直接压片复合辅料及其应用前景

随着片剂生产工业的发展,对多功能性辅料的要求特别是对流动性和可压性的要求也越来越高。复合辅料是2种或是多种已有辅料经过一定的处理得到的亚微颗粒,所有辅料各取所长、优势互补。这种多功能复合辅料显著的减少了片剂中的辅料数量。文章介绍直接压片(direct compression,DC)复合辅料的优势、局限,例举了已经上市的DC辅料及其应用前景。     

进口药用辅料的机遇与风险

药用辅料是药品制剂除活性成分外的赋形剂和附加剂,在安全性方面进行了合理评估。随着2016年国家局发布的《关于调整原料药、药用辅料与药品关联审批审评有关事项的的公告》,国内药用辅料市场发生了巨大的变化,本文主要介绍了国内辅料市场的现状并从政策、贸易战、运输等方面探讨进口药用辅料的机遇和风险。     

功能性辅料的发展和应用

目的综述功能性辅料的研究进展。方法通过查阅国内外文献,阐述了功能性辅料的概念以及各国药典的收录情况。以乳糖、微晶纤维素、滑石粉和吐温80为例,简要介绍了辅料的功能性对制剂的影响。结果与结论通过建立药用辅料的功能性评价平台,合理选择辅料及灵活的工艺,以质量源于设计的理念为指导,可以获得质量可控的产品。     

微粒型口腔崩解片的研究概况

介绍了将药物制成肠溶或缓释的微粒后再与适宜的辅料压制得到微粒型口腔崩解片的技术。综述了其中载药微粒和辅料颗粒的制备方法、辅料的选择等研究概况。     

固体制剂用新辅料的开发

辅料的种类和质量对药物制剂有重要影响。按辅料开发N3种方式：1）研发新的化合物或化学改性：2）对原有辅料进行物理修饰；（3）把两种或多种辅料预混处理得到新的复合辅料，归纳综述了目前固体制剂用新辅料的开发状况和趋势，着重介绍了预混辅料的研发进展。     

我国药用辅料的管理、风险因素分析及监管对策思考

目的:防控药用辅料的风险,加强药用辅料管理.方法:结合药品行业现状,采用法规分析和文献调研法,梳理辅料管理风险因素,提出相应的监管对策.结果:在我国实施辅料关联审评审批制度和药品上市许可持有人制度的背景下,介绍药用辅料管理概况,明确了药用辅料管理各环节风险因素,以及上市许可持有人对辅料供应商质量审计的主要事项.结论:药...     

关联审评政策下药用辅料与药包材变更管理的思考

目的:为我国关联审评审批政策下药用辅料与药包材变更管理制度的实施提供参考.方法:简要介绍了中国、美国、欧盟及日本药用辅料和药包材的管理政策,研究和梳理药用辅料和药包材变更管理制度.结果 与结论:在关联审评审批制度下,药品制剂注册申请人需更加关注药用辅料和药包材对制剂质量的影响,应将药用辅料和药包材科学合理地纳入药品全生...     

我国药用辅料的现状及监管建议

目的促进药用辅料行业健康发展,确保药品安全。方法对目前国内药用辅料生产、使用、管理制度等情况进行总结,分析存在的问题,介绍国外药用辅料的管理经验,提出相关监管建议。结果与结论我国药用辅料行业发展仍相对落后,药用辅料生产、应用、监管等各方面均应予以加强。     

中药软胶囊的辅料与制备工艺研究进展

［摘要］软胶囊是将药材提取物、液体药物与适宜辅料混匀后用滴制法或压制法密封于软质囊材中的胶囊剂。制备软胶囊的辅料分为内容物用辅料包括稀释剂、助悬剂、乳化剂等和囊壳用辅料两部分。介绍了中药软胶囊的囊壳基础处方与新型囊壳制备工艺,以及软胶囊的渗油和老化等问题的解决办法。     

磷脂药物制剂研究进展

磷脂作为药用辅料早有应用 ,它可作为脂肪乳剂的乳化剂、脂质体制剂的主要辅料。以磷脂作为制剂的研究已经引起注意 ,此文不仅在磷脂作为药用辅料方面进行概要介绍 ,而且对以磷脂酰胆碱为主药的制剂及药物与磷脂形成复合物进行了综述 ,以期对新的药物制剂研究提供参考     

老年肾病综合征60例分析

目的了解老年肾病综合征的病因及并发症。方法回顾分析成都铁路分局医院2000年9月至2010年9月及广州南方医院肾内科1992年1月至1999年12月收治的60例老年肾病综合征病例。结果①继发性老年肾病综合征5例。②原发性老年肾病综合征并发症:高脂血症43例,感染9例,急性肾功能衰竭4例,血糖升高4例,消化性溃疡4例。结论①此组患者继发性老年肾病综合征较少。②原发性老年肾病综合征主要并发症:高脂血症、感染、急性肾功能衰竭、血糖升高及消化性溃疡。     

非甾体抗炎药的临床研究新进展

非甾体抗炎药(NSAIDs)是临床上广泛应用的一类具有解热镇痛,大部分还有抗炎、抗风湿作用的药物.非甾体抗炎药的不良反应如消化道损害,肝肾损害发生率较高,针对这些不良发应开发了许多新的药物,如非甾体缓(控)释剂、非甾体和胃肠道保护剂的复方制剂、NO型非甾体药物等.近期研究还发现,非甾体抗炎药除了传统的治疗作用外,对阿尔茨海默病、早产、癌症等疾病均有预防或治疗作用,其临床应用不断扩展.本文就非甾体抗炎药的临床研究新进展作一综述.     

