阅读说明：本技术 红细胞模拟粒子、其制备方法及含其的质控物或校准物 (Erythrocyte-simulating particle, preparation method thereof and quality control substance or calibrator containing erythrocyte-simulating particle ) 是由 宋瑞霞 谢键 于 2018-12-25 设计创作，主要内容包括：一种红细胞模拟粒子、其制备方法及含有该红细胞模拟粒子的质控物或校准物。制备红细胞模拟粒子的方法包括采用pH为5.0～9.0、渗透压为300～800Osm/kg·H-2O的红细胞处理液对红细胞进行氧化处理和固定处理,其中,该红细胞处理液含有选自卤素含氧酸盐的至少一种氧化剂和选自醛或酸的至少一种固定剂；和将经该红细胞处理液处理后的红细胞洗涤并悬浮在保存液中。该方法采用环境友好的卤素含氧酸盐作为氧化剂,获得了能够长期稳定保存的且在红细胞检测通道中与天然血液红细胞粒子性质类似的红细胞模拟粒子。(A red blood cell mimic particle, a method for preparing the same, and a quality control substance or calibrator containing the red blood cell mimic particle. The method for preparing the erythrocyte mimic particle comprises the steps of adopting pH value of 5.0-9.0 and osmotic pressure of 300-800 Osm/kg.H 2 O, wherein the erythrocyte treating solution contains at least one oxidizing agent selected from halogen oxysalts and at least one fixing agent selected from aldehydes or acids; and washing and suspending the red blood cells treated with the red blood cell treatment solution in a preservation solution. The method adopts environment-friendly halogen oxysalt as an oxidant, and obtains the erythrocyte simulated particles which can be stably stored for a long time and have the property similar to that of natural erythrocyte particles in an erythrocyte detection channel.)

A method of making red blood cell mimetic particles, the method comprising:

the pH value is 5.0-9.0, and the osmotic pressure is 300-800 sm/kg.H₂O, wherein the erythrocyte treatment solution contains at least one oxidizing agent selected from halogen oxysalts and at least one fixing agent selected from aldehydes or acids; and

and washing and suspending the red blood cells treated by the red blood cell treatment solution in a preservation solution.

The method of claim 1, wherein the at least one oxidizing agent is selected from the group consisting of hypohalites, halates, and perhalates of chlorine, bromine, and iodine; preferably, the at least one oxidizing agent is selected from the group consisting of sodium and potassium salts of hypochlorous acid, chlorous acid, chloric acid, perchloric acid, bromic acid, iodic and periodic acids; further preferably, the at least one oxidizing agent is selected from the group consisting of sodium perchlorate, potassium perchlorate, sodium bromate, potassium bromate, sodium chlorate and potassium chlorate.

The method according to claim 1 or 2, wherein the concentration of the at least one oxidizing agent in the red blood cell treatment fluid is 0.01 to 20g/L, preferably 0.05 to 10g/L, more preferably 0.05 to 5 g/L.

The method according to claim 3, wherein the at least one oxidizing agent is a perchlorate, in particular sodium perchlorate, and has a concentration in the red blood cell treatment fluid of 8 to 20g/L, preferably of 8 to 10 g/L; or the at least one oxidant is bromate, especially sodium bromate, and the concentration of the at least one oxidant in the erythrocyte treatment solution is 0.25-2 g/L, preferably 0.25-1 g/L, and more preferably 0.25-0.5 g/L; or the at least one oxidant is chlorate, especially sodium chlorate, and the concentration of the at least one oxidant in the erythrocyte treatment solution is 0.5-2 g/L, preferably 0.5-1 g/L.

The method of any one of claims 1 to 4, wherein the at least one fixing agent is selected from the group consisting of formaldehyde, glutaraldehyde, glyoxal, methylglyoxal, p-trifluoromethylbenzaldehyde, paraformaldehyde, chromic acid, picric acid, tannic acid and acetic acid.

The method according to any one of claims 1 to 5, wherein the concentration by volume of the at least one fixing agent in the red blood cell treatment liquid is 0.01 to 0.5 vol%.

