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Bacterial endotoxin is considered as one of the critical risk factors in medical devices, especially implanted devices that directly or indirectly contact with blood circulating system. In that case, endotoxin limits for implanted medical devices is important in determine the safety of medical devices. According to GB/T 14233.2-2005, the requirements of endotoxin index for intrathoracic medical devices is 2.15 EU per device. However, the definition of "intrathoracic medical devices" is vague. Specifically, "for cardiovascular system application" instead of "intrathoracic application" is more reasonable. With the deeper understanding of the risk of endotoxin in medical devices and considering the internationally accepted standards, the limits of endotoxin in medical devices for cardiovascular system application is acceptable at 20 EU per device.
Subject(s)
EndotoxinsABSTRACT
This paper mainly studied the effect of Xiyanping injection on the bacterial endotoxin lipopolysaccharide (LPS)-induced fever in rabbits, preliminarily investigated the mechanisms, and provided pharmacological basis for the clinical application. The rabbit model of endotoxin-induced fever was established by using LPS as the inducer; The changes of rectal temperature were measured; The levels of prostaglandin E2 (PGE2), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and phospholipaseA2 (PLA2) in the serum were measured; The levels of PGE2, cyclic adenosine monophosphate (cAMP), and arginine vasopressin (AVP) in cerebrospinal fluid as well as hypothalamus were detected. The animal welfare and experimental process are in accordance with the regulations of the Animal Ethics Committee of China Pharmaceutical University in this study. The results showed that Xiyanping injection (12.5, 25, and 50 mg·kg-1) could significantly reduce LPS-upregulated body temperature of rabbits, and the duration of action could reach 5.5-8.5 h. At the doses of 25 and 50 mg·kg-1, the antipyretic effect of Xiyanping injection was comparable to that of analgin injection (50 mg·kg-1). Furthermore, Xiyanping injection and analgin injection both reduced the levels of PGE2, IL-1β, TNF-α, and PLA2 in the serum of febrile rabbits to the varying degrees. In addition, Xiyanping injection also down-regulated the levels of PGE2, cAMP, and AVP in the hypothalamus, and PGE2 and cAMP in the cerebrospinal fluid. The level of AVP in the cerebrospinal fluid was up-regulated. This study indicated that Xiyanping injection could significantly improve the endotoxin-induced fever in rabbits, and mechanisms were closely related to the regulation of the levels of PGE2, TNF-α, IL-1β, PLA2, cAMP, and AVP in serum, hypothalamus, and cerebrospinal fluid.
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Endometriosis is a multiple disease that afflicts the health of women at childbearing age,and its incidence rate has been increasing year by year,furthermore,there has been a trend to be younger.At present,the pathogenesis of endometriosis has been not expounded completely,its cure rate is not high with high recurrence rate.In recent years,studies have shown that the human is a commensal body composed of a large number of microorganisms,and especially the microorganisms in the intestinal are closely related to the health of the body.Based on the previous studies on endometriosis,this paper proposes that its pathogenesis may be related to intestinal microbiological disorder,and aims to provide new ideas for the treatment of endometriosis.
