CN107907639A - Hot air sterilization endotoxin indicator kit - Google Patents
Hot air sterilization endotoxin indicator kit Download PDFInfo
- Publication number
- CN107907639A CN107907639A CN201711151173.3A CN201711151173A CN107907639A CN 107907639 A CN107907639 A CN 107907639A CN 201711151173 A CN201711151173 A CN 201711151173A CN 107907639 A CN107907639 A CN 107907639A
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- China
- Prior art keywords
- endotoxin
- indicator
- reagents
- hot air
- bottle
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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
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
Abstract
The present invention discloses a kind of hot air sterilization endotoxin indicator kit, including box body and its interior 20 bacterial endotoxin indicator bottles and ten reagents bottles, and wherein endotoxin indicator is the Escherichia coli O111 of the filling purification in glass ampule：B4 or O55：The exquisite endotoxin dry product of the bacterial strains such as B5 extraction, the potency of endotoxin indicator is 1000 10000EU/ bottles, without stabilizer, excipient and dispersant.During use, endotoxin indicator is placed in dry heat sterilization devices to be verified or is added in the article for treating depyrogenation, hot air sterilization is front and rear to detect level of endotoxin with reagents, prove that this reduces phlegm and internal heat original equipment or technique can make level of endotoxin at least decline 3 log units, the present invention meets 2010 annex of Chinese Pharmacopoeia, Ⅹ VI sterilization project regulation, easy to use.
Description
Technical field
The present invention discloses a kind of endotoxin indicator kit, belongs to detection examination by International Patent Classification (IPC) (IPC) division
Agent box manufacturing technology field, is used to verify that dry heat sterilization devices remove endotoxin more particularly, to one kind（Pyrogen）The reagent of effect
Box.
Background technology
Remove the major issue that bacterial endotoxin is pharmacy and biological products industry.Dry heating method is normal except pyrogen removal
Means.Dry heat sterilization devices are necessary according to the requirement of pharmaceutical production specification as the important equipment in drug for injection production
Make device authentication.2010 annex of Chinese Pharmacopoeia, Ⅹ VI sterilization project provides：Bacterial endotoxin inactivation checking test is to prove to do
The experiment of heat sterilization depyrogenation process validity.It will generally be added not less than the bacterial endotoxin indicator of 1000 units and wait to reduce phlegm and internal heat
In former article, it was demonstrated that the pyrogen removal technique can make endotoxin potency decline more than 1000 times, and endotoxin indicator goes out xeothermic
The change of potency is judged by reagents before and after bacterium process, but there is presently no refer to dedicated for hot air sterilization endotoxin
Show the kit of agent, and the bacterial endotoxin indicator purity used in the experiment purchased is inadequate, when high-temperature heating, carbonizes, so that
Influence experimental result.
The content of the invention
In view of the deficiencies of the prior art, the present invention provides a kind of hot air sterilization endotoxin indicator reagent easy to use
Box, meets 2010 annex of Chinese Pharmacopoeia, Ⅹ VI sterilization project regulation, in use, endotoxin indicator is placed in be verified do
Heat sterilization equipment is added in the article for treating depyrogenation, and hot air sterilization is front and rear to detect level of endotoxin with reagents, it was demonstrated that should
Reduce phlegm and internal heat original equipment or technique can make level of endotoxin at least decline 3 log units.
To reach above-mentioned purpose, the present invention is achieved by the following technical solutions：
A kind of hot air sterilization endotoxin indicator kit, including box body and its interior some bacterial endotoxin indicator bottles and horseshoe crab
Reagent bottle, wherein：
Bacterial endotoxin indicator bottle, filling high-purity endotoxin in it, and endotoxic potency are 1000 ~ 10000EU/ bottles；
Reagents bottle, filling gel method reagents or sizing technique reagents in it.
Further, the high-purity endotoxin in the bacterial endotoxin indicator bottle is from Escherichia coli O111：B4 or
O55：The exquisite endotoxin of B5 bacterial strains extraction.
Further, the reagents bottle is ampoule bottle, and the loading amount of its interior reagents is 0.1ml.
