CN202649117U - Endotoxin detection system - Google Patents
Endotoxin detection system Download PDFInfo
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- CN202649117U CN202649117U CN 201220282951 CN201220282951U CN202649117U CN 202649117 U CN202649117 U CN 202649117U CN 201220282951 CN201220282951 CN 201220282951 CN 201220282951 U CN201220282951 U CN 201220282951U CN 202649117 U CN202649117 U CN 202649117U
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Abstract
The utility model discloses an endotoxin detection system, and belongs to the field of endotoxin monitoring. According to the endotoxin detection system, an optical path detecting system is integrated on the basis of a conventional laser particle size detector and dual laser source irradiation is adopted. Output light is received by a multi-point scattered light receiver after entering a detection cell through an optical path and enters a quantitative arithmetical logic unit after a photovoltaic conversion process and a signal amplification process. Endotoxin concentration is calculated and displayed by the quantitative arithmetical logic unit, a pre-warning system is triggered once the endotoxin concentration exceeds a limiting value, and online monitoring is achieved. The endotoxin detection system has the advantages that quantitative detection of the endotoxin concentration is achieved, detection sensitivity is high, reagent is not consumed, liquid medicine is not polluted, detection time is short, and reliability is high.
Description
Technical field
The utility model relates to a kind of endotoxin detection system, relates in particular to a kind of endotoxin detection system that detects based on laser particle, belongs to endotoxin monitoring field.
Background technology
Bacterial endotoxin is lipopolysaccharides, is also referred to as liposome, is the composition of Gram-negative bacteria mantle, extensively is present in occurring in nature, and this material enters blood of human body can cause heating, is commonly called as pyrogen reaction.Because this type of material may cause the people and produce serious adverse reaction, therefore in drug injection, all need strict control.
At present, water for injection and injection production run also can't be carried out on-line monitoring by induced by endotoxin, and endotoxic detection adopts limulus reagent test or rabbit method to check after also depending on and producing end.The sensitivity that these methods and process not only detect is low, and in case when finding that endotoxin in the product exceeds standard, entire block will be with waste disposal, this not only can bring economic loss to enterprise, also can bring huge clinical practice risk to enterprise simultaneously.Therefore, in order to ensure water for injection and injection quality safety, prevent the burst pollution in the production run, ultrafiltration membrane integrity during monitoring is produced realizes that the on-line monitoring of induced by endotoxin is significant.
The laser particle detector not yet is applied to endotoxic detection at present, we analyze the higher Ma Erwen Nano ZSZEW3600 type laser diffraction analyzer of sensitivity, it can detect particle in the solution of endotoxin concns more than 10EU/ml, and this can't satisfy endotoxic detectable concentration in the injection.The laser particle detector is different at the astigmatic signal of different angles according to particle, the astigmatism of the multiple spot more than 2 o'clock signal is carried out granularmetric analysis, but can't detect particle concentration, therefore can't be used for endotoxic quantitative detection.
The utility model content
The defective that the utility model exists for prior art, and the endotoxin detection system that a kind of detection sensitivity is high, can realize online detection is proposed.
This endotoxin detection system comprises lasing light emitter, short focus lens, grating, long focus lens, detection cell, the scattered light receiver, photoelectric commutator, signal amplifier, signal processor, data acquisition unit, quantitative arithmetical unit, data display equipment and prior-warning device, wherein: the output light of lasing light emitter is successively by short focus lens, enter detection cell behind grating and the long focus lens, the light that appears of detection cell receives the laggard photoelectric commutator that enters by the scattered light receiver, the output signal of photoelectric commutator is passed through signal amplifier successively, enter quantitative arithmetical unit behind signal processor and the data acquisition unit and carry out endotoxin concns calculating, quantitatively output connection data display and the prior-warning device of arithmetical unit.
Described lasing light emitter adopts the double light beam laser source; Described detection cell is made by optical glass, and detection cell comprises online detection cell and offline inspection pond; Described online detection cell is provided with liquid outlet and inlet, online detection cell is connected in the injection production line pipeline by this liquid outlet and inlet, be equipped with electromagnetic valve at liquid outlet and inlet, also be provided with the ultrasonic probe that disturbs for getting rid of bubble at the inlet place; Described offline inspection pond is the detachable detection cell of semitight, and this detection cell top is provided with filling opening; Described scattered light receiver adopts the multiple spot wide angle scattered light receiver more than 3.
Technique effect:
1, detect and not consume reagent, to liquid without any pollution, economic environmental protection.
2, light path system has been carried out integrated, improved detection sensitivity, can detect the above endotoxin solution of 0.5EU/ml.
3, combine quantitative operational method to the multiple spot more than 3 o'clock astigmatism signal, realized endotoxic quantitative detection.
4, detecting pattern is divided into two kinds of online detection and offline inspection, and applying flexible, practicality is good, detection time is short, can satisfy the on-line monitoring requirement of water for injection, injection and integrity of ultrafiltration membrane.
