CN103592442A - Method for detection of content of bacterial endotoxin in recombinant porcine interferon alpha 1 freeze-dried powder injection - Google Patents
Method for detection of content of bacterial endotoxin in recombinant porcine interferon alpha 1 freeze-dried powder injection Download PDFInfo
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
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- G01N33/579—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving limulus lysate
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- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/52—Assays involving cytokines
- G01N2333/555—Interferons [IFN]
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Abstract
The invention discloses a method for detection of the content of bacterial endotoxin in a recombinant porcine interferon alpha 1 freeze-dried powder injection. A modified limulus amebocyte lysate test method is used, 2ml of water used for bacterial endotoxin inspection is used for dissolving the recombinant porcine interferon alpha 1 freeze-dried powder injection, and limulus lysate test interfering factors are removed by 10min of boiling at 100 DEG C; in the case of no exceeding of the maximum effective multiples, the water used for the bacterial endotoxin inspection is used for stepwise dilution of recombinant porcine interferon alpha 1 protein processed by boiling; first, the contents of the bacterial endotoxin with various dilution concentrations are detected, then an interference test is started from lowest dilutability with a negative reaction result, and a lowest concentration for forming a gel with the limulus test in the circumstance of no interference is found, so that the specific content of the bacterial endotoxin in the recombinant porcine interferon alpha 1 freeze-dried powder injection can be determined. The method provides a bacterial endotoxin detection method for the production and application of the recombinant porcine interferon alpha 1 freeze-dried powder injection.
Description
Technical field
The invention belongs to microorganism field, relate to a kind of bacteria endotoxin content detection method of biological products, be specifically related to the detection method of bacteria endotoxin content in a kind of Recombinant Swine Interferon α1 freeze drying powder injection.
Background technology
Interferon is as current generally acknowledged antiviral active drug, and security performance is good, and has good antiviral and immunoloregulation function, is current application prospect one of biopreparate the most widely.What animal was applied to veterinary clinic the earliest with interferon is leukocyte interferon of pig, but this kind of interferon expression amount is low, needs to adopt biochemical separated method to obtain, and cost is higher, is unfavorable for large-scale production.My chamber adopts technique for gene engineering to obtain a kind of Recombinant Swine interferon ɑ (preparation method of recombinant porcine alpha interferon, the patent No. 2008100201804), and clinic trial result shows that it can effectively treat the diseases such as pig virus diarrhoea.
Bacterial endotoxin is a kind of constituent of gram-negative bacteria cell membrane, only, when bacterium death or breeding, is just discharged into extracellular, brings into play various effects.Endotoxin chemical nature is lipopolysaccharides (LPS).Bacterial endotoxins test is a kind of method for detection of contaminated with endotoxins in medicine and middle product thereof that recent two decades grows up.Traditional bacterial endotoxins test is rabbit pyrogen test.Version < < Chinese Pharmacopoeia > > in 2005 is the form about bacterial endotoxins test coordination case with reference to U.S., Europe, day tripartite, and in conjunction with domestic actual conditions, determined that limulus test is as the standard detecting method that detects rHu-IFN-q Hybridomacells preparation bacteria endotoxin content.The advantages such as this law and traditional rabbit method relatively have highly sensitive, without individual difference, are subject to ectocine little, test favorable reproducibility, and expense is cheap are applicable to producer pyrogen monitoring and the intermediate product of production overall process are detected very much.But the existing bacterial endotoxins test of veterinary biologics is still traditional rabbit pyrogen test at present, therefore sets up bacteria endotoxin content detection method new in veterinary biologics and have great importance.
Summary of the invention
The object of the invention is just to provide the detection method of bacteria endotoxin content in a kind of Recombinant Swine Interferon α1 freeze drying powder injection.
