CN102128917A - Clinical biochemical quality control products and preparation process thereof - Google Patents
Clinical biochemical quality control products and preparation process thereof Download PDFInfo
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- CN102128917A CN102128917A CN2010105767736A CN201010576773A CN102128917A CN 102128917 A CN102128917 A CN 102128917A CN 2010105767736 A CN2010105767736 A CN 2010105767736A CN 201010576773 A CN201010576773 A CN 201010576773A CN 102128917 A CN102128917 A CN 102128917A
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Abstract
The invention discloses clinical biochemical quality control products and a preparation process thereof. Multiple clinical biochemical quality control products are prepared by using the combined effect of trehalose, multiple complex enzyme stabilizers, complex protein protectant and complex enzyme protectant; and the products have low viscosity, are easily complexly dissolved and mixed uniformly and have low matrix effects. The products protect enzymes such as ALT, AST, TBIL, DBIL, TBA, ALP, gamma-GT, CHO, TP, ALB, BUN, CR, UA, GLU, TG, HDL-C, LDL-C, Apo-A1, Apo-B, LDH, CK, CK-MB, AMY, ADA and the like or proteins, lipids and metabolites thereof respectively, and have good stability; if the sealed products are stored at the temperature of 20 DEG C below zero, the valid period is 12 months; if the products are stored at the temperature of between 2 and 8 DEG C, the valid period is at least 6 months; and due to long valid period stability, the products can meet the control requirements of clinical biochemical examination and quality control.
Description
Technical field
The present invention relates to the protection liquid of the multinomial clinical biochemical index of human or animal's fresh serum or blood plasma and preparation and the biochemistry quality control product or the Quality Control thing fabricating technology of stabilizing agent.
Background technology
Along with Biochemical Analyzer and biochemical reagents thereof are widely used in clinical medical inspection, supporting multinomial clinical biochemical quality-control product seems particularly important to its quality control.Analyze in the quality control process at clinical biochemical, the periodic calibration and the quality control thereof of Biochemical Analyzer are absolutely necessary, and new instrument is installed, changes between the reagent, chamber of different batches or indoor Quality Control occurs all should carrying out the calibration of instrument after unusual, each maintenance.The matching used quality-control product of Biochemical Analyzer is the quality control material (definite value and non-definite value) that is used for in-vitro diagnosis, be material, material, article or the equipment that a kind of detection system that is intended to be used for medical usage is used, its objective is estimate or confirmatory measurement precision, accuracy of measurement, because the performance characteristics such as the issuable analysis deviation of change detecting system of reagent or analytical instrument.The quality control material can be used for quality control in proficiency testing, the laboratory.The reliability of the testing result of Biochemical Analyzer and biochemical reagents combination depends on the monitoring of quality-control product, could guarantee the accuracy of reporting the result and the comparability of different experiments chamber testing result.Quality-control product is as the metrology traceability of Biochemical Analyzer measurement result, estimates and guarantees the clinical trial unique foundation of accuracy as a result.At present, the Biochemical Analyzer quality control method adopts usually: the calibration object calibration Biochemical Analyzer and the matched reagent that 1. are suitable for, 2. use the quality-control product that is suitable for to carry out quality monitoring, 3. analysis and judgement biochemistry detection result's reliability.
Summary of the invention
The object of the invention provides a kind of clinical biochemical quality-control product and preparation technology thereof.The freeze-drying quality-control product viscosity of clinical biochemical quality-control product of the present invention is low, redissolves easily and mixing, and matrix effect is less.
The present invention utilizes trehalose and multiple complex enzyme stabilizing agent and compound protein protective agent, the protectant combined effect of complex enzyme; Comprise protective agent (code name is SH001), stabilizing agent (code name is SH060); Both become multinomial clinical biochemical quality-control product by proper proportion and human or animal's serum (or blood plasma) combination freeze-drying.
Biochemistry quality control product prescription of the present invention is formed and is comprised SH001 protective agent, SH060 stabilizing agent; Both combine by proper proportion and human or animal's serum (or blood plasma):
⑴, SH001 protective agent are prepared by following component and concentration range: chemical reagent is pure for analyzing; sodium chloride 4.0～6.0g/L, citric acid 0.1～0.5g/L, sodium citrate 1.0～2.5g/L, sodium dihydrogen phosphate 0.5～1.5g/L, adenine 0.1～0.8g/L, compound protein protective agent HPD(Protein protectant HPD) 0.5～2.0g/L, dithiothreitol (DTT) (DTT) 1.0～5.0g/L, biological bacteriostatic agent is an amount of.
⑵, SH060 stabilizing agent are prepared by following component and concentration range: chemical reagent is pure for analyzing; its concentration range is respectively: sweet mellow wine 6.0～16.0g/L, trehalose 5.0～10g/L, glycerine 2.0～5.0g/L, complex enzyme protective agent HP 1.0～5.0g/L, complex enzyme stabilizing agent AES 2.5～6.0g/L, bovine serum albumin(BSA) (bovine serum albumin, BSA) 1.0～2.5g/L, sodium azide 0.2～0.6g/g.
