不同保存条件下Wm84株腮腺炎减毒活疫苗的稳定性

采用留样观察法对Wm84株腮腺炎减毒活疫苗在不同保存条件和不同规格疫苗(1 mL/支21批、0.5mL/支24批)的稳定性进行了比较.结果表明不同规格疫苗的稳定性均较好,疫苗保存温度越低其稳定性越好.     

云芝多糖及其注射剂的稳定性研究

作者对云芝多糖和云芝多糖注射剂进行了影响因素试验,加速试验和室温留样考察,结果表明,二者具良好的化学稳定性。     

人狂犬病免疫球蛋白使用效果观察

为了解人狂犬病免疫球蛋白的作用效果,我们将观察对象随机分成了A、B、C三组,分别采用三种措施进行狂犬病的预防治疗,即：A组联合使用狂犬病疫苗与人狂犬病免疫球蛋白;B组联合使用狂犬病疫苗与抗狂犬病血清(马源);C组仅注射狂犬病疫苗,并采用小鼠中和试验对这三组成员在免疫后3、7、14、45天及1年时的中和抗体水平进行检测。结果表明：狂犬病疫苗与人狂犬病免疫球蛋白或抗狂犬病血清联合使用,可使体内更早出现抗狂犬病的中和抗体。注射人狂犬病免疫球蛋白后未发生临床副反应。     

乙型肝炎人免疫球蛋白的稳定性研究

目的 考察乙型肝炎人免疫球蛋白的稳定性.方法 对乙型肝炎人免疫球蛋白成品进行(25±2)℃条件下为期6个月的加速稳定性试验和(6±2)℃条件下为期4年的长期稳定性试验,对考察的制品按2010版《中国药典》三部进行全面检测,检测其抗-HBs效价、蛋白质含量、纯度、pH值、分子质量大小分布(单体+二聚体)、麦芽糖含量、甘氨酸、无菌检查、异常毒性检查、热稳定性试验、热原检查、外观检查、鉴别试验等质量指标,用t检验分析各质量指标检测数据的变化趋势.结果 乙型肝炎人免疫球蛋白制品在进行加速试验后,单体+二聚体、抗-HBs效价值都有下降趋势.在进行长期试验后,除单体+二聚体有所下降趋势之外,其他各项质量指标的变化均无统计学意义.结论 乙型肝炎人免疫球蛋白的稳定性良好,在进行6个月的加速破坏性试验和4年的长期稳定性试验后,其质量仍能符合2010版《中国药典》三部的规定要求.     

激活补体试验检测静注人免疫球蛋白Fc段生物学活性的优化

优化激活补体试验的条件,完善静注人免疫球蛋白Fc段生物学活性的检测方法。方法采用补体活化经典途径的原理,分别探讨致敏红细胞密度和贮存时间对人免疫球蛋白Fc段生物学活性检测结果的影响;比较手工法和微孔板分光光度法检测Fc段生物学活性的检测结果。结果在致敏红细胞A541 nm=1.3和致敏红细胞贮存5 d时,检测结果较稳定。微孔板分光光度法检测优于手工法。结论完善了人免疫球蛋白Fc段生物学活性的检测方法,检测结果准确、重复性好。     

酚氧化酶纸条制备与应用

制备出一种酚氧化酶试纸条,一３７℃６ｈ内可完成酵母样真菌的酚氧化酶试验,较常规培养基试验法至少能提前１８－２４ｈ获得结果。该纸条置４℃保存,有效期６个月,对鉴定酵母样真菌具有快速、准确实用性。     

风湿定胶囊的稳定性研究

本文拟通过风湿定胶囊药理的稳定性来验证本药品的有效期。     

酚氧化酶试纸条制备与应用

制备出一种酚氧化酶试纸条,于３７℃６ｈ内可完成酵母样真菌的酚氧化酶试验,较常规培养基试验法至少能提前 １８～２４ｈ获得结果。该纸条置４℃保存,有效期６个月,对鉴定酵母样真菌具有快速、准确、实用性。     