The method of any one of claims 1-6, wherein the method further comprises: before the oxidation treatment and the fixation treatment of the red blood cells with the red blood cell treatment solution, the red blood cells are subjected to a spheroidization treatment.

A method of making red blood cell mimetic particles, the method comprising:

the pH value is 5.0-9.0, and the osmotic pressure is 300-800 sm/kg.H₂O, wherein the first erythrocyte treating solution contains at least one oxidant selected from halogen oxysalts;

the pH value is 5.0-9.0, and the osmotic pressure is 300-800 sm/kg.H₂O, wherein the second erythrocyte treating solution contains at least one fixing agent selected from aldehyde or acid; and

the red blood cells treated with the first red blood cell treatment solution and the second red blood cell treatment solution are washed and suspended in a preservation solution.

The method of claim 8, wherein the at least one oxidizing agent is selected from the group consisting of hypohalites, halates, and perhalates of chlorine, bromine, and iodine; preferably, the at least one oxidizing agent is selected from the group consisting of sodium and potassium salts of hypochlorous acid, chlorous acid, chloric acid, perchloric acid, bromic acid, iodic and periodic acids; further preferably, the at least one oxidizing agent is selected from the group consisting of sodium perchlorate, potassium perchlorate, sodium bromate, potassium bromate, sodium chlorate and potassium chlorate.

The method according to claim 8 or 9, wherein the concentration of the at least one oxidizing agent in the first red blood cell treatment fluid is 0.01-20 g/L, more preferably 0.05-10 g/L, and preferably 0.05-5 g/L.

The method according to claim 10, wherein the at least one oxidizing agent is perchlorate, in particular sodium perchlorate, and has a concentration in the first red blood cell treatment fluid of 8 to 20g/L, preferably of 8 to 10 g/L; or the at least one oxidizing agent is bromate, especially sodium bromate, and the concentration of the bromate in the first erythrocyte treating solution is 0.25-2 g/L, preferably 0.25-1 g/L, and more preferably 0.25-0.5 g/L; or the at least one oxidant is chlorate, especially sodium chlorate, and the concentration of the at least one oxidant in the first erythrocyte treating solution is 0.5-2 g/L, preferably 0.5-1 g/L.

The method of any one of claims 8 to 11, wherein the at least one fixing agent is selected from the group consisting of formaldehyde, glutaraldehyde, glyoxal, methylglyoxal, p-trifluoromethylbenzaldehyde, paraformaldehyde, chromic acid, picric acid, tannic acid and acetic acid.

The method according to any one of claims 8 to 12, wherein the concentration by volume of the at least one fixing agent in the second red blood cell treatment liquid is 0.01 to 0.5 vol%.

The method according to any one of claims 8 to 13, wherein after the oxidation treatment, the red blood cells subjected to the oxidation treatment are washed with a buffer solution and then subjected to the fixation treatment.

The method of any one of claims 8-14, wherein the method further comprises: before the red blood cells are subjected to the oxidation treatment with the first red blood cell treatment solution, the red blood cells are subjected to a sphering treatment.

The method according to claims 1 to 15, wherein the preservation solution has a pH of 5.0 to 9.0 and an osmotic pressure of 300 to 8000 sm/kg-H₂O and comprises 0.01 to 10g/L of preservative and 0.01 to 5g/L of stabilizer,

preferably, the preservative is at least one selected from the group consisting of caspases and aminoglycosides, and the stabilizer is at least one selected from the group consisting of imidazolidinyl ureas;

more preferably, the preservative is at least one caropine preservative and at least one aminoglycoside antibiotic.

The method according to any one of claims 1 to 16, wherein the erythrocytes are from a mammal, preferably a human or a mammal having an erythrocyte volume close to that of a human, such as a monkey or a pig.

An erythrocyte mimetic particle produced by the method of any one of claims 1 to 17.

A quality control or calibrator for a hematology analyzer, comprising the red blood cell simulating particles according to claim 18.

The quality control substance or calibrator of claim 19, wherein said quality control substance or calibrator further comprises at least one of a leukocyte-mimicking particle, a platelet-mimicking particle, and a nucleated red blood cell-mimicking particle.