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Objective:To establish a bacterial endotoxins testing method for L-oxiracetam injection. Methods: According to the gel-clot technique for bacterial endotoxin inspection and the related regulations in Chinese Pharmacopoeia (2015 edition, volume Ⅳ, general rule 1143), tachypleus amebocyte lysate (TAL) from two different manufacturers were used for bacterial endotoxins test on 3 batches of L-oxiracetam injection with methodology studies. Results:Diluted to 8. 3 mg·ml-1 , the samples showed no interference a-gainst the bacterial endotoxins test. Conclusion:The bacterial endotoxins test method for L-oxiracetam injection is applicable with the endotoxin limit of 3 EU·ml-1 .
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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 the detection of bacterial endotoxins in tertiary butyl alcohol. Methods:The in-terference experiment and bacterial endotoxins test for 3 batches of the products from 2 companies were carried out with tachypleus ame-bocyte lysate. Results:There was no interference in the bacterial endotoxins test. The limit of bacterial endotoxins was 0. 25 EU/ml. Conclusion:The established method of bacterial endotoxins test is feasible for tertiary butyl alcohol.
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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 evaluate the effectiveness of ultrafiltration technology in endotoxin removal from purified recombinant MUC1-MBP fusion protein (MUC1-MBP)and to demonstrate the effect of ultrafiltration on endotoxin removal.Methods CM Sepharose FF weak cation exchange (CM)(CM group), CM combined with Phenyl Sepharose 6 FF exchange (C6)(CM+C6 group),CM combined with ultrafiltration (CM+ultrafiltration group), and CM combined with C6 and ultrafiltration (CM+C6+ultrafiltration group)were used to purify the MUC1-MBP from E.coli. and remove endotoxin;the expression level of endotoxin was detected by Chromogenic End-point Tachypleus Amebocyte Lysate.Results There was a single band at the expected molecular weight of 62 000 by SDS-PAGE analysis.and the purity>96% by Quantity One analysis.The endotoxin levels in CM group and CM +C6 group were quite high and there was no significant difference between two groups (P>0.05 );the endotoxin level in CM+ultrafiltration group was significantly lower than that in CM group, and there was significant difference (P0.05 ). Conclusion The effects of CM or CM combined with C6 on endotoxin removal are quite poor, especially C6;CM combined with ultrafiltration are quite effective on endotoxin removal,and ultrafiltration plays an important role in endotoxin removal.
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OBJECTIVE:To establish a method for bacterial endotoxin test of Boric acid rinse.METHODS:According to appendix volumeⅡof Chinese Pharmacopoeia(2005 edition),the tachypleus amebocyte lysate(TAL)method was applied for the pre-inference test and interfence test to investigate non-inference concentration,pH value and sensitivity of TAL.RESULTS:Boric acid did not interfere with TAL and the reaction of bacterial endotoxin at 2 times diluted concentration with pH value adjusted above 6.The sensitivity 0.25 EU?mL-1 of TAL was available.CONCLUSION:The TAL method can control the limit of bacterial endotoxins in Boric acid rinse.
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OBJECTIVE:To establish a method for the bacterial endotoxin test of chlorphenamine maleate injection. METHODS: The interference test and bacterial endotoxin test of 28 batches of chlorphenamine maleate injections from 14 manufacturers were carried out in accordance with the bacterial endotoxin test approved by Chinese Pharmacopeia (2005 edition). RESULTS: Diluted to a concentration of below 0.025 mg?mL-1,the samples showed no interference action on bacterial endotoxin test. The limit value of the bacterial endotoxin was 5 EU?mg-1. The results of the bacterial endotoxin test of the 28 batches of samples were all accorded with the standard of the established quality control. CONCLUSION: The established TAL method is applicable for bacterial endotoxin test of chlorphenamine maleate injection.
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Objective To investigate the pollution of endotoxin in drinking water and the removal efficiency of endotoxin through the conventional drinking water treatment in Wuhan city,Hubei Province.Methods In Mar 2008,the water samples of Pinghumen and Zongguan drilking water plants which sourced from the Yangtze River and Hanjiang River respectively,were collected.The samples were tested by Limulus amebocyte lysate test recorded by Chinese Pharmacopoeia(2005 edition).Results The endotoxin content in raw water of the Yangtze River was(100.98?2.75)EU/ml and in tap water was(18.53?0.01)EU/ml.The endotoxin concent in the raw water of the Hanjiang River was(86.40?1.69)EU/ml and in tap water was(41.68?1.94)EU/ml.The removal rates of two drinking water plants were 81.65% and 51.76% respectively.Conclusion The conventional drinking water treatment can remove the endotoxin in dgreeds,but the content of endotoxin in the product water is still higher.
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OBJECTIVE To discuss the application of tachypleus amebocyte lysate test in transfusion reaction. METHODS Based on agglutination when tachypleus amebocyte lysate test encountered bacterial endotoxin, the quantity of the bacterial endotoxin was tested. RESULTS Twenty-three cases were analyzed with tachypleus amebocyte lysate test, the main reasons were excessive pyrogen, improper combined drug compatibility, excessive agents or unqualified pyrogen of the agent added, pollutions on transfusion devices and air in the treatment room, disobeying axenic operation rules, overlong drug dispensing, too fast transfusion speed, etc. CONCLUSIONS On prevention of transfusion reaction, all the axenic operation rules should be strictly followed, single dose transfusion, to reduce transfusion reaction.
