kit according to the second embodiment of the present invention, a transfer needle to be communicated and a vial B containing vial A and B solution containing A liquid mixing at the time of use A solution and B solution including. The transfer needle can be used without particular limitation as long as the communication member having a hollow needle for communicating vial A and vial B on both sides.
[0064]

　standard reagent for dialysate analysis, it is ideally prepared after dialysate basically the same component composition of interest. Therefore, in addition to appropriate liquid A or liquid B of "electrolyte component carbonate ions are likely to form a precipitate by reaction" of the "bicarbonate ions and / or carbonate ions" A solution and in the solution B described above other ingredients to be contained in may be determined in accordance with the dialysate of interest. Specifically, the preferred electrolyte composition of the dialysate after mixing the liquid A and liquid B (standard reagent) is as shown in Table 1 above. Then, for example, an example and the electrolyte composition of the standard reagent, if reagents for artificial kidney dialysis fluid powder formulation "phosphorus Pack (TM) Dialysis agent TA3" (manufactured by Nipro Corporation), the above-mentioned Table 2 it is as of.
[0065]
　pH of standard reagent for dialysate analysis, it is ideally of the same order as prepared after dialysis fluid of interest, for example, preferably 7.0-7.5.
[0066]
[Standard reagent according to the third embodiment, the aqueous solution of the dialysis liquid and for artificial kidneys for fluid replacement]
　according to the third embodiment of the present invention, the dialysate for analysis containing bicarbonate ions and / or carbonate ions solution for standard reagent is a preparation containing sodium bicarbonate in baking soda dialysate, in this specification, also referred to as a standard reagent for the liquid B, or simply B solution. Further, aqueous dialysis solution containing a third bicarbonate ions and / or carbonate ions according to the embodiment of the present invention is a formulation comprising sodium bicarbonate in baking soda dialysate, in the present specification, the dialysate for B agent concentrate, or simply referred to as a B agent concentrate. Moreover, the third auxiliary liquid aqueous solution for artificial kidney containing bicarbonate ions and / or carbonate ions according to the embodiment of the present invention is a formulation comprising sodium bicarbonate in an artificial kidney for fluid replacement, as used herein, artificial kidney for replacement fluid for B aqueous solution, or simply referred to as a replacement fluid for B aqueous solution.
[0067]
　Third Standard reagent B solution according to the embodiment of the present invention, B aqueous solution for dialysate for B concentrate solution and artificial kidney for replacement fluid contains at least one of bicarbonate and carbonate ions, pH is it is 8.6 to 10.5. Solution B, but B agent concentrate and the pH of the replenisher for the B aqueous solution is 8.6 or more, preferably 9.0 or more, 9.2 or more is more preferable. Solution B, by setting the pH of the B concentrate solution and replenisher for B aqueous solution 8.6 or higher, B solution, pH changes B concentrate solution and replenisher for B aqueous solution, change in the bicarbonate ion concentration and release of carbon dioxide is suppressed for a long time, it is possible to obtain a stable solution B, B concentrate solution and replenisher for B aqueous solution. Also, B solution, but not B agent upper limit of the pH of the retentate and a replacement fluid for B aqueous solution particularly limited, the safety in handling, from the viewpoint of influence on the manufacturing equipment, and 10.5 or less, preferably 10.2 or less, more preferably 10.1 or less. The pH adjustment, can also be used a general pH adjusting agents in the art, with sodium bicarbonate and sodium carbonate, be carried out by adjusting the ratio, in terms adjustment work is easy ,preferable.
[0068]
　Solution B, the B concentrate solution and replenisher for B aqueous solution may contain a component other than the electrolyte component which may react to form precipitates with carbonate ions. For example, in order to adjust to a predetermined pH, it may contain a basic component such as sodium hydroxide. It is more preferable because it is easy to control the pH of a combination of sodium bicarbonate and sodium carbonate.
[0069]
　B solution, bicarbonate ion concentration in the B concentrate solution and replenisher for B aqueous solution may be appropriately set depending on purposes and is not particularly limited. Incidentally, B solution herein, B agent concentrate, replacement fluid for B aqueous solution, standard reagents, and the bicarbonate ion concentration in the dialysate and for artificial kidneys fluid replacement, reversibly bicarbonate ions in basic conditions to present as carbonate ion, it refers to the concentration of the sum of bicarbonate and carbonate ions.
