医药论文英文摘要中的常见错误与评改

1 .中文文题、摘要 (见 2 0 0 2年第 2 1卷第 1 2期 80 9～ 81 0页 )胃肠分溶型补脾益肠丸包衣工艺与崩解时限的研究[摘　要 ]　目的 :通过对不同包衣材料及配比生产的胃肠分溶型补脾益肠丸崩解时限的考察 ,找出该双层丸的崩解时限与包衣工艺的相关性。方法 :应用喷雾包衣工艺 ,经处方、工艺筛选改变肠溶丸粒径、包衣厚度、膜材料种类及配比。结果 :用改进后适当配比肠溶丙烯酸树脂Ⅱ作肠溶包衣材料的包衣工艺 ,能克服按传统工艺生产的肠溶丸在肠液中不易崩解的缺点 ,提高了工艺技术 ,使崩解时限由 (5 9.5± 2 .6)min缩短到 (2 0 .5± 2 .1)…     

用正交设计法研究肠溶衣片的包衣工艺条件

本文用正交设计法研究了温度、材料用量及包衣速度三因素,对肠溶衣片崩解时限的影响。在本实验条件下(一次包衣数量为20万片,平均片重为0.2g)制备的肠溶衣片其最佳工艺条件为:热风温度20℃、包衣材料用量135ml/万片、包衣速度100ml/min。     

头孢克肟肠溶滴丸的制备及其质量评价

目的:制备头孢克肟肠溶滴丸并评价其质量。方法:采用滴制法制备头孢克肟滴丸,并包肠溶衣,以圆整度、重量差异及溶散时限作为评定指标,设计正交试验对包衣材料、包衣液浓度、包衣层数进行考察,优选出肠溶滴丸的最佳包衣工艺并进行验证试验,同时考察制剂的体外累积释放度。结果:最佳包衣工艺为包衣材料聚丙烯酸树脂Ⅱ号,包衣液浓度10%,包衣层数3层。验证试验表明制剂的各项指标均符合《中国药典》2010年版相关要求;45min时在碱性释放介质(pH=6.8)中体外累积释放度为(93.4±1.67)%。结论:头孢克肟肠溶滴丸的制备工艺合理,在碱性介质中释放完全,质量合格。     

兰索拉唑肠溶微丸胶囊的制备

目的:制备兰索拉唑肠溶微丸胶囊。方法:采用流化床包衣技术,在空白丸芯上依次包以主药层、隔离层和肠溶层,制备成兰索拉唑肠溶微丸,将肠溶微丸装入普通胶囊制成兰索拉唑肠溶微丸胶囊,并考察3批制剂的载药率及在人工肠液和人工胃液中的释放情况。结果:所制微丸圆整度高,外观亮泽,载药均匀、载药率高(平均值在96%以上),包衣效果好;其在人工肠液中45min的体外累积释放率大于(94.3±0.76)%,在人工胃液中2h的释放量小于(6.2±1.6)%。结论:所制兰索拉唑肠溶微丸胶囊工艺可行,重现性良好,质量稳定可靠,具有良好的体外释药性和耐酸力。     

硫酸亚铁糖衣片崩解迟缓问题的解决

目的:解决硫酸亚铁糖衣片崩解迟缓问题.方法:将滑石粉、淀粉以3:1比例混合均匀后代替滑石粉使用,将玉米朊代替明胶使用.结果:改进后工艺生产的硫酸亚铁糖衣片的崩解时限小于30 min.结论:用玉米朊(包隔离层),滑石粉、淀粉(3:1)的混合粉做包衣材料,能明显缩短硫酸亚铁糖衣片的崩解时限.     

胃康灵胶囊崩解迟缓问题的解决

目的:解决胃康灵胶囊崩解迟缓问题.方法:对细粉包衣工艺和崩解时限进行考察.结果:工艺改进后生产的胃康灵胶囊的崩解时限小于20min,能明显缩短胃康灵胶囊的崩解时限.     

蒜氨酸微丸-蒜酶肠溶双层片制备工艺优选及体外抗肿瘤作用评价

目的 优选蒜氨酸微丸-蒜酶肠溶双层片的制备工艺,并评价其体外抗肿瘤作用.方法 以蒜氨酸的累积释放率为评价指标,以崩解剂种类和用量、肠溶衣用量及微晶纤维素(MCC)与蒜氨酸的质量比为考察因素,采用单因素试验优选蒜氨酸微丸的制备工艺;以大蒜辣素产率为评价指标,以蒜酶层中MCC的用量、包衣温度为考察因素,采用单因素试验优选蒜...     

