JPH0542830Y2 - - Google Patents

Description

[Detailed explanation of the idea]

<Industrial Application Field> The present invention relates to a reagent container containing a solid or powdered reagent inside. <Prior Art> Drugs that are difficult to store in a solution state, such as antibiotics and blood products, are commercially available as freeze-dried powders to maintain quality during storage. Among these drugs, freeze-dried serum is used to calibrate the reagents at the start of analysis and to check for abnormalities in the analyzer during the analysis of sample serum, and it must be dissolved before use. It is used as a liquid reagent by dissolving it in a liquid (referred to as control serum). Conventionally, control serum was prepared by pouring a lysate into a vial containing freeze-dried serum using a pipette or the like. <Problems to be solved by the invention> However, with the method of preparing control serum by introducing the lysate into a vial with a pipette, accurate preparation may not be possible depending on the equipment used, and the operation is cumbersome. That was a problem. This idea was created in view of the above problems.
It is an object of the present invention to provide a reagent container that allows accurate and easy preparation operations by introducing a solution. <Means for Solving the Problems> In order to solve the above problems, the present invention provides a method in which a rubber stopper is hermetically sealed at the mouth of a vial or test tube containing a solid or powdered drug; A reagent container is used in which the inside of the vial or test tube is reduced in pressure to one atmosphere by a predetermined amount of solution introduced in a closed manner. Note that closed introduction means introduction in such a way that the inside of the vial or test tube is maintained airtight, and there is virtually no gas introduced from the outside or leakage of internal gas to the outside. It means to be done. <Function> Since the reagent container of the present invention is constructed as described above, the rubber stopper 3 of the reagent container 1 is pierced with the puncture needle 7 of the solution bag 5 as shown in FIG. When the inside of the solution bag 5 is communicated with the solution solution bag 5, the solution solution in the bag 5 is introduced into the vial 2 until the atmospheric pressure inside the vial 2 and the pressure outside the vial 2 become equal. Therefore, if the pressure inside the vial 2 is reduced to exactly one atmosphere when a predetermined amount of solution determined by the reagent contained therein is introduced into the vial 2, then Even if the air pressure outside the vial 2 changes somewhat, a liquid reagent with a substantially constant concentration can be obtained. <Example> Next, an example of the present invention will be described based on the drawings. FIG. 1 is a front cross-sectional view of a reagent container according to an embodiment of the present invention, and FIG. 2 is a diagram for explaining the operation of introducing a solution into the reagent container of FIG. 1. As shown in FIG. 1, the reagent container 1 of the present invention is composed of a vial 2 and a rubber stopper 3 that is plugged into the mouth of the vial 2 to airtightly seal the inside of the vial 2. The pressure is reduced to one atmosphere by a predetermined amount of solution introduced in a closed manner. The vial 2 is made of glass and contains freeze-dried serum 4 therein. Glass test tubes can also be used instead of vials. The rubber stopper 3 hermetically seals the inside of the vial 2, and is generally made of butyl rubber, silicone rubber, neoprene rubber, etc.
The material is not particularly limited as long as it can airtightly seal the inside of the vial 2 and has good chemical resistance. In addition, the reason why the pressure inside the vial 2 was set to 1 atm when a predetermined amount of solution was introduced was because the atmospheric pressure at the time of preparation of the preparation is usually 1 atm, except when the place is at a high altitude. This is because it is around atmospheric pressure, and is not necessarily limited to one atmospheric pressure. When using the reagent container of the present invention, for example, as shown in FIG.
An infusion tube 6 having a puncture needle 7 at its tip is connected to the flexible solution bag 5 containing the reagent container 1, and if necessary, using a holder 9 to facilitate the puncturing operation, What is necessary is to pierce the puncture needle 7 through the stopper 3. The lysis solution is introduced into the vial 2 through the infusion tube 6 and dissolves the serum 4 in the vial 2. Note that 8 is a rubber cover that protects the puncture needle 7 in a sterile manner, and 10 is a clamp. [Solution solution storage capacity of the reagent container] A 10 ml vial was filled with water and its weight was measured, and the amount of water when the reagent container was filled with water, that is, the solution solution storage capacity was determined from the weight of the vial and the weight of the rubber stopper. However, the results shown in Table 1 were obtained.

[Amount of solution introduced]

Freeze dryer (1st to 3rd) with reduced pressure to 487mmHg
We prepared a 10 ml vial with a rubber stopper in a container (using a bag), and conducted a test by introducing the dissolving solution (using water) from the dissolving solution bag into the vial, and the results shown in Table 2 were obtained. I got it. It can be seen from Table 2 that the amount of solution introduced (hereinafter referred to as solution introduction capacity) is 5 ml.

【table】

[Change in the ability to introduce the solution over time]

Prepare 4 lots (10 bottles per lot) of 10 ml vials with rubber stoppers in a freeze dryer (using the third batch) with a reduced pressure of 487 mmHg, and dry them for 0 months and 2 months.
When the ability to introduce the solution was measured after 1 month, 6 months, and 12 months, the results shown in Table 3 were obtained.
From Table 3, it can be seen that the ability to introduce a dissolved solution hardly decreases during storage.

【table】

[Table] The setting value was 5ml.
<Effects of the invention> By using the reagent container of the invention, reagents can be prepared accurately and easily. Furthermore, since the solution is introduced in a closed manner, there is no risk of contamination of the reagents, and since the rubber stopper is not removed, even if powdered medicine is contained, it will not be scattered.

[Brief explanation of the drawing]

FIG. 1 is a front cross-sectional view of a reagent container according to an embodiment of the present invention, and FIG. 2 is a diagram for explaining the operation of introducing a solution into the reagent container of FIG. 1. Explanation of symbols, 1... Reagent container, 2... Vial, 3... Rubber stopper, 4... Lyophilized serum, 5... Lysing solution bag, 6... Infusion tube, 7... Puncture needle,
8...Rubber cover, 9...Holder.

Claims (1)

[Scope of utility model registration request] A rubber stopper is hermetically sealed at the mouth of a vial or test tube containing a solid or powdered drug, and the inside of the vial or test tube is filled with a predetermined amount of solution introduced in a closed manner. A reagent container that is evacuated to one atmosphere.