The Stability In Vivo And Pharmacokinetics Of Safflower Yellow

With the development of the modern medicine and technology, traditional Chinesemedicine has got more widespread attention and application. The rational development andutilization of the traditional Chinese medicine resources have achieved remarkableeconomic and social benefits. It plays an important role in the prevention of disease and thepromotion of people’s health. Danhong preparation is the traditional Chinese mixedmedicine, which is made up of danshensu and safflower yellow. It commonly used inproving blood circulation, dispersing blood stasis and swelling the pain. At present,Danhong injection has been widely used in clinical, but it has complex composition, lowsecurity and allergic reactions. So developing and studying Danhong oral dosage forms canimprove the stability and security of drug.Dispersible tablet is a new pharmaceutical preparation with a lot of development andutilization value, especially in clinical applications. The dispersible tablets have a lot ofadvantages, such as dose accuracy, good stability, easy to carry, and low production cost.Formulation screening and process of Danhong dispersible tablets has been optimized earlyin the laboratory. This subject will do research on danshensu and safflower yellow, whichare the water-soluble extract of Salvia and safflower, to ensure that the quality of thepreparation are control.Because the quality of the active pharmaceutical ingredient is related to the quality ofthe preparations，this subject carried out relevant research on the quality of danshensu andsafflower yellow. We have examined their character, identification method, moisturecontent, heavy metal content, arsenic salt content and residue on ignition. We set out thecontent limitation of danshensu and hydroxysafflor yellow A(HSYA),which provided aguarantee for the quality control.The stability of oral drug in the gastrointestinal tract will directly affect theeffectiveness of the drug absorbed in the gastrointestinal tract into the blood circulation. This subject used the high performance liquid chromatography to examine the stability ofsafflower yellow pigment in the artificial gastric juice and artificial intestinal fluid. Underdifferent pH environment, the stability of hydroxysafflor yellow A (HSYA) is different,which was mainly determined by the acid strength of HSYA. HSYA contains hydroxyl,weakly acidic, and therefore may change in an alkaline environment. The results showedthat, HSYA is relatively stable in artificial gastric juice, so its bioavailability can beimproved by increasing its absorption in the gastric juice. HSYA is largely destruct in thehigh alkaline intestinal fluid, so it requires the use of appropriate formulation to avoid thedrug destruction before entering the blood circulation.In this study, we use the high performance liquid chromatography to determine theconcentration of HSYA after oral administration of safflower yellow and DanhongCompound Tablets in rats. Plasma concentration-time dates were used DAS2.1.1pharmacokinetic software processing to analyze. Parameter shows that the safflower yellowand Danhong Compound Tablets meet the two-compartment open model in rats in vivoplasma concentration. Compared with the safflower yellow, area under concentration-timecurve (AUC) of Danhong compound tablets was significantly increased, and The peak time(Tmax) was speed up, and the peak concentration (Cmax) increased. The results showed thatDanshensu of Danhong Compound Tablets can improve the absorption of HSYA, whichwill be conducive to the better efficacy of safflower yellow.