⑶, SH001 protective agent and SH060 stabilizing agent preparation back are placed 2～8 ℃ of refrigerators and are preserved stand-by.
The multinomial clinical biochemical quality-control product of the present invention step of preparation process is as follows:
⑴, matrix source: the healthy people's blood donation of Blood Center or animal derived whole blood or serum or blood plasma.
⑵, quality requirements: infectiousness indexs such as biological borne causal agent such as hepatitis type B virus (HBsAg), anti-HCV, anti-HIV are all negative.
⑶, haemocyte separate: get the mankind (or animal derived) fresh whole blood 200～400mL, putting horizontal centrifuge 3000 leaves heart 30min and makes haemocyte composition and serum or separating plasma, slowly draw supernatant, count its volume X mL(X and be 100～250mL) stand-by.
⑷, biochemical component protection: in 200mL serum or blood plasma matrix, slowly add SH001 protective agent 50～60 mL, shake up gently and put 2 ℃～8 ℃ 4～8h and preserve stand-by.
⑸, biochemical component are stablized: serum or blood plasma that above-mentioned steps ⑷ handles through protection, slowly add SH060 stabilizing agent 30～40mL again, and fully 2 ℃～8 ℃ 4～8h preservations are put in sealing behind the mixing.
⑹, sampling detect: get two whiles of 1～2mL and detect at the TC6060 automatic clinical chemistry analyzer, whether observation ALT, AST, TBIL, DBIL, TBA, ALP, γ-GT, CHO, TP, ALB, BUN, CR, UA, GLU, TG, HDL-C, LDL-C, Apo-A1, Apo-B, LDH, CK, CK-MB, AMY, ADA, Ca, IP, K, Na, clinical biochemical indexs such as CL, Mg meet the requirement of multinomial clinical biochemical quality-control product sign value.As do not meet and then add the high, medium and low value quality-control product that corresponding biochemical component is mixed with three levels respectively.
⑺, packing and freeze-drying are preserved: adopt Brown Glass Brown glass bottles and jars only that multinomial clinical biochemical quality-control product is pressed certain specification, as quantitatively packing such as 1ml, 2ml, 4ml, 5ml, snap frozen, put 24 ~ 30h freeze-drying in the medical freeze drier, seal preservation.
When separating, haemocyte avoids haemolysis, the essential clean and autoclave sterilization sterilization of employed experiment utensil; Quality-control product prepares overall process must sterile working or carry out in 100,000 grades of environment purifications.
Clinical biochemical quality-control product quality monitoring of the present invention:
⑴, redissolution: get quality-control product 2.0mL * 20, accurately add the 2.0ml double distilled water and make its redissolution;
⑵, homogeneity are measured: carry out with reference to " external diagnosis reagent calibration object, quality-control product investigative technique governing principle ".
⑶, definite value quality-control product assignment: calibration object (as Roche or Randox) the calibration Biochemical Analyzer (as TC6060) and the supporting biochemical reagents of selecting to have real traceability, measure the quality-control product of 20 redissolution then by the instrument operation instructions, the quality-control product reference range is calculated in statistical study.
Clinical biochemical quality-control product employing trehalose of the present invention and multiple complex enzyme stabilizing agent and compound protein protective agent, the protectant combined effect of complex enzyme; Have substance protection and stabilizations such as protein, enzyme and lipid in the blood, on the one hand, kept enzyme and the needed environment of protein structure physiologically active; On the other hand, stabilizing agent can be enzyme and albumen raising usefulness; Be to adopt freeze drying technology to be more conducive to the long preservation of various biochemical components once more.Therefore, the quality-control product for preparing is through biological traceability chain program and reference method assignment thereof; Can be used as Biochemical Analyzer before the deadline and the quality-control product of the biochemical reagents that match, satisfy clinical biochemical check demand.
The freeze-drying quality-control product viscosity of the present invention's development is low, redissolves easily and mixing, and matrix effect is less; Preserving the term of validity below the airtight postposition-20 ℃ was 12 each months, preserved time limit for 2 ℃～8 ℃ and was at least 6 months, and 2 ℃～8 ℃ preservations of uncork use can be stablized a week.
Specific embodiment
Clinical biochemical quality-control product of the present invention comprises SH001 protective agent and SH060 stabilizing agent.
Clinical biochemical quality-control product prescription of the present invention is composed as follows:
(1), SH001 protective agent: sodium chloride 5.0g/L, citric acid 0.25g/L, sodium citrate 2.0g/L, sodium dihydrogen phosphate 1.0g/L, adenine 0.5g/L, compound protein protective agent HPD 1.0g/L, dithiothreitol (DTT) (DTT) 2.5g/L, biological bacteriostatic agent an amount of (0.5%).
(2), SH060 stabilizing agent: sweet mellow wine 8.0g/L, trehalose 7.5g/L, glycerine 4.0g/L, complex enzyme protective agent HP 2.5g/L, complex enzyme stabilizing agent AES 4.0g/L, BSA 2.0g/L sodium azide 0.5g/g.
