中药调剂规范化研究(I):大黄不同调剂处理的化学同质性及条件优选

目的:基于化学同质性探讨大黄饮片粒度规格及调剂学处理对临床合理用药的影响规律。方法:比较饮片粒度、提取溶剂、提取时间、提取次数、先下/后下处理方式对大黄蒽醌类成分煎出量的影响。结果:大黄不同粒度饮片水/醇提时总蒽醌提取量最高差别1.9/6.4倍;水/醇提不同时间最高差别2.2/1.8倍;水/醇提不同次数最高差别2.8/1.8倍;水/醇提先下和后下最高差别2.3/1.7倍。从化学同质性来看,所考察不同调剂处理因素得到的提取物均不同质。其中,相同处理方式下醇提样品的蒽醌单体含量明显高于水提样品。水提取时,0.8~1.2 cm的大黄饮片提取量较高,与超微粉碎后提取量相差不大且更经济;大黄先下提取时蒽醌提取量随水提时间延长主要呈增加趋势;后下提取30,60 min时蒽醌提出量均高于先下方式;水提前2次蒽醌提出量超过提取6次总量的50%。而醇提取大黄时,细粉的提取量较高,与1 000目超微粉碎提取量相差不大;后下方式提取量均低于先下方式;醇提30 min后提取量增加不显著;醇提前2次蒽醌提出量超过提取6次总量的70%。综合考虑,大黄水提时后下提取30 min,提取2次为宜;醇提时先下提取30 min为宜,提取2次为宜。结论:不同调剂处理方式对大黄蒽醌成分的提取量有显著影响;亟待建立中药调剂操作规范(good usage practice,GUP)。

Research on good usage practice for Chinese Materia Medica (I): chemical equivalence of different prepare procedures and optimal conditions for good clinical usage of rhubarb

Objective : To probe into the influences of different granule sizes and to prepare procedures on rational clinical usage of rhubarb based on chemical equivalence. Method : The effects of particle size, extract solvent, extract time and repeat times, and pre-extract or pro-extract of rhubarb on the extract amounts of the anthraquinones (AQs) were compared. Result : The different prepare procedures investigated in the paper revealed significant influence on the extract amounts of the AQs and those extracts were not chemical equivalent. Ethanol extracted more AQs than water did, when other conditions were same. When extracted with water, the rhubarb of piece size 0.8-1.2 cm could extract relatively high amount of AQs nearly equal to superfine grinded powders, and the former was cheap. The water extraction of AQs showed an increasing trend with the extraction time extended. And pro-extract manner with water could extract more AQs than pre-extract manner with a extraction time of 30, 60 min. The water extraction of AQs repeated two times exceeded half of the amount of totally six times. When extracted with ethanol, the rhubarb of fine powders could extract relatively high amount of AQs nearly equal to superfine grinded powders. And pre-extract manner with ethanol could extract more AQs than pro-extract manner. The ethanol extraction of AQs increased in 30 min and then increased slower. The ethanol extraction of AQs repeated two times exceeded 70% of the amount of totally six times. So, the optimal conditions for water extraction rhubarb were pro-extract, two times repeated and 30 min per time; and the optimal conditions for ethanol extract were pre-extract, two times repeated and 30 min per time. Conclusion : The different prepare procedures showed significant influence on the extraction of rhubarb AQs. There is great need to establish a good usage practice (GUP) for Chinese Materia Medica to maintain rational clinical usage.