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CN2434678Y - Bacterial endotoxin analyzer - Google Patents
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CN2434678Y - Bacterial endotoxin analyzer - Google Patents

Bacterial endotoxin analyzer Download PDF

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CN2434678Y
CN2434678Y CN 00238539 CN00238539U CN2434678Y CN 2434678 Y CN2434678 Y CN 2434678Y CN 00238539 CN00238539 CN 00238539 CN 00238539 U CN00238539 U CN 00238539U CN 2434678 Y CN2434678 Y CN 2434678Y
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bacterial endotoxin
blue light
reactor
endotoxin
control device
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何永胜
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TIANJIN YIRUI BIOLOGICAL ENGINEERING Co Ltd
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Beijing Gold Mountainriver Tech Development Co Ltd
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Abstract

一种细菌内毒素测定仪,是由外壳、设置在底板上的单片机、集成电路、温控装置和电控装置及其相关电路;设置在底板上的反应器、装在反应器上的光电检测器、加热器及恒温块构成的,每套光电检测器内装有蓝色发光二极管和硅蓝光电池,蓝色发光二极管的前端设置有准直孔;可同时实现动态比浊法、动态比色法和凝胶限量法三法合一定量测定细菌内毒素,可适用于对药品、食品及人体的各种体液中细菌内毒素定量测定。

A bacterial endotoxin tester is composed of a shell, a single-chip microcomputer arranged on a bottom plate, an integrated circuit, a temperature control device, an electric control device and related circuits; a reactor arranged on the bottom plate, and a photoelectric detection device installed on the reactor Each set of photodetectors is equipped with a blue light-emitting diode and a silicon blue light battery, and the front end of the blue light-emitting diode is provided with a collimation hole; it can realize dynamic turbidimetry and dynamic colorimetry at the same time The method combined with the gel limit method for the quantitative determination of bacterial endotoxin can be applied to the quantitative determination of bacterial endotoxin in medicines, food and various body fluids of the human body.

Description

细菌内毒素测定仪Bacterial endotoxin analyzer

本实用新型涉及一种通过鲎试剂与微量细菌内毒素产生凝集反应实现对药品、医疗器具、水、食品饮料、临床检验及人体的各种体液中细菌内毒素定量测定的细菌内毒素测定仪。The utility model relates to a bacterial endotoxin measuring instrument for quantitative determination of bacterial endotoxin in various body fluids of medicines, medical appliances, water, food and beverage, clinical examination and human body through agglutination reaction between Limulus reagent and trace bacterial endotoxin.

内毒素是革兰氏阴性细菌细胞壁结构中的类脂多糖体,此种脂多糖经细菌胞壁合成后被转运到细胞表面构成胞壁外膜的组成成分,在细菌死亡溶溃后从细胞结构中释放出来。内毒素一方面对宿主具有多种毒害作用,另一方面它又可发挥诸多对机体有益的生物学活性,细菌内毒素定量测定对于医药生产、临床检验和食品检验等具有重要的指导意义。Endotoxin is a lipopolysaccharide in the cell wall structure of Gram-negative bacteria. This lipopolysaccharide is synthesized by the bacterial cell wall and then transported to the cell surface to form a component of the outer membrane of the cell wall. After the bacteria dies and dissolves, it is released from the cell structure released in. On the one hand, endotoxin has multiple toxic effects on the host, and on the other hand, it can exert many beneficial biological activities on the body. The quantitative determination of bacterial endotoxin has important guiding significance for pharmaceutical production, clinical testing and food testing.

细菌内毒素定量测定可分为凝胶法、比浊法、比色法、ELISA(酶联免疫测定)法,目前,动态比浊法和动态比色法被广泛地采用,并为许多国家药典所收肇;经常使用的细菌内毒素测定仪,其测定原理是根据内毒素与鲎试剂反应液的浊度变化(透过光量比)值所需时间的一阶对数值与细菌内毒素浓度的对数值成反比例关系而定量的。The quantitative determination of bacterial endotoxin can be divided into gel method, turbidimetric method, colorimetric method and ELISA (enzyme-linked immunoassay) method. Received: The commonly used bacterial endotoxin analyzer, its determination principle is based on the first logarithmic value of the time required for the turbidity change (transmitted light ratio) value of the reaction solution of endotoxin and Limulus reagent and the relationship between the concentration of bacterial endotoxin The logarithmic values are inversely proportional and quantitative.