The present invention is achieved by the following technical solutions:
Detect a method for bacteria endotoxin content in Recombinant Swine Interferon α1 freeze drying powder injection, adopt improvement tachypleus amebocyte lysate inspection technique, comprise the following steps:
With 2ml bacterial endotoxin, check that water dissolves Recombinant Swine Interferon α1 freeze drying powder injection, 100 ℃ are boiled 10min and remove limulus test disturbing factor, with bacterial endotoxin, check that water carries out stepwise dilution to Recombinant Swine Interferon α1 albumen after boiling processing in the situation that being no more than maximum effectively multiple, first check the bacteria endotoxin content of each dilute concentration, and then start to do interference test from the negative minimum dilutability of reaction result, find out in glitch-free situation and can form with limulus test the least concentration of gel, thereby determine endotoxic concrete content in Recombinant Swine Interferon α1 freeze drying powder injection.
Advantage of the present invention is:
Can detect rapidly the bacteria endotoxin content in Recombinant Swine Interferon α1 freeze drying powder injection.
Adopt heating to remove disturbing factor, testing result accurately and reliably.
Easy and simple to handle, without the large-scale equipment of valuable precision, testing cost is low.
Embodiment
Embodiment 1
1. reagent
Test sample: (lot number is 20121116 to Recombinant Swine Interferon α1 freeze drying powder injection, and tiring is 1.0 * 10
6iU, endotoxin content is 25EU)
Bacterial endotoxin checks water: endotoxin content is less than the sterilized water for injection that 0.015EU/ml and induced by endotoxin are tested noiseless effect
Bacterial endotoxin national standard: purchased from National Institute for Food and Drugs Control, every 10000EU.
Tachypleus amebocyte lysate: purchased from Xiamen tachypleus amebocyte lysate factory, 0.1ml/ props up (λ=0.25EU/ml)
2. instrument and equipment
Vortex mixer, sealed membrane, test tube (10 * 75mm), suction pipe, tweezers (metal), can.
The all glass waress that use in experiment generally, after washing lotion is soaked, take out and rinse successively (available purified water immersion) well by tap water, purified water.
Vessel used in test, need to through 250 ℃ dry roasting 30 minutes above standby, to remove exogenous endotoxin.Remove exogenous endotoxic glassware and should in regulation, use (if glassware is packed with masking foil, in the situation that not unpacking, can in two weeks, use), otherwise must again remove the exogenous endotoxin that may exist.
3. determine Bacterial endotoxin limit
Formula L=K/M calculates.M is per kilogram clinical maximum dosage per hour, according to medicine operation instructions, determine, if inject time less than 1 hour, by calculating in 1 hour.K is the acceptable endotoxin dosage of per kilogram of body weight maximum per hour, represents injection K=5EU/ (kgh) with EU/ (kgh)
This chamber Recombinant Swine Interferon α1 freeze drying powder injection is by the calculating of tiring: per kilogram is per hour clinical maximum with 1000IU(20 kilogram of sucking pig 20000IU interferon of Recombinant Swine Interferon α1 freeze-dried powder agent dose), L is 5EU/2000IU=0.0025EU/IU, every Recombinant Swine interferon-' alpha ' freeze-drying finished product 20000IU, every Recombinant Swine Interferon α1 freeze drying powder injection endotoxin limit value is 50EU.
4. determine maximum valid dilution multiple (MVD)
Maximum valid dilution multiple refers to that need testing solution is allowed to the maximum multiple (MVD) diluting in test, is being no more than the detection of carrying out endotoxin limit value under the concentration of this extension rate.With following formula, determine MVD:MVD=cL/ λ
The Bacterial endotoxin limit that wherein L is test sample; C is the concentration of need testing solution, and λ is the sign sensitivity (EU/ml) of tachypleus amebocyte lysate in gel method, or minimum endotoxin concns on the typical curve using in photometric means.
This chamber Recombinant Swine Interferon α1 freeze drying powder injection: c=10000IU/ml, L is 0.0025EU/IU, λ is 0.25EU/ml, MVD=100.
5. sensitivity of the limulus reagent inspection test
The endotoxic least concentration that makes tachypleus amebocyte lysate produce aggegation under this inspection technique defined terms is the sign sensitivity of tachypleus amebocyte lysate, with EU/ml, indicates.When using the tachypleus amebocyte lysate of new lot number or test condition that any change that may affect assay has occurred, should carry out sensitivity of the limulus reagent inspection test.
