Studies On Preparation Technology And Quality Standard For Xujinjiegu Capsules

Objectives:The Xujinjiegu Capsule is originated from a clinical experiential prescription, which consists of Radix Dipsaci,Semen Persicae,Flos Carthami and Rhizoma Chuanxiong. We set up the extraction process and made it into hard capsules, the quality specification is madeMethods:The extraction process was studied by orthogonal design, imperatorin and isoimperatorin as the detective compositions with yield of the extraction. To optimize the alcohol extraction procedure of Fructus Evodiae by the uniform design and orthogonal design, and to compare the two experimental methods in terms of their feasibility, we take the extraction rates of evodiamine and rutecarpine as criteria by HPLC. After being made into inclusion compound withβ—CYD, the mentholum was made into granules together with the extraction of Fructus Evodiae. The qualitative analysis method of the four composition of the prescription was set up by TLC; the quantitative analysis method of Fructus Evodiae was set up by HPLC.Results:The optimized extraction procedure of Fructus Evodiae is to reflux it with 70% alcohol (8-fold alcohol as much as Fructus Evodiae and 2 hours for the first time; 7-fold alcohol and 1.5 hours for the second time), The optimum extraction procedure of Rhizoma Chuanxiong and Radix Angelica dahurica is to be percolated with 8-fold 80% alcohol after the crude drug has been immersed for 24 hours. The Naotongliting Capsule, the quality specification of which was made successfully.Conclusions:It was proved that optimum design of experiment procedure of the extraction and the preparation is reliable, and the process is suitable for industrial production of the Xujinjiegu Capsule. The medicaments comply with the provisions of the CP. The contents of evodiamine and rutecarpine were determined by HPLC, the four composition of the prescriptions were evaluated by TLC.