多酶片崩解时限的探讨

多酶片为肠溶衣与糖衣的双层包衣片，其崩解时限的检查，即不能按肠溶衣片项下的规定检查，也不能按糖衣片项下的规定检查，本文探讨了多酶片崩解时限的检查方法。     

呋喃妥因HPMCP包衣片质量及人体生物利用度研究

本文采用新研制开发的肠溶辅料羟丙基甲基纤维素酞酸酯（ＨＰＭＣＰ）将呋喃妥因制成肠溶薄膜衣片，实验考察了包衣片剂质量及用尿药法测定了其了其人体生物利用度，并与呋喃妥因市售片及丙烯酸树肠溶衣片进行了比较。体外质量考察结果表明，ＨＰＭＣＰ包衣片硬度及脆碎度与二种对照片相当；ＨＰＭＣＰ包衣片及丙烯酸树脂包衣片的崩解时限分别为２．４９±０．２１）ｍｉｎ和（７．４９±１．１７）ｍｉｎ，其溶出度参数Ｔ５０则分别     

奥美拉唑肠溶微丸制备及其质量影响因素探讨

目的研究奥美拉唑肠溶微丸制备方法及影响因素.方法采用挤压-滚园法制备微丸,逐渐滚成圆球形,用中性包衣材料隔离后方可包肠溶衣.结果使用了MCC∶淀粉＝7∶ 10(w/w)混合物做稀释剂,使用挤出-滚圆法制丸,圆整度好的微丸,处方中添加高效崩解剂释药速率有所提高.结论该方法可广泛应用于奥美拉唑肠溶微丸制备,质量稳定.     

Polymer Blends Used for the Coating of Multiparticulates: Comparison of Aqueous and Organic Coating Techniques

PURPOSE: The purpose of this study was to use polymer blends for the coating of pellets and to study the effects of the type of coating technique (aqueous vs. organic) on drug release. METHODS: Propranolol HCl-loaded pellets were coated with blends of a water-insoluble and an enteric polymer (ethyl cellulose and Eudragit L). Drug release from the pellets as well as the mechanical properties, water uptake, and dry weight loss behavior of thin polymeric films were determined in 0.1 M HCI and phosphate buffer, pH 7.4. RESULTS: Drug release strongly depended on the type of coating technique. Interestingly, not only the slope, but also the shape of the release curves was affected, indicating changes in the underlying drug release mechanisms. The observed effects could be explained by the higher mobility of the macromolecules in organic solutions compared to aqueous dispersions, resulting in higher degrees of polymer-polymer interpenetration and, thus, tougher and less permeable film coatings. The physicochemical properties of the latter were of major importance for the control of drug release, which was governed by diffusion through the intact polymeric films and/or water-filled cracks. CONCLUSIONS: The type of coating technique strongly affects the film microstructure and, thus, the release mechanism and rate from pellets coated with polymer blends.     

包衣工艺对布地奈德结肠定位片控释衣膜的影响

目的:优化布地奈德结肠定位片控释衣膜的包衣工艺。方法:采用单因素试验考察喷枪位置、喷液速度、喷气雾化压力、片床温度、进风温度及进风流量等包衣参数对定位片微孔型半透膜和肠溶膜包衣的影响。结果:确定喷枪口离片床距离约10～20cm;微孔型半透膜及肠溶膜包衣液的喷射速度分别为3、1mL·min-1,喷气雾化压力分别为2、1.5bar(1bar=105Pa),进风温度分别为50～55、40～45℃,片床温度分别为(40±1)、(30±1)℃,进风流量分别为5、7m3·min-1;采用优化的包衣参数制得的布地奈德结肠定位片半透膜包衣增重10%,肠溶膜包衣增重5%,24h体外累积释放度为(77.5±8.6)%,释药时滞为(6.0±0.5)h。结论:优化后的包衣工艺适合布地奈德结肠定位片控释衣膜包衣。     

干法包衣技术及应用

目的综述了干法包衣技术的特点、设备、常用辅料及影响因素,并对其在药剂学上的应用进行了简述。方法查阅国内外文献,对干法包衣进行整理、归纳、总结。结果干法包衣技术应用范围广,操作简便。结论干法包衣技术发展迅速,为药物制剂发展提供了广阔的前景。     

