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Abstract; Aim To solve the problems in the appliea- tion of egg yolk leeithin endotoxin test method, and and to establish the baeterial endotoxin examination method for egg yolk lecithin (for injeetion). Methods The ethanol solution of Tween 80 ( the volume ratio of tween 80 to anhydrous ethanol was 2. 5 • 2. 7, mixed for 4 min) was used to prepare lecithin solution of egg yolk at 0. 1 kg • L 1 , and 10 test water was added to 1 mL lecithin solution of egg yolk (500 EU • mL 1 standard solution of endotoxin IOjxL was added for pos¬itive control). After diluted 20 times with endotoxin test water, the standard curve range was 10 ~0. 01 EU • mL 1 by kinetic-turbidimetrie assay. Methodology of endotoxin test was studied using limulus lysate from two manufacturers and eight hatches of samples. Results The recoveries of eight hatches of samples all met the requirement of interference test between 50% and 200% stipulated in the pharmacopoeia, which solved the problems of the current endotoxin test method in practical application. Conclusions The bacterial en¬dotoxin test method of egg yolk lecithin with good dura-bility is established to provide the basis for the revision of pharmacopoeia.
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Objective To establish a bacterial endotoxin test method for high concentration vitamin B6 injection. Method The test was taken according to the bacterial endotoxin test in Chinese pharmacopoeia 2015 edition. Result By diluting the sample concentration to 1.04 mg/ml with the buffer of pH6.5-7.5, and using λ=0.06 EU/ml of TAL reagent, the interference could be effectively avoided. Conclusion The method was useful, which could be used to test the bacterial endotoxin in high concentration vitamin B6 injection. The bacterial endotoxin limit was defined as 0.06 EU/mg.
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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 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 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 confirm the interference effect of heparin lithium on turbidimetry method for detecting total protein , and to conduct performance evaluation of it .Methods Eight different concentrations of total protein urine specimen with and with ‐out heparin lithium were detected respectively ,to confirm the interference of heparin lithium on the experiment .Adding different concentration of heparin lithium solution to the prepared total protein samples with concentration of 0 .172 ,0 .427 g/L(a series of interference experiment samples ,with heparin lithium concentrations of 0 .000 ,0 .025 ,0 .030 ,0 .035 ,0 .040 ,0 .045 ,0 .050 mg/L ) , repeat four times detection ,and then conduct the dose‐effect experiment of interference .Results The biggest bias of the testing re‐sults in the two paired samples was 159 .37% ,the mini‐bias was 11 .37% ,the difference of the results in two groups was statistical significant(t= 17 .24 ,P< 0 .05) .95% confidence interval of the interference effect in the total protein samples with concentration of 0 .172 g/L was 0 .034 ~ 0 .062 ,while in the total protein samples with concentration of 0 .427 g/L was 0 .043 - 0 .053 .When the heparin lithium were 0 .025 mg/mL and 0 .050 mg/mL respectively ,the results of bias of the total protein samples with concentra‐tion of 0 .172 g/L were 27 .33% ,58 .14% respectively .But in the 0 .427 g/L total protein samples ,the results of bias were 11 .24% 、18 .74% respectively .Dose effect of interference both showed a linear relationship in the series concentration of the hepa ‐rin lithium and interference of sample of 0 .172 g/L and 0 .427 g/L ,and the linear equations were Y = 1 .974X - 0 .001 03 ,Y = 1 .599 X - 0 .000 5 respectively .Conclusion Heparin lithium is the exogenous interfering substance to the detection of total protein in tur ‐bidimetry method ,it is the positive interference to the determination results of total proteins ,especially for the low level of total pro‐tein detection ,and as heparin lithium concentration increases ,the stronger the interference effect .
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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 apply EP7‐A2 document for evaluating the interference of hemolysis the total bilirubin detection in clinic .Methods The interferent was affirmed according to thepaired‐differencetest required by the EP7‐A2 document .The rela‐tion between interferent concentration and interference degree was analyzed by using the dose‐effect test .Results The paired‐difference test results showed that 5 .00 g/L hemoglobin had negative interference effect on two kinds of total bilirubin reagents . But the reagent kit A had little interference degree of hemolysis;The dose‐effect test results showed that hemoglobin produced the linear negative interference effect on the reagent kit A of total bilirubin detection .The linear equation of low value sample was Y=-0 .146X+14 .1 ,r=0 .964 ,which of middle value sample was Y = -0 .546X+92 .24 ,r=0 .947 and which of high value sample was Y= -1 .153X+307 .2 ,r=0 .979 .Conclusion Hemolysis has a negative interference effect on total bilirubin detection in clinic . The total bilirubin value could be corrected by using the hemoglobin concentration of sample;the EP7‐A2 document has certain ap‐plication value in the aspect of analyzing interference and evaluation .
