药品包装的质量控制

在制药生产中，为了保证药 品的质量始终如一，方便药物的 使用，并最终构成为商品，需对 药品进行包装。广义上的包装是 指包装材料的选用、标准的制 订、验收、预处理、存贮及药品的 包装过程。 药用包装材料包括两大类， 一类是直接接触药品的包装材 料、容器（包括油墨、粘合剂、衬 垫填充）。本类包装材料的管理 应视同原料的管理。另一类是指 除直接接触药品的包装材料、容 器外的材料，如包装盒、袋、箱、 说明书及不直接与药品接触的 盖子等。 一、内包装材料的质量控制 １、必要的验证。由于内包装 材料在相当长的一段时间内与 产…     

直接接触药品的包装材料和容器管理办法

第一章总则 第一条为加强直接接触药品的包装材料和容器(以下简称"药包材")的监督管理,保证药包材质量,根据<中华人民共和国药品管理法>(以下简称<药品管理法>)及<中华人民共和国药品管理法实施条例>,制定本办法.     

药品包装材料与药物相容性研究的现状及展望

常用药品包装材料是指直接接触药品的包装材料和容器.目前主要药品包装材料有5类：玻璃、橡胶、塑料、陶瓷和金属.直接接触药品的包装材料,与内在药物合起来才称为药品.药品生产企业或医院制剂室,在选择使用不同的药品包装材料时,既要考虑到药品包装材料对内在药品质量的保护作用,更要注意药品包装材料与药品的相容性,防止药品包装材料中的有毒有害物质迁移到药品中,或者对药品活性成分有吸附作用,使药品的疗效下降甚至消失.药品包装材料与药物是不可分割的,药品包装材料对保证内在药物质量的稳定性、有效性和安全性起着至关重要的作用.为了选择合适的药品包装材料,就必须要进行药品包装材料与药物的相容性试验,这是一种评价药品包装材料性能优劣、质量好坏的最直观的有效方法.本文综述了药品包装材料与药物相容性试验的基本思路,包括玻璃材料、塑料材料及橡胶材料等与药物相容性试验的研究现状,并对我国的药物相容性研究进行了展望.     

国家食品药品监督管理局要求进一步加强直接接触药品的包装材料和容器监管

为贯彻实施《直接接触药品的包装材料和容器管理办法》,2004年8月9日,国家食品药品监督管理局印发了《关于进一步加强直接接触药品的包装材料和容器监督管理的通知》。《通知》指出:自2004年7月20日起,凡列入《直接接触药品的包装材料和容器管理办法》中的直接接触药品的包装材料和容器产品,按《直接接触药品的包装材料和容器管理办法》规定申请注册。2004年7月20日前各省、自治区、直辖市食品药品监管部门按《药品包装用材料、容器管理办法(暂行)》已经批准注册的《药包材注册证》继续有效,待有效期届满后按《办法》规定申请再注册。《通知…     

变更直接接触药品包装材料或容器的要求及研究验证

目的总结变更直接接触药品的包装材料或容器的补充申请要求及其研究验证。方法分别阐述了变更直接接触药品的包装材料或容器、变更非无菌液体或半固体制剂包装容器的大小和/或形状、固体制剂包装系统中的干燥剂和惰性填充物的前提条件及研究验证工作。结果与与结论变更直接接触药品包装材料或者容器的补充申请较为多见,在补充申请事项中占有相当大的比例。参考《药品注册管理办法》和《已上市化学药品变更研究的技术指导原则》,认真细致地做好相应的变更研究验证和申报工作,能从根本上保证变更直接接触包装材料或容器后的药品质量。     

浅谈药品内包装材料存在的问题及改进

包装是药品不可缺少的组成分部,只有选择恰当的包装材料和包装方式,才能真正有效地保证药品质量和广大人民群众的用药安全.随着我国药品市场的日趋完善,处方药、非处方药的分类管理,都对药品的包装提出了更高的要求,特别是现在<国家药品监督管理局令>第十三号<直接接触药品的包装材料和容器管理办法>的实施加强了药品内包材的管理.现在药品的包装不仅应具有保护药品的作用,还应有便于使用、贮存、运输、环保、耐用、美观、易于识别等功能.     

药品内包装材料影响液体制剂质量的几种现象

内包装是直接接触药品的包装,是影响药品质量的一个重要因素。然而目前不少医院自制制剂的内包装材料没有系统的采购计划,质量波动较大,甚至发生因为容器不符合要求和包装不善致使药品质量下降或变质情况。现谈谈工作中发现的内包装材料影响液体制剂的几种现象。 1.胶塞中氧化锌含量较多,使胶塞脆性增加,输     

谈中成药内包装与药物相容性问题

《药品管理法》第六章第五十三条规定"药品包装必须适合药品质量的要求,方便储存、运输和医疗使用".并在第五十二条指出"直接接触药品的包装材料和容器,必须符合药用要求,符合保障人体健康、安全的标准".药品监督管理局2000年10月15日首次以局长令的形式颁布了《药品包装、标签和说明书管理规定》.规定中指出药品的包装分内包装与外包装.并分别强调内外包装的要求:药品内包装材料、容器的更改,应根据所选用药品包装材料的性质而定,并做相应的稳定性实验,考察药品包装材料与药品的相容性;外包装应根据药品的特性选用不易破损的包装材料,进一步保证药品在运输、储藏及使用过程中的安全性.总之合理的选用药品包装材料,在保障药品质量中发挥着重要作用.     

