阅读说明：本技术 一种葡萄糖质控液 (Glucose quality control liquid ) 是由 刘峻 于 2018-07-17 设计创作，主要内容包括：本发明提供的葡萄糖质控液,包含：磷酸二氢钾,二水合磷酸氢二钠,氯化钾,硝酸钠,二水合依地酸二钠,TritonX-100,Parmetol K40,并且用蒸馏水或纯化水做溶剂。本发明提供的葡萄糖质控液可以作为多种品牌的POCT血糖仪的质量控制,能够满足临床室内、室间质量控制应用的需要,同时节省总体试剂的使用成本。(The invention provides a glucose quality control liquid, comprising: potassium dihydrogen phosphate, disodium hydrogen phosphate dihydrate, potassium chloride, sodium nitrate, disodium edetate dihydrate, triton x-100, Parmetol K40, and distilled or purified water as a solvent. The glucose quality control liquid provided by the invention can be used for quality control of POCT glucometers of various brands, can meet the requirements of control application of clinical indoor and indoor quality, and simultaneously saves the use cost of the total reagent.)

1. A glucose quality control solution, comprising a phosphate diluent, the phosphate diluent comprising: potassium dihydrogen phosphate, disodium hydrogen phosphate dihydrate, potassium chloride, sodium nitrate, disodium edetate dihydrate, triton x-100, parmetol k40, using distilled or purified water as solvent.

2. The glucose control solution of claim 1, wherein: 0.055 wt% of potassium dihydrogen phosphate, 0.237 wt% to 0.238 wt% of disodium hydrogen phosphate dihydrate, 0.15 wt% of potassium chloride, 0.019 wt% to 0.020 wt% of sodium nitrate, 0.038 wt% to 0.040 wt% of disodium edetate dihydrate, 0.005 wt% to 0.0055 wt% of TritonX-100 and 0.05 wt% to 0.06 wt% of Parmetol K40.

Technical Field

The invention relates to the field of in-vitro diagnostic reagents for medical instruments.

Background

The main components of the glucose quality control liquid are phosphate diluent and beta-D (+) anhydrous glucose. Among them, phosphate is the most widely used buffer in biochemical studies, and since they are the second order dissociation and have two pKa values, the pH range of the buffer prepared by using them is the widest. beta-D (+) anhydrous glucose is D-glucose anhydrous substance after purification and crystallization, or contains one molecule of crystal water. White odorless crystalline particles or crystalline powder. Is easily soluble in water, very easily soluble in boiling water, and slightly soluble in ethanol. The storage condition is 2-8 ℃. When D-glucose is dissolved in water, the optical rotation changes with time and gradually approaches +57.2 degrees. This is because the solution at this point formed a stable system containing 1/3 alpha-D-glucose and 2/3 beta-D-glucose.

The glucose quality control liquid of a commercially available glucometer generally adopts water for injection as a solvent, the pH value of the water for injection is 5.0-7.0, and the conductivity is 1.3us/cm, the quality control liquid produced by the method has more clinical adverse reactions and poor stability due to larger conductivity, and the technical index of the water quality used by the prepared quality control liquid has the pH value of 6.0-7.0, the water quality is closer to neutrality, and the conductivity is 0.65us/cm, so that the quality of the quality control liquid is prevented from being influenced by microorganisms. Meanwhile, after being unpackaged, the commercially available quality control product can be stored at a certain temperature for 8 hours and 7 days, wherein the Langdao quality control product can be stored for a long time when being frozen at the temperature of-20 ℃, but the use of the quality control product is complicated for users. The diluent used by the prepared quality control liquid contains Parmetol K40, so that the long-term stability of the quality control liquid is guaranteed, the quality control liquid is stored in a sealed manner at 2-8 ℃ for 9 months, the quality control liquid can be stored stably for one month at 2-8 ℃ after being used after being opened, the quality control liquid is longer than the general quality control liquid, and the result of testing blood on an instrument is quite optimistic.

