壳聚糖用于金银花等絮凝澄清研究

目的 研究壳聚糖絮凝技术用于金银花、栀子药材的中药水提液精制的可行性.方法 考察两种澄清法的沉淀效果对主要有效成分含量影响,并对其稳定性进行了比较.结果 壳聚糖絮凝法与醇沉法同样能使药液澄清,前者保留药液中的有效成分比醇沉法多,壳聚糖絮凝法缩短生产周期,降低成本.结论 壳聚糖絮凝法可代替乙醇沉淀法用于金银花、栀子药材的中药水提液的澄清.     

Study of the influence of coating methods on lipid spheres manufactured on rotor fluidized bed process

Abstract

Different previous works have shown that various kinds of spheres can be manufactured by rotor granulation in a ‘single-pot process’ using a lipid base: hydrogenated castor oil. This single-pot technology is based on wet granulation where all components are placed in the powder form in the rotor bowl; then, they are continuously suspended in a fluidized air, with a tangentially sprayed liquid solution. This process allows the granulation and manufacturing of sphere during the same time. Previous experiments have studied the influence of the formulation and the manufacturing process parameters on spheres in terms of feasibility and dissolution properties. Both the spraying time and the weight of liquid sprayed were found to be the most relevant parameters that govern the final quality of the sphere. Now, in a second part of the work, a first comparison is made with two different fluid bed methods: the tangential rotor spray and the Wurster bottom spray for coating the lipid spheres previously manufactured with the rotor tangential spray. The external aspect of the coated spheres manufactured has been evaluated with an electronic microscopy analysis and a study of dissolution properties of the active ingredient has been done by USP in vitro dissolution tests.     

氨酸法工艺在复合肥料生产中的应用

介绍氨酸法工艺用于复合肥料生产的发展进程及其特点,比较了氨酸法管式反应器工艺与氨酸法料床直接反应工艺的优缺点.进行了初步的技术经济比较.氨酸法工艺用于传统团粒法生产装置的改造切实可行.     

抗肿瘤药泰克地那林的合成工艺改进

以4-乙酰氨基苯甲酸(2)为原料,与草酰氯反应,不经分离,直接与2-硝基苯胺反应得到中间体N-(2-硝基苯基)-4-乙酰氨基苯甲酰胺(4),再经催化氢化得到泰克地那林.以4-乙酰氨基苯甲酸计,总收率为22.2%,目标化合物的结构经质谱、红外光谱及核磁共振氢谱确证,该合成工艺简单易行.     

Two approaches for bio-lubricant production from soybean oil with organosilicon

With the rapid increasing of environmental pollution concerns and declining petroleum assets, bio-based lubricants industry has aroused increasingly more attention and study. The present paper proposed two methods (a two-step process and a direct hydrosiylation process) for the production of biolubricant from soybean oil with organosilicon. At first, soybean oil was subjected to transesterification with potassium hydroxide under certain conditions. Then, the transesterified soybean oil was undergone urea inclusion for obtaining unsaturated fatty acid methyl esters (UFAMEs). After urea inclusion, the content of UFAMEs was increased to 88.1%. Next, the chemical modification of UFAMEs by the two-step process (epoxidation and ring-opening reaction) and the direct hydrosiylation process (with triethylsilane in present of catalyst) were systematically studied, respectively. With the optimal conditions, the conversions of UFAMEs in the two-step process and direct hydrosiylation process were 86.1% and 82.1%, respectively. In addition, the structure characteristics of material and products were determined by Fourier-transformed infrared (FTIR) spectroscope and ²⁹Si-Nuclear magnetic resonance (²⁹Si-NMR) spectrascopy. The lubrication performances of the two products were proved to be much better than soybean oil according to industry standards. Therefore, both of the two processes appeared to be feasible for bio-lubricant production.     

不同方法提取淫羊藿苷的正交试验研究

目的 :筛选淫羊藿苷最佳提取方法和提取工艺条件。方法 :分别采用乙醇回流法和乙醇超声波法提取淫羊藿苷 ,并以淫羊藿苷的含量为指标 ,对提取工艺中的乙醇用量、乙醇浓度、提取时间、提取次数等因素进行考察。结果与结论 :乙醇回流法对淫羊藿苷的提取效果优于乙醇超声法 ;乙醇回流法提取淫羊藿苷的最佳提取工艺条件是用8倍药材量的60 %乙醇提取淫羊藿3次 ,每次40min。     

烟拉文的合成工艺改进

以烟酸为原料,与氯甲酸乙酯反应,生成混合酸酐,再与1,2-丙二胺反应得到烟拉文粗品,通过形成二硝酸盐再碱化的方法得到烟拉文纯品.以1,2-丙二胺计,总收率为38.8%,结构经IR、MS及1H-NMR确证,该合成工艺简单易行.     

