Research Of Prepared Technics And Quality Standard Of FuYankang Concentrated Pill

Common gynecological inflammatory diseases include vulvovaginitis, cervicitis,endometritis,annexitis and pelvic inflammation,etc.FuYankang Tablets is a sort of pure Chinese materia medical preparation effective in curing gynecological inflammatory diseases,which has been clinical applicated for years.At present,the same Chinese herbs prescription as the FuYankang Tablets,there are two dosage forms of Chinese patent drug in curing chronic gynecological disease which have been recognized by Chinese state official standards.One is tablets,the other is pilula which is produced directly by pulverizing the herbs.It is incovenient for patients to take FuYankang tablets because of the big piece shape and too much tablets in a dose.Furthermore, similar tablet products are launched by many manufacturers which leads to disorderly sales situation.Meanwhile,the pilula of the same Chinese herbs prescription has the same problem of a large dose.FuYankang concentrated pill,however,is a product that combines tradi-tional Chinese medicine with modern technology.It not only embodys the advance of modern pharmaceutical technology but also keeps the advantage of tradi-tional decoction and accords with the characteristic of the drug.What' s more,contrary to water-paste pill and honeyed pill,FuYankang concentrated pill is easy for the patients to take due to the small piece shape and dose.Moreover,compare with FuYankang tablets,there is no granulation and tunicatus during the manufacturing process,which could reduce production cost and provide one more dosage form to dorctors and patients.Therefore,on the premise of unchanging the prescription of FuYankang tablets,this study changes tablets into concentrated pill according to the charateristic of dosage form and quality requirements in the Chinese phar-macopeia of 2005.According to the requirements of registration and classification of traditional Chinese medicine and natural medicine and the application materials preparation in "Management of Drug Registration".FuYankang concen-trated pill is one of changes in pharmaceutical dosage forms of domestic sales which have been listed in classâ…§.The effective constituent in the prescription is complicated.The purpose of this study is to reserve the effective constituent,reflect the integrated effect of compound preparation and keep the quality of the medicine safe,stable,controllable and meeting the clinical application.Therefore,under the guidance of the tradional Chinese medicine theory, how to use modern technology to reform the dosage form is the most important and difficult part in this study.In the aspect of preparation technology,the preparative method of the concentrated pill is improved in accordance with the foundation of FuYankang tablets in "National Drug Standards" WS₃-B-1935-95 of SFDA.The technique of technics uses vacuum concentration to avoid high temperature and longtime concentration which causes sticking to the bottom of the pan and agglomerating and even breaking or reducing the content of active principles.In the aspect of quality standard,this study uses TLC method to identify 13 Chinese herbs and HPLC method to assay the content of Matrine and Sodium Danshensu in FuYankang concentrated pill.In the TLC method,this study makes improvements in solving the problems of the composition of developing agent and assaying conditions.Finally,the TLC method of five traditional Chinese herbs were drawn up,which were Rhizoma Zedoariae,Cortex Phellodendri,Rhizoma Corydalis,Radix Sophorae Flavescentis and Radix Salviae Miltiorrhizae.On the other hand,the HPLC method solves the assaying problems of chromatographic conditions and preparation of reference substance and samples for test.In the end,the assaying method and fingerprints of matrine(recovery rate:98.27 %;RSD:0.61%)and Sodium Danshensu(recovery rate:97.56%;RSD:0.95%)were provided.This HPLC method is stable,reliable and accurate.The study also completed the inspection items of FuYankang concentrated pill including moisture test,weight variation,dissolving time limit,microbial limit bacter-ioscopy and determination of the heavy metal content,etc.From the results mentioned above,under the guidance of the theory of traditional Chinese medicine,by utilizing the latest achievements in the modernization of traditional Chinese medicine and quality control flexibly, this study made dosage reformation from FuYankang tablets to FuYankang concentrated pill on the basis of the nature of effective constituent and requirement of clinical application.It completed preparation process and preliminary quality standard of FuYankang concentrated pill successfully.All of this will ground a preliminary foundation for applying for new dosage form of medicine in the future.