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Objective To explore the verification process for the analytic performance of the quantitative project of molecular di-agnosis.Methods Based onMedical laboratory accreditation criteria for quality and competence in the field of molecular diagnos-tics application note(CL-36)(2014)and the relevant documents published by Clinical and Laboratory Standards Institute (CLSI), the performance verification methodology of PCR detection for hepatitis b virus nucleic acid was achieved.for.Results The within-run precision of DNA detection for the hepatitis b virus was 0.109 and 0.105;and the between-run precisionwas 0.1 57 and 0.137. Compared with the reference laboratory,the regression equation was Y =0.947+0.343X ,and the linear correlation coefficient was 0.990.The linear range was 5.00-1.10 and thequantitative detection limit was 500 IU/mL.Hemolysis had no effect on the detec-tion of samples.Conclusion The laboratory with molecular diagnostic program should conduct analytic performance verification,and the appropriate method should be chosen to clear performance verification.Conclusion Clearing the performance indicators of de-tection projects has a very positive role in the clinical use of detection projects..
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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 find the reasons for the low dissolution of clarithromycin tablets and study the interference from filter film adsorption at various time points to explore the appropriate processing approach for dissolution solution of clarithromycin tablets. Meth-ods:Clarithromycin tablets from two different manufacturers were used. The dissolution solution was prepared according to Japanese Orange Book. The dissolution was determined after different processing and the adsorption rate of the filter film was calculated. Re-sults:Totally 14 kinds of filter films were tested with different adsorption for clarithromycin, and the adsorption rate of some kinds of filter films exceeded the prescribed limit. Conclusion:The absorption rate of filter films for clarithromycin can be decreased by boiling the films and using American membranes. The interference from filter film adsorption can be reduced and inhibited by rejecting the first filtrate above 5ml or centrifuging dissolution solution.
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OBJECTIVE:To establish a method for detecting bacterial endotoxins in methylthioninium chloride injection (MCI) quantitatively. METHODS: Kinetic turbidimetric limulus test was applied to detect bacterial endotoxins in MCI quantitatively, and compared with gel-clot method. RESULTS: MCI was un-interfered with the test for bacterial endotoxins at the concentration of 0.125 mg?mL-1; the content of bacterial endotoxins in all samples tested (10 mg?mL-1) were not more than 0.25 EU?mg -1, which were in accordance with the result of gel-clot method. CONCLUSIONS: Kinetic turbidimetric limulus test provides a new way to detect bacterial endotoxins in MCI quantitatively.
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OBJECTIVE: To establish a method for endotoxin assay in aminoglycoside antibiotics for injection.METHODS: Kinetic turbidimetric limulus test was used for endotoxin assay in aminoglycoside antibiotics for injection.The recovery rate of bacterial endotoxin was determined though pre-interference experiments in which quantitative endotoxin was added to different concentrations of aminoglycosides with the concentration optimized,then an interference test on 4 different samples was conducted.RESULTS: At a concentration of 0.5 mg?mL-1,aminoglycosides didn't interfere with the limulus test if the amount of standard endotoxin was at 5.000,0.500,and 0.050 EU?mL-1,respectively.CONCLUSIONS: The kinetic turbidimetric limulus test could be used for endotoxin assay in aminoglycoside antibiotics for injection.
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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 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 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 a method for test of bacterial endotoxin on cefalotin sodium for injection by gel clot.METHODS:Cefalotin sodium for injection was diluted in water for determination of bacterial endotoxin and allocated to sample negative and sample positive controls to determine its maximum noninterference concentration;Then bacterial endotoxins were diluted into solutions of different concentrations with the test solutions,and interference test was carried out by using tachy?pleus amebocyte lysate sensitivity compound nucleus.RESULTS:The maximum noninterference concentration of cefalotin sodium for injection was6.68mg/ml;And cefalotin sodium at the concentration of1.67mg/ml did not interfere with the test for bacterial endotoxins.CONCLUSION:The present method can replace pyrogen test with rabbit for examination of bacterial endotoxin in cefalotin 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.