Studies On Preparation Technology And Quality Standard Of Guosongqianggu Granules

Gusongqianggu granules,according to formula in Henan Luoyang orthopedicHospital, composes of Astragalus, Radix Aconiti Lateralis,cornua cervi degelatinatum,Epimedium Brevicornum, Kudzu root and other four traditional Chinese medicinecompound preparation.It has the beneficial gas to invigorate the kidney, the strongmuscle strong bone, warm promotes blood circulation positive, regulates the flow ofvital energy the analgetic. It was used for treating the primary stage, sequentialosteoporosis and the chondrification sickness.This clinical practice several years, thecurative effect is only then remarkable, the security is high.But as a result of thedecoction difficulty with decoction, takes the quantity to be big, the feeling in themouth is not good, preserves the carryhome inconveniently and so on manyshortcomings, but the granular formulation carryhome is convenient, is advantageousfor the preservation, conforms to custom which the modern people apply drugs, drawsup changes the dosage-form the granular formulation.Therefore this topic hasconducted the system research to this compound prescription preparation craft and thequality specification. Now its about the objective, methods, results and conclusions:Objective1.To determine the preparation process of Guosongqianggu Granules2.To study the quality standard of Guosongqianggu GranulesMethodsBased on the study of literature, according to the medicine effective componentsof the physical and chemical properties and pharmacological action, determine thewater extraction and alcohol extraction of Chinese materia medica. Orthogonal testwas employed for selecting the optimum of water extracting process by the indexes ofthe content of astragaloside and total solid matters. Purify technology was optimizedby precipitating with ethanol. Orthogonal test was employed for selecting theoptimum of alcohol extraction process by the indexes of the contents of ginsenosideRg1and total solid matters.The optimized process was verified.Dry granulating technology was adopted to make granules and moistureabsorption percentage was chosen as index to investigate suitable supplementarymaterial.The study of quality standard: Astragalus, Radix Aconiti Lateralis,EpimediumBrevicornum, Kudzu root and Radix Noto ginseng in compound Gusongqianggugranules were identified by thin layer chromatography while The content ofAstragaloside in this preparation was determined by high efficiency liquidchromatography-Evaporative light-scattering techniques （HPLC-ELSD).And thecontent of Epimedium glycoside, ginsenoside Rg1and notoginsenoside R1in thispreparation was determined by high efficiency liquid chromatography(HPLC).ResultThe optimized preparation process was as follows: Astragalus, Radix AconitiLateralis,cornua cervi degelatinatum,Polygonum multiflorum extracted3times with12times the amount of water,1hour each time.concentrated to a relative density of1.05~1.07(50℃).After the liquid cooled down to room temperature, adding ethanolslowly and stirring quickly to make sure the concentration was70%.Then the liquidstand24hours.，after filtration,set aside. Brevicornum,Rhizoma drynariae,Kudzu rootand Radix Noto ginseng extracted10times amount of70%ethanol concentration,3times with1.5hours for each time. the water extraction and alcohol extraction liquidwas merged together. Then the liquid was filtered and recovered the ethanol untilnon-ethanol taste.the liquid was concentrated to clear paste which would be dried byvacuum drying and shattered. The dry powder and the seventy percent amount ofdextrin mixed together completely which would make granules by drying granulatingtechnology.In the quality standard：the TLC stain is distinctly and the method was highlyspecific with good reproducibility. HPLC was used to determine the content ofAstragaloside， Epimedium glycoside, ginsenoside Rg1and notoginsenosideR1.Tentative per gram granules contain astragalus glycosides content shall not be lessthan0.66mg; per gram granules contain the content of epimedium glycoside shall notbe less than2.99mg;per gram granules contain notoginseng saponin R1shall not beless than0.75mg;per gram granules contain ginseng saponin Rg1shall not be lessthan2.16mg. To combine qualitative identification and quantitative determination,set GuSong QiangGu granules quality standards. ConclusionThe preparation process of Gusong Jiangu granules is simple, reasonable and feasible,so it is suitable for industrial production. The quality standard is controllable, whichcan be used to control the quality of Gusong Qianggu granules.