菌种冻干法的改良

本文介绍冷冻干燥保存菌种的改良预冻法,利用干冰加乙醇迅速吸热致冷的原理,使制品速冻,通过菌种保护剂的共融点,而保证冻干菌种质量。冷冻干燥保存菌种是当前世界各国普遍采用的长期保存菌种较好方法。冷冻干燥的整个过程尽管不十分复杂,但影响菌种冻干质量的因素很多。据报导冷冻条件的掌握对冷冻干燥后菌种的存活率有显著的影响。如冷冻温度、速度、方法的选择都直接影响菌种的存活率。我站菌种室,始建初期,受实验条件的限制,冻干的预冻阶段,一直采用分装后,置普通冰箱冰格内或-40℃的低温冰箱中过夜,后上机冻干。此法冷冻温度偏高,冷冻速度极慢。而后,我们试用干冰加乙醇的改良预冻法冻干菌种,与进口的爱德华预冻机在预冻温度、速度方面进行了比较观察。     

真空冷冻干燥技术的研究现状和发展

介绍了真空冷冻干燥技术的现状和发展趋势,提出目前国内外对冻干工艺的研究主要集中于在冻干过程中控制晶核的形成和成长、使整个冻干过程置于严格控制之下两方面。从制冷系统、控制系统和整合的冻干生产线3个方面分析了冻干设备的发展,阐述了冻干技术在医药行业的发展和意义,指出国内冻干设备的发展现状与国际水平差距很小,具有广阔的应用前景。     

真空冷冻干燥的工艺流程

介绍了真空冷冻干燥的原理和应用现状,阐述了冻干工艺流程,包括前处理工艺、预冻、升华干燥、解析干燥、后处理工艺,分析了冻干曲线的设计参数,包括预冻降温速率、预冻的最低温度、预冻时间、冷阱的降温时间和温度、抽真空时间、开始加热时间等,指出了只有充分了解国内外冻干工艺的研究现状,及时跟进国际国内先进技术的发展,与客观实践相结合,总结经验,才能更经济地做出更高质量的冻干制品。     

LGJ－25型冷冻干燥机的研制

LGJ－25型冷冻干燥机集预冻、冻干功能于一体，干燥箱为钟罩式结构，搁板选用电加热方式。本文介绍机器的技术指标、零部件设计选择及实验结果。     

LGJ—25型冷冻干燥机的研制

LGJ－25型冷冻干燥机集预冻、冻干功能于一体，干燥箱为钟罩式结构，搁板选用电加热方式。本文介绍机器的技术指标、零部件设计选择及实验结果。     

质控冻干菌种的简易制备法

一般冷冻干燥方法制备冻干菌种,操作比较复杂,费用也高〔１〕。我们用普通安瓿非真空封口的方法制备质控冻干菌种,操作简便,费用低廉,准确可靠,有利于细菌临床检验质量控制工作的开展。１材料和方法１．１材料１．１．１标准菌种来源：由北京卫生部药品生物制品鉴定...     

自制血浆作为凝血试验质控品在临床的应用

目的探索制作方法简单,实验室应用性能稳定,使用效期长的室内凝血质控品。方法选择血站或血库按标准制作的新鲜血浆,分装后超低温冰冻后-30℃保存,并对其精密度及稳定性进行评价,同时将自制血浆同进口冻干质控血浆进行比较。结果制作方法简单,质控品应用精密度及稳定性能良好,与进口冻干质控血浆有相似效果,稳定性至少为1年。结论自制血浆作为凝血检验的室内质控品可以替代进口冻干血凝质控品应用于实验室。     

冻干人血浆引起癌症患者肝功能损伤的调查

癌症患者在化疗过程中常用冻干人血浆予以支持治疗,但临床发现给予冻干人血浆治疗的病人出现肝功能损伤者明显增多。为此,特对我科1991年收治的化疗病人进行回顾性调查,现将调查结果报告如下: 病例选择凡属1991年我科收治的癌症化疗病人,具有完整的临床资料即用冻干人血浆前后都有肝功能化验结果,且用冻干人血浆前肝功能必须正常者,均列为调查对象。     

人外周血淋巴细胞培养基冻干工艺研究

目的对染色体分析用人外周血淋巴细胞培养基进行冻干工艺进行优化。方法首先以澄清度和细胞培养分裂相比例为检测指标确定冻干前培养液浓缩倍率。其次运用正交试验设计法L934法，以冻干粉外观、水分残留率、分裂相比例为检测指标，对冻干工艺过程的的预冻、升华干燥、解析干燥等三个阶段的主要参数进行考察和分析，获得主要参数最优组合的冻干曲线。最后，以优化的冻干工艺生产的三批冻干培养基进行适用性验证。结果确定冻干前培养液的浓缩倍率为3．O。正交实验分析表明：主干燥时间和主干燥真空压力对细胞分裂相比例的影响有显著的统计学意义（P〈0．05）。优化的冻干参数为预冻温度一45℃、时间2h；升华干燥阶段温度从-45℃升温至20℃，时间14h，真空压力35Pa；解析干燥阶段的温度维持于28℃，真空压力为1．0Pa，终点测试压力无变化时通入干燥无茵空气至冻干箱内压力为76kPa后压塞，再通入干燥无菌空气至箱体内压力为1个标准大气压时冻千结束。用优化冻干工艺生产的三批培养基的验证结果显示外观合格率、水分残留率、常温保存180d后的分裂相比例均符合质量标准要求。结论优化的淋巴细胞培养基冻干工艺可行，可用于制备常温贮存的人外周血淋巴细胞培养基。     