[0070]
　Volume of solution B is preferably an amount enough to mixing operation is made possible with the solution A with one hand, for example, preferably 2 ~ 8 mL, more preferably 4 ~ 6 mL, about 5mL is best.
[0071]
　B liquid is preferably stored and filled into vials. Capacity vials, if it is possible to fill the liquid B, is not particularly limited, it is preferably of the order of magnitude that can be mixed with vial A with one hand.
[0072]
　Incidentally, the volume of the vial space in relation to the capacity and liquid B loading vials is increased, usually, over time tends to pH tends to rise, but the pH in the third embodiment of the present invention with 8.6 or more, it is possible to ensure good stability over time regardless of the volume of the vial space. Thus, the volume of the vial space is not particularly limited, for example, about 20 to 70% of the vial ZenMitsururyou are preferred.
[0073]
　Solution B according to the third embodiment of the present invention, in the standard reagent for solution (herein for dialysate analysis containing an electrolyte component which may react to form precipitates with carbonate ions, standard reagents use a solution, or simply referred to as solution a.) in combination with can be a standard reagent for dialysate analysis. The electrolyte component which may react to form precipitates with carbonate ions, calcium ions, magnesium ions, and these electrolyte components, for example, calcium chloride, may be contained in the liquid A as magnesium chloride it can. Calcium chloride, in the case of using magnesium chloride is contained as an electrolyte in the A solution. And, of course, in the present invention, carbonate ions and hydrogen carbonate ions shall not be contained in the A solution.
[0074]
　The solution A, calcium chloride, in addition to magnesium chloride, sodium chloride, potassium chloride, and other electrolytes and organic acid salts such as sodium acetate may be contained. Further, it is possible to use hydrochloric acid or an organic acid as a pH adjusting agent, as the organic acid, acetic acid, citric acid, oxalic acid, tartaric acid, maleic acid, ascorbic acid, oxaloacetic acid, gluconic acid, isocitric acid, malic acid, and / or it is preferred to use citric acid. Further, it is preferable to mix the glucose optionally in solution A.
[0075]
　Calcium chloride, calcium chloride dihydrate, calcium chloride monohydrate, calcium chloride anhydride or the like is used. The magnesium chloride, magnesium chloride hexahydrate is preferred.
[0076]
　The sodium acetate, anhydrous sodium acetate, sodium acetate trihydrate is preferably used. Further, by adding acetic acid and (glacial acetic acid) and sodium hydroxide may also be a result of sodium acetate.
[0077]
　Volume of solution A in an amount enough to mixing operation is made possible with the liquid B preferably one hand, for example, preferably 2 ~ 8 mL, more preferably 4 ~ 6 mL, about 5mL is best.
[0078]
　pH of solution A, depending on the pH of the solution B, the pH of standard reagents combined A solution and B solution is adjusted to be 7.2-7.4, corrosion to manufacturing apparatus and the like in view of the effects, preferably pH3 or more, pH 4 or higher is more preferable. Further, pH of the solution A is preferably 6 or less, more preferably pH5 or less. If the pH of the liquid A is too high, in order to maintain the pH of the standard reagent obtained by mixing the solution B to a predetermined range, forced to no longer obtained was set to a low pH of the solution B, so that bicarbonate ions no longer possible to suppress the change of the content.
[0079]
　A solution is also preferably stored and filled into vials. Capacity vials, if it is possible to fill the liquid A is not particularly limited, as capable of mixing the liquids A and B in the vials A, and more than the total capacity of liquid A and liquid B it is preferable, and more preferably 1.1 times or more the total volume of the liquid a and liquid B.
[0080]
　Capacity of standard reagents combined A solution and B solution is not particularly limited, as a minimum amount necessary to check the dialysate after preparation, usually, is preferably not less than 3 mL, more 5mL is more preferable. Further, a standard reagent prepared by an aqueous solution according to the third embodiment of the present invention, it is desirable to use up in one use principle, from this point, the capacity of the standard reagent is preferably equal 50 mL, less 30mL more preferable.
