Technique Of Preparation And Quality Standard Study Of Tangshen Kang Capsule

Diabetic Nephropathy(DN)which is one of common and serious complications of Diabetic Mellitus(DM)is an important microvascular complication of DM causing the injury of the renal.Because DN is multiple and high hazard,prevention and treatment of diabetes and its complications have been listed as the national "Eleventh Five-Year Plan" and "Twelfth Five-Year Plan",and are explicitly proposed as the main task of drug research in the future.Comprehensive treatment of the multi-channel,multi-target and multi-level of Traditional Chinese Medical prescription targeting different pathogenesis of DN has a distinct advantage in this complex disease.So international researchers focus on finding effective measures and medications from Traditional Chinese Medicine(TCM).This prescription originates from a clinic-empirical recipe of national famous Professor Zhang Bolin under the guide of TCM theory,and consists of Coptis Chinesis,Astragalus membranaceus,Epimedium brevicornum,Salvia miltiorrhiza,Anemarrhena asphodeloides,Leonzurus japonicus,etc.Tangshen Kang Capsule has been used for many years as a hospital preparation in the First Hospital of Tianjin,and has a good effect on treating DN.Therefore,we will develop the prescription into the sixth new drugs.The main research of this subject is as follows:1)Studies on extraction process:The process route of prescription is according the need of the clinics and production,and the property of various chemical components of natural medicine.From the view of the contents of berberine hydrochloride,icariin and solid,the optimum extraction conditions of Coptis Chinesis and Epimedium brevicornum and other herbals were determined respectively by single factor experiment,the orthogonal design,intuitive analysis and variance analysis.From the view of the contents of icariin and the rate of impurity removing,the optimum purification process of Epimedium brevicornum and other herbals was determined by the orthogonal design,intuitive analysis and variance analysis.drying processes were studied.2)Studies on preparation process:From the view of molding rate,powder rate and hygroscopicity,the types of auxiliary components,proportion and wetting agents were investigated to optimize the molding techniques.3)Studies on quality standard:According to the addenda general rule of the capsule in the 2005 part 1 of Chinese Pharmacopoeia,a series of quality studies about Tangshen Kang Capsule performed as:character,distinguish,weight deviation,disintegration time,microbial limit tests and the content determination.Coptis Chinesis,Leonurus japonicus,Anemarrhena asphodeloides,Salvia miltiorrhiza and Astragalus membranaceus were identified by thin layer chromatography.The separation of the stains is apparent,and the blank test shows no interference.We used high performance liquid chromatography to determine icariin.Method study indicates that this method is strong specializated,and easy to operate.We have studied the primary stabilization.According to modern research results of pharmacology and chemistry,with the innovative methods of technic designs,we optimized the extraction process,and manufactured the capsule.Furthermore,we also studied the quality standard and primary stabilization.With all the pharmaceutical studies having been done,it sets the stage for a valuable preparation whose curative effect is confirmed and quality is controllable for the medicinal market.