Further, the quantity of the bacterial endotoxin indicator bottle and reagents bottle is respectively 20 ampoule bottles and ten
Branch ampoule bottle.
Endotoxin indicator is from Escherichia coli O111 in the present invention：B4 or O55：The exquisite endogenous toxic material of the bacterial strains such as B5 extraction
Element, by special process drying in glass ampule.The potency of endotoxin indicator is every bottle of 1000 ~ 10000EU.Endotoxin
Indicator is free of any stabilizer, excipient and dispersant, prevents from carbonizing in high-temperature heating, influences experimental result.Due to glass
Solids content in glass container is seldom, so appearing as an empty bottle.
Endotoxin indicator in use, is positioned over the cold spot area of dry heat sterilization devices by the present invention under maximum load state
Domain, carries out endotoxin challenge experiment.With the supporting reagents of kit using gel method or sizing technique detection endotoxin indicator
Before hot air sterilization program starts and hot air sterilization EP (end of program) after potency situation of change, if the potency of endotoxin indicator
Decline at least 1000 times, then this hot air sterilization reaches the sterilizing requirement of States Pharmacopoeia specifications.
It is an advantage of the invention that endotoxin indicator purity is high, titer plateaus, without stabilizer, excipient and dispersant,
Do not carbonized in high-temperature sterilization, do not influence the endotoxin bioactivity after sterilizing；Meet Chinese Pharmacopoeia additionally, due to the present invention
2010 annex, Ⅹ VI sterilization project provides, easy to use.
Brief description of the drawings
Fig. 1 is schematic structural view of the invention.
Embodiment
The invention will be further described below in conjunction with the accompanying drawings：
Embodiment：Referring to Fig. 1, a kind of hot air sterilization endotoxin indicator kit, including box body 1 and its interior 20 thin
Bacterium endotoxin indicator bottle 11 and ten reagents bottles 12, Escherichia coli O111：The exquisite endotoxin of B4 extractions, by special work
Skill drying makes bacterial endotoxin indicator bottle in glass ampule, and the potency of endotoxin indicator is every bottle of 1000-
10000EU, endotoxin indicator are free of any stabilizer, excipient and dispersant；Gel method or sizing technique reagents, loading amount are
0.1ml/ branch, filling in apyrogeneity ampoule, freeze-drying sealing.
The application method of the present invention：
1. the challenge experiment of endotoxin indicator
Experiment carries out under the conditions of dry heat sterilization devices maximum load, and 1- is placed respectively in each cold spot position of dry heat sterilization devices
2 endotoxin indicators do not opened.Run actual xeothermic depyrogenation program.After hot air sterilization process, each is taken out
Endotoxin indicator；
2. determine without the processed endotoxin indicator potency of hot air sterilization
2.1 take 1-2 branch without the processed endotoxin indicator of hot air sterilization, with 1.0 ml baterial endotoxin test water
Dissolving, acutely shakes 15 minutes on vortex mixer；
If the reagents in 2.2 kits is sizing technique reagents, step 2.1 gained endotoxin solution is diluted into P/Cm
Times, make its theoretical value in the endotoxin standard curve range of linearity.Wherein, P is endotoxin indicator sign value, and Cm is endotoxin
Close to the value of intermediate point in the standard curve range of linearity.If the endotoxin standard curve range of linearity is 0.01-100 EU/ml, Cm
Take 1.0 EU/ml；If the endotoxin standard curve range of linearity is that 0.1-1.0 EU/ml, Cm take 0.25 EU/ml or 0.5 EU/
ml；
Press《Pharmacopoeia of People's Republic of China》Annex " bacterial endotoxins test " photometry determines non-sterilized treated
Endotoxin indicator potency；
If reagents is gel method reagents in 2.3 kits, by step 2.1 resulting solution dilute P/2 λ, P/ λ, 2P/ λ and
4P/ λ times.Wherein, P is endotoxin indicator sign value, and λ indicates sensitivity for reagents.Such as：Selection λ is 0.125EU/ml
Reagents come verify potency for 1250EU/ branch endotoxin indicator active unit.The extension rate of endotoxin indicator
For P/2 λ=5000, P/ λ=10,000,2P/ λ=20,000 and 4P/ λ=40,000 times；
Press《Pharmacopoeia of People's Republic of China》The sxemiquantitative of annex " bacterial endotoxins test " gel experiment method determine without
The endotoxin indicator potency that sterilization treatment is crossed；
3. determine the processed endotoxin indicator potency of hot air sterilization
3.1 dissolve above-mentioned through the processed endotoxin indicator of hot air sterilization with 1ml baterial endotoxin tests with water, are revolving
Acutely shaken 15 minutes on the mixer of whirlpool；
If 3.2 kits it is supporting be sizing technique reagents, by step 3.1 gained endotoxin solution dilution P/ (1000Cm)
Times.P is endotoxin indicator sign value, and Cm is close to the value of intermediate point in the endotoxin standard curve range of linearity.If P=
1250EU/ branch, Cm=1.25EU/ml, then P/ (1000Cm)=1250/ (1000 × 1.25)=1.0 times, that is, do not have to dilution.
