精制蝮蛇抗栓酶的毒性限度试验

蝮蛇抗栓酶为一种抗血栓药物,具有去纤、降粘、解聚、溶栓等抗凝效应。目前已广泛应用于临床。国内生产厂家一般采用蝮蛇的原毒液经柱层析分离、分别收集蛋白峰,经化验合格,合峰、无菌灌装、冷干制剂。

健阴栓微生物限度检查方法适用性试验及体外抑菌作用研究

目的:进行健阴栓微生物限度检查方法适用性试验及体外抑菌作用研究,为该药临床应用提供参考.方法:参考《中华人民共和国药典:四部》(2015年版),对健阴栓进行微生物限度检查方法适用性试验,采用试管二倍稀释法和琼脂平板法,对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、铜绿假单胞菌和白色念珠菌进行体外抑菌作用的研究,测定其最低抑菌浓度(MIC)与最低杀菌浓度(MBC).结果:健阴栓的需氧菌总数可采用1:10供试液按平皿法测定,霉菌及酵母菌总数计数可采用1:10供试液以薄膜过滤法冲洗液500 ml/膜测定,控制菌采用常规法检验;体外抑菌作用试验结果显示,该药对大肠埃希菌和白色念珠菌无抑菌作用,对金黄色葡萄球菌的MIC和MBC分别为0.25和0.5 g/ml,对铜绿假单胞菌、枯草芽孢杆菌的MIC和MBC均为0.25 g/ml.结论:健阴栓有较强的抑菌作用.

紫苏方胶囊微生物限度检查方法的研究

目的:建立中药抗菌药物紫苏方胶囊微生物限度检查方法并对其进行验证。方法:参照2015年版《中国药典》四部通则,利用卵磷脂、L组氨酸、聚山梨酯80的中和作用,采用薄膜过滤法和平皿法测定紫苏方胶囊对金黄色葡萄球菌等5种试验菌种的回收率,并对其进行了控制菌适用性试验。结果:5种试验菌回收率均在0.5~2.0范围,控制菌可检出。结论:本试验所建立方法可用于紫苏方胶囊的微生物限度检查。

阿奇霉素片微生物限度检查方法的适用性验证

目的:建立大环内酯类抗生素药物阿奇霉素片微生物限度检查方法并对其进行验证。方法:参照2015年版《中国药典》四部通则,采用薄膜过滤法测定阿奇霉素片对金黄色葡萄球菌等5种试验菌种的回收率,并对其进行了控制菌适用性试验。结果:5种试验菌回收率均在0.5~2.0范围,控制菌可检出。结论:本试验所建立方法可用于阿奇霉素片的微生物限度检查。

盐酸米那普仑片微生物限度检查方法的适用性验证

目的:建立抗抑郁药物盐酸米那普仑片微生物限度检查方法并对其进行验证。方法:参照2015年版《中国药典》四部通则,采用薄膜过滤法和平皿法测定盐酸米那普仑片对金黄色葡萄球菌等5种试验菌种的回收率,并对其进行了控制菌适用性试验。结果:5种试验菌回收率均在0.5~2.0范围,控制菌可检出。结论:本试验所建立方法可用于盐酸米那普仑片的微生物限度检查。

进口与国产头孢克洛干混悬剂的微生物限度检查方法及影响因素分析

目的:建立进口和国产头孢克洛干混悬剂的微生物限度检查方法,并比较分析影响因素。方法:根据《中华人民共和国药典》2015年版四部通则1105非无菌产品微生物限度检查:微生物计数法,通则1106非无菌产品微生物限度检查:控制菌检查法和通则1107非无菌药品微生物限度标准,采用中和法,薄膜过滤法相结合建立头孢克洛干混悬剂的微生物限度检查方法的适用性试验。结果:计数方法适用性试验中,稀释剂对照组菌落数与菌液对照组菌落数的比值均在0. 5~2间,试验组菌落数减去供试品对照组菌落数与菌液对照组菌落数的比值均在0. 5~2间;控制菌检查方法适用性试验中,试验组检出阳性试验菌。结论:中和法,薄膜过滤法相结合可消除头孢克洛干混悬剂微生物的抑菌作用,可用于头孢克洛干混悬剂的微生物限度检查。影响头孢克洛干混悬剂的微生物限度方法适用性的因素主要与样品原料的分散性和中和剂的有效单位有关。

苯磺贝他斯汀片微生物限度检查方法的验证

目的：建立苯磺贝他斯汀片的微生物限度检查法,并对其进行验证。方法：按2015版《中国药典》（四部）相关内容,以试验菌回收率在0.5-2为要求,细菌、霉菌及酵母菌采用常规平皿法;大肠埃希菌采用常规法。结果：采用常规法,白色念珠菌的回收率小于50%,其余试验菌的回收率均在0.5-2之间。通过增加稀释液法,可消除供试品对白色念珠菌的抑制作用,其回收率在0.5-2之间;控制菌采用常规法即可检出。结论：细菌计数采用常规平皿法,霉菌及酵母菌计数采用培养基稀释法,控制菌按常规法,可作为苯磺贝他斯汀片微生物限度检查方法。