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A fim de garantir a qualidade final de produtos os laboratórios de análise microbiológica fornecem dados sobre a qualidade dos mesmos em todas as suas etapas de produção. A crescente preocupação com a saúde dos pacientes conduz à busca de métodos que forneçam resultados precisos e rápidos, pois possibilitam que ações corretivas sejam tomadas em tempo real. O presente trabalho teve por objetivo avaliar o potencial de tecnologia alternativa no monitoramento de endotoxina bacteriana na água tratada para diálise e dialisato e avaliar o potencial da citometria de fluxo na análise de água. Para isso utilizou-se Portable Test System (PTS®) como método alternativo para detecção de endotoxina bacteriana no monitoramento da água tratada para diálise e dialisato, o qual foi validado frente ao método convencional farmacopeico. Paralelamente realizou-se revisão narrativa da literatura a fim de avaliar a aplicabilidade da citometria de fluxo em análises de água. A análise dos diferentes parâmetros de validação para endotoxina bacteriana no método alternativo mostrou que, exceto para a menor diluição analisada, houve linearidade e precisão nos resultados. Por outro lado a concentração de 0,25 UE/mL foi a menor que apresentou exatidão e especificidade. Observou-se ainda, que o limite de detecção foi de 0,125UE/mL e o de quantificação de 0,25 UE/mL, portanto o intervalo foi de 0,25-1,0 UE/mL. Adicionalmente pela análise de resistência pode-se perceber que ao variar analistas não houve diferença significativa. Em relação ao tempo de análise em uma condição de rotina laboratorial com muitas amostras, o PTS® mostrou-se demorado. Ressalta ainda, que seria importante que a legislação vigente determinasse a análise mensal de endotoxinas no dialisato. A revisão da literatura evidencia o potencial da tecnologia de citometria de fluxo, pois a mesma mostrou-se satisfatória quando comparada a metodologias convencionais para análise de água. O trabalho desenvolvido permitiu concluir que o PTS®) mostrou-se adequado para analisar amostras in loco, permitindo análises em tempo real, que para as quais haja a expectativa de ausência de endotoxinas ou de concentração respeitando o intervalo de 0,25 UE/mL a 1,0 UE/mL. Quanto a citometria de fluxo, esta mostrou-se uma tecnologia promissora em analisar amostras de água, sendo portanto recomendável proceder a estudos de validação e aplicabilidade
In order to guarantee the final quality of products, the microbiological analysis laboratories provide data about their quality at all production stages. The growing concern for patients' health leads to the search for methods that provide accurate and fast results, as they enable corrective actions to be taken in real time. The present work aimed to evaluate the alternative technology potential in the monitoring of bacterial endotoxin in treated water for dialysis and dialysate and to evaluate the potential of flow cytometry in water analysis. The different validation parameters analysis for bacterial endotoxin in alternative method showed that, except for the lowest dilution analyzed, there was linearity and precision in the results. On the other hand, the concentration of 0.25 EU / mL was the lowest that presented accuracy and specificity. It was further observed that the detection limit was 0.125UE / mL and the quantification limit was 0.25 EU / mL, so the range was 0.25-1.0 EU / mL. Additionally by the ruggedness analysis it was possible to perceived that when varying analysts there was no significant difference. Regarding the analysis time in a laboratory routine condition with many samples, the PTS® was was time consuming. It was also observed that it would be important to determine monthly analysis of endotoxins in dialysate. The literature review evidence the flow cytometry technology potential of the because it was satisfactory when compared to conventional methodologies for water analysis. The research showed that the PTS® was suitable for analyzing samples in loco, allowing real-time analyzes, for which there is expectation of endotoxins absence or concentration respecting the range of 0.25 EU / mL to 1.0 EU / mL. For the flow cytometry, it was shown to be a promising technology for analyzing water samples, and it is therefore advisable to carry out validation and applicability studies
Subject(s)
/classification , Renal Dialysis , Dialysis , Endotoxins/analysis , Flow Cytometry/instrumentationABSTRACT
OBJECTIVE: To remove bacterial endotoxin from glycyrrhizic acid for injection by ultrasonic-assisted ultrafiltration technology. METHODS: On the basis of clarifying the influences of molecular weight cut off, ultrasonic power, glycyrrhizic acid concentration and pH,the ultrafiltration transmittance of glycyrrhizic acid and the rejection of bacterial endotoxin were selected as indexes to optimize the parameters for ultrasonic-assisted ultrafiltration. RESULTS: The impact of glycyrrhizic acid concentration was relatively low. The optimal separation conditions were as following: molecular weight cut off 10×103, ultrasonic power 300 W and pH 7.7. The predicted value of the ultrafiltration rejection of bacterial endotoxin was 93.7%, meanwhile the transmittance of glycyrrhizic acid was 92.2%, which was close to the model-predictive value. CONCLUSION: This mathematical model has good regression with high fitting degree, and can solve the separation contradiction between glycyrrhizic acid and bacterial endotoxin. This study provides scientific data for the purification of pharmaceutics in which saponins are the main components.
