Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1991-05-10
1994-02-22
Schain, Howard E.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
530344, 530416, 530417, C07K 328, C07K 1506, A61K 3702
Patent
active
052887081
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a new substance BPC, the process for its preparation from human or animal gastric juice and its use in the therapy.
2. Description of the Prior Art
Gastric juice, considered as a secretion of the parietal as well as other cells, contains a number of electrolyte components, hydrochloric acid, a number of enzymes, namely, pepsin, other proteinases, rennin, lipase, urease and lysozyme. There are present many peptides and peptide fragments, e.g. peptide hormones gastrins, a highly potent gastric secretion stimulants, first discovered by J. S.Edkins, Proc.Roy.Soc.L., 76B, 376 (1905).
In normal gastric juice are present glycoproteins (mucins), desribed by F.Hanrowitz, Chem. and Biology of Proteins, 1950, p.199., and Intrinsic Factor (IF), which is a thermolabile mucoprotein with M.W. about 60.000. This factor promotes vitamin B.sub.12 absorption, Castle et al, Am.J.Med Sci. 178, 748 (1929).
Till now, a substance having very strong antistress actions and other body-protection activities was not found in gastric juice.
DESCRIPTION OF THE INVENTION
Until now the gastrointestinal tract, especially stomach, was considered only as a target organ for stress. There was never discussed the possibility that gastrointestinal tract, preferably the stomach, may be the organ which can initiate the defensive response of the whole organism. This response, actually directed against stress, must be realized in the formation and release of a new endogenous agent. Our attempt was directed to isolate this agent from stomach juice. Finally we isolated the expected substance from the stomach juice of 542 patients. This substance was nominated with abbreviation BPC which means: Body Protection Compound.
The structure of this substance is very complex and after our investigation until now can be characterized as folded protein with partial sequence from N-terminus: . --COOH
It has a molecular weight of about 40.000.+-.5.000 Daltons, determined by gel filtration.
The agent BPC was prepared from human or animal gastric juice. This juice was first homogenized and centrifuged, the supernatant was purified by dialysis, ion-exchange chromatography, again by dialysis and lyophilisation and finally the agent BPC was obtained using gel-chromatography, dialysis and lyophilisation.
Until now this compound, has not been described or published anywhere Moreover, it has never been used as a medicament.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows the UV Spectrum of BPC and
FIG. 2 shows the IR Spectrum of BPC.
The investigation of the biological actions of the BPC using many methods in vivo and in vitro shows:
SURPRISINGLY BROAD SPECTRUM OF ACTIVITIES
But, it is known that many diseases and pathological states can be awakened by stress or on the other hand the trauma or disease can induce stress itself. These results also suggest that BPC is produced by stress independent of its provenance.
The agent BPC according to the invention was investigated in vitro and in vivo (rat, mouse, rabbit and guinea-pig) and following pharmacological properties were found:
1. Acute toxicology
Acute toxicology was determined in mice (18-25 gb.w.) (sacrifice after 30 days of experimental period) of both sexes, BPC was administered via i.v. and i.g.. The lethal dose couldn't be obtained even with high dose such as 100 mg/kg b.w., which is at least 10.sup.3 -10.sup.5 fold higher than minimal effective doses. In prolonged procedure BPC was injected via i.p., i.v., i.g. (30 mg/kg) once a day over 30 days. No pathological signs (morphological or physiological) were registered. In addition, the mean effective doses are from 0.01 to 50 ug/kg by i.p. administration and TI at least 1000.
2. Ulcer induced by water immersion or restraint stress
Male rats (180-240 g) of Wistar strain were used. Animals were put in cold water (26.degree. C.) for 3 hours or restrainted for 48 hours. After the end of experimental periods the stomach was investigated for the presence of a lesions ("s
Duvnjak Marko
Jukic Jerka
Krizanac Simun
Mise Stjepan
Petek Marijan
Schain Howard E.
Touzeau Lynn
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