Study On Preparation Technology And Quality Control Of Gu-bi-kang Granules

ObjectiveCompared the quality of various kinds of medicinal materials in prescription,and picked out fine quality among these medicinal materials.Researched on the preparation technology and quality specification for Gu-bi-kang which prescription have laid a foundation for the new drug research.Method1.The optimum process conditions for extraction of mixed volatile oil was determined by the volume of volatile oil.The ratio of the oil in inclusion complex was used to evaluate the technology based onorthogonal design.The orthogonal design was used to select the optimum alcohol extraction procedure according to extracting transfer rates of tanshinone-ii a.The orthogonal design was used to select the optimum alcohol extraction procedure according to extracting transfer rates of icariin and naringin.Compared the flocculation clarification and alcohol precipitation process according to extracting.Transfer rates of icariin,naringin,tanshinone-ii a,extraction rate of extractum,absorption value and polysaccharide content.Moreover,compared the vacuum drying method with the spray drying method.All in all,above these comparative study could select out the best molding technological conditions.2.The HPLC detection was used for the quantitative analysis of indexical component in salvia,bitter orange,glycyrrhiza,astragalus and other medicinal materials in several batch,and then analyzed the contents of total flavonoids and total saponins contents both in the bitter orange and glycyrrhiza with UV method.Study on quality control of the granules by TLC and HPLC.ResultThe best volatile oil extraction condition was to add 8 folds water into the mixture of crude drugs with medicinal shattered into 20 mesh thick powders,and to extract the herb medicine for 5 h with advanced soaking for 0.5 h with water.The best packed preparation condition was based on the following conditions:the proportion of volatile oil and the?-cyclodextrin was 1:8,added 4 times water,triturated 3 hours.The optimum extracting condition was:Using the 95%alcohol extraction of the herbs,boiling two times,1.0,0.5 hours respectively,the amount of 95%alcohol was used for 8,6 times of the drug mixture respectively.The optimum extracting condition was:macerating all kinds of herbs for 0.5 hours in water,boiling three times,2.0,1.5,1.5 hours respectively,the amount of water was used for 12,10,10 times of the drug mixture respectively.Flocculation process:the concentration of meterials vs extract solution was 1:4,the rate of gelatin and chitosan was 2:1 mL,PH was 5,the flocculation temperature was 50 ?,the whisking speed was 50 r · min-1.Alcohol precipitation process:we specified the optimum purification condition was extracted to herb ratio in range of 1:2,precipitation with alcohol containing 70%water by the contrast test.Compared with the alcohol precipitation process,the comprehensive score of flocculation process was a litter better,especially for the amount of polysaccharide.The amount of medicinal materials was huge in this prescription and multiple the yield of extract can't make into the corresponding prepara-tion.The alcohol precipitation process about the yield of extract removal efficiency was much better than flocculation process.And the alcohol precipitation process was easy for industry with the simple operation to amplify into large scale production.Therefore,the alcohol precipitation process was selected for the purification process.Drying technology was select the 70 ? vacuum drying with decompression.Selected the best molding technological conditions:selected the lactose,microcrystalline cellulose,stevioside as excipient,the 95%alcohol was used as the wetting a-gent,its amount was 32-38%of extract powder.And the dry granule CHR was 74%.The study was selected out a high quality batch of medicinal materials,by utilizing HPLC and UV detection of the quantitative analysis of component in each taste medicinal material in several batches.Studied on the medicinal materials methods in prescription by utilizing TLC method.And for the sake of assay of icariin and nar inginof studied the new method of high performance liquid chromatography.ConclusionIn preparation technology,we studied the optium process conditions for extraction of volatile oil by single factor.The best inclusion compound with oil was decided by orthogonal design,and picked the alcohol extraction procedure and the water extracting technology by orthogonal design.And verified the every process route.The results suggest the assay method was validated in the research of content.The 6 taste medicinal materials in prescription were identified by TLC.For the sake of assay of icariin and naringin,the new high performance liquid chromatography methods was established.