[0081]
　Standard reagent for dialysate analysis, it is ideally prepared after dialysate basically the same component composition of interest. Therefore, in addition to appropriate liquid A or liquid B of "electrolyte component carbonate ions are likely to form a precipitate by reaction" of the "bicarbonate ions and / or carbonate ions" A solution and in the solution B described above other ingredients to be contained may be determined in accordance with the purpose and the like of the dialysate and dialysis of interest. Specifically, the preferred electrolyte composition of the dialysate after mixing the liquid A and liquid B (standard reagent) is as shown in Table 1 above. Then, for example, As an example of the electrolyte composition of the standard reagent, if reagents for artificial kidney dialysis fluid powder formulation "phosphorus Pack (TM) Dialysis agent TA3" (manufactured by Nipro Corporation), the above-mentioned table it is as of 2.
[0082]
　Standard reagent for dialysate analysis according to the third embodiment of the present invention, a vial containing a vial and liquid B including A solution and a liquid A and liquid B at use and communicates by, for example, transfer needle mixed and can be used. Such transfer needle can be used without particular limitation as long as the communication member a hollow needle provided on either side for communicating the vial containing the vial and solution B containing A solution. In place of the transfer needle, for example, it was weighed accurately the contents of each vial using a pipette or the like, may be mixed liquids A and B by a means such as mixing the both in a separate container and it may be mixed by from one vial of the vial filled with a vial and liquid B filled with crowded the contents were poured to the other vial.
[0083]
　B agent concentrate for dialysate according to a third embodiment of the present invention, it is usually preferred to store filled into the bag.
[0084]
　Third B agent concentrate according to embodiments of the present invention, in the preparation (herein for dialysate containing an electrolyte component which may react to form precipitates with carbonate ions, the dialysate for A agents, or simply referred to as a agent.) and may be a sodium bicarbonate dialysate formulated in combination. A dosage may be a solid preparation even liquid, in the case of solid preparation, an electrolyte component which may react to form precipitates with carbonate ions containing as its salt, the aqueous solution upon use After a, and it is combined with B agent. The electrolyte component which may react to form precipitates with carbonate ions, calcium ions, magnesium ions, and these electrolyte components, for example, calcium chloride, may be contained in the A agent as magnesium chloride it can. Calcium chloride, in the case of using magnesium chloride is contained as an electrolyte in the A agent. And, of course, in the third embodiment of the present invention, carbonate ions and hydrogen carbonate ions shall not be included in the A agent. The A agent, the other may other electrolytes and organic acid salt described above as a good component be contained in the liquid A for standard reagent, also contain glucose, or the like. B agent concentrate is usually appropriately diluted before use, A agent (dissolution if necessary, be diluted) to prepare a dialysis solution in combination with.
[0085]
　A agent generally those used as the A agent for sodium bicarbonate dialysate, can be used to adjust appropriately to match the pH of the third according to the embodiment B agent concentrate of the present invention. The pH of the A agent, the same as the pH of a standard reagent A solution, as described above. The electrolyte composition of the dialysate obtained by mixing the A agent and the B agent concentrate may be determined according to the dialysis purposes like, for example, it is preferable that the composition shown in Table 1 above, By way of example , as shown in Table 2.
[0086]
　Replacement fluid for B aqueous solution according to the third embodiments of the invention, A for replacement fluid in the artificial kidney for replacement fluid formulations (herein including an electrolyte component which may react to form precipitates with carbonate ions agents, or simply referred to as a replacement fluid for a aqueous solution.) and can be an artificial kidney for fluid replacement in combination. The electrolyte component which may react to form precipitates with carbonate ions, calcium ions, magnesium ions, and these electrolyte components, for example, calcium chloride, may be contained in the liquid A as magnesium chloride it can. Calcium chloride, in the case of using magnesium chloride is contained as an electrolyte in the replacement fluid for the A agent. And, of course, in the third embodiment of the present invention, carbonate ions and hydrogen carbonate ions shall not be contained in the A solution. The replacement fluid for agent A, the other may other electrolytes and organic acid salt described above as a good component be contained in the liquid A for standard reagent, also contain glucose, or the like.
