Study On The Preparation And Quality Standards Of Huaihu Capsules

Menopausal syndrome and its indications is common disease plaguing manymenopausal women. With the intensification of the degree of aging in China and thesurge in number of patients, a drug little side-effect and treatment significantly ispressing. Huaihu capsules are new traditional Chinese medicine preparation, made byHuaimi and Pepper. The purpose of this project is about the pharmacy section,including the preparation process (extraction process and the forming process) andquality standards.In the extraction process of the study, the active ingredients are extracted from Huaimi and white Pepper using modern extraction methods, and the use of single factorand orthogonal experiments to establish the optimization of extraction technology.The optimum technique of Rutin is as follows:300mL,80%ethanol as solution,extracted for2times, and1h each time. The optimum technique of Piperine is asfollows:100mL,95%ethanol as solution, extracted for2times, and1h each time.In the preparation molding process of the study, the capsule agent is selected. Themolding process is established by the kind of excipient such as starch、dextrin、lactose、microcrystalline cellulose, the amount, the wetting agent. The result is asfollows: the wetting agent is75%ethanol as solution, the excipient is dextrin, the ratiobetween material and excipien is1:0.5.With the above-described method, the powderis granulated, dried and loaded in capsules.In the quality standard of the study, the preparation comply with therequirements of the capsules of Chinese Pharmacopoeia of2010. The TLCidentification is established to identify rutin, and HPLC to control the content of rutinand piperine. Three batches of samples are measured, and the results are conformed toa prescribed regulations.