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Objective:To establish the bacterial endotoxin test for HSSYO-001-3S. Methods: HSSYO-001-3S was dissolved in dimethylsulfoxide,diluted by BET water and centrifuged,and then the supernatant was used for the bacterial endotoxin test. The ex-periment was carried out according to the gel-clot technique for bacterial endotoxin inspection and the related regulations in Chinese Pharmacopoeia (2015 edition,volumeⅣ,general rule 1443). Results:HSSYO-001-3S was added with cosolvent and diluted by BET water to 1 mg·ml-1,and there was no interference effects to bacterial endotoxin test from the supernatant diluted four times or more. Conclusion:Bacterial endotoxin test can be used to control the quality of HSSYO-001-3S.
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Objective: To investigate the effects of a dry aqueous extract of Notobasis syriaca (N. syriaca) on lipopolysaccharide (LPS)-induced inflammation in rats. Methods: Rats were fed the dried extract [500 mg/(kg•d)] for three consecutive days and then were intraperitoneally injected with LPS (1 mg/kg). Two hours after LPS injection, rats were sacrificed and blood and brain regions were collected. Inflammatory mediators' levels in plasma and homogenates of brain regions were determined by ELISA. Results: Pretreatment with the N. syriaca extract resulted in significant anti-inflammatory effects (P<0.05), including: i) attenuated LPS-induced hypothermia; ii) decreased hypothalamus and hippocampus prostaglandin E2 levels in the LPStreated rats; and, iii) reduced hypothalamus and hippocampus interleukin-6 and tumor necrosis factor-levels in the LPS-treated rats. Conclusions: These results suggest that N. syriaca possesses anti-inflammatory properties. Thus, it is possible that long-term consumption of this plant may result in beneficial pharmacological effects.
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Objective:To investigate the effects of a dry aqueous extract of Notobasis syriaca (N. syriaca) on lipopolysaccharide (LPS)-induced inflammation in rats.Methods:Rats were fed the dried extract [500 mg/(kgod)] for three consecutive days and then were intraperitoneally injected with LPS (1 mg/kg). Two hours after LPS injection, rats were sacrificed and blood and brain regions were collected. Inflammatory mediators’ levels in plasma and homogenates of brain regions were determined by ELISA.Results:Pretreatment with the N. syriaca extract resulted in significant anti-inflammatory effects (P<0.05), including: i) attenuated LPS-induced hypothermia; ii) decreased hypothalamus and hippocampus prostaglandin EConclusions:These results suggest that N. syriaca possesses anti-inflammatory properties. Thus, it is possible that long-term consumption of this plant may result in beneficial pharmacological effects.
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OBJECTIVE:To adopt gel method for the determination of bacterial endotoxin in Fat emulsion(10%)/amino acid (15)/glucose (20%) injection. METHODS:According to the gel method in term ofbacterial endotoxin test methodin Chinese Pharmacopeia(2015 edition),the maximal valid dilution(MVD)of samples were determined through interference test and the vali-dated. The results were compared with chromogenic method. RESULTS:In gel method,the interference to agglutination reaction of TAL and bacterial endotoxin can be excluded when samples were diluted 24 times or less. In chromogenic method,the samples should be diluted 76 times or less. CONCLUSIONS:Gel method can be used for bacterial endotoxin test of Fat emulsion(10%)/amino acid(15)/glucose(20%)injection.