[0087]
　Usually, artificial kidneys for replacement fluid is mixed before use comprising two liquid of the A aqueous solution for rehydration and replacement fluid for B aqueous solution, for example, multi-chamber having at least two chambers partitioned by the communicable isolation means the container, it is preferable that the multi-chamber container preparation comprising houses a aqueous solution for rehydration and replacement fluid for B agent aqueous solution to the first and second chambers, respectively. Such multi-chamber containers can be used, for example, preferably a plastic double bag type container, such as polypropylene, those used in conventional filtration type artificial kidneys for replenisher, filling method, using it can be similarly applied to a method.
[0088]
　A aqueous solution for replacement fluid is generally possible to use those used as replacement fluid for A agent for artificial kidneys, appropriately adjusted to suit the pH of the replacement fluid for B aqueous solution according to the third embodiment of the present invention can. The pH of the A agent solution for replacement fluid, is similar to the pH for standard reagent A solution, as described above. The electrolyte composition of the replenisher obtained by mixing the replacement fluid for the A agent solution and replacement fluid for B agent aqueous solution, for example, preferably be a composition shown in Table 1 above, In one example, as shown in Table 2.
[0089]
　For example, multiple chambers formulation according to the third embodiment of the present invention, after filling the replacement fluid for A aqueous solution and replenisher for B aqueous solution in multiple chambers in each chamber, to seal the respective inlets. Then, according to the indication of the final sterilization of the Japanese Pharmacopoeia, and the final product by carrying out a high-pressure steam sterilization.
[0090]
　After sterilization, multiple chambers, in order to avoid contact with the outside air, it is preferable to exterior with a gas barrier property of the packaging material. Exterior may be sealed contained in a packaging container comprising a gas barrier packaging material, also if the packaging material is a film may be sealed package. The gas barrier packaging materials, ethylene-vinyl alcohol copolymer film or the like, are known many materials and products, generally can be used those commercially available.
[0091]
　Further, when the exterior of the multi-chamber container, for the interior and exterior and anoxia, or housed together an oxygen scavenger may be substituted, such as a nitrogen gas or carbon dioxide gas, accommodating an oxygen scavenger it is preferable to. Further it is preferable to house together as oxygen detecting agent for the purpose of detecting the pinhole of the exterior. The oxygen scavenger and oxygen detecting agent, can generally be used those commercially available.
[0092]
　Incidentally, the third artificial kidney for auxiliary liquid according to the embodiment of the present invention, by the pH of the replacement fluid for B aqueous solution to a predetermined value, the exterior and with a gas barrier packaging material of the above, carbon dioxide generating bundled type of oxygen scavenger, measures such as by substitution of nitrogen gas and carbon dioxide gas is not essential.
[0093]
　Is specifically described below based on the present invention embodiment, the present invention is not intended to be limited to these examples.
Example
[0094]
1. First embodiment
Examples 1-1
　According to the composition of Table 3, each component of the liquid A were mixed and dissolved in water for injection to prepare a solution A by adding water for injection to a total volume of 100 mL. At this time, by properly mixing hydrochloric acid, was adjusted to pH of solution A is 4.7. The resulting A solution was filtered through a pore size of 0.22μm membrane filter, COP resin vial volume 10 mL (Yamato Special Glass Co., Ltd., "PVD-10" (COP vial); contact angle 100.8 degrees of water, filled with 5.0mL in total light transmittance 91.5%), after the rubber stopper, to obtain a vial a liquid a is sealed by an aluminum cap.
[0095]
　According to the composition of Table 4, the sodium bicarbonate dissolved in water for injection, adjusted to pH9.1 by adding sodium hydroxide as an aqueous solution for 1 mol / L injection was prepared solution B (total volume 100 mL). Resulting B was filtered with a pore size of 0.22μm membrane filter, COP resin vial volume 10 mL (Yamato Special Glass Co., Ltd., "PVD-10" (COP vial); contact angle 100.8 degrees of water, filled with 5.0mL in total light transmittance 91.5%), after the rubber stopper, to obtain a vial B of B liquid was sealed by an aluminum cap. The contact angle of water was measured using an automatic contact angle meter (KRUSS Co., Ltd. "DSA100S"), the total light transmittance was measured using a haze meter (Nippon Denshoku Industries Co., Ltd., "NDH7000") .
