GMP改造--中药饮片生产企业发展的必由之路

本文主要介绍药品生产质量管理规范（GMP）改造是中药饮片现代化产业发展战略的需要和如何实施中药饮片生产GMP硬件改造。实践证明，通过GMP硬件改造，能够满足我公司中药饮片生产的需要，降低劳动强度，提高生产效率，顺应市场的需要。     

关于开展中药饮片GMP认证咨询服务的通知

各中药饮片生产企业： 国家食品药品监督管理局已决定对中药饮片实施批准文号管理，并启动了中药饮片生产企业GMP认证工作。规定所有中药饮片生产企业必须在2007年底以前通过GMP认证，逾期未通过认证的，不得生产中药饮片。     

我国中药饮片GMP实施现状及对策探讨

目的:为加强我国中药饮片的规范化生产提供建议。方法:通过对2013年9月至2014年9月我国被注销及收回的《药品生产质量管理规范》(GMP)证书的初步统计,分析中药饮片生产成为GMP实施中"重灾区"的原因。结果与结论:2013年9月至2014年9月,我国共有44家中药饮片生产企业的GMP证书被收回,其中1家被注销。从企业角度讲,检验工作困难、原料来源难控制是主要难题,可通过道地药材就近加工、规范上游产业链生产的办法加以解决;从政府角度讲,中药饮片质量标准不完善、GMP规定不能完全适用于中药饮片生产是问题所在。只有实行批准文号管理、完善中药饮片GMP规范体系,才能生产出既符合国情、又继承传统的中药饮片。     

国家食品药品监督管理局关于加强中药饮片生产监督管理的通知

为加强中药饮片生产质量管理，国家局于2004年下发了《关于推进中药饮片等类别药品监督实施GMP工作的通知》，要求“自2008年1月1日起，所有中药饮片生产企业必须在符合GMP的条件下生产”。为做好该项工作，进一步加强中药饮片生产、流通、使用的监督管理，现将有关事宜通知如下：     

山东省食品药品监督管理局积极推进中药饮片生产企业实施GMP工作

为积极推进我省中药饮片GMP认证工作，提高中药饮片生产企业的GMP水平，省局于5月24日～25日在临沂市对中药饮片GMP认证工作进行了专项部署，各市局和50家企业代表参加了会议。会议期间，邀请了国内知名中药饮片GMP专家讲课，组织参观了已通过GMP认证的中药饮片生产企业。会上，省局明确要求企业要认清形势，提高认识，抓紧准备，同时要求企业生产、     

2010年广西中药饮片生产企业GMP跟踪检查情况分析

分析2010年广西中药饮片生产企业跟踪检查中发现的缺陷项目情况,找出中药饮片生产企业实施GMP运行过程中的薄弱环节,对如何加强中药饮片生产企业的技术监督管理提出建议。     

中药饮片GMP

国家食品药品监督管理局近日下发的《关于推进中药饮片等类别药品监督实施GMP工作的通知》。规定,自今年起,未获得《药品GMP证书》的中药饮片生产企业一律不得从事中药饮片的生产经营活动。统计到2007年年底的结果     

中药制剂生产实施GMP的思考

中药制剂生产正面临最好的机遇与最严峻的挑战，必须抓紧国际GMP的实施，带动中药现代化、国际化。从中药制剂生产过程可分为中药前处理、中药提取和剂型制造三个阶段的观点出发，在中药制剂生产实施GMP过程中，应特别注意中药特性，重视对中药材、中药饮片的质量控制，对前处理、提取工艺过程的控制以及对中药提取和储存过程中微生物污染的控制。还就中药制剂生产中质量管理队伍建设，工艺措施和批号管理，规范净药材和中药提取物委托生产GMP管理等提出了讨论意见。     

中药饮片生产企业GMP认证后加强管理的建议

目的促进中药饮片生产企业严格按照《药品生产质量管理规范》(GMP)要求进行管理。方法按照GMP管理内容,根据3个主要影响中药饮片质量的关键因素,提出加强完善的办法和建议。结果与结论GMP认证后的中药饮片生产企业,可以在良好的环境条件下进行有序地生产,生产出符合标准的中药饮片。     

谈对实施GMP的认识

GMP是当前社会药品生产和质量管理的基本准则,主要是说明实施GMP的必要性以及其企业中存在的问题以及对策.     

