Ionized magnesium.sup.2+ concentrations in biological samples

• US 5,364,642 A
• Filed: 12/30/1992
• Issued: 11/15/1994
• Est. Priority Date: 04/08/1991
• Status: Expired due to Fees

• Current Assignee: The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: The Research Foundation for The State University of New York (State University of New York)
• Inventors: Altura, Bella T., Altura, Burton M.
• Primary Examiner(s): HEGGESTAD, HELEN F
• Application Number:
  US07/998,518
• Time in Patent Office: 685 Days
• Field of Search: 426/74, 426/801, 436/16, 436/19
• US Class Current: 426/74
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/28 Compounds containing heavy metals
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: G01N 2800/04 Endocrine or metabolic disorders
• CPC Class Codes: G01N 2800/2807 Headache; Migraine
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH
• CPC Class Codes: Y10S 426/801 Pediatric
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/109163 Inorganic standards or controls
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

The present invention provides a method for preparing and storing biological samples prior to measuring ionized Mg²⁺ concentrations in order to obtain accurate and reproducible readings. A novel method for accurately reading ionized magnesium ion concentrations in biological samples is provided. A method for monitoring ionized Mg²⁺ concentrations and ionized Ca²⁺ :Mg²⁺ ratios in a patient, useful in diagnosing and prognosing disease states including cardiopulmonary bypass surgery, hypertension, abnormal pregnancy, head trauma, and fetal abnormalities is provided as well as a composition and a method of treating a patient with ionized Mg²⁺ or ionized Ca²⁺ and Mg²⁺.

Claims

1. A composition for prevention or treatment of magnesium deficiencies or magnesium imbalances in an individual, the composition comprising as an active ingredient bioavailable magnesium salt, wherein a concentration of bioavailable magnesium salt in said composition is an amount sufficient to maintain normal concentrations of ionized magnesium in a range of approximately 0.53 to 0.67 mM for the biological sample of whole blood, serum or plasma in the individual.

6. A dietary supplement comprising the composition of claim 1 or 2.

7. An infant formula useful in providing normal ionized Ca²⁺ and normal ionized Mg²⁺ concentrations in a neonate or infant, said formula comprising conventional ingredients of the formula and the composition of claim 1 or 2.

8. The infant formula of claim 7 wherein the conventional ingredients comprises protein, carbohydrate, water, vitamins, minerals and an edible fat.

2. A composition for prevention or treatment of magnesium deficiencies or imbalances or calcium deficiencies or imbalances, or calcium/magnesium imbalances in an individual, the composition comprising as the active ingredients thereof,

(A) bioavailable calcium salt;

(B) bioavailable magnesium salt; and

(C) wherein a concentration of the bioavailable calcium salt and the bioavailable magnesium salt in said composition is that amount sufficient to provide a normal molar ratio of ionized Ca²⁺ ;

ionized Mg²⁺ in an individual wherein the normal molar ratio of ionized Ca²⁺ ;

ionized Mg²⁺ is selected from the group consisting of about 1;

1 to about 2.5;

1 in whole blood, plasma or serum of an adult, about 1.9;

1 to about 2.6;

1 in whole blood, plasma or serum of a neonate, infant or child and about 0.90;

1 to about 1.15;

1 in cerebral spinal fluid.

3. A composition of claim 2 wherein the normal molar ratio of ionized Ca²⁺ :

ionized Mg²⁺ in whole blood, plasma or serum of an adult is about 2;

1.

4. A composition of claim 2 wherein the concentration of calcium salt is about 640 mg.

5. A composition of claim 2 wherein the concentration of magnesium salt is about 200 mg.

9. A composition of claim 2 wherein the concentration of calcium salt is about 320 mg to about 1280 mg.

10. A composition of claim 2 wherein the concentration of magnesium salt is about 100 mg to about 400 mg.

11. A composition for prevention or treatment of magnesium deficiencies or magnesium imbalances in an individual, the composition comprising as an active ingredient bioavailable magnesium salt, wherein a concentration of bioavailable magnesium salt in said composition is an amount sufficient to maintain normal concentrations of ionized magnesium in a range of approximately 1.10-1.23 mM for the biological sample of cerebral spinal fluid in the individual.