冻干神经生长因子活性稳定性试验研究

用不同的物质作保护剂冻干纯化鼠神经生长因子,经检定以人血白蛋白作为赋形剂和保护剂冻干神经生长因子制品外观洁白细腻,结构强度良好,生物活性符合要求,残存水分低于３％。采用留样观察法检测其稳定性,将制品放置４℃～８℃,在０、０．５、１、２、３、６、９、１２、１８、２４、２５个月分别测定其各自的活性。结果表明神经生长因子冻干制品在４℃～８℃保存,２５个月仍然保持原有生物活性     

抗鹅免疫球蛋白轻链单克隆抗体的鉴定及其应用

免疫球蛋白是机体固有免疫系统的组成部分,是机体防御的第一道防线。本研究对抗鹅免疫球蛋白轻链单克隆抗体进行了特征分析并将其应用到不同免疫试验中用以检测鹅免疫球蛋白。用此单克隆抗体制备的免疫亲和层析柱用以分离血清中的鹅免疫球蛋白;偶联辣根过氧化物酶 (Horseradish peroxidase,HRP) 后的单克隆抗体用作第二抗体来检测鹅特异性抗体。此外,该单克隆抗体可以识别和定位外周血淋巴细胞中的SIg+淋巴细胞。研究表明,该单克隆抗体可在多种条件下检测或分离鹅免疫球蛋白并作为研究鹅体液免疫的有力工具。     

Comparison between the effectiveness of expiration and abdominal bracing maneuvers in maintaining spinal stability following sudden trunk loading

The purpose of this study was to clarify the effectiveness of expiration and abdominal bracing maneuvers in response to sudden trunk loading in healthy subjects. Fifteen healthy male subjects were anteriorly loaded under different experimental conditions. Tests were conducted at rest and while performing each of the stabilization maneuvers (expiration and abdominal bracing) at 15% of the maximal voluntary isometric contraction of the internal oblique muscle. Subjects had no knowledge of the perturbation timing. An electromyographic biofeedback system was used to control the intensity of internal oblique muscle activation. Muscular pre-activation of three trunk muscles (internal oblique, external oblique, and L3 erector spinae muscles) and lumbar acceleration in response to loading were measured. The expiration and abdominal bracing maneuvers promoted torso co-contraction, reduced the magnitude of lumbar acceleration, and increased spinal stability compared to the resting condition. There were no differences between the expiration and abdominal bracing maneuvers in the pre-activation of the three trunk muscles or in lumbar acceleration in response to loading. It appears that both expiration and abdominal bracing maneuvers are effective in increasing spinal stability in response to sudden anterior loading.     

Light and storage time influence the microbial quality of minimally processed rocket

Ready-to-eat minimally processed fruits and vegetables are an ideal substrate for the growth of microorganisms, including human pathogens and mycotoxin-producing species, which question their quality and safety for customers. While we are aware of the importance of production workflows in structuring the products' microbial communities, we still know little about the factors that shape microbiomes during the timeframe products are available to customers, and beyond this timeframe. Here, we study the influence of storage light condition (light or dark) on microbiological and physico-chemical parameters of minimally processed rocket leaves at different shelf life timepoints (the day the product becomes available to consumers, expiration date, 3 days after the expiration date). Our results suggest that the total microbial load increases from the day the product becomes available to consumers, to the expiry date and after the product's expiration. However, when studying the composition of the fungal microbiome, we did not observe significant changes in its structure as the effect of product shelf life or storage light condition. We also found that products stored under light condition had a higher total bacterial load compared to those stored in darkness. Our results might be helpful in crafting improved workflows for product's storage during its shelf life, which might ultimately lead to a re-evaluation of storage times resulting in reduced food waste due to product spoilage or expiration.     

