CN1715925A - A method for bacterial endotoxin inspection by measuring turbidity value - Google Patents
A method for bacterial endotoxin inspection by measuring turbidity value Download PDFInfo
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- CN1715925A CN1715925A CN 200410020886 CN200410020886A CN1715925A CN 1715925 A CN1715925 A CN 1715925A CN 200410020886 CN200410020886 CN 200410020886 CN 200410020886 A CN200410020886 A CN 200410020886A CN 1715925 A CN1715925 A CN 1715925A
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- turbidity value
- endotoxin
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- 238000000034 method Methods 0.000 title claims abstract description 49
- 239000002158 endotoxin Substances 0.000 title claims abstract description 47
- 238000007689 inspection Methods 0.000 title claims abstract description 5
- 238000012360 testing method Methods 0.000 claims abstract description 53
- 238000001514 detection method Methods 0.000 claims abstract description 20
- 241000239218 Limulus Species 0.000 claims abstract description 16
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 15
- 230000035484 reaction time Effects 0.000 claims abstract description 7
- 230000035945 sensitivity Effects 0.000 claims description 13
- 239000003814 drug Substances 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 238000012544 monitoring process Methods 0.000 abstract description 2
- 238000002360 preparation method Methods 0.000 abstract description 2
- 238000003908 quality control method Methods 0.000 abstract description 2
- 238000011179 visual inspection Methods 0.000 abstract 1
- 239000000523 sample Substances 0.000 description 34
- 241000239222 Tachypleus Species 0.000 description 29
- 239000006166 lysate Substances 0.000 description 29
- 230000001186 cumulative effect Effects 0.000 description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 7
- 231100000284 endotoxic Toxicity 0.000 description 6
- 230000002346 endotoxic effect Effects 0.000 description 6
- 239000008367 deionised water Substances 0.000 description 4
- 229910021641 deionized water Inorganic materials 0.000 description 4
- 238000002835 absorbance Methods 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- 238000004513 sizing Methods 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 239000012525 endotoxin sample Substances 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 229920006008 lipopolysaccharide Polymers 0.000 description 2
- 239000013642 negative control Substances 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 239000004475 Arginine Substances 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 239000012480 LAL reagent Substances 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- UFUVLHLTWXBHGZ-MGZQPHGTSA-N [(2r,3r,4s,5r,6r)-6-[(1s,2s)-2-chloro-1-[[(2s,4r)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](OP(O)(O)=O)[C@@H](SC)O1 UFUVLHLTWXBHGZ-MGZQPHGTSA-N 0.000 description 1
- 230000004523 agglutinating effect Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229960002291 clindamycin phosphate Drugs 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000003344 environmental pollutant Substances 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 231100000719 pollutant Toxicity 0.000 description 1
- 108010048121 pro-clotting enzyme Proteins 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000376 reactant Substances 0.000 description 1
- 239000012898 sample dilution Substances 0.000 description 1
- 229960002668 sodium chloride Drugs 0.000 description 1
- 235000002639 sodium chloride Nutrition 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000008354 sodium chloride injection Substances 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 238000007817 turbidimetric assay Methods 0.000 description 1
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- Investigating Or Analysing Materials By Optical Means (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
一种通过测定浊度值来进行细菌内毒素检查的方法，其特征在于：将供试品与鲎试剂等比混合，反应温度为37.0±1℃，反应时间为60±1分钟；检测浊度值，浊度值定义为：A0’＝－lg(It/I0’)，其中I’ 0为初始透射光强度，It为检测时透射光强度；浊度值大于等于0.055时，为阳性结果；浊度值小于0.055时，为阴性结果。本发明可以通过专门的仪器来测量实现，减少了人工目测判断凝胶与否的误差，提高了结果的准确性；可望替代常规凝胶法进行细菌内毒素的检查，用于药品质量控制和制剂的生产过程监控等。A method for detecting bacterial endotoxin by measuring turbidity value, characterized in that: the test product is mixed with Limulus reagent in equal proportions, the reaction temperature is 37.0±1°C, and the reaction time is 60±1 minute; the turbidity is detected value, the turbidity value is defined as: A 0 '=-lg(I t /I 0 '), where I' 0 is the initial transmitted light intensity, I t is the transmitted light intensity during detection; when the turbidity value is greater than or equal to 0.055, It is a positive result; when the turbidity value is less than 0.055, it is a negative result. The present invention can be measured and realized by a special instrument, which reduces the error of manual visual inspection to judge whether the gel is or not, and improves the accuracy of the result; it is expected to replace the conventional gel method for bacterial endotoxin inspection, and is used for drug quality control and Production process monitoring of preparations, etc.
