A Correlation Study On Drug Quality And Safety

Cefradine (CED) is the first generation of semi-synthetic cephalosporin antibiotics. It has a lot of preparations in clinic, among which cefradine injections are widely used. The adverse drug reaction (ADR) on clinic hematuria induced by cefradine injections, especially on children's hematuria. has been keeping on increasing these years, reported by National Center for ADR Monitoring. The ADR has a character of faster occurrence and higher incidence of children. There are no relevant ADR reports abroad currently. The durg safety and drug quality are closely related to the clinical use of medicine. There have been case-related incidences in China, such as the ADR induced by houttuynia injection, which has showed that the production of the cosolvent——Tween 80(Polysorbate—80) is one trigger of the adverse reaction. Therefore, it is necessary to do systematic research on the ADR induced by cefradine from the two respects of the drug quality and clinical medicine use, in the hope of avoiding or reducing the o currence of clinical related ADR.The keystone of the article lies in tracing the major factor causing children's hematuria ADR by cefradine injections. According to the clinical ADR data, we found that more children than adults would suffer from the hematuria adverse reaction, on the occasion of the larger dose and excessive concentration of administration; Through examining and analyzing differents of 12 batches of manufacturers' medicine according to Chinese Pharmacopoeia, we found all quality indicators of injections complyed with the relevant provisions of the quality, except the particulate matter; Through a combination checking of practical clinical medicine use of different concentrations, we found that high concentration of injections would trigger particulate matter in an abnormal increase in solutions; To the same study for the preparation dissolved in accordance with the two different ways (by hand-swirling or by mechanical means), the result demonstrated that the number of particulate matter brought by a hand-swirling were more than the latter way's; The initial study on the compatibility between rubber closures and pharmaceutical products demonstrated that reservation conditions and the rubber is two of leading to the abnormity of solution clarification and particulate matter.On the basis of the research above, the high-dose and particulate matter are two major study objects. The reasults of animal experiments indicated that the particulate matter was another important factor to cause and /or to accelerate the hematuria besides the high concentration of drug, which should not be ignored; The study on the threshold dose and more added particulate matter solution of animal experiment showed that more particulate matter woud lead to the occurrence of hematuria. The test of two age groups' animals given the same dose of the drug indicated that the younger animals were easier to bring in hematuria ADR.Pathological study showed that the high concentration of drug made the kidney bleeding. Particulate matter led to a strong physical injury on kidney, there were obvious granular or crystalline materials in kidney. These demonstrated that the chemical and physical effects would have a certain impact on the kidney, even led to the occurrence of hematuria.