Experimental study on box shape steel reinforced concrete beam

Experimental study on the fundamental behavior of box shape steel reinforced concrete （SRC） beams was conducted. Seven 1 ： 3 scale model SRC beams were tested to failure. The experimental results indicate that the flexural strength increases with the increase of the ratio of flexural reinforcement and the thickness of flange of the shape steel; the shear strength increases with the increase in the thickness of the web of the shape steel. Concrete filled in the box shape steel can prevent the early failure of specimens due to the buckling of the box shape steel, and increase the ultimate load. Measures should be made to strengthen the connection and co-work between the shape steel and the concrete. Formulae for flexural and shear strength of the composite beams are proposed, and the calculated results are in good agreement with the experimental results. In general, the box shape SRC beam is a kind of ductile member, and it is suitable for extensive engineering application.

盐酸头孢噻呋细菌内毒素检查方法学研究

研究旨在填补盐酸头孢噻呋无菌原料检查标准的空白,建立其细菌内毒素检查方法。试验依据要求复核了鲎试剂的灵敏度,通过干扰试验对预处理方法进行验证,并采用建立的方法对收集的7个批次的供试品进行了细菌内毒素检测。结果显示,鲎试剂的灵敏度符合要求,供试品稀释至终浓度为0.125 g/L时对鲎试剂无干扰作用,检测的7个批次的供试品的细菌内毒素含量均符合规定。研究表明,试验所建立的检查方法科学合理,可应用该细菌内毒素检查法对盐酸头孢噻呋无菌原料进行质量监测。

Determination and Evaluation of Strength Characteristics of Dry Jet Mixing

Dry jet mixing (DJM) for soft soil stabilization has been widely used since 1980s. The quality and strength of stabilized columns are fundamental parameters to evaluate the stabilization work. This paper presents the standard penetration test (SPT) method and its test results on cement columns. It is shown that SPT is an effective and simple method for inspecting and evaluating cement columns. The strength characteristics along the length of the column, a good correction between SPT blow count and the unconfined compressive strength are achieved.

医疗器械的细菌内毒素检验

依据细菌内毒素检查法实验操作规范,介绍医疗器械细菌内毒素检验的凝胶限度试验方法和注意事项。

羟乙基淀粉40氯化钠注射液中细菌内毒素的检查方法

目的:建立羟乙基淀粉40氯化钠注射液细菌内毒素的检查方法。方法:按《中国药典》2015年版四部通则1143细菌内毒素检查法及相关规定,对3批供试品分别用凝胶限度试验和动态浊度法进行干扰试验和细菌内毒素检查。结果:3批供试品的内毒素结果都符合规定。结论:羟乙基淀粉40氯化钠注射液可适用细菌内毒素检查法控制质量,其细菌内毒素限值确定为0.50EU·mL^-1。

注射用多索茶碱细菌内毒素检查法研究

目的:建立注射用多索茶碱的细菌内毒素检查(BET)方法。方法:按照《中国药典》2020年版四部规定,确定注射用多索茶碱细菌内毒素限值,用凝胶限度试验进行方法验证。结果:注射用多索茶碱在2.0 mg·mL^(-1)浓度以下对细菌内毒素检查无干扰作用,细菌内毒素限值为0.25 EU·mg^(-1)。结论:注射用多索茶碱可用细菌内毒素检查法代替家兔热原检查法。

Stabilization of saline silty sand using lime and micro silica

Many construction and post-construction problems have been reported in the literature when saline soils have been used without understanding of their abnormal behavior,especially their inferior bearing capacity in the natural condition.The strength of these soils further decreases on soaking.Saline soil deposits cover extensive areas in central Iran and are associated with geotechnical problems such as excessive differential settlement,susceptibility to strength loss and collapse upon wetting.Because of these characteristics,some of the roads constructed on saline soils in Taleghan area have exhibited deterioration in the form of raveling,cracking and landslides.The main objective of this work is to improve the load-bearing capacity of pavements constructed on Taleghan saline soils using lime and micro silica.Soil samples from Hashtgerd-Taleghan road were collected and tested for improving their properties using lime and micro silica at different dosages ranging from 0 to 6%.The load-bearing capacity of stabilized soil mixtures was evaluated using California Bearing Ratio(CBR) and unconfined compressive strength tests.The test results indicate that the lime improves the performance of soil significantly.The addition of 2% lime with 3% micro silica has satisfied the strength-deformation requirements.Therefore,improved soil can be used as a good subbase in flexible pavements.

