大黄配方颗粒质量分析及标准建议
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摘要
目的:比较目前市场上不同厂家的大黄配方颗粒企业标准和全检结果,对质量差异进行分析,并对质量标准和市场监管提出建议。方法:对比各企业间大黄配方颗粒质量标准的差异,采用企业标准,对9家企业109批大黄及炮制品配方颗粒进行全检。结果与结论:各企业大黄配方颗粒批间质量稳定,但不同企业间质量差异较大;建议在全国范围内,统一中药配方颗粒质量标准,加强监管。
Objective: To compare the enterprise standard and the total inspection results of rhubarb granules for prescriptions of different manufacturers in the market, analyze the quality differences, and put forward suggestions for quality standards and market supervision. Methods: The quality standards of rhubarb granules for prescriptions among different enterprises were compared. 109 batches of rhubarb granules in 9 enterprises were fully inspected by using enterprise standards. Results and Conclusion: The quality of rhubarb granules for prescriptions was stable among different batches, but the quality difference among different enterprises was large.It is suggested that the quality standards of the traditional Chinese medicine granules for prescriptions should be unified and the supervision should be strengthened nationwide.
Objective: To compare the enterprise standard and the total inspection results of rhubarb granules for prescriptions of different manufacturers in the market, analyze the quality differences, and put forward suggestions for quality standards and market supervision. Methods: The quality standards of rhubarb granules for prescriptions among different enterprises were compared. 109 batches of rhubarb granules in 9 enterprises were fully inspected by using enterprise standards. Results and Conclusion: The quality of rhubarb granules for prescriptions was stable among different batches, but the quality difference among different enterprises was large.It is suggested that the quality standards of the traditional Chinese medicine granules for prescriptions should be unified and the supervision should be strengthened nationwide.
引文
[1]国家药品监督管理局.国药监注[2001]325号关于印发《中药配方颗粒管理暂行规定》的通知[S]. 2001.
[2]国家食品药品监督管理总局办公厅.食药监办药化管〔2013〕28号关于严格中药饮片炮制规范及中药配方颗粒试点研究管理等有关事宜的通知[S]. 2013.
[3]国家食品药品监督管理总局.关于征求《中药配方颗粒管理办法(征求意见稿)》意见的公告2015年第283号[S]. 2015.
[4]国务院.国发〔2016〕15号国务院关于印发中医药发展战略规划纲要(2016-2030年)的通知[S]. 2016.
[5]李敏,刘渝,李丽霞,等.大黄配方颗粒原料药筛选研究[J].中药材,2006,(4):381-383.
[6]涂瑶生,崔景朝,陈长洲,等.大黄配方颗粒两种制备工艺的比较研究[J].中国实验方剂学杂志,2004,(5):7-8.
[7]李敏,李晓芳,李丽霞,等.干燥方法对大黄配方颗粒中蒽醌类成分的影响[J].中成药,2006,(9):1289-1293.
[8]叶殷殷.大黄配方颗粒制备工艺及质量标准的研究[D].广州中医药大学,2010.
[9]刘渝.大黄配方颗粒原料药(饮片)及成品质量标准研究[D].成都中医药大学,2006.
[10]李敏,李丽霞,刘渝,等. HPLC法测定大黄配方颗粒中大黄酸、大黄素、大黄酚的含量[J].现代中药研究与实践,2005,(5):32-34.
[11]黄良永,郑江萍,梁俊,等.大黄配方颗粒蒽醌成分的HPLC指纹图谱研究[J].中国药师,2014,17(8):1305-1308.
[12]李养学,胥爱丽,董玉娟,等.大黄配方颗粒的UHPLC指纹图谱研究[J].北方药学,2014,11(8):8-9.
[13]毕晓黎,谭志灿,李素梅,等.大黄与酒大黄配方颗粒红外光谱研究[J].中国实验方剂学杂志,2013,19(12):86-88.
[14]赵自明,陈玉兴,杜铁良,等.超微粉碎大黄配方颗粒小肠推进药理等效性研究[J].中华中医药杂志,2011,26(5):1051-1057.
[15]张乐.大黄配方颗粒的药学部分研究[D].成都中医药大学,2007.
[2]国家食品药品监督管理总局办公厅.食药监办药化管〔2013〕28号关于严格中药饮片炮制规范及中药配方颗粒试点研究管理等有关事宜的通知[S]. 2013.
[3]国家食品药品监督管理总局.关于征求《中药配方颗粒管理办法(征求意见稿)》意见的公告2015年第283号[S]. 2015.
[4]国务院.国发〔2016〕15号国务院关于印发中医药发展战略规划纲要(2016-2030年)的通知[S]. 2016.
[5]李敏,刘渝,李丽霞,等.大黄配方颗粒原料药筛选研究[J].中药材,2006,(4):381-383.
[6]涂瑶生,崔景朝,陈长洲,等.大黄配方颗粒两种制备工艺的比较研究[J].中国实验方剂学杂志,2004,(5):7-8.
[7]李敏,李晓芳,李丽霞,等.干燥方法对大黄配方颗粒中蒽醌类成分的影响[J].中成药,2006,(9):1289-1293.
[8]叶殷殷.大黄配方颗粒制备工艺及质量标准的研究[D].广州中医药大学,2010.
[9]刘渝.大黄配方颗粒原料药(饮片)及成品质量标准研究[D].成都中医药大学,2006.
[10]李敏,李丽霞,刘渝,等. HPLC法测定大黄配方颗粒中大黄酸、大黄素、大黄酚的含量[J].现代中药研究与实践,2005,(5):32-34.
[11]黄良永,郑江萍,梁俊,等.大黄配方颗粒蒽醌成分的HPLC指纹图谱研究[J].中国药师,2014,17(8):1305-1308.
[12]李养学,胥爱丽,董玉娟,等.大黄配方颗粒的UHPLC指纹图谱研究[J].北方药学,2014,11(8):8-9.
[13]毕晓黎,谭志灿,李素梅,等.大黄与酒大黄配方颗粒红外光谱研究[J].中国实验方剂学杂志,2013,19(12):86-88.
[14]赵自明,陈玉兴,杜铁良,等.超微粉碎大黄配方颗粒小肠推进药理等效性研究[J].中华中医药杂志,2011,26(5):1051-1057.
[15]张乐.大黄配方颗粒的药学部分研究[D].成都中医药大学,2007.