Reasearch On Preparation And Quality Standard Of Qianliean Capsule

Qianliean Capsule,a compound preparation of Chinese medicine,is from effective prescription in clinic,formed by twelve breeds of herbs such as Radix Salviae Miltiorrhizae,Fructus Citri Reticulatae Immaturus,Cortex Phellodendri Amurensis,etc.,with the function of activating blood circulation to dissipate blood stasis,promoting qi to remove stasis,clearing away heat evil and promoting dieresis,which can be mainly used for the disuria and urine retention and micturition disorders.The study of preparation process,quality standard and preliminary stability was carried out to develop a new kind of preparation with security,efficacy and stability.It accomplished the pharmaceutical research on a new kind of traditional Chinese medicine.During the research of preparation process,the extraction technology was mainly studied,with the method of extraction by both alcohol and water.The response surface methodology was applied in the extraction technology.On the basis of investigation of single factor,the salvianolic acid B and hesperidin were selected as criterion to optimize the best alcohol extraction conditions by Box-Behnken design,while the rosmarinci acid and berberine were selected to optimize the best water extraction by central composite design.Meanwhile,the concentration and drying technology were investigated to formulate the preparation process.Through verification,three batches of semi-products were prepared and passed the proposed quality standard,which proved the preparation technology to be reasonable,stabile,and feasible.In the research of quality standard,the microscopical chatacteristics,qualitation and quantitation were required to be checked out.The method of microscopical chatacteristics of Semen Vaccariae Segetalis,TLC identification of Radix Salviae Miltiorrhizae,Fructus Citri Reticulatae Immaturus,Cortex Phellodendri Amurensis showed it qualified for the standard of qualitation.Besides,the total identification herbs amounted to a third of herbs in prescription.The method of quantitation analysis in the same time by HPLC of salvianolic acid B,hesperidin,naringin and berberine were established.Meanwhile,the specificity of determination method was studied and the results showed it rational and reliable.During the research of exploratory development,the quantitative analysis of multi-components by single marker(QAMS)was introduced into determination of the amount of index components of preparation.Meanwhile,the applicability and feasibility of QAMS applyed in different types of compounds were explored and evaluated.The relative correction factor of hesperidin to salvianolic acid B and berberine hydrochloride was calculated.The method was evaluated by comparison of the quantitative results between external standard method and QAMS method,and no significant defferences were found,which showed it accurate and feasible.Consequently,QAMS could be applyed in different type of compounds in chinese herbal preparation with good applicability and feasibility,which accomplished the quantitation analysis of multi-components by single marker in chinese herbal preparation.During the preliminary experiments on the stability,the description,properties and content of all the products came up to the required standard after the experiments of accelerating test and remaining the samples in six months,while the samples remaining in nine months and in a year is being investigated.The studies suggest that the preparation technology of Qianliean capsule is scientific and reasonable,the quality standard reliable,and the properties sTab.