The Pharmaceutical Research Of Yinshanlian Soft Capsule

Development of soft capsule is very vigorous in the domestic and overseas, and the development of traditional Chinese medicine soft capsules varieties boom is continuing unabated. Compared with other oral medicine formulation, its better sea Ling can cover the stench and smell of some of the contents;good compliance; high bioavailability; accurate loading capacity:easy to use for clinical application, easy to dose adjustment; suitable for drugs which is made to be tablets difficultly; improveddrug stability. In this thesis Yinshanlian soft capsule is a compound preparation of varieties of traditional Chinese medicine, in order to fully control the quality of drugs and determine the therapeutic effect of the formulation and improve its parameters, we present pharmaceutical research and related pharmacodynamic evaluation of the formulation, based on looking up, researching and analysing of relevant literature, test methods and results of the formulation are as follows:With orthogonal design method, extracted active ingredients of six Chinese herba L medicines, using yield of dry extracts and extraction amount of Chlorogenic acid, Protocatechuic acid, Geniposide, Scutellarin as indexes, and furthering optimize extraction technology of Chinese herbal medicines of Yinshanlian soft capsule, we ultimately determine the optimum extraction conditions: with 12 times the amount of water, soaked 0 min, extracted three times, three hours once time. And based as aboved research, we research pharmaceutical formulations process.To establish relevant quality standards of formulation, selecting thin layer chromatography(TLC), filtering suitable agent, co Lor ratio of solvent, a thin plate type and other conditions, establishing a rapid and accurate identification approach of Geniposide, Scutellarin, Glycyrrhetinic acid, Schizandrol. By high performance Liquid chromatography(HPLC), se Lecting the appropriate conditions for liquid chromatography and sample processing method. Establishing a appropriate method to determine the active ingredients content of Chlorogenic acid, Protocatechuic acid, Geniposide, Scutellarin of Yinshanlian soft capsules as inspecting the project indicators. Their linear ranges respectively are : 0.05392~0.10784 mg/m L(r=0.9998;0.04480~0.08960mg/m L(r=0.9998);0.04350~0.1015mg/m L(r=0.9999);0.0390~0.0910 mg/m L(r=0.9998); The average recoveries were:98.61%(RSD=0.65%);97.5%(RSD=1.06%); 97.6%(RSD=0.56%); 97.9%(RSD=0.91%), respectively. The results showed a good linear relationship between mass concentration and the peak area within the above range. The test method of the determination is simple and accurate, and good separation, high sensitivity, can be used as a quality standard for Yinshanlian soft capsules.Stable studies show good stability of the formulation and the property of the preparation is good.To determine the therapeutic effect of the drug, we studied pharmacological activity in vivo and made pharmacodynamic evaluation. Investigated the effect on Xylene-induced ear edema in mice, Lithocholic acid induced rats acute cholecystitis and CCl4 induced acute liver injury. The results show that the preparation has anti-inflammatory, protection of gallbladder, liver pharmacological effects.