压力蒸汽灭菌指示剂的筛选和效果验证

利用结晶物质在一定温度下熔融的特性,通过对几种灭菌指示剂内容物进行熔点测定,选出苯甲酸化学试剂和升华硫化学试剂作为高压灭菌指示剂和灭菌参考指示剂。试验表明,这两种指示剂终点明确,简便快速,价格便宜,能满足121℃高压灭菌的温度要求,可以对高压灭菌的日常监测提供依据。     

高温灭菌操作中常见错误的分析

高温灭菌是指用热能杀死微生物。其原理是高温使原生质中的蛋白质变性、使酶失活,致使微生物死亡。高温灭菌主要有高压蒸汽灭菌法、干热灭菌法和灼烧灭菌法几种。如果操作不当,即达不到预期的灭菌效果。现就常见错误分析如下。1高压蒸汽灭菌蒸汽灭菌属湿热灭菌,由于湿热灭菌有潜能存在,被灭菌物体的温度比蒸汽的低,蒸汽在其表面凝结成水,放出潜能,可迅速提高被灭菌物体的温度。又由于水和水蒸汽比空气的热容量大、导热快、穿透力强,所以,与干热灭菌相比,灭菌需要的温度低、时间短。由于高压蒸汽灭菌法水蒸汽的温度随其所受压力的…     

应用于湿热灭菌的生物指示剂现状与分析

从研究历史、应用现状、类型划分、菌株使用和考察因素5方面对应用于湿热灭菌的生物指示剂进行了分析。发现目前市售生物指示剂生产使用环节中缺乏关键因素D值的测定,建议由第三方提供技术支持衔接完善。同时,对生物指示剂深入的探索和开发,才能够实现其在灭菌工艺验证整体环节中的应用。     

灭菌生物指示剂的研究及在灭菌监测中的应用

本文论述有关生物指示剂的历史概况，在灭菌监测中，与物理、化学指示方法比较，生物指示剂的作用与地位。在生物制品、医院、食品行业等领域，生物指示剂的应用越来越受到人们的重视，并产生了良好的效果。本文论述了灭菌监测及生物指示剂的应用，与医院的感染的关系。美国药典（ＵＳＰ）和中国卫生部与也专门规定了生物指示剂的标准，应用及有关规定。在应用时，菌株的选择和具体方法尤为受人关注，本文列出有关应用中须注意的问题     

高压蒸气灭菌方法的研究

在组织培养中常用高压蒸气灭菌法对一些物品及试剂进行灭菌,但是由于使用方法等问题,经常出现因灭菌不彻底而导致组织培养污染的现象。如何正确使用高压蒸气灭菌方法,我们进行了比较研究,现报告如下:1　材料与方法1.1　材料　标准菌株大肠杆菌及金黄色葡萄球菌(大医附二院...     

紫甘薯花青素提取物抗氧化能力的稳定性

目的:比较不同因素对花青素总抗氧化能力的影响.方法:本文采用铁离子还原法测定了两种紫红薯花青素经光照、温度、防腐剂、金属离子和杀菌工艺处理后的总抗氧化能力的变化.结果:两个品种(紫A4和京薯6)花青素提取物的总抗氧化能力随光照和加热时间延长而下降,温度越高,下降速度越快.防腐剂苯甲酸钠时两种花青素提取物总抗氧化能力的影响不明显.四种金属离子(K+、Mg2+、Ca2+、Zn2+)和四种杀菌工艺(巴氏灭菌、煮沸灭菌、高温短时灭菌、高压蒸汽灭菌)对其总抗氧化能力有不同程度的影响.其中Zn2+显著降低其总抗氧化能力,其它金属离子使其总抗氧化能力稍有增加.高温短时灭菌的影响最小,高压蒸汽灭菌的影响最大.结论:花青素抗氧化能力的稳定性受到光照、温度、金属离子和杀菌工艺等因素的影响.     

