Methodology Validation of Microbial Limit Test of Bupi Qiangli Ointment

[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting in sample recovery test. [Result] The medium dilution method （1：10 test solution, 0.5 ml/plate） could effectively eliminate the inhibition effect of the Bupi Qiangli Ointment, and the recovery of Staphylococcus aureus was greater than 70% in the 3 batches of samples; and the conventional method exhibited the recoveries of E. coil, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in the 3 batches of samples. [Conclusion] Due to Bupi Qiangli Ointment has strongly antibacterial effect on Staphylococcus au- reus, the medium dilution method was used for bacterial counting, and the conventional method was used for mold and yeast counting; and the conventional method was used for controlled bacterium examination of E. coll.

Validation of Microbial Limit Test Methods of Tongmai Tangyanming Capsule

[ Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [ Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules, the microbiological limits of non-sterile products were verified. [ Results] Tongmai Tangyanming Capsule has a strong inhibitory effect on Bacillus subtilis and Candida albicans. The antimicrobial activity was significantly eliminated after increasing the diluent （ 1 ： 20） ; and the recoveries were in the range of 0.5 -2 when the total quantities of aerobic microbes were determined by dilution method （1：20）. When the total quantities of mould and yeast were determined by dilution method （1：20）, the recoveries were from 0.5 to 2, and Escherichia coli, cholate-tolerant Gram-negative bacteria and Salmonella can be detected by the test solution dilution method. [ Condusions] With the plate method, the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent, and conventional method was used for examination of control bacteria including E. coli, cholatetolerant Gram-negative bacteria and Salmonella. This method has been proved effective for microbial limit test of Tongmai Tangyanming Capsule, and can effectively control the quality of the preparation. The method is accurate and reliable.

Applicability of Microbial Limit Test Method for Qingyan Zhisou Powder

[Objectives]This study was conducted to establish a microbial limit test method for Qingyan Zhisou Powder.[Methods]Applicability tests were carried out according to Microbial Limit Tests of Non-sterile Products,General Rules 1105-1107 of Part IV of Chinese Pharmacopoeia,2020.[Results]Qingyan Zhisou Powder had a strong bacteriostatic effect on Pseudomonas aeruginosa.After increasing the dilution ratio(1:40),the bacteriostatic effect was obviously eliminated.When the total number of aerobic microbes was determined by the test liquid dilution method(1:40),the recovery values were in the range of 50%-200%;and when using the test liquid(1:10)to determine the total number of mold and yeasts,the recovery ranged from 50%to 200%.Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria were detected by both the routine method and dilution method in experimental groups.[Conclusions]The microbial limit test of Qingyan Zhisou Powder adopted the test liquid dilution method,and the routine method could be used for the test of Escherichia coli,Salmonella and bile-tolerant Gram-negative bacteria.The applicability test of the method is feasible,with scientific and accurate results,and the method can effectively control the quality of the preparation and is recommended for popularization.

Establishment of Microbial Limit Test Methods for Two Hospital Preparations

[Objectives] This study was conducted to establish microbial limit test methods for traditional Chinese medicine preparations Yunpi Granules and Bupi Qiangli Paste. [Methods] According to General Rules of Part IV of Chinese Pharmacopoeia, applicability tests were conducted on microbial limit test methods for the above two traditional Chinese medicine preparations by the plate method. [Results] The established methods showed recovery values in the range of 0.5-2.0 for both experimental strains, and the control bacteria could be detected in the experimental group, but not in the negative control group. [Conclusions] The microbial limit test methods were reliable for the two traditional Chinese medicine preparations and could be used for quality control.

