Stabilizers for reconstituted, lyophilized samples

• US 4,127,502 A
• Filed: 06/10/1977
• Issued: 11/28/1978
• Est. Priority Date: 06/10/1977
• Status: Expired due to Term

• Current Assignee: Clinical Diagnostic Systems Inc.
• Original Assignee: Eastman Kodak Company
• Inventors: Lynn, Shirley Y., Wu, Tai-Wing, Li Mutti, Charles M.
• Primary Examiner(s): Wolk, Morris O.
• Assistant Examiner(s): Turk, Arnold
• Application Number:
  US05/805,507
• Time in Patent Office: 536 Days
• Field of Search: 23/230 B, 252/408
• US Class Current: 436/16
• CPC Class Codes: G01N 2496/05 containing blood cells or plasma
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control

Abstract

A serum matrix or serum-derived composition which, after lyophilization and reconstitution, has a reduced optical density, evidencing improved homogeneity.

Claims

1. A stabilized serum matrix or serum-derived composition comprising

lipids,

and a clarity stabilizer comprising a sugar, sugar amine, or sugar alcohol in at least an amount sufficient to measurably reduce the optical density of the composition, after lyophilization and reconstitution with water, below the optical density of said lyophilized and reconstituted matrix or composition lacking said stabilizer, when measured at 700 nm. using a 1 cm. path length.

2. A composition as defined in claim 1, wherein said stabilizer is present in an amount sufficient to maintain the optical density of the composition, after lyophilization and reconstitution with water, at a level comparable to the optical density of said composition prior to lyophilization, when measured at about 700 nm. using a 1 cm. path length.

3. A composition as defined in claim 2, wherein said stabilizer is present in an amount sufficient to render the reconstituted composition optically clear.

4. A stabilized serum matrix or serum-derived composition comprising

lipids,

and a clarity stabilizer selected from the group consisting of glucose, sucrose, lactose, arabinose, sorbitol, fructose, xylitol, mannitol, and glucosamine;

said stabilizer being present in at least an amount sufficient to measurably reduce the optical density of the composition, after lyophilization and reconstitution with water, below the optical density of said lyophilized and reconstituted matrix or composition lacking said stabilizer, when measured at 700 nm. using a 1 cm. path length.

5. A composition as defined in claim 4, wherein said stabilizer is present in an amount sufficient to maintain the optical density of the composition, after lyophilization and reconstitution with water, at a level comparable to the optical density of the matrix or composition prior to lyophilization, when measured at about 700 nm. using a 1 cm. path length.

6. A serum assay standard, comprising

a lipid selected from cholesterol, cholesterol esters and triglyceride;

and a clarity stabilizer comprising a sugar, sugar amine, or sugar alcohol in at least an amount sufficient to measurably reduce the optical density of the standard, after lyophilization and reconstitution with water, below the optical density of said lyophilized and reconstituted standard lacking said stabilizer, when measured at 700nm. using a 1 cm. path length.

7. A standard as defined in claim 6, wherein said stabilizer is present in an amount sufficient to maintain the optical density of the standard, after lyophilization and reconstitution with water, at a level comparable to the optical density of the matrix or composition prior to lyophilization, when measured at about 700 nm. using a 1 cm. path length.

8. A standard as defined in claim 7, wherein said stabilizer is present in an amount sufficient to render the reconstituted standard optically clear.

9. A serum assay standard comprising

a lipid selected from cholesterol, cholesterol esters, and triglyceride;

and a clarity stabilizer selected from the group consisting of glucose, sucrose, lactose, arabinose, sorbitol, xylitol, mannitol, and glucosamine;

said stabilize being present in at least an amount sufficient to measurably reduce the optical density of the standard, after lyophilization and reconstitution with water, below the optical density of said lyophilized and reconstituted standard lacking said stabilizer, when measured at 700 nm. using a 1 cm. path length.

10. A standard as defined in claim 9, wherein said stabilizer is present in an amount sufficient to maintain the optical density of the standard, after lyophilization and reconstitution with water, at a level comparable to the optical density of the matrix or composition prior to lyophilization, when measured at about 700 nm. using a 1 cm. path length.

11. A standard as defined in claim 10, wherein said stabilizer is present in an amount sufficient to render the reconstituted standard optically clear.

12. In a method of maintaining homogeneity in a lipid-containing serum matrix or serum-derived composition, wherein said matrix or composition is lyophilized and then reconstituted;

the improvement comprising the step of

adding to said matrix or composition prior to the lyophilization step, a clarity stabilizer comprising a sugar, sugar amine, or sugar alcohol in at least an amount sufficient to measurably reduce the optical density of the composition, after lyophilization and reconstitution with water, below the optical density of said lyophilized and reconstituted matrix or composition lacking said stabilizer, when measured at 700 nm. using a 1 cm. path length;

whereby upon reconstitution with water said matrix or composition has a reduced amount of turbidity.