六味地黄凝胶的制备及质量标准研究

Study on Preparation and Quality Standard of Liuwei Dihuang Gel

目的制备六味地黄凝胶并建立其质量标准。方法以黏度、离心稳定性、失水率为考察指标,通过L9(34)正交试验设计筛选六味地黄凝胶成型工艺条件;采用薄层色谱法(TLC)对制剂中熟地、茯苓、泽泻、牡丹皮进行定性鉴别;并通过高效液相色谱法(HPLC)测定制剂中莫诺苷、马钱苷、丹皮酚的含量。结果凝胶剂优选处方为:1%卡波姆-940、15%丙二醇、1.8%三乙醇胺、药液比为1∶0.5;TLC鉴别斑点清晰,阴性无干扰;莫诺苷、马钱苷、丹皮酚分别在10.0~450.0 g/mL、5.0~125.0 g/mL、50.0~450 g/mL范围内呈良好线性关系;精密度、稳定性、重复性良好;加样回收率分别为98.45%、95.15%、98.66%,RSD分别为1.31%、0.96%、4.00%。结论通过该方法制备的凝胶质量可控、质地均匀、易于涂布,为临床六味地黄方治疗幼儿脑瘫提供了一种安全有效的经皮给药途径。

Objective To prepare Liuwei Dihuang gel and establish its quality standard.Methods Based on the indicators of viscosity,centrifugal stability,and water loss,the processing conditions of Liuwei Dihuang Gel are selected by L9(34)orthogonal test design.Radix Rehmanniae Preparata,Poria,Rhizoma Alismatis and Cortex Moutan Radicis in the preparation are identified by TLC.The contents of monoside,equisetin and paeonol in the preparation are determined by HPLC.Results The preferred prescription of the gel is 1%carbomer-940,15%propylene glycol,1.8%triethanolamine and the ratio of concentrated solution is 1:0.5.TLC identification spots are fairly clear and the blank tests show no interferences.The determination of monoside,equisein and paeonol keep the good linear relation in the range of 10.0~450.0 g/mL,5.0~125.0 g/mL and 50.0~450 g/mL with good precision,stability and repeatability.The recoveries of monoside,equisein and paeonol are 98.45%,95.15%and 98.66%.RSD values are 1.31%,0.96%and 4.00%.Conclusion The gel prepared by the method has controllable quality,uniform texture and easy coating,and provides a safe and effective transdermal adiministration route for the clinical Liuwei Dihuang prescription to treat infatile cerebral palsy.