CN105203724A - Method for inspecting bacterial endotoxin of ibuprofen raw material - Google Patents
Method for inspecting bacterial endotoxin of ibuprofen raw material Download PDFInfo
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- CN105203724A CN105203724A CN201410293711.2A CN201410293711A CN105203724A CN 105203724 A CN105203724 A CN 105203724A CN 201410293711 A CN201410293711 A CN 201410293711A CN 105203724 A CN105203724 A CN 105203724A
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- brufen
- endotoxin
- bacterial endotoxin
- raw material
- test
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- 239000002158 endotoxin Substances 0.000 title claims abstract description 64
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 title claims abstract description 53
- 238000000034 method Methods 0.000 title claims abstract description 23
- 239000002994 raw material Substances 0.000 title claims abstract description 21
- 229960001680 ibuprofen Drugs 0.000 title abstract description 6
- 230000035945 sensitivity Effects 0.000 claims abstract description 15
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 14
- 238000007689 inspection Methods 0.000 claims abstract description 11
- 238000012360 testing method Methods 0.000 claims description 51
- 241000239222 Tachypleus Species 0.000 claims description 17
- 239000006166 lysate Substances 0.000 claims description 17
- 231100000284 endotoxic Toxicity 0.000 claims description 12
- 230000002346 endotoxic effect Effects 0.000 claims description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract description 11
- 238000004090 dissolution Methods 0.000 abstract description 6
- 238000007865 diluting Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 28
- 239000000523 sample Substances 0.000 description 16
- 239000013642 negative control Substances 0.000 description 9
- 239000011259 mixed solution Substances 0.000 description 6
- 239000013641 positive control Substances 0.000 description 6
- 239000002904 solvent Substances 0.000 description 6
- 239000003153 chemical reaction reagent Substances 0.000 description 5
- 229940090044 injection Drugs 0.000 description 5
- 238000002347 injection Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 238000002360 preparation method Methods 0.000 description 4
- 241000239218 Limulus Species 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 101100515513 Arabidopsis thaliana XI-E gene Proteins 0.000 description 2
- 229940088523 ibuprofen injection Drugs 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000012086 standard solution Substances 0.000 description 2
- 206010002556 Ankylosing Spondylitis Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010029240 Neuritis Diseases 0.000 description 1
- PPWHTZKZQNXVAE-UHFFFAOYSA-N Tetracaine hydrochloride Chemical compound Cl.CCCCNC1=CC=C(C(=O)OCCN(C)C)C=C1 PPWHTZKZQNXVAE-UHFFFAOYSA-N 0.000 description 1
- 230000004523 agglutinating effect Effects 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229940121657 clinical drug Drugs 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000003344 environmental pollutant Substances 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 231100000719 pollutant Toxicity 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 201000003068 rheumatic fever Diseases 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000013207 serial dilution Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
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- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Abstract
The invention discloses a method for inspecting bacterial endotoxin of an ibuprofen raw material. The method comprises the following steps: taking a proper amount of ibuprofen; adding endotoxin-free anhydrous sodium carbonate with the weight 0.25-0.5 times that of ibuprofen and 15-45 wt%(v/v) of an ethanol solution for dissolution; diluting through bacterial endotoxin inspection water; inspecting bacterial endotoxin by adopting a gel method. Through the adoption of the method, bacterial endotoxin of the ibuprofen raw material with the bacterial endotoxin limit value of 0.035 EU/mg can be inspected, and the bacterial endotoxin inspection method is quite high in accuracy and sensitivity.
Description
Technical field
The present invention relates to the inspection method of bacterial endotoxin, relate to a kind of method checking brufen raw material bacterial endotoxin specifically.
