丹参片对冠状动脉药物支架术后患者远期预后的临床研究

[目的]观察丹参片对冠状动脉药物支架术后患者远期预后的影响。[方法]80例冠脉动脉药物支架术后1年的患者随机分为对照组与治疗组,治疗组在服用规范西药治疗基础上加服丹参片6个月,随访两组的临床终点事件。[结果]术后再梗率、PCI术、CABG术、心源性疾病住院率、术后脑中风中,两组间（P〉0.05）无统计学意义。然心功能衰竭发生率、心功能分级、心绞痛分级、自觉疗效（P〈0.05）有统计学意义,其中心绞痛分级（P〈0.01）有显著统计学意义。[结论]丹参片对冠状动脉药物支架术后患者有远期疗效。     

扶正化瘀片治疗肝炎后肝硬化的研究

Objective: To investigate the efficacy and safety of the Fuzheng Huayu Tablet (扶正化瘀片, FZHYT), which is used to reinforce qi and resolve stasis in patients with posthepatitic cirrhosis (PHC). Methods: A multicenter, randomized, controlled clinical trial was conducted in 180 patients with PHC. The patients were randomly assigned using random numbers to a treatment group treated with FZHYT and a placebo group; the treatment course was 6 months for both groups. Overall response, adverse events (AEs), and the 2-year survival rate were assessed after treatment. Evaluations were made on changes in liver function, liver fibrosis, coagulation, hemodynamics, degrees of esophagogastric varices, ascites, quality of life (QOL), and scores of main symptoms. Results: The overall response was significantly higher in the treatment group than the placebo group (86.7% vs. 62.2%, P<0.01). Patients in both groups had signi?cant improvements in liver function [total bilirubin (TBIL), albumin (ALB)], liver fibrosis [hyaluronic acid (HA), type Ⅳ collagen (CⅣ)], coagulation [prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), and thrombin time (TT)], hemodynamics portal venous flow (PVF), and splenic vein flow (SVF) after treatment. Between-group comparisons showed that compared with the placebo group patients in the treatment group achieved significantly greater improvements in TBIL, ALB, HA, C Ⅳ, PT, APTT, PVF, SVF, time to ascites resolution, 2-year survival, QOL, and symptom scores (P<0.05 or P<0.01). There were no significant AEs during the treatment. Conclusions: FZHYT is effective and safe for the treatment of hepatic cirrhosis as it is associated with improved liver function, liver ?brosis, coagulation, portal hypertension state, QOL, 2-year survival rate, and fewer AEs.     

The Influence of Engravings on the Sticking of Tablets. Investigations with an Instrumented Upper Punch

The purpose of this study was to investigate the influence of engravings on the sticking of tablets. Therefore, an instrumented upper punch capable of measuring the pull-off force, which occurs when the punch detaches itself from the upper surface of a tablet, was equipped with small cones of different angles between the punch face and the cones’ lateral face. The cones could be screwed into a threaded hole at the center of the punch face. The adhesion forces of two formulations known to stick to engravings during production increased with a greater steepness of the cones’ lateral face. With microencapsulated acetylsalicylic acid, no quantitative differences could be found between the adhesion forces obtained with plain and modified punch faces, indicating that the sticking behavior of the substance was not affected by shear forces. Starch 1500® showed higher adhesion force signals in comparison to those obtained with a plain punch face. Microcrystalline cellulose, which gave no adhesion force signals with a plain punch face and did not stick to the cones, showed distinct pull-off signals. The instrumented upper punch equipped with shear cones is a valuable instrument for detecting the adhesion caused by engravings and is therefore a helpful tool for tablet formulation development and the design optimization of tablet identification.     

