茵陈五苓散对大鼠酒精性肝损伤防治作用的研究

目的观察茵陈五苓散对大鼠酒精性肝损伤血清ALT、AST和病理组织学的影响，为临床酒精性肝损伤的防治提供实验依据。方法采用白酒灌胃造模，50只Wistar大鼠随机分成正常组、模型组、预防1组、预防2组、治疗组，分别于实验第5周、第9周末尾静脉取血，分离血清，测定ALT、AST。并于第9周取血后肝脏取材，常规HE染色，光镜观察。结果模型组血清ALT、AST明显升高，预防1、2组、治疗组血清ALT、AST均低于模型组，差异具有显著性（均P〈0．01）。模型组成功建立酒精性肝损伤病理学模型，预防组、治疗组病理学改变较模型组显著减轻。结论茵陈五苓散能有效地预防和治疗大鼠酒精性肝损伤。     

再论大柴胡汤证之归属

大柴胡汤证不是少阳阳明合病，而是小柴胡汤证由气分向血分发展的必然阶段，病势有深浅之分，病位却不是由少阳及于阳明．而是由气郁发畏为气滞热郁血瘀。“心下急”、“郁郁微烦”为其辨证眼目。     

八宝眼粉质量标准的研究

目的:建立八宝眼粉的质量控制方法.方法:采用化学反应和薄层色谱法(TLC)鉴别方中炉甘石、人工牛黄、冰片;采用气相色谱法(GC)测定冰片的含量.结果:鉴别效果满意;冰片在0.09808～0.78464 μg范围内呈良好的线性关系,平均加样回收率为101.5%,RSD=1.40%(n=5).结论:本方法简便、快速准确,可作为该制剂质量控制方法.     

注射用熊胆粉及其原料熊胆粉指纹图谱研究

目的:建立注射用熊胆粉及其原料熊胆粉指纹图谱的分析方法.方法:采用反相高效液相色谱法(RP-HPLC法).色谱柱用Shim-pack VP C18柱(4.0 mm×150 mm,5μm);流动相为甲醇-0.03 mol/L磷酸二氢钠溶液,梯度洗脱;检测波长为210 nm.结果:样品中各成分可得到较好的分离,指纹性较好;方法学考察表明,RP-HPLC法具有较好的重现性;指纹图谱相似度评价相关系数均大于0.9.结论:该指纹图谱可作为熊胆粉、注射用熊胆粉具有专属性的指纹图谱,适于作熊胆粉及其制剂的质量控制方法.     

干粉吸入剂的有效性及质量评价

综述了影响干粉吸入剂有效性的因素,并对其体内外测定方法及质量控制进行了概述.     

注射用柴胡挥发油脂质体制备工艺研究

目的 :探讨将柴胡挥发油制成注射用脂质体的制备工艺可行性。方法 :通过研究柴胡挥发油脂质体的处方组成、挥发油包封率、冻干可行性以及二者的指纹图谱变化。结果 :柴胡挥发油的包封率为 81.9%。经冷冻干燥后 ,脂质体中被包封挥发油的保留率为 88.6 %。结论 :将柴胡挥发油制备成注射用脂质体在制备工艺上是可行的。     

当归微粉的特征及对阿魏酸溶出的影响

目的:比较当归普通粉和微粉的粉体学特征、水溶性及醇溶性浸出物含量、指标成分阿魏酸溶出量,探索微粉化技术在当归中的应用价值.方法:通过激光粒度分析仪对普通粉和微粉进行表征,扫描电镜(SEM)观察普通粉和细粉的表面形态,测定粉体学参数休止角和堆密度,冷浸法测定水溶性及热浸法测定醇溶性溶出物的含量,利用超声提取进行水溶性指标成分阿魏酸的溶出实验,采用HPLC测定阿魏酸的含量.结果:当归普通粉和微粉的粉体学特征及表面形态差异显著,但水溶性及醇溶性浸出物量、水溶性指标成分阿魏酸的溶出差别不大.结论:微粉化应用于当归,通过对粉体学特征的影响而影响其制剂学性质,但不能显著提高其醇溶性及水溶性浸出物和指标成分阿魏酸的溶出量,生产中不宜对当归进行微粉化.     

反相高效液相色谱法测定益康唑癣粉中硝酸益康唑的含量

目的:建立益康唑癣粉中硝酸益康唑的含量测定方法.方法:采用C18色谱柱,甲醇-水-三乙胺(85 ∶ 15 ∶ 0.1)(冰醋酸调节pH为6.0)为流动相,检测波长为230nm.结果:浓度在0.4147～4.147μg范围内,硝酸益康唑的线性关系良好(r=0.9996),平均回收率为100.2%,RSD为0.53%(n=9).结论:所建含量测定方法可行,操作简便,结果准确,专属性好,可用于控制益康唑癣粉的质量.     

幼泻停敷脐散对IBS-D模型大鼠血清中TNF-α和IL-10含量的影响

目的:探讨幼泻停敷脐散对IBS-D模型大鼠血清中TNF-α和IL-10含量的影响及作用机制。方法:将Wistar大鼠随机分成正常对照组、模型对照组、得舒特组、幼泻停敷脐散高剂量组、幼泻停敷脐散中剂量组、幼泻停敷脐散低剂量组。观察大鼠的活动状况;测定大鼠的小肠运动、血浆中TNF-α和IL-10含量的变化。结果:正常对照组行动活跃、精神良好、皮毛润泽、饮食不减、实验后体重高于实验前,模型各组均出现不同程度的精神萎靡、活动明显减少,大便松散、稀便;幼泻停敷脐散高剂量、中剂量组及得舒特组的小肠运动减慢,与模型组比较有显著性差异,P0.01;幼泻停敷脐散高、中剂量组及得舒特组的TNF-α和IL-10含量降低,与正常组比较,无显著性差异,P0.05,与模型组比较有极显著性差异,P0.01。结论:幼泻停敷脐散能抑制IBS-D模型大鼠的小肠运动和血浆中TNF-α和IL-10含量异常升高,对IBS-D模型大鼠有很好的治疗作用。     

Assessing compressibility and compactibility of powder formulations with Near-Infrared Spectroscopy

Context: The compressibility and compatibility of a powder formulation is usually determined by compaction and following destructive tensile strength and relative density measurement of the final compact.

Objective: In this study, a non-destructive method with Near-Infrared Spectroscopy (NIRS) was designed and evaluated for the measurement of powder compressibility and compactibility.

Materials and Methods: 12 different formulations with a wide range of difference in properties were investigated by compaction and analysis of the resulting tablets. Two similar tablet batches were produced with every formulation. Relative density and tensile strength were measured with the traditional, destructive method on one tablet batch while a newly developed non-destructive chemometric NIRS method was applied for the second batch. The outcomes of the two approaches were compared to validate the developed method. All data sets were applied to three established mathematical equations to calculate equation factors, which are claimed to represent the formulation compressibility and compactibility. The study focus was set on the equation factor value comparison between the traditional and the newly designed method.

Results & Discussion: The results showed a high similarity between the outcomes of the two methods. An essential difference was noticed for the outcomes of the equation factors after application to the Leuenberger equation.

Conclusion: The approach with the NIRS is suggested as a promising tool for a reliable inline quality monitoring in the tablet manufacturing process.