Background technology
Brufen has anti-inflammatory, analgesia, refrigeration function.Be applicable to treatment rheumatic arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and neuritis etc.Bacterial endotoxin is the major pollutants matter in injection medicine, enters blood in a large number and will cause exothermic reaction-" pyrogen reaction ", be detrimental to health, even threat to life, therefore injection needs to check bacterial endotoxin.When brufen makes the raw material of injection medicine, the inspection should carrying out bacterial endotoxin controls, and in order to data for clinical drug use, endotoxin limit value L controls at 0.035EU/mg.By Zhang Debo at " research of brufen bacterial endotoxins test " document (Chinese Journal of Modern Applied Pharmacy 2012,29(3): the method for the inspection brufen bacterial endotoxin of report 261 ~ 264): add 1.5 times amount in Ibuprofen samples without endotoxic natrium carbonicum calcinatum, check endotoxin with baterial endotoxin test with after water-soluble solution, the endotoxin limit value L of the method is 0.20EU/mg.When brufen endotoxin limit value L is 0.035EU/mg, adopt the literature method of Zhang Debo to detect, test sample positive control is negative, and the inspection of need testing solution interference bacterial endotoxin is described.Brufen is almost insoluble in water, easily molten in ethanol, but ethanol can disturb the inspection of bacterial endotoxin.Therefore need to adopt one can sample dissolution, the method that need testing solution can be made again not affect tiny electrolytic cell carries out the baterial endotoxin test of the brufen raw material for injection product.
Summary of the invention
The object of the invention is to provide a kind of method checking the bacterial endotoxin of brufen raw material, to solve prior art Problems existing.
Bacterial Endotoxin Test of the present invention, comprise the following steps: take brufen raw material and 1/4 ~ 1/2 times amount without endotoxic natrium carbonicum calcinatum, with 15 ~ 45%(v/v) ethanolic solution make the brufen solution being not less than 14.28mg/ml, brufen solution corresponding to each sensitivity tachypleus amebocyte lysate is prepared again, then with reference to the gel method inspection in " Chinese Pharmacopoeia " version annex bacterial endotoxins test in 2010 with baterial endotoxin test dilute with water.
The present inventor is through repeatedly studying discovery, adopt 15 ~ 45%(v/v) ethanolic solution and 1/4 ~ 1/2 times amount both can solve the solubility problem of brufen raw material without endotoxic natrium carbonicum calcinatum, sample solution can be avoided again the interference of brufen tiny electrolytic cell, may be used for checking that endotoxin limit value L is the brufen raw material of 0.035EU/mg.
Brufen bacterial endotoxins test provided by the invention, easy and simple to handle, sensitive and accurate, brufen checks bacterial endotoxin requirement as injection raw material can be met completely.
Embodiment
embodiment 1
1 instrument and reagent
1.1 instrument
Electric-heated thermostatic water bath (Shanghai supply and marketing company of instrument group), XW-80A vortex mixer (Qingpu Shanghai Hu Xi instrument plant), clean bench (HENGZI), electric drying oven with forced convection (the eternal experimental apparatus factory in Chongqing), electronic balance (sartorius), test glassware used all at 250 DEG C of baking 2h, to remove the Exogenous bacteria endotoxin that may exist.
1.2 reagent
(0.1ml/ props up tachypleus amebocyte lysate for TAL, Zhanjiang Andusi Biology Co., Ltd., sensitivity 0.25EU/ml, lot number: 1206201; Zhanjiang Bo Kang Marine Bio Co., Ltd., 0.1ml/ props up, sensitivity 0.25EU/ml, lot number: 1206130; Zhanjiang Andusi Biology Co., Ltd., 0.1ml/ props up, sensitivity 0.06EU/ml, lot number: 1207082; Zhanjiang Bo Kang Marine Bio Co., Ltd., 0.1ml/ props up, sensitivity 0.06EU/ml, lot number: 1207131); Bacterial endotoxin working standard (CSE, Nat'l Pharmaceutical & Biological Products Control Institute, specification: 120EU/ props up, lot number: 150601-201072); Ethanol; Natrium carbonicum calcinatum; Baterial endotoxin test use water (BET water, Zhanjiang Andusi Biology Co., Ltd., 50ml/ bottle, lot number: 1010140); Brufen raw material (commercially available).