Validation of Microbial Limit Test Methods of Compound Gangbangui Capsule

[Objectives] This study was conducted to establish a method for microbial limit test of Compound Gangbangui Capsule. [Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules,the microbiological limits of non-sterile products were verified. [Results]Compound Gangbangui Capsule has a strong inhibitory effect on S. aureus,and the antimicrobial activity was significantly eliminated after increasing the diluent（ 1∶ 20）; and the recoveries were in the range of 0. 5-2. 0 when the total quantities of aerobic microbes were determined by dilution method（ 1∶ 20）. When the total quantities of mould and yeast were determined by conventional method（ 1∶ 20）,the recoveries were from 0. 5 to 2. 0,and Escherichia coli can be detected in experimental groups by the test solution dilution method. [Conclusions]With the plate method,the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent and conventional method,respectively,and control bacteria,E. coli was examined by conventional method. This method has been proved effective for microbial limit test of Compound Gangbangui Capsule,and can effectively control the quality of the preparation. The method is accurate and reliable.

Validation for Microbial Limit Test Method of Compound Yu E Nose Drops

[Objectives] This study was conducted to establish a method for microbial limit test of Compound Yu E Nose Drops.[Methods] According to the Chinese Pharmacopoei (General Rules in the fourth part of the 2015 edition),the microbial limit test method for Compound Yu E Nose Drops was verified.[Results] Compound Yu E Nose Drops has a strong inhibitory effect on Staphylococcus aureus and Bacillus subtilis,and the inhibitory activity was significantly eliminated after increasing the diluent (1∶ 20).The recoveries were all in the range of 0.5-2.0 when the total quantities of aerobic microbes were determined by the dilution method (1∶ 20).When the total quantities of mould and yeast were determined by the conventional method,the recoveries were both in the range of 0.5-2.0.When examining control bacteria,Escherichia coli,S.aureus and Pseudomonas aeruginosa can all be detected in the test groups by the test liquid dilution method.[Conclusions] For Compound Yu E Nose Drops,the total quantities of aerobic microbe can be counted by the dilution method;the quantities of mould and yeast can be examined by the conventional plate method;and the conventional method can be used for control microbe examination.

Cautionary Remarks When Testing Agreement between Two Raters for Continuous Scale Measurements: A Tutorial in Clinical Epidemiology with Implementation Using R

Background: When continuous scale measurements are available, agreements between two measuring devices are assessed both graphically and analytically. In clinical investigations, Bland and Altman proposed plotting subject-wise differences between raters against subject-wise averages. In order to scientifically assess agreement, Bartko recommended combining the graphical approach with the statistical analytic procedure suggested by Bradley and Blackwood. The advantage of using this approach is that it enables significance testing and sample size estimation. We noted that the direct use of the results of the regression is misleading and we provide a correction in this regard. Methods: Graphical and linear models are used to assess agreements for continuous scale measurements. We demonstrate that software linear regression results should not be readily used and we provided correct analytic procedures. The degrees of freedom of the F-statistics are incorrectly reported, and we propose methods to overcome this problem by introducing the correct analytic form of the F statistic. Methods for sample size estimation using R-functions are also given. Results: We believe that the tutorial and the R-codes are useful tools for testing and estimating agreement between two rating protocols for continuous scale measurements. The interested reader may use the codes and apply them to their available data when the issue of agreement between two raters is the subject of interest.

Study on the Forming Limit Nomogram of Tensile Stamping Operations

Based on plasticity theory and physical experiments, the quantitative relationships between elongation δ obtained byuniaxial tensile test and forming limits of tensile stamping operations are given, which mainly resolves the problem thatforming limits can be derived from simple tensile test. The forming limit nomogram of tensile stamping operationsis also established to apply to engineering.

