CN116448990A - Sheath liquid for analyzing urinary sediment - Google Patents

Sheath liquid for analyzing urinary sediment Download PDF

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Publication number
CN116448990A
CN116448990A CN202310513386.5A CN202310513386A CN116448990A CN 116448990 A CN116448990 A CN 116448990A CN 202310513386 A CN202310513386 A CN 202310513386A CN 116448990 A CN116448990 A CN 116448990A
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China
Prior art keywords
sodium
urinary sediment
sheath fluid
urine
sheath liquid
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Pending
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CN202310513386.5A
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Chinese (zh)
Inventor
章志勇
张琳
刘持卿
邵长伟
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Zhongxia Medical Technology Qingdao Co ltd
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Zhongxia Medical Technology Qingdao Co ltd
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Priority to CN202310513386.5A priority Critical patent/CN116448990A/en
Publication of CN116448990A publication Critical patent/CN116448990A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention belongs to the technical field of in-vitro diagnostic reagents, and particularly relates to a sheath fluid for analyzing urinary sediment. The sheath liquid for analyzing urinary sediment of the invention comprises the following raw materials: sodium chloride, anhydrous sodium sulfate, glycerol, EDTA-2K, tween-80, sodium pyrithione, BIT20% -D, hydrochloric acid, tris buffer, sodium tetraborate, boric acid, 8-hydroxyquinoline sulfate, disodium hydrogen phosphate and sodium dihydrogen phosphate. According to the invention, the surfactant is added into sheath liquid required by a urinary sediment channel for urine detection, so that bioactive components with different polarities and solubilities contained in urine can be well dissolved in the sheath liquid, which is favorable for realizing good drainage of urine in the urine detection process.

