摘要
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Summary
Cytarabine is an effective chemotherapeutic agent used in the treatment of acute lymphoblastic leukaemia. The handling of injectable cytotoxic drugs is centralised by the pharmaceutical department. The aim of this study is to develop a post-production quality program to check Cytarabine concentrations in preparations, thereby securing chemo-infusions given to hospitalised children. Cytarabine concentrations are assessed by UV-spectrophotometry. The production process is validated when error percent of Cytarabine concentration does not exceed 15%. Control was performed on 47 preparations containing Cytarabine (26 infusion bags and 21 syringes) among which 90%conformity was obtained (one infusion bag and three syringes were rejected). The proposed analytical method is easy-to-apply, rapid and economical compared to other available techniques. The suggested quality control is the basis for an efficient and effective monitoring process of production. Non-conformity implies the destruction of the preparation followed by a new production. This study will be followed by its daily application and the development of this control process on others drugs.