5, set up early warning system, triggered early warning in the time of can exceeding standard at the endotoxin concns of solution, realized on-line monitoring, reliability is high.
Description of drawings
Fig. 1 is composition structural representation of the present utility model, number in the figure title: 1, lasing light emitter; 2, lack focus lens; 3, grating; 4, long focus lens; 5, detection cell; 6, scattered light receiver; 7, photoelectric commutator; 8, signal amplifier; 9, signal processor; 10, data acquisition unit; 11, quantitative arithmetical unit; 12, data display equipment; 13, prior-warning device.
Fig. 2 is quantitative measurement of endotoxin Computing Principle synoptic diagram.
Fig. 3 is detection early warning process flow diagram of the present utility model.
Embodiment
The structure of the utility model endotoxin detection system as shown in Figure 1, comprise lasing light emitter 1, short focus lens 2, grating 3, long focus lens 4, detection cell 5, scattered light receiver 6, photoelectric commutator 7, signal amplifier 8, signal processor 9, data acquisition unit 10, quantitative arithmetical unit 11, data display equipment 12 and prior-warning device 13, wherein: the output light of lasing light emitter 1 is successively by short focus lens 2, enter detection cell 5 behind grating 3 and the long focus lens 4, the light that appears of detection cell 5 receives the laggard photoelectric commutator 7 that enters by scattered light receiver 6, the output signal of photoelectric commutator 7 is successively by signal amplifier 8, enter quantitative arithmetical unit 11 behind signal processor 9 and the data acquisition unit 10 and carry out endotoxin concns calculating, quantitatively output connection data display 12 and the prior-warning device 13 of arithmetical unit 11.
The utility model carries out integrated on the basis of conventional laser particle diameter detector to light path system, the scattering light path that is preferably about 90 ° detects.Lasing light emitter 1 is the double light beam laser source, adopts the FLS-2600B lasing light emitter of Canadian EXFO company; Short focus lens 2 adopts the Extra-low Dispersion lens; Grating 3 adopts coupling fiber type fiber grating; Long focus lens 4 adopts low consumption NV-202m lens.Detection cell 5 is made by optical glass, comprise two kinds in online detection cell and offline inspection pond: the up and down two ends of online detection cell are provided with liquid outlet and inlet, online detection cell is connected in the injection production line pipeline by liquid outlet and inlet and forms the loop, to realize the continuous detecting of liquid, be equipped with electromagnetic valve at liquid outlet and inlet, also be provided with ultrasonic probe at the inlet place, be used for getting rid of bubble and disturb; The offline inspection pond is the detachable detection cell of semitight, and this detection cell top is provided with filling opening, is used for manually changing solution.Scattered light receiver 6 adopts the Picometrix LLC high speed multiple spot wide angle scattered light receiver module of API company, is multi-point and arranges every logarithm; Photoelectric commutator 7 adopts U.S.'s perseverance to open the HESMC photoelectric commutator of Electronics Co., Ltd.; Signal amplifier 8 is comprised of amplifying circuit and filtering circuit, and wherein amplifying circuit is connected into the differential amplifier circuit form by three ICL7650 amplifiers, and wave filter is RC network commonly used; Signal processor 9 adopts the CONVERTER-VLC.602 programmable signal processor of Italian VAL.CO; The A/D converter Max132 of the U.S. letter of data acquisition unit 10 employings company.Quantitatively arithmetical unit 11 is by our unit's independent research, quantitatively the Computing Principle of arithmetical unit as shown in Figure 2, according to light scattering formula I=KbCf (D) f (E) f (Δ λ), in the formula: I is scattered light signal intensity, K is proportionality constant, b is sample path length to be measured, C is endotoxin concns (unit: EU/ml), f (D) is the particle diameter parametric function, and f (E) is the scattering spectrum function, and f (Δ λ) is function of wavelength, sample path length to be measured (colorimetric pool) is fixing, wavelength is fixed, so b and f (Δ λ) are constant, the light scattering formula can be reduced to I=KCf (D) f (E).Endotoxin standard solution detection with variable concentrations can draw the constant K value, the scattered light signal intensity of system's endotoxin particle in three above different angles detection solution, according to I=KCf (D) f (E), calculate f (D) and f (E) by the scattered light signal of any two angles wherein, be S=fC+g with the light scattering simplified formula, in the formula: S is astigmatism, S is processed by the ln linearization data of I to obtain, related coefficient f=Kf (D) f (E), g is corrected parameter, scattered light signal with all the other angles calculates endotoxin content in the solution again, realizes quantitatively detecting.Data display equipment 12 adopts 128 * 64 dot matrix display terminals of the golden company of initiating, and is used for showing detected endotoxin concns value; Prior-warning device 13 adopts integrated achievement electronics CMS7000-500 alarm monitoring software and piezoelectric type early warning system, the detection early warning flow process of system as shown in Figure 3, can preset the endotoxin concns limit value in early warning software, attention device is reported to the police when endotoxin concns surpasses limit value in the liquid that detects.
