Design And Evaluation Of Traditional Chinese Medicine Compound Recipe Jingzhiguanxin Osmotic Pump Controlled Release Formulations

Traditional Chinese medicine (TCM) is a precious heritage of China, which is a main preventative and therapeutic method of laboring people in thousands years. However, traditional Chinese medicine preparations (TCMP) could not meet the requirement of treatment for people in the 21st century. It is faced with many problems such as backward techniques, outdated dosage forms, default and insufficient of qualitative evaluation, which have hindered the TCM development toward the world. It is urgent to expand TCMP by making full use of advanced science and technology.Jingzhiguanxin (JZGX) tablet has been listed in the first section of 2005's edition of "Pharmacopoeia of the People's Republic of China", and composed of "danshen" (Radix Salviae Miltiorrhizae), "chishao" (Radix Paeoniae Rubrae), "chuanxiong" (Rhizoma Chuan-xiong), "honghua" (Flos Carthami) and "jiangxiang"(Lignum Dalbergiae Odorafera). It is primarily applied to the treatment of coronary artery disease and coronarism. The main action mechanism of JZGX prescription is improving blood circle and clearing up silt in the body. In this doctoral paper, JZGX was selected as model drug of TCMP and prepared into osmotic pump controlled preparation, which provided a new method of traditional Chinese medicine modernization.It is backward for the qualitative analytical methods of JZGX in pharmacopoeia and could not precisely analyze the contents of drugs. So the qualitative analytical methods of danshensu, paeoniflorin, ferulic acid and safflower yellow A, which were the maker compounds of JZGX, were built. TLC methods were used to identify four compounds, UV method was used to measure safflower yellow A, and HPLC methods were used to determine four compounds. The total HPLC method of danshensu, paeoniflorin and safflower yellow A was built for the first time, which was fast, convenient, met the need of determination. The correlation of different methods and compounds was fine by f₂ factor comparison. Above-mentioned analytical methods provided suitable means in future study of JZGX controlled preparation.