Description
Technical field:
The present invention relates to the assay method of bacterial endotoxin, provide a kind of especially and carried out the standard that bacterial endotoxin is checked by measuring turbidity value.
Bacterial endotoxin (Bacterial Endotoxin) be gramnegative bacterium produce have various bioactive macromolecular substances, its main chemical compositions is lipopolysaccharides (LPS).Endotoxin is the major pollutants matter in the injection medicine (raw material etc.).
The detection for bacterial endotoxin method has rabbit test method(s), limulus test.(LimulusAmebocyte Lysate LAL) is the principle of utilizing tachypleus amebocyte lysate and endotoxin generation agglutinating reaction to limulus test, a kind of external detection method of bacterial endotoxin gradient of infection in qualitative or detection by quantitative medicine or the body blood.The concrete practice is divided into gel method and sizing technique again.
Gel method is exactly a kind of qualitative, endotoxic method of determination limit.Its principle is with endotoxin sample and tachypleus amebocyte lysate mixed in equal amounts in the test tube of special use, insulation reaction after the C factor in endotoxin and the tachypleus amebocyte lysate reacts, activates proclotting enzyme, cut off the arginine peptide bond of coagulagen ad-hoc location, produce gel thereby form coagulated protein.In the Chinese Pharmacopoeia appendix in 2000 for the regulation of bacterial endotoxins test, be exactly according to the method, be used for judging in the test sample endotoxic limit the quantity of whether up to specification, need the experimenter to estimate gel whether to occur to judge the positive and negative result, the workload of experiment own is bigger, and is prone to personal error.
Sizing technique is to utilize the principle of kinetic turbidimetric assay, promptly in endotoxin and tachypleus amebocyte lysate course of reaction, adopt its turbidity of instrumentation detection record to change, default turbidity value, time required when turbidity value changes to this preset value, the logarithm of this characteristic reaction time and the logarithm of endotoxin concns were linear as the characteristic reaction time.The method requires the good reproducibility of typical curve.
Present also clear and definite without comparison corresponding relation between gel method and two kinds of methods of sizing technique, drug control institutions and manufacturer be the main gel method that adopts in real work, relies on and manually checks, and time-consuming, effort, artificial interference factor are more.
Summary of the invention:
The object of the present invention is to provide and a kind ofly carry out the standard method that bacterial endotoxin is checked by measuring turbidity value, this method is easy and simple to handle, testing result is accurate.
The invention provides and a kind ofly carry out method of checking bacterial endotoxin, it is characterized in that by measuring turbidity value:
---test sample is mixed (volume) with the tachypleus amebocyte lysate geometric ratio, and temperature of reaction is 37.0 ± 1 ℃, and the reaction time is 60 ± 1 minutes;
---detect turbidity value, turbidity value is defined as: A
0Lg (the I of '=-
t/ I
0'), I ' wherein
0Be initial transmission light intensity, I
tTransmitted intensity during for detection;
---turbidity value is more than or equal to 0.055 o'clock, positive result; Turbidity value is less than 0.055 o'clock, negative result.
The present invention is undertaken in the method for checking bacterial endotoxin by measuring turbidity value, and used detecting instrument is required not to be strict, and being reflected in the test tube of described test sample and tachypleus amebocyte lysate carried out, and the cumulative volume of reactant liquor is 0.2 milliliter to 0.7 milliliter.The test tube that is adopted, its internal diameter can be between 5.4 millimeters to 10.2 millimeters.The detection wavelength coverage that detects turbidity value is between 400 to 700nm.Be preferably 660nm.
