鲁抗集团千吨青霉素生产基地生产车间全部通过国家GMP认证

2001年11月10日,国家药品认证管理中心的专家一行3人来到鲁抗集团,对该公司千吨青霉素生产基地的201车间进行了为期两天的GMP认证检查。专家组对201车间的生产现场、文件记录等进行了严格、细致的检查,对该车间的GMP管理工作给予了充分肯定,同意上报国家药品监督管理局颁发认证证书。至此,鲁抗集团千吨青霉素生产基地的生产车间全部通过了国家GMP认证。201车间是鲁抗集团最早建成投产的半合青生产车间,主要生产6-APA、氨苄西林、阿莫西林和氨苄西林钠,为了使该车间尽快通过国家GMP认证,增强产品的市场竞争力,鲁抗集团于2001年7月份投…     

GMP模拟车间在制药工程专业人才培养中的应用研究

目的：探讨GMP模拟车间在制药工程专业人才培养中的地位和作用。方法通过对GMP模拟车间及制药工程专业教育现状进行分析,突出GMP模拟车间在提高制药工程专业人才培养质量方面的地位和作用,并以山东中医药大学为例展示现阶段GMP模拟车间的建设进程及教学成果。结果与结论目前,我国制药工程专业本科教育存在实践平台缺失、实践机会少、学生动手能力差等一系列问题,因此,各高校应重视GMP模拟车间的建设,全面提升制药工程专业人才培养质量,为我国制药行业的长足发展注入更加优质的人才资源。     

鲁抗集团兽药产品通过国家农业部兽药GMP认证验收

2005年12月5日,由国家农业部委派的兽药GMP认证专家一行4人来到鲁抗集团,对这个公司的10个兽药原料药车间和1个兽药制剂车间进行了为期3天的GMP验收。兽药GMP认证专家在听取了鲁抗公司负责人对公司兽药生产车间的厂房布局、生产工艺等相关内容的介绍后,深入到生产现场,对鲁抗公司的仓储管理、组织机构、人员设置、厂房设备、生产质量管理、文件记录等软、硬件进行了严格细致的验收检查。认证专家认为鲁抗公司目前的兽药生产符合国家兽药GMP管理规定,同意向国家农业部推荐颁发兽药GMP认证证书。至此,鲁抗公司的11个兽药生产车间顺利通…     

北京双鹤药业股份有限公司片剂分厂实施GMP认证的调查报告

北京双鹤药业股份有限公司片剂分厂是原北京药厂在双桥的片剂车间。改制后,更名为北京双鹤药业片剂分厂。但分厂管理的范围仍然是片剂生产车间这部分。物料进厂、成品出厂、仓库管理、产成品检验及留样观察仍属于公司。因此,我们的调查也主要以车间生产管理为主。 该厂是通过对1994年7月建成的老车间改造实施GMP的。1994年建厂时的思路也是按GMP要求设计的。但是并没有完全达到GMP要求,也没有按GMP要求来管理。生产能力原为25亿～30亿片/年,改造以后,实际达到     

标准操作规程与GMP实施的关系探讨

本文结合个人工作情况及输液生产车间特点论述了药品生产车间标准操作规程的特点、包含的内容以及在生产过程控制和GMP实施中的重要性,阐明了完善的软件系统(标准操作规程)是实施GMP管理的基础和先决条件。标准操作规程只有随着国家GMP要求的不断发展,逐步完善和更新,才能在保证产品质量与可靠性,降低原材物料消耗,提高企业经济效益等方面发挥必要的作用。     

GMP实施与认证课程实践教学模式改革探索

GMP作为国家推行的保证药品生产过程质量的强制性规范,实践性极强。针对GMP实施与认证课程传统教学中存在的问题,对实践教学模式进行改革探索,完善实训资源建设,提高课程的实践性,培养符合药品生产岗位实际需要的人才。     

"九五"期间鲁抗公司有19个车间通过国家GMP认证

截至2000年11月份,山东鲁抗医药集团有限公司的主要产品,包括头孢类粉针剂、口服固体制剂;头孢类无菌原料药;青霉素粉针剂、口服固体制剂;青霉素类口服原料药;兽用抗生素原料药;普通口服原料药;生物制品;注射剂和大输液等的19个生产车间顺利通过了国家GMP认证,从而使该公司成为国内通过GMP认证车间最多、品种最齐全的制药企业。 “九五”期间,该公司产品质量管理体系成为该企业各项专业管理体系中运行最规范、保证措施最有效、成果最突     

鲁抗集团投资600余万元对片剂车间进行GMP改造

20 0 1年 8月份 ,山东鲁抗集团公司投资 6 0 0余万元对该公司的片剂车间进行了系统的GMP改造。改造后的片剂车间已成为完全符合GMP要求 ,能生产非 β -内酰胺类药的口服固体制剂车间 ,也可生产多品种、高质量的片剂、胶囊和颗粒剂 ,具有年产片剂 7.2亿片、胶囊 1亿粒、颗粒剂 2 5 0万包的生产能力。该车间于 10月 1日正式投料生产 ,10月 15日产出的 3批成品 ,经该公司质监部门按照药典标准、企业内控标准严格检验 ,各项指标全面达标鲁抗集团投资600余万元对片剂车间进行GMP改造@马敬勇…     

