Preparation Process And Quality Standard Research Of Modified Simiao Granule

Modified Simiao granule(MSG)is composed of Phellodendri Chinensis Cortex,Atractylodis Rhizoma,Sargentodoxae Caulis,Corydalis Rhizoma,Cyathulae Radix,Coicis Semen,Glycyrrhizae Radix et Rhizome.It comes from the clinic of gynecology and has obvious curative effect on the Woman abdominal pain diseases of humid-heat stasis syndrome,such as abdominal pain,backache,back pain,more leucorrhea and color yellow.Based on the related problems of traditional decoction,this topic studied the pharmaceutical part of MSG by the theoretical knowledge of traditional Chinese medicine and modern pharmaceutical technology.Including preparation process and quality standard reaearch.1.Preparation technology researchExtraction technology: by searching the physicochemical properties of the chemical ingredients in the prescription,and combining the characteristics of quality control index of preparation,including Pharmacodynamic activity,controllability,importance and so on,The content of 7 components of Phellodendrine,berberine hydrochloride,rhodoglycoside,tetrahydroxanthine,chlorogenic acid,glycyrrhizin and ammonium glycyrrhizin and dry paste rate were selected as the control indexes of the extraction process.According to the results of preliminary experiments,the content of each index reach a higher transfer rate by extracting the Cortex phellodendri with ethanol,and extracting the remaining 6herbs and the drag residue of Cortex phellodendri with water.The content of cortex phellodendri alkali,berberine hydrochloride and dry extract rate were taken as evaluation indexes in the alcohol extract part of Cortex phellodendri.The alcohol extraction process optimized by the orthogonal design based on information entropy theory.The results were as follows: adding 9 times amount of 55% ethanol,extracting for 3 times,each time 80 minutes.The content of rhodiola glucoside,tetrahydropalmatine,chlorogenic acid,liquorice glycosides,glycyrrhizic acid,ammonium and dry paste rate were taken as comprehensive evaluation index in the water extract part of remaining 6 herbs and the drag residue of Cortex phellodendri.The water extraction process optimized by the orthogonal designbased on information entropy theory.The results were as follows: adding 10 times amount of water,extracting for 2 times,each time 30 minutes.Concentration and purification process: the extract of Cortex phellodendri is decompressed to recover ethanol and concentrated to thick paste.Rhodiola glucoside,chlorogenic acids,glycyrrhizic acid ammonium,tetrahydropalmatine,liquorice glycosides,dry paste rate and clarify degree were taken as the evaluation index in the water extraction part.Considering the actual production cos,water extract is concentrated by atmospheric pressure.Filtration,centrifugation and alcohol precipitation were selected for the purification process of concentrated water extraction at normal pressure.The last choice is centrifuge purification.The optimal centrifugal parameters were optimized by the uniform design,the results were as follows: the liquid was concentrated to four times the volume of the drug,and the centrifuge was centrifuged for 50 min at 5000 r/min.Forming and sorting process:the types and dosage of molding excipients,the types and dosage of flavoring agents,the concentration of wetting agents,the temperature and time of the drying of particles were investigated with the molding rate,particle character,hygroscopicity and taste.The molding process was as follows:the thickened paste were dried under reduced pressure,adding 0.32 times the dosage of dextrin,smashing,75% ethanol was used to be moistening agent,and the granule was dried under 60 degrees for 2 h which were divided into 8 g per bag.2.Quality standard researchThe formulation was formulated as "Modified Simiao Granule" and its granule properties were described.According to the requirements of the granule inspection,the corresponding indicators were checked respectively,and the results were all in conformity with the regulations.TLC methods were established for the four kinds of traditional Chinese medicine(TLC)in MSG,such as Cyathulae Radix,Corydalis Rhizoma,Phellodendri Chinensis Rortex,Glycyrrhizae Radix et Rhizoma.The chromatographic spots were clear,well separated,Rf suitable,reproducible and negative.HPLC was established for the determination of content.The obtained chromatographic conditions were reproducible and specific,and the content required for each bag was(8 g/ bags)containing cortex phellodendrine,Ammonium Glycyrrhizinate,berberine hydrochloride and glycyrrhizin,not less than 2.473 mg,8.349 mg,3.103 mg,7.111 mg.Establishing a draft quality standard study for Modified Simiao Granule,the method is simple and feasible.