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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 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 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 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 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 evaluate the security of big animals with a new bioartificial liver system .Methods Six Tibet pigs re-spectively received treatment of hybrid artificial liver and simple bioartificial liver ,observed and recorded the vital signs ,venous pressure ,transmembrane pressure and slurry pot pressure each hour ,and collected blood to make endotoxin and bacterial culture test in the zero hour ,fourth and eighth hour .Results Compared with the zero hour ,venous pressure ,transmembrane pressure ,slur-ry pot pressure were much higher in the fifth hour (P0 .05) .The mean arterial pressure and respiratory rate in all time point showed no significant changes (P>0 .05) .Com-pared with the zero hour ,the heart rate was much lower in the second hour (P<0 .01) .The values of blood endotoxin were less than 0 .5 EU/mL in the zero hour ,fourth and eighth hour from beginning ,and the bacterial culture test showed no growth of bacteria . Conclusion The experiment of big animals with a new bioartificial liver system was safe ,the efficacy in the treatment of hepatic failure could be assessed further .
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F-18 FDG (2-[18-F] fluoro-2-deoxy-D-glucose) is the most frequently used radiopharmaceutical for PET and PET CT imaging exams. The FDA recently approved the use of the PTS TM (Portable Test System) as an alternative to the standard test proposed by the United States Pharmacopeia using the LAL (Limulus Amebocyte Lysates), that takes longer to perform (about 1h) than the PTS TM (15 min). Recent studies have demonstrated that radiation could interfere with the PTS TM test. In order to study the effects of radiation on the PTS TM test and/or equipment, 27 batches of F-18 FDG produced in the Nuclear Engineering Institute were analyzed. The results showed that no direct correlation with radiation was found in any of the cases.
O FDG-18 é o radiofármaco mais utilizado nos exames de PET e PET CT. O FDA recentemente aprovou o uso do PTS TM (Portable Test System) como método alternativo ao teste padrão de endotoxina, proposto pela Farmacopéia Americana, considerando que no primeiro há um tempo de espera de 1 hora frente a somente 15 minutos do segundo. Estudo recentes demonstram que a radiação poderia interferir no teste do PTS TM. De modo a avaliar os efeitos da radiação no teste PTS TM foram analisados 27 lotes de F-18 FDG produzidos no Instituto de Engenharia Nuclear. Os resultados demonstraram que em todos os casos nenhuma correlação direta com a radiação foi observada.
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Endotoxins/chemistry , Research/methods , Radiation , Endotoxins/analysis , Nuclear Medicine , RadiopharmaceuticalsABSTRACT
OBJECTIVE: To establish a bacterial endotoxin test method for fluorescein sodium injection.METHODS: Based on the bacterial endotoxin test method stated in Chinese Pharmacopoeia 2005 edition(second part),an interference test was conduced on different batches of fluorescein sodium samples using tachypleus amebocyte lysate from different companies.RESULTS: At a concentration of no more than 0.75 mg?mL-1,fluorescein sodium showed no interfere with the bacterial endotoxin test.CONCLUSION: It is feasible for bacterial endotoxin test of fluorescein sodium injection be conducted in a limit value of 0.15 EU?mL-1.
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OBJECTIVE:To improve the method of positive control test in bacterial endotoxin test.METHODS:A new method rather than a routine method was adopted for the bacterial endotoxin test in which the tachyplens amebocyte lysate(TAL)was dissolved directly by sample solutions or its diluted solution,which was then added with 2.0 ? endotoxins solution for positive control test for the common injections including metronidazole and glucose saline etc.RESULTS:The Et values of all the test samples detected by the improved method were similar to those by the routine method,which stood at 2.0 Es～0.5 Es,suggesting that the improved method has no interfere on the bacterial endotoxin test.CONCLUSION:The method is simple and time-saving.
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OBJECTIVE:To improve the related standards in China Pharmacopoeia and to enhance its operation.METH_ ODS:Issues on“general rules on preparations”,“bacteria endotoxin test”,assaying of glucose injection in China Pharmacopoeia were analyzed and discussed.RESULTS&CONCLUSION:The dosage forms recorded are limited and some varieties of preparations are hard to be classified.How long exactly the gel formed by tachypleus amebocyte lysate and bacteria endotoxins remained cemented should be regarded as positive,which should be clearly defined.In determining the optical rotation by po?larimetry,ammonia test solution should be added to the semi-products to achieve balance but not in the finished products for differentiation.
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OBJECTIVE:To investigate the feasibility of bacterial endotoxin test(BET) for floxuridine(FuDR) injection and to perform the test.METHODS:To refer to BET in appendix of China Pharmacopoeia,edition 2000.RESULTS:Bacterial endotoxin could be detected in 60 times dilution of FuDR injection by limulus lysate with a sensitivity of 0.5EU/ml.CONCLUS_ION:BET for FuDR injection is feasible.