Description

Sheath liquid for analyzing urinary sediment
Technical Field
The invention belongs to the technical field of in-vitro diagnostic reagents, and particularly relates to a sheath fluid for analyzing urinary sediment.
Background
Urine sediment analysis is a most conventional detection way in urine analysis and is also the most direct basis for judging whether a patient has health conditions of parts such as kidneys, wherein sheath liquid for urine sediment analysis is a necessary reagent for the urine sediment detection process, and the principle of action is that a urine sample enters a urine analyzer under the drainage of the sheath liquid to further realize the detection of urine.
However, since urine is one of body fluids, the bioactive components contained therein are complex, including creatinine, phosphate, various hormones, trace elements, urea, uric acid, and the like, and even, even if the urine contains Red Blood Cells (RBC), white Blood Cells (WBC), epithelial Cells (EC), and the like, due to pathological changes of the body, the urine contains blood cells such as urine tube (CAST), and the like, the detection of the above components in urine sediment can be well realized to examine the physical health condition of a patient. However, the above components may have poor solubility, poor dyeing condition, and blocked equipment due to the difference of the respective polarities and solubility, and the like, so that the urine needs to be guided by the sheath liquid before being introduced into the urine sediment detector, and the sheath liquid needs to provide a certain conductivity to realize the detection of the urine.
However, the existing urine analyzers and sheath liquid for urine analysis have few researches, mainly depend on import, have high reagent price, are easy to precipitate or crystallize when being used for urine sediment analyzers, and are easy to cause blockage of components in the urine analyzers.
Disclosure of Invention
In order to solve the technical problems, the invention provides a sheath liquid for analyzing urinary sediment.
The sheath liquid for analyzing the urinary sediment provided by the invention comprises the following raw materials: sodium chloride, anhydrous sodium sulfate, glycerol, hydrochloric acid, tris buffer, sodium tetraborate, boric acid, disodium hydrogen phosphate and sodium dihydrogen phosphate.
The sheath liquid for urinary sediment analysis further comprises a nonionic surfactant, wherein the nonionic surfactant is selected from any one of Tween-80, tween-60 and Tween-20.
Preferably, the nonionic surfactant contained in the sheath liquid for urinary sediment analysis is tween-80.
The sheath liquid for urinary sediment analysis also comprises a complexing agent, wherein the complexing agent is ethylene diamine tetraacetic acid dipotassium.
The sheath liquid for analyzing the urinary sediment also contains preservative sodium pyrithione and 1-2 benzisothiazolin-3-one.
Preferably, the mass fraction of the preservative 1-2 benzisothiazolin-3-one is more than or equal to 20%.
Further, the sheath liquid for analyzing urinary sediment provided by the invention comprises the following raw materials in concentration: 7-10 g/L of sodium chloride, 28-36 g/L of anhydrous sodium sulfate, 35-45 g/L of glycerin, 0.21-0.41 g/L of ethylene diamine tetraacetic acid, 0.71-0.91 g/L of tween-80, 0.39-0.59 g/L of sodium pyrithione, 0.59-0.89 g/L of 1-2 benzisothiazolin-3-one, 0.8-1.5 g/L, tris g/L of hydrochloric acid buffer solution, 1.45-2.48 g/L of sodium tetraborate, 0.3-0.8 g/L of boric acid, 0.2-0.6 g/L of 8-hydroxyquinoline sulfate, 0.15-0.5 g/L of disodium hydrogen phosphate and 0.11-0.55 g/L of sodium dihydrogen phosphate.
Preferably, the sheath liquid for analyzing the urinary sediment comprises the following raw materials in concentration: 7.5 to 9.5g/L of sodium chloride, 30 to 34g/L of anhydrous sodium sulfate, 38 to 40g/L of glycerin, 0.25 to 0.35g/L of ethylene diamine tetraacetic acid, 0.8 to 0.86g/L of tween-80, 0.45 to 0.55g/L of sodium pyrithione, 0.62 to 0.8g/L of 1-2 benzisothiazolin-3-one, 1 to 1.5g/L, tris of hydrochloric acid buffer solution, 1.5 to 2g/L of sodium tetraborate, 0.4 to 0.6g/L of boric acid, 0.3 to 0.5g/L of 8-hydroxyquinoline sulfate, 0.2 to 0.4g/L of disodium hydrogen phosphate and 0.3 to 0.5g/L of sodium dihydrogen phosphate.
The pH value of the sheath liquid for analyzing the urinary sediment provided by the invention is 6.6-9.0 at room temperature, the conductivity is 30-50, and the osmotic pressure is 1030-1185 mosm/kg.
The invention has the beneficial effects that:
(1) According to the sheath liquid for urine sediment analysis, the pH of the sheath liquid is maintained to be 6.6-9.0 at room temperature by adding various buffer preparations and is almost consistent with the pH range of body fluid, meanwhile, the prepared sheath liquid also has higher osmotic pressure, and when the sheath liquid is combined with the dilution liquid for urine sediment analysis, a urine sample can smoothly enter the urine analyzer under the action of the higher osmotic pressure, so that the detection of the urine sample is realized;
(2) According to the invention, the surfactant, namely Tween-80, is added into sheath liquid required by the urine sediment detection channel, so that bioactive components with different polarities and solubilities contained in urine can be better dissolved in the sheath liquid, and good drainage of the urine can be realized in the urine detection process;