浅谈药品GMP及强化实施的政策和措施

我国制药工业企业从80年代初开始引进GMP概念,至今已将近20年,走过了一个学习、认识、实践的历史过程,对药品GMP有了较为深刻的理解,也在实践中广泛运用,加强了药品生产全过程的质量管理,提高了企业管理水平,保证了药品质量。截至1999年12月的资料,获得原中国药品认证委员会颁发的药品GMP认证证书的企业或车间有87个,已通过原国家医药管理局组织评审的达标企业或车间有227个,通过国家药品监督管理局(SDA)组织的GMP认证检查的企业和车间有92个,另有30多家血液制品企业通过GMP认证,上述企业(或车间)合计400多个,占全国6000多家企业的7％。连同最近SDA公布的获得GMP认证证书的90家企业和车间,全国获得GMP认证的     

按GMP要求设计车间工艺布局的一些体会

工艺布局的合理与否是制剂车间,原料药精、烘、包车间在新建或技术改造中体现《药品生产管理规范》(简称GMP)的成败关键,在推行实施GMP中一般同志都希望能有1～2个标准模式,以便大家模仿套用,但事实上,由于各厂条件不一,要求不一很难做到。关于工艺布局设计的准则在中国医药工业公司颁布的《药品生产管理规范》和《实施指南》中已作了规定。但在实际设计过程中要使设计的车间符合GMP规定,除了设计     

Efficacy of gut lavage,hemodialysis, and hemoperfusion in the therapy of paraquat or diquat intoxication

Clinical and in vitro investigations were carried out to test the efficacy of gut lavage, hemodialysis, and hemoperfusion in the treatment of poisoning with paraquat or diquat. In a patient suffering from diquat intoxication 130 times more diquat was removed by gut lavage 30 h after ingestion than was removed by complete aspiration of the gastric contents.Determination of in vitro clearances for paraquat and diquat by hemodialysis showed that, at serum concentrations of 1–2 ppm, such as are frequently encountered in poisoning in man, toxicologically relevant quantities of herbicide cannot be removed from the body. At a concentration of 20 ppm, on the other hand, hemodialysis proved to be effective, the clearance being 70 ml/min at a blood flow rate of 100 ml/min. The efficacy of hemoperfusion with coated activated charcoal was on the whole better. Especially at concentrations around 1–2 ppm, the clearance values for hemoperfusion were some 5–7 times higher than those for hemodialysis.In a patient suffering from paraquat poisoning, both hemodialysis as well as hemoperfusion were carried out. The in vitro results could be confirmed: At serum concentrations of paraquat less than 1 ppm no clearance could be obtained by hemodialysis while by hemoperfusion with activated charcoal quite high clearance values were measured and the serum level dropped down to zero.

---

Zusammenfassung Klinische Untersuchungen und Laboratoriumsversuche wurden durchgeführt, um die Wirksamkeit von Darmspülung, Hämodialyse und Hämoperfusion bei Paraquat- und Deiquat-Vergiftungen zu prüfen.Bei einem Patienten wurde 30 Std nach Deiquat-Aufnahme durch Darmspülung 130mal mehr Deiquat entfernt als durch vollständige Aspiration des Mageninhaltes. In vitro-Versuche ergaben, daß bei Blutserumkonzentrationen von 1–2 ppm, die bei Vergiftungen oft gemessen werden, durch Hämodialyse keine toxikologisch relevanten Paraquat- oder Deiquat-Mengen entfernt werden können. Dagegen erwies sich die Hämodialyse bei 20 ppm und einer Blutumlaufgeschwindigkeit von 100 ml/min mit einer Clearance von 70 ml/min als wirksam. Die Hämoperfusion mit beschicheter Aktivkohle war in diesen Versuchen aber eindeutig überlegen, denn insbesondere bei Konzentrationen um 1–2 ppm waren die Clearance-Werte 5–7mal höher als bei der Hämodialyse.Die in vitro-Ergebnisse wurden bei einem Patienten mit einer Paraquat-Vergiftung bestätigt: Bei Konzentrationen unter 1 ppm war die Hämodialyse wirkungslos, während durch Hämoperfusion relativ hohe Clearance-Werte erreicht wurden, so daß der Serumspiegel rasch unter die Nachweisgrenze abfiel.

