Enzyme reference composition

• US 4,325,832 A
• Filed: 01/21/1980
• Issued: 04/20/1982
• Est. Priority Date: 03/05/1979
• Status: Expired due to Term

• Current Assignee: Beckman Instruments, Inc. (Danaher Corporation)
• Original Assignee: Beckman Instruments, Inc. (Danaher Corporation)
• Inventors: Louderback, Allan L.
• Primary Examiner(s): Gron, Teddy S.
• Application Number:
  US06/114,009
• Time in Patent Office: 820 Days
• Field of Search: 252/408, 23/230 B, 435/2, 435/4, 435/21, 435/18, 435/22, 435/20, 435/17, 435/24, 435/26, 435/15, 435/16, 435/19, 435/25, 435/188, 424/2, 424/3
• US Class Current: 435/4
• CPC Class Codes: C12N 9/96 Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
• CPC Class Codes: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions

Abstract

A stable enzyme reference composition having an excellent shelf-life. The composition comprises at least one enzyme of known value; about 20 to about 40 weight percent of at least one alkylene polyol having from 2 to 5 carbon atoms; about 3 to about 8 grams (gm) per deciliter (dl) total protein present in a human serum albumin matrix; and about 60 to about 80 weight percent water.

Claims

1. An enzyme reference composition of the type comprising:

(a) at least one enzyme constituent of known value;

(b) from about 20 to about 40 weight percent of at least one alkylene polyol having from 2 to 5 carbon atoms;

(c) from about 3 to about 8 grams per deciliter total protein; and

(d) from about 60 to about 80 weight percent water;

characterized in that said total protein consists essentially of human serum albumin.

2. The composition of claim 1 having a pH of from about 5.8 to about 8.7.

3. The composition of claim 1 having a pH of from about 6 to about 8.5.

4. The composition of claim 1 having a pH of from about 6 to about 7.

5. The composition of claim 1 having a pH of from about 6.4 to about 6.6.

6. The composition of any one of claims 2-5 or 1 comprising from about 30 to about 34 weight percent of said alkylene polyol, from about 4 to about 5 grams per deciliter of total protein, and from about 66 to about 70 weight percent water.

7. The composition of any one of claims 2-5 or 1 wherein at least one of said enzymes is selected from a group consisting of acid phosatase, aldolase, alkaline phosphatase, amylase, cholinesterase, creatine kinase, α

-glytamyl transpeptidase, α

-hydroxybutyric dehydrogenase, isocitric dehydrogenase, lactic dehydrogenase, leucine aminopeptidase, lipase, alanine amino transferase, and aspartate amino transferase.

8. The composition of any one of claims 2-5 or 1 wherein said enzyme moiety comprises acid phosphatase, alkaline phosphatase, amylase, creatine kinase, aspartate amino transferase, alanine amino transferase, γ

-glutamyl transpeptidase, and lactic dehydrogenase.

9. The composition of any one of claims 2-5 or 1 comprising:

(a) from about 0 to about 350 International Units per liter alkaline phosphatase;

(b) from about 0 to about 20 International Units per liter acid phosphatase;

(c) from about 0 to about 400 International Units per liter amylase;

(d) from about 0 to about 600 International Units per liter creatine kinase;

(e) from about 0 to about 200 International Units per liter aspartate amino transferase;

(f) from about 0 to about 200 International Units per liter alanine amino transferase;

(g) from about 0 to about 300 International Units per liter γ

-glutamyl transpeptidase; and

(h) from about 0 to about 500 International Units per liter lactic dehydrogenase wherein the enzyme activities are stated for 37°

C.

10. The composition of any one of claims 2-5 or 1 further comprising sodium, potassium, calcium, phosphorous, and magnesium.

11. The composition of any one of claims 2-5 or 1 comprising:

(a) from about 0 to about 350 International Units per liter alkaline phosphatase;

(b) from about 0 to about 20 International Units per liter acid phosphatase;

(c) from about 0 to about 400 International Units per liter amylase;

(d) from about 0 to about 600 International Units per liter creatine kinase;

(e) from about 0 to about 200 International Units per liter aspartate amino transferase;

(f) from about 0 to about 200 International Units per liter alanine amino transferase;

(g) from about 0 to about 300 International Units per liter γ

-glytamyl transpeptidase;

(h) from about 0 to about 500 International Units per liter lactic dehydrogenase;

(i) from about 125 to about 157 milliequivalents per liter sodium;

(j) from about 3.5 to about 4.5 millequivalents per liter potassium;

(k) from about 8.4 to about 10.6 milligrams per deciliter calcium;

(l) from about 1.6 to about 2.4 milligrams per deciliter phosphorous;

(m) from about 1.6 to about 2.4 milligrams per deciliter magnesium; and

(n) from about 88 to about 112 milliequivalents per liter chloride;

wherein the enzyme activities are stated for 37°

C.

12. The composition of any one of claims 2-5 or 1 comprising:

(a) from about 0 to about 350 International Units per liter alkaline phosphatase;

(b) from about 0 to about 20 International Units per liter acid phosphatase;

(c) from about 0 to about 400 International Units per liter amylase;

(d) from about 0 to about 600 International Units per liter creatine kinase;

(e) from about 0 to about 200 International Units per liter aspartate amino transferase;

(f) from about 0 to about 200 International Units per liter alanine amino transferase;

(g) from about 0 to about 300 International Units per liter γ

-glytamyl transpeptidase;

(h) from about 0 to about 500 International Units per liter lactic dehydrogenase;

(i) from about 125 to about 157 milliequivalents per liter sodium;

(j) from about 3.5 to about 4.5 milliequivalents per liter potassium;

(k) from about 8.4 to about 10.6 milligrams per deciliter calcium;

(l) from about 1.6 to about 2.4 milligrams per deciliter phosphorous;

(m) from about 1.6 to about 2.4 milligrams per deciliter magnesium; and

(n) from about 88 to about 112 milliequivalents per liter chloride;

wherein the enzyme activities are stated for 37°

C.; and

wherein said acid phosphatase is derived from human seminal fluid, said alkaline phosphatase is derived from calf intestine;

said amylase is derived from pig pancreas;

said creatine kinase is derived from monkey muscle;

said aspartate amino transferase and alanine amino transferase are derived from pig heart;

said γ

-glutamyl transpeptidase is derived from pig intestine; and

said lactic dehydrogenase is derived from chicken heart.