Near-Infrared Spectroscopic Monitoring of the Film Coating Process

Purpose. The purpose of this study was to investigate the potential of near-infrared (near-IR) spectroscopy for non-destructive at-line determination of the amount of polymer coat applied to tablet cores in a Wurster column. Methods. The effects of coating composition on the near-IR spectroscopic determination of ethylcellulose (Aquacoat ECD-30) or hydroxypropylmethylcellulose (HPMC)-based (Spectrablend) coating were evaluated, as were the performance of several chemometric techniques. Results. Tablets were coated with up to 30% ethylcellulose or 22% HPMC, and samples were pulled at regular intervals during each coating run. Near-IR reflectance spectra of the intact tablets were then collected. The spectra were preprocessed by multiplicative scatter correction (MSC) or second derivative (D2) calculations, and calibrations developed using either principal components (PCs) or multiple spectral wavelengths. The near-IR method provided predictions of film applied with standard errors of 1.07% w/w or less. Conclusions. Near-IR spectroscopy can be profitably employed in a rapid and non-destructive determination of the amount of polymer film applied to tablets, and offers a simple means to monitor the film coating process.     

The Effect of Swelling Characteristics of Superdisintegrants on the Aqueous Coating Solution Penetration into the Tablet Matrix During the Film Coating Process

The mechanism and the extent of sorption of water molecules by tablets containing superdisintegrants and microcrystalline cellulose, following the aqueous film coating of formulated tablets, were investigated. The penetration of water from the coating solution into the tablet matrix resulted in significant changes in physical properties of the coated tablet cores, such as residual moisture content, tensile strength, and pore-size distribution. The swelling and the morphological characteristics of each individual disintegrant compound and microcrystalline cellulose were found to have important implications on the extent of penetration of water from the aqueous film coating solution. A hypothesis concerning the interaction between microcrystalline cellulose and the superdisintegrant particles present in the tablet matrix is proposed.     

盐酸莫西沙星涂膜剂的制备与质量控制

目的制备盐酸莫西沙星涂膜剂,建立其质量控制方法。方法以壳聚糖为凝胶材料制备盐酸莫西沙星涂膜剂,采用高效液相色谱（HPLC）法测定盐酸莫西沙星含量。结果盐酸莫西沙星质量浓度在10．0～100．0μg／mL范围内与峰面积线性关系良好,平均回收率为100.04％,RSD为0．55％（n＝6）。结论该涂膜剂制备工艺简单;HPLC法方便可靠,可用于该制剂的质量控制。     

Coating Formulations for Microneedles

Purpose To develop a rational basis for designing coating solution formulations for uniform and thick coatings on microneedles and to identify coating strategies to form composite coatings, deliver liquid formulations, and control the mass deposited on microneedles. Materials and Methods Microneedles were fabricated using laser-cutting and then dip-coated using different aqueous, organic solvent-based or molten liquid formulations. The mass of riboflavin (vitamin B₂) coated onto microneedles was determined as a function of coating and microneedle parameters. Coated microneedles were also inserted into porcine cadaver skin to assess delivery efficacy. Results Sharp-tipped microneedles, including pocketed microneedles, were fabricated. Excipients that reduced coating solution surface tension improved coating uniformity, while excipients that increased solution viscosity improved coating thickness. Evaluation of more than 20 different coating formulations using FDA approved excipients showed that hydrophilic and hydrophobic molecules could be uniformly coated onto microneedles. Model proteins were also uniformly coated on microneedles using the formulations identified in the study. Pocketed microneedles were selectively filled with solid or liquid formulations to deliver difficult-to-coat substances, and composite drug layers were formed for different release profiles. The mass of riboflavin coated onto microneedles increased with its concentration in the coating solution and the number of coating dips and microneedles in the array. Coatings rapidly dissolved in the skin without wiping off on the skin surface. Conclusions Microneedles and coating formulations can be designed to have a range of different properties to address different drug delivery scenarios.     

铁笛丸包衣工艺改进的研究

目的：解决铁笛丸糖衣变色等外观质量难题。方法：4种改进方法与原法所得产品留样对比观察。结果：4种改进方法的产品均符合外观质量要求。结论：包隔离层冷热吹风法最好。     

水性薄膜包衣技术在骨仙片生产的工艺研究

目的确定骨仙片水性薄膜包衣工艺方法。方法采用水性薄膜包衣技术,考察骨仙薄膜衣片和骨仙糖衣片包衣工艺,比较其外观、水分、崩解时限、抗热性、抗湿性及抗磨性等质量因素。结果实验结果表明,骨仙薄膜衣片,其外观、崩解时限、抗热性、抗湿性、抗磨性均优于其糖衣片。结论骨仙片水性薄膜包衣工艺可替代其糖衣工艺。