CS203719B1 - Antistaphylococ gag lyzate for local use - Google Patents

Description

CZECHOSLOVAK SOCIALIST REPUBLIC (19) DESCRIPTION OF THE INVENTION CERTIFICATE 203719 (11) (Bl) 1 (22) Registered 21 02 79 (21) (PV 1156-79) (51) Int. Cl, 3 A 81 K 39/12 L_J (40) Published 30 06 80 OFTAD FOR INVENTIONS AND DISCOVERIES (45 j Published 15 05 83 (75) '

The inventor PILLICH JIŘÍ RNDr.CSc., BRNO

and VÝMOLA FRANTIŠEK MUDr. CSc., PRAGUE (54) Antistaphylococcal phage lysate for topical use 1

The present invention relates to an antistaphylococcal ligand lysate for topical use, with a polyvalent effect on Staphylocoecus sp. This lysate is intended for the treatment of staphylococcal diseases, the aim of which is the systematic e-counseling of the causative agent, Staphylococcus aureus, from infection sites and potential lesions. There is currently no amantistaphylococcal phage lysate for topical use in the treatment of acute, subacute or chronic staphylococcal disease or superposed purulent staphylococcal complications.

Suitable conditions for the application of the pathogenic properties of staphylococci are during viral epidemics, mainly influenza. High lethality in humans during these epidemics is often caused by superinfectious alveoli caused by antibiotic-resistant Staphylococcus aureus. Serious factors that provide the opportunity to use ubiquitous staphylococci altered skin, hospital environment and polytraumatism. Purulent processes of the skin, subcutaneous skin and adnexa, suppuration in the morning deposits, may result in septic state or go into a long-term chronic process. The treatment options of staphylococcal diseases are greatly enhanced by the antistaphylococcal 203719 2 phage lysate for topical use, with a polyvalent effect on Staphylocoecus sp., According to the invention, which comprises as active ingredient in sterile liquid medium with a pH of 6.9 to 7 2 specific phage particles in an amount of 1,109 to 5,10 1 / ml.

The antistaphylococcal phage lysate of the present invention is intended primarily for topical application (inhalation, drip, spray, wetted lung, instillation, etc.) to the early lesions and lesions of infectious agents (nasopharynx, intestinal and urinary tract). This application form is an integral part of the therapeutic regimen of both chronic and acute forms of staphylococcal disease.

For perfect lysis of the bacterial, host, i.e. staphylococcal culture, it uses exclusively virulent phage with a very broad spectrum of activity. The fluid specific phage is obtained both directly from the bacterial culture isolated from the pathogenic material and as an artificial mu- tant from tempered bacteriophages that have been released after induction by various chemical-chemical agents (UV-radiation, mitomycin). C, hydrogen peroxide, etc.). By testing on a larger amount of bacterial spheres, the polyvalent lytic effect of the respective phage is demonstrated.

Claims (1)

203719 3 The polyvalent specific virulent phage that is useful for the preparation of medicinal products must meet a number of requirements: it must be homogeneous [to be controlled], it must not be lysogenic, ie it must not contain a mixture of virulent and tempered phages; It has to have considerable stability in its activity and its titer, ie the concentration of active phage particles per 1 ml, must not induce the L-foamy in the production strain under in vivo conditions. The control and stability of the phage strain is carried out with the appropriate specific antiserum obtained by immunizing rabbits with the phage strain studied. The host staphylococcal culture must have the following characteristics: it must have typical properties corresponding to Staphylococcusaureus strains [biochemical, phagological and taxonomical], must exhibit maximum absorption and production of the respective bacteriophage, must exhibit loss of lysophenia or <at least markedly difficult phage release into the environment without the use of inducing agents; To be well sensitive to common antibiotics, not to exhibit mutants (pigmentation variants need to be excluded), the growth of basic synthetic soils must be easy to cultivate and to have a good culture stability, to demonstrate stability of the anti-germ structure during electrophoretic follow-up. The antistaphylococcal phage lysate of the invention is a sterile clear colorless liquid with a high concentration of active phage particles in 1 ml, pH 6.9-7.2. Non-pyrogenic properties. In the synthetic medium used, none of the microbes that can be contaminated with the preparation are propagated without aeration or shaking. No preservative is added to the lysate to maintain maximum phage activity. Therefore, absolute sterility is necessary to prevent manipulation of the preparation infection. SUBSTITUTE Antistaphylococcal phage lysate for topical use with a polyvalent effect on Staphylococcus sp., Characterized in that it contains the component in sterile liquid as an antistaphylococcal phage lysate according to the invention, acting selectively on pathogenic staphylococci but not simultaneously damaging normal bacterial flora. Under no circumstances has a hypersensitive or toxic reaction been reported. Antibiotics do not inactivate phage particles. Local-use antistaphylococcal phage lysate is standardized based on bacterial cell pre-lysis and phage activity. The details of the preparation follow from the example of implementation. EXAMPLE A bacterial host culture of a selected Staphylococcus aureus strain was cultured with a shaker in a synthetic medium of this composition: potassium dihydrogen phosphate 4.5 g ammonium chloride 3.0 g disodium phosphate 10.5 g calcium chloride 1 M 0.3 g glycerin 8.0 ml gelatin 1.5 ml amino acid mixture [Difco] 5.0 g distilled water 1000 ml The cultivation takes place at 35 to 37 ° C for 16 to 18 hours. An active phage strain is added to the grown bacterial culture. After completion of the lysis (about 3 to 6 hours) of the bacterial culture, the lysate is centrifuged. A phage particle titre of 1 ml is determined in the supernatant. The test is carried out for biological safety according to CSL and the preparation is filled with dolavičky. According to CS3, a sterility test is also carried out. The finished preparation has an H value of about 7.0, a phage content of 1.109 to 5.1010. When stored in the dark and at a temperature of 2 to 4 ° C, the shelf life is at least 12 months. In a medium having a pH of 6.9 to 7.2 specific phage particles in an amount of 1.109 to 5.1010 // ml. Severograíia, n. P., Race 7, Most