[0096]
[table 3]

[0097]
[Table 4]

[0098]
　In the obtained vial A and kit comprising a vial B, electrolyte component which may react to form precipitates with carbonate ions are contained in a vial A, bicarbonate ions and carbonate ions are contained in a vial B because there, even after being stored for a long time, there is no possibility of causing a precipitate contents of the vial B.
[0099]
　To prepare a standard reagent using this kit. In other words, remove the rubber stopper of the vial B, then after removing the rubber stopper of the vial A, poured A solution vial B. A rubber stopper to a vial B, was prepared standard reagents mixed by inversion twice. Resulting standard reagents, it had the desired composition.
[0100]
Example 1-2: Preparation of standard reagent
　in the same manner as in Example 1-1, to obtain a standard reagent kit for dialysate analysis consisting of a vial A and vial B. Using this kit, three tester, in the same manner as in Example 1-1, poured A solution vial B, by Invert twice, standard reagents were prepared (n = 3 each) .
[0101]
Test Example 1-1: pH, bicarbonate ion concentration (n = 3 each)
　and the pH and bicarbonate ion concentration of the standard reagent obtained in Example 1-2, blood gas analyzer (Siemens "RapidLAB 348EX" ) was measured using a. The results are shown in Table 5.
[0102]
[table 5]

[0103]
　From this result, according to the kit of the present invention, the liquid contained in the water-repellent resin vials that fall mixing poured into the other vial, by very simple method, a mixture of good reproducibility reliably Ryoeki it is possible to obtain a standard reagent stable composition was confirmed.
[0104]
Example 1-3: Preparation of standard reagent
　in the same manner as in Example 1-1, to obtain a standard reagent kit for dialysate analysis consisting of a vial A and vial B. Remove the rubber plug of the vial A, then after removing the rubber stopper of the vial B, it poured A solution vial B. A rubber stopper to a vial B, was prepared standard reagents and twice Invert (n = 5).
[0105]
Test Example 1-2: residual amount of the liquid A
　in Example 1-3, upon preparation of the kit, previously weighed empty container weight vials A, then weighed mass of vial A filled with solution A, the filling liquid to calculate the amount (g). Thereafter, in the preparation of standard reagent, A solution weighed mass of vial A after poured into a vial B, subtracting the mass of the empty vessel previously measured to calculate the residual liquid amount (g), divided by the density of solution A and it calculates the remaining fluid volume (mL) to. The ratio of the residual liquid amount to the filling liquid amount (percentage) was residual liquid ratio of liquid A (%). The results are shown in Table 6.
[0106]
[Table 6]

[0107]
Example 1-4: Preparation of standard reagent
　in the same manner as in Example 1-1, to obtain a standard reagent kit for dialysate analysis consisting of a vial A and vial B. Remove the rubber plug of the vial B, then after removing the rubber stopper of the vial A, it poured solution B into a vial A. A rubber stopper to a vial A, was prepared standard reagents and twice Invert (n = 5).
[0108]
Comparative Example 1-1: standard reagents prepared
　except for using a glass vial instead of a COP resin vial as the vial B (Maruemu Corp. "borosilicate glass vials" (10 mL)) in the same manner as in Example 1-4, to obtain a standard reagent kit for dialysate analysis consisting of a vial a and vial B. Remove the rubber plug of the vial B, then after removing the rubber stopper of the vial A, it poured solution B into a vial A. A rubber stopper to a vial A, was prepared standard reagents and twice Invert (n = 5).
