小儿紫癜疹消颗粒的提取工艺及质量标准研究

Study on Preparation Technology and Quality Standard of Children's Purpura Rash Eliminate Particles

目的优选小儿紫癜疹消颗粒的提取工艺及质量标准的建立。方法以丹皮酚为考察指标,采用水蒸气蒸馏方法提取牡丹皮,单因素考察加水倍数对牡丹皮的提取影响;以总黄酮和黄芩苷提取量为综合评价指标,采用正交试验考察煎煮时间、提取次数、加水倍数对水煎煮工艺的影响;采用薄层色谱法对该处方中的茜草、牡丹皮、黄芩等药材分别进行定性鉴别研究;采用HPLC法测定黄芩苷的含量。结果牡丹皮提取最佳工艺为6倍量水,提取5 h。水煎煮最佳提取工艺加6倍量水,煎煮3次,每次1 h;定性薄层色谱斑点清晰,阴性对照无干扰;黄芩苷线性范围0.1596～0.9576μg(r=0.9998),平均回收率为98.48%,RSD为2.47%。结论优选的提取工艺稳定可行,所建立的定性定量方法较好,简便、准确、重复性好,可作为小儿紫癜疹消颗粒剂的质量控制方法。

Objective To optimize the extraction technology and quality standard of,Children ＇s Purpura Rash Eliminate Particles.Methods The effects of water extract on the extraction of Moutan Cortex were studied by steam distillation method.The extraction of total flavonoids and baicalin extraction is comprehensive scoring.The effects of boiling time,extraction times and water addition times on the process were investigated by orthogonal test,The qualitative identification of Rubiaceae,Moutan Cortex and Scutellaria baicalensis in the prescription was studied by TLC.The content of baicalin was determined by HPLC.Results Moutan Cortex extract the best process for 6 times the water,extraction for 5 hours,optimum extraction process of water decoction was as following：the extracted 3 times with 6 times the water with 1 h each time.TLC identification spots were fairly clear and the blank test showed no interference.The linear range of 0.1596～0.9576μg（r=0.9998）,the average recovery was 98.48% and the RSD was 2.47%.Conclusion The optimized extraction technology is stable and feasible.The qualitative and quantitative method is simple,accurate and reproducible.It can be used as a quality control method for Children ＇s Purpura Rash Eliminate Particles.