Study On Preparation Technology And Quality Standard Of Sanqi Tongshu Drop Pills

Sanqi tongshu capsule is one of the prescription preparations included in the 2015 edition of Chinese Pharmacopoeia.Sanqi tongshu capsule is a classic preparation for the treatment of cardiovascular and cerebrovascular embolism which has the effect of promoting blood circulation and removing blood stasis,activating collaterals and dredging blood vessels.In this study,Sanqi Tongshu capsule was transformed into dropping pill to improve the bioavailability and efficacy.Single factor analysis and orthogonal experimental design were used in this study to optimize the extraction and preparation molding process.The best extraction and preparation molding technology were validated by three batches of process.The quality control standard of Sanqi Tongshu dropping pills was established by investigation of properties,quality inspection,fingerprint and content determination.The accelerated stability and long-term stability test of three batches of Sanqi Tongshu dropping pills were studied.Based on the extraction method of notoginseng trisogenatrol saponin in Chinese Pharmacopoeia(Part I),the best extraction process was determined by adding mixed enzyme(cellulase: α-amylase = 1:1).The amount of the mix enzyme was 1.5% of the total amount of notoginseng,p H=5,the temperature of enzymolysis was 50 ℃,and the duration of enzymolysis was 3 hours.After the reaction,the water bath at 80 ℃ was inactivated for 30 min,adjusted to neutral p H,filtered,and the enzymatic hydrolysate was reserved for use.Take the dregs of a decoction into the post,the percolation was carried out at a flow rate of 1 ～2ml/min with 60% ethanol as the solvent.Then,the percolation was collected with 6 times the amount of medicinal materials,and the percolation was reduced to a concentrated solution with no alcohol taste.Then dilute the solution with enzymatic hydrolysate,filtration,the filtrate through good preprocessing type D101 macroporous adsorption resin column(resin content:medicine for 1:1),start with 1L distilled water elution,abandon to liquid water,and to undertake elution with 40% ethanol solution 2 L,collection of eluent,filtration,filtrate reduced pressure concentration,vacuum drying at 55 ℃,ground into fine powder,then get the notoginseng trisogenatrol saponin powder.The best preparation technology of Sanqi Tongshu dropping pill was that mixing notoginsenoside powder and matrix(PEG4000: PEG6000 = 2:1)with the proportion of 1:2.After melting uniformly at 80 ℃,the mixture was condensed by liquid paraffin.The temperature of the condensing agent was controlled at 5-10 ℃,the height was 50 cm,the dropping speed was 30 drops / min and the dropping distance was 5 cm.The quality control standard draft of Sanqi Tongshu dropping pill was established.It was light yellowish brown to yellowish brown with slight fragrance and bitter taste.The dropping pill contained ginsenoside Rg1 no less than 163.9mg/g,ginsenoside Re no less than 19.6mg/g and notoginsenoside R1 no less than 36.3mg/g.According to Chinese Pharmacopoeia(2015edition),HPLC fingerprint of Sanqi Tongshu dropping pills was established,5 common peaks were confirmed and 3 of them were identified,and the quality control standard was improved.The properties,water content,weight difference,dissolution time limit,content determination and other items of the dropping pill were all in line with the quality control standard draft according to the results of accelerated stability and long-term stability test.The quality of the drug remained stable within 9 months.In conclusion,the preparation technology of Sanqi Tongshu dropping pill established in this study was feasible.The dropping pill with stable,good and controllable quality met the requirements of Chinese Pharmacopoeia.