CN101021456B - Method for producing tripartite group blood cell analyser diluent - Google Patents
Method for producing tripartite group blood cell analyser diluent Download PDFInfo
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- CN101021456B CN101021456B CN2007100515775A CN200710051577A CN101021456B CN 101021456 B CN101021456 B CN 101021456B CN 2007100515775 A CN2007100515775 A CN 2007100515775A CN 200710051577 A CN200710051577 A CN 200710051577A CN 101021456 B CN101021456 B CN 101021456B
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Abstract
A method to produce dilution of trisection group hemocyte analyzer, its production technology is: (1) purity water preparation, (2) buffer solution collocation, (3) solution collocation, (4) constant volume collocation and (5) filter filling. Active effects of this invention are: (1) Takes NaCl and Na2SO4 as essential component of dilution to lower cost. (2) Based on mol ratio of NaCl and Na2SO4 in dilution, optimal leukocyte classified result can be achieved effectively. (3) Using GMP quality managerial principle together with practical experience to constitute scientific and rational production technology. The production contains no preservative and its shelf life is two years. (4) Its technology simple and can realize industrialization easily.
Description
Technical field
The present invention relates to a kind of production method of tripartite group blood cell analyser diluent.
Background technology
Tripartite group blood cell analyser is that present China popularizes the routine blood test detecting instrument that uses, this quasi-instrument and reagent are import in China for a long time, high and supply of material reason such as untimely brings heavy financial burden and inconvenience for hospital and patient because of the reagent price.Popularize in the tripartite group blood cell analyser that uses in China, various brands are no less than 20 kinds, because the dilution ratio of various instruments and the difference of assay method, the agent prescription of various instruments has nothing in common with each other, the cellanalyzer of different model and manufacturer must use special-purpose matched reagent, and this is an important difficult point of cellanalyzer reagent exploitation.
The cellanalyzer cell count is to finish in the consistent electric field that dilution forms, the essence of dilution is exactly electrolyte solution, and different instruments are owing to the area requirement difference of the power of the electronic signal of pair cell formation, so slightly variant to electrolytical conductivity size requirements.Simultaneously because this parameter of mean corpuscular volume, the original osmotic pressure that requires to measure the pH value of environment and osmotic pressure and blood is approaching, otherwise the big young pathbreaker of mean corpuscular volume is because red blood cell rises greatly or shrinkage becomes greatly or diminish.
Various electric-resistivity method three classification cellanalyzer reagent preparation principles are basic identical, and composition is also similar mainly to be made up of chloride, sulfate, buffer system (phosphate or borate buffer etc.) etc.But different brands model instrument, because the software and hardware structure difference, its blood specimen consumption, dilution consumption and dilution are different with the amount ratio of hemolytic agent.Each concentration of component of dilution of instrument that causes the different brands model is different and can not be general.
Agent prescription in the past mainly is that physical and chemical indexs such as the pH value, osmotic pressure, conductivity according to dilution are adjusted the reagent preparation prescription.Its major defect is: 1, cost of products height; 2, adding antiseptic influence the classification and determination effect, increases production cost, and 3, dilution prescription composition ignored the influence to leukocyte differential count.
Summary of the invention
The production method that the purpose of this invention is to provide a kind of tripartite group blood cell analyser diluent, this method technical recipe is reasonable, does not add antiseptic.
The present invention is achieved like this, and the raw material of production mainly is NaCl, Na
2SO
4, KCL, ethylenediamine tetraacetic acid and phosphate buffer, its processing step is:
1, pure water preparation: pure water adopts the tap water preparation, and step comprises (1) electrodialysis desalination; (2) yin, yang ion exchange column desalination; (3) 0.22 microns super considered the filtering particulate, made pure electrical conductivity of water less than 5 μ s/cm;
2, damping fluid preparation: preparation 1/30M, the Na of PH6.0～8.0
2HPO
4-KH
2PO
41000 liters of damping fluids, fully mix even, 0.22 micron ultra-filtration filters;
3, dissolving preparation: 5～2000g ethylenediamine tetraacetic acid, 5～3000gKCL, 50～5000gNaCl, 50～20000gNa
2SO
4, and NaCl and Na
2SO
4Mol ratio between 0.5～1.5, with 100～500 liters of Na
2HPO
4-KH
2PO
4The damping fluid heating for dissolving is fully mixed evenly, cools off standby;
4, constant volume preparation: the solution that above-mentioned dissolving is standby and remaining phosphate buffer are mixed, and the usefulness conductivity is fully mixed even less than the pure water constant volume to 1000 of 5 μ s/cm liter.
