Study On The Antithrombus Material Basis Of Traditional Chinese Medicinal Preparation Naodesheng

The prescription of Naodesheng pian(wan)which is composed ofRadix et Rhizoma Notoginseng,Rhizoma Chuanxiong,Flos Carthami,Radix Puerariae lobatae and Fructus Crataegi comes from ChinesePharmacopoeia 2005 edition.The major actions of this recipeinclude promoting blood circulation to remove blood stasis anddispersing stagnation to remove obstruction in meridiens andcollateralls.It is indicated for sequelae of apoplexy anddizziness due to stagnat blood in in meridians and collaterallsIt is applicable to cerebral arteriosclerosis,stoke and sequelaeof cerebral hemorrhage.It has good effects testified by theclinical applications.Based on pharmacological research,thethesis studies on the antithrombus material basis of traditionalchinese medicinal preparation Naodesheng,including extraction andpurification process,chemical constituents,content analysis,fingerprint,bioequivalence,serum pharmacochemistry etc,aims toprovide bases of the secondary development for the Naodeshengpreparation.Supercritical fluid CO₂ extraction technology was used toextract the essential oil from Ligsticum chuanxiong by orthogonal design,the technological parameters ascertained by the experimentwere proved to be stable and reliable.The antithrombotic functionscreening study on the different extracts from Ligsticum chuanxiongwas carried out.The results show that the effect of oil that reducedsignificantly thrombus wet weight is superior to total extracts,indicate the production process is feasible.Using GC-MS method,35 chemical constituents were identified.The chromatographicfingerprint of supercritical fluid CO₂ extract of Ligsticumchuanxiongwas developed by GC,26 peaks were identified by GC-MS.The method has good reproducibility and stability.The researchshould provide a good foundation of quality evaluation criteria inline with international standards for Ligsticum chuanxiong and itsextract.The method of solvent and the purification technology ofmacroporous adsorption resin were used to study the extraction andpurification process about the effective part of compoundNaodesheng.According to the elution rate and the purity of theproducts,the preparation performance of total flavonoids inNaodesheng by D-101 macroporous resin was investigated,and thepurification technological parameters optimized by the orthogonaltest and single-factor test were proved to be stable and reliable,these can make transition to industrialization.The contents ofpuerarin and hydroxysafflor yellow A were determined by HPLC,andthe total flavonoids with colorimetry.The analysis method waswell repeated and good credibility.The research can effectivelycontrol the quality of total flavonoids extract of Naodesheng.Thefingerprint of the total flavonoids extract of Naodesheng wasstudied by HPLC,with result that 23 peaks were common respectively.The method is stable,well repeated and may offerscientific basis for the quality evaluation of total flavonoidsextract of Naodesheng.The antithrombus pharmacology trial is apply to screen theeffective fraction of Naodesheng from different extractionprocesses.The results show that the preparation of mixedextraction(Flos Carthami Radix Puerariae lobatae and FructusCrataegi)is same effect of antithrombus as the originalpreparation,and superior to that of separate extraction.Theresearch should provide a reference for developing Naodesheng softcapsules made up of active fractions from Naodesheng tablets.The modern analysis methods were carried out to study on thequality standard of Naodesheng soft capsules.The contents ofnotoginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1 weredetermined by HPLC-ELSD,and puerarin and hydroxysafflor yellow Aby HPLC--UV.The methods are sensitive,reproducible and reliable.The fingerprint of Naodesheng soft capsules was developed byHPCE.Through analyzing the fingerprint of all samples,34 peakswere assigned common peaks in the spectrum of 10 batches.The methodis stable,well repeated.Besides Naodesheng soft capsules,3batches Naodesheng tablets from the different manufacturers alsohas been studied,so that we could find out their commonness anddifference.In short,this research not only elucidate therelationship between different preparation Naodesheng,but alsomay lay the foundation for establishing a international qualitystandard.Naodesheng soft capsules and reference tablets were given to6 rabbits in a randomized crossover design.Puerarin concentrations in plasma were determined by HPLC.The pharmacokinetic parametersand relative bioavailability were calculated with PKSolver 2.0program to evaluate the bioequivalence of the two preparatons.Thestatistical analysis of the results shows that the two preparatonsare bioequivalent.we researched on the serum pharmacochemistry ofNaodesheng soft capsules and Naodesheng tablets,in order to provideguidance for clarifying the material basis.