CA1076008A - Stabilized hematological reagent solutions - Google Patents

Stabilized hematological reagent solutions

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Publication number
CA1076008A
CA1076008A CA265,047A CA265047A CA1076008A CA 1076008 A CA1076008 A CA 1076008A CA 265047 A CA265047 A CA 265047A CA 1076008 A CA1076008 A CA 1076008A
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CA
Canada
Prior art keywords
solution
sodium
phenoxyethanol
fluoride
alkali metal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA265,047A
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French (fr)
Inventor
Douglas Armstrong
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coulter Electronics Inc
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Coulter Electronics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US05/670,924 external-priority patent/US4102810A/en
Application filed by Coulter Electronics Inc filed Critical Coulter Electronics Inc
Application granted granted Critical
Publication of CA1076008A publication Critical patent/CA1076008A/en
Expired legal-status Critical Current

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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
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • 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
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

STABILIZED HEMATOLOGICAL REAGENT SOLUTIONS

ABSTRACT
The conjoint use of an ethoxylated phenol such as 2-phenoxyethanol, as a bacteriostatic and fungistatic agent and an alkali metal fluoride such as sodium fluoride as a stabilizer in a system used for specified hematological reagents. Sodium fluoride is added as a counterbalancing agent to the action of 2-phenoxyethanol, and in some instances functions also as an anticorrosion agent for certain solutions. A solution employing 2-phenoxyethanol and sodium fluoride is described employed as a water bath additive, as a cleaning solution for electronic particle counting apparatus, as a lysing reagent and as an artificial plasma which can be used as a control in blood sample, analysis.

Description

10~6008 BACKGROUND OF THE INVENTION
This invention concerns the use of 2-phenoxyethanol as a bacteriostatic and fungistatic agent and sodium fluoride as a stabilization agent in reagents utilized in hematological studies utilizing electronic particle analysis apparatus of the COULTER type.

In Canadian Patent 1,a45,960, there was disclosed a multipurpose, electrolytic solution for use in hematological procedures principally, enumeration of blood cells and the determination of hemoglobin concentration and other important parameters of a blood sample by means of automated electronic particle analysis apparatus of the COULTER type. The solution was balanced osmotically for mean cell volume stability, was azide-free and utilized
2-phenoxyethanol as a bacteriostatic and fungistatic agent.
Sodium fluoride was employed to counterbalance the cell wall weakening activity of 2-phenoxyethanol and thus `
stabilize the mean cell volume of the red cells. Also, sodium fluoride served to aid in the conversion of hemoglobin to cyanmethemoglobin for the determination of hemoglobin colorimetrically.
The use of a bacteriostatic and fungistatic agent brings about heretofore undesirable variations in the mean cell volume of the red cells leading to the unstabilization of the mean red cell volume. In the desirability of utiliz-ing a bacteriostatic agent as a replacement for sodium azide,as explained in Canadian Patent 1,045,960, 2-phenoxyethanol was selected although it had never been employed heretofore in such capacity. However, the 2-phenoxyethanol may lead to the destruction of the cell walls or change of cell volume. In order to avoid the problems of hemolysis or crenation, a stabilizer was utilized in the resulting system. Although sodium fluoride had long been known to be a preservative, such as for preserving glucose in blood samples, its utility as a stabilizer with the resulting system was unexpected.

- 4 - `

~.~

SUMMARY OF THE INVENTION
The invention is directed to the combination of an ethoxylated phenol such as 2-phenoxyethanol and an alkali metal fluoride such as sodium fluoride as effective for use in other reagent solutions that are utilized for other purposes in hematoloqical analytical procedures, particularly those employing electronic particle study methods.

DESCRIPTION OF THE PREFERRED EMBODIMENTS
I have discovered that 2-phenoxyethanol and sodium fluoride, could be utilized in a resulting system or combination in a red blood cell lysing reagent. Such a lysing reagent must be able to lyse the red cells quickly, destroying the red cell membrane to a particle size sufficient-ly low that white cells can be sensed and counted, for example.
Simultaneously, the lysing agent must release hemoglobin from the red cells, and the hemoglobin converted to cyanmethemoglobin so as to enable colorimetric determinations to proceed. The combination of the aforementioned two agents provided extremely active antibacterial and antifungal functions, particularly when combined with a quaternary ammonium compound. The use of sodium fluoride maintained the fluoride concentration and also aided in the conversion of hemoglobin to the cyanmethemoglobin.
The utilization of colorimetric hemoglobin de-terminations requires a calibrator solution which is utilized for calibrating the colorimeter. Specifically, a calibrator solution is prepared from fresh saline washed human red blood 2~ cells which are lysed to destroy the red blood cell walls.
After complete lysis of the cells, the released hemoglobin is converted to cyanmethemoglobin and diluted to the required concentration for use in colorimetric determinations. One problem arising is the rediness of the hemoglobin solution to grow bacteria, particularly bacteria of the type whose growth is encouraged in the presence of the cyanide ion, the same being required for the formation of cyanmethemoglobin.

