Studay On Preparation Technology And Quality Standards Of Small Bupleurum Dripping Pills

Small Bupleurum dripping pills is a new dosage form based on small Bupleurum decoction.Small Bupleurum dripping pills is a modern compound preparation for the treatment of viral colds,acute and chronic bronchitis,acute gastroenteritis and other diseases.It is composed of seven flavors of Radix Bupleuri,Radix Scutellariae,ginseng,liquorice,Pinellia ternata,ginger and jujube.In this study,small Bupleurum dripping pills was studied on the preparation technology and the study of the quality standard and the preliminary stability study with the guidance of the theory of traditional Chinese medicine.The purpose of this study is transform small Bupleurum decoction into solid dropping pills with using the extraction and separation technology of Chinese medicinal materials,high efficiency solid preparation technology,accordingly to improve the inconveniences of carrying,To improve the compliance of the patients,and to improve the curative effect and reduce the adverse reaction withon quantify the effective components of the traditional Chinese medicine.According to the chemical properties and pharmacological actions of the effective components of seven Chinese herbal compounds in combination,combined with the characteristics of their functional indications,it hold the active ingredients of all herbs maximally,The orthogonal test method is used in this subject.Through many experiments,the best preparation process was finally screened out,from the selection of extraction technology,the selection of matrix species,the selection of coolant species,the selection of dropping temperature,the screening of upper temperature of coolant,the screening of the ratio of main drug to substrate,and the distance between drops,etc.In the extraction process,the ginger are extracted according to the prescription amount,they are soaked firstly with ethanol for 24 hours,they are extracted secondly with percolation extraction method,the ethanol is reclaimed thirdly from percolate liquid,Finally,the collected liquid is reserved for subsequent use;The Radix Bupleuri,Radix Scutellariae,ginseng,liquorice,Pinellia ternata and jujube are extracted according to the prescription amount,they are dipped firstly into 8 times water,they are decocted and extracted secondly for 1.5 hours and 3 times,Finally,filter liquor is collected after filtrating;The mixed liquid of the extract liquid and other ingredients is combined,then decompressed and condensed into a thickening paste,the thickening paste is reserved for subsequent use;After vacuum drying,he thickening paste become dry paste over crushing by a pulverizer and through 80 mesh sieves,the dry paste is reserved for subsequent use.In the preparation process,the mixture of PEG4000:PEG6000=1:2 are selected as matrix;the two methyl silicone oil 350cs are selected as condensing agent;The ratio of the main drug to the matrix was 1:1.5;The temperature of the solution is 85±2?;The dripping distance is 8cm.In the quality research,It's done that the TLC identification of Radix Bupleuri,Scutellaria,Codonopsis and Glycyrrhiza;It's done that methodological study of system about baicalin of the effective component in Scutellaria baicalensis,the result was that the average content of baicalin is 9.377mg/g;The strict quality standard is set up for the medicinal materials,intermediates and finished products,and the quality control standard of this product in the whole process is perfected.Ultimately determine character of the small Bupleurum dripping pills is brown or dark brown pills,sweet,slightly bitter;Determine weight difference of the small Bupleurum dripping pills is ±7.5%;Determine dissolution time limit of the small Bupleurum dripping pills is 11 minutes and 10 seconds;Determine the average content of baicalin in the small Bupleurum dripping pills is 9.377mg/g;Determine specification of baicalin of the small Bupleurum dripping pills is 400mg/pill;The short-term stability of small Bupleurum dripping pills was inspection in the accelerated and long term conditions.The results of this research show that the preparation technology is stable,the quality standard is comprehensive,and the results of stability are good,scientific and feasible.There will be the ability to support large-scale production.