[0109]
Test Example 1-3: residual amount of the liquid B
　in Example 1-4 and Comparative Example 1-1, upon production of the kit, weighed mass of empty containers previously vial B, vial B was then filled with liquid B weighed mass was calculated filling liquid amount (g). Thereafter, in the preparation of standard reagent, B solution weighed mass of vial B after poured into vials A, subtracting the weight of the empty container in advance measured to calculate the residual liquid amount (g), divided by the density of Solution B and it calculates the remaining fluid volume (mL) to. Further, the ratio of the residual liquid amount to the filling liquid amount (percentage) residual liquid ratio of B solution (%) and. The results are shown in Table 7.
[0110]
[Table 7]

[0111]
Reference Example 1-1
　in water for injection 90 mL, dissolved by addition of sodium bicarbonate 0.42 g, the total amount added water for injection to prepare a solution B as 100 mL. The resulting solution B was filtered through a pore size of 0.22μm membrane filter, filled with 5.0mL to COP resin vial the same volume 10mL of Example 1-1, after the rubber stopper, sealed with an aluminum cap to obtain a vial B of B solution. The ratio of the space of the resultant vial B was 65%.
[0112]
Reference Example 1-2
　in water for injection 90 mL, dissolved by addition of sodium bicarbonate 0.42 g, was added a 0.1 mol / L sodium hydroxide aqueous solution for injection and adjusted to pH 8.6, the total amount added water for injection 100mL solution B except prepared as got vial B in the same manner as in reference example 1-1.
[0113]
Reference Examples 1-3 to 1-8
　in injectable water 90 mL, was added an appropriate amount of 0.1 mol / L sodium injectable aqueous hydroxide, then it was dissolved by adding sodium bicarbonate 0.42 g, 0.1 mol / L and added 1 mol / L sodium injectable aqueous hydroxide appropriately adjusted to each pH shown in Table 8, except that the total amount of added water for injection to prepare a solution B as 100 mL, in the same manner as in reference example 1-1 to obtain a vial B.
[0114]
Test Example 1-4: B solution stability test
　Reference Examples 1-1 to 10 days after preparation for vial B obtained in 1-7 (during room temperature storage) vials obtained in Reference Example 1-8 after 9 days of preparation for the (stored at room temperature is between), pH, (it displays the measurement value at this point in the table 8 as "start") that the carbon dioxide concentration of the space, and the bicarbonate ion concentration was measured . Thereafter, each vial, and stored at 60 ° C., after and 21 days after 10 days from the start of storage at 60 ° C., again, pH, carbon dioxide concentration of the space, and the bicarbonate ion concentration was measured. Following the method of each measurement. The results are shown in Table 8.
[0115]
(A) pH measurements (n = 3 each)
　liquid 2mL in vials taken in a test tube, was measured using a pH meter.
[0116]
(B) the carbon dioxide concentration (n = 3 each) of the space
　takes the space of the gas in the vial 0.1 mL, by analyzing by gas chromatography, the proportion of carbon dioxide occupying the space (%) I was asked. Incidentally, the carbon dioxide concentration in the initial occupying the space, as well as the carbon dioxide concentration in the atmosphere is 0.04%. The results are shown in Table 8.
[0117]
(C) bicarbonate ion concentration (n = 3 each)
　per liquid 2mL in a vial, by analyzing using high performance liquid chromatography under the following conditions (HPLC), were measured bicarbonate ion concentration.
HPLC apparatus :( manufactured by Shimadzu Corporation) "LC20AD"
Column: Shodex Co. "IC SI-90 4E" (particle size 9 .mu.m, an inner diameter of 4 mm, made of diameter 250 mm, Shodex Co.)
Mobile phase: boric acid 0 in an aqueous solution of 1L .371g, D- mannitol 3.28 g, and tris solution containing the (hydroxymethyl) aminomethane 1.15g
[0118]
[Table 8]

[0119]
　Results from this accelerated test, free of electrolyte component which may react to form precipitates with carbonate ions, B solution containing at least one of carbonate ion and hydrogen carbonate ion is filled in a water-repellent resin vial when stored Te, release into the space of carbon dioxide is suppressed, less temporal variation in pH and bicarbonate ion concentration, to be stable over a long period of time can be presumed. Especially in the reference examples 1-3 to 1-8 in which the pH was 8.9 or more, it can more reliably prevent the carbon dioxide is released into the space during the storage at room temperature until the beginning from the time of preparation, high temperature more reliably suppress temporal variations in pH and bicarbonate ion concentration in it has been found that high stability over a long period of time can be obtained.