The present invention is undertaken in the method for checking bacterial endotoxin by measuring turbidity value in addition, neither be very high to the requirement of reagent, and the tachypleus amebocyte lysate that is adopted, its sensitivity can be 0.015-0.5EU/ml.
The key parameter turbidity value that needs to detect of the present invention is defined as: A
0Lg (the I of '=-
t/ I
0'), I ' wherein
0Be initial transmission light intensity, I
tTransmitted intensity during for detection, turbidity value and incident intensity are irrelevant, have therefore eliminated the influence of measuring pipe size, reaction system original state.In addition, this parameter can easily be measured by a lot of existing technological means and realize, can also measure realization by special instrument, has reduced the artificial visually examine and has judged gel whether error, has improved result's accuracy; Be expected to substitute conventional gel method and carry out the inspection of bacterial endotoxin, be used for the production process monitoring of drug quality control and preparation etc.
Description of drawings:
Fig. 1 changes signal for the reaction system turbidity value.
Embodiment:
The assay method that conventional bacterial endotoxin is limited the quantity of is: at first need to carry out the test sample interference test, the bacterial endotoxin working standard is diluted to 2.0 λ, 1.0 λ, 0.5 λ and 0.25 λ concentration, each dilution is done 4 pipes (10mm internal diameter test tube), vibrate above-mentioned test tube mixing content gently, the sealing mouth of pipe is put in 37 ± 1 ℃ of water-baths.Be incubated 60 ± 2 minutes and treat observations, other gets endotoxin and checks water and test sample dilution, respectively does 2 negative control pipes.4 pipes of its maximum concentration 2.0 λ should be all positive, and 4 pipes of least concentration 0.25 λ should be all negative, and the negative control pipe is then noiseless when all negative.Can limit the quantity of according to the test sample endotoxin and select the tachypleus amebocyte lysate of suitable sensitivity, do experiment according to said method and check whether the test sample endotoxin exceeds and limit the quantity of.
The present invention carries out method of checking bacterial endotoxin by the mensuration turbidity value, on endotoxin determinator, measure the turbidity value that contains endotoxin sample and tachypleus amebocyte lysate reaction system, be 60 minutes when the reaction time, turbidity value is more than or equal to 0.055 o'clock, positive result; Turbidity value is less than 0.055 o'clock, negative result.
Embodiment 1.
The operation steps of conventional gel method is: test sample and tachypleus amebocyte lysate geometric ratio are mixed in the special-purpose test tube, and volume is 0.2ml, mixing, and the sealing mouth of pipe is put in 37 ± 1 ℃ of water-baths, be incubated 60 ± 2 minutes, and the taking-up test tube is turnback slowly, observations.When in vitro gel is indeformable, not from the positive result of tube wall slippage person; Gel can not be kept perfectly, and from the negative result of tube wall slippage person.
On endotoxin determinator, test sample and tachypleus amebocyte lysate geometric ratio are mixed in 7mm internal diameter flat based tubes, temperature of reaction is 37.1 ℃, the reaction cumulative volume is 0.3ml, sensitivity of the limulus reagent is 0.06EU/ml, and test sample is the standard endotoxin solution, and concentration is 0,0.03,0.06,0.12EU/ml, when reaching 60 minutes detection time, its corresponding turbidity value is respectively 0.005,0.024,0.055 and 0.090; This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and detected, and the result shows: turbidity value is 0.005 and 0.024 o'clock, and the result of gel method is negative; Turbidity value is 0.055 and 0.090 o'clock, and the result of gel method is positive.
Embodiment 2.
On endotoxin determinator, test sample and tachypleus amebocyte lysate geometric ratio are mixed in 5.4mm internal diameter flat based tubes, temperature of reaction is 37.2 ℃, the reaction cumulative volume is 0.3ml, sensitivity of the limulus reagent is 0.5EU/ml, test sample is for containing endotoxic deionized water, reaction time, detecting its corresponding turbidity value was 0.063 when reaching 15 minutes; This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and are detected, and the result shows: turbidity value is 0.063, and the result of gel method is positive.