基于LMS Test.Lab的车内噪声优化

针对某车型怠速工况车内噪声偏大且耳压感强烈的问题,以模态试验测试与怠速工况频谱分析相结合的方法进行问题识别,发现后背门一阶模态频率与发动机二阶频率相近是引起车内噪声偏大且有耳压感的原因。对比调整后背门限位装置压缩量前后驾驶员右耳处噪声变化情况,试验结果表明车内噪声降低,耳压感消失。

Defining laboratory reference values and decision limits＇ populations, intervals, and interpretations

This article provides a brief overview of various approaches that may be utilized for the analysis of human semen test results. Reference intervals are the most widely used tool for the interpretation of clinical laboratory results. Reference interval development has classically relied on concepts elaborated by the International Federation of Clinical Chemistry Expert Panel on Reference Values during the 1980s. These guidelines involve obtaining and classifying samples from a healthy population of at least 120 individuals and then identifying the outermost 5% of observations to use in defining limits for two-sided or one-sided reference intervals. More recently, decision limits based on epidemiological outcome analysis have also been introduced to aid in test interpretation. The reference population must be carefully defined on the basis of the intended clinical use of the underlying test. To determine appropriate reference intervals for use in male fertility assessment, a reference population of men with documented time to pregnancy of 〈 12 months would be most suitable. However, for epidemiological assessment of semen testing results, a reference population made up ofunselected healthy men would be preferred. Although reference and decision limits derived for individual semen analysis test results will undoubtedly be the interpretational tools of choice in the near future, in the long term, multivariate methods for the interpretation of semen analysis alone or in combination with information from the female partner seem to represent better means for assessing the likelihood of achieving a successful pregnancy in a subfertile couple.

The Permutation Test as an Ancillary Procedure for Comparing Zero-Inflated Continuous Distributions

Empirical estimates of power and Type I error can be misleading if a statistical test does not perform at the stated rejection level under the null hypothesis. We employed the permutation test to control the empirical type I errors for zero-inflated exponential distributions. The simulation results indicated that the permutation test can be used effectively to control the type I errors near the nominal level even the sample sizes are small based on four statistical tests. Our results attest to the permutation test being a valuable adjunct to the current statistical methods for comparing distributions with underlying zero-inflated data structures.

Failure and limit energy of aircraft brake pairs

The test methods of the limit energy of aircraft brake pairs and the confirming methods for their failure were introduced. The test results of the rejected take-off (RTO) of brake pairs were analyzed. It is confirmed that the failure reality for brake pair is the destruction of the friction materials. Therefore, after the limit energy test of brake pairs, three criteria for their failure were put forword. The definition of the maximum brake pressure and the selection of the initial test energy were introduced. The products of USA and domestic substitute of brake pairs for Boeing 737 airplane were tested by these methods. The test results show that the limit energy of brake pairs can be determined by 2 or 3 experiments, thus the test cost is reduced.

Achieving Ultra-Low Detection Limit Using Nanofiber Labels for Rapid Disease Detection

Early diagnosis of diseases is critical in its effective management. Traditional disease detection methods require specialized equipment and trained personnel. With the introduction of rapid diagnostic test kits (RDTs), disease detection has become easier and faster. However, these RDTs have failed to compete with the specialized laboratory equipment due to their high detection limits and false alarm rates. This paper presents a novel method of using carbon nanofibers (CNFs) grown on glass microballoons (NMBs) to achieve ultra-low detection limits in RDTs. The NMBs have millions of nanosized CNFs grown on each microballoon, with each CNF having a strong bonding affinity for antibodies. The NMBs conjugated with secondary antibodies have therefore a significantly higher probability of capturing minute antigen concentrations in solution. Furthermore, the dark color formation at the capture zone makes visual disease detection possible. Human Immunoglobulin G (IgG) was selected as the model analyte to study the performance of NMBs using a sandwich immunoassay protocol. Ultra-low electrical detection limit of (4 pg/ml) and rapid re- sponse (~1 minute) was achieved using this method.

