Study On Preparation Technology And Quality Standard Of Ginseng Royal Jelly Capsule

ObjectivesThe original prescription of Shenge Fengwangjiang Jiaonang is composed of Panax ginseng C.A.Mey.,Pueraria lobata(Willd.)Ohwi and royal jelly freeze-dried powder,which has anti-aging effect.This study combined modern science and technology to optimize the preparation process,and undertake preliminary quality standard research.MethodsThe topic mainly contains three parts:extraction process,forming process,and quality standards of Shenge Fengwangjiang Jiaonang.1.Extraction technology research:According to material properties in the prescription,prescription was divided into two parts.Pueraria lobata(Willd.)Ohwi use the method of water extract.Puerarin transfer rate and yield of dry extract are evaluation of water extracting process.The amount of water,decocting time,decocting times are factors affecting the extraction technology of water.Ginseng total saponins content and yield of dry extract are index of alcohol extracting process.The amount of alcohol,refluxing time,refluxing times are factors affecting the extraction technology of alcohol.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 Panax ginseng C.A.Mey.,Pueraria lobata(Willd.)Ohwi and royal jelly freeze-dried powder by TLC method and determined the content of puerarin,10-hydroxy-2-decenoic acid and total saponins by Using high performance liquid chromatography(HPLC)and UV-visible spectrophotometer method,then established the quality standard initially.4.Preliminary stability test study:In order to examine the quality of the stability of the case of Shenge Fengwangjiang Jiaonang,according to the raw material drug and preparation stability test guidelines on the three batches of products(batch number were 170201,170202,170203)in accordance with the established quality standards Traits,identification,examination,content determination was carried out 3 months of accelerated stability test and 3 months of long-term stability test.Results1.Extraction process result:Water extraction process conditions:The optimal conditions of water extraction are adding I2 times water boiling for J2 times,each time T3h.Alcohol extraction process conditions:the optimal conditions of alcohol extraction are adding Ii times 70%alcohol refluxing for Ji times,each time Ti h.2.Forming process results:According to the proportion of prescription to take three flavor powder to 100 r/min speed mixing T4 minutes,the choice of dextrin as excipients,drug ratio of 13,mixed with I4 of the total amount of drug E%ethanol Wetting agent,stir quickly after M mesh sieve granulation,the wet particles placed in Q? oven drying T5 hours,with M mesh sieve.Put the particles into the capsule to get the finished product3.Establish quality standards:Set up the TLC qualitative identification method for Panax ginseng C.A.Mey.,Pueraria lobata(Willd.)Ohwi and royal jelly freeze-dried powder.The high performance liquid content determination method for puerarin and 10-hydroxy-2-decenoic acid.Chromatographc conditions for puerarin and 10-hydroxy-2-decenoic acid:Thermo C18(4.6 mm×250 mm,5 ?m)chromatographic column;mobile phase was methanol(A)-;0.01 mol/L hydrochloric acid solution(B),and the elution conditions was 0 to 45 min,(A)25%to 55%,the flow rate of 1.0 mL/min,detection wavelength of 210 nm and 250 nm.And the content of puerarin,10-hydroxy-2-decenoic acid and total saponins in each capsule cannot be less than 9.69 mg,2.28 mg and 32.20 mg,respectively.4.Preliminary stability test study:Three batches of Shenge Fengwangjiang Jiaonang in the accelerated test and long-term test conditions for the preservation of the 3-month indicators are consistent with the provisions,preliminary description of the stability of the product preparation.ConclusionBy analyzing the the preparation process of Shenge Fengwangjiang 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.The initial stability test of the Shenge Fengwangjiang Jiaonang was also studied.