The multinomial clinical biochemical quality-control product of the present invention step of preparation process is as follows:
⑴, matrix source: the healthy people's blood donation of Blood Center or animal derived whole blood or serum or blood plasma.
⑵, quality requirements: infectiousness indexs such as biological borne causal agent such as hepatitis type B virus (HBsAg), anti-HCV, anti-HIV are all negative.
(3), haemocyte separates: get the mankind (or animal derived) fresh whole blood 200mL, put horizontal centrifuge 3000 and leave the heart 30min haemocyte composition is separated with serum (blood plasma), slowly draw supernatant, counting its volume is that 100mL is stand-by.
(4), biochemical component protection: in 100mL serum (blood plasma) matrix, slowly add SH001 protective agent 25mL, shake up gently and put 2～8 ℃ of 4～8h and preserve stand-by.
(5), biochemical component is stablized: through protecting the serum of handling (blood plasma), slowly add SH060 stabilizing agent 25mL again, fully 2 ℃～8 ℃ 4～8h preservations are put in sealing behind the mixing.
(6), sampling detects: get one of 1mL and detect at the TC6060 automatic clinical chemistry analyzer, observe 30 indexs of clinical biochemical and whether meet the requirement of biochemical intermediate value quality-control product level.
(7), packing and freeze-drying are preserved: adopt Brown Glass Brown glass bottles and jars only that multinomial clinical biochemical quality-control product is pressed the quantitative packing of 2.0ml, snap frozen, put 24h freeze-drying in the medical freeze drier, seal preservation.
(8), definite value quality-control product assignment: calibration object (as Roche) the calibration TC6060 Biochemical Analyzer and the supporting biochemical reagents of selecting to have real traceability, measure the quality-control product of 20 redissolution then by the instrument operation instructions, the quality-control product reference range is calculated in statistical study.
(9), preservation and clinical use: multinomial clinical biochemical quality-control product seals rearmounted 2 ℃～8 ℃ or-20 ℃ of preservations, uses for the clinical biochemical analysis.
Claims (2)
1. a clinical biochemical quality-control product is characterized in that: comprise protective agent (SH001) and stabilizing agent (SH060); Both combine by proper proportion and human or animal's serum or blood plasma;
(1), protective agent (SH001) is formed and concentration range: sodium chloride 4.0～6.0g/L, citric acid 0.1～0.5g/L, sodium citrate 1.0～2.5g/L, sodium dihydrogen phosphate 0.5～1.5g/L, adenine 0.1～0.8g/L, compound protein protective agent HPD 0.5～2.0g/L, dithiothreitol (DTT) (DTT) 1.0～5.0g/L, biological bacteriostatic agent are an amount of;
(2), stabilizing agent (SH060) is formed and concentration range:
Sweet mellow wine 6.0～16.0g/L, trehalose 5.0～10g/L, glycerine 2.0～5.0g/L, complex enzyme protective agent HP 1.0～5.0g/L, complex enzyme stabilizing agent AES 2.5～6.0g/L, BSA 1.0～2.5g/L sodium azide 0.2～0.6g/g.
2. the preparation technology of a clinical biochemical quality-control product is characterized in that: preparation according to the following steps,
(1), haemocyte separates: get human or animal derived fresh whole blood 200～400mL, put horizontal centrifuge 3000 and leave heart 30min and make haemocyte composition and serum or separating plasma, slowly draw supernatant, count its volume and be 100～250mL, stand-by;
(2), biochemical component protection: slowly add SH001 protective agent 50～60 mL in 200mL serum or blood plasma matrix, shake up gently and put 2～8 ℃, it is stand-by to preserve 4～8h;
(3), biochemical component is stable: serum or blood plasma through above-mentioned protection is handled, slowly add SH060 stabilizing agent 30～40mL again, fully sealing is put 2～8 ℃ behind the mixing, 4～8h preserves;
(4), sampling detects: get two whiles of 1～2mL and detect at the TC6060 automatic clinical chemistry analyzer, observe ALT, AST, TBIL, DBIL, TBA, ALP, γ-GT, CHO, TP, ALB, BUN, CR, UA, GLU, TG, HDL-C, LDL-C, Apo-A1, Apo-B, LDH, CK, CK-MB, AMY, ADA, Ca, IP, K, Na, CL, Mg totally 30 clinical biochemical indexs add corresponding biochemical component and can be mixed with quality-control product;
(5), packing and freeze-drying are preserved: adopt Brown Glass Brown glass bottles and jars only that multinomial clinical biochemical quality-control product is pressed the quantitative packing of certain specification, snap frozen, put 24 ~ 30h freeze-drying in the medical freeze drier, seal preservation.
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| CN112904028A (en) * | 2021-01-21 | 2021-06-04 | 宁波职业技术学院 | Serum amyloid protein A quality control product and preparation method thereof |
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Application publication date: 20110720 |