冻干食品的优良品质及市场前景

真空冷冻干燥技术,简称真空冻干技术, 本技术可加工任何食品、药品,脱水后为冻干食品。1 冻干食品的生产效益高 冻干食品的技术含量高,品质优良,销售量逐年增加,总是供不应求。它的生产成本虽然比较高,可是它的销售价格更高,因而经济效益是非常可观的。 外商 1997年 4季度在中国收购冻干食品的价     

96-1型磁力搅拌器液体搅拌均匀性效果验证

为了满足生物制品在分装过程中液体均匀性的要求,按照2010年版<药典>三部中生物制品分装和冻干规程的规定,以96-1型磁力搅拌器进行色水搅拌试验、氯化钠注射剂搅拌试验、明胶溶液搅拌试验,验证了96-1型磁力搅拌器液体搅拌效果满足分装过程中液体搅拌均匀性的要求,具有分装生产的适用性.验证结果确认了该方法能满足分装生产的需...     

医学药用过滤器安全使用的分析

目的:为提高在医学研究和药品、生物制品生产过程中的过滤技术。方法:通过对医药过滤器的原理、分类与选择的阐述,对两种过滤器使用性能进行比较分析,对除菌过滤、超滤进行探析。结果:明确了医药过滤器的应用要点;根据工艺要求,合理地设计和选配适宜的、最佳的过滤方案与配置。正确地使用过滤器,有效的控制了杂质、微生物,降低制品的污染水平;采用微过滤或超过滤去除细菌,并较好地解决了热原和澄明度的问题。结论:利用好过滤技术,在制药、生物制品的生产过程中对流体和气体中的杂质与细菌进行有效的控制,按药品生产质量管理规范(GMP)的要求保障药品、制品的质量与使用安全。     

Besonderheiten bei der Regulierung biologischer Arzneimittel in der individualisierten Medizin

The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions. The development of biomarkers accelerates the process towards stratified or individualised therapies. Increased requirements for companion diagnostics are a possible consequence. Progress in analytical processes and in biotechnology make a higher degree of individualization likely, possibly to the degree that medicinal products will be individually manufactured for each patient. Current principles of medicinal product testing and market authorization may be applicable only with limitations, because the individual medicinal products are not uniform and are not repeatedly manufactured. The assessment of the process, performed on several different medicinal products manufactured by the same process could potentially serve as a basis for the assessment. For the evaluation of risk for the patient in clinical trials new concepts must be considered, which can be facilitated by interaction of regulatory authorities and developers.     

微囊藻的分离纯化培养及产毒特性鉴定

目的建立微囊藻的分离纯化培养方法,并鉴定其生长和产毒特性。方法采用96孔板结合极限稀释法,对郑州市西流湖微囊藻进行分离纯化培养;用倒置显微镜观察分离微囊藻株的细胞学和生长特点;用可见分光光度法测定分离微囊藻培养液的吸光度,并绘制分离藻株的生长曲线,计算其生长速率常数和倍增时间;用全细胞PCR和ELISA鉴定分离微囊藻株的产毒性,用ELISA测定其微囊藻毒素粗提物的浓度,并计算其产毒量。结果成功从郑州市西流湖分离出2株微囊藻Microcystis XLH6和Microcystis XLH10,其生长曲线均呈“S”型,生长速率常数均呈先迅速升高然后逐渐降低的趋势;一个生长周期内Microcystis XLH6和Microcystis XLH10的平均生长速率常数分别为0.294和0.345,平均倍增时间分别为82h和70h。全细胞PCR和ELISA结果均为阳性,2株微囊藻均为产毒株,冻干藻细胞Microcystis XLH6和Microcystis XLH10的微囊藻毒素产量分别为1.0μg/mg和2.4μg/mg。结论郑州市西流湖有产毒微囊藻污染,96孔细胞培养板可用于分离纯化微囊藻。     

Stammdokumentationen: weniger Papier, mehr Inhalt

The process of reviewing the European pharmaceutical legislation resulted in a codex, which contains two new instruments related to marketing authorisation of biological medicines: Plasma Master File (PMF) and Vaccine Antigen Master File (VAMF). In the manufacture of plasma derivatives (e. g. coagulation factors, albumin, immunoglobulins), usually the same starting material, i. e. a plasma pool, is used for several products. In the case of vaccines, the same active substance, i.e. vaccine antigen, may be included in several combination vaccine products. The intention behind the introduction of PMF and VAMF was to avoid unnecessary and redundant documentation, and to improve and harmonise assessment by means of procedures for certification of master files on the community level.     

