药物药剂学评价因素研究.pdfVIP

·经验交流· 药物药剂学评价因素研究 △ 南京市210009) 中图分类号 R952；R969．3文献标识码 A 文章编号 1001—0408(2008)26—2077—04 摘要 目的：为构建药剂学评价的理论和方法奠定基础。方法：综合文献及经验，归纳并阐释包含制剂的合理性、质量的可控性及 传输的有效性等方面的药剂学评价因素。结果：制剂的合理性包括荆型、规格及包装量的选择；质量的可控性包括活性成分、杂质、 包装及稳定性；传输的有效性包括溶出度或释放度、装置包装。结论：该评价因素系统具有系统性、动态性及实用性。 关键词临床药物评价；药荆学；口服固体制剂；注射荆；因素 Clinical PharmaceuticalEvaluationFactorsof Drugs ZHU Affiliatedto Medical Han—yong，WEILong-jing，RENYi-sheng(BrainHospital Nanjing University， 210029，China) Naniing DING of Quan(Tumor 210009，China) HospitalJiangsuProvince，Nanjing ABSTRACTOBJECTIVE：Toabasison andmethodofthe lay constructingtheory pharmaceutical theliteratureand authorssummarizedand the evaluationfactors Bysynthesizing experience，the explainedpharmaceutical whichincluded of rationality etc．RESULTS-Thefactorsofratio- preparations，qualitycontrollability，anddeliveryefficacy of includedthechoiceof and nalitypreparations form，specificationamount；thefactorsof controlla- dosage package quality includedactive and thefactorsof includeddissolution bility constituent，foreignmatter，packagestability，and delivery efficacy or anddevice ofevaluationfactorsis and releasingdegree packaging，CONCLUSION：Thissystem systematic，dynamicprac- tical． KEYWORDSClinicaI solid evaluation；Pharmaceutics；Oral drugs preparations；Injections；Factors 临床药物评价(Clinicaldrugsevaluation)即药品再评价 (Drugsreevaluation)，是指在药品使用环节，从药剂学、临床药