海南省中药前处理及提取物委托加工现状调查及对策

Investigation and Solutions of Out-source Manufacture of Pre-treatment and Extraction of TCM in Hainan Province

目的进一步规范海南省中药前处理及提取的委托生产行为,完善委托监管方式方法,促进中药前处理及提取委托生产的良性发展。方法通过对海南省中成药生产企业的现状调查及数据分析,探讨其技术审查要点及推进政策。结果与结论针对海南省药品生产企业中药前处理及提取委托生产中存在的问题提出对策,为相应生产规范性文件的制定提供参考。

Objective To standardize out-sourcing manufacture of TCM pretreatment and extraction in Hainan Province and to improve the regulation and supervision of out-sourcing production,consequently,to facilitate out-sourcing TCM pretreatment and extract into the positive development.Methods The key points of technical review and the policy of advances were discussed by present situation investigation and data analysis of entrust production for TCM pretreatment and extraction in Hainan Province.Results and Conclusions Some suggestions and strategies are proposed in allusion to the problems of out-scourcing production of the TCM pretreatment and extraction in the pharmaceutical production enterprise for Hainan Province.A reference is provided for developing the rules about TCM production of pre-treatment and extraction in Hainan Province.