HPLC法应用于桃仁通痹丸生产工艺中混合均匀度的研究  

Study on the Mixing Uniformity of TaoRen TongBi Pill by HPLC

作　　者：杨真真 蔡建峰 黄秋萍 邹福贤 YANG Zhen-zhen;CAI Jian-feng;HUANG Qiu-ping;ZOU Fu-xian(The Center of Traditional Chinese Medicine preparation,Quanzhou Orthopedic-Traumatological Hospital,Quanzhou 362000,China)

机构地区：[1]泉州市正骨医院中药制剂室,福建泉州362000

出　　处：《海峡药学》2024年第9期28-32,共5页Strait Pharmaceutical Journal

摘　　要：目的通过高效液相色谱法研究桃仁通痹丸中间体药粉和软材的混合均匀度,确定混合终点。方法采集不同混合时间、不同取样位置的样品,通过高效液相色谱法测定样品中主要成分羟基红花黄色素A含量,以样品中含量变化为指标,分析混合过程含量变化的趋势,确定混合工艺参数。结果经过统计学分析和验证,桃仁通痹丸药粉和软材在混合10~30 min含量变化RSD均<5%,符合口服固体制剂混合均匀度要求,确定最佳混合工艺参数为混合时间10~20 min,混合转数24 r·min^(-1)。结论本文建立了高效液相色谱法研究桃仁通痹丸生产过程中混合工艺的含量均匀性,该方法简便、稳定,可用于确定混合终点,同时本文可为口服固体制剂混合工艺的研究、验证,提供一种科学的分析思路,具有较好的指导意义。OBJECTIVE To study on the mixing uniformity of the intermediate powder and soft material of TaoRen TongBi Pill by HPLC and determine the mixing endpoint.METHODS Samples with different sampling locations at different mixing times were collected,and the main component in the sample of hydroxy saffron yellow pigment A was determined by HPLC,and the change trend of the content in the mixing process was analyzed,and the parameters of the mixin g process were determined.RESULTS After statistical analysis a nd verification,the RSD change of Taoren Tongbi Pill powder and soft material w as<5%after 10-30 min mixing,which met the requirements of mixing uniformity of oral solid preparations,and the optimal mixing process parameters were dete rmined on mixing time of 10-20 min and mixing revolution of 24 r·min^(-1).CONCLUSION In this paper,the mixing uniformity of the mixing p rocess in the production process of TaoRen TongBi Pill was studied by HPLC,whic h was simple and stable,and could be used to determine the mixing endpoint.At the same time,this method can provide a scientific analysis idea for the resear ch and verification of the mixing process of oral solid preparations,which has good guiding significance.

关 键 词：高效液相色谱法 含量测定 混合均匀度 羟基红花黄色素A 

分 类 号：R927[医药卫生—药学]