沙漠干热环境腹部肠管枪弹伤后血清内毒素与肝脏环氧化酶-2的表达研究

目的:探讨沙漠干热环境下腹部肠管枪弹伤后血清内毒素和肝脏环氧化酶-2(COX-2)表达之间的关系.方法:沙漠干热环境组和常温环境组健康长白仔猪各42头随机等分为对照组和伤后1h、2h、4h、8h、12h和24h组,实验组建立腹部枪弹伤肠管穿透模型后,用显色基质鲎试剂法检测各组血清内毒素水平,免疫组化图像分析法测定各组肝组织COX-2的表达.结果:沙漠干热环境和常温环境下,伤后各实验组血清内毒素水平和肝脏COX-2表达水平均高于对照组(P＜0.01),两种环境下内毒素均在8h组达到高峰,分别为(0.971±0.04)EU/ml、(0.627±0.08)EU/ml,沙漠干热环境组内毒素峰值明显高于常温环境组(P＜0.01);除对照组和1h组外,其余各时间组的干热环境内毒素值明显高于常温环境(P＜0.01).在沙漠干热环境组,各实验组肝脏COX-2表达水平明显高于相对应的常温组(P＜0.01),肝脏COX-2的表达水平在沙漠干热环境组和常温纽中的第1个高峰值均出现在伤后2h组,沙漠干热环境组的第2个高峰值出现在伤后8h组,而常温环境组的第2个高峰出现在伤后12h组;血清内毒素水平和肝脏COX-2表达水平在沙漠干热环境组和常温环境组均具有相关性,相关系数分别为0.928和0.847,(P＜0.01).结论:沙漠干热环境下腹部肠管枪弹伤后血清内毒素和肝脏COX-2表达较常温组明显提高,且二者密切相关,提示在沙漠干热环境下腹部肠管枪弹伤后血清内毒素和COX-2在继发性肝损害过程中可能起重要作用.     

联动灌装线的验证研究

目前国内对小瓶清洗,干热灭菌,灌封三位一体联动分装线的验证处于起步阶段,而国外的某些验证试验方法对于国内大多数制药行业又是不切实际的,依据国内外的有关资料,按照现行GMP的要求,结合生产的实际情况,建立了一套验证试验方法,实验证明是适用的。     

云南元谋不同海拔土壤微生物对车桑子碳、氮、磷化学计量特征及土壤特性的影响

了解不同气候下土壤微生物对植物生态化学计量特征的影响有利于理解未来温度变化下植物与土壤的相互关系。该文以车桑子(Dodonaea viscosa)为研究对象,从云南省元谋县两个海拔区采集车桑子根际土壤样品,并设定相应的两个温度处理,通过微生物灭菌和接种处理,测定了车桑子叶片养分及其所在的土壤特性,研究了温度、微生物及温度与微生物的交互作用对车桑子的碳(C)、氮(N)、磷(P)化学计量特征的影响,分析其N、P养分特征与土壤特性间的关系。研究结果表明:相比于灭菌处理,两个海拔区的土壤微生物对车桑子养分吸收都有促进作用,对P的促进作用极为显著。温度对车桑子C、N、P化学计量特征无显著影响,但温度与微生物的交互作用对车桑子的C、N、P化学计量特征有显著影响。这种交互作用主要体现在:在接种高海拔区土壤微生物的处理中,温度没有显著影响车桑子的C、N、P化学计量特征,而在接种低海拔区土壤微生物的处理中,相比于高温条件,低温显著抑制了车桑子对N、P的养分吸收。土壤微生物对养分吸收的促进作用可能源于其中有益微生物(如丛枝菌根真菌)的直接促进作用,而并非是通过土壤微生物的养分循环过程。由于接种微生物处理使车桑子从土壤中吸收了更多的N、P,从而使该处理的土壤有效N、P显著低于灭菌处理。在元谋干热河谷未来气温变凉的情况下,由于土壤微生物对植物的反馈作用,该区车桑子的生长可能会受到一定的抑制。     

定量测定生物材料中少量蛋白质的一种简便方法

Lowry 等人通常使用定量测定蛋白质的方法需要操作40分钟左右,并且需要三种试剂。经 Miller 改进的这种技术,测定时间缩短约20分钟。通过以下方法可以缩短测定时间:用升高温度(50℃)以缩短显色时间和改用两种试剂,即用较小体积、较浓的碱性铜试剂和较多量、较稀的酚试剂。     

Quantitative assessment of sterilization efficiency using lyophilized calcium alginate biological indicators

Biological indicators were prepared using either Bacillus stearothermophilus or Bacillus subtilis incorporated into lyophilized calcium alginate beads. These were subjected to a variety of moist heat and dry heat treatments as appropriate and then dissolved in buffer to allow enumeration of survivors. The utility of these spore carriers as biological indicators for the quantitative assessment of heat sterilization processes is discussed.     

Effect of heating and steam sterilization on soil manganese

Summary The effect of heating, drying and steam sterilization on manganese was studied in a number of Indian soils. It was concluded that these measures increased all forms of active manganese, in all the soils. By increasing the temperature upto 250°C and by longer heating the active manganese still increased. Steam sterilization was also effective in releasing the active manganese almost equally. Air drying in sun at an atmospheric temperature of 40–44°C also increased the active manganese to a good extent.     