一般的细菌内毒素测定仪是由电控部分、温控部分、反应器部分、光电检测部分等构成的,通常一台测定仪只能用一种动态比浊法进行内毒素的定量测定,当采用动态比色法测定时,必须用另一台测定仪进行,而且光电检测部分必须采用中心在405nm波长,且范围很窄的光线,而要得到如此窄范围和如此波长的光线,国内外现有测定仪只能采用滤光片或光栅获得,此结构不但成本高,而且很难获得任意多路405nm波长的光线;近年来普遍采用白炽灯或波长大于700nm的红色发光二极管和深结普通光电池实现动态比色法进行内毒素的定量测定,这种结构不能实现在同一台测定仪上同时进行动态比浊法、动态比色法和凝胶限量法三种方法的定量测定,不能实现快速细菌内毒素定量测定,检测周期长,而且由于光路的孔径较大,其直径与长度之比大于1,光路轴线与试管孔的底面距离较大,一般大于5mm,影响光路检查范围。A general bacterial endotoxin tester is composed of an electric control part, a temperature control part, a reactor part, a photoelectric detection part, etc. Usually, a tester can only use a dynamic turbidimetric method for quantitative determination of endotoxin. When the dynamic colorimetric method is used for measurement, another measuring instrument must be used, and the photoelectric detection part must use light with a wavelength centered at 405nm and a very narrow range. To obtain light with such a narrow range and such a wavelength, existing domestic and foreign Some measuring instruments can only be obtained by using optical filters or gratings. This structure is not only costly, but also difficult to obtain any number of light rays with a wavelength of 405nm; Realize the quantitative determination of endotoxin by dynamic colorimetry. This structure cannot realize the quantitative determination of dynamic turbidimetry, dynamic colorimetry and gel limit method on the same measuring instrument at the same time, and cannot realize rapid bacterial Quantitative determination of endotoxin requires a long detection period, and due to the large aperture of the optical path, the ratio of diameter to length is greater than 1, and the distance between the axis of the optical path and the bottom surface of the test tube hole is relatively large, generally greater than 5mm, which affects the inspection range of the optical path.

本实用新型的目的在于提供一种检测周期短,检查范围宽,可实现快速动态比浊法定量测定、可获得多路光线检查范围、可同时实现动态比浊法、动态比色法和凝胶限量法三法合一定量测定细菌内毒素的细菌内毒素测定仪。The purpose of the utility model is to provide a short detection period, a wide inspection range, which can realize fast dynamic turbidimetry quantitative determination, can obtain multi-channel light inspection range, and can simultaneously realize dynamic turbidimetry, dynamic colorimetry and gel Bacterial endotoxin analyzer for the quantitative determination of bacterial endotoxin by three methods of limited method.

本实用新型的目的是这样实现的:The purpose of this utility model is achieved in that:

一种细菌内毒素测定仪,是由外壳、设置在底板上的单片机、集成电路、温控装置和电控装置及其相关电路;设置在底板上的反应器、装在反应器上的光电检测器、加热器及恒温块构成的,每套光电检测器内装有蓝色发光二极管。蓝色发光二极管的前端设置有准直孔。准直孔的直径与长度之比小于1。A bacterial endotoxin tester is composed of a shell, a single-chip microcomputer arranged on a bottom plate, an integrated circuit, a temperature control device, an electric control device and related circuits; a reactor arranged on the bottom plate, a photoelectric detection device installed on the reactor It is composed of detector, heater and constant temperature block, and each set of photodetectors is equipped with blue light-emitting diodes. The front end of the blue light-emitting diode is provided with a collimation hole. The diameter-to-length ratio of the collimating holes is less than one.

本实用新型改进了现有内毒素测定仪光电检测部分的结构,设置有准直孔并装有蓝色发光二极管和硅蓝光电池,能够获得任意多路波长的光线,扩大光线检查范围,可同时实现动态比浊法、动态比色法和凝胶限量法三法合一定量测定细菌内毒素,本实用新型操作简便,检测周期短,检查快速准确,30~40分钟便可完成,检查范围宽,从0.001~1000EU/ml,应用范围广泛,定量检测可监测到医药生产过程中的内毒素含量变化趋势,便于厂家及时采取措施,避免出现不合格产品而造成经济损失,同时,定量测定对许多疾病的诊断及治疗效果的判断具有重要意义,特别适合于对人体多种体液中的内毒素水平进行定量测定。The utility model improves the structure of the photoelectric detection part of the existing endotoxin measuring instrument, is provided with a collimation hole and is equipped with a blue light-emitting diode and a silicon blue light battery, can obtain light of any multiple wavelengths, expand the light inspection range, and can simultaneously Realize dynamic turbidimetric method, dynamic colorimetric method and gel limit method combined quantitative determination of bacterial endotoxin, the utility model is easy to operate, short detection cycle, fast and accurate inspection, can be completed in 30-40 minutes, wide inspection range , from 0.001 to 1000EU/ml, with a wide range of applications. Quantitative detection can monitor the change trend of endotoxin content in the process of pharmaceutical production, which is convenient for manufacturers to take timely measures to avoid economic losses caused by unqualified products. At the same time, quantitative detection is important for many It is of great significance for the diagnosis of diseases and the judgment of treatment effects, especially suitable for the quantitative determination of endotoxin levels in various body fluids of the human body.