The determination of the Bacterial endotoxin limit of 2 brufen raw materials
Brufen endotoxin limit value L calculates, L=0.375EU/mg(K=5EU/kgh, M=13.33mg/kgh), according to the endotoxic limit of the ibuprofen injection made, and consider and add other auxiliary materials in addition, in order to ensure the security of the clinical application of ibuprofen injection, the Bacterial endotoxin limit of bulk drug is decided to be L=0.035EU/mg.
The calculating of 3 minimum effective dilute concentrations (MVC)
Minimum effective dilute concentration computing formula is: MVC=λ/L, and wherein L is the Bacterial endotoxin limit of test sample, and the L of brufen raw material is 0.035EU/mg.λ is the sign sensitivity of tachypleus amebocyte lysate in gel method, and when λ is 0.25EU/ml, 0.125EU/ml, 0.06EU/ml or 0.03EU/ml, corresponding minimum effective dilute concentration is as table 1:
The minimum effective dilute concentration of table 1
| Sensitivity EU/ml | 0.25 | 0.125 | 0.06 | 0.03 |
| MVC（mg/ml） | 7.14 | 3.57 | 1.71 | 0.86 |
4 brufen raw material dissolving methods are selected
Brufen endotoxin limit value is L=0.035EU/mg, the tachypleus amebocyte lysate being 0.03EU/ml by sensitivity calculates, take brufen and be about 57.12mg, add 4ml ethanolic solution and a certain amount of natrium carbonicum calcinatum sample dissolution, be prepared into the brufen solution that concentration is not less than 14.28mg/ml, only under the concentration being not less than 14.28mg/ml, progressively could prepare with baterial endotoxin test dilute with water the need testing solution that concentration is not less than minimum effective dilute concentration corresponding to each sensitivity, and measuring the pH of the need testing solution of 0.86mg/ml, result is as table 2.
Table 2 brufen dissolving method and pH
Because brufen can not dissolve by scheme 1,5 completely, therefore get rid of this two kinds of dissolving methods, the pH of scheme 7, not in 6 ~ 8 scopes, disturbs tiny electrolytic cell, therefore concentration of alcohol screening is 15 ~ 45%(v/v), natrium carbonicum calcinatum consumption is 1/4 ~ 1/2 times of brufen sample weighting amount.
Comparative example
When brufen Bacterial endotoxin limit L is 0.035EU/mg, adopt Zhang Debo at " research of brufen bacterial endotoxins test " document (Chinese Journal of Modern Applied Pharmacy 2012,29(3): 261 ~ 264), the method for the inspection brufen bacterial endotoxin of report is tested, and result is as table 3.
Table 3 brufen baterial endotoxin test result
| Numbering | NPC(test sample negative control) | PPC(test sample positive control) | PC(positive control) | NC(negative control) |
| Batch 1 | -- | -- | ++ | -- |
Note: "+" represents that reaction is for positive ， “ – " represent that reaction is for negative.
Conclusion: test sample positive control is negative, illustrates and adopts the method need testing solution interference baterial endotoxin test.
Embodiment 2
1 ethanolic solution is to the interference test of bacterial endotoxin and tachypleus amebocyte lysate
Table 4 ethanolic solution is to the interference test of bacterial endotoxin and tachypleus amebocyte lysate
Note: "+" represents that reaction is for positive ， “ – " represent that reaction is for negative.
Conclusion: the ethanolic solution of 45% and 15% to bacterial endotoxin and tachypleus amebocyte lysate noiseless.