药品生产质量管理规范（2010年修订）检查指南

第四十四条药品生产企业使用的直接接触药品的包装材料和容器，必须符合药用要求和保障人体健康、安全的标准，并经国务院药品监督管理部门批准注册。直接接触药品的包装材料和容器的管理办法、产品目录和药用要求与标准，由国务院药品监督管理部门组织制定并公布。     

药品包装材料对药品质量和安全性的影响

常用药品包装材料是指直接接触药品的包装材料和容器。目前主要药品包装材料有4类:玻璃、橡胶、塑料和金属。药品包装材料与其所包装药品有可能发生相互影响,例如可吸收药品中的有效成分而降低其疗效,也可释出一些有害物质而损害机体组织。因此,应加强药品包装材料的质量控制,根据药品特性正确选用包装材料,并应注意包装材料相关的药品安全问题。     

Effects of cadralazine on the respiration, circulation, kidney, autonomic nervous system, digestive system, blood and so on

The general pharmacological effects of cadralazine and its major metabolite ISF 2405 were studied by comparing them with those of hydralazine. Cadralazine at 3.0 mg/kg, i.v., increased respiratory movement and heart rate and decreased blood pressure in cats. Cadralazine at 3.0 mg/kg, i.v., inhibited the hypertensive response induced by adrenaline, but showed little effect on the hypotensive response induced by acetylcholine in cats. Cadralazine and ISF 2405 at 10(-4) g/ml had negative chronotropic effects on isolated guinea-pig atria. The drug at 2.5 mg/kg, p.o., inhibited the passage of BaSO4 in the gastrointestinal tract in mice. The drug at 5.0 mg/kg, i.d. or more inhibited gastric secretion in rats. Cadralazine, except at higher doses, had little effect on spontaneous gastric motility and uterine spontaneous movement in rats. Cadralazine at 2.5 mg/kg, p.o., or more reduced or tended to reduce urine volume and urinary excretion of electrolytes. The drug showed little effect on coagulation and osmotic fragility in blood cell in rats nor on hemolysis and platelet aggregation in rabbits. ISF 2405, however, showed slight or moderate influence on hemolysis at concentrations as high as 0.01-1.0%. Cadralazine at 5.0 mg/kg, p.o. or more antagonized carrageenin-induced hind paw edema in rats. In conclusion, these effects of cadralazine were found to be qualitatively identical with those of hydralazine.     

L-Tryptophan's effects on mouse killing, feeding, drinking, locomotion, and brain serotonin

Injections of the serotonin precursor l-tryptophan (25, 50, and 100 mg/kg IP), inhibited mouse killing behavior in rats, as indicated by a dose dependent increase in latencies to attack and kill mice. Tests in 24 hr food deprived rats revealed that feeding behavior was also significantly decreased by about 30% by tryptophan injections (50--100 mg/kg IP). Concomitant with the behavioral changes were increased levels of brain serotonin and its metabolite 5-hydroxyindoleacetic acid. Drinking, latencies to sniff mice, and ability to locomote on a rotating rod were not affected by l-tryptophan injections, although spontaneous activity in an open field was reliably reduced by 33% with a dose of 100 mg/kg. Thus, while the degree of selectivity for tryptophan's effects on behavior remains open to question, these findings are consistent with hypotheses of an inhibitory role for central serotonergic systems, particularly in mouse killing and feeding behaviors.     

Effects of BRL38227, salbutamol,and aminophylline,alone and in combination,on plasma potassium and on the heart

The present study was undertaken in order to examine the effects of the potassium channel activator BRL38227 and of aminophylline on hypokalaemia, cardiac stimulation (increased heart rate and contractility, dQ/dt), and electrocardiogram (ECG) changes induced by the β₂-adrenoceptor agonist, salbutamol in the anaesthetised cat. Salbutamol (1.25 μg.kg^?1min^?1), but not BRL38227 (0.1–1.0 μg.kg^?1 min^?1), infusion elicited a marked hypokalaemia (plasma K⁺ >2.5 mmolliter ^?1). This dose of salbutamol also elicited an immediate cardiac stimulation which appeared to be maximal and changes in ECG were evident as a reduction in QTc interval (20%) and T-wave height (80%). Cardiac stimulation following either BRL38227 or aminophylline was more gradual in onset, the maximum response being about 50–80% of the salbutamol effect. No ECG changes were observed in cats receiving BRL38227 whilst T-wave amplitude was reduced (50–60%) following aminophylline. Combination of salbutamol with aminophylline resulted in a greater degree of hypokalaemia, cardiac stimulation, and T-wave depression. The salbutamol-induced reduction in QTc was converted to a slight prolongation after infusion for 75 min. The ECG changes observed were not indicative of arrhythmia. Conversely, BRL38227 had no effect on salbutamol-induced hypokalaemia, cardiac stimulation, or T-wave depression, though the degree of QTc interval shortening was reduced. When BRL38227 was administered in conjunction with aminophylline, plasma potassium and QTc were unchanged. Depression of T-wave amplitude by aminophylline was slightly reduced in the combination group. Effects on heart rate and dQ/dt were similar to those seen for BRL38227 alone. Salbutamol-induced hypokalaemia was reversed by the nonselective β-adrenoceptor antagonist, propranolol, but not by the β¹-adrenoceptor selective antagonist, atenolol, confirming a β²-adrenoceptor selective effect. Cardiac stimulation was reversed by both propranolol and atenolol. In conclusion, salbutamol-induced hypokalaemia, cardiac stimulation, and ECG changes, as well as the additive effect of aminophylline, were demonstrated in the anaesthetised cat, but were unchanged by BRL38227. Furthermore, combination of BRL38227 with aminophylline did not result in any adverse effects on the parameters measured. Thus, on the basis of these results in the cat, combination of BRL38227 with the bronchodilator drugs, salbutamol or aminophylline, would not be expected to exacerbate the cardiovascular effects of these drugs. © 1992 Wiley-Liss, Inc.