Compound Antianxiety Capsules Pharmaceutical Research

Objective:Fufang Kangjiaolv Capsule is originated from a experiential prescription with clinical experiences, which consists of Valerianae jatamansi Rhizoma et Radix, Albizia Cortex, the parched Ziziphi spinosae Semen and Junci Medulla. It can regulate qi and relieve depression, nourishing blood for tranquillization. The purpose of this work is to set up the extraction and hard capsule processes, establish the quality specification of the capsule and study on stability of the capsule.Methods:1. Study on raw material extraction process:The extraction process of Valerianae jatamansi Rhizoma et Radix was determined by orthogonal design with the content of hesperidin as an indicator. The optimum extraction conditions of Albizia Cortex and the parched Ziziphi Spinosae Semen were determined by the orthogonal design with the content of jujuboside A as an indicator. The extraction process of Junci Medulla was determined by orthogonal design with the content of the total extract as an indicator.2. Study on dosage form:The excipients were selected according to the hygroscopic characteristics and fluidity.3. The study on quality specification and primary stability of the capsule:By using TLC, we have made qualitative analysis on each constitute of Fufang Kangjiaolv capsule; By using HPLC, we have made quantitative analysis on hesperidi and have studied the primary stability.Results:1. Extraction processes:Valerianae jatamansi Rhizoma et Radix:10-fold,35% ethanol extract 3 times,1 hour everytime; Albizia Cortex and the parched Ziziphi spinosae Semen:10-fold, H2O extract 3 times,2 hours everytime; Junci Medulla:50-fold,95% ethanol extract 3 times,1 hours everytime;2. Fufang Kangjiaolv Capsule's preparation technology is determined. Dry extract is crushed to fine powder,mixed with 0.5 times dextrin, granulate, dry, subpackage. Relative humidity should below 80% during the preparation of capsules.Three groups semi-works production indicate that preparation technology is stable and feasible.3. Fufang Kangjiaolv Capsule's quality standard is initial established. The components were evaluated by TLC, including hesperidin, chlorogenic acid, jujuboside A, Albizia Cortex.The content of hesperidin was determined by HPLC method.The quality standard is sensitive, accurate, repeatable and specific. Quality of Fufang Kangjiaolv Capsule is stable within one year.