[0120]
2. Second embodiment
examples 2-1
　According to the composition of Example 1-1 in the same Table 3, each component of the liquid A were mixed and dissolved in water for injection, and water for injection to a total volume of 100 mL A liquid was prepared. At this time, by properly mixing hydrochloric acid, was adjusted to pH of solution A is 4.7. A obtained solution was filled into vials each 5 mL, after the rubber stopper, to obtain a vial of liquid A was sealed by seaming with aluminum seals.
[0121]
　According to the composition of Example 1-1 and the same table 4, it was dissolved sodium bicarbonate in water for injection, adjusted to pH9.1 by addition of sodium hydroxide to prepare a solution B (total volume 100 mL). The resulting solution B was filled into vials each 5 mL, after the rubber stopper, to obtain a vial of Solution B was sealed by seaming with aluminum seals. At this time, the volume of the space of the vial of solution B was 65% of the vial ZenMitsururyou.
[0122]
　The resulting vial A, in a kit consisting of a vial B and transfer needle (Nipro Co., Ltd.), electrolyte component which may react to form precipitates with carbonate ions are contained in a vial A, bicarbonate ions and because the carbonate ions are contained in a vial B, even after being stored for a long time, there is no possibility of causing a precipitate contents of the vial B.
[0123]
　To prepare a standard reagent using this kit. That is, the vial A and vial B communicates with transfer needle to obtain a standard reagent and mixing. pH of the mixture of A solution and B solution (n = 3) is 7.3, the solution after mixing is to be a target pH (pH 7.2 ~ 7.4) without problems was confirmed. The composition of the resulting standard reagent shown in Table 9.
[0124]
[Table 9]

[0125]
Reference Examples 2-1 to 2-10
　According to the composition of Table 10, the sodium hydrogen carbonate was dissolved in water for injection by adding sodium hydroxide to adjust to a predetermined pH shown in Table 10, to prepare a solution B. The resulting solution B was filled into vials each 5 mL, after the rubber stopper, to obtain a vial of Solution B was sealed by seaming with aluminum seals. At this time, the volume of the space of the vial was 43% of the vial ZenMitsururyou. Incidentally, it was not added sodium hydroxide in Reference Example 2-1.
[0126]
[Table 10]

[0127]
Test Example 2-1: B solution stability test
　Reference Examples 2-1 to 2 days after the preparation of the obtained vial 2-10 (during room temperature storage) was measured pH, carbon dioxide concentration in the space . Thereafter, each vial, and stored at 40 ° C., after 2 weeks and after 4 weeks storage start at 40 ° C., again, pH, carbon dioxide concentration in the space portion was measured. Following the method of each measurement.
[0128]
(A) pH measurements (n = 3 each)
　liquid 2mL in vials taken in a test tube, was measured using a pH meter. The results are shown in Table 11.
[0129]
(B) the carbon dioxide concentration (n = 3 each) of the space
　takes the space of the gas in the vial 0.1 mL, by analyzing by gas chromatography, the proportion of carbon dioxide occupying the space (%) I was asked. Incidentally, the carbon dioxide concentration in the initial occupying the space, as well as the carbon dioxide concentration in the atmosphere is 0.04%. The results are shown in Table 11.
[0130]
[Table 11]

[0131]
　Results from this accelerated test, free of electrolyte component which may react to form precipitates with carbonate ions, B solution containing at least one of carbonate ion and bicarbonate ion, Reference Examples 2-1 to 2 at -10 all, in especially reference examples 2-3 to 2-10 in which the pH of 8.6 or more, the release of the space of the carbon dioxide is suppressed, less variation in pH, stability over a long period of time is presumed It has been. Further, it can be said from this that, with less variation in the bicarbonate ion concentration.
