Study On The Quality Standard And Preliminary Stability Of Fufang Anxiety Capsules

Objective:FufangKangjiaolv Capsule is originated from an experiential prescription with clinical experiences.It can regulate qi and relieve depression,nourishing blood for tranquillization.The study aims to make further quality standard,stability of FufangKangjiaolv Capsule.Based on the guidance of Chinese Pharmacopoeia capsule formulation's general requirement and the application requirements of the new Chinese medicine class XI drugs in Provisions for Drug Registration.We systematically studied the quality standard,stability of FufangKangjiaolv Capsule in preparation for the pharmacodynamics,safety evaluation and the development of new drugs.Method:The study on the quality standard of FufangKangjiaolv Capsule:By thin layer chromatography(TLC)method for the FufangKangjiaolv Capsule Jatamansi Radix,Semen,Albizia,rushes qualitative identification;Referring to Chinese Pharmacopoeia(2015)capsules under the relevant provisions of FufangKangjiaolv Capsule were examined three batches of water,the amount of difference,disintegration time,microbial limits;due to complex drug Valerianae Jatamansi Rhizoma et Radix produced in Yunnan,according to the literature over the issue of the presence of heavy metals in soil area,so increasing the heavy metals,arsenic salt checks;Determination of the cotent of effective components using high performance liquid chromatography(HPLC)method to establish the main drugs of FufangKangjiaolv Capsule.The preliminary stability investigation of FufangKangjiaolv Capsule:The stabilities of three batches of middle-scale products were investigated by accelerated test and long-term test.Results:FufangKangjiaolv Capsule's quality standard was initially established.The components were evaluated by TLC,including Valerianae Jatamansi Rhizoma et Radix,by using hesperidin,chlorogenic acid as the reference;Parched Ziziphi Spinosae Semen,by using jujuboside A,jujuboside B,spinosin as the reference;Albizia Cortex,by using Episyringaresinol glncopyranoside as the reference..In accordance with Chinese Pharmacopoeia(2015),the capsule's moisture,load difference,disintegration time and microbial limit were examined,and all met the reguirments.The content of the capsule's heavy metals and arsenic salt were qualitative and quantitative examination,the heavy metal content of the capsule was less than 10?g/g,the arsenic salt less than 5?g/g.An HPLC method for simultaneous determination of chlorogenic acid,hesperidin,spinosin,buddleoside in FufangKangjiaolv Capsule was established;The content of Episyringaresinol glncopyranoside was determined by HPLC.The limits of chlorogenic acid,hesperidin and spinosin were set as 1.24,2.15,0.38 mg/capsule,respectively.The results of preliminary stability test showed that the quality of products was stable,so the shelf period of FufangKangjiaolv Capsule was tentatively recommended as 12 months.Conclusion:The specification established in this study can be used for quality control of FufangKangjiaolv Capsule,a composite film packaging can improve the stability of the preparation.The study provides pharmaceutically experimental basis for the new drug application.