Study On Preparation Technology And Quality Standard Of Anzhikang Capsules

ObjectivesResearch and develop a new health food with auxiliary hypolipidemic function(tentatively named Anzhikang Capsule).Optimize the production process of Anzhikang capsules and determine the main indicators of their quality standards.MethodsThe topic mainly contains three parts:extraction process,forming process,and quality standards of Anzhikang Jiaonang.1 Extraction technology research:By consulting the Pharmacopoeia and related literature,the extraction solvent and extraction methods of the indexes and pharmacological active components of the four flavors were determined.Red yeast rice and Alismatis rhizoma use the method of alcohol extract.Content of lovastatin and 23-Acetazolol B content and yield of dry extract are evaluation of alcohol extracting process.Ethanol concentration,extraction time,extraction times and the amount of alcohol are factors affecting the best alcohol extraction process.Crataegi fructus and Nelumbinis folium use the method of alcohol extract.Total flavonoid content and yield of dry extract are evaluation of alcohol extracting process.Ethanol concentration,extraction time,extraction times and the amount of alcohol are factors affecting the best alcohol extraction process.2 Forming process research:According to the nature of the traditional Chinese medicine effective substances and the formulation process design theory,capsules are used as the formulation of the prescription.Based on the properties of the drug itself(fluidity,hygroscopicity)and the properties of the particles(moisture absorption rate,difficulty in granulation,molding rate),etc.,appropriate excipients,dosages,etc.were selected to optimize the molding process parameters.3 Quality standards research:In order to ensure the stability of the capsule and control the quality of the capsule,the quality standard is preliminarily formulated in the two aspects of the qualitative and quantitative aspects.This study identified Red yeast rice,Alismatis rhizoma,Crataegi fructus and Nelumbinis folium by TLC method and determined the content of puerarin,lovastatin and total flavonoid by using HPLC and UV-vis method,then initially established its quality standards.Results1 Extraction process result:The optimal alcohol extraction process conditions of Red yeast rice and Alismatis rhizome are adding D1 times E1 alcohol refluxing for F1 times,each time G1 h.The optimal alcohol extraction process conditions of Crataegi fructus and Nelumbinis folium are adding D2 times E2 alcohol refluxing for F2 times,each time G2 h.2 Forming process results:According to the prescription proportion,the two powders were weighed and mixed at a speed of H r/min for I min.The mannitol was used as an excipient.The granulation method was:wet granulation,the drug-assisted ratio was K,and the wetting agent was J ethanol,P mesh sieve granulation,granulation granulation placed in L ? oven drying M h,N mesh sieve whole,into 0 capsules,that is,too.3 Establish quality standards:Established a qualitative identification method for TLC of Red yeast rice,Alismatis rhizoma,Crataegi fructus and Nelumbinis folium in Anzhikang capsule.The high performance liquid content determination method for Chromatographc conditions for lovastatin:Waters Sunfire C18(4.6 mm×250 mm,5 ?m)chromatographic column;detection wavelength of 238 nm;mobile phase:methanol-water-phosphoric acid(385:115:0.14),flow rate:1 mL/min;column temperature:30?.An Zhikang capsule contains lovastatin(C24H36O5)should be not less than 0.94mg;and each piece of total flavonoids as rutin(C27H30O16)should be not less than 3.95 mg.ConclusionA stable and feasible preparation process of Anzhikang Jiaonang is established by the research of extraction and forming process,with producing qualified capules.This study carried out qualitative identification and content determination through the relevant quality standards to guarantee that the formulation quality of Anzhikang Jiaonang achieve the expected experimental objective.