Preparation And Preliminary Evaluation Of Compound Danshen Capsule

Volatile substances are a very complex and unstable system.Their chemical properties are active and their original chemical composition is easy to change,which may reduce the efficacy.The inherently unstable nature of volatile materials is the key to the current quality of solid formulations that contain volatile materials.The use of modern formulation technology to solve the problem of stability of volatile substances,and to maintain the release behavior of volatile substances after the process is consistent with conventional decoctions,tablets,capsules,is the current difficult and key point of the formulation process.In view of the above problems,the compound Danshen preparation was used as a model drug.According to the physical and chemical properties of each component,the water-soluble extract of Salvia miltiorrhiza,the fat-soluble extract of Salvia miltiorrhiza,the total saponins of Panax notoginseng and borneol were prepared into different dosage forms and loaded into a certain proportion.In the capsule,a compound Danshen compound capsule which is simultaneously released by various components is prepared.The details are as follows:1.Establishment of determination method of index component content in compound Danshen compound capsule preparation processTo establish a method for determining the content of the essential components{monophenolic acid B,tanshinone IIA,notoginsenoside R₁,ginsenoside?Rg₁,Rb₁,Re?,borneol and isoborneol}in compound Danshen compound capsules,and to carry out methodological methods verification.2.Study on preparation technology of water-soluble extract particles of Salvia miltiorrhizaThe content of salvianolic acid B in the water-soluble extract of Salvia miltiorrhizawas determined to be 47.89%.The prescription of water-soluble extract of Salvia miltiorrhiza Bunge was 25%water-soluble extract of Salvia miltiorrhiza Bunge and 75%dextrin,and the cumulative dissolution rate was determined to be 96%at 45 min.3.Study on the preparation process of solid dispersion of Danshen fat-soluble extract The content of tanshinone IIA in the fat-soluble extract of Salvia miltiorrhiza Bunge was determined to be 96.13%.The formulation of solid dispersion of Danshen fat-soluble extract was selected as the fat-soluble extract of Salvia miltiorrhiza:P188:SDS was 1:6:1,and its cumulative dissolution rate at 45 min was determined.The dissolution rate is about 80%.Fourier transform infrared spectroscopy and electron scanning microscopy of the solid dispersion showed no significant interaction between tanshinone IIA and excipients P188 and SDS.4.Study on the preparation technology of Panax notoginseng saponinsThe average content of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re and ginsenoside Rb1 in the total saponins extract of Panax notoginseng was 8.73,31.03,4.47 and 28.92%,respectively.The prescription of Panax notoginseng saponins was composed of total saponins of Panax notoginseng.The extract:dextrin was 1:2,and the cumulative dissolution rate at 45 min was determined to be above 95%.5.Study on the preparation technology of borneol soft capsuleThe quality of soft capsule shell is one of the key factors affecting the release of soft capsule.On the basis of single factor experiment,the dosage of glycerin,sorbitol,polyethylene glycol 400?PEG400?and gelatin was investigated by Box-Behnken response surface method,and the capsule shell rate was used as an index to optimize the shell prescription.The optimal prescription is gelatin:glycerol:sorbitol:PEG400=1:0.67:1:0.11,and the dissolution rate of the shell is 4923.27 mg/?min.cm²?.The characteristics of the optimal prescription shell were analyzed by differential scanning calorimetry?DSC?,water vapor permeability?WVP?and water adsorption isotherm?GAB equation?.The content of borneol and isoborneol in borneol was 34.44 and24.38%,respectively.The composition of the screening contents was borneol:polyoxyethylene hydrogenated castor oil RH40:PEG400=3:1:3,and the borneol and isoborne brain were determined.The cumulative dissolution rate at 45 min was above80%.6.Study on Synchronous Drug Delivery System of Compound Danshen Compound CapsulesThe dissolution method was established.The prescription and preparation process of compound Danshen compound capsules were studied.The in vitro release of the components of compound Danshen compound capsules was evaluated.The results showed that tanshinone IIA,borneol,isoborneol and notoginsenoside R1,ginsenoside?Rg₁,Rb₁,Re?and salvianolic acid B dissolve quickly.7.ConclusionAccording to the"Chinese Pharmacopoeia"and related literature,this study established a method for determining the content of various indicators in compound Danshen compound capsules.Through the solid dispersion technology,the dissolution amount of the poorly soluble substance tanshinone IIA was effectively improved.The preparation of compound Danshen compound capsule improved the stability of borneol.The research of this subject provides a certain basis for the preparation of traditional Chinese medicines,especially the preparation of volatile Chinese medicine preparations.