The technical indexes of the glucose quality control solution used as an in vitro diagnostic reagent mainly relate to accuracy and precision, and according to related technologies, the quality control solution with the accuracy of +/-11 wt% and the precision CV of less than or equal to 8.00 wt% is found to be suitable for POCT blood glucose analyzers with various styles in the market, and the test effect is superior to that of reagents matched with some blood glucose meters.

Disclosure of Invention

The invention provides a glucose quality control liquid, comprising: 0.055 wt% of potassium dihydrogen phosphate, 0.237 wt% -0.238 wt% of disodium hydrogen phosphate dihydrate, 0.15 wt% of potassium chloride, 0.019 wt% -0.020 wt% of sodium nitrate, 0.038 wt% -0.040 wt% of disodium edetate dihydrate, 0.005 wt% -0.0055 wt% of TritonX-100, 0.05 wt% -0.06 wt% of Parmetol K40, and distilled water or purified water as a solvent.

The phosphate diluent disclosed by the invention not only can be used for diluting glucose to prepare a quality control liquid, but also can be used for diluting blood after a large number of experiments, and the efficacy and the blood dilutability of the quality control liquid are optimal under the proportion of the concentration.

The glucose quality control liquid provided by the invention can be used for quality control of POCT glucometers of various brands, can meet the requirements of control application of clinical indoor and indoor quality, and simultaneously saves the use cost of the total reagent.

Detailed Description

The technical solution of the present invention is further explained by the following embodiments. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting of the invention.

Preparation examples

The phase targets of the invention:

designing a technical formula of phosphate diluent containing Parmetol K40 bactericide in the first stage;

preparing a glucose quality control liquid level 1 of 5.80mmol/L (a glucose quality control liquid level 2 of 13.6 mmol/L) in the second stage;

establishing a mature process flow according to the formula;

in the fourth stage, the blood glucose meter and other instruments are used for accuracy test, precision test, repeated test and clinical calibration consistency test, and the blood glucose meter and other instruments are put into production formally.

The final purpose is as follows: a method for preparing 5.80mmol/L glucose control solution level 1(13.6mmol/L glucose control solution level 2) for testing blood sugar sample is provided.

1. The additional conditions required for the solutions studied in the present invention are as follows:

1.1 analytical balance (0.0001g)

1.2 magnetic stirrers;

1.3 digital temperature controller;

1.4pH meter;

1.5 conductivity meter;

1.6 beaker;

1.7 the pH and conductivity of the prepared phosphate diluent are measured, and the specific steps are as follows:

1.7.1 taking a small amount of phosphate diluent in a small beaker of 100 ml;

1.7.2 inserting electrodes of the calibrated pH meter and the conductivity meter into the solution in sequence;

1.7.3 pressing the "read" buttons of the pH meter and the conductivity meter, respectively;

1.7.4 waiting for 1min-2min, recording the reading on the pH meter and the reading on the conductivity;

2. the key technical key is as follows:

2.1 the volume of the solvent for dissolving the raw material should be 60 wt% of the target volume in order to avoid the generation of foam;

2.2 for organic matter Parmetol K40 and Triton X-100, one plays the role of sterilization, and the other disperses the cells in the blood sample to facilitate the detection of the instrument, and simultaneously reduces the surface tension of the diluent to reduce the generation of bubbles and eliminate the interference of the bubbles on the measurement, and the substance also has the function of sheath fluid; the adding sequence is that TritonX-100 is added first and then Parmetol K40 is added;

2.3 the preparation process of the quality control liquid comprises the steps of firstly preparing a concentrated solution with a certain concentration, and then diluting to ensure the uniformity of the solution;

2.4 the prepared glucose quality control liquid needs to be kept stand;

2.5 the invention adopts a low-speed stirring and dissolving method, and stirring is needed for 30min after preparation.

The content of 2.6 Parmetol K40 is 0.05-0.06 wt%, the prepared calibration solution has better stability, and the test result is more accurate;

2.7 the water quality is preferably three-stage distilled water or purified water and meets certain standards.