我国实施药品GMP的回顾与展望

目的推进我国GMP的深入实施。方法回顾了我国实施GMP20年以来的发展历程,针对现存的问题,提出了提高GMP认证水平的方法和思路,展望了我国实施GMP的发展方向。结果与结论我国实施药品GMP至今,制药行业的整体水平实现了历史性的跨越,医药领域新技术、新工艺飞速发展,具备了提升GMP标准的条件,药品GMP事业必将显现出更强大的生命力。     

我国血液制品企业GMP检查缺陷分析及监管思路探索

目的：为完善我国药品GMP管理,提高企业GMP管理水平提供参考。方法：基于检查37家（次）血液制品生产企业在实施GMP中存在的381项缺陷,采用数据统计的方法进行分类评估,并提出针对性建议。结果与结论：目前,在我国血液制品GMP管理中,存在部分企业实施GMP主动意识不强、企业违反GMP成本较低等问题。建议通过落实企业主体责任、加大检查及处罚力度等办法,减少目前我国血液制品GMP监管中的问题。     

Inhibitory effects of guanosine 3'':5''-cyclic monophosphate on the synthesis of dopamine in the rat kidney.

1. In the present study the effects of M&B 22,948, a guanosine 3':5'-cyclic monophosphate (cyclic GMP) selective phosphodiesterase inhibitor and of 8-bromo cyclic GMP were examined on the synthesis of dopamine from L-3,4-dihydroxyphenylalanine (L-DOPA) in rat cortical slices and in whole kidney homogenates. The deamination of newly-formed dopamine into 3,4-dihydroxyphenylacetic acid (DOPAC) was also studied. The assay of L-DOPA, dopamine, noradrenaline and DOPAC was performed by high performance liquid chromatography (h.p.l.c.) with electrochemical detection. 2. Incubation of renal slices and homogenates of whole kidney with exogenous L-DOPA (0.1-10.0 microM) resulted in a concentration-dependent formation of both dopamine and DOPAC. 3. The addition of M&B 22,948 (10 microM) to the incubation medium resulted in a marked reduction in the accumulation of both newly-formed dopamine and DOPAC in kidney slices; the inhibitory effect of M&B 22,948 on DOPAC formation was greater than that on dopamine. 8-Bromo cyclic GMP (250 microM) produced only a slight decrease in the tissue levels of newly-formed dopamine (5-13% reduction), but was found to decrease significantly (51-68% reduction) the formation of DOPAC in kidney slices. The addition of 8-bromo cyclic GMP plus M&B 22,948 to the incubation medium resulted in similar effects to those described for M&B 22,948 alone. 4. In kidney homogenates, in contrast to results observed in kidney slices, M&B 22,948 (10 microM) and 8-bromo cyclic GMP (250 microM) were found to affect neither the formation of dopamine nor its deamination to DOPAC.(ABSTRACT TRUNCATED AT 250 WORDS)     

对GMP实施成果及药品认证风险的理性思考

目的全面实施GMP是我国医药发展史上的一个里程碑。GMP认证检查应确立发展理念,拓展思路,更新方式,规范行为。方法论述了通过实施GMP,我国药品生产企业的生产环境和生产条件发生的根本性转变,制药工业总体水平显著提高。结果实践证明,GMP是行之有效的科学化、系统性的管理手段。结论面对药品安全风险的高发期,需要以积极而理性的社会心态,正视目前存在的质量隐患,强化认证跟踪检查,建立药品安全监管的长效机制。     

1-(4-Aminophenyl)isoquinoline derivatives. Potent inhibitors of calcium-independent and calcium-dependent phosphodiesterases from rat cerebral cortex

