淋巴结核丸对MDR-TB感染小鼠的保护性及内脏病变程度影响的实验研究

目的:观察淋巴结核丸对耐多药结核菌(mutiple drugs resistant Bacillus tuberculosis,MDR-TB)的体内抑菌作用.方法:用MDR-TB感染小白鼠,观察其小白鼠存活率和内脏病变指数.结果:实验表明淋巴结核丸对MDR-TB感染的小鼠具有显著的保护作用,保护率分别为70%、80%,而异、利、乙组无保护作用;肺病变指数高、低剂量组分别为0.10和0.52,均具有抑制结核病变的作用,而异、利、乙组无效;在肺、肝、脾菌培与异、利、乙组相比具有非常显著性差异P<0.01,而异、利、乙组与实验空白对照组相比无明显差异P>0.05.结论:淋巴结核丸对MDR-TB感染小鼠具有明显的保护作用;该药具有抑制小鼠肺结核病变、抑制降低肺、脾、肝脏器内的结核杆菌的作用.而异烟肼、利福平、乙胺丁醇组对MDR-TB无抑菌作用.     

正交试验优选蜂胶软胶囊的最佳压丸工艺

目的优选蜂胶软胶囊压制法的最佳工艺路线和工艺参数,以确保产品质量的稳定。方法采用正交试验方法,以崩解时限为指标,以定型时间、干燥温度、相对湿度、干燥时间为因素进行正交试验,优选蜂胶软胶囊的最佳压丸工艺。结果最终确定最佳工艺为：定型时间12 h,干燥温度25℃,相对湿度30%,干燥时间24 h。结论优选工艺合理,保证了产品质量的稳定。     

槐花散与槐角丸治疗Ⅰ期内痔出血疗效对比探讨

目的：分析总结槐花散与槐角丸治疗Ⅰ期内痔出血的临床疗效及临床使用参考价值。方法选取2013年3月-2014年9月来该院就诊的Ⅰ期内痔出血患者62例，以随机数字表法分为槐花散组和槐角丸组，每组各31例，其中槐花散组应用槐花散进行治疗，疗程为1周；槐角丸组患者服用槐角丸，疗程为1周，分析比较两组患者临床疗效及并发症发生情况。结果槐角丸组患者中，13例显效、14例有效、4例无效，其总有效率为87.1%明显低于槐花散组的23例、8例及100.0%，槐花散组疗效更佳，槐角散组患者中，有1例肠胃不适，有1例肛门不适，并发症发生率6.5%明显低于槐角丸组的3例、3例及19.4%，槐花散组并发症发生率更低，结果差异有统计学意义（P<0.05）。结论槐花散与槐角丸应用于Ⅰ期内痔出血均具有肯定疗效，但槐花散疗效更高，安全性高，值得临床推广应用。     

丹栀逍遥丸联合心理护理对结直肠癌术后抑郁焦虑状态及细胞因子表达的影响

目的:分析丹栀逍遥丸联合心理护理对结直肠癌(CRC)术后病人抑郁焦虑状态的作用及机制.方法:CRC术后患者46例,随机均分为丹栀逍遥丸联合心理护理组(联合组)和对照组,联合组术后化疗时进行丹栀逍遥丸联合心理护理干预,对照组仅进行术后化疗;应用汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)对2组患者进行评分,应用Luminex技术检测血清人肿瘤坏死因子α(TNF-α)、白介素6(IL-6)、白介素1 β(IL-1β)表达水平.结果:联合组HAMD评分显著低于对照组,差异有统计学意义(P＜0.05),两组HAMA评分差异无统计学意义(P＞0.05);与对照组比较,联合组TNF-α、IL-6显著降低,差异有统计学意义(P＜0.05),两组IL-1β差异无统计学意义(P＞0.05).结论:丹栀逍遥丸联合心理护理降低术后化疗CRC病人炎性细胞因子水平,改善抑郁心境.     

归脾丸对乙醇致胃溃疡作用研究

目的：探讨归脾丸抗乙醇致小鼠胃溃疡的机制,为临床使用中药治疗乙醇致胃溃疡提供理论依据。方法：该实验通过检查胃溃疡指数,检测血清和胃组织中NO含量,测定血浆及胃黏膜中GSH-PX的含量,来观察归脾丸对乙醇致小鼠胃溃疡的影响。结果：归脾丸能明显降低溃疡指数（P〈0.01）,提高血清和胃组织中NO含量（P〈0.01）,归脾丸能明显提高乙醇致小鼠胃溃疡模型中血浆和胃黏膜中GSH-PX的含量（P〈0.05）。结论：归脾丸可对抗乙醇致胃溃疡。     

