JPH023170Y2 - - Google Patents

Description

[Detailed Description of the Invention] [Technical Field] The present invention relates to an endotoxin detection and measurement tool.

[Prior Art] Endotoxin is said to be a lipopolysaccharide present in the cell walls of Gram-negative bacteria, and has a wide variety of physiological activities including pyrogenicity in extremely small amounts.

In recent years, in the fields of medicine, pharmaceutical preparations, and hygiene, heat generation in living organisms due to the use of contaminated medical instruments and preparations has become a problem, and its detection and measurement are frequently performed not only in final products but also in the manufacturing process.

Horseshoe crab blood cell extract (ameibocyte lysate) is used as a method for detecting endotoxin.
Alternatively, there is a limulus test that uses an enzyme precursor isolated from this lysate and a coloring agent. This method is an excellent method that allows endotoxin to be detected extremely quickly compared to the conventional rabbit pyrogenicity test, and various endotoxin detection and measurement tools based on this method are commercially available.

However, in the detection and measurement of endotoxin in aqueous solutions using conventional detection and measurement tools, it is necessary to use endotoxin-free pipettes and syringes to collect the sample liquid, but it takes a lot of time and effort to prepare these samplers. It takes. Furthermore, since there is a risk of contamination with endotoxin during the operation, it is very complicated and requires careful attention to the measurement environment.

The inventors of the present invention conducted extensive research into devices that would simplify these points, and came up with the idea of using the reaction container holding the endotoxin detection reagent as a sample liquid collector, and further considered the shape of the container, etc. As a result, they discovered that a transparent container with a tubular shape with both ends sealed and with both ends open for detection and measurement was advantageous, and the applicant filed an application. (Jitsugan 1984
(No. 49492, No. 58-100449, etc.) The detection and measurement tools shown in these documents are simple and excellent in practical use. It is time-consuming to seal the container with melt-sealing or a sealing plug to prevent it from coming off, and there is also a risk of contamination with endotoxin during the sealing process.

[Purpose of the invention] Given the current situation, the inventors of the present invention have devised an industrially simple and inexpensive way to eliminate endotoxin by wrapping the tube with a membrane-like material, such as a film, without having to seal both ends of the tube with individual melt seals or airtight plugs. The inventors discovered that the pipe can be sealed without worrying about contamination caused by contamination, etc., and completed the present invention.

[Structure of the invention] That is, the gist of the invention resides in an endotoxin detection and measurement tool in which a transparent capillary containing an endotoxin detection reagent is hermetically encapsulated with a membrane-like material.

The transparent capillary used in the present invention is made of, for example, glass, polymethyl methacrylate, polystyrene, etc., has transparency to the extent that the state of the reaction liquid present inside the tube can be observed, and has an inner diameter of 0.1 to 5 mm. are conveniently used.

Any reagent used for detecting endotoxin in an aqueous solution can be used as the endotoxin detection reagent, such as horseshoe crab ameibocyte lysate, coagulation enzyme precursor isolated from horseshoe crab ameibocyte lysate, etc. and a color former. In addition, from the viewpoint of storage stability, these are preferably freeze-dried products, and a stabilizer for the reagent may be added.

As the membrane-like material, any material can be used as long as it is substantially impermeable to moisture and can be sealed around the periphery, such as aluminum film laminated with polymer, polyvinyl chloride film, polyolefin film, etc. , ethylene vinyl chloride copolymer film, etc. can be used. It is preferable that the film-like product has a notch near the center so that it can be easily opened during use.

A more detailed explanation will be given below with reference to the drawings.

FIG. 1 is a cross-sectional view of one example of the endotoxin detection and measurement tool of the present invention, and FIG. 2 is a cross-sectional view taken along A--A in FIG.
It is a sectional view at A′.