[0132]
3. Third embodiment
Examples 3-1 to 3-8 and Comparative Examples 3-1 to 3-2
　According to the composition of Table 12, the sodium hydrogen carbonate was dissolved in water for injection, in Table 12 by addition of sodium hydroxide adjusted to a predetermined pH indicated, to prepare a solution B. The resulting solution B was filled into vials each 5 mL, after the rubber stopper, to obtain a vial of Solution B was sealed by seaming with aluminum seals. At this time, space volume of the vial was 43% of the vial ZenMitsururyou. Incidentally, in Comparative Example 3-1 was not used sodium hydroxide.
[0133]
[Table 12]

[0134]
Examples 3-9 - 3-12 and Comparative Examples 3-3 to 3-6
　According to the composition of Table 13, using sodium carbonate instead of sodium hydroxide, or increasing the hydrogen carbonate ion concentration, vial capacity and filled except that reduce the volume of the space by changing the liquid volume is, to obtain a vial of solution B in the same manner as in example 3-1. In the Comparative Examples 3-3 to 3-6 it was not used sodium carbonate.
[0135]
[Table 13]

[0136]
Test Example 3-1: Stability test liquid B
　after 2 days from the preparation for Examples 3-1 to 3-8 and vials obtained in Comparative Examples 3-1 and 3-2 (during which the room temperature storage), performed example 3-9 ~ 3-12 and Comparative examples 3-3 ~ after 17 days from the preparation for a vial obtained in 3-6 (during room temperature storage) was measured pH, carbon dioxide concentration of the space. Thereafter, each vial, and stored at 40 ° C., after 2 weeks and after 4 weeks storage start at 40 ° C., again, pH, carbon dioxide concentration in the space portion was measured. Following the method of each measurement.
[0137]
(A) pH measurements (n = 3 each)
　liquid 2mL in vials taken in a test tube, was measured using a pH meter. The results are shown in Table 14.
[0138]
(B) the carbon dioxide concentration (n = 3 each) of the space
　takes the space of the gas in the vial 0.1 mL, by analyzing by gas chromatography, the proportion of carbon dioxide occupying the space (%) I was asked. Incidentally, the carbon dioxide concentration in the initial occupying the space, as well as the carbon dioxide concentration in the atmosphere is 0.04%. The results are shown in Table 14.
[0139]
[Table 14]

[0140]
　From the above results, whereas in Comparative Examples 3-1 to 3-6, the 2 days to 17 days after after preparation 0.1 or more pH higher than the pH of the preparation was observed, Example 3 both the 1-3-12, variations of pH less after preparation, can not hardly observed over time variation even in a high temperature state was confirmed. In Comparative Examples 3-3 to 3-6 which is not a pH within a predetermined range, the pH variation after preparation to the volume of the vial space increases are observed remarkably larger tendency (Comparative Example 3-3VS Comparison examples 3-5, Comparative examples 3-4VS Comparative example 3-6), example 3-9 ~ with little subject that the effect of the space volume in 3-12, pH after preparation even larger volume of the space portion variation can be suppressed has been confirmed (example 3-9VS example 3-11, example 3-10VS example 3-12).
[0141]
Example 3-13
　According to the composition of the same table 3 and Example 1-1, the components of solution A were mixed and dissolved in water for injection to prepare a solution A by adding water for injection to a total volume of 100 mL. At this time, by properly mixing hydrochloric acid, was adjusted to pH of solution A is 4.7. The resulting solution A to vials to obtain a vial of liquid A was filled by 5 mL.
[0142]
　Similarly, in accordance with the composition of the same table 4 as in Example 1-1, it was dissolved components of the liquid B in water for injection to prepare a solution B by addition of water for injection to a total volume of 100 mL. The resulting solution B vial capacity 10mL was filled by 5mL give a vial B solution. Volume of the space of the vial of solution B was 65% of the vial ZenMitsururyou.
[0143]
　The vials and vials of solution B obtained liquid A, communicates with transfer needle (Nipro Co., Ltd.), to obtain a standard reagent and mixing. pH of the mixture of A solution and B solution (n = 3) is 7.3, the solution after mixing is to be a target pH (pH 7.2 ~ 7.4) without problems was confirmed. The composition of the resulting standard reagents shown in Table 15.
[0144]
[Table 15]