5, filter can: the dilution that the constant volume mixing is good, filter with 0.22 micron super worry, with the can of 20L flexible plastic bucket, sealing, packing;
6, wrappage are handled: (1) 20L flexible packaging was soaked 6～12 hours with 5～30% liquid detergents; (2) conductivity is washed 3～4 times less than the pure pond of 5 μ s/cm, and requiring does not have till the foam; (3) swing and wash completely, water is emptied, add the formaldehyde of 50～1000 μ l in each packing, seal stand-by;
7, to require be to produce in the clean production environment of 300,000 grades clean room or relative closure to process of producing product.All production equipments and pipeline (comprising pure water cation exchange column equipment and pipeline afterwards) must soak with 5～30%NaOH solution after the preparation every day, emit NaOH solution before the preparation, with conductivity less than the purified rinse water of 5 μ s/cm 3～4 times, measure the wash water pH value near neutrality till.Last filtration can must be carried out as much as possible in confined conditions, and can finishes and packs at once.
The feature of this product is: the raw material of production mainly is NaCl, Na
2SO
4, KCL, ethylenediamine tetraacetic acid and phosphate buffer, prescription had both guaranteed that dilution conductivity, pH value and osmolar concentration meet instrument and measure requirement, had determined optimum N aCl and Na again
2SO
4Molar ratio range cooperates hemolytic agent to improve the accuracy that leukocyte differential count is measured.Do not add antiseptic in this formula for a product, adopt scientific and reasonable production technology to guarantee product quality, shelf life of products can reach 2 years.
Good effect of the present invention is: (1) NaCl and Na
2SO
4Be the main composition of dilution, the dilution cost is reduced; (2) by control NaCl and Na
2SO
4Molar ratio in dilution is effectively assisted and is obtained best leukocyte differential count result; (3) this product utilization GMP quality management principles in conjunction with practical experience, has been formulated scientific and reasonable production technology, and product does not add antiseptic, and the shelf-life can reach 2 years; (4) production technology of this method realizes industrialization simply, easily.
Embodiment
Embodiment one, be example with homemade TEK-II series tripartite group blood cell analyser diluent, its processing step is:
1, pure water preparation: pure water adopts the tap water preparation, and step comprises (1) electrodialysis desalination; (2) yin, yang ion exchange column desalination; (3) 0.22 microns super considered the filtering particulate.Require pure electrical conductivity of water less than 5 μ s/cm;
2, damping fluid preparation: preparation 1/30M, the Na of PH=7.0
2HPO
4-KH
2PO
41000 liters of damping fluids, fully mix even, 0.22 micron ultra-filtration filters;
3, dissolving preparation: ethylenediamine tetraacetic acid: 0.2g/l, potassium chloride: 0.28g/l, NaCl:2.74g/l, Na
2SO
4: 8.78g/l, wherein NaCl and Na
2SO
4Optimum mole ratio be 1: 1.30～1: 1.35, with 100～300 liters of Na
2HPO
4-KH
2PO
4The damping fluid heating for dissolving is fully mixed evenly, cools off standby;
4, constant volume preparation: the solution that above-mentioned dissolving is standby and remaining phosphate buffer are mixed, and the usefulness conductivity is fully mixed even less than the pure water constant volume to 1000 of 5 μ s/cm liter;
5, filter can: the dilution that the constant volume mixing is good, filter with 0.22 micron super worry, with the can of 20L flexible plastic bucket, sealing, packing;
6, wrappage are handled: (1) 20L flexible packaging was soaked 6～12 hours with 5～30% liquid detergents; (2) conductivity is washed 3～4 times less than the pure pond of 5 μ s/cm, and requiring does not have till the foam; (3) swing and wash completely, water is emptied, add the formaldehyde of 100～500 μ l in each packing, seal stand-by;
7, to require be to produce in the clean production environment of 300,000 grades clean room or relative closure to process of producing product.All production equipments and pipeline (comprising pure water cation exchange column equipment and pipeline afterwards) must soak with 5～30%NaOH solution after the preparation every day, emit NaOH solution before the preparation, with conductivity less than the purified rinse water of 5 μ s/cm 3～4 times, measure the wash water pH value near neutrality till.Last filtration can must be carried out as much as possible in confined conditions, and can finishes and packs at once.
Example: identical Morie osmolarity, different N aCl and Na
2SO
4The dilution of mol ratio be used with identical non-potassium cyanide haeomolytic agent, measure clinical blood sample result and be compared as follows.
Table 1 dilution prescription
The Morie osmolarity of 3 dilution prescriptions is identical in the table 1, and its physical and chemical index is approaching, and is as shown in table 2.
The physical and chemical index of table 2 dilution
Above-mentioned 3 different dilutions of prescription are measured 5 parts of clinical blood samples with identical autogamy non-potassium cyanide haeomolytic agent on the TEK-II tripartite group blood cell analyser, relatively find leukocyte differential count value difference, along with NaCl and Na
2SO
4The increase of mol ratio, the lymphocyte degree increases, the neutrophil leucocyte degree reduces.Table 3 is the leukocyte differential count test result of No. 1 blood sample.Table 4 is the leukocyte differential count test result of No. 2 blood samples.Table 5 is the leukocyte differential count test result of No. 3 blood samples.Table 6 is the leukocyte differential count test result of No. 4 blood samples.Table 7 is the leukocyte differential count test result of No. 5 blood samples.Table 8 is that autogamy TEK-II reagent and manual sort result compare.
