正交试验法优选补肾祛瘀颗粒的提取工艺

目的:优选补肾祛瘀颗粒的提取工艺,为该制剂的工业化生产提供参考。方法:采用UV测定总多糖和总黄酮含量,检测波长分别为489,510 nm;采用HPLC测定二苯乙烯苷含量,流动相乙腈-水(22∶78),检测波长320 nm。以总多糖得率为指标,通过正交试验考察料液比、提取时间、提取次数、醇沉浓度对水提工艺的影响;以总黄酮、二苯乙烯苷提取量和浸膏得率的综合评分为指标,通过正交试验考察提取时间、提取次数、乙醇用量及体积分数对醇提工艺的影响。结果:最佳水提工艺为加12倍量水浸泡1 h,回流提取3次,每次1.5 h,醇沉浓度80%;总多糖得率8.682%。最佳醇提工艺为加10倍量80%乙醇回流3次,每次1.5 h;总黄酮和二苯乙烯苷提取量分别为660.19 mg·g-1和145.91μg·g-1,浸膏得率11.81%。结论:优选的提取工艺合理可行,为补肾祛瘀方的临床推广与应用提供实验依据。     

星点设计-效应面法优选糖肾宁颗粒的成型工艺

目的:优选糖肾宁颗粒的成型工艺。方法:以成型性、溶解性、吸湿性及吸湿后外观为指标,通过单因素试验确定辅料种类,采用星点设计-效应面法优选辅料配合比例、用量、润湿剂浓度等成型工艺参数。结果:最佳成型工艺为提取物-糊精-甘露醇(4∶3∶3),加入75%乙醇制软材,干燥温度55℃。总评"归一值"(overall desirability,OD)平均值0.786,与模型方程理论预测值(0.78)的偏差0.8%。制备的颗粒剂合格收率88.44%,溶化时间0.5 min,临界相对湿度约70%,休止角34.8度,堆密度0.49 g·m L-1。结论:优选的成型工艺稳定可行,制备的糖肾宁颗粒具有合格率高、溶化性好、抗吸湿性强的特征,为该制剂的大生产提供参考。     

培元颗粒的处方与制备工艺考察

目的:优选培元颗粒的处方与成型工艺,为该方的研究与开发提供参考。方法:采用单因素试验法,以颗粒成型性、吸湿性、流动性为评价指标,优选培元颗粒的处方组成和成型工艺参数,并对培元颗粒的水分、流动性、堆密度等参数进行测定。结果:培元颗粒的最佳处方与成型工艺为干膏粉-糊精-可溶性淀粉(5∶3∶3),以90%乙醇为润湿剂,湿法制粒,60℃干燥1 h。收率、水分、休止角、堆密度及临界相对湿度分别为95.78%,5.08%,30.73度,0.526 g·m L-1,70%。结论:优选的培元颗粒处方与成型工艺合理、可行,颗粒剂的水分、流动性、堆密度均符合2010年版《中国药典》的规定。     

紫丹银屑颗粒联合窄谱中波紫外线治疗血虚风燥证寻常型银屑病的临床分析

目的:观察紫丹银屑颗粒联合窄谱中波紫外线治疗血虚风燥证寻常型银屑病的临床疗效及对血清白介素-17(IL-17),IL-22和IL-23的影响。方法:将符合条件的116例患者采用随机按数字表法分成对照组和观察组各58例。对照组采用窄谱中波紫外线(NB-UVB)治疗。观察组在对照组治疗的基础上加用紫丹银屑颗粒,4 g/次,3次/d。两组疗程均为8周。所有患者进行3个月随访,记录复发情况。于治疗前、治疗后和治疗结束后1,2,3个月进行皮损面积和严重程度指数(PASI)评分;记录复发时间。进行治疗前后皮肤病生活质量指数(DLQI)和瘙痒程度视觉模拟(VAS)评分,检测治疗前后IL-17,IL-22,IL-23水平。结果:治疗后观察组PASI,DLQI和VAS评分均低于对照组(P0.05,P0.01);观察组临床有效率为93.1%,对照组为84.48%,观察组高于对照组,但差异无统计学意义;在治疗后3个月的随访期间,观察组复发率为40.74%,低于对照组的63.26%(P0.05);观察组平均复发时间长于对照组(P0.05);治疗后观察组血清IL-17,IL-22,IL-23水平均低于对照组(P0.01)。结论:紫丹银屑颗粒联合窄谱中波紫外线治疗血虚风燥证寻常型银屑病,能减轻皮损和瘙痒,提高患者的生活质量,并能稳定病情,降低复发率,同时可调节血清IL-17,IL-22,IL-23等辅助性T细胞17(TH17)细胞因子。     