Antiviral activity of commercial immunoglobulin preparations

Immunoglobulin preparations for intravenous use of five different firms--Biotest, Hoechst, Merieux, Sandoz, WWSS--were used for the study. Antibody level for Epstein-Barr, cytomegalia, herpes simplex, varicella-zoster and measles viruses was determined in these preparations stored at 4 degrees C and in order to determine their stability they were tested after incubation at 37 degrees C and 61 degrees C. The influence of immunoglobulin (Bioglobulin and Sandoglobulin) on mouse survival infected with HSV-1 was determined. Results of serological studies revealed differentiated antibody level for particular virus antigens both in various series of a given preparation as well as between immunoglobulins of different producers. Protective activity of immunoglobulin was mainly found when given 24 hours before challenge with HSV-1. This was the case not only when preparations stored at 4 degrees C were given but also for those which were incubated at 37 degrees C for months. Forty percent higher rate of survival of mice as compared to control group was seen when immunoglobulin were given 8 hours after infection.     

Time-dependent responses of expiration reflex in cats

We investigated the effectiveness of the "expiration reflex" in 10 anesthetized spontaneously breathing cats. The expiration reflex was produced by mechanical stimulation of the vocal folds and electrical stimulation of the superior laryngeal nerve at different moments in the respiratory cycle and at various levels of respiratory chemical drive. The effectiveness of the expiration reflex was evaluated from sudden changes in expiratory flow immediately following the stimulation. Both mechanical and electrical stimulations given during early inspiration caused little or no expiratory efforts, whereas stimulations given during early expiration or hypocapnic apnea produced a typical expiration reflex. Changes in arterial CO2 and O2 partial pressures influenced neither the relationships between the stimulation and its effect on the expiration reflex nor the strength of the expiration reflex. These results indicate that the timing of stimulation with relation to the phase of the respiratory cycle is critical to its effect on the expiration reflex and that changes in respiratory chemical drive do not modify the expiration reflex characteristics.     

Decay of inspiratory muscle pressure during expiration in conscious humans

In eight conscious spontaneously breathing adults we studied the decay of pressure developed by the inspiratory muscles during expiration (PmusI). PmusI was obtained according to the following equation: PmusI(t) = Ers X V(t) - Rrs X V(t), where V is volume and V is flow at any instant t during spontaneous expiration, and Ers and Rrs are, respectively, the passive elastance and resistance of the total respiratory system. Ers was determined with the relaxation method, and resistance with the interrupter method. All subjects showed marked braking of expiratory flow by PmusI. The mean time for PmusI to reduce to 50 and 0% amounted, respectively, to 23 and 79% of expiratory time. During expiration, 24-55% of the elastic energy stored during inspiration was used as resistive work and the remainder (45-76%) as negative work.     

In vitro stability studies of a Factor IX concentrate (Bebulin)

Factor IX: C activity decay was studied in lyophilized concentrates (Bebulin, IMMUNO) stored at room temperature and in reconstituted preparations frozen and stored at -20 degrees C. A very slight, practically identical, decay of Factor IX: C was found in lyophilized concentrates kept at room temperature, in reconstituted lyophilized concentrates frozen and stored at -20 degrees C and lyophilized concentrates kept at +4 degrees C. At the end of the experiment, which was 4-5 months after the expiration date of the product, a 15-30% decay of Factor IX: C could be found in the concentrates with respect to initial levels.     

Detection of antibody to Varicella-Zoster virus by immune adherence hemagglutination.

A serologic test for measurement of antibody to V-Z virus by immune adherence hemagglutination is described. Initial evaluation of the test has shown it to be highly sensitive, specific, rapid, and simple to perform. The V-Z antigen may be stored at -70 degrees, and the test could be performed in any routine serology laboratory.     

