Method of making soybean Bowman-Birk inhibitor concentrate and u

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex

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514783, 426430, A61K 3578, A61K 4700, B11B 100, A23L 120

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active

052177173

DESCRIPTION:

BRIEF SUMMARY
afiltration step(s) are eliminated by starting with soy solubles and applying the acetone treatment to a substrate that has a substantially higher concentration of BBI than that in the defatted soy flour/flake of the prior art, resulting in a more economical process.
It was surprisingly found that a BBIC produced in accordance with the method of the invention is a significantly improved inhibitor of malignant cell transformation over prior art BBI products. Methods for the administration of said BBIC to inhibit the malignant transformation of cells and to prevent or inhibit the progression of cancer are also provided.


BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a histogram showing the number of tumors observed in the animal study treatment groups.
FIG. 2(a) is a photograph of a normal (untreated) hamster cheek pouch.
FIG. 2(b) is a photograph showing a DMBA-treated hamster cheek pouch with tumors.


DETAILED DESCRIPTION OF THE INVENTION

In accordance With the present invention, soybean solubles are diluted with water to 18% solids and then centrifuged to produce "purified" soybean solubles. The purified solubles are diluted with water to 8% solids to produce reslurried "purified" soybean solubles which are subjected to ultrafiltration (1,000 m.w. membrane). The resulting crude BBI concentrate is diluted with water (1:1) and then subjected to a second ultrafiltration step (1,000 m.w. membrane) to produce a "semi-crude" BBI concentrate. The semi-crude concentrate is treated with acetone (2.2:1) to produce a BBI concentrate precipitate. After settling and decanting, the resulting "purified" BBI concentrate precipitate is air dried, ground, reslurried with water to 15% solids, filtered (Buchner funnel/Whatman #1) and then lyophilized to produce a BBI concentrate product.
In another embodiment of the invention, "purified" soybean solubles are produced as described above and then diluted to 10% solids. The resulting reslurried "purified" soybean solubles are then treated as described in the foregoing to produce a "semi-crude" BBI concentrate which is treated with acetone (1.66 to 1) to produce a BBI concentrate precipitate. A BBI concentrate is produced as described above, with the exception that the filtered precipitate is spray dried rather than lyophilized.
In still another embodiment of the invention, soybean solubles are diluted with water to 15-20% solids and centrifuged to produce "purified" soybean solubles. The purified solubles are diluted with water to 10% solids to produce reslurried "purified" soybean solubles which are subjected to ultrafiltration (1,000 m.w. membrane). The resulting "crude" BBI concentrate is diluted with water (1:1) and spray dried to produce a BBI concentrate product. soybean solubles are diluted with water to 16% solids and centrifuged to produce "purified" soybean solubles. The "purified" solubles are diluted with water to 10% solids. The resulting reslurried "purified" solubles are then subjected to ultrafiltration (10,000 m.w. membrane), producing a crude BBI concentrate. The crude concentrate is diluted with water (1:1) and again subjected to ultrafiltration (1,000 m.w. membrane) to produce a "semi-crude" BBI concentrate which is spray dried to produce a BBI concentrate product.
In another embodiment of the invention, the ultrafiltration step(s) are eliminated by starting with soy solubles and applying the acetone treatment to a substrate that has a substantially higher concentration of BBI than that in defatted soy flour/flake. Soy bean soluble were centrifuged to produce "purified" soybean solubles. Acetone is added to the supernatant to produce a "crude" BBI concentrate precipitate, which is allowed to settle. The resulting precipitate containing the partially purified BBI is then resuspended in water and centrifuged. Acetone is then added to the supernatant and the resulting water soluble, acetone insoluble precipitate allowed to settle, and then are dried to produce a BBI concentrate product.
It was observed that the BBI concentrate produced in accordance with the

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