According to the sign value (λ) of sensitivity of the limulus reagent, bacterial endotoxin national standard or bacterial endotoxin working standard are checked to water dissolves with bacterial endotoxin, on eddy mixer, mix 15 minutes, then the endotoxin standard solution of making 2 λ, λ, 0.5 λ and tetra-concentration of 0.25 λ, every dilution one step should mix for 30 seconds on eddy mixer.Get the 10mm * 75mm test tube that minute 0.1ml tachypleus amebocyte lysate solution is housed or redissolve after 0.1ml/ prop up 18 of the former ampoules of tachypleus amebocyte lysate of specification, wherein 16 pipes add respectively the endotoxin standard solution of 0.1ml variable concentrations, parallel 4 pipes of doing of each endotoxin concns; Other 2 pipes add the inspection of 0.1ml bacterial endotoxin to use water as negative contrast.After solution in test tube is mixed gently, the sealing mouth of pipe, vertically puts into the thermostat of 37 ℃ ± 1 ℃, is incubated 60 minutes ± 2 minutes.
All positive when Cmax 2 λ pipes, least concentration 0.25 λ pipe is all negative, and negative control pipe is negative, tests valid.Be calculated as follows the geometrical mean of reaction end concentration, be the measured value (λ c) of sensitivity of the limulus reagent.
λc=lg-1（∑X/4）
In formula, X is the logarithm value (lg) of reaction end concentration.Reaction end concentration refers to the concentration of last result that is positive in the endotoxin concns that series successively decreases.
It should be noted that, when actual measurement sensitivity λ c (comprises 0.5 λ～2.0 λ at 0.5 λ～2.0 λ, λ is the sign value that tachypleus amebocyte lysate is sensitive) time, can be for bacterial endotoxin inspection, and take and indicate the sensitivity (the results are shown in Table 1) that sensitivity is this batch of tachypleus amebocyte lysate.
6. interference test trial test
Get a Recombinant Swine Interferon α1 freeze drying powder injection, then with 2ml bacterial endotoxin check water dissolve after as stoste.According to drafting endotoxin limit value, adding endotoxin checks that water dissolves and is diluted to and is no more than the serial dilution degree that MVD stipulates: 1:10,1:20,1:40,1:80,1:100, more respectively each dilutability is made to the Recombinant Swine Interferon α1 solution that contains and do not contain 2 λ bacterial endotoxin standard items.Set up positive control (the standard endotoxin that adds 2 λ) and negative control (bacterial endotoxin inspection water), wherein each dilutability is parallel does two simultaneously, calculates average recovery rate.
Recombinant Swine Interferon α1 stoste 1:20,1:40,1:80,1:100 dilute after additional 2 λ bacterial endotoxin standard items, the detection of bacterial endotoxin recovery all in effective range 50%～200%, shows that Recombinant Swine Interferon α1 freeze drying powder injection can get rid of disturbing factor under this experiment condition.Formal interference experiment is selected 1:20 dilutability.
7. interference test
Recombinant Swine Interferon α1 stoste 1:20 dilution, by each serial solution of table 2 preparation.With reference to operating under sensitivity of the limulus reagent inspection test item, record the disturbed condition of test liquid.
Result is observed and judgement:
Only have when the parallel pipe of Recombinant Swine Interferon α1 solution (A) and negative control solution (D) all negative, and the result of control series solution that tachypleus amebocyte lysate indicates sensitivity is within the scope of sensitivity of the limulus reagent time, test validly, calculate the geometrical mean (Es and Et) that serial tachypleus amebocyte lysate indicates the control series solution of sensitivity and disturbs the reaction end concentration of reagent series solution.When Es comprises 0.5Es and 2Es at 0.5 λ～2 λ (comprising 0.5 λ and 2 λ) and Et at 0.5Es～2Es() time, think test sample noiseless effect under this concentration.If Recombinant Swine Interferon α1 solution has interference to test being less than under the extension rate of MVD, Recombinant Swine Interferon α1 solution should be no more than to the further dilution of MVD, then repeat interference test.This experimental result shows that Recombinant Swine Interferon α1 stoste 1:20 dilution detects noiseless to tachypleus amebocyte lysate.