If P=1250EU/ branch, Cm=0.25EU/ml, then P/ (1000Cm)=1250/ (1000 × 0.25)=5 times, that is, dilute 5
Times；
According to《Pharmacopoeia of People's Republic of China》Annex " bacterial endotoxins test " photometry determines that hot air sterilization is handled
The endotoxin indicator potency crossed
If 3.3 kits it is supporting be that sensitivity is λ gel method reagents, need step 3.1 gained endotoxin solution point
Xi Shi not be P/ (10002 λ), P/ (1000 λ), 2P/ (1000 λ), and 4P/ (1000 λ) times；
According to《Pharmacopoeia of People's Republic of China》The method of annex " bacterial endotoxins test " gel sxemiquantitative experiment determines to do
The endotoxin indicator potency that heat sterilization is crossed；
4. endotoxin potency declines the calculating of multiple
Potency declines multiple=the endotoxin indicator potency average value without hot air sterilization processing/by hot air sterilization processing
The potency average value for the endotoxin indicator crossed.
If potency, which declines multiple, is more than 1000, the xeothermic depyrogenation effect of the equipment meets standard, otherwise, do not meet rule
It is fixed.
The foregoing descriptions are merely the embodiment using this origination techniques content, any those skilled in the art use this wound
Make done modifications and changes, all belong to the scope of the claims of this creation opinion, and be not limited to those disclosed embodiments.
Claims (4)
1. a kind of hot air sterilization endotoxin indicator kit, it is characterised in that including box body and its interior some bacterial endotoxins
Indicator bottle and reagents bottle, wherein：
Bacterial endotoxin indicator bottle, filling high-purity endotoxin in it, and endotoxic potency are 1000 ~ 10000EU/ bottles；
Reagents bottle, filling gel method reagents or sizing technique reagents in it.
2. hot air sterilization endotoxin indicator kit according to claim 1, it is characterised in that：The bacterial endotoxin
High-purity endotoxin in indicator bottle is from Escherichia coli O111：B4 or O55：The exquisite endotoxin of B5 bacterial strains extraction.
3. hot air sterilization endotoxin indicator kit according to claim 1, it is characterised in that：The reagents bottle
For ampoule bottle, the loading amount of its interior reagents is 0.1ml.
4. hot air sterilization endotoxin indicator kit according to claim 1, it is characterised in that：The bacterium endogenous toxic material
The quantity of plain indicator bottle and reagents bottle is respectively 20 ampoule bottles and ten ampoule bottles.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711151173.3A CN107907639A (en) | 2017-11-18 | 2017-11-18 | Hot air sterilization endotoxin indicator kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711151173.3A CN107907639A (en) | 2017-11-18 | 2017-11-18 | Hot air sterilization endotoxin indicator kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107907639A true CN107907639A (en) | 2018-04-13 |
Family
ID=61846351
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711151173.3A Withdrawn CN107907639A (en) | 2017-11-18 | 2017-11-18 | Hot air sterilization endotoxin indicator kit |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107907639A (en) |
-
2017
- 2017-11-18 CN CN201711151173.3A patent/CN107907639A/en not_active Withdrawn
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20180413 |
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| WW01 | Invention patent application withdrawn after publication |