中药黑膏药制剂生产中的质量风险管理

通过对危害分析与关键控制点（HACCP）的概念、优点和应用原则的简单介绍,将其应用于中药黑膏药制剂的生产过程,以对黑膏药进行质量风险管理。对黑膏药的生产过程进行危害分析得到11个关键控制点,通过对关键控制点的控制、关键限值的建立、纠正措施的制定等对黑膏药实施质量风险管理。     

氯雷他定分散片的制备及影响因素考察

目的制备符合质量要求的氯雷他定分散片。方法采用湿法制粒,单冲压片制备氯雷他定分散片。正交试验优选处方,对优化处方进行分散时限和溶出度考察。结果优选处方制备的氯雷他定分散片质量稳定。结论所选的处方因素对溶出度影响不大,对分散时限有较大影响。     

氯雷他定片的制备及质量控制

目的:制备氯雷他定片并建立其质量控制方法。方法:将氯雷他定与十二烷基硫酸钠、淀粉、微晶纤维素等辅料混合制备片剂。采用紫外分光光度法测定氯雷他定含量。结果:氯雷他定检测浓度线性范围为4~28μg/ml(r=0.9 999),平均回收率为99.9%,相对标准偏差为0.3%。结论:该制剂制备工艺简单,质量控制方法可行。     

食品卫生监督中的HACCP管理

HACCP(hazard analysis and critical point)即危害分析与关键控制点,由食品的危害分析(HA)以及关键控制点(CCP)两部分构成.国际标准CAC /RCP-1"食品卫生通则1997年修订版"对HACCP的定义是:鉴别、评价和控制对食品安全至关重要的危害的一种体系,近年来受到世界各国重视并采用作为食品行业的一种新的产品安全质量保障体系,该体系以进行危害分析和和关键点控制为两大监督支柱,通过分析食品生产的各个环节,找出具体的容易发生安全卫生危害环节,并采取有效的预防控制措施,对各个环节实施严格地监控从而实现对食品安全卫生质量的有效控制,将潜在危害消灭在生产过程中.     

浅析在中药注射剂生产企业中建立危害分析和关键控制点管理体系

目的:提高中药注射剂质量,避免因中药注射剂质量不合格引起的药害事件的发生。方法:以最终灭菌小容量中药注射剂的生产工艺为例,介绍危害分析和关键控制点(HACCP)管理体系的原理和步骤。结果与结论:对中药注射剂的生产过程进行危害分析,找出关键控制点,确定关键限值,建立监测体系和纠偏措施,保证HACCP管理体系的有效实施,可提高中药注射剂的质量。     

氯雷他定口腔崩解片的制备

目的制备氯雷他定口腔崩解片并制定质量标准。方法优化处方后采用直接压片法制备，用高效液相色谱法测定氯雷他定的含量。结果氯雷他定口腔崩解片在30 s内可完全崩解，含量测定方法简便、快速。结论该处方设计合理，检测方法可靠，质量可控。     

氯雷他定口腔崩解片的制备

目的:优化氯雷他定口腔崩解片的制备工艺。方法:采用正交设计法优化处方和工艺,直接粉末压片法制备氯雷他定口腔崩解片,HPLC测定含量。结果:辅料交联聚维酮和微晶纤维素的用量分别为10%和35%,片剂的硬度为3.0～3.5kg.mm-2,氯雷他定口腔崩解片口感良好;崩解时间<30s,2min内溶出百分率>90%。结论:采用实验筛选出的制备工艺条件制成的口腔崩解片,符合口腔崩解片的质量标准,工艺设备简单,操作方便。     

应用危害分析和关键控制点原理分析中药注射剂生产过程的危害及其预防措施

目的 在中药注射剂生产过程中建立危害分析和关键控制点(HACCP)体系,提高中药注射剂的质量管理效率.方法 应用HACCP的原理,分析中药注射剂生产过程中的危害,总结预防措施.结果与结论 对中药注射剂生产过程危害的分析,为找出关键控制点奠定了基础;对关键控制点实施监控,对提高中药注射剂质量起到了事半功倍的效果.     