门诊药房服务对门诊整体服务流程优化的影响

门诊药房是医院门诊服务系统的重要组成部分，同时也是提升医院门诊服务质量的关键环节之一。本文研究了流程管理理论在门诊管理和门诊药房管理中的应用，分析了门诊药房服务模式，讨论了门诊药房服务管理对门诊整体服务流程优化的影响。     

常规控制图在药品生产过程控制中的应用

摘 要 目的：通过建立常规控制图,掌握产品质量指标的变化情况,避免不合格情况发生。方法: 根据不同类型质量参数的特点及控制要求,选取几类有代表性的参数,对监测结果进行处理,绘制质量控制图,以确认生产过程是否受控。结果:通过分析控制图,可让操作人员尽快发现特殊原因导致的过程变异,并采取纠正/预防措施,确保产品持续符合既定的质量标准和工艺规程。结论:常规控制图可作为药品生产过程的监控工具,能减少不合格品率,使产品质量得到持续提升。     

绿色制药工艺的研究进展

本文概述了制药工业中绿色化学的起源和发展,展示了绿色制药工艺的研究前沿和课题,介绍了常用的绿色技术、技巧和手段,分析了塞来昔布、西他列汀、普瑞巴林、沙格列汀、阿瑞匹坦、埃索美拉唑、多奈哌齐等药物的合成工艺改进.     

肥胖患者两种低位硬膜外穿刺法的比较

目的比较肥胖患者两种低位硬膜外穿刺法的成功率、置管顺利度及术后腰痛的发生率。方法对120例盆腔及下肢手术的肥胖患者随机分为A、B两组,A组为旁入法,B组为直入法,作为对照组。每组各60例。A组结合人体脊柱解剖特点,采用棘突中点旁开1．5cm处为穿刺点,沿对应棘突进行穿刺;B组采用直入法以棘突间隙中点为穿刺点,垂直进针。观察两组病人穿刺的成功率、置管顺利度及术后腰痛的发生率。结果A组穿刺成功率98．33%,B组为66．67%,差异具有显著性(P＜0．05)。差异具有统计学意义(P＜0．05)。A组置管顺利度96．7%,B组为56．7%。具有显著差异性(P＜0．01)。A组术后腰痛的发生率3%,B组为20%,差异亦有显著性(P＜0．01)。结论肥胖患者低位硬膜外棘突中点旁入法优于直入法,值得推广应用。     

两种粒状过磷酸钙生产工艺的比较

介绍粒状过磷酸钙干燥工艺与免干燥工艺的生产方法,投资、成本和效益对比。说明免干燥工艺投资少、成本低、效益好,但产品强度、质量不如干燥工艺,2种方法生产粒状过磷酸钙产品都是过磷酸钙企业提高效益的好途径。     

盐酸左布诺洛尔的合成工艺改进

以5-羟基-α-萘满酮与R-环氧氯丙烷反应，生成中间产物5-(2，3-环氧丙氧基)-α-萘满酮，不经分离，直接加入叔丁基胺反应得游离碱，盐酸成盐后得到了盐酸左布诺洛尔。该工艺路线可简化反应，使产率达到60％，光学纯度大于90％。     

化学药品注射剂灭菌工艺选择及工艺验证常见问题探讨

注射剂的灭菌是保证制剂质量和用药安全的重要工艺步骤,本文结合日常技术审评经验,从灭菌工艺选择、工艺验证内容及工艺验证中常见问题等方面,对化学药品注射剂灭菌工艺选择及验证中常见问题进行探讨。     

注射用奈达铂的制备及质量研究

目的 对注射用奈达铂的制备工艺及质量检测进行研究.方法 对使用的溶剂和赋形剂进行筛选,确定处方,并通过对pH值范围、活性炭用量和冻干工艺进行筛选,确定其制备工艺;采用高效液相色谱法测定制剂的含量和有关物质.结果 最佳处方为奈达铂50 mg,右旋糖酐150 mg,乙醇适量.pH值范围为6.5～7.5,活性炭用量0.1％;最佳冻干过程为--40℃预冻6h,18 h内升温至25℃,25℃再干燥4h.结论 本品制备工艺可靠,适于工业化生产,质量可控.     

辛伐他汀的半合成

报道了从洛伐他汀(lovastatin)合成调血脂药辛伐他汀(simvastatin)，用三甲基氯硅烷保护活泼羟基，通过胺解、羟基保护、甲基化、去保护等反应合成了辛伐他汀，通过元素分析，IR，UV，^1H—NMR，^13C—NMR及MS证实其结构。     

Optimization of Conditions for Preparing 2- to 5-Micron-Range Gelatin Microparticles by Using Chilled Dehydration Agents

Pharmaceutical Research -     

Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

PURPOSE: The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. MATERIALS AND METHODS: The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. RESULTS: The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. CONCLUSIONS: Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.     

我国药品首次工艺验证存在问题及探讨

通过调查研究的方法,找到我国制药企业在首次工艺验证中普遍存在的问题,借助对国内外法规及相关文献研究,并结合我国制药企业的现状,提出对问题的解决策略,该研究对我国制药企业有效开展首次工艺验证有一定的指导意义。     

妥布霉素结晶工艺的改进

采用加晶种控制结晶的方式进行妥布霉素结晶工艺改进，并考察了结晶过程中乙酸添加量、搅拌速度、晶体淋洗等因素对结晶收率、效价的影响。改进工艺的结晶产率及效价得到提高，取得良好效果。