中药配方颗粒剂治疗原发性高血压的多中心、随机对照、非劣效性临床研究

  目的：观察中药配方颗粒剂治疗1、2级原发性高血压的临床疗效  方法：采用多中心区组随机对照的方法,将227例1、2级原发性高血压患者分为治疗组(116例)与对照组(111例)。治疗组予中药配方颗粒剂(复方黄芩汤或复方仙麦汤),对照组予中药饮片汤剂(复方黄芩汤或复方仙麦汤)。两组疗程均为1个月,观察血压值(SBP、DBP)、血压达标率、中医证候积分及用药安全性。脱落、剔除病例共26例。疗程4周,采用非劣效检验分析两组在诊室血压平均下降水平、血压达标率以及中医证候积分情况,以及不良事件发生的差异性  结果：①试验期间,符合FAS集225例,其中治疗组115例,对照组110例;PPS集201例,其中治疗组99例,对照组102例。②在FAS与PPS集中,治疗前后组内比较,两组SBP与DBP水平差异均有统计学意义(P<0.05);而组间SBP与DBP水平治疗前后差值比较,差异均无统计学意义(P>0.05),非劣效检验成立。③组间治疗后血压达标率比较,差异均无统计学意义(P>0.05)。④组间治疗后中医证候积分比较,差异均无统计学意义(P>0.05)。⑤组间不良反应发生率比较,差异均无统计学意义(P>0.05)  结论：中药配方颗粒剂治疗1、2级原发性高血压的疗效并不劣于传统中药饮片汤剂。     

Lipofuscin Granules in the Epileptic Human Temporal Neocortex with Age

Lipofuscin granules (LGs), the “age pigments”, are autofluorescent cell products from lysosomes that diverge in number and size among brain regions. Human temporal cortex from 20- to 55-year-old epileptic subjects were studied with the fat soluble dye Sudan Black, under confocal and electron microscopy. Ultrastructural analysis showed that with age LGs increase in area, but not in number. Proportionally to the LGs area, the electron lucid portion increases and the electron dense reduces over time. The robust increase in lipid components is possibly due to modifications in the neuronal metabolism with age in physiological and pathological conditions.     

近红外光谱法快速测定侧柏叶配方颗粒槲皮苷含量

目的：建立测定侧柏叶配方颗粒中槲皮苷含量的近红外光谱定量模型,快速测定槲皮苷含量。方法：用积分球漫反射光谱采样系统测定样品的近红外光谱,做一阶导数预处理,采用偏最小二乘法（Partial Least Squares, PLS）建立定量模型。结果：定量模型的最佳主因子数为7,内部交叉验证均方差为0.096,决定系数 r 为0.998,外部验证预测均方差为0.068,系统精密度 RSD 为0.10％,方法精密度 RSD 为0.60％。结论：建立的预测模型测定侧柏叶配方颗粒中槲皮苷含量,快速、简便可行。     

逍遥颗粒中薄荷挥发油提取工艺研究

目的:优选逍遥颗粒中薄荷挥发油的最佳提取工艺。方法:采用水蒸气提取法提取逍遥颗粒中薄荷挥发油,以挥发油提出量为评价指标,采用单因素法结合正交试验设计优选最佳提取工艺。结果:逍遥颗粒中薄荷挥发油的最佳提取工艺为:加水12倍量,浸泡4 h后,提取4 h。结论:本次实验结果可以为逍遥颗粒中薄荷挥发油提取工艺的确定提供科学依据。     

Immunocytochemical localization of heat-shock protein 60-related protein in Beta-cell secretory granules and its altered distribution in non-obese diabetic mice

Summary Immuno-electron microscopy technique was employed to investigate the cellular distribution of 60 kDa heat-shock protein (HSP60) in pancreatic Beta cells of control and non-obese diabetic mice. In thin sections prepared from control mice, antibody to mammalian HSP60 cross-reacted with protein(s) located to mitochondria and secretory granules. In particular, prominent binding of the antibody was seen to the insulin core of the mature insulin-secreting granules. In comparison, very little immunoreactivity was observed with immature secretory granules or with the Golgi apparatus. No binding to secretory granules or mitochondria was observed with normal mouse serum or with unrelated sera. On Western blots, HSP60 antibody specifically interacted with a single 62 kDa islet cell protein. These results suggest the existence of an HSP60-related protein with a novel location in mature secretory granules of Beta cells. The preferential association of the HSP60-related protein with the insulin core was gradually lost in Beta cells of pre-diabetic non-obese diabetic mice, and correlated with the progression of insulitis. The decrease in the granular binding of the HSP60 antibody was accompanied by an increase in cytoplasm staining, and was concomitant with a significant expansion of the insulin core diameter. The altered distribution of the HSP60-related protein in prediabetic mice, together with our observation that immature secretory granules accumulate in these animals indicate that the presence of HSP60-related protein in secretory granules might be associated with the secretory function of Beta cells.