While setting up bacterial endotoxins test in detecting before the endotoxin check test of carrying out new drug or without the kind of endotoxin check item, must carry out interference test; When the prescription of tachypleus amebocyte lysate, test sample, production technology change or experimental enviroment in while there is any variation that likely affects test findings, must re-start interference test.
8. detection of bacterial endotoxin
Get Recombinant Swine Interferon α1 freeze drying powder injection, after then dissolving with 2ml bacterial endotoxin inspection water, as stoste, on vortex Vib., it is dissolved completely.Get tachypleus amebocyte lysate, every adds 0.1ml detection of bacterial endotoxin water to dissolve, therefrom getting 1 adds the bacterial endotoxin standard items of 0.1ml2 λ as positive control, 1 adds 0.1ml detection of bacterial endotoxin to use water as negative contrast, parallel each the dilution Recombinant Swine Interferon α1 solution 0.1ml that adds of all the other every 4 flags.After solution in test tube is mixed gently, the sealing mouth of pipe, vertically puts into the thermostat of 37 ± 1 ℃, is incubated observations after 60 ± 2min.
9. result is judged
At Recombinant Swine Interferon α1 solution, form under the maximum dilution multiple and glitch-free situation of gel, calculate endotoxin content in Recombinant Swine Interferon α1 freeze drying powder injection.
The geometrical mean of the sensitivity of endotoxin concns=tachypleus amebocyte lysate in Recombinant Swine Interferon α1 freeze drying powder injection * all parallel pipe reaction end concentration.
Table 1 indicates the sensitivity of the limulus reagent of sensitivity 0.25EU/ml and checks experiment
The preparation of table 2 gel method interference test solution
Claims (1)
1. detect a method for bacteria endotoxin content in Recombinant Swine Interferon α1 freeze drying powder injection, it is characterized in that adopting improvement tachypleus amebocyte lysate inspection technique, comprise the following steps:
With 2ml bacterial endotoxin, check that water dissolves Recombinant Swine Interferon α1 freeze drying powder injection, 100 ℃ are boiled 10 min and remove limulus test disturbing factor, with bacterial endotoxin, check that water carries out stepwise dilution to Recombinant Swine Interferon α1 albumen after boiling processing in the situation that being no more than maximum effectively multiple, first check the bacteria endotoxin content of each dilute concentration, and then start to do interference test from the negative minimum dilutability of reaction result, find out in glitch-free situation and can form with limulus test the least concentration of gel, thereby determine endotoxic concrete content in Recombinant Swine Interferon α1 freeze drying powder injection.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103837673A (en) * | 2014-03-18 | 2014-06-04 | 张嵩 | Method for detecting content of bacterial endotoxin of bromhexine hydrochloride raw material |
| CN109387637A (en) * | 2018-10-12 | 2019-02-26 | 四川升和药业股份有限公司 | Danshen injections Test for Bacterial Endotoxins |
| CN111759969A (en) * | 2020-07-17 | 2020-10-13 | 贵州松桃信仁苗药有限公司 | Traditional Chinese medicine composition for treating vaginal relaxation |
| 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 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103837673A (en) * | 2014-03-18 | 2014-06-04 | 张嵩 | Method for detecting content of bacterial endotoxin of bromhexine hydrochloride raw material |
| CN109387637A (en) * | 2018-10-12 | 2019-02-26 | 四川升和药业股份有限公司 | Danshen injections Test for Bacterial Endotoxins |
| CN111759969A (en) * | 2020-07-17 | 2020-10-13 | 贵州松桃信仁苗药有限公司 | Traditional Chinese medicine composition for treating vaginal relaxation |
| 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 |
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