(3) In addition, the ethylene diamine tetraacetic acid dipotassium (EDTA-2K) is added into the sheath liquid, and the addition of the complexing agent is favorable for combining and removing easily-crystallized components such as phosphate, urea uric acid and the like possibly contained in urine before the urine enters the detection channel, so that the detection channel is prevented from being blocked due to crystallization of the components in the urine, and the smooth implementation of urine detection is facilitated.
Detailed Description
The present invention will now be further described in connection with specific embodiments in order to enable those skilled in the art to better understand the invention.
Example 1
Accurately weighing the following raw materials by mass, 10g of sodium chloride, 36g of anhydrous sodium sulfate, 45g of glycerin, 0.4g of EDTA-2K, 0.91g of tween-80, 0.59g of sodium pyrithione, 0.89g of 1-2 benzisothiazolin-3-one, 1.5g of hydrochloric acid, 2.48g of Tris buffer solution, 0.8g of sodium tetraborate, 0.6g of boric acid, 0.5g of 8-hydroxyquinoline sulfate, 0.5g of disodium hydrogen phosphate and 0.55g of sodium dihydrogen phosphate, and dissolving the raw materials in deionized water to prepare 1L of sheath liquid.
Example 2
Accurately weighing the following raw materials by mass, namely 7g of sodium chloride, 28g of anhydrous sodium sulfate, 35g of glycerol, 0.25g of EDTA-2K, 0.71g of tween-80, 0.39g of sodium pyrithione, 0.59g of 1-2 benzisothiazolin-3-one, 0.8g of hydrochloric acid, 1.45g of Tris buffer solution, 0.3g of sodium tetraborate, 0.2g of boric acid, 0.1g of 8-hydroxyquinoline sulfate, 0.1g of disodium hydrogen phosphate and 0.15g of sodium dihydrogen phosphate, and dissolving the raw materials in deionized water to prepare 1L of sheath liquid.
Example 3
Accurately weighing the following raw materials by mass, namely 8g of sodium chloride, 32g of anhydrous sodium sulfate, 40g of glycerol, 0.35g of EDTA-2K, 0.8g of tween-80, 0.45g of sodium pyrithione, 0.8g of 1-2 benzisothiazolin-3-one, 1.0g of hydrochloric acid, 2.0g of Tris buffer solution, 0.5g of sodium tetraborate, 0.4g of boric acid, 0.3g of 8-hydroxyquinoline sulfate, 0.3g of disodium hydrogen phosphate and 0.3g of sodium dihydrogen phosphate, and dissolving the raw materials in deionized water to prepare 1L of sheath liquid.
Comparative example 1
Based on example 3, no Tween-80 was added.
Comparative example 2
EDTA-2K was not added on the basis of example 3.
Comparative example 3
Accurately weighing the following raw materials by mass, namely 16g of sodium chloride, 16g of anhydrous sodium sulfate, 0g of glycerol, 0.35g of EDTA-2K, 0.8g of tween-80, 0.45g of sodium pyrithione, 0.8g of 1-2 benzisothiazolin-3-one, 0.75g of hydrochloric acid, 1.5g of Tris buffer solution, 1g of sodium tetraborate, 0.8g of boric acid, 0.3g of 8-hydroxyquinoline sulfate, 0.3g of disodium hydrogen phosphate and 0.3g of sodium dihydrogen phosphate, and dissolving the raw materials in deionized water to prepare 1L of sheath liquid.
Test example 1
The products prepared in examples 1 to 3 and comparative examples 1 to 3 were used for the detection of urine samples, and the detection results are shown in Table 1 below.
For ease of representation, the detected parameters are represented by the relevant symbols in the following table, in particular: RBC-red blood cell count; WBC-white blood cell count; epithelial cell count in EC-urine; CAST-urinary catheter type; BAST-cell count.
Table 1 results of the test for urine testing of the products of the examples and comparative examples
As can be seen from the above table, the sheath liquid for detecting urinary sediment prepared in each embodiment of the present invention has a good technical effect in the process of detecting and draining urine, and almost has the same effect as the existing market sheath liquid product, especially the sheath liquid product in embodiment 3 of the present invention has the highest accuracy.
In order to more intuitively show the detection accuracy of the product of the present invention versus the existing market products, the accuracy of the product of example 3 for urinary sediment detection is shown in table 2.
From the following table 2, it can be seen that the accuracy of the product of example 3 of the present invention when used for detection is more than 95%, and the average accuracy can be up to 99%.
TABLE 2 accuracy of application of the sheath fluid product of example 3 of the invention to urinary sediment detection
Test example 2
The economic accounting of the sheath phase related product for urinary sediment in the present invention is shown in Table 3.
TABLE 3 price list of sheath liquid products for urinary sediment in the market of the invention
From the above table 3, it can be seen that the price of the product of the present invention is compared with the price of the existing domestic or imported sheath liquid product for urinary sediment in the market: the product of the invention has obvious price advantage, and simultaneously combines the detection data of the table 1, namely the sheath liquid for urinary sediment prepared by the invention has the advantages of simple and easily obtained raw materials on the premise of reaching the technical effect almost equivalent to the existing products in the market, can completely meet the detection requirement, and can be used as an imported reagent or a good substitute of a high-price domestic reagent.