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Objective:To establish a bacterial endotoxin test for safflower yellow for injection to control the drug quality and reduce the incidence of clinical pyrogenic reaction. Methods:The bacterial endotoxin test was carried out according to the methods and guid-ing principles in Chinese Pharmacopoeia ( 2015 edition, volumeⅣ) . A systematic study was carried out to investigate the interference of safflower yellow for injection with limulus reagent and agglutination reaction to bacterial endotoxin in order to detect the non-interfer-ence concentration of bacterial endotoxin. Results: Safflower yellow for injection with the concentration below or equal to 0. 4 mg· ml-1 had no interference with tachypiens amebocyte lysate. Conclusion: Bacterial endotoxin test ( gel method) can be used for the limit test of bacterial endotoxin of safflower yellow for injection, and the results are accurate and reproducible.
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Objective:To establish the bacterial endotoxin test method and the abnormal toxicity test method for reduced glutathi -one for injection.Methods:According to the requirements and methods in Chinese Pharmacopoeia (2015 edition, part IV), the bacte-rial endotoxin test and the abnormal toxicity test for reduced glutathione were studied .Results:The limit of bacterial endotoxin for re-duced glutathione was 0.125 EU· mg-1 , and the limit of abnormal toxicity was 1.0 g· kg-1 .Conclusion: The bacterial endotoxin test method and the abnormal toxicity test method are feasible .The abnormal toxicity should be supplemented in the quality standard for reduced glutathione , and the bacterial endotoxin test can replace the pyrogen test .
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Objective:To establish a method to determine the content of bacterial endotoxin in iodixanol. Methods:The standard curve of kinetic turbidimetric method was established and the dilution ratio was optimized by interference test. Bacterial endotoxin in the samples was determined. Results:The dilution ratio of 1 ∶12 did not interfere with the test. The recovery rate of bacterial endotox-in was 50%-200%. Conclusion:The kinetic turbidimetric method is suitable for the determination of bacterial endotoxin in iodixanol.
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OBJECTIVE:To establish a method for the bacterial endotoxin test of vinpocetine raw material. METHODS:Ac-cording to the bacterial endotoxin test in the Chinese Pharmacopoeia(2010 edition,Ⅱ)Appendix Ⅺ E,the samples with different batches were used for interference test and bacterial endotoxin test by tachypleus amebocyte lysate from 2 manufacturers. RE-SULTS:The vinpocetine solutions with high concentration have interference effect on the agglutination reaction of bacterial endotox-in and the interference can be eliminated by diluting. CONCLUSIONS:The non-interference concentration of vinpocetine solutions is 0.25 mg/ml. Bacterial endotoxin test can be used to control the quality.
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Objective:To establish bacterial endotoxin test for brozopine. Methods: Interference pre-test and interfering factors test were conduced on 3 batches of samples from 2 manufacturers to confirm the applicability of bacterial endotoxin test and the non-in-terfering concentration. The bacterial endotoxin test was carried out based on the method described in the second part of Chinese Phar-macopeia (2010 edition) and relevant standards and guidelines. Results: The three batches of brozopine showed no interference in bacterial endotoxin test at the concentration less than or equal to 2. 5 mg·ml-1 . The bacterial endotoxin test of the three bathes of samples all met the requirements. Conclusion:Bacterial endotoxin test can be used for the quality control of brozopine.
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OBJECTIVE:To establish a method for bacteria1 endotoxin test for Peramivir hydrate and sodium chloride injec-tion. METHODS:Maximum non-interference concentration of the sample with different batohes were used for interference test. was determined by interference test according to endotoxin gel method stated in Chinese Pharmacopiea (2010 edition)and bacterial en-edotoxintest by tachypleus amebocyte lysate from 2 manufact urers. RESULTS:The interference on bacterial endotoxin test could be excluded when the sample was diluted to 2.5 mg/ml and the limit of bacterial endotoxins was 0.5 EU/ml. CONCLUSIONS:The established method can be used to detect the bacterial endotoxin of Peramivir hydrate and sodium chloride injection.
