归芪补肾颗粒成型工艺及其质量控制

目的:建立归芪补肾颗粒剂的成型工艺条件及其质量控制方法。方法:选用单因素实验设计,以颗粒剂的成型率、吸湿率为指标筛选归芪补肾颗粒的成型的最佳条件;采用TLC法对处方中黄芪、当归、川芎、牡丹皮、白术、厚朴进行定性鉴别;运用HPLC测定阿魏酸含量,检测波长316 nm。结果:最佳成型工艺为:浸膏-乳糖-糊精(1:0.5:1.3),润湿剂为65%乙醇,制得颗粒流动性好。黄芪、当归、川芎、牡丹皮、白术、厚朴的TLC鉴别斑点清晰且阴性无干扰;阿魏酸在20.25~101.25 mg·L^-1的范围内呈良好线性关系,平均回收率为96.76%,RSD为1.09%,阿魏酸含量不得低于0.056 mg·g^-1。结论:优选成型工艺可行,建立的质量控制方法专属性强、重复性好,能用于控制归芪补肾颗粒的质量。

Research on formation technology and quality control of Guiqibushen Granules

OBJECTIVE To establish the optimal formulation of Guiqibushen Granules and establish its quality standards. METHODS Single-factor method with forming rate and hygroscopicity as the judgment criteria was adopted to find out the best conditions of Guiqibushen Granules. TLC was used for qualitative identification of Astragalas membranaceus (Fish.), Angelica sinensis, Ligusticum Chuanxiong, Cortex Moutan, Atractylodes Macrocephala and Magnoliae Officinalis. HPLC was adopted to determine the content of ferulicacid at 316nm.RESULTS The optimal molding process was as follows: content of extracta sicca-lactose-dextin=1:0.5:1.3, 65% ethanol was added for making pellets, and the flowability was good. Spots of those traditional Chinese medicines on TLC plates were clear without interference by blank reference. Linear range of methods was 20.25-101.25 mg·L^-1 (r=0.999 3). Average recovery was 96.76% with RSD of 1.09%. Content of ferulic acid was not less than 0.056 mg·g^-1.CONCLUSION Technology of preparation process is feasible. The established quality control method is specific and reproducible, can be adopted for quality control of Guiqibushen Granules.