Diagnostic and therapeutic compositions

• US 5,348,852 A
• Filed: 04/27/1992
• Issued: 09/20/1994
• Est. Priority Date: 08/10/1990
• Status: Expired due to Fees

• Current Assignee: Analytical Control Systems Incorporated
• Original Assignee: Analytical Control Systems Incorporated
• Inventors: Bonderman, Ruby P.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Freed, Rachel
• Application Number:
  US07/875,206
• Time in Patent Office: 876 Days
• Field of Search: 435/188, 435/2, 435/4, 436/8, 436/12, 436/13, 436/14, 436/15, 436/16, 436/18
• US Class Current: 435/4
• CPC Class Codes: A01N 1/021 Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin
• CPC Class Codes: C09H 3/00 Isolation of glue or gelatine from raw materials, e.g. by extracting, by heating gelatine for foodstuffs A23J1/10
• 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
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

Compositions, such as liquid therapeutic or diagnostic compositions, and methods for their preparation and involving their use. The compositions comprise an effective amount of gelatin from cold water fish skin as a protein base. The indicated gelatin provides many significant advantages and improvements, including for instance its high stabilizing effect on labile organic substrates included in the compositions, and its low temperature gelling properties which provide improved compositions which do not substantially gel during refrigeration. Further representative advantages relate to its behavior as a zwitterion thus reducing or eliminating needs for buffers, and its surprising behavior similar to human serum protein in protein analyses such as the biuret procedure.

Claims

1. A liquid diagnostic control composition suitable for reproducibly monitoring the concentration of an enzyme in a biological fluid from a patient wherein said enzyme has a predetermined stability in said fluid, said diagnostic composition comprising between about 0.5 and about 10% on a per weight basis of gelatin from a cold water fish and an amount of said enzyme, said enzyme being of greater stability in said control than in said fluid and wherein said composition is substantially ungelled at a temperature of about 10°

C.

2. A diagnostic control composition according to claim 1, wherein said enzyme is creatine phosphokinase.

3. A diagnostic control composition according to claim 1, wherein said enzyme is lactate dehydrogenase.

4. A diagnostic control composition according to claim 1 wherein said enzyme is glutamyl transpeptidase.

5. A diagnostic control composition according to claim 1 wherein said enzyme is aspartate aminotransferase.

6. A diagnostic control composition according to claim 1 wherein said enzyme is alkaline phosphatase.

7. A diagnostic blood control composition according to claim 1, wherein said gelatin is present in a concentration of about 6%.

8. A diagnostic control composition according to claim 1 wherein said enzyme is selected from the group consisting of lactate dehydrogenase, creatine phosphokinase, aspartate aminotransferase, alkaline phosphatase, malic dehydrogenase, glucose-6-phosphate dehydrogenase, esterase, glutamic-oxaloacetate transaminase, glutamic-pyruvate transaminase, acid phosphatase, amylase, glutamyl transpeptidase, isocitric dehydrogenase, alpha-hydroxybutyric dehydrogenase, lipase, alanine aminotransferase, peroxidase, cholesterol oxidase, cholesterol esterase, uricase, urease and glycerol kinase.

9. A diagnostic control composition according to claim 1 wherein said enzyme is a blood constituent.

10. A liquid diagnostic control composition comprising between about 0.5 and about 10% on a per weight basis of gelatin from a cold water fish and an enzyme and wherein said composition is substantially ungelled at a temperature of about 10°

C.

11. A liquid diagnostic control composition suitable for reproducibly monitoring the concentration of an enzyme in a biological fluid from a patient, said diagnostic composition comprising between about 0.5 and about 10% on a per weight basis of gelatin from a cold water fish and an enzyme selected from the group consisting of creatine phosphokinase, lactate dehydrogenase, glutamyl transpeptidase, aspartate aminotransferase and alkaline phosphatase and wherein said composition is substantially ungelled at a temperature of about 10°

C.

12. A liquid diagnostic control composition suitable for reproducibly monitoring the concentration of an enzyme in a biological fluid from a patient, said diagnostic composition comprising between about 0.5 and about 10% on a per weight basis of gelatin from a cold water fish and an enzyme selected from the group consisting of lactate dehydrogenase, creatine phosphokinase, aspartate aminotransferase, alkaline phosphatase, malic dehydrogenase, glucose-6-phosphate dehydrogenase, esterase, glutamic-oxaloacetate transaminase, glutamic-pyruvate transaminase, acid phosphatase, amylase, glutamyl transpeptidase, isocitric dehydrogenase, alpha-hydroxybutyric dehydrogenase, lipase, alanine aminotransferase, peroxidase, cholesterol oxidase, cholesterol esterase, uricase, urease and glycerol kinase and wherein said composition is substantially ungelled at a temperature of about 10°

C.