藏药独一味滴丸治疗阻生齿拔除术后并发症疗效观察

目的:观察独一味滴丸治疗阻生齿拔除术后并发症的临床疗效。方法:将62例患者随机分为治疗组、对照组各31例。2组均在拔牙术后进行创面常规处理。治疗组术后口服独一味滴丸,疗程3～5天;对照组口服甲硝唑,疗程5～7天。在服药3天后依据拔牙创面有无疼痛、出血和创面感染情况评价疗效。结果:总有效率治疗组为93.55%,对照组为77.42%,2组相比差异显著。结论:独一味滴丸治疗阻生齿拔除术后并发症疗效显著。     

理气活血滴丸治疗老年慢性稳定型心绞痛有效性及安全性的随机对照多中心临床研究

目的对理气活血滴丸Ⅳ期临床研究中老年患者数据进行分析,系统评价理气活血滴丸在老年慢性稳定型心绞痛人群广泛使用条件下安全性和有效性。方法2016年3月至2017年8月于上海长征医院等41家中心随机纳入慢性稳定型心绞痛患者2433例,其中老年患者1142例,口服理气活血滴丸,10粒/次,3/d,连服4周。进行老年患者有效性、安全性和生活质量等指标的分析。结果服用4周后,老年患者心绞痛症状有效率71.50%,硝酸甘油停减率84.40%,心电图疗效有效率57.08%,共发生不良事件45例(3.95%)。和筛选期相比,治疗4周后患者生活质量显著提高(P<0.001)。结论理气活血滴丸治疗老年慢性稳定型心绞痛疗效可靠,安全性好,患者生活质量明显提高,值得临床推广应用。     

复方丹参滴丸与普罗布考联用溶解颈动脉斑块的近期疗效观察

目的复方丹参滴丸联用普罗布考、阿司匹林溶解软斑块,以达到对干预急性冠脉综合征及脑梗死发生的临床观察。方法将1000例颈动脉粥样硬化斑块的患者随机分为两组,治疗组563例,给予复方丹参滴丸10丸,3次/d,口服;普罗布考500mg,2次/d,口服;阿司匹林300mg,1次/d,口服,2周后改为100mg,1次/d,口服,共28d。对照组437例,给予普罗布考及阿司匹林口服(用法、用量同治疗组),并对两组进行疗效对比。结果治疗组中有231例在28d的治疗中斑块完全溶解,249例斑块缩小,有效率85.3%;对照组中105例斑块消退,99例块缩小,有效率46.7%。治疗组在用药期间未发生肝、肾功能异常变化。结论复方丹参滴丸对颈动脉斑块溶解疗效确切,联合用药比单一西药治疗效果显著。     

Implementation of two sustainable chromatographic methods for the simultaneous micro-quantitation and impurity profiling of metformin and rosuvastatin in recently approved fixed dose pills: Greenness and whiteness studies

Rosuvastatin-Metformin is an emerging fixed dose combination (FDC) for the treatment of diabetes mellitus-associated dyslipidemia. Generally, the beneficial outcomes of FDC in reduction of pills burden, cost and complexity of medications protocols, encouraged analysts and we in turn for the development of rapid sustainable analytical methods for the simultaneous estimation of such important drug combinations. Within this framework, two validated analytical methodologies have been implemented for the neat separation and quantitation of metformin (MET) and rosuvastatin (RSV) in presence of the pharmacopeial impurities cyanoguanidine (CYG) (impurity A of MET) and the rosuvastatin-related substance B (RSV-impurity B). The latter was freshly prepared and then confirmed using Liquid Chromatography-Mass spectrometry (LC-MS). Method I represented the first electro-driven separation method for the assay of this FDC using Micellar Electrokinetic Chromatography (MEKC). The optimized conditions were 50 mM borate buffer containing 100 mM sodium dodecyl sulfate (SDS) at pH 9.2 using a deactivated fused silica capillary (50 cm effective length × 50 μm id). Method II was High Performance Liquid Chromatography (HPLC) method using Microsorb MV-C18 (4.6 × 250 mm, 5 μm particle size) column with 20 mM sodium dihydrogen phosphate buffer (pH 3.5), acetonitrile and methanol as mobile phase constituents. The separation was achieved with a linear gradient program and flow rate 1.5 mL/min all over the run. The Diode Array Detector (DAD) detector was set at wavelengths 243 nm for RSV and 235 nm for MET in both methods. The 4 peaks were separated in about 8 and 5 min for methods I and II, respectively. Linear relationships were obtained between peak areas and concentrations of metformin and rosuvastatin in the ranges 10–100 μg/mL for MEKC and 1–150 μg/mL for HPLC. The 2 techniques fulfilled the International Council for Harmonization (ICH) validation criteria, as well as the green and white analytical chemistry principles which were evaluated using the trendiest AGREE, hexagon and RGB12 tools. The interpretation of scores indicated that the suggested methods outperformed the reported methods in terms of eco-friendliness and sustainability. They offered fast, feasible, stability indicating and accurate analysis of both drugs in bulk and in pills.