盐酸头孢他美匹酯片的试制

盐酸头孢他美匹酯 ( cefetamet pivoxil hy-drochloride,1 )为口服头孢菌素 ,主要用于治疗上、下呼吸道感染和尿路感染及淋病性尿道感染等。目前 ,1片研究的关键在于解决其溶出度和稳定性问题。由于 1遇水后粘性很强 ,不易制粒压片 ;同时 1遇热、见光易分解、变色。因此 ,采用常规湿法制粒工艺压片非常困难。我们曾用粉末直接压片 ,但所得片子的片重差异、溶出度和含量均不合格。本实验通过改进处方工艺 ,采用特殊湿法制粒工艺制得 1片。对其进行质量分析 ,各项检验结果均符合规定 ,同时对其进行稳定性考察 ,结果表明本品在 1 8个月内较稳定…     

HACCP在口服固体制剂包衣工艺中的应用

目的:运用风险管理工具进行口服固体制剂风险管理。方法:采用HACCP对肠溶片包衣工艺进行危害分析,确定关键控制点和监控程序,比较实施前后质量情况。结果:实施HACCP后,A产品释放度和外观质量明显改善,降低了质量风险。结论:HACCP是一种有效的评估危害和建立控制体系的风险管理工具。     

Degraded and undegraded carrageenans and experimental gastric and duodenal ulceration

The prevention of histamine-induced gastric and duodenal ulceration in the guinea-pig has been examined using a series of undegraded and degraded carrageenans. Undegraded carrageenans were active at lower doses than degraded carrageenans. The high viscosity of the undegraded carrageenans in solution prevented their use in larger doses. Degradation of carrageenan without serious loss of sulphate, gives a product which allows the dose to be increased to an extent that its effect more than offsets the slight loss in activity caused by the degradation. No single feature of carrageenan structure can be related to anti-ulcer activity although degradation, and hence reduction of molecular size, generally reduces activity. Sulphate contents over 30% have little apparent effect on activity; κ-carrageenans were not consistently different in anti-ulcer activity from Λ-carrageenans. This contrasts with the antipeptic activity of carrageenans where κ-carrageenans are less active than their Λ-counter-parts. As with antipeptic activity, the degree of anti-ulcer activity is probably determined by a combination of structural features which includes molecular size and polyanionic properties.     

Affective and Anxiety Disorders and Alcohol and Drug Dependence:

Depression and anxiety frequently coexist in patients with substance use disorders. This clinically-oriented article examiens the relationship between these conditions and emphasizes data showing that substances of abuse can cause signs and symptoms of both depression and anxiety. These substance-related syndromes appear to have a different course and prognosis than uncomplicated, independent anxiety and major depressive disorders, and clinicians should consider the role of alcohol and other drugs in all patients presenting with these complaints. The authors will also outline an approach for diagnosing and managing patients with the combination of a substance use and depressive or anxiety disorder.     

Alcohol and Substance Use and Abuse in Women and Children

No abstract available for this article.     

Modelling and simulation of variability and uncertainty in toxicokinetics and pharmacokinetics

Two important methodological issues within the framework of the variability and uncertainty analysis of toxicokinetic and pharmacokinetic systems are discussed: (i) modelling and simulation of the existing physiologic variability in a population; and (ii) modelling and simulation of variability and uncertainty when there is insufficient or not well defined (e.g. small sample, semiquantitative, qualitative and vague) information available. Physiologically based pharmacokinetic models are especially suited for separating and characterising the physiologic variability from the overall variability and uncertainty in the system. Monte Carlo sampling should draw from multivariate distributions, which reflect all levels of existing dependencies in the intact organism. The population characteristics should be taken into account. A fuzzy simulation approach is proposed to model variability and uncertainty when there is semiquantitative, qualitative and vague information about the model parameters and their statistical distributions cannot be defined reliably.