107~;008 2-Phenoxyethanol and sodium fluoride can be utilized, the 2-phenoxyethanol serving as a very active bacteriostatic agent, particularly, in the presence of a quaternary ammonium compound.
- 5 Blood cells taken from humans or animals when suspended in a suitable medium or synthetic plasma are utilized as a "control" or "calibrator" in the operation of blood cell counting instruments. The blood cells are obtained from humans, clotting being prevented by employing anti- O
coagulants. Plasma is removed by centrifugation and the red cells washed under sterile conditions with sterile saline solution, the cells being later packed down for subsequent suspension in a preserving and stabilizing medium. Accordingly, such a medium as an artificial plasma herein is provided which is formulated for adding to such separated red blood cells. The medium includes a diluent such as described in Canadian Patent 1,045,960 and further includes bovine albumin, lactose, and additional 2-phenoxyethanol. The solution is mixed thoroughly with the osmolality adjusted with sodium chloride to approxi-mately 370 milliosmoles per kilogram water. After adjusting the osmolality, the solution is filtered and the filtrate stored in sterile glass bottles. Sodium fluoride is present in the solution functioning as a cell volume stabilizer. The addition of the bovine albumin and the lactose has been made to provide further physical-chemical balance of the passage ~ 7 --of water across the cell membrane to the inside of the cell.
2-Phenoxyethanol is used as a bacteriostatic and fungistatic agent. The medium or solution then can be added to washed blood cells as required to produce the desired count.
The use of the 2-phenoxyethanol and sodium fluoride agents as a blanking reagent in hematological determinations is contemplated.
Examples of preferred embodiments of the invention are as follows:
Approximate A. As a lysing reagent Unit Weight Example (1) Sodium chloride 7.936 grams/
li~er Potassium chloride 0.4 "
Sodium di-hydrogen phosphate 0.342 "
15 - Di-sodium phosphate 1.922 N
- Sodium Ethylenediaminetetracetic 0.3 "
acid (EDTA) - Sodium fluoride 0.5 "
2-Phenoxyethanol 3.3 "
Distilled Water quantity to produce one Quaternary Ammonium Compound, liter Bretol 10.0 grams/
liter Sodium Nitrite 0.20 "
Potassium Cyanide 0.6 "
Polyoxyethylated Alkylphenol 8.0 ml/liter Distilled water to 1000 ml Approximate B. As a blanking reagent Unit Weight (Example 12) Sodium chloride 7.847 grams/liter Potassium chloride 0.396 "
Mono sodium phosphate monohydrate 0.188 "
Di-sodium phosphate anydrons 2.071 "
Di-sodium EDTA, di-hydrate 0.376 "
2-Phenoxythanol 2.20 "
Sodium fluoride 0.495 "
Sodium nitroferricyanide 0.010 grams/liter Sodium nitrite 0.010 C.C.S.S. (Polyoxethylated Alkylphenol) General Analine 0.40 ml.
New York Film Bretol* (Fine Organics Co. New 0.500 grams/liter York) Distilled water to 1000 ml.
(1 gal.U.S. 3.785 Litre) - C. As a detergent cleaner having bacteriostatic, fungistatic and stabilizing characteristics Example (3) Sodium chloride 7.506 grams/liter Potassium chloride 0.379 "
Mono sodium phosphate mono-hydrate 0.180 n Di-sodium phosphate anydrons 1.846 grams/liter Di-sodium EDTA Di-hydrate 0.360 "
2-Phenoxyethanol (Dowanol*EPh) 2.10 "
Sodium fluoride 0.474 "

