJ strands. In the present study, we found that claudin‐7 was localized along the entire lateral membranes of epididymal epithelium, including the apical junctional region throughout the epididymis, but claudin‐8 was restricted to the apical junctional region. This finding raises the possibility that aberrant TJ strands may be formed on lateral membranes. Thus, we focused on examining whether TJ strands exist on lateral membranes of epididymal epithelium. Freeze‐fracture electron microscopy showed that aberrant TJ strands were observed in only a few principal cells in all segments of the epididymis except for the initial segment, indicating that the occurrence of aberrant strands is very rare. Aberrant TJ strands were smooth and not subdivided into individual particles in the protoplasmic face, and complementary grooves in the extracellular face were almost free of particles. Aberrant TJ strands in the distal caput and corpus epididymis were accompanied by many vesicle‐like structures but those in the proximal caput and cauda epididymis were not. These results suggest that most of claudin‐7 in lateral membranes may exist in a nonpolymerized form and may play some different roles other than the formation of TJ strands, for example, in the formation of a pool of claudin proteins or in the reinforcement of cell adhesion. Anat Rec, 1431‐1438, 2007. © 2007 Wiley‐Liss, Inc.     

丹参桐固体分散物的研究

应用聚乙烯吡喀烷酮（PVP）为载体,采用喷雾干燥制备了丹参酮（Tanshinone TAN)的固体分散物。测定了TAN原料药、固体分散物以及机械混合物的体外溶出度,并通过X－射线衍射、扫描电观察、以及用红光光谱和紫外光谱分析对固体分散物进行了研究。结果表明,TAN固体分散物的溶出度与TAN原料药和机械混合物相比有显著提高;TAN以超细态分散于载体中;TAN分子和载体分子之间未发生化学反应。     

基于熵权法评价干燥方法对经典名方华盖散基准样品质量属性的影响

目的 优选经典名方华盖散基准样品的干燥方法。方法 采用真空干燥、真空带式干燥、喷雾干燥、冷冻干燥方法制备华盖散基准样品,应用扫描电子显微镜、差式扫描量热分析、HPLC等方法测定基准样品的质量属性,以得粉率、玻璃化转变温度及成分含量转移率等为评价指标,运用熵权法对各指标赋予权重进行综合评价。结果 喷雾干燥基准样品粒子呈类球形、粒径最小,冷冻干燥基准样品不规则、蓬松、溶化性好。指标成分盐酸麻黄总碱、苦杏仁苷、橙皮苷、甘草苷、甘草酸转移率分别为85.66%～104.78%、90.81%～104.16%、91.42%～94.86%、83.98%～94.69%、87.85%～94.45%,指纹图谱相似度均大于0.9。结论 经综合评价得出冷冻干燥方法最佳,3批验证工艺重复性、可行性较好,为经典名方基准样品质量属性研究提供了理论依据和实践价值。