Table 3 sample 1 leukocyte differential count test result
WBC is a quantity of leucocyte in the table, and LY% is the lymphocyte degree, and Mid% intermediate cell degree, GR% are the neutrophil leucocyte degree.
Table 4 sample 2 leukocyte differential count test results
Table 5 sample 3 leukocyte differential count test results
Table 6 sample 4 leukocyte differential count test results
Table 7 sample 5 leukocyte differential count test results
Table 8 autogamy TEK-II reagent and manual sort result are relatively
Table 9 classification comparability assay
By above statistics as can be known, autogamy non-potassium cyanide haeomolytic agent and dilution prescription are measured blood sample, and the correlativity that intermediate cell detects brings up to 75% by original 65%, has improved cellanalyzer clinical detection result's reliability thus greatly.
Claims (1)
1. the production method of a tripartite group blood cell analyser diluent is characterized in that production craft step is:
1) pure water preparation: pure water adopts the tap water preparation, and step comprises (1) electrodialysis desalination; (2) yin, yang ion exchange column desalination; (3) 0.22 microns ultra-filtration filters remove particulate, make pure electrical conductivity of water less than 5 μ s/cm;
2) damping fluid preparation: preparation 1/30M, the Na of PH6.0～8.0
2HPO
4-KH
2PO
41000 liters of damping fluids, fully mix even, 0.22 micron ultra-filtration filters;
3) dissolving preparation: 5～2000g ethylenediamine tetraacetic acid, 5～3000gKCL, 50～5000gNaCl, 50～20000gNa
2SO
4, and NaCl and Na
2SO
4Mol ratio between 0.5～1.5, with 100～500 liters of Na
2HPO
4-KH
2PO
4The damping fluid heating for dissolving is fully mixed evenly, cools off standby;
4) constant volume preparation: solution that above-mentioned dissolving is standby and remaining Na
2HPO
4-KH
2PO
4Damping fluid is mixed, less than the pure water constant volume to 1000 of 5 μ s/cm liter, fully mixes even with conductivity;
5) filter can: the dilution that the constant volume mixing is good, with 0.22 micron ultra-filtration filters, with the can of 20L flexible plastic bucket, sealing, packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007100515775A CN101021456B (en) | 2007-02-12 | 2007-02-12 | Method for producing tripartite group blood cell analyser diluent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007100515775A CN101021456B (en) | 2007-02-12 | 2007-02-12 | Method for producing tripartite group blood cell analyser diluent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101021456A CN101021456A (en) | 2007-08-22 |
| CN101021456B true CN101021456B (en) | 2010-11-10 |
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ID=38709291
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2007100515775A Expired - Fee Related CN101021456B (en) | 2007-02-12 | 2007-02-12 | Method for producing tripartite group blood cell analyser diluent |
Country Status (1)
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|---|---|
| CN (1) | CN101021456B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101281193B (en) * | 2008-06-04 | 2010-11-10 | 南昌百特生物高新技术股份有限公司 | Blood cell analyzer dilution |
| CN103004749A (en) * | 2012-12-17 | 2013-04-03 | 江苏美诚生物科技有限公司 | Diluent for hematology analyzer |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1238455A (en) * | 1998-06-04 | 1999-12-15 | 梁建华 | Diluent and cleaning liquid for blood analysis counter |
-
2007
- 2007-02-12 CN CN2007100515775A patent/CN101021456B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1238455A (en) * | 1998-06-04 | 1999-12-15 | 梁建华 | Diluent and cleaning liquid for blood analysis counter |
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|---|---|
| CN101021456A (en) | 2007-08-22 |
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Inventor after: Lan Haijun Inventor after: Tu Zongcai Inventor after: Luo Liping Inventor after: Xiang Shengluo Inventor after: Liu Chengmei Inventor after: Bi Shuangtong Inventor after: Zhang Zhaoqin Inventor after: Yang Shuibing Inventor after: Luo Shunjing Inventor after: Zou Changchun Inventor before: Luo Shunjing Inventor before: Liu Chengmei Inventor before: Zou Changchun Inventor before: Tu Zongcai |
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Free format text: CORRECT: INVENTOR; FROM: LUO SHUNJING LIU CHENGMEI ZOU CHANGCHUN TU ZONGCAI TO: LAN HAIJUN LUO LIPING XIANG SHENGLUO LIU CHENGMEI BI SHUANGTONG ZHANG ZHAOQIN YANG SHUIBING LUO SHUNJING ZOU CHANGCHUN TU ZONGCAI Free format text: CORRECT: ADDRESS; FROM: 330031 NO. 999, XUEFU AVENUE, HONGGUTAN NEW DISTRICT, NANCHANG CITY, JIANGXI PROVINCE TO: 330000 NO. 1666, JINSHA 2ND ROAD, XIAOLAN INDUSTRIAL PARK, NANCHANG CITY, JIANGXI PROVINCE |
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