Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1993-09-20
1995-06-13
Lilling, Herbert J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
435 711, 435 712, 435 713, 4352521, 4352528, 4352534, 435822, 435849, 435851, 435852, 435871, 435885, 435886, C12P 2100, A61K 3574
Patent
active
054242878
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention is concerned with an extract of bacterial macromolecules and, more particularly, with an extract based on modified bacterial proteins, a process for its preparation and a pharmaceutical composition containing this extract as an active ingredient.
BACKGROUND OF THE INVENTION
Bacterial products are already known which have a therapeutic activity and which are obtained by alkaline hydrolysis. The applicant's patent CH 633 188 discloses for example a concentrate of bacterial lysates having anti-infective properties. The lysates of each bacterial strain are obtained through a progressive alkaline hydrolysis (pH 9-10) which leads to the destruction of the apparent structure of the bacteria.
Actually, the present inventors have established, that bacterial extracts could be obtained having various immunopharmacological properties, such as for example an important immunomodulator activity, by using a different alkaline treatment which makes it possible to retain intact the apparent structure of the treated bacteria. Specifically, this treatment consists in an alkaline extraction using conditions of a high pH and, especially, of a stable pH.
SUMMARY OF INVENTION
Thus, the object of the present invention is on the one hand an extract based on modified bacterial proteins and, on the other hand, a process for the preparation of this protein extract, as they are defined in the claims, respectively.
The invention is also directed at a pharmaceutical composition containing, as the active ingredient, the extract based on bacterial proteins modified according to the invention (designated in the following as "protein extract").
The chemical treatment of bacteria, for example by dilute NaOH, causes deep modifications of the primary, secondary and tertiary structures of bacterial proteins. One can thus note a partial deamidation of asparagine and of glutamine, which is conducive to the formation of aspartic acid and glutamic acid, respectively. Partial racemizations of several amino acids also occur during this process, mainly of aspartic acid, serine and arginine. The overall physicochemical modifications of the structure of the proteins produce polypeptides, the amphionic properties of which are acid. These polypeptides all have low isoelectric points ranging from 2.5 to 5.5, with a higher concentration in the vicinity of 4.5. These structural changes thus produce protein extracts which exhibit immunomodulator properties in vitro and in vivo.
In the protein extract according to the invention, the sum of the constituent amino acids amount to at least 50% (as weight percentage of the lyophilized product), and preferably from 55 to 85% of the protein extract and the lipopolysaccharide content (LPS) is preferably lesser than about 2.times.10.sup.-3 %. The molecular weight of the constituent elements of the protein extract according to the invention is comprised between 10,000 and 1,000,000. Further, this protein extract includes in its proteinic amino acids, some having a D and an L configuration and a preponderant proportion of acid groups such as those of aspartic acid and glutamic acid. The main amino acids which are racemized are serine with about 25% to 45% of D configuration, aspartic acid with about 10 to 30% and arginine with about 3 to 20%. The use of the term "modified proteins" indicates, amongst others, the presence of amino acids in the D configuration in the protein extract, the L configuration being that of native proteins.
On the other hand, the protein extract according to the invention can include at the most about 10.sup.-3 % lipopolysaccharides, at the most about 2% free amino acids, at the most about 8% glucides, at the most about 4% amino sugars and at the most about 15% desoxyribonucleic acids.
DETAILED DESCRIPTION OF THE INVENTION
In principle, any Gram-positive or Gram-negative bacterial strain or strains can be used as starting material or materials in the process according to the invention, such as Escherichia coil or one or more of the bacterial s
Bauer Jacques
Hirt Pierre
Schulthess Adrian
Laboratoires OM SA
Lilling Herbert J.
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