不同厂家山萸肉配方颗粒质量对比分析
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摘要
目的比较6个厂家的山萸肉配方颗粒的质量情况。方法参照2015年版《中国药典》四部通则中颗粒剂要求对不同厂家的样品进行粒度、水分、溶化性、装量、药物引湿性、浸出物和含量测定,考察其质量。结果 6个厂家样品粒度、水分、溶化性、装量均符合规定,但不同厂家样品的浸出物、含量差距较大。结论不同厂家的山萸肉配方颗粒质量存在较大差距,临床用药需加以注意。
OBJECTIVE Quality comparative of Fructus Corni formula granule by six different manufacturers.METHODS According to the requirement of granules in the《Chinese Pharmacopoeia》2015,the particle size,moisture,solubility,weight,wettability,extract and content of the samples from different manufacturers were tested,to study the quality of the samples.RESULTS The particle size,moisture,solubility and weight from samples of the six manufacturers were in accordance with the regulations,but the extract and content of the samples of different manufacturers have a big gap.CONCLUSION The quality of Fructus Corni formula granule of different manufacturers had a big gap,which should be paid attention to in clinical use.
OBJECTIVE Quality comparative of Fructus Corni formula granule by six different manufacturers.METHODS According to the requirement of granules in the《Chinese Pharmacopoeia》2015,the particle size,moisture,solubility,weight,wettability,extract and content of the samples from different manufacturers were tested,to study the quality of the samples.RESULTS The particle size,moisture,solubility and weight from samples of the six manufacturers were in accordance with the regulations,but the extract and content of the samples of different manufacturers have a big gap.CONCLUSION The quality of Fructus Corni formula granule of different manufacturers had a big gap,which should be paid attention to in clinical use.
引文
[1]国家药典委员会编.中国药典(一部)[S].北京:中国医药科技出版社,2015,172.
[2]刘迎迎.固本降浊汤治疗慢性肾功能衰竭的临床研究[D].山东:山东中医药大学,2009.
[3]国家药典委员会编.中国药典(四部)[S].北京:中国医药科技出版社,2015,7-8.
[4]常云凤,郝磊,张肖建,等.不同厂家五味子配方颗粒的质量比较[J].中国药物警戒,2017,14(5):278-282.
[5]刘成红,魏萍,张淑兰.高效液相色谱法测定山茱萸中马钱苷的含量[J].解放军药学学报,2005,21(2):144-146.
[6]许丹,樊宝娟,孙文基.不同生长期和不同产地山茱萸中马钱苷的测定[J].西北大学学报(自然科学版),2008,38(4):602-604.
[7]李文烈,曹海芳,魏刚,等.中药制剂质量控制的研究进展[J].中国执业药师,2012,9(7):32-35.
[2]刘迎迎.固本降浊汤治疗慢性肾功能衰竭的临床研究[D].山东:山东中医药大学,2009.
[3]国家药典委员会编.中国药典(四部)[S].北京:中国医药科技出版社,2015,7-8.
[4]常云凤,郝磊,张肖建,等.不同厂家五味子配方颗粒的质量比较[J].中国药物警戒,2017,14(5):278-282.
[5]刘成红,魏萍,张淑兰.高效液相色谱法测定山茱萸中马钱苷的含量[J].解放军药学学报,2005,21(2):144-146.
[6]许丹,樊宝娟,孙文基.不同生长期和不同产地山茱萸中马钱苷的测定[J].西北大学学报(自然科学版),2008,38(4):602-604.
[7]李文烈,曹海芳,魏刚,等.中药制剂质量控制的研究进展[J].中国执业药师,2012,9(7):32-35.