* Trade Mark _ g _ Approximate Unit Weight C.C.S.S.(Polyoxethylated Alkylphenol) 14.9 ml Lime Oil . 08 ml Green dye 0.56 ml Distilled water to 1000 ml (1 gal U.S. ~ 3.785 Litre) D. As a water bath additive Example (4) (a) As the Buffer system:
. 10 Triethanolamine Hydro-chloride 17.4 grams/
.liter Sodium Hydroxide,pellets 1.86 "
(b) As the anti-corrosion system and chelating agent:
Triethanolamine Hydro-- chloride (The amount indicated in ~a) above also functions for this purpose) Ethylenediamine tetracetic acid, tetrasodium salt4.00 n Sodium fluoride 20.00 "
(c) As the nonionic surfactant for cleaning (wetting agent) Pluronic*F-68, 20.00 "
(Manufactured by Wyn-dotte Chemicals Corp.) (d) pH indicator system:
Blue dye (French's Food 20.00 ml/
Dye) liter Bromo Cresol Purple 0.2 grams/
- liter Thymol Blue 0.4 "
(a), (b), (c) and (d) are mixed with enough distilled water to make 1000 ml and together when mixed added to the same volume (1000 ml) of 2-phenoxyethanol.

* Trade Mark i076008 The recommended volume for effective use is 1 volume of the resultant solution in 100 volumes distilled or deionized water.
During use, should there be a build-up of acid in the water bath, the following color changes take place as the pH falls:
pH Color Change 7.4 Definite blue 6.8 Greenish blue 6.5 Bluish green 6.0 Dark green 5.5 Light green E, As a control or calibrator solution;
Exa~ple (5~ ApproxL~ate Unit ~eight Sodium chloride 7,936 grams~liter - ~ Potassium chloride Q,4 ~' r Sodium di hydrogen phosphate Q,l9 Di~sodiu~ phosphate 1,922 n Sodium Ethylenediaminete-tracetic acid (EDTA) Q,3 Sodiu~ fluoride 0,5 2-phenpxyethan~l 3~3 ~' Distilled water quantity topro-duce one liter To 1000 ~1 of said solution is addedr Bovine albumin 3,4% by weight Lactose 4,3% ~
2-Phenoxyethanol to ~34%
Osmolality adjusted to approxi~ately 370 mosmols~kg water, ~076008 , .
The solutions specified above are adjusted to a pH of between 7 and 8, preferably, 7 2 - 7.5 by the suitable buffering agent, EDTA and phosphate salt. The osmolality of the solutions preferably is maintained at 320-340 milliosmoles. The concentration of sodium fluoride ranges fxom .03 to .1 percent by weight of total solution, with a preference of 0.05 percent, and the concentration of 2-phenoxyethanol ranges from 2 percent to 1.0 percent by weight of total solution, with a preference of ~34 percent in the calibrator or control solution, and 2 percent in the solutions used for other purposes.
The desirable characteristic of osmotic halance is procured through the judicious use of both sodium and potassium chloride. Buffering with use of sodium hydroxide is eliminated herein.
The use of osmotic balancing agents such as sodium chloride, potassium chloride and of buffering agents such as sodium hydroxide in such reagents is known. Also known ~as the use of a chelating agent which in cooperating with the phosphate salt employed served as buffering agents to achieve a desired pH range in which the diluent was operative. Such a chelating agent is ethylenediaminetetracetic acid (EDTA).
Preparation of the solutions do not require any special procedures or any special order of addition of ingredients to the water. Consequently, the invention does not concern any methodology in formulation of the diluent The mixture of ingredients is done mechanically by moderate stirring over a one to two hour period. The solution then is filtered through a 0.2 micron filter and storable in plastic containers directly.

. 1076008 ~ .~

Although preferred formulations have been specified above, the range of pH and osmolality may be broadened for useful purposes. Thus, the pH range may be maintained from between pH of 7.0 to 8Ø
Likewise, the useful range of osmolality can be between 300 to 380 milliosmoles. This can be accomplished by varying the amount of active ingredients.
It will be appreciated by the skilled artisan that the solutions described herein can be utilized in the same manner as previously available isotonic solution for the purposes described but avoids the adverse problems attendant in use of such prior solutions.
What I claim lS:

Claims (10)

