Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Hemic or immune system
Patent
1998-11-25
2000-11-07
Lankford, Jr., Leon B.
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Hemic or immune system
514 2, 514 8, 514 21, A61K 3526
Patent
active
061433314
DESCRIPTION:
BRIEF SUMMARY
The invention concerns a pharmaceutical composition, which is stable during storage and which can be obtained from a thymus extract and has immunomodulating and inflammation-inhibiting properties.
The production of pharmaceutical preparations from the thymus is known and described from many aspects in the literature. Such extracts contain so-called thymus factors, which comprise peptides produced from thymus. Their structure and function has still not been fully clarified in many cases. However, it is known that thymus factors cause the maturation of T lymphocytes as well as their proliferation by lymph tissue. In addition, it is also known that they play a basic role in the rejection of transplanted tissue as well as in autoimmune diseases. They are thus the subject of intensive investigations.
Thymus factors or peptides are generally called thymosines, of which thymostimulin and thymopoietin, thymosine-.alpha.-1, thymosine-.beta.-4 have perhaps been best investigated. It is known, e.g., that thymosine-.alpha.-1 and thymosine-.beta.-4 reinforce the antigen presentation to macrophages, for which reason they are also used for the treatment of autoimmune diseases and, among other applications, also in defects in the immune system, such as cancer and allergies.
The preparation and extraction of thymus peptides is known and described, for example, by T. L. K. Low and A. L. Goldstein in "Methods in Enzymology", Vol. 116, p. 213 (1985). In addition, these [products] may also be obtained from sanorell pharma GmbH and Co., Rechtmurgstr. 27, D-72270 Baiersbronn, e.g., under the name Thymosand.RTM..
The storage of aqueous thymus extracts obtained by extraction, however, is limited. Thus, attempts have also been made to synthetically produce pharmaceutically active partial peptides, such as, e.g., the pentapeptide of amino acids 32 to 36 of thymopoietin as well as its analogs (Justus Liebigs Ann. Chem. 1990, 245-247).
The invention thus has the object of making available a pharmaceutically usable mixture of thymus factors, which is stable during storage and which has a pronounced anti-inflammatory effect as well as an immunomodulating action.
This object is now achieved according to the invention in that a thymus tissue homogenized in a way known in and of itself is extracted by means of an aqueous solution, the solid components are separated from the extract and this extract is filtered through an ultrafiltration membrane with an exclusion volume of 30 kD. The process according to the invention is now characterized by the fact that the 30 kD ultrafiltrate that is obtained is subjected to at least one additional filtration on an ultrafilter with an exclusion volume of 3 kD and the retentate is used.
It has been shown surprisingly that a retentate is obtained, which is obviously free of destabilizing factors and which retains its immunomodulating properties, but in addition shows pronounced anti-inflammatory or inflammation-inhibiting properties, by means of an ultrafiltration on a membrane with an exclusion volume of 3000 daltons.
The thymus cells required for the process of the invention are taken from young calves and are rapidly further processed after removal. The preparation of homogenized tissue is known to the person skilled in the art and can be produced, for example, by means of commercially available homogenizers and/or ultrasound treatment. The homogenate is preferably subjected to an autodigestion for at least 10 hours, appropriately at least 20 hours at 2-6.degree. C., usually at 3-5.degree. C. The extraction of the homogenate is conducted by means of water or an aqueous solution, which can be buffered as needed in the neutral or biologically common pH range. The extract thus obtained still contains solid components, which are separated, for example, by means of centrifuging or filtering through filters with appropriately large pores (2.0 .mu.m, 0.8 .mu.m, 0.2 .mu.m). If need be, additional separation or purification steps can be conducted with ammonium sulfate and also other treatments, e.g., with pheno
REFERENCES:
Database Biosis, Biosciences Information Service, Philadelphia, PA, US; Matthiessen H P et al.: "Low Molecular Mas Inhibitors From Calf Thymus Selective for T-Lymphocyte Proliferation" pp. 1131-1136.
Becker Gerhard
Koch Susanne
Lankford , Jr. Leon B.
Sanorell Pharma GmbH & Co.
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