Research on technological parameters of pressure forming with hot granule medium on AA7075 sheet

Hot granule medium pressure forming （HGMF） process is a new process in which granule medium replaces the medium in existing flexible-die hot forming process, such as liquids, gases or viscous medium. Hot forming of light alloy sheet parts can be realized based on the properties of granule medium, such as withstanding high temperature and pressure, filling well, sealing and loading easily. In this work, the forming of AA7075 cylindrical parts by HGMF process is taken as an example to establish the constitutive relation and forming limit diagram （FLD） of AA7075 sheet which is related to temperature by hot uniaxial tensile test of sheet metal. Based on the assumption that granule medium is applied to extended Drucker-Prager linear material model, the finite element model of HGMF process is established and the effect of technological parameters, such as forming temperature, blank-holder gap and drawing ratio, on the sheet metal formability, is studied. The limit drawing ratio curve of AA7075 cylindrical parts at forming temperature of 175-300 ℃ is obtained by HGMF process test, and the limit drawing ratio reaches the maximum value of 1.71 at 250 ℃. The results of numerical simulation are consistent with the results of process test, and the forming force, distribution of wall thichness and form of instability are predicted correctly, which provides reference for the application of HGMF process.

Analysis of influence factors of unconfined compressive strength for composite soil stabilizer-stabilized gravel soil

In order to investigate the effect o f some factors on the unconfined compressive strength(UCS)for composite soil stabilizer-stabilized gravel soil(CSSSGS),the orthogonal test is adopted to set up the experimental scheme.Three levels o f each factor armconsidered to obtain the change laws o f UCS,in which the binder dosages are8%,10%,and12%;the curing times ae7,14and21d;the gradation nae0.3,0.35and0.4;and the degrees of compaction are95%,97%,and99%.The range analysis clearly indicates that the influence degree o f the four factors on UCS is in such an order:dosage,age,gradation,and degree o f compaction.The variance analysis shows that only the composite soil stabilizer dosage can significantly affect UCS.In road construction,the examination o f composite soil stabilizer dosage and base-course maintenance should be given much more attention to obtain satisfactory base-course strength,compared w ith gradation floating and the change of degree o f compaction.

Influence of specimen uniformity on mechanical behaviour of unsaturated soil

Pressure plate instrument is employed during drying, and unconfined compressive strength test is performed on the unsaturated specimen. Curves of shear force versus shear displacement, and curves of saturation degree versus time are investigated. The results show that the specimens with similar curves of saturation degree versus time have nearly identical mechanical behavior. In particular, the uniform specimens should be chosen within the lower equilibrium saturation degree because steady test results are presented. Further, the conclusion is verified by the repeated test. Thus, the method for distinguishing the uniform unsaturated specimen is obtained. In the light of the method, an improved test process is proposed. The uniform specimens should be chosen by this method under the specific matric suction, and then shear tests are carried out on the chosen unsaturated specimen. Namely, initial value of unsaturated soil is not zero matric suction but a specific suction.

The compressive strength experimental study of cemented soil under H2SO4 corrosive in earlier period

In order to simulate and study the erosion effect process such as the changes of corrosive depth and unconfined compression strength of cemented soil sample in earlier period from 0 day to 60 days, a series of tests including unconfined compressive tests, measuring the blocks＇ sizes, and taking photos, are conducted on the cemented soil blocks which were cured in different concentrations of H2SO4 solutions. The results of tests show that the corrosive depth is increasing and the unconfined compression strength is decreasing with the increase of H2SO4 solution concentration at the same erosion time, and the corrosive degree is increasing with the corrosive time. In the earlier state, the corrosive effect is serious, but the effect becomes slow in the later state in the same concentrated H2SO4 solution. After take statistics the date, a coefficient a is put forward to predict the reduction of the compressive strength of cemented soil in various concentration of H2SO4 solution, which could be used in practical design.

Particle Size Effect on Shear Properties of Bottom Ash Added-Geocomposite Soil

It is well known that the finer particle of cementing material has more pozzolanic reaction than the coarser. This paper investigates the shear properties of geocomposite soil with various particle sizes of bottom ash. The geocomposite soil （GCS） in this study consists of dredged soil, bottom ash and cement for recycling dredged soil and bottom ash. Three different particle sizes of bottom ash passing No. 4 sieve, No. 40 sieve, and No. 140 sieve were added into soil mixtures, namely as GCS 4, GCS 40, and GCS 140, respectively. These bottom ashes have the same chemical component except for different particle sizes. Several mixtures were prepared with various contents of bottom ash ranging from 0 to 100% at 50% intervals by the weight of dry dredged soil. In this study, several series of unconfined compression test were carried out on the mixtures with various curing times. It is found that the unconfined compressive strength is a function of curing time and bottom ash content. For the curing time less than 28 days, the GCS 4 has higher unconfined compressive strength than the GCS 40 and GCS 140 due to the interlocking effect and friction between the particles with angular shape of coarse bottom ash. For the curing time larger than 28 days, the GCS 140 has higher strength due to the pozzolanic reaction. However, the ratios of secant modulus to unconfined compressive strength of three mixtures are almost the same, and in range of （46-100）, regardless of mixing condition and curing time.