Study On Quality Standard And Preliminary Stability Of Compound White Peony Red Particles

Objective: the primary function of compound white peony red particles for clinicalprescription, mainly used for the treatment of coronary heart disease, but the lack ofquality control standards, so in order to establish a quality standard of compound whitepeony red particles, the study in accordance with the "China Pharmacopoeia"(2010Edition) quality standards guiding principle as the basis, establish the TLC identificationof compound white peony red particles determination of moisture content, particle size,check and main component, then to study the stability of peony red particles, indetermining the storage control based on the initial conditions the valid period. On thebasis of quality standard of writing compound white peony red granules (Draft) anddrafting instructions.Methods:1by thin layer chromatography (TLC) method for RadixPaeoniae Rubra, compound white peony red granules in safflower, rhodiola root,Chuanxiong qualitative identification.2according to the Pharmacopoeia method Chineseappropriate, respectively, examination of ten batches of compound white peony redparticles, particle size, water solubility. Determination of the content of paeonifloringlycoside3effective components using HPLC method to establish the main drugs ofRadix Paeoniae Rubra compound white peony red in the grain. Chromatographic columns(Kromasil, C18,5μm,4.6mm*250mm), using methanol-water (40:60) as the mobilephase, isocratic elution, flow rate of1.0ml/min, the detection wavelength of232nm,column temperature30degrees Celsius. The sample solution preparation were screened,through L9(34) orthogonal experiment optimization a test for the optimum extractionprocess of solution.4in the stability studies, respectively, do influence factors test andaccelerated test, and by classical constant temperature method to predict the effectiveperiod.Results:1.TLC in the identification of Radix Paeoniae Rubra identification bychloroform, ethyl acetate, methanol, formic acid (10:1.25:3:0.1) as the agent, spraying 5%vanillin sulfuric acid solution; safflower identification with ethyl acetate, formate:water: methanol (7:2:3:0.4) as the agent, Rhodiola in chloroform methanol, acetone:water (6:3:1:1) the lower solution as the agent, with iodine vapor smoke15-20minutes,view in365nm UV, TLC spots were clear, good separating degree, negative sampleswithout interference, Rhizoma Chuanxiong; differential with n-hexane: ethyl acetate (5:1)as developing agent, view in254nm UV, TLC spots were clear, good separating degree,negative samples without interference.2water compound white peony grains in theexamination of not more than2%, the granularity of inspection is not through the sum of10mesh sieve and through the powder of60mesh sieve, not more than4%., the meltingof the inspection, soluble granules all can melt. In HPLC3, paeoniflorin concentrationdetected in the range of0.008to0.512mg/ml and the peak area (r=0.9998) showed a goodlinear. The average recovery was100.31%, RSD=1.38%.Conclusion:1according to the"Chinese Pharmacopoeia"(2010Edition) quality standard guidelines requirements,established a TLC identification of compound white peony red particles, moisture andparticle size check method of project,determination, the completion of the quality standardof compound white peony red granules (Draft).2.preliminary forecast valid compoundwhite peony red particles.3the criteria established in this study can be used for qualitycontrol of compound white peony red particles.