2 sensitivity of the limulus reagent are checked
By the requirement of version Chinese Pharmacopoeia in 2010 two annex Ⅺ E, Sensilivily Check is carried out to tachypleus amebocyte lysate, check with water-soluble solution bacterial endotoxin working standard with bacterium endogenous toxic material, vortex mixer mixes 15 minutes, then the endotoxin standard solution of 2 λ, λ, 0.5 λ, 0.25 λ concentration is made, often dilute a step and all should mix 30s on vortex mixer, each batch get redissolution after the former ampoule of tachypleus amebocyte lysate 18 that props up of 0.1ml/, wherein 16 pipes add the endotoxin standard solution of the above-mentioned variable concentrations of 0.1ml respectively, and each endotoxin concns is parallel does 4 pipes.Other 2 pipes add 0.1ml baterial endotoxin test and use water as negative control.After in test tube, solution mixes gently, the closed mouth of pipe vertically puts into thermostat water bath insulation (60 ± 2) minute of (37 ± 1) DEG C.The results are shown in Table 5.
Table 5 sensitivity of the limulus reagent inspection test
Note: "+" represents that reaction is for positive ， “ – " represent that reaction is for negative.
Conclusion: through checking, the sensitivity determination value of tachypleus amebocyte lysate used all (comprises 0.5 λ and 2 λ) between 0.5 λ ~ 2 λ, conforms with the regulations.
3 interference test trial tests
Brufen raw material does interference trial test, use the ethanolic solution of solvent 1(45% and 1/4 times amount respectively without the mixed solution of endotoxic natrium carbonicum calcinatum) and the ethanolic solution of solvent 2(15% and 1/2 times amount without the mixed solution of endotoxic natrium carbonicum calcinatum) sample dissolution, through baterial endotoxin test dilute with water, and suitably ultrasonic, stepwise dilution obtains 7.14mg/ml, 3.57mg/ml, 1.71mg/ml, 0.86mg/ml serial dilutions as test sample negative control.The need testing solution of another preparation and NPC same concentrations gradient, each concentration all prepares serial solution containing 2 λ bacterial endotoxins as test sample positive control, and each concentration is parallel does two pipes, makes positive control, negative control simultaneously.The tachypleus amebocyte lysate of Qu Liangge producer 0.25EU/ml is tested, in table 6 respectively.
Table 6 brufen interference trial test result
Note: "+" represents that reaction is for positive ， “ – " represent that reaction is for negative.
As seen from the results in Table 6, the reaction of brufen solution to tachypleus amebocyte lysate and bacterial endotoxin has inhibiting effect, but when mass concentration is diluted to 1.71mg/ml and is following, its inhibiting effect can be excluded, and sensitivity of the limulus reagent corresponding to this concentration is 0.06EU/ml.
4 formal interference tests
According to trial test result, select Liang Ge producer to be the tachypleus amebocyte lysate of 0.06EU/ml, the concentration that brufen is diluted to 1.71mg/ml carries out interference test as need testing solution.Use the ethanolic solution of solvent 1(45% and 1/4 times amount respectively without the mixed solution of endotoxic natrium carbonicum calcinatum) and the ethanolic solution of solvent 2(15% and 1/2 times amount without the mixed solution of endotoxic natrium carbonicum calcinatum) sample dissolution, through baterial endotoxin test dilute with water, preparation is containing the bacterial endotoxin serial solution of 2 λ, λ, 0.5 λ, 0.25 λ, and each concentration is parallel does 4 pipes.And the bacterial endotoxin serial solution of 2 λ, λ, 0.5 λ, 0.25 λ is contained with the preparation of BET water, each concentration is parallel does 4 pipes.Make negative control, test sample negative control simultaneously, respectively parallelly do two pipes.The results are shown in Table 7.
Table 7 brufen interference test result
Note: "+" represents that reaction is for positive ， “ – " represent that reaction is for negative.