附图说明Description of drawings

图1为本实用新型结构示意图;Fig. 1 is the structural representation of the utility model;

图2为图1中A-A剖视图;Fig. 2 is A-A sectional view among Fig. 1;

图3为图2中B向剖视图;Fig. 3 is a sectional view of B direction in Fig. 2;

图4为图2中C向剖视图;Fig. 4 is a sectional view along direction C in Fig. 2;

图5为本实用新型的光源线路板结构局部示意图;Fig. 5 is a partial schematic diagram of the circuit board structure of the light source of the present invention;

图6为本实用新型的光电信号接收板结构局部示意图。Fig. 6 is a partial schematic diagram of the structure of the photoelectric signal receiving board of the present invention.

下面结合附图及较佳实施例对本实用新型作进一步说明:Below in conjunction with accompanying drawing and preferred embodiment the utility model is further described:

参阅图1所示,细菌内毒素测定仪从外观看主要是由外壳1、反应器2、面板4、指示灯5、测试灯6、试管孔7等构成的,其反应器2上设置有若干个试管孔7,每个试管孔7对应一个测试灯6,试管孔7内可插入标准试管3,面板4上设置有电源指示灯和温控指示灯5,外壳1与底板联结。Referring to Figure 1, the bacterial endotoxin analyzer is mainly composed of a shell 1, a reactor 2, a panel 4, an indicator light 5, a test lamp 6, a test tube hole 7, etc. from the outside, and the reactor 2 is provided with several A test tube hole 7, each test tube hole 7 corresponds to a test lamp 6, can insert a standard test tube 3 in the test tube hole 7, the panel 4 is provided with a power supply indicator light and a temperature control indicator light 5, and the shell 1 is connected with the base plate.

参阅图2所示,图中将外壳1取下,细菌内毒素测定仪从内部结构看主要是由光电信号接收板8、光电检测器9、加热器及恒温块10、光源线路板12及底板11构成的,其单片机、集成电路、温控装置和电控装置及其相关电路等(图中均未画出)为现有技术,设置在底板11上,反应器2上装有若干套光电检测器9,反应器2上还装有构成恒温功能的加热器及恒温块10和温度传感器,通过螺钉联结为一体并固联在底板11上。Referring to Fig. 2, the shell 1 is removed in the figure, the bacterial endotoxin tester is mainly composed of a photoelectric signal receiving board 8, a photodetector 9, a heater and a constant temperature block 10, a light source circuit board 12 and a base plate from the internal structure 11, and its single-chip microcomputer, integrated circuit, temperature control device, electric control device and related circuits (not shown in the figure) are prior art, and are arranged on the bottom plate 11, and several sets of photoelectric detection devices are installed on the reactor 2. The reactor 9 and the reactor 2 are also equipped with a heater, a thermostatic block 10 and a temperature sensor constituting a constant temperature function, which are connected as a whole by screws and fixedly connected on the bottom plate 11.