Embodiment 3.
On endotoxin determinator, test sample and tachypleus amebocyte lysate geometric ratio are mixed in employing 5.4mm internal diameter flat based tubes, temperature of reaction is 37.1 ℃, the reaction cumulative volume is 0.3ml, sensitivity of the limulus reagent is 0.03EU/ml, test sample is that concentration is 0.24EU/ml standard endotoxin aqueous solution, when reaching 60 minutes detection time, its corresponding turbidity value is 0.07; This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and are detected, and the result shows: turbidity value is 0.07, and the result of gel method is positive.
Embodiment 4.
On endotoxin determinator, test sample and tachypleus amebocyte lysate geometric ratio are mixed in employing 7mm internal diameter flat based tubes, temperature of reaction is 37.1 ℃, the reaction cumulative volume is 0.5ml, sensitivity of the limulus reagent is 0.03EU/ml, test sample is for containing endotoxic deionized water, and when reached 25 minutes detection time, its turbidity value was 0.063 o'clock, adopt spectrophotometer to its 400,600 and three of 700mm detect under the wavelength and measure, absorbance is respectively 0.444,0.166 and 0.151 as a result.This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and are detected, and the result shows: turbidity value is 0.063 o'clock, and the result of gel method is positive.
Embodiment 5.
Adopt spectrophotometer, under 22. ℃ room temperature, the test tube that adopts the 10.2mm internal diameter is as the reaction assay pipe, and test sample is for containing endotoxic deionized water sample, and sensitivity of the limulus reagent is 0.5EU/ml, mensuration system volume is 0.7ml, the ratio of test sample and tachypleus amebocyte lysate is 1: 1, and the detection wavelength set is 660mm, measures its absorbance, in the time of 85 minutes, absorbance is 0.124.
On endotoxin determinator, test sample and tachypleus amebocyte lysate geometric ratio are mixed in employing 7mm internal diameter flat based tubes, temperature of reaction is 37.1 ℃, and the reaction cumulative volume is 0.7ml, and sensitivity of the limulus reagent is 0.5EU/ml, when reaching 85 minutes detection time, its corresponding turbidity value is 0.10.This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and are detected, and the result shows: turbidity value is 0.10 o'clock, and the result of gel method is positive.
Embodiment 6.
On endotoxin determinator, clindamycin phosphate sodium chloride injection and the tachypleus amebocyte lysate geometric ratio of 1.5mg/ml is mixed in 7mm internal diameter flat based tubes, temperature of reaction is 37.0 ℃, sensitivity of the limulus reagent is 0.125EU/ml, reaction volume 0.3ml, in the time of 60 minutes, measuring turbidity value is 0.004.This test sample and tachypleus amebocyte lysate are done the parallel control detection according to gel method simultaneously, and the result shows: turbidity value is 0.004 o'clock, and the result of gel method is negative.
Embodiment 7.
On endotoxin determinator, test sample and tachypleus amebocyte lysate geometric ratio are mixed in 5.4mm internal diameter flat based tubes, temperature of reaction is 37.0 ℃, the reaction cumulative volume is 0.2ml, sensitivity of the limulus reagent is 0.25EU/ml, test sample is for containing endotoxic deionized water, when reaching 60 minutes detection time, its corresponding turbidity value is 0.14; This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and are detected, and the result shows: turbidity value is 0.14 o'clock, and the result of gel method is positive.
Embodiment 7
On endotoxin determinator, test sample and tachypleus amebocyte lysate geometric ratio are mixed in 7mm internal diameter flat based tubes, temperature of reaction is 37.0 ℃, the reaction cumulative volume is 0.3ml, sensitivity of the limulus reagent is 0.06EU/ml, test sample is a sodium-chloride water solution, concentration is 140mM, and when reaching 60 minutes detection time, its corresponding turbidity value is 0.004; This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and are detected, and the result shows: turbidity value is 0.004 o'clock, and the result of gel method is negative.