Reference numeral 1 is a thin tube that can be used as a reaction container and a sample fluid collector. Although the inner diameter of the tube is uniform in the drawings, the inner diameter of the tube at both ends or at one end may be different from the inner diameter of the intermediate portion. Further, the thin tube may be a U-shaped tube other than a straight tube. Further, a scale may be provided near the end to indicate the amount of sample liquid to be introduced. 2 is an endotoxin detection reagent. In the drawing, it is located at the center of the tube, but it may be located at one end. 3 is a membrane-like substance, and in the drawing, a thin tube is sandwiched between two flat membranes and the four circumferences are sealed.
A flat membrane may be folded in two and sealed on three sides, or a thin tube may be placed inside a cylindrical membrane and both ends of the membrane sealed. Further, in the drawing, only one thin tube is housed in one membrane-like material, but a large number of thin tubes may be housed therein. It is also possible to take measures such as reducing the pressure inside the membrane or adding a desiccant agent together with the thin tube. 4
5 is the sealing part of the membranous material, and may be heat-sealed or sealed using adhesive. 5 is a cut to make it easier to take out the thin tube from the membranous material, and it is a triangular cut in the part where the membranous material is sealed. , or a break. When a cylindrical membrane is used as the membrane, the part where the cut is to be made may be heat-sealed in advance to prevent the seal from being broken from the cut.

The endotoxin detection measurement tool of this invention has an inner diameter of
Prepare a 0.1 to 5 mm thin tube, insert one end of it into an aqueous solution of endotoxin detection reagent prepared separately, introduce the aqueous solution into the tube, take it out, and tilt the tube or suction from the other end to drain the aqueous solution inside the tube. The reagent is moved to the center and in that state is preferably lyophilized to evaporate the water so that the reagent is fixed to the inner wall of the capillary, and the reagent is hermetically encapsulated with a membranous material such as a film. Since the endotoxin detection reagent encapsulated in this way is firmly attached to the inner wall of the capillary, it will not fall off during transportation, storage, or handling.

In this type of measurement tool, a thin tube is removed from a membrane-like material, one end of the thin tube is immersed in the sample liquid, and the sample liquid is introduced into the tube by capillary action or by suctioning with an inhaler attached to the other end. Dissolve the endotoxin detection reagent in the solution. Since this detection reagent has excellent solubility in water, it is easily dissolved by simply touching the dry reagent with water. Furthermore, since the tube is thin, the sample liquid introduced in this manner will not flow out of the tube even if the tube is placed horizontally. Next, the tube into which the sample liquid has been introduced is kept at a predetermined temperature, for example by placing it in a warmer, to allow the reagent and sample liquid in the tube to react, and the tube is tilted to check the state of gelation or color development. The presence or absence of endotoxin in the sample fluid can be easily checked by Since the measurement tool of the present invention has the above-mentioned configuration, compared to conventional measurement tools, it does not require an endotoxin-free sample liquid sampler, and there is no need to transfer sample liquid using the sampler. This simplifies the process and also reduces the risk of contamination with endotoxin during operation. Furthermore, since it is a thin tube, only a small amount of sample liquid is required for measurement, and the amount of endotoxin detection reagent is also small compared to conventional methods. In addition, the time and effort required to manufacture and use detection and measurement tools are reduced, making them more suitable for industrialization.

The detection and measurement tool of the present invention has such features,
In practical terms, it is also superior to conventional detection and measurement tools.

[Brief explanation of the drawing]

FIG. 1 is a sectional view showing one embodiment of the present invention, and FIG. 2 is a sectional view taken along line A-A' in FIG. 1...tubule, 2...endotoxin detection reagent,
3... Membrane-like substance, 4... Membrane-like substance seal part, 5...
cut.

Claims (1)

[Claims for Utility Model Registration] 1. An endotoxin detection and measurement tool comprising a transparent capillary with an inner diameter of 0.1 to 5 mm, which contains an endotoxin detection reagent and is hermetically encapsulated with a membrane-like material. 2. The endotoxin detection and measurement tool according to claim 1, wherein the endotoxin detection reagent is horseshoe crab amebocyte lysate. 3. The endotoxin detection and measurement tool according to claim 1, wherein the endotoxin detection reagent is a reagent comprising an enzyme precursor separated from horseshoe crab amebocyte lysate and a coloring agent. 4. The endotoxin detection and measurement tool according to claim 1, 2, or 3 of the utility model registration claim, wherein the endotoxin detection reagent is a lyophilized product. 5. The endotoxin detection and measurement tool according to any one of claims 1 to 4 of the utility model registration claim, characterized in that the membrane-like material has a notch in its center.