3. The preparation method of the glucose quality control level 1 (glucose quality control level 2) comprises the following steps:

3.1 preparing a volume of phosphate diluent, wherein the diluent comprises: 0.055 wt% of potassium dihydrogen phosphate, 0.237 wt% -0.238 wt% of disodium hydrogen phosphate dihydrate, 0.15 wt% of potassium chloride, 0.019 wt% -0.020 wt% of sodium nitrate, 0.038 wt% -0.040 wt% of disodium edetate dihydrate, 0.005 wt% -0.0055 wt% of TritonX-100, 0.05 wt% -0.06 wt% of Parmetol K40, and distilled water or purified water meeting a certain standard as a solvent;

3.2 filling 3000ml of phosphate diluent into a 5000ml beaker, placing the beaker on a magnetic stirrer, and enabling a stirring rotor to rotate at a constant speed;

3.3 then slowly adding 52.3g (glucose quality control liquid level 2: 122.51g) of beta-D (+) anhydrous glucose into the 5000ml beaker, and continuously stirring the mixture on a magnetic stirrer for about 30 min;

3.4, adding phosphate diluent into a 5L beaker to reach the constant volume of 5L after the chemicals are completely dissolved;

3.5 transferring 500ml of the mixed solution obtained in the step 3.4 into another 5L beaker, then using phosphate diluent to make the volume to 5L, placing the beaker on a magnetic stirrer to continuously stir for 30min, and standing the beaker for 30min

3.6 after dissolving evenly, obtaining the solution before filling, putting 0.22um acetate fiber filter membrane soaked in triple distilled water into a filter, filtering for three times to obtain the required glucose quality control liquid level 1 of 5.80mmol/L (glucose quality control liquid level 2 of 13.6 mmol/L)

3.7 if the solution is clear and transparent, sampling and detecting, continuously making three batches, starting to test the accuracy of the solution, and if precipitation and turbidity phenomena exist, removing the solution and preparing again;

3.8, after the test is qualified, the on-machine verification test is carried out by using the glucose quality control liquid level 1 of 5.80mmol/L (the glucose quality control liquid level 2 of 13.6 mmol/L)

Citation: YYT 0456.1-2014 reagent part 1 for hematology analyzers: cleaning fluid; YYT 0456.3-2014 reagent part 3 for hematology analyzers: a diluent; ISO18113-2 part 2: professional in vitro diagnostic reagents; part 1 of the standardization work guide of GBT 26124-: standard construction and writing (Abstract)

Effects of the embodiment

Description of the content of each substance component

In comparative example 1, the inorganic salt outside the reference range was added, and the conductivity was 40.23ms/cm, which was outside the standard range of conductivity of 5.00 to 6.00 ms/cm.

In comparative example 2, when TritonX-100 was added in excess, the resulting foam was extremely difficult to remove and required to stand for 30min or more.

In comparative example 3, when an excessive amount of Parmetol K40 was added, the solution stability was poor and the expected storage date could not be reached.

The substances were added in the proportions described in example 1, with an electrical conductivity of 5.3ms/cm, and the foam produced was very readily eliminated within the specified conductivity standard. Example 2 also has excellent conductivity.

Effect example 2

In comparative example 1, disodium hydrogen phosphate dihydrate was replaced with sodium hydroxide, which is widely used for pH adjustment of a solution, but is dissolved in a solution to generate heat, and easily breaks the ionization balance in the solution, so that the pH does not reach the intended range.

In comparative example 2, potassium chloride was replaced with sodium chloride, wherein the physical and chemical properties of potassium chloride and sodium chloride are similar, but potassium chloride has higher solubility than sodium chloride and is more suitable for industrial production, and the conductivity of potassium chloride is lower than 5.00ms/cm by replacing sodium chloride with sodium chloride.

The present invention is capable of other embodiments, and various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention.

The present invention is not limited to the above preferred embodiments, and any modifications, equivalent replacements, improvements, etc. within the spirit and principle of the present invention should be included in the protection scope of the present invention.