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OBJECTIVE: To summarize and analyze the factors of building the bacterial endotoxin test laboratory. These factors should meet the GPCL quality management concepts. METHODS: Give Some specific methods and experience in five aspects were given, which combine the GPCL quality management concepts with the characteristics of bacterial endotoxin test. RESULTS AND CONCLUSION: Summarizes The applications of GPCL concept for bacterial endotoxin test laboratory is summarized.
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Objective To study the process of removing bacterial endotoxins by ultrafiltration technology in dextran 40 injection. Methods Dextran 40 solution was ultrafiltrated by 100,200,and 300 kDa aperture ultrafiltration membranes with composite, PES and PVDF materials. In order to optimize ultrafiltration process,the content of effective component and endotoxins were detected by HPLC and kinetic-turbidimetry,respectively,and the change of particle size distribution in dextran 40 solution was analyzed before and after ultrafiltration. Results The transmittance of dextran 40 was close to the same MWCO and different membrane material. When MWCO reached 300 kDa,the transmittance was above 91%,which met the requirement of filtration. The endotoxin removal rates by 100-300 kDa composite ultrafiltration membranes were more than 99%. But the endotoxin removal rates of both of PES and PVDF membranes were less than 40%,which were unable to guarantee the removal efficiency of the endotoxin in dextran 40 solution. The particle size declined after ultrafiltration by 300 kDa composite membrane, and level of the insoluble particles decreased. Conclusion The 300 kDa composite ultrafiltration membrane can effectively remove endotoxin in dextran 40 solution with less main components loss. The material can meet requirements for producing dextran 40 injection.
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Objective:To establish a detection method for bacterial endotoxins in nedaplatin for injection. Methods:The experi-ment was carried out and the result was evaluated according to the appendix XIE of Chinese Pharmacopoeia 2010 Vol. II. Results:There was no interference from nedaplatin for injection to bacterial endotoxin in TAL reaction. Conclusion:The method is feasible to detect bacterial endotoxin in nedaplatin for injection, which can replace the rabbit pyrogen test.
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Objective: To investigate the ultrafiltration effect of polysulfone hollow fiber ultrafiltration membrane and polysulfone plate ultrafiltration membrane with relative molecular weight by different cut-off on the decarburization fluid of Reduning Injection. Methods: The transfer rates of chlorogenic acid and geniposide, fingerprint similarity, and removal of bacterial endotoxin, protein, oxalate, and resin before and after ultrafiltration were used as inspect indicators to optimize the purification technology for the decarburization fluid of Reduning Injection. Results: The obvious effect of polysulfone hollow fiber ultrafiltration membrane with the relative molecular weight 10000 on oxalate and resin in the decarburization fluid of Reduning Injection was observed. Bacterial endotoxin (100%) in the decarburization fluid of Reduning Injection was removed by the polysulfone plate ultrafiltration membrane with the relative molecular weight 5000. Conclusion: The stability and the preparation safety of Reduning Injection could be ensured by the two stage combination of the ultrafiltration membrane technology.
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Objective To verify the diagnosis of the bacterial infections and to identify the pathogens, by PCR detection and bacterial endotoxin limulus test. Methods This study enrolled 50 patients receiving liver al-lografts from October 2005 to October 2007 in Ruijin Hospital. Peripheral blood samples were taken on DO, D1, D7 and D14. After preparation of the samples, PCR detection, bacterial endotoxin limulus test were performed. Results The sensitivity, specificity, and accuracy in the diagnosis was 66.7% ,95.0%, and 78.0% for the PCR, and 84.2%,83.9%,and 84.0% for limulus test respectively. It took 3 hours on average for the accomplishment of all these tests. Conclusions Positive PCR test plus negative limulus test suggest G+ infection, which may need the drugs targeting on G+ bacteria;positive PCR test plus positive limulus test, suggest G-infection or mixed infection, which may need drugs against the G-bacteria;negative PCR test, suggests the lack of severe infection. PCR test and limulus test were both remarkably faster than traditional cultural methods in diagnosis.