Improve Preparation Process And Study Quality Control Of Compound Zaorenanshen Capsule

Objective：Compound zaorenanshen Capsules originate from famous veteran terandoctors of Department of Cardiology. It has an efficacy with liver and tranquilizing themind by nourishing the heart. It is mainly used for the treatment of dizziness, insomnia,amnesia which caused by blood deficiency of heart and liver. Made it into thetraditional Chinese medicine preparation in order to facilitate patients taking andcarrying. This project has made an experimental study on extraction technologyparameters and molding technology，quality control and preliminary stability，theoptimal extraction and molding technology condition was selected， in order toconsummate preparation quality control method and assure it quality.Methods:1. By orthogonal experimental design，taking the contents of Jujuboside A and theyield of extraction as the evaluating indexes，to inspect alcohol volume，concentration ofalcohol，extraction time and times，and taking the multiple guidelines grading method tooptimize alcohol extraction technology.2. Qrthogonal design method was employed for conducting the multiple guidelinesevaluation and selecting the optimum water extraction technology with the contents offerulic acid and berberine hydrochloride and the yield of extraction as the detectiveindex，and to inspect immersion time，water volume，extraction time and times，3. Concentrate the extracting liquid using alcohol precipitation and chitosanclarifier test respectively in order to purify it. Then the extract was studied dry process，and obtain the most optimal conditions.4. Ratio of accessories was investigated by taking moisture absorption percentageas index；Optimum molding technology was screened by taking shaping rate of granuleas indexes，and investigated angle of repose，moisture absorption percentage and criticalrelative humidity of granule. 5. Semen Ziziphi Spinosae，Angelica sinensis，Coptis chinensis，polygala root, RadixAucklandiae were identified by thin layer chromatography.6. According to the addenda general rule of the capsules in the2010part1ofChinese Pharmacopoeia，a series of quality studies about Compound zaorenanshenCapsules performed as：moisture content，content uniformity，disintegration time，microbial limit.7. The contents of ferulic acid and berberine hydrochloride was determined byUPLC method，the contents of Jujuboside A was determined by UPLG-ELSD method.8. Preliminary stability of three batches of samples was studied during the periodof three months can offer reference for casing and storaging condition.Results:1. The best alcohol extraction technology was as follow：add80%concentrationalcohol and6times volume，extracting2times per2hour.2. The best water extraction technology was add8times and boiling2times with3h for each time.3. The chitosan purification method was confirmed as the optimal purificationprocess. The best conditions for the relative density of liquids as1.05（60℃），1%chitosan clarifier addition amount25%， and standing24hours. The bestconcentration condition is drying into a dry paste at70℃with the vacuum drying.4. To select the Lactose and β-Cyclodextrin as adjuvant material，with80%alcoholto make granule and to dry under60℃.5. TLC spots were clear， the method is simple，accurate，and the negative controlhad no interference6. Every preparing check was up to the general rule of capsules in ChinesePharmacopoeia2010edition.7. The assay methods of the content of Jujuboside A and ferulic acid and berberinehydrochloride were sufficiently simple，sensitive，specificity and reproducible. 8. According to preliminary stability investigation，every preparing check wasaccorded with regulation.Conclusion： The production process of Compound zaorenanshen Capsules isreasonable and practicable；the quality control method is simple，convenient andfeasible，strong specificity，reproducible and can effectively control the drug quality；The preliminary stability research indicates that the quality of three batches samples arebasic stability.