Correlation method estimation of the modulation signal in the weak equivalence principle test

In a test of the weak equivalence principle （WEP） with a rotating torsion pendulum, it is important to estimate the amplitude of the modulation signal with high precision. We use a torsional filter to remove the free oscillation signal and employ the correlation method to estimate the amplitude of the modulation signal. The data analysis of an experiment shows that the uncertainties of amplitude components of the modulation signal obtained by the correlation method are in agreement with those due to white noise. The power spectral density of the modulation signal obtained by the correlation method is about one order higher than the thermal noise limit. It indicates that the correlation method is an effective way to estimate the amplitude of the modulation signal and it is instructive to conduct a high-accuracy WEP test.

Beep test评估11～15岁少年游泳运动员有氧能力的效度研究

目的:评估现有通过beep test估算VO_2max的公式在我国少年游泳运动员中的适用性,以及能否建立预测准确性更高的公式。斱法:28名男子和25名女子少年游泳运动员,年龄11~15岁,先进行beep test获得最快折返跑速度,随后通过递增负荷跑台测试获得VO_2max测试值。通过逐步回归法建立新的VO_2max估算公式,计算分别通过Léger、Barnett(a)、Barnett(b)、Matsuzaka和新公式的VO_2max估算值,采用差值比较、相关分析、误差分析和一致性分析进行各估算值的效度检验。结果:1)通过Léger、Barnett(a)、Barnett(b)和Matsuzaka公式得出的VO_2max估算值均显著低于测试值,%Error为(68.4~90.0)%,与测试值间的差值为7.63~9.02ml/kg/min,一致性界限为0.49~17.55 ml/kg/min。2)VO_2max的新预测公式为VO_2max=61.435+3.211S-2.003BMI-5.189×G(r=0.715,P=0.004,SEE=2.25 ml/kg/min),其中G表示性别(男=0,女=1),S为最快折返跑速度。3)新公式得出的VO_2max估算值与测试值无显著差异,%Error下降至16.1%,与测试值间的差值减少到0.02±3.09 ml/kg/min,一致性界限为-6.03~6.08 ml/kg/min。结论:beep test适用于我国少年游泳运动员有氧能力的评估,但现有VO_2max估算公式的效度水平一般。基于本研究所选取群体新建的估算公式有效提高了预测的准确性。

火灾下活性粉末混凝土梁斜截面承载性能研究

为探明火灾下活性粉末混凝土(Receative power concrete,RPC)梁斜截面承载性能退化规律,设计制作了六根RPC简支梁试件,开展了恒载下ISO834标准火灾试验,获得了时间-位移曲线、荷载-位移曲线、内部温度变化、裂缝开展、破坏形态、高温爆裂等数据,分析了剪跨比、荷载水平、配箍率、纵筋配筋率对火灾下RPC梁斜截面承载性能的影响规律。结果表明:剪跨比、荷载水平是影响RPC梁斜截面耐火极限的关键因素,剪跨比由2.5增至3.5,荷载水平由0.25增至0.45,RPC梁耐火极限可降低30 min以上;配箍率对RPC梁的斜截面承载力和耐火极限影响显著;纵筋配筋率对RPC梁耐火极限影响甚微。火灾高温、爆裂削弱了RPC梁的斜截面承载性能,爆裂导致内部材料直接受火,加速其力学性能劣化,使梁斜截面承载力降低33.5%以上。该研究可为火灾下RPC梁斜截面承载安全及火灾后加固修复提供参考。

Dead Space Breathing in Patients with Malignancies: Determination by Cardiopulmonary Exercise Testing

