化橘红配方颗粒与饮片汤剂的化学等量性和药效等效性研究

Study on Chemical and Pharmacodynamic Equivalence of Slice Decoction and Dispensing Granules of Citri Grandis Exocarpium

目的考察化橘红配方颗粒与饮片汤剂间的化学等量性和药效等效性。方法运用薄层色谱(TLC)、高效液相色谱(HPLC)进行成分分析,通过氨水喷雾引咳小鼠试验和小鼠酚红排泌祛痰试验进行药效学研究,从而考察化橘红配方颗粒与饮片汤剂的化学等量性和药效等效性。结果薄层色谱图中,化橘红配方颗粒与饮片汤剂在柚皮苷相应的位置上,显相同颜色的斑点;高效液相特征图谱中,辨识归属特征共有峰12个,化橘红配方颗粒与饮片汤剂的相似度均>0.9;化橘红配方颗粒与饮片汤剂柚皮苷和野漆树苷的含量相当(P>0.05)。相同剂量的化橘红配方颗粒与饮片汤剂对小鼠止咳潜伏期和咳嗽次数,以及酚红排泌量的作用差异均无统计学意义(P>0.05)。结论化橘红配方颗粒与化橘红饮片汤剂的共有药效组分相似,主要成分含量相当,止咳祛痰作用效果等效。

Objective To investigate the chemical and pharmacodynamic equivalence between Citri Grandis Exocarpium dispensing granules and Citri Grandis Exocarpium slice decoction.Methods Thin layer chromatography(TLC)and high performance liquid chromatography(HPLC)were used for component analysis.Pharmacodynamical study was performed by the test of ammonia inducing cough and phenolsulphonphthalein excretion in mice.Our aim is to investigate the chemical equivalence and efficacy equivalence of Citri Grandis Exocarpium dispensing granules and Citri Grandis Exocarpium slice decoction.Results In the TLC of Citri Grandis Exocarpium dispensing granules and their slice decoction,the same color spots were observed at the corresponding positions of naringin.Twelve peaks in the HPLC characteristic chromatogram were identified as belonging characteristic common peak,and the similarity between Citri Grandis Exocarpium dispensing granules and their slice decoction was greater than>0.9.The contents of naringin and rhoifolin in Citri Grandis Exocarpium dispensing granules and their slice decoction were statistically equivalent(P<0.05).There was no significant difference in cough latency,cough frequency and the phenolsulfonphthalein excretion between Citri Grandis Exocarpium dispensing granules and their slice decoction with the same dose(P<0.05).Conclusion The chemical compositions were consistent,the contents of main components were equivalent and the effect of relieving cough and eliminating phlegm were equivalent between Citri Grandis Exocarpium dispensing granules and Citri Grandis Exocarpium slice decoction.