Nutritional availability to rats of selenium in four seafoods: crab (Callinectes sapidus), oyster (Crassostrea virginica), shrimp (Penaeus duorarum) and Baltic herring (Clupea harengus)

1. The present study was conducted to determine the biological availability to rats of the selenium in four high-Se seafoods: crab (Callinectes sapidus), oyster (Crassostrea virginica), shrimp (Penaeus duorarum) and Baltic herring (Clupea harengus). 2. Weanling male rats were fed on a Se-deficient Torula yeast diet for 4 weeks followed by either continued depletion or repletion for 4 weeks with 0.05, 0.1 or 0.2 microgram Se as selenite/g, or 0.1 or 0.2 microgram Se as freeze-dried cooked test food/g. Plasma and liver Se levels or glutathione peroxidase (EC 1.11.1.9; GSH-Px) activities were used as indicators of body Se status. 3. Except for oysters, the biological availability of Se in all these seafoods was close to that of selenite (selenite 100%) when the criterion used was either plasma Se level or plasma GSH-Px activity. 4. By the criterion of increased liver Se level of restored hepatic GSH-Px activity, only herring-Se had a biological availability comparable to that of selenite-Se under all conditions tested, whereas crab-Se and oyster-Se were distinctly inferior in this regard. 5. Increasing the amount of crab-Se, oyster-Se or shrimp-Se supplied in the diet from 0.1 to 0.2 microgram/g changed the apparent availability (%) of Se for hepatic GSH-Px restoration from 38 to 78, 22 to 53 and 57 to 90 respectively. 6. The present study demonstrates that the availability of Se in certain foods is a function of the criterion chosen, the level of Se supplied in the diet, and possibly other unknown interacting dietary factors.     

Cholesterol-lowering effect of Agemaki, a kind of shellfish, in mice

Agemaki (Sinonovacula constricta) is an edible and popular shellfish in the western part of Japan. The present study demonstrated the effects of feeding Agemaki on cholesterol and triglyceride concentrations in mice plasma and liver. Mice were fed a diet containing 0.1% cholesterol and 0.1% Na-cholate for 1 week, and then a cholesterol-free diet or a cholesterol-enriched one for 2 weeks. To both diets, freeze-dried Agemaki was added at a 5% level. There was no statistically significant effect on the body-weight gain, food intake, and liver weight by feeding Agemaki in both dietary regimens. However, Agemaki significantly lowered the concentrations of plasma and liver cholesterol and also of plasma triglyceride in mice feeding on the cholesterol-rich diet. A similar tendency was also observed for the mice feeding on the cholesterol-free diet. The analysis of freeze-dried Agemaki revealed a relatively larger proportion of n-3 polyunsaturated fatty acids and plant sterols, which may possibly decrease plasma lipids. So far as we know, this is the first report showing hypolipidemic effect of Agemaki.     

Enhanced stability of meningococcal polysaccharide vaccines by using lactose as a menstruum for lyophilization.

A comparison is made between lactose and mannitol as additives for the lyophilization of meningococcal polysaccharide vaccines. From the stability data obtained on storage at high temperatures, it is concluded that vaccines containing lactose as a menstruum for lyophilization are much more stable than vaccines prepared with the currently used additive, mannitol. The enhanced stability of these vaccines makes it possible to store also group A vaccines at 5°C instead of at -20°C, and to use them in places without freezing facilities.     

Effects of ingestion of tomatoes, tomato juice and tomato purée on contents of lycopene isomers, tocopherols and ascorbic acid in human plasma as well as on lycopene isomer pattern

Tomatoes are an important part of the diet. Lycopene, the predominant carotenoid in tomatoes, is hypothesised to mainly mediate the health benefits of tomato products. Anticancer activity of tomato products and lycopene has been suggested by numerous studies. The aim of the present study was to investigate the effect of ingestion of three different tomato-based foodstuffs on plasma contents of lycopene, tocopherols and ascorbic acid. Because isomers of lycopene may have different biological activities, a special interest was to look how the lycopene isomer pattern is changed depending on the matrix of tomato products. Following a 2-week depletion phase volunteers ingested 12.5 mg lycopene/d for 4 weeks comprising tomatoes, tomato juice or tomato purée. The basal levels of lycopene in plasma were comparable for all groups and decreased significantly during the 2 weeks of depletion to approximately half of the basal values. Following intervention, plasma lycopene concentration increased significantly. Conversely, supplementation did not significantly affect levels of tocopherols and ascorbic acid in plasma. Regarding isomers of lycopene, the (Z)-lycopene:(all-E)-lycopene plasma isomer ratio was significantly changed during the study for all groups. A remarkable enrichment of the relative contents of (5Z)-lycopene was observed during the depletion period, which supports the hypothesis that lycopene (Z)-isomers are formed within the human body after ingestion of (all-E)-lycopene. After dietary intervention with lycopene-rich products the isomer ratios returned to those observed at the start of the study. Further investigations will clarify the process of isomerisation in more detail.     

The international standard for anti-smallpox serum

At the request of the WHO Expert Committee on Biological Standardization, the National Institute for Medical Research, London, obtained 63 samples of convalescent human plasma from patients recovering from smallpox. The sera were pooled and distributed into ampoules and freeze-dried.