Studies On The Preparation Process And Quality Standard Of Guanxindanshen Soft Capsules

The main content of this paper is guanxindanshen soft capsules Preparation and quality control standards,laing the foundation for further development of new drugs and dosage forms of expansion,and provide experimental evidences for preliminary studies.Experimental methods is mainly orthogonal method in this paper,prefered the best extraction and preparation of the formulations:first pulverizing sanqi APIs,making powder;Crushed Salvia into flour,the main Salvia extract ethanol percolation for extraction time,extraction times,the ethanol concentration make orthogonal designing to optimize the extraction program and the extract yield is index,and the best solution is 90%ethanol concentration,extraction for 6 hours and extracted once.In this process,the basis of solidliquid ratio can be optimized to percolate remaining tanshinone ⅡA for the detection of targets,the results are detectable by TLC.The data show 1:8 and 1:10 solid-liquid content of less than the difference in the final extraction of the active ingredient,and in order to save costs,we choose 1:8 ratio of liquid percolation extraction Salvia.And then boiling water for residues of Salvia percolation process after extraction orthogonal optimized to extract yield index,the optimal solution is solid-liquid ratio 1:10,extraction twice,1h/times.On the concentration process and concentrated density parallel optimization results show that the density is concentrated in the state of 1.25 and 1.30,in favor of the experimental operation,and the process and parameters are close to production.So this issue will concentrate the density provided between 1.25 to 1.30.The above-obtained thick paste and crushed notoginseng powder mix evenly,granulating,drying,crushing,over 120 mesh sieve,then add 2%glyceryl monostearate,drop sesame oil,soybean oil added to a predetermined amount,fully mixed and compressed into 800 soft capsules,the cage,stereotypes,wash pill,drying,guanxindanshen soft capsules.In this paper,TLC identification guanxindanshen soft capsules Salvia,Panax,dalbergia other herbs,determination of Tanshinone ⅡA by HPLC.In Salvia,Panax,dalbergia of identification when TLC spots were clear and specific;use of HPLC measurement sample tanshinone ⅡA content.The mobile phase was methanol-water(3:1),measured by the effective linear range of tanshinone ⅡA is 0.045ug～0.45ug,and the average recovery rate was 97.43%,RSD=1.11%;the effective linear range of ginsenosides Rg1,PNS R1,ginsenoside Rbl is 0.06ug～0.6ug,and the average recovery rate values were 98.56%,97.04%,98.33%,RSD 0.68%,0.44%,0.80%.Acording to the experimental results and literature analysis,the soft capsule guanxindanshen quality standards for the finished pharmaceutical is at least Tanshinone ⅡA 300ug/tablets,total saponin content of not less than 6mg/tablets.The method is sensitive and reproducible,which can be used for quality control guanxindanshen soft capsules.Finally,three batches of samples at room temperature to stay kind of soft capsules for six months,and the packaging of samples is used four times inspect packaging.The stable studying contents containing:character,identification,disintegration,determination,microbial limit test,and the purpose is to investigate the formulation and long-term storage stability at room temperature.