Human Insulin: Clinical Pharmacological Studies in Normal ManSpringer Science & Business Media, 31 мая 1986 г. - Всего страниц: 312 Since insulin became available for the treatment of diabetes in 1922 a number of major advances have been made, which include the modification of insulin to vary its timing of action, its purification, and latterly, the production of human insulin. Human insulin in quantities sufficiently large for therapy has been made available by two techniques developed in parallel during the late 1970s. These involve either (i) formulation in E. coli bacteria suitably encoded by DNA recombinant methods of the A- and B-chains of human insulin followed by a chain combination reaction ('biosynthetic' human insulin) or (ii) enzymatic conversion (transpeptidation) of porcine insulin brought to react with a threonine ester by porcine trypsin in a mixture of water and organic solvents, yielding human insulin ('semi-synthetic' human insulin). This book includes the first clinical-pharmacological studies of each of the highly purified 'semi-synthetic' human insulin preparations: Actrapid ® HM; Monotard® HM; Protaphane® HM; Actraphane® HM; and Ultratard® HM (Novo Industri A/S, Copenhagen). The preliminary studies established their safety and efficacy relative to their porcine and bovine counterparts emphasising the relevance of species and formulation on the pharmacokinetics and biological responses to insulin. Additional investigations with human insulin demonstrated the influence of insulin concentration, site of administration, the addition of aprotinin to insulin and the mixing of 'short-' and 'intermediate-acting' formulations on insulin 'bioavailability'. Examination of the 'within' and 'between' subject day-to-day variation in absorption and the effect of subcutaneous insulin also demonstrates the dominating influence of insulin responsiveness. |
Содержание
Introduction | 1 |
112 The discovery of insulin | 5 |
113 Summary | 9 |
12 THE EVOLUTION OF INSULIN | 10 |
122 Purity and immunogenicity of insulin | 12 |
1222 Clinical implications of the quest for insulin purity | 15 |
insulin species etc | 18 |
123 Human insulin | 19 |
42 INSULIN PREPARATIONS WITH PROLONGED EFFECT | 134 |
421 Intermediateacting insulin preparations | 135 |
4212 A study of human semisynthetic and biosynthetic and porcine NPH isophane insulins U40 | 151 |
U100 U40 porcine insulin U40 | 161 |
422 Longacting insulin preparations | 170 |
43 FACTORS INFLUENCING SUBCUTANEOUS ABSORPTION OF HUMAN INSULIN | 178 |
U40 versus U100 short and intermediateacting insulin preparations | 185 |
shortacting insulins | 187 |
1231 Human cadaveric pancreas | 20 |
1232 Total peptide synthesis | 21 |
1234 Recombinant DNA technology | 27 |
124 SUMMARY | 32 |
Objectives of Investigations | 34 |
Investigational Procedures | 36 |
32 LABORATORY METHODS | 38 |
ClinicalPharmacological Studies | 46 |
411 Study of safety and efficacy of human insulin in normal man | 47 |
412 Comparison of subcutaneous human porcine and bovine insulin in man | 55 |
413 Comparative study of subcutaneous human and porcine insulin in man without the concomitant use of somatostatin | 62 |
414 The influence of somatostatin on the metabolic and hormonal responses to subcutaneous human and porcine insulin | 70 |
415 Doseresponse study of human porcine and bovine insulin | 83 |
416 Comparative study of intravenous and intramuscular administration of human insulin | 98 |
417 A study of intravenous human porcine bovine and intramuscular human insulin in normal man | 108 |
418 A study of the hormonal counterregulatory responses to subcutaneous and intravenous human semisynthetic biosynthetic and porcine insulins | 119 |
intermediateacting insulin study | 197 |
4323 General discussion and summary | 202 |
433 Insulin mixtures | 203 |
4331 Soluble and NPH mixtures | 205 |
4332 Soluble and Lente mixtures | 214 |
4333 Discussion | 223 |
434 Within and between subject variation | 224 |
4341 Soluble insulin U100 | 226 |
4342 Lente insulin U100 | 231 |
4343 General discussion | 236 |
Summary | 237 |
Acknowledgements | 248 |
Bibliography | 250 |
291 | |
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Human Insulin: Clinical Pharmacological Studies in Normal Man D.R. Owens Недоступно для просмотра - 2011 |
Часто встречающиеся слова и выражения
3-hydroxybutyrate Actrapid HM admixed admixture alanine analysis aprotinin assay bioavailability biosynthetic blood bovine insulin C-peptide and insulin C-peptide levels C-peptide nmol/l clinical coefficient of variation compared Comparison concentrations means control day method cortisol diabetes mellitus diabetic patients Diabetologia difference diluent diluent control dose level estimated Galloway Gerich given subcutaneously sc glucagon Glucose mmol/l glycerol growth hormone Heding human and porcine human insulin hypoglycaemic effect hypoglycaemic potency hypoglycaemic response injected immediately insulin absorption insulin antibodies insulin concentrations insulin IRI Insulin nmol/l insulin preparations insulins on plasma intermediate-acting intramuscular intravenous IU/ml lactate Lente insulin Markussen metabolic Monotard HM NPH insulin observed pancreatic plasma insulin levels plasma insulin profiles porcine and bovine porcine and human porcine insulin proinsulin protamine Protaphane HM radioimmunoassay regimens sc injection Schlichtkrull semi-synthetic separate injections shown as means six subjects soluble insulin somatostatin somatostatin infusion species of insulin study days subcutaneous injection treatment trypsin U/kg body weight Ultralente values
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