Claims (8)

1. The sheath fluid for analyzing the urinary sediment is characterized by comprising the following raw materials: sodium chloride, anhydrous sodium sulfate, glycerol, hydrochloric acid, tris buffer, sodium tetraborate, boric acid, disodium hydrogen phosphate and sodium dihydrogen phosphate.
2. The sheath fluid for urinary sediment analysis of claim 1 further comprising a nonionic surfactant selected from the group consisting of tween-80, tween-60 and tween-20.
3. The sheath fluid for urinary sediment analysis of claim 1, wherein the sheath fluid for urinary sediment analysis comprises a nonionic surfactant tween-80.
4. The sheath fluid for urinary sediment analysis of claim 1, wherein the raw material of the sheath fluid for urinary sediment analysis further comprises a complexing agent, and the complexing agent is ethylene diamine tetraacetic acid dipotassium.
5. The sheath fluid for urinary sediment analysis of claim 1, further comprising sodium pyrithione and 1-2 benzisothiazolin-3-one as preservatives.
6. The sheath fluid for urinary sediment analysis according to claim 5, wherein the mass fraction of the preservative 1-2 benzisothiazolin-3-one in the raw material of the sheath fluid is not less than 20%.
7. The sheath fluid for urinary sediment analysis of claim 1, wherein the concentration of each raw material in the sheath fluid is: 7-10 g/L of sodium chloride, 28-36 g/L of anhydrous sodium sulfate, 35-45 g/L of glycerin, 0.21-0.41 g/L of ethylene diamine tetraacetic acid, 0.71-0.91 g/L of tween-80, 0.39-0.59 g/L of sodium pyrithione, 0.59-0.89 g/L of 1-2 benzisothiazolin-3-one, 0.8-1.5 g/L, tris g/L of hydrochloric acid, 1.45-2.48 g/L of buffer solution, 0.3-0.8 g/L of sodium tetraborate, 0.2-0.6 g/L of boric acid, 0.1-0.5 g/L of 8-hydroxyquinoline sulfate, 0.15-0.5 g/L of disodium hydrogen phosphate and 0.11-0.55 g/L of sodium dihydrogen phosphate.
8. The sheath fluid for urinary sediment analysis of claim 1, wherein the concentration of each raw material in the sheath fluid is: 7.5-9.5 g/L of sodium chloride, 30-34 g/L of anhydrous sodium sulfate, 38-40 g/L of glycerin, 0.25-0.35 g/L of ethylene diamine tetraacetic acid, 0.8-0.86 g/L of tween-80, 0.45-0.55 g/L of sodium pyrithione, 0.62-0.8 g/L of 1-2 benzisothiazolin-3-one, 1-1.5 g/L, tris of hydrochloric acid buffer solution, 1.5-2 g/L of sodium tetraborate, 0.4-0.6 g/L of boric acid, 0.3-0.5 g/L of 8-hydroxyquinoline sulfate, 0.2-0.4 g/L of disodium hydrogen phosphate and 0.3-0.5 g/L of sodium dihydrogen phosphate.
CN202310513386.5A 2023-05-09 2023-05-09 Sheath liquid for analyzing urinary sediment Pending CN116448990A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102998437A (en) * 2012-11-26 2013-03-27 江苏美诚生物科技有限公司 Sheath fluid used for urinary sediment analysis and preparation method thereof
CN105122034A (en) * 2013-03-15 2015-12-02 艾瑞思国际股份有限公司 Flowcell, sheath fluid, and autofocus systems and methods for particle analysis in urine samples
CN111781128A (en) * 2020-06-15 2020-10-16 迪瑞医疗科技股份有限公司 Sheath fluid for urine analyzer and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102998437A (en) * 2012-11-26 2013-03-27 江苏美诚生物科技有限公司 Sheath fluid used for urinary sediment analysis and preparation method thereof
CN105122034A (en) * 2013-03-15 2015-12-02 艾瑞思国际股份有限公司 Flowcell, sheath fluid, and autofocus systems and methods for particle analysis in urine samples
CN111781128A (en) * 2020-06-15 2020-10-16 迪瑞医疗科技股份有限公司 Sheath fluid for urine analyzer and preparation method thereof

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