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Aim To evaluate the equivalence between micro kinetic chromogenic assay anrl kinetic chromogenic assay in order to provide data support for the use of alternative methods.Methods Detection conditions; micro kinetic chromogenic assay and kinetic chromogenic assay limulus reagent were used, sample amount of each well and limulus reagent was 25 jxL ( kinetic chromogenic assay was 100 jxL) , detection wavelength was 405 nm, ONSET OD value was 0.03, and half- well elisa plate was used for detection ( kinetic chromogenic assay was ordinary ELISA plate).The equivalence of the two methods was evaluated by various statistical methods, such as equivalence test, in collaboration with four laboratories in China.Results The results of one-way an OVA, paired T test and equivalence test were consistent, indicating that there were some differences between the existing kinetic chromogenic assay of different manufacturers, while there was no significant difference between the trace or conventional amount of reagent used by each manufacturer.Conclusions Micro kinetic chromogenic assay is e- quivalent to existing reagents in terms of accuracy and recoverv.J.
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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 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 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 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 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 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
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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 study the restraining factors in the intravenous immune globulin(IVIG.)bacterial endotoxin test.METHODS:A series tests were designed;the sensitivity of limulus was checked and the limit of endotoxin was validated;the effects of vehicle and pH value on the IVIG endotoxin test results were observed so as to find out the chief restraining factors of this test method.RESULTS:Lower pH value has an inhibition effect on the in IVIG bacterial endotoxin test.CONCLUSION:Bacterial endotoxin test can replace the rabbit testing method in the pyrogen test of IVIG.When the condition of lower pH is changed.
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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.