     

In vitro studies on sterically stabilized liposomes (SL) as enzyme carriers in organophosphorus (OP) antagonism

This study describes a new approach for organophosphorous (OP) antidotal treatment by encapsulating an OP hydrolyzing enzyme, OPA anhydrolase (OPAA), within sterically stabilized liposomes. The recombinant OPAA enzyme was derived from Alteromonas strain JD6. It has broad substrate specificity to a wide range of OP compounds: DFP and the nerve agents, soman and sarin. Liposomes encapsulating OPAA (SL)* were made by mechanical dispersion method. Hydrolysis of DFP by (SL)* was measured by following an increase of fluoride ion concentration using a fluoride ion selective electrode. OPAA entrapped in the carrier liposomes rapidly hydrolyze DFP, with the rate of DFP hydrolysis directly proportional to the amount of (SL)* added to the solution. Liposomal carriers containing no enzyme did not hydrolyze DFP. The reaction was linear and the rate of hydrolysis was first order in the substrate. This enzyme carrier system serves as a biodegradable protective environment for the recombinant OP-metabolizing enzyme, OPAA, resulting in prolongation of enzymatic concentration in the body. These studies suggest that the protection of OP intoxication can be strikingly enhanced by adding OPAA encapsulated within (SL)* to pralidoxime and atropine.     

Aquatic Insects and Trace Metals: Bioavailability,Bioaccumulation, and Toxicity

Abstract

The uptake of metals from food and water sources by insects is thought to be additive. For a given metal, the proportions taken up from water and food will depend both on the bioavailable concentration of the metal associated with each source and the mechanism and rate by which the metal enters the insect. Attempts to correlate insect trace metal concentrations with the trophic level of insects should be made with a knowledge of the feeding relationships of the individual taxa concerned. Pathways for the uptake of essential metals, such as copper and zinc, exist at the cellular level, and other nonessential metals, such as cadmium, also appear to enter via these routes. Within cells, trace metals can be bound to proteins or stored in granules. The internal distribution of metals among body tissues is very heterogeneous, and distribution patterns tend to be both metal and taxon specific. Trace metals associated with insects can be both bound on the surface of their chitinous exoskeleton and incorporated into body tissues. The quantities of trace meals accumulated by an individual reflect the net balance between the rate of metal influx from both dissolved and particulate sources and the rate of metal efflux from the organism. The toxicity of metals has been demonstrated at all levels of biological organization: cell, tissue, individual, population, and community. Much of the literature pertaining to the toxic effects of metals on aquatic insects is based on laboratory observations and, as such, it is difficult to extrapolate the data to insects in nature. The few experimental studies in nature suggest that trace metal contaminants can affect both the distribution and the abundance of aquatic insects. Insects have a largely unexploited potential as biomonitors of metal contamination in nature. A better understanding of the physico-chemical and biological mechanisms mediating trace metal bioavailability and exchange will facilitate the development of general predictive models relating trace metal concentrations in insects to those in their environment. Such models will facilitate the use of insects as contaminant biomonitors.     

Steroidal sapogenin contents in some domestic plants

In order to find out the values of the steroid resources for the future use. the compositions and contents of steroidal sapogenins from 13 domestic plants have been investigated. As a result,Dioscorea nipponica, D. quinqueloba andSmilax china were found to have large amount of diosgenin. And pennogenin inTrillium kamtschaticum andParis verticillata, yuccagenin inAllium fistulosum, hecogenin inAgave americana and neochlorogenin inSolanum nigum were appeared to be major steroidal sapogenins.     

Pharmacological treatment of COVID-19: an opinion paper

The precocity and efficacy of the vaccines developed so far against COVID-19 has been the most significant and saving advance against the pandemic. The development of vaccines has not prevented, during the whole period of the pandemic, the constant search for therapeutic medicines, both among existing drugs with different indications and in the development of new drugs. The Scientific Committee of the COVID-19 of the Illustrious College of Physicians of Madrid wanted to offer an early, simplified and critical approach to these new drugs, to new developments in immunotherapy and to what has been learned from the immune response modulators already known and which have proven effective against the virus, in order to help understand the current situation.     

Alzheimer’s disease – current trends in basic and clinical research. Highlights from the 16th ECNP

Advances in the molecular biological knowledge of neuronal nicotinic acetylcholine receptors (nAChRs) have led to a growing interest by the pharmaceutical industry in the development of novel compounds that selectively modulate nAChR function. The ability of (-)-nicotine, an activator of nAChRs, to enhance attentional aspects of cognition in animals and humans, to exert neuroprotective and anxiolytic-like effects, and presumably to mediate the negative correlation between smoking and Alzheimer's (and Parkinson's) Disease, has focused interest on the potential therapeutic utility of modulators of nAChR function for treatment of some of the deficits associated with these progressive, neurodegenerative conditions. Numerous compounds are known which activate nAChRs and which might serve as lead compounds toward the development of such agents. The pharmacologic diversity of neuronal nAChR subtypes suggests the possibility of developing selective compounds which would have more favourable side-effect profiles than existing agents. This broader class of agents, collectively called cholinergic channel modulators (ChCMs), is anticipated to encompass compounds which would have more favourable side-effect profiles than existing agents, which generally exhibit low selectivity. This selectivity may be achieved by preferentially activating some subtypes of nAChRs (i.e., Cholinergic Channel Activators, ChCAs) or inhibiting the function of other subtypes (Cholinergic Channel Inhibitors, ChCIs). An overview of the biology of nAChRs and the rationale for the use of ChCMs for the treatment of dementia related to neurodegenerative diseases are presented, followed by a discussion of lead compounds and compounds under consideration for clinical evaluation.