Show according to table 7 result, negative control pipe, test sample negative control pipe, result is feminine gender.The Es of two groups of tachypleus amebocyte lysate is 0.06EU/ml, and between 0.5 λ ~ 2 λ, (comprise 0.5 λ and 2 λ), Et (comprises 0.5Es and Es) between 0.5Es ~ 2Es, and test effectively.Illustrate that brufen is when 1.71mg/ml mass concentration, noiseless to the agglutinating reaction of tachypleus amebocyte lysate and bacterial endotoxin.
5 brufen baterial endotoxin test
Get 3 batches of brufen raw materials in right amount each, select the tachypleus amebocyte lysate of 0.06EU/ml, use the ethanol of solvent 1(45% and 1/4 times amount respectively without the mixed solution of endotoxic natrium carbonicum calcinatum) and the ethanol of solvent 2(15% and 1/2 times amount without the mixed solution of endotoxic natrium carbonicum calcinatum) sample dissolution, preparation concentration is not less than the brufen solution of 14.28mg/ml, then uses baterial endotoxin test dilute with water sample.Requirement with reference to version " Chinese Pharmacopoeia " two annex Ⅺ E in 2010 checks.The results are shown in Table 8.
Table 8 brufen raw material tiny electrolytic cell result
Note: "+" represents that reaction is for positive ， “ – " represent that reaction is for negative.
From the check result of table 8, NPC and NC is feminine gender; PPC and PC is the positive, and test effectively.Result shows that the baterial endotoxin test of 3 batch samples all conforms with the regulations.
Claims (1)
1. one kind is detected the endotoxic method of brufen raw material, comprise the following steps: take brufen raw material and 1/4 ~ 1/2 times amount without endotoxic natrium carbonicum calcinatum, with 15 ~ 45%(v/v) ethanolic solution make the brufen solution being not less than 14.28mg/ml, brufen solution corresponding to each sensitivity tachypleus amebocyte lysate is prepared again, then with reference to the gel method inspection in " Chinese Pharmacopoeia " version annex bacterial endotoxins test in 2010 with baterial endotoxin test dilute with water.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111856017A (en) * | 2020-07-24 | 2020-10-30 | 褚培忠 | Method for detecting endotoxin in alcohol solution |
| CN112415156A (en) * | 2019-08-22 | 2021-02-26 | 华北制药集团新药研究开发有限责任公司 | Method for detecting bacterial endotoxin of anidulafungin raw material medicine |
| CN113219177A (en) * | 2021-06-07 | 2021-08-06 | 辰欣药业股份有限公司 | Method for detecting bacterial endotoxin in egg yolk lecithin by gel method |
| CN115420565A (en) * | 2022-08-22 | 2022-12-02 | 昆明积大制药股份有限公司 | Method for detecting bacterial endotoxin in triamcinolone acetonide injection |
| CN118858605A (en) * | 2024-06-11 | 2024-10-29 | 艾伟拓(江苏)医药科技有限公司 | A DLin-MC3-DMA endotoxin detection method |
-
2014
- 2014-06-27 CN CN201410293711.2A patent/CN105203724A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112415156A (en) * | 2019-08-22 | 2021-02-26 | 华北制药集团新药研究开发有限责任公司 | Method for detecting bacterial endotoxin of anidulafungin raw material medicine |
| CN111856017A (en) * | 2020-07-24 | 2020-10-30 | 褚培忠 | Method for detecting endotoxin in alcohol solution |
| CN113219177A (en) * | 2021-06-07 | 2021-08-06 | 辰欣药业股份有限公司 | Method for detecting bacterial endotoxin in egg yolk lecithin by gel method |
| CN115420565A (en) * | 2022-08-22 | 2022-12-02 | 昆明积大制药股份有限公司 | Method for detecting bacterial endotoxin in triamcinolone acetonide injection |
| CN118858605A (en) * | 2024-06-11 | 2024-10-29 | 艾伟拓(江苏)医药科技有限公司 | A DLin-MC3-DMA endotoxin detection method |
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Application publication date: 20151230 |