双藤通脉颗粒对深静脉血栓形成家兔6-酮-PGF_(1α)及PT的影响

目的:观察双藤通脉颗粒对家兔下肢深静脉血栓形成后6-酮-PGF1α及PT的影响。方法:本实验通过结扎家兔的股静脉造成深静脉血栓的模型,共分为:正常组、模型组、双藤通脉颗粒低剂量组、双藤通脉颗粒高剂量组和丹王颗粒组5组,测定各组6-酮-PGF1α及PT的值。结果:双藤通脉颗粒高剂量组、双藤通脉颗粒低剂量组和丹王颗粒组的6-酮-PGF1α及PT的值明显高于模型组(P <0 0 5 ) ,而双藤通脉颗粒低剂量组与丹王颗粒组无明显差异(P >0 0 5 ) ;双藤通脉颗粒高剂量组与丹王颗粒组有明显的差异(P <0 0 5 )。结论:双藤通脉颗粒具有提高6-酮-PGF1α含量、延长凝血时间,从而抑制静脉血栓形成的作用。     

临床试验机构伦理委员会简介

依据世界卫生组织“生物医学研究审查伦理委员会操作指南”和我国“药物临床试验质量管理规范”,成立本机构伦理委员会,对其组成原则、工作职责和议事原则等方面作一简要介绍。     

香加皮临床应用情况及不良反应预防

阐述了香加皮临床应用情况、及其毒性杠柳毒苷来源情况,药理作用等。对香加皮、五加皮(南加皮、北五加皮)进行鉴别,并对香加皮市场药店流出误投现象进行调查。     

八味健骨片Ⅰ期临床试验研究

目的 :观察健康人体对单次和连续口服八味健骨片的耐受性及安全性 ;确定临床服药的安全范围 ;提出Ⅱ期临床试验给药方案。方法 :筛选健康受试者 3 4人 ,分别采用单次给药及连续给药观察该药的安全性和耐受性。结果 :八味健骨片单次给药未出现不良反应 ,连续给药出现恶心、心悸、纳呆、便秘的不良反应 ,但继续用药可自行缓解。结论 :正常人体对八味健骨片的耐受较好 ,临床使用比较安全。建议本品Ⅱ期临床试验的用法为 :口服 ,每次 4片 ,1日 3次。     

射干主根与须根中6种异黄酮类成分的含量比较

目的用HPLC法测定射干主根与须根中射干苷、野鸢尾苷、鸢尾黄素、野鸢尾黄素、次野鸢尾黄素及白射干索6种异黄酮类成分的含量。方法色谱柱：KromasilC18（250mm×4．6mm,5μm）;流动相：0．2％磷酸水溶液（A）和乙腈（B）,梯度洗脱,检测波长265nm,柱温：30℃,流速1．0mL·min-1。结果射干主根中射干苷和鸢尾黄素的含量远远高于须根,主根和须根中野鸢尾苷、野鸢尾黄素和白射干素的含量相差不大（主根略高于须根）,而须根中次野鸢尾黄素的含量稍高于主根。结论该方法能准确简便地分析射干中6种成分的含量,可为射干药材的合理用药提供一定的科学依据。     

治未病学术思想探源及研究展望

“治未病”一词在中国古典医籍中首见于《内经》，其学术思想源于古代哲学，并得到了后代医家的继承与发挥，其内容主要包括养生防病、将病防发、有病早治、既病防变、病盛防危、病后防复几方面。“治未病”学术思想奠定了现代中医预防医学的理论基础，内容丰富，阐述全面，具有无限生机，期待进一步关注、整理、挽救、挖掘和提高。     

脉络宁氯化钠注射液人体耐受性试验研究

南京金陵药业股份有限公司研发的脉络宁氯化钠注射液，是由金银花、玄参、牛膝、石斛等组成的复方制剂，具有清热养阴，活血化瘀之功。现代研究表明：脉络宁具有降低血粘度、提高纤溶活性、防治高凝状态、解除血管痉挛、改善微循环等药理作用，故本品广泛用于各种循环障碍性疾病的治疗。     

紫外分光光度法测定射干中总异黄酮的含量

目的:建立射干药材中总异黄酮的含量测定方法,为控制药材的内在质量提供依据。方法:采用紫外分光光度法对射干药材中的总异黄酮含量测定,测定波长为266nm。结果:射干苷浓度在1~9μg/mL范围内与吸收度呈良好的线性关系(r=0.9998,n=5),平均加样回收率为98.52%(RSD=1.9%,n=5)。结论:该方法准确,简便,重现性好,可用作测定射干中总异黄酮的含量的方法。     

化学发光酶免疫法测定八味健骨片中杠柳毒苷血药浓度的可行性研究

为了建立八味健骨片临床药物动力学研究方法,通过分析组方成分、临床前药学研究结果,估算血药浓度,并经实验证明,地高辛免疫反应药物监测系统可以检出口服八味健骨片、香加皮提取物的动物血清中的强心苷响应值,与给予地高辛片的检出结果一致；在Ⅰ期临床耐受性试验受试者血清中也检出响应值,检测值大小与给药时间、给药剂量相关；临床阴性对照显示,该反应具有特异性。结果提示,可以用地高辛免疫反应临床药物监测系统对杠柳毒苷的交叉反应进行以毒性成分为目标的药物动力学研究。     

Treatment of Patients with Erectile Dysfunction by Shugan Yiyang Capsule(疏肝益阳胶囊):A Multi-Centered Randomized Controlled Trial

Objective: To evaluate the efficacy and safety of Shugan Yiyang Capsule (SGYY, 疏肝益阳ficiency Syndrome type with or without blood stasis. Methods: A multi-centered, randomized, double-blinded, placebo-controlled trial in 304 patients was conducted by dividing them into 3 groups, who received re101), 1.0g taken three times a day for 4 weeks. Besides, 205 patients were arranged in an open-label studyand treated with SGYY 1.0 g taken three times a day for 4 weeks. The total effective rate, total remarkablyeffective rate, erection recovery rate tested by penis hardness test ring, time taken for improving erection among groups, as well as therapeutic effect between psychogenic ED group and mild arteriogenic ED group were compared. Adverse reactions related to SGYY were recorded. And a 3-month follow-up study was conducted on 105 cured patients. Results: The trial was completed in 500 patients. The total effective rate and total remarkably effective rate in the SGYY treated double-blinded group were 88.0% and 64.0% respectively, and those in the open-label group 90.5% and 65.0%, respectively, all significantly higher th an thosein the placebo (21.0%, 6.0%) and SYBS groups (60.0%, 29.0%), P＜0.01. At the same time, the e rection recovery rate and improving time in SGYY group were significantly better than those in other groups ( P＜0.01). No adverse reactions related to SGYY were found. The successful rate of potency to have intercourse within 3 months was over 80% (100 patients out of the 105 cured patients). Conclusion: SGYY was an effective and safe treatment for patients with psychogenic and mild arteriogenic ED of Gan stagnation and Shen deficiency Syndrome type with or without blood stasis, especially for psychogenic ED patients.