Degradation of biochemical activity in soil sterilized by dry heat and gamma radiation.

The activities of three enzymes present in soil, phosphatases, urease, and decarboxylase, were monitered as indicators of the loss of biochemical information occurring when soil was sterilized by dry heat (0.08% relative humidity), gamma radiation, or a combination of both. More enzymatic activity was retained in soil sterilized by a long exposure to dry heat at relatively low temperature (8 weeks at 100.5 degrees C) than by a shorter exposure to a higher temperature (2 weeks at 124.5 degrees C). No enzymatic activity was detectable in soil sterilized by an even higher temperature (4 days at 148.5 degrees C). Soil sterilized with 7.5 Mrads of radiation retained much higher enzymatic activity than with heat sterilization. Combining sublethal doses of heat radiation effectively sterilized the soil and yielded enzymatic activities higher than those of soil sterilized by dry heat alone but lower than those of soil sterilized by radiation.     

Degradation of biochemical activity in soil sterilized by dry heat and gamma radiation

The activities of three enzymes present in soil, phosphatases, urease, and decarboxylase, were monitered as indicators of the loss of biochemical information occurring when soil was sterilized by dry heat (0.08% relative humidity), gamma radiation, or a combination of both. More enzymatic activity was retained in soil sterilized by a long exposure to dry heat at relatively low temperature (8 weeks at 100.5°C) than by a shorter exposure to a higher temperature (2 weeks at 124.5° C). No enzymatic activity was detectable in soil sterilized by an even higher temperature (4 days at 148.5° C). Soil sterilized with 7.5 Mrads of radiation retained much higher enzymatic activity than with heat sterilization. Combining sublethal doses of heat radiation effectively sterilized the soil and yielded enzymatic activities higher than those of soil sterilized by dry heat alone but lower than those of soil sterilized by radiation.     

Colorful Drying

Drying is one of the standard unit operations in the pharmaceutical industry and it is important to become aware of the circumstances that dominate during the process. The purpose of this study was to test microcapsulated thermochromic pigments as heat indicators in a fluid bed drying process. The indicator powders were manually granulated with α-lactose monohydrate resulting in three particle-size groups. Also, pellets were coated with the indicator powders. The granules and pellets were fluidized in fluid bed dryer to observe the progress of the heat flow in the material and to study the heat indicator properties of the indicator materials. A tristimulus colorimeter was used to measure CIELAB color values. Color indicator for heat detection can be utilized to test if the heat-sensitive API would go through physical changes during the pharmaceutical drying process. Both the prepared granules and pellets can be used as heat indicator in fluid bed drying process. The colored heat indicators give an opportunity to learn new aspects of the process at real time and could be exploded, for example, for scaling-up studies.     

Comparison of the efficacy of steam sterilization indicators.

Twenty-one commercially available chemical steam sterilization indicators were processed in an empty autoclave for various times at temperatures between 240 and 270 degrees F (ca. 116 and 132 degrees C). The time required to reach a sterilized reading at each temperature was plotted on a semilogarithmic time-temperature plot and compared with the time-temperature sterilization curve for Bacillus stearothermophilus. Five of the indicators had time-temperature kinetics similar to those of B. stearothermophilus, but three of these overestimated the effect of processing. Two of the indicators overestimated the effect of processing and were less sensitive to temperature changes when was B. stearothermophilus. Thirteen of the indicators had time-temperature curves that crossed the B. stearothermophilus plot. One indicator produced such ambiguous results that no determinations could be made with it. Out of 21 indicators tested, only 2 appear to be capable of accurately integrating the time-temperature effect at temperatures between 240 and 270 degrees F. The other indicators should be used only after careful analysis of their suitability for use at a given temperature.     

Comparison of the efficacy of steam sterilization indicators.

Twenty-one commercially available chemical steam sterilization indicators were processed in an empty autoclave for various times at temperatures between 240 and 270 degrees F (ca. 116 and 132 degrees C). The time required to reach a sterilized reading at each temperature was plotted on a semilogarithmic time-temperature plot and compared with the time-temperature sterilization curve for Bacillus stearothermophilus. Five of the indicators had time-temperature kinetics similar to those of B. stearothermophilus, but three of these overestimated the effect of processing. Two of the indicators overestimated the effect of processing and were less sensitive to temperature changes when was B. stearothermophilus. Thirteen of the indicators had time-temperature curves that crossed the B. stearothermophilus plot. One indicator produced such ambiguous results that no determinations could be made with it. Out of 21 indicators tested, only 2 appear to be capable of accurately integrating the time-temperature effect at temperatures between 240 and 270 degrees F. The other indicators should be used only after careful analysis of their suitability for use at a given temperature.     

