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Objective To study the characteristics and regularities of Chinese drugs preparations ADR in order to improve the rational drug use.Methods A total of 112 cases of TCM ADR reports collected in 2009~2011 which have been presented to the Guangzhou ADR Monitoring Center.Results Of the 112 cases,26 kinds of drugs were involved,quinquagenarian were the main crowd,intravenous infusion was the main route of administration,the main types of TCM ADR were lesions of skin and accessories.Conclusion Great importance should be attached to TCM ADR monitoring to promote rational drug use in the clinic.
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OBJECTIVE:To provide approaches and avenues for the Chinese drugs preparations manufacturers in the GMP depuratory authentication.METHODS:The features and difficulties in the GMP depuratory authentication of the Chinese drugs preparations such as the optimizing of depuratory regulations,the determination of the acceptable standards,the choice of testing methods,clarification of expiration date and re-authentication were analyzed.RESULT&CONCLUSION:The depuratory regulations of the manufacturing facilities for the Chinese drugs preparations must be optimized.