Embodiment 8
On endotoxin determinator test sample and tachypleus amebocyte lysate geometric ratio are mixed in 7mm internal diameter flat based tubes, temperature of reaction is 37.5 ℃, and the reaction cumulative volume is 0.3ml, sensitivity of the limulus reagent is 0.015EU/ml, test sample is no heat source water, and when reaching 60 minutes detection time, its corresponding turbidity value is 0.003; This test sample and tachypleus amebocyte lysate are done parallel control according to gel method simultaneously and are detected, and the result shows: turbidity value is 0.003 o'clock, and the result of gel method is negative.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102333854A (en) * | 2009-02-25 | 2012-01-25 | 亚历法克斯控股有限公司 | Method for the bacteriological investigation of a biological sample and relative device |
| CN102348984A (en) * | 2009-03-13 | 2012-02-08 | 兴和株式会社 | Method for measuring biogenous biologically active substances, a program for implementing the same, and apparatus for measuring biogenous biologically active substances |
| CN101477103B (en) * | 2009-01-05 | 2012-06-27 | 范能全 | Full-pyrogen detection method for pyrogenicsubstance content in injection |
| CN101855539B (en) * | 2007-11-12 | 2012-08-22 | 国立大学法人广岛大学 | Method and kit for measurement of endotoxin level |
| CN109884252A (en) * | 2019-03-18 | 2019-06-14 | 天津市宇驰检测技术有限公司 | Wasted nickel catalyst method |
| CN109884251A (en) * | 2019-03-18 | 2019-06-14 | 天津市宇驰检测技术有限公司 | Finishing pollution detection method |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3586075D1 (en) * | 1984-06-27 | 1992-06-25 | Wako Pure Chem Ind Ltd | METHOD FOR DETERMINING ENDOTOXIN. |
| US5637474A (en) * | 1994-10-31 | 1997-06-10 | Wako Pure Chemical Industries, Ltd. | Process for measuring amount of endotoxin or (1→3)-β-D-glucan by kinetic turbidimetric method |
| AU2003215035A1 (en) * | 2002-06-21 | 2004-01-06 | Hemofarm Koncern A.D. Pharmaceutical And Chemical Industry | Process for determining endotoxin level in hemoglobin solutions |
-
2004
- 2004-07-02 CN CNB2004100208862A patent/CN100383528C/en not_active Expired - Fee Related
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101855539B (en) * | 2007-11-12 | 2012-08-22 | 国立大学法人广岛大学 | Method and kit for measurement of endotoxin level |
| CN101477103B (en) * | 2009-01-05 | 2012-06-27 | 范能全 | Full-pyrogen detection method for pyrogenicsubstance content in injection |
| CN102333854A (en) * | 2009-02-25 | 2012-01-25 | 亚历法克斯控股有限公司 | Method for the bacteriological investigation of a biological sample and relative device |
| CN102333854B (en) * | 2009-02-25 | 2013-11-27 | 亚历法克斯控股有限公司 | Method for bacteriological investigation of biological sample and relative device |
| CN102348984A (en) * | 2009-03-13 | 2012-02-08 | 兴和株式会社 | Method for measuring biogenous biologically active substances, a program for implementing the same, and apparatus for measuring biogenous biologically active substances |
| CN102348984B (en) * | 2009-03-13 | 2014-04-02 | 兴和株式会社 | Method for measuring biogenous biologically active substances, a program for implementing the same, and apparatus for measuring biogenous biologically active substances |
| CN109884252A (en) * | 2019-03-18 | 2019-06-14 | 天津市宇驰检测技术有限公司 | Wasted nickel catalyst method |
| CN109884251A (en) * | 2019-03-18 | 2019-06-14 | 天津市宇驰检测技术有限公司 | Finishing pollution detection method |
| CN109884251B (en) * | 2019-03-18 | 2021-10-22 | 天津市宇驰检测技术有限公司 | Decoration pollution detection method |
| CN109884252B (en) * | 2019-03-18 | 2021-10-22 | 天津市宇驰检测技术有限公司 | Exhaust gas detection method |
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| CN100383528C (en) | 2008-04-23 |
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