Rationale: Patients with cancer commonly experience dyspnea originating from ventilatory, circulatory and musculoskeletal sources, and dyspnea is best determined by cardiopulmonary exercise testing (CPET). Objectives: In this retrospective pilot study, we evaluated patients with hematologic and solid malignancies by CPET to determine the primary source of their dyspnea. Methods: Subjects were exercised on a cycle ergometer with increasing workloads. Minute ventilation, heart rate, breathing reserve, oxygen uptake (V’O2), O2-pulse, ventilatory equivalents for carbon dioxide and oxygen (V’E/V’CO2 and V’E/V’O2, respectively) were measured at baseline and peak exercise. The slope and intercept for V’E/V’CO2 was computed for all subjects. Peak V’O2 4% predicted indicated a circulatory or ventilatory limitation. Results: Complete clinical and physiological data were available for 36 patients (M/F 20/16);32 (89%) exhibited ventilatory or circulatory limitation as shown by a reduced peak V’O2 and 10 subjects with normal physiologic data. The largest cohort comprised the pulmonary vascular group (n = 18) whose mean ± SD peak V’O2 was 61% ± 17% predicted. There were close associations between V’O2 and spirometric values. Peak V’E/V’O2 and V’E/V’CO2 were highest in the circulatory and ventilatory cohorts, consistent with increase in dead space breathing. The intercept of the V’E-V’CO2 relationship was lowest in patients with cardiovascular impairment. Conclusion: Dyspneic patients with malignancies exhibit dead space breathing, many exhibiting a circulatory source for exercise limitation with a prominent pulmonary vascular component. Potential factors include effects of chemo- and radiation therapy on cardiac function and pulmonary vascular endothelium.

Relationship between the Initial Fracture Stress and Fatigue Limit—Simple Prediction Method of Tensile Fatigue Limit of Composite

This article presents an experimental study that clarifies the relationship between the initial fracture stress and fatigue limit of glass fiber reinforced unsaturated polyester resin specimens with a laminated structure taken from a pultruded square pipe. Quasi-static bending and tension tests are performed with acoustic emission (AE) measurements to identifying the occurrence of initial fracture during testing. AE and observation results have clarified the occurrence of initial fracture was detected by maximum acoustic energy values and corresponding fiber breakage in the unidirectional (UD) bundles. Moreover, the ratio of initial fracture stress to ultimate strength is 32% in bending and 26% in tension, when comparing stress and strains on the tension side of the UD layer. These values are in good agreement with each other and with the measured tensile fatigue limit when the cyclic stress is at 25% of the tensile strength. Initial fracture stress obtained by static tests is close values to the fatigue limit which will greatly contribute to the prediction of the fatigue limit.

赤丹丸微生物限度检查方法适用性研究

目的建立医院制剂赤丹丸的微生物限度检查方法。方法根据四部通则1105-1107,2020年版《中国药典》的规定,采用常规法和稀释法计算赤丹丸中各个菌株的回收比,并对控制菌进行检查。结果赤丹丸有较强的抑菌性,当采用1∶100稀释法时,各试验菌株的回收比均在0.5~2范围内,常规法检出相应的控制菌。结论赤丹丸采用1∶100稀释法用于需氧菌总数、霉菌及酵母菌总数的计数,常规法用于控制菌的检查。

钢壳沉管隧道耐火极限标准与防火保护技术研究——以深中通道沉管隧道为例

为提高我国超大断面钢壳沉管隧道火灾防控水平,以深中通道海底沉管隧道为例,采用热力耦合模拟和材性试验等方法开展钢壳沉管隧道耐火极限标准研究,考虑到龙骨、拼缝等防火构造薄弱环节,进行管节结构和管节接头耐火试验,并提出相应的防火保护技术方案。主要结论如下:1)管节结构的耐火极限标准为火灾时,应将结构内侧钢壳最高温度控制在300℃以内;2)OMEGA橡胶管节接头的耐火极限标准为OMEGA橡胶超过70℃的时间小于2 h,超过100℃的时间小于1 h,且最高温度不得超过150℃;3)GINA橡胶管节接头的耐火极限标准为GINA橡胶超过100℃的时间小于1 h,且最高温度不得超过150℃;4)管节结构可采用35 mm单层防火板L型拼缝,对接面涂热膨胀胶;5)管节接头可采用35 mm防火板+50 mm陶瓷纤维毯双层防火保护体系,龙骨自由端取500 mm,拼缝处采用防火胶封堵。