同时参阅图3、图4所示,每一套光电检测器9的光路内孔装有一个350-550nm波长的蓝色发光二极管14和与之对应的一个浅结的硅蓝光电池16,硅蓝光电池16的P-N结结深小于100μm,光电检测器9内还装有微动开关13,微动开关13的支脚及蓝色发光二极管14的支脚与光电检测器9一侧的光源线路板12焊接,蓝色发光二极管14的前端是光路的准直孔15,准直孔15的直径与长度之比小于1,准直孔15与试管孔7相通,光路内孔轴线与试管孔7的底面距离小于5mm,光电检测器9上端设置有指示灯孔,孔内装有绿色发光二极管17,其管脚及硅蓝光电池16正负极与光电检测器9另一侧的光电信号接收板8焊接。Referring to Fig. 3 and shown in Fig. 4 at the same time, the optical path inner hole of each cover photodetector 9 is equipped with a blue light-emitting diode 14 of 350-550nm wavelength and a corresponding shallow junction silicon blue light cell 16, silicon blue light The P-N junction depth of the battery 16 is less than 100 μm, the photodetector 9 is also equipped with a microswitch 13, the legs of the microswitch 13 and the legs of the blue light-emitting diode 14 are welded to the light source circuit board 12 on one side of the photodetector 9 , the front end of the blue LED 14 is the collimating hole 15 of the optical path, the ratio of the diameter of the collimating hole 15 to the length is less than 1, the collimating hole 15 communicates with the test tube hole 7, and the distance between the axis of the inner hole of the optical path and the bottom surface of the test tube hole 7 Less than 5mm, the upper end of the photodetector 9 is provided with an indicator hole, and a green light-emitting diode 17 is housed in the hole, and its pins and the positive and negative poles of the silicon blue light battery 16 are welded to the photoelectric signal receiving plate 8 on the other side of the photodetector 9 .

参阅图5所示,光源线路板12联结在光电检测器9一侧,光源线路板12上依次排列有若干个,如八个蓝色发光二极管14及四个电阻19、八组可插入微动开关13的支脚,光源线路板12两端设置有连线排位18,通过扁平连线与电控部分、温控部分及相关电路、单片机、集成电路等连接。Referring to Fig. 5, the light source circuit board 12 is connected to one side of the photodetector 9, and several light source circuit boards 12 are arranged in sequence, such as eight blue light-emitting diodes 14 and four resistors 19, eight groups of which can be inserted into micro-movement The legs of the switch 13 and the two ends of the light source circuit board 12 are provided with connection positions 18, which are connected with the electric control part, the temperature control part and related circuits, single-chip microcomputers, integrated circuits, etc. through flat connections.

参阅图6所示,光电信号接收板8联结在光电检测器9另一侧,光电信号接收板8上依次排列有若干个,如八个硅蓝光电池16及八个电阻19,光电信号接收板8两端设置有连线排位18,通过扁平连线与电控部分、温控部分及相关电路、单片机、集成电路等连接。Referring to shown in Figure 6, the photoelectric signal receiving board 8 is connected to the other side of the photodetector 9, and several photoelectric signal receiving boards are arranged successively on the photoelectric signal receiving board 8, such as eight silicon blue light cells 16 and eight resistors 19, the photoelectric signal receiving board The two ends of the 8 are provided with connection positions 18, which are connected with the electric control part, the temperature control part and related circuits, single-chip microcomputers, integrated circuits, etc. through flat connections.

本实用新型的外观造型、反应器型状、试管孔位个数及排列形式可根据需要随意设计,不受本实用新型实施例的限制,本实用新型旨在保护光电检测部分的改进结构。The appearance of the utility model, the shape of the reactor, the number of test tube holes and the arrangement can be freely designed according to the needs, and are not limited by the embodiment of the utility model. The utility model aims to protect the improved structure of the photoelectric detection part.

本实用新型的工作原理:细菌内毒素测定仪的测定原理是根据内毒素与鲎试剂反应液的浊度变化(透过光量比)值所需时间的一阶对数值与细菌内毒素浓度的对数值成反比例关系而定量的。本实用新型通过单片机进行数据采集、温度控制及上位计算机的通讯,上位计算机对数据进行计算处理,具体工作过程如下:Working principle of the utility model: the measuring principle of the bacterial endotoxin measuring instrument is based on the first-order logarithmic value of the time required for the turbidity change (ratio of transmitted light) of the reaction solution of endotoxin and Limulus reagent and the correlation of the bacterial endotoxin concentration. The values are quantified in an inverse proportional relationship. The utility model carries out data acquisition, temperature control and communication of the host computer through the single chip microcomputer, and the host computer calculates and processes the data, and the specific working process is as follows:

1、用串口线连接好细菌内毒素测定仪和计算机,打开测定仪的电源开关5,打开计算机电源开关;1. Connect the bacterial endotoxin tester and the computer with a serial cable, turn on the power switch 5 of the tester, and turn on the power switch of the computer;

2、计算机进入WIN95/WIN98系统,运行细菌内毒素测定软件;2. The computer enters the WIN95/WIN98 system and runs the bacterial endotoxin determination software;

3、按软件程序里的采集按钮,进入采集状态;3. Press the acquisition button in the software program to enter the acquisition state;