The effects of a series of 1-(4-aminophenyl)isoquinoline derivatives on the activity of calcium-independent and calcium-dependent phosphodiesterases purified from rat cerebral cortex were examined. Agents were approximately equipotent (IC50 values, 0.2 to 25 microM) in inhibiting the calcium-dependent hydrolysis of either cyclic AMP or cyclic GMP, while they were 6-35 times more effective as inhibitors of cyclic AMP hydrolysis when compared to cyclic GMP hydrolysis using the calcium-independent enzyme. The diastereomers of 3-(carbomethoxy)propenamido demonstrated a marked difference in specificity. The cis-isomer was very potent in inhibiting cyclic AMP or cyclic GMP hydrolysis by either enzyme (IC50 values, 0.2 to 8 microM) while the trans-isomer was only effective in inhibiting calcium-independent cyclic AMP hydrolysis (IC50 values, 2.5 microM). Kinetic analyses of the type of inhibition of the calcium-dependent enzyme revealed that the various agents were competitive inhibitors of cyclic GMP hydrolysis and noncompetitive inhibitors of cyclic AMP hydrolysis. A reverse pattern of inhibition by the isoquinoline derivatives was found using the calcium-independent phosphodiesterase, i.e. noncompetitive inhibition of cyclic GMP while competitive inhibition of cyclic AMP. Inhibition of phosphodiesterases by these agents was also manifest using intact brain slices prepared from rat cerebral cortex. Thus, the agents were found to potentiate forskolin-elicited accumulations of cyclic AMP by 100-700% and increased the half-time for the decline in cyclic AMP following forskolin stimulation from 3 to 6 min.     

我院2003～2007年药品入库验收中不合格饮片的回顾性分析

目的:探讨中药饮片入库验收把握质量的一般规律。方法:整理、归纳我院2003～2007年中药饮片入库验收记录,分析拒收不合格中药饮片的原因。结果:5年中验收中药饮片5288批次,其中不合格饮片138批次,占验收总数的2.61%。不合格原因有30余种,加工炮制不合规范的饮片被拒收批次最多。结论:提高中药炮制水平是保证饮片质量的当务之急。     

原料药实施新版药品G MP缺陷情况分析

目的：为原料药生产企业实施新版药品 GMP 和进一步完善质量管理体系提供参考。方法对125家次原料药生产企业在新版药品GMP认证中发现的缺陷情况和主要问题进行了统计和分析。结果与结论原料药生产企业应在质量管理体系、人员培训、验证管理和文件管理等方面,规范各项药品生产质量管理活动。     

beta-Adrenergic receptor-mediated increases in mouse cerebellar cyclic GMP levels in vitro

Noradrenaline produced a stereospecific and dose-related stimulation of cyclic GMP levels in incubated mouse cerebellar slices. The effect was mimicked by beta-agonists such as isoprenaline while the alpha-agonist phenylephrine was only weakly active. Experiments with selective beta 1- and beta 2-adrenoceptor agonists and antagonists, indicated that beta 2-receptors are the dominant class involved in the cyclic GMP response.     

Lack of effect of cholinergic agents or endogenous guanosine 3':5'-monophosphate on renin release by slices of rat renal cortex in vitro

Cyclic GMP, in concentrations exceeding 50 μM, and cyclic AMP, in concentrations exceeding 1 μM, significantly increased the release of renin by slices of rat renal cortex. Stimulants of cyclic AMP accumulation, such as epinephrine or norepinephrine, 1 μM, produced a significant increase of renin release but did not alter cyclic GMP levels. In contrast, acetylcholine, carbamylcholine, bethanachol, methachol and NaN₃ increased cyclic GMP accumulation without modifying renin release. These results suggest that exogenous cyclic GMP acts as a weak agonist of cyclic AMP on renin release in renal cortex. The effects observed with exogenous cyclic GMP, however, may not represent a physiological action since various stimulants of endogenous cyclic GMP accumulation did not alter renin secretion.     

实施GMP与目前的工作

目的使我国的GMP工作尽快与国际接轨。方法论述GMP实施过程中存在的问题、现状及对策。结果与结论规范药品生产企业在药品生产过程中的质量管理工作,保证人民用药安全有效。