气候变化背景下全球陆地干湿变化研究综述

气候变化背景下,全球水循环加剧,出现了大气变干与植被变绿等陆地干湿变化趋势的解耦现象,旱区面积变化也存在争议。为回答上述问题,在梳理常见干湿指标变化趋势与驱动因素的基础上,根据指标变化方向对其进行归类,然后从机理角度解析影响不同指标趋势耦合或解耦的关键要素,并提出未来干湿变化研究展望。结果表明,气候变化背景下,饱和水汽压差、干燥度指数和土壤水分指标显著变干,植被绿度和生产力显著变湿(增加),降水、径流、陆地水储量和其他复合指标区域分异明显、但整体趋势不显著。二氧化碳浓度增加、气温升高和土地利用变化是导致不同指标趋势分异的重要因素,不同指标的趋势分异也解释了旱区面积评估在不同维度上的差异。未来研究中应开展干湿变化的综合评估,其综合性主要体现在以下四个方面：1)关注大气-生态-水文多维度评估;2)解析自然与人类双重压力下,不同维度要素间的关联、互馈过程,及其对系统干湿演变的促进、限制与调节作用;3)重视干湿演变程中的极端灾害事件和空间上以旱区为代表的气候变化敏感性区域;4)构建以脆弱性评估与适应性治理为核心的气候变化应对路径。     

Automatic equipment for media sterilization

A device is described based on the principle of a simple analog computer which gives an exact determination of the moment at which the heat energy supply should be interrupted to attain a chosen sterilization effect. The temperature of the medium to be sterilized is measured and at temperatures above 100°C. the dependence of the thermal destruction coefficient of microbial spores on temperature is simulated. This variable is integrated with respect to time and the value of this integral at any given moment corresponds to the sterilization effect, at that moment. The device is also fitted with an extrapolator which evaluates, depending on the instantaneous temperature of the medium, the value of sterilization effect which will be produced during the cooling of the medium after the interruption of the heat, energy supply. The total sterilization effect, in the course of the cycle, is continuously and automatically evaluated as a sum of the integrated sterilization effect and of data supplied by the extrapolator. At the moment when this total sterilization effect attains the prescribed value, the device gives a signal for the interruption of the heat energy supply. The value of the sterilization effect is adjustable within broad limits and its evaluation is performed without substantial simplifying assumptions. By the use of this device an exact scale-up method for sterilizing media is achieved, yielding at the same time accurate reproducibility of media sterilization. An automatic control of the sterilization cycle is also possible by means of the device.     

Intermittent drying of bioproducts--an overview

Unlike the conventional practice of supplying energy for batch drying processes at a constant rate, newly developed intermittent drying processes employ time-varying heat input tailored to match the drying kinetics of the material being dried. The energy required may be supplied by combining different modes of heat transfer (e.g. convection coupled with conduction or radiation or dielectric heating simultaneously or in a pre-selected sequence) in a time-varying fashion so as to provide optimal drying kinetics as well as quality of the bioproduct. This is especially important for drying of heat-sensitive materials (such as foods, pharmaceutical, neutraceutical substances, herbs, spices and herbal medicines). Intermittent heat supply is beneficial only for materials which dry primarily in the falling rate period where internal diffusion of heat and moisture controls the overall drying rate. Periods when little or no heat is supplied for drying allow the tempering period needed for the moisture and heat to diffuse within the material. As the moisture content increases at the surface of the biomaterial during the tempering period, the rate of drying is higher when heat input is resumed. It is possible to control the heat input such that the surface temperature of the product does not exceed a pre-determined value beyond which thermal damage of the material may occur. This process results in reduction in the use of thermal energy as well as the mass of air used in convective drying. Thus, the thermal efficiency of such a process is higher. The quality of the product, as such color and ascorbic acid content, is also typically superior to that obtained with a continuous supply of heat. However, in some cases, there will be a nominal increase in drying time. In the case of microwave-assisted and heat pump drying, for example, the capital cost of the drying system can also be reduced by drying in the intermittent mode.

This paper provides an overview of the basic process, selected results from experiments and mathematical models for a variety of biomaterials dried in a wide assortment of dryers. It begins with a classification of intermittent drying processes that may be applied e.g. time-varying temperature, air flow rate, operating pressure as well as heat input by different modes and in different temporal variations. The beneficial effects of improving the quality of dried bioproducts by different intermittent processes are also included and discussed.