Use flow process when the utility model detects online is: according to need of production, quantitatively preseting endotoxin concns limit value and coefficient f and parameter g in the arithmetical unit, open production line, make solution enter online detection cell, calculate endotoxin concns according to S=fC+g, when this concentration during less than limit value system keep operation, early warning system is reported to the police when this concentration is higher than limit value.
Operation steps during the utility model offline inspection is: quantitatively preseting coefficient f and parameter g in the arithmetical unit, take out the offline inspection pond, clean up with pure water, with solution to be measured swing wash 2 ~ 3 times after, add solution to be measured, detection cell is placed native system, calculate endotoxin concns according to S=fC+g.
The below provides the quantitative detection example of endotoxin off-line of red sage roo drip liquid:
Change the offline inspection pond, get the working stamndard endotoxin, use and check that water is mixed with the standard solution of concentration 100EU/ml, re-use and check that water progressively dilutes the standard solution for series concentration, the series concentration that is mixed with is respectively 0.5,1,5,10,50EU/ml, places detection cell to detect solution, carries out data regression by quantitative arithmetical unit and calculates, linear equation is: S=0.056C+0.165, R
2=0.997, result of calculation sees Table 1.
Table 1
(Shanghai Worldbest ﹠ Anhui Jinhui Pharmaceutical Co., Ltd. provides, lot number: 05110209), adopt respectively native system detection method and tachypleus amebocyte lysate nephelometry to calculate endotoxin content, the results are shown in Table 2 to get the red sage roo drip liquid intermediate.
Table 2
The result shows that the endotoxin content that native system records and tachypleus amebocyte lysate nephelometry are comparatively approaching.The tachypleus amebocyte lysate nephelometry is for Chinese Pharmacopoeia records method at present, and measurement result is comparatively accurate, and the result that native system records is close with it, and this has also illustrated the reliability of native system.
The below provides the endotoxin of red sage roo drip liquid online quantitatively detection example:
Get two parts of red sage roo drip liquids, a (Shanghai Worldbest ﹠ Anhui Jinhui Pharmaceutical Co., Ltd. provides, lot number: 10011605), another part carries out respectively on-line monitoring for the liquid after polluting to two parts of liquids for normal liquid.Detected parameters is set: f is that 0.056, g is 0.165, and the endotoxin limit value is 1EU/mL, opens production line and detects, and calculates endotoxin concns by regression equation S=0.056C+0.165, the results are shown in Table 3.
Table 3
The result shows that when contaminated with endotoxins surpassed limit value, native system can be reported to the police, and can satisfy the quantitative monitoring of the contaminated with endotoxins situation in the injection production.
Claims (6)
1. endotoxin detection system, it is characterized in that: comprise lasing light emitter (1), short focus lens (2), grating (3), long focus lens (4), detection cell (5), scattered light receiver (6), photoelectric commutator (7), signal amplifier (8), signal processor (9), data acquisition unit (10), quantitative arithmetical unit (11), data display equipment (12) and prior-warning device (13), wherein: the output light of lasing light emitter (1) is successively by short focus lens (2), enter detection cell (5) behind grating (3) and the long focus lens (4), the light that appears of detection cell (5) receives the laggard photoelectric commutator (7) that enters by scattered light receiver (6), the output signal of photoelectric commutator (7) is successively by signal amplifier (8), enter quantitative arithmetical unit (11) behind signal processor (9) and the data acquisition unit (10) and carry out endotoxin concns calculating, quantitatively output connection data display (12) and the prior-warning device (13) of arithmetical unit (11).
2. endotoxin detection system according to claim 1 is characterized in that: described lasing light emitter (1) employing double light beam laser source.
3. endotoxin detection system according to claim 1, it is characterized in that: described detection cell (5) is made by optical glass, and detection cell (5) comprises online detection cell and offline inspection pond.
4. endotoxin detection system according to claim 1 is characterized in that: the multiple spot wide angle scattered light receiver of described scattered light receiver (6) employing more than 3.
5. endotoxin detection system according to claim 3, it is characterized in that: described online detection cell is provided with liquid outlet and inlet, online detection cell is connected in the injection production line pipeline by this liquid outlet and inlet, be equipped with electromagnetic valve on described liquid outlet and the inlet, also be provided with the ultrasonic probe that disturbs for getting rid of bubble at the inlet place.
6. endotoxin detection system according to claim 3, it is characterized in that: described offline inspection pond is the detachable detection cell of semitight, and this detection cell top is provided with filling opening.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201220282951 CN202649117U (en) | 2012-06-14 | 2012-06-14 | Endotoxin detection system |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 201220282951 CN202649117U (en) | 2012-06-14 | 2012-06-14 | Endotoxin detection system |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013185621A1 (en) * | 2012-06-14 | 2013-12-19 | 南京拓鉒医药科技有限公司 | Endotoxin detection systems and detection methods thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013185621A1 (en) * | 2012-06-14 | 2013-12-19 | 南京拓鉒医药科技有限公司 | Endotoxin detection systems and detection methods thereof |
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