4、测定仪的电源开关打开30分钟后,加热器及恒温块10和温度传感器形成的闭路控制电路在单片机的操纵下,将测定仪的恒温块准确控制在37度正负1度的范围内;4. Thirty minutes after the power switch of the tester is turned on, the closed-circuit control circuit formed by the heater, the constant temperature block 10 and the temperature sensor will accurately control the constant temperature block of the tester within the range of 37 degrees plus or minus 1 degree under the control of the single-chip microcomputer ;

5、将混合鲎试剂的样品试管3插入试管孔7中,此时微动开关13发出信号,单片机对插入试管的孔分别依次进行计时和采集数据;5. Insert the sample test tube 3 of the mixed LAL reagent into the test tube hole 7. At this moment, the microswitch 13 sends a signal, and the single-chip microcomputer performs timing and data collection successively to the holes inserted into the test tube;

6、蓝色发光二极管14发出一束光线,穿过试管中的混合液,打在光电池16上,光信号转成电信号,通过单片机转成数字信号发送给上位计算机;6. The blue light-emitting diode 14 emits a beam of light, which passes through the mixed solution in the test tube and hits the photocell 16. The light signal is converted into an electrical signal, which is converted into a digital signal by a single-chip microcomputer and sent to the upper computer;

7、测定仪中的单片机向上位计算机发出握手信号,每间隔10秒钟,就将所采集的数据传送到上位计算机;7. The single-chip microcomputer in the measuring instrument sends a handshake signal to the host computer, and transmits the collected data to the host computer every 10 seconds;

8、上位计算机将收到的数据进行计算,绘出各试管孔的S曲线;8. The upper computer calculates the received data and draws the S-curve of each test tube hole;

9、计算机对反应时间到达60分钟的试管孔7进行报警,可将试管3拔出垂直翻转180度进行凝胶观察,并和定量结果进行对照;所有试管3到达60分钟后,计算机和测定仪自动结束采集,可通过计算机将计算出的定量结果输出;9. The computer gives an alarm to the test tube hole 7 whose reaction time reaches 60 minutes, and the test tube 3 can be pulled out and turned vertically 180 degrees for gel observation, and compared with the quantitative result; after all the test tubes 3 reach 60 minutes, the computer and measuring instrument The collection is automatically terminated, and the calculated quantitative results can be output through the computer;

10、关机结束。10. The shutdown is over.

Claims (3)

1、一种细菌内毒素测定仪,是由外壳(1)、设置在底板(11)上的单片机、集成电路、温控装置和电控装置及其相关电路;设置在底板(11)上的反应器(2)、装在反应器(2)上的光电检测器(9)、加热器及恒温块(10)构成的,其特征在于每套光电检测器(9)内装有蓝色发光二极管(14)。1. A bacterial endotoxin tester is composed of a shell (1), a single-chip microcomputer arranged on a base plate (11), an integrated circuit, a temperature control device, an electric control device and related circuits thereof; The reactor (2), the photoelectric detector (9) installed on the reactor (2), the heater and the constant temperature block (10) are composed, and it is characterized in that blue light-emitting diodes are housed in each set of photodetectors (9) (14). 2、根据权利要求1所述的细菌内毒素测定仪,其特征在于蓝色发光二极管(14)的前端设置有准直孔(15)。2. The bacterial endotoxin analyzer according to claim 1, characterized in that a collimation hole (15) is provided at the front end of the blue light-emitting diode (14). 3.根据权利要求1或2所述的细菌内毒素测定仪,其特征在于准直孔(15)的直径与长度之比小于1。3. The bacterial endotoxin analyzer according to claim 1 or 2, characterized in that the ratio of the diameter to the length of the collimation hole (15) is less than 1.
CN 00238539 2000-06-28 2000-06-28 Bacterial endotoxin analyzer Expired - Lifetime CN2434678Y (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102650593A (en) * 2012-04-24 2012-08-29 湖南迪斯生物技术有限公司 Endotoxin fungus detector
CN102112866B (en) * 2008-07-30 2014-07-16 兴和株式会社 Method and device for measuring physiologically active substances derived from living organisms
CN106226525A (en) * 2016-07-18 2016-12-14 丁卫东 A kind of limulus test endotoxin fungal detection instrument

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102112866B (en) * 2008-07-30 2014-07-16 兴和株式会社 Method and device for measuring physiologically active substances derived from living organisms
CN102650593A (en) * 2012-04-24 2012-08-29 湖南迪斯生物技术有限公司 Endotoxin fungus detector
CN106226525A (en) * 2016-07-18 2016-12-14 丁卫东 A kind of limulus test endotoxin fungal detection instrument

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