Human leukocytic pyrogen test for the detection of exogenous fever-producing substances
First Claim
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1. A method for determining the pyrogenicity of a substance, comprising the step of:
- incubating said substance in the presence of a cell mixture for at least 46 hours at 35°
to 39°
C., wherein said cell mixture comprises human lymphocytes and human monocytes with a cell ratio of lymphocytes to monocytes of at least 2;
1 and a composition with respect to the total of all cells present comprising at least 15% monocytes and no more than 10% granulocytes and wherein said cells have a cell contact ratio of from 0.0 to 0.75.
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Abstract
A method for determining the pyrogenicity of a substance, comprising the step of incubating said substance in the presence of a cell mixture for at least 46 hours at 35° to 39° C., wherein the cell mixture comprises human lymphocytes and human monocytes with a cell ratio of lymphocytes to monocytes of at least 2:1 and a composition with respect to the total of all cells present comprising at least 15% monocytes and no more than 10% granulocytes and wherein the cells have a contact ratio of from 0.0 to 0.75.
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Citations
48 Claims
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1. A method for determining the pyrogenicity of a substance, comprising the step of:
incubating said substance in the presence of a cell mixture for at least 46 hours at 35°
to 39°
C., wherein said cell mixture comprises human lymphocytes and human monocytes with a cell ratio of lymphocytes to monocytes of at least 2;
1 and a composition with respect to the total of all cells present comprising at least 15% monocytes and no more than 10% granulocytes and wherein said cells have a cell contact ratio of from 0.0 to 0.75.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)
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42. A method for determining the pyrogenicity of a substance, comprising the step of incubating said substance in the presence of a cell mixture for 46 to 50 hours at 37±
- 0.5°
C. in a flat-bottomed container, wherein said cell mixture comprises human lymphocytes and human monocytes with a cell ratio of lymphocytes to monocytes of at least 2;
1 and a composition with respect to the total of all cells present comprising at least 15% monocytes and no more than 10% granulocytes in a liquid culture medium at a cell concentration of about 5×
106 total lymphocyte and monocyte cells per milliliter and wherein said flat-bottomed container has a bottom surface area of about 5 square centimeters per milliliter of cell mixture. - View Dependent Claims (43, 44, 45, 46, 47, 48)
- 0.5°
Specification