The embodiment of the invention in which an exclusive property or privilege is claimed is defined as follows:
1. An isotonic, asmotically balanced aqueous solution for use in or in connection with hematological determinations, which comprises:
(i) sodium chloride, potassium chloride and one or more sodium phosphates, in osmotically balanced proportions, (ii) an alkali metal fluoride, (iii) 2-phenoxyethanol, (iv) ethylenediaminetetraacetic acid or an alkali metal salt thereof, and one or more of the following:
(v) a polyoxethylated alkylphenol, (vi) a quaternary ammonium compound, potassium cyanide and sodium nitrite, and (vii) bovine serum albumin and lactose.
2. A solution as defined in claim 1, in which the alkali metal fluoride is sodium fluoride.
3. A solution as defined in claim 1 wherein the alkali metal fluoride is present in a concentration of from 0.03 to 0.1% by weight.
4. A solution as defined in claim 1 wherein the alkali metal fluoride is sodium fluoride present in a concentration of from 0.03 to 0.1% by weight.
5. A solution as defined in any one of claims 1, 2 or 3 wherein the 2-phenoxyethanol is present in a concentration of from 0.2 to 1.0% by weight.
6. A solution as defined in claim 4 wherein the 2-phenoxyethanol is present in a concentration of from 0.2 to 1.0% by weight.
7. A solution as defined in any one of claims 1 to 3 wherein component (i) comprises sodium chloride, potassium chloride, sodium dihydrogen phosphate and disodium phosphate, in osmotically balanced proportions.
8. A solution as defined in claim 4 wherein component (i) comprises sodium chloride, potassium chloride, sodium dihydrogen phosphate and disodium phosphate, in osmotically balanced proportions.
9. A solution as defined in any one of claims 1, 2 or 3 which comprises components (i) to (iv) and component (v), and which also comprises a dispersed dye.
10. A solution as claimed in any one of claims 1, 2 or 3 having a pH of from 7.0 to 8.0 and an osmolality of from 300 to 380 milliosmoles.
CA265,047A 1976-03-26 1976-11-05 Stabilized hematological reagent solutions Expired CA1076008A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US05/670,924 US4102810A (en) 1975-01-13 1976-03-26 Stabilized hematological reagent solutions

Publications (1)

Publication Number Publication Date
CA1076008A true CA1076008A (en) 1980-04-22

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Application Number Title Priority Date Filing Date
CA265,047A Expired CA1076008A (en) 1976-03-26 1976-11-05 Stabilized hematological reagent solutions

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JP (1) JPS52117434A (en)
AU (1) AU511980B2 (en)
BE (1) BE849701A (en)
CA (1) CA1076008A (en)
CH (1) CH622619A5 (en)
DE (1) DE2709576A1 (en)
DK (1) DK62977A (en)
FI (1) FI770587A7 (en)
FR (1) FR2345164A1 (en)
GB (1) GB1572509A (en)
HK (1) HK90985A (en)
IL (1) IL50858A (en)
IT (1) IT1066691B (en)
MX (1) MX3977E (en)
NL (1) NL7613738A (en)
NO (1) NO770897L (en)
SE (1) SE7701509L (en)
ZA (1) ZA771549B (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4132598A (en) * 1977-06-03 1979-01-02 Modrovich Ivan Endre Stabilized liquid phosphate containing diagnostic compositions and method of preparing same
US4346018A (en) 1980-06-16 1982-08-24 Coulter Electronics, Inc. Multi-purpose blood diluent and lysing agent for differential determination of lymphoid-myeloid population of leukocytes
US4506018A (en) * 1982-12-30 1985-03-19 Becton, Dickinson And Company Blood diluent
DE4022878A1 (en) * 1990-07-18 1992-01-23 Boehringer Mannheim Gmbh PRESERVATION OF DIAGNOSTIC TESTS

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1493772A (en) * 1965-07-28 1967-09-01 Organon Nv Method for the treatment of erythrocytes
US3962125A (en) * 1975-01-13 1976-06-08 Coulter Diagnostics, Inc. Multi-purpose diluent for use in blood analysis by electronic instrumentation of the coulter type

Also Published As

Publication number Publication date
IL50858A0 (en) 1977-01-31
AU1987176A (en) 1978-06-01
IT1066691B (en) 1985-03-12
FR2345164A1 (en) 1977-10-21
BE849701A (en) 1977-04-15
ZA771549B (en) 1978-10-25
IL50858A (en) 1979-07-25
NL7613738A (en) 1977-09-28
SE7701509L (en) 1977-09-27
DK62977A (en) 1977-09-27
NO770897L (en) 1977-09-27
AU511980B2 (en) 1980-09-18
CH622619A5 (en) 1981-04-15
FI770587A7 (en) 1977-09-27
GB1572509A (en) 1980-07-30
DE2709576A1 (en) 1977-10-06
JPS52117434A (en) 1977-10-01
HK90985A (en) 1985-11-22
MX3977E (en) 1981-10-20
FR2345164B1 (en) 1982-11-05

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