[Effective incorporation of lipopolysaccharides in liposomes for modulation of pyrogenicity and release of tumor necrosis factor].
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Biomedical subjects
Publications and source records attributed to H J Jacker.
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Submitted is the revised version of a proposal for a guideline for biological testing of materials (biomaterials) which remain temporarily or permanently, resp., at or in the human body or have contact with drugs or body fluids outside the human body.
Cell cultures are a highly sensitive toxicological model used also for the testing of biomaterials. Beside the safety tests provided in the Pharmacopoeia of GDR cultures from human amnionepithelial cells and fibroblasts are used. The paper reports the results of some methodical investigations concerning the procedure of extraction of biomaterials, the evaluation of test results and the comparison with the results of other biological tests.
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For the investigation of plastics and elastics several sensitive biological methods are in use. In the Pharmacopeia of GDR, 2nd edition, a safety-test on isolated frogheart is prescribed for plastics and a safety-test on daphnia magna for elastics. Ionescu-Stoian had recommended a test using saccharomyces cerevisiae. We found a good conformity of the result given by this test with the results of the daphnia-test. On the other hand, the saccharomyces cerevisiae-test is much more sensitive than the test with isolated frogheart.
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A survey of the biological methods for quality control of plastics and elastomers included in pharmacopoeias is given. The value of some of these methods (test for pyrogen-like substances, test for acute systemic toxicity in mice, tests on frog hearts, on Daphnia magna and on rat sperm, mode of extraction) is discussed.