Effects of auditory stimulus timing in the respiratory cycle on the evoked cardiac response in man at rest

The present experiments were carried out in 21 healthy adults to study the effects of auditory stimulus timing within the respiratory cycle on evoked cardiac response. The stimulus (80 dB white noise) was started by the first and finished by the second R-wave after change in respiratory phase, and presented in different series in either early inspiration or early expiration. The spirogram and eight sequential interbeat intervals (IBI) after respiratory phase change were recorded. The mean of IBI and standard deviation (SD) were calculated separately for each IBI of 20 trials for each subject, during both the prestimulus and poststimulus phases. The stimulus effects were expressed as changes from prestimulus conditions, in terms of delta IBI and delta SD. The mean of each of the eight IBI and its SD were found to vary consistently in the same direction, i.e., SD increased with increasing mean IBI. Stimulation during early inspiration did not produce any effect during this respiratory phase. It was not before the beginning of the following expiration that a significant deceleration was evoked, which was associated with an enhanced delta SD, whereas stimulation during early expiration promptly evoked a biphasic cardiac response of the deceleration - acceleration pattern and an increase and decrease in delta SD, respectively. While SD was found to be a function of age, no such finding was obtained for delta IBI and delta SD. These results are discussed in terms of the "vagal gating" hypothesis.     

A Closed-Loop Model of the Respiratory System: Focus on Hypercapnia and Active Expiration

Breathing is a vital process providing the exchange of gases between the lungs and atmosphere. During quiet breathing, pumping air from the lungs is mostly performed by contraction of the diaphragm during inspiration, and muscle contraction during expiration does not play a significant role in ventilation. In contrast, during intense exercise or severe hypercapnia forced or active expiration occurs in which the abdominal “expiratory” muscles become actively involved in breathing. The mechanisms of this transition remain unknown. To study these mechanisms, we developed a computational model of the closed-loop respiratory system that describes the brainstem respiratory network controlling the pulmonary subsystem representing lung biomechanics and gas (O₂ and CO₂) exchange and transport. The lung subsystem provides two types of feedback to the neural subsystem: a mechanical one from pulmonary stretch receptors and a chemical one from central chemoreceptors. The neural component of the model simulates the respiratory network that includes several interacting respiratory neuron types within the Bötzinger and pre-Bötzinger complexes, as well as the retrotrapezoid nucleus/parafacial respiratory group (RTN/pFRG) representing the central chemoreception module targeted by chemical feedback. The RTN/pFRG compartment contains an independent neural generator that is activated at an increased CO₂ level and controls the abdominal motor output. The lung volume is controlled by two pumps, a major one driven by the diaphragm and an additional one activated by abdominal muscles and involved in active expiration. The model represents the first attempt to model the transition from quiet breathing to breathing with active expiration. The model suggests that the closed-loop respiratory control system switches to active expiration via a quantal acceleration of expiratory activity, when increases in breathing rate and phrenic amplitude no longer provide sufficient ventilation. The model can be used for simulation of closed-loop control of breathing under different conditions including respiratory disorders.     

Smooth muscle dynamics and maximal expiratory flow in asthma.

A computational model for maximal expiratory flow in constricted lungs is presented. The model was constructed by combining a previous computational model for maximal expiratory flow in normal lungs and a previous mathematical model for smooth muscle dynamics. Maximal expiratory flow-volume curves were computed for different levels of smooth muscle activation. The computed maximal expiratory flow-volume curves agree with data in the literature on flow in constricted nonasthmatic subjects. In the model, muscle force during expiration depends on the balance between the decrease in force that accompanies muscle shortening and the recovery of force that occurs during the time course of expiration, and the computed increase in residual volume (RV) depends on the magnitude of force recovery. The model was also used to calculate RV for a vital capacity maneuver with a slow rate of expiration, and RV was found to be further increased for this maneuver. We propose that the measurement of RV for a vital capacity maneuver with a slow rate of expiration would provide a more sensitive test of smooth muscle activation than the measurement of maximal expiratory flow.