Modes of action of microbially-produced phytotoxins

Some of the most potent phytotoxins are synthesized by microbes. A few of these share molecular target sites with some synthetic herbicides, but many microbial toxins have unique target sites with potential for exploitation by the herbicide industry. Compounds from both non-pathogenic and pathogenic microbes are discussed. Microbial phytotoxins with modes of action the same as those of commercial herbicides and those with novel modes of action of action are covered. Examples of the compounds discussed are tentoxin, AAL-toxin, auscaulitoxin aglycone, hydantocidin, thaxtomin, and tabtoxin.     

Role of animal models in the study of drug-induced hypersensitivity reactions

Drug-induced hypersensitivity reactions (DHRs) are a major problem, in large part because of their unpredictable nature. If we understood the mechanisms of these reactions better, they might be predictable. Their unpredictable nature also makes mechanistic studies very difficult, especially prospective clinical studies. Animal models are vital to most biomedical research, and they are almost the only way to test basic hypotheses of DHRs, such as the involvement of reactive metabolites. However, useful animal models of DHRs are rare because DHRs are also unpredictable in animals. For example, sulfonamide-induced DHRs in large-breed dogs appear to be valid because they are very similar to the DHRs that occur in humans; however, the incidence is only approximately 0.25%, and large-breed dogs are difficult to use as an animal model. Two more practical models are penicillamine-induced autoimmunity in the Brown Norway rat and nevirapine-induced skin rash in rats. The toxicity in these models is clearly immune mediated. In other models, such as amodiaquine-induced agranulocytosis/hepatotoxicity and halothane-induced hepatotoxicity, the drug induces an immune response but there is no clinical toxicity. This finding suggests that regulatory mechanisms usually limit toxicity. Many of the basic characteristics of the penicillamine and nevirapine models, such as memory and tolerance, are quite different suggesting that the mechanisms are also significantly different. More animal models are needed to study the range of mechanisms involved in DHRs; without them, progress in understanding such reactions is likely to be slow.     

青光眼滤过术后眼压失控的原因分析

目的探讨小梁切除术后眼压失控的原因,进一步指导临床,争取进一步降低手术失败率。方法回顾性分析了我院2006年5月到2007年5月收治的术后眼压失控的病例;对其第一次抗青光眼手术前后的情况进行分析,归纳。结果首次在我院接受小梁切除术的病例23例,24只眼,急性闭角型青光眼13例,慢性闭角型青光眼6例,恶性青光眼1例,开角型青光眼2例,先天性青光眼婴幼儿型1例;术前眼压14～24mmHg者7例,25～34mmHg者8例,35～60mmHg者9例,平均眼压33.4mmHg;术前闭角型青光眼房角除2例外均窄IV关闭;术后发生浅前房者9例。结论术前高眼压状态,房角功能差,切除的小梁组织范围小,术后浅前房的发生与术后眼压失控关系密切。     

Analytical aspects of drugs of natural origin

The current importance of drugs of natural origin and their different phytotherapeutical preparations are mentioned. Analytical aspects related to vegetable drugs and their extracts are discussed. An overview is given on procedures used for the isolation of reference compounds, sample preparation for high-performance liquid chromatographic analysis, identification of vegetable drugs and detection of adulterants. The different approaches currently employed for the standardization of extracts are presented. The various aspects are discussed with the aid of illustrative examples.     

我院2013年一季度门诊处方点评分析

目的 了解医院门诊处方质量和合理用药情况,通过对门诊处方书写常见问题的分析,促进和提高本院合理用药水平.方法 每月随机抽查25名的门诊医师,每个医师随机抽查50份共1350份处方进行点评、统计和分析.结果 有178张处方存在不合理现象,占13.19%,处方书写不规范166张,处方用药不适宜22张.超常处方5张,分别占全部抽查处方的比率为12.30%、1.63%、0.37%.结论 门诊处方尚存在许多问题,处方合格率有待提高.     

600例老年人胃钡餐检查结果分析

目的探讨老年人胃的发病情况。方法以600例老年人为研究组,3000例非老年人为对照组,通过双对比造影检查结果进行对照分析。结果3000例对照组中,2700例胃炎,46例胃溃疡,142例十二指肠球部溃疡,胃息肉l8例,胃食管返流45例,食管裂孔疝10例,胃平滑肌瘤4例,胃癌22例。600例研究组中,516例胃炎,20例胃溃疡,28例十二指肠球部溃疡,胃息肉6例,胃食管返流60例,食管裂孔疝10例,胃平滑肌瘤6例,胃癌54例。结论老年人胃溃疡、胃食管返流、胃癌发病率高于非老年人。     

Pharmacotherapy of onychomycosis

Fungal infections of the nails are frequent in some segments of the population. Dermatophytes, yeasts and moulds are potential pathogens. A series of antifungal treatments are available to the clinician, differing by both their mechanistic nature and mode of administration. The pharmacodynamic and pharmacokinetic properties of each antifungal agent are distinct. This review focuses on the characteristics of amorolfine, bifonazole, ciclopirox, fluconazole, griseofulvin, itraconazole, ketoconazole, ravuconazole, R126638 and terbinafine. Single drug treatments and combined therapies are presented. None of the current drug regimens have demonstrated reliable efficacy against all cases of onycho-mycosis. Treatment failures, relapses and reinf-ections remain stubborn pro-blems in the management of onychomycosis.     

Proof of the general validity of Dost's law of corresponding areas

Summary In Part I, assumptions made in the construction of pharmacokinetic models and the solutions derived from them are discussed. It is shown that, under certain conditions, the drug in any compartment of a general model can be described by a sum of exponentials, where the exponents are the eigenvalues and the factors the components of the eigenvectors of the kinetic matrix. In Part II proof is presented that Dost's Law of corresponding areas is universally valid for any compartment model if linear processes are assumed to occur. Two practical examples are analysed.