正清风痛宁片含量测定方法改进

目的:采用HPLC法测定正清风痛宁片中青藤碱含量。方法:色谱条件为:采用Kromasil-C_(18)柱,以乙腈-0.78%磷酸二氢钠溶液(12:88)为流动相;检测波长:265nm;流速1ml·min~(-1);柱温:30℃。结果:青藤碱在0.38～1.92μg范围内具有良好的线性关系,r=0.9999。平均回收率为98.3%,RSD=0.8%。结论:本法操作简单,重复性好,准确,可用来控制本制剂质量。     

反相高效液相色谱法同时测定四维钙片中多种维生素含量

目的对四维钙片中的维生素C（VitC）、维生素B1（vitB1）及维生素B2（VitB2）进行含量测定。方法采用反相高效液相色谱法，使用Zorbax Eclipse XDB—C8柱（150mm×4．6mm，5μm），流动相为0．05％乙酸溶液（含0．005mol／L己烷磺酸钠、1．3％三乙胺，用冰醋酸调节pH值至3．5）-甲醇（90：lO），检测波长为254nm。结果VitC，VitB1，，VitB2质量浓度分别在7～60μg／mL，1～10μg／mL，1～10μg／mL范围内与峰面积线性关系良好，r分别为0．9998，0．9997，0．9998（n=8）；平均回收率分别为100．3％，99．1％，98．5％，RSD分别为1．2％．1．5％．1．6％（n=9）。结论该方法准确、简单,能够有效控制制剂的质量。     

Figures of Merit Comparison of Reflectance and Transmittance Near-Infrared Methods for the Prediction of Constituent Concentrations in Pharmaceutical Compacts

The purpose of this work was to demonstrate how multivariate figures of merit, in conjunction with accuracy and precision statistics, can be used to evaluate the performance of near-infrared reflectance and transmittance spectroscopy for the nondestructive chemical quantification of intact pharmaceutical compacts. A total of 174 four-component compacts were produced at five compaction pressures following a fully balanced quaternary design. Near-infrared spectra were measured in both reflectance and transmittance modes. Partial least-squares regression was used to model spectroscopic response, and net analyte signal theory was used to generate the figures of merit. It was discovered that sample positioning variation more negatively impacted the performance (analytical sensitivity, S/N ratio, limit of detection) of the transmittance method. Process analytical technology implementation teams should consider these aspects during technology selection, method development, and validation.     

高效液相色谱法测定清心片中丹酚酸B的含量

[目的]建立高效液相色谱(HPLC)对清心片中丹酚酸B的定量分析方法.[方法]采用HPLC法.色谱柱:YMC-pack C18柱(150mm×4.6mm,5μm);流动相:甲醇-乙腈-甲酸-水(3:10:1:59);检测波长:286nm;柱温:25℃.[结果]丹酚酸B质量浓度与峰面积呈良好的线性关系.丹酚酸B的平均回收率为99.62%,RSD为1.46%(n=8).[结论]该方法可用于清心片中丹酚酸B的含量测定.     

HPLC法测定灵仙跌打片中齐墩果酸的含量

目的:建立灵仙跌打片中齐墩果酸的高效液相色谱测定方法。方法:采用高效液相色谱法测定,Hypersil ODS-C18(200 mm×4.6 mm,5μm)色谱柱,甲醇-0.5%的冰乙酸溶液(84∶16)为流动相,检测波长210 nm,流速:1.0 mL.min-1,柱温:室温,进样量10μL。结果:齐墩果酸在0.3506-2.1036μg具有良好的线性关系,r=0.9998;平均加样回收率为98.77﹪,RSD%为1.02﹪(n=6)。结论:该方法操作简单,重现性好,适用于灵仙跌打片中的齐墩果酸含量测定。     

了哥王片总黄酮含量测定方法的研究

目的:为制定了哥王片的含量测定方法提供科学的依据。方法:采用可见分光光度法对了哥王片中的总黄酮进行含量测定。结果:本方法具有准确、重复性好、稳定可靠,其平均回收率100.8%(RSD=1.2%)。结论:该法可作为制定了哥王片含量测定的方法。     

虎杖浓缩片的制备工艺及含量测定

目的：优化虎杖浓缩片的制备工艺，测定其中有效成分含量。方法：以崩解时限、吸湿性、外观作为评价指标对处方工艺进行筛选，制备虎杖浓缩片，用HPLC和差示分光光度法分别测定有效成分的含量。结果：最佳处方组成为每片含主药（总有效部位）0．195g、乳糖0、08g、微晶纤维素0．10g、羧甲基纤维素钠0、02g、硬脂酸镁0．002g。所制片剂硬度较好，外观光洁。白藜芦醇苷、白藜芦醇、大黄素、大黄素甲醚和总蒽醌等有效成分的含量测定结果符合规定。结论：本法处方合理。工艺简单，适用于工业化生产。