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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 establish the method of assaying bacterial endotoxin in cardioplegia solution.METHODS:The tachpleus amebocyte lysate(TAL) test for bacterial endotoxin in cardioplegia solution was performed in accordance with Chinese Pharmacopoeia(2005 Edition,Volume Two).RESULTS:The 8-fold diluents of cardioplegia solution did not interfere with the test for bacterial endotoxins,with Et=0.5 Es～2 Es.CONCLUSION:It is feasible to detect bacterial endotoxins in cardioplegia solution with TAL at a sensitivity of 0.06 EU?mL-1.
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OBJECTIVE:To establish a method for testing the bacterial endotoxin in ceftazidime/tazobactam sodium for injection.METHODS:Based on the bacterial endotoxin test method stated in Chinese Pharmacopoeia(2005 edition),an interference test was conduced on different batches No.of ceftazidime/tazobactam sodium samples using actachypleus amebocyte lysate(TAL)from different companies.RESULTS:No interference was found in the bacterial endotoxin test after ceftazidime/tazobactam sodium for injection was diluted to 5.0 mg?mL-1.Its limit value of bacterial endotoxin was 0.1 EU?mL-1.CONCLUSION:Actachypleus amebocyte lysate test was suitable for determining bacterial endotoxin in ceftazidime/tazobactam sodium for injection.
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OBJECTIVE: To establish bacterial endotoxin test for cardioplegic solution (compound jiagaimei solution).METHODS: Semi-quantitative analysis stated in volume Ⅱ of Chinese Pharmacopoiea (2005 edition) was used to detect 3 batches of compound jiagaimei solution with tachypleus amebocyte lysate (TAL).RESULTS: The interference factors of bacterial endotoxin test could be overcome through 6-fold dilution of cardioplegic solution.The content of bacterial endotoxin in 3 batches of samples were 0.36,0.36 and 0.255 EU?mL-1,respectively.They were all lower than the limitation of bacteria endotoxin of 1.5 EU?mL-1.CONCLUSION: It is feasible to detect bacterial endotoxin of compound jiagaimei solution using semi-quantitative analysis.
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OBJECTIVE: To establish bacterial endotoxin test for adenosine disodium triphosphate (ATP) raw material by TAL method. METHODS: The sensitivity of TAL and the limit of endotoxin were reviewed and confirmed. Preliminary interference test was used to determine the dilution ratio of samples and interference test was applied to determine maximum non-interference concentration. Bacterial endotoxin test was performed on 11 batches of samples according to the method stated in Chinese Pharmacopoeia (2005 edition). RESULTS: The sensitivity of TAL was up to the standard and the limit of endotoxin in samples were 2.0 EU?mg-1. The maximum non-interference concentration was 0.125 mg?mL-1. Results of bacterial endotoxins test of 11 batches of samples were all in line with the standard. CONCLUSIONS: It is feasible to detect the bacterial endotoxin of ATP raw material by TAL methods, which can replace pyrogen test.
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OBJECTIVE:To establish the method for bacterial endotoxin test of Kuzhi injection. METHODS: The test sample dilution method was applied to exclude the interference of the Kuzhi injection in the bacterial endotoxin tachypleus amebocyte lysate(TAL) test. RESULTS: Diluted to 16 times, the Kuzhi injection showed no interference in the bacterial endotoxin TAL test. CONCLUSION: The established method is applicable for the bacterial endotoxins test of the Kuzhi injection.
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OBJECTIVE:To explore the feasibility of detecting bacterial endoxins in low molecular weight heparins calcium injection LMWHC by tachypleus amebocyte lysate(TAL).METHODS:Bacterial endotoxins in samples were detected qualita?tively and quantitatively by kinetic turbidimetric assay and gel-clot method.RESULTS:Diluted to the concentration of25IU/ml,LMWHC had an obvious interference action to the TAL test,while not at the concentration of12.5IU/ml.The contents of bacterial endotoxins in all samples were less than0.01EU/IU.CONCLUSION:It is feasible to detect bacterial endotoxins in LMWHC by TAL test.
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OBJECTIVE: To study the effect of samples having different pH values in the bacterial endotoxins test (BET). METHODS: The BET was conducted as an assay of the concentration of endotoxins by using kinetic-turbidimetric technique. Samples having different pH values but containing same concentration reference standard endotoxin (RSE) were tested by TAL/LAL reagents. The average result on the standard curve was calculated and the mean recovery observed. RESULTS: The reagents had three highly sensitivities in pH 5.20, pH 7.83/pH 6.23 and pH 10.55. After adjustment to pH 6 to 8, the mean recovery was 76.5%～115.9% or 85.8%～99.8%. When the sample pH value was less than 3 or more than 12, the test was unsuitable for the inhibition test, and the mean recovery was less than 56.8%. CONCLUSION: It is necessary to adjust the pH of the solution to be tested in the BET, adjust the sample to pH (6.5～7.5) when using TAL reagents, and adjust to pH (6.2±0.1) or pH(6.7～7.8) when using LAL reagents.
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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 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