Study On Preparation Technology And Quality Standard Of Shurun ??capsule

ObjectivesThe subject is to develop a new health food with temporary functions(temporarily named Shurun capsule)under the guidance of traditional Chinese medicine theory,combined with modern science and technology,optimize the preparation process of Shurun capsules,and study its quality standards.The topic mainly contains three parts:extraction process,forming process,and quality standards of Shurun Jiaonang.1.Extraction technology research:According to the related literatures of the four herbs in the formula,prescription was divided into two parts.FoliumSennae use the method of alcohol extract.The content of Senex A and yield of dry extract are evaluation of extraction process parameters.By single factor test and orthogonal test,and ultimately determine the optimal alcohol extraction process of FoliumSennae.Catsia tora Linn,Scrophularia ningpoensis,and Citrus aurantium L.use the method of alcohol extract.The content of Naringin,harpagoside and yield of dry extract are evaluation of extraction process parameters..By single factor test and orthogonal test,and ultimately determine the optimal alcohol extraction process of Catsia tora Linn,Scrophularia ningpoensis,and Citrus aurantium L.2.Forming process research:This study detersmines to use wet granulation according to process results and practical situation.With the molding rate and moisture absorption as the index and refer to liquidity of granules,this study determined the impact of types of supplementary material,medicine auxiliary ratio and ethanol concentration on the molding process.Through the experiment,the study optimizes the best molding process.3.Quality standards research:In order to guarantee the quality of the capsule,this carried out the routine examination and studied the quality standard from qualitative and quantitative aspects.This study identified FoliumSennae,Catsia tora Linn,Scrophularia ningpoensis and Citrus aurantium L.by TLC method and determined the content of Senex A and total anthraquinone by Using high performance liquid chromatography(HPLC)and UV-visible spectrophotometer method,then established the quality standard initially.Results1.Extraction process result:The alcohol extraction process parameters for FoliumSennae:The optimal conditions of alcohol extraction are adding 20 times 50%alcohol refluxing for 3 times,each time 15 minutes.The extracts were combined,filtered,and the filtrate was concentrated to a relative density of 1.00-1.05(60?)and dried under reduced pressure to give a dry extract.The extraction process parameters for Catsia tora Linn,Scrophularia ningpoensis,and Citrus aurantium L.:the optimal conditions of alcohol extraction are adding 14 times 65%alcohol refluxing for 2 times,each time 2 hours.The extracts were combined,filtered,and the filtrate was concentrated to a relative density of 1.00-1.05(60?)and dried under reduced pressure to give a dry extract.2.Forming process results:According to the proportion of prescription to take two flavor powder to 100 r/min speed mixing 20 minutes,the choice of lactose as excipients,drug ratio of 8:1,mixed with 20%of the total amount of drug 95%ethanol Wetting agent,stir quickly after 40 mesh sieve granulation,the wet particles placed in 50? oven drying 2 hours,with 40 mesh sieve.Put the particles into the capsule to get the finished produc.t3.Establish quality standards:Set up the TLC qualitative identification method for FoliumSennae,Catsia tora Linn,Scrophularia ningpoensis,and Citrus aurantium L.The high performance liquid content determination method for the content of Senex A.Chromatographc conditions for Senex A:Thermo C18(4.6 mm×250 mm,5 ?m)chromatographic column;Acetonitrile-5mmol/L four heptanyl ammonium bromide was used as acetic acid sodium acetate buffer(PH5.0 1?10)[note](35:65)mixed solution 1000ml,with four heptanyl ammonium bromide 2.45 g as mobile phase.the flow rate of 1.0 mL/min,detection wavelength of 340 nm.And the content of Senex A and total anthraquinone per gram cannot be less than 0.49 mg and 4.52 mg,respectively.ConclusionBy analyzing the the preparation process of Shurun Jiaonang,a stable and feasible molding process was established,and a batch of qualified capsules was prepared.This study carried out qualitative identification and content determination as well,and set up quality standards to ensure the good quality of the capsules.