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Object To establish a method for the determination of bacterial endotoxin in SAFFLOR INJECTION * Methods Thirty batches of SAFFLOR INJECTION were subjected to Limulus lysate test in comparison with pyrogen test to ascertain whether there are any interference between the lysate and SAFFLOR INJECTION Results SAFFLOR INJECTION showed no inhibition or enhancement actions in bacterial endotoxin test with Limulus lysate, while showed a 100% coincidental rate with pyrogen test Conclusion This method was found to be simple, quick, accurate and is suitable for the determination of bacterial endotoxin in SAFFLOR INJECTION
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Object To prove the feasibility of bacterial endotoxin test (BET) in Shenmai Freeze-dried Powder Injection by interference test. Methods Interference primary screening test and interference test were conducted in BET of Shenmai Freeze-dried Powder Injection to detect whether the interference existed or not and to explore the method of removing the interference. Results There was inhibition on BET with 0.5 EU/mL tachypleus amebocyte lysate (TAL). Interference could be excluded by using 0.25 EU/mL TAL and diluting the samples. Conclusion It is feasible to use 0.25 EU/mL TAL or TAL with more sensitivity in BET of Shenmai Freeze-dried Powder Injection.
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Objective To establish a method for the determination of bacterial endotoxin in Ilex pubescens compound injection(LPCJ) .Methods According to China Pharmacopoeia (second part,2000),interference test was carried out to detect the endotoxins in LPCJ with limulus lysate agents (?was 0.25 EU/mL).Results Inhibition action was found in bacterial endotoxin test for LPCJ and in the 10-,20-,30-and 40-fold diluted liquid of LPCJ.It was proved that the maximum noninterference concentration was the 50-fold dilution.The inspection results are the same as that of rabbit pyrogen test.Conclusion The 50-fold diluted LPCJ is suitable for the determination of bacterial endotoxin and can be used as the quality control standard for its preparation.
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OBJECTIVE:To establish a method for the bacterial endotoxin test of nicardipine hydrochloride glucose injection.METHODS:The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the addenda of China Pharmacopeia 2005 edition(second part).RESULTS:Nicardipine hydrochloride glucose injection showed interference on the bacterial endotoxin test when water was taken as solvent.The preliminary interference test and interference test revealed that using thinnerⅠas solvent,the sample injection in over 4-fold dilution had no interference on the bacterial endotoxin test.CONCLUSIONS:It is feasible for bacterial endotoxin test of nicardipine hydrochloride glucose injection be conducted in a limit value of 0.5 EU?mL-1.The bacterial endotoxin text can substitute pyrogen test in the detection of nicardipine hydrochloride glucose injection.
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OBJECTIVE:To establish a method for the bacterial endotoxin test of ~(131)Ⅰ-epidepride injection.METHO_ DS:After dilution with 10 parts of water,~(131)Ⅰ-epidepride injection was detected with a method of tachypleus amebocyte lysa_te(TAL) and subjected to verification test.RESULTS:The interference of the dilute ~(131)Ⅰ-epidepride injection on TAL can be eliminated after dilution,the bacterial endotoxin levels for 3 batches of 131Ⅰ-epidepride injection were all below 50EU/ml.CONCLUSION:The method for the bacterial endotoxin test of ~(131)Ⅰ-epidepride injection is feasible.
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OBJECTIVE:To establish a bacterial endotoxin test for compound diclofenac sodium and lidocaine hydrochlo?ride injection(CDL).METHODS:The limitation of endotoxin in CDL was determined and a interference test was performed to determine the maximum non-interference concentration.RESULTS:CDL could interfere the detection of bacterial endotoxin,which could be overcome through300-fold dilution of the preparation.CONCLUSION:The bacterial endotixin test can be used to replace the detection of pyrogen in CDL.
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OBJECTIVE:To establish a bacterial endotoxin test for monitoring pyrogen in wilsonii injection METHODS:Bacterial endotoxin test procedure and guiding principle in Chinese Phamacopoeia were used RESULTS:The test showed that the reaction with limulus agent was not interfered by wilsonii injection with a sensitivity of 0 25Eu/ml CONCLUSION:Limulus lysate method can be used to take the place of rabbit method for monitoring pyrogen in wilsonii injection
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OBJECTIVE:To investigate BET for five Chinese medicinal herbs for injection METHODS:By interfering test Suanghuanglian for injection showed no interference with BET,Yinzhihuang for injection had inhibiting action,Salviae mtltiorrhizae composita,Qingkailing and Shengmai for injections revealed enhancing action on BET RESULTS:The interference could be eliminated when the samples were diluted with dextran solution CONCLUSION:Five Chinese medicinal herbs for injection can be examined by BET instead of the pyrogen test method