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Objective To develop a HPLC method for determination of pueratin.Methods The separation was carried out on a Waters Symmetry C18 column(4.6 mm×250 mm, 5 μm), the mobile phase was composed of acetonitrile and 1% formic acid(11∶89), the detection wavelength was set at 250 nm, the flow rate was 1.0 ml/min, the column temperature was 30 ℃ and the injection volume was 10 μl.Results The linearity was obtained over 2~40 μg/ml (r=0.999 8) for pueratin.The RSD of precision were less than 2%.The average recovery was between 98% and 103%.Conclusion This HPLC method was simple, accuracy and suitable for the quality control of Jiangzhi Hugan capsule.
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Objective:To establish a method for the determination of puerarin and balcalin in Xiao’ er Shuangjie Zhixie granules by HPLC. Methods:An Agilent Zorbax SB-C18 column (250 mm × 4. 6 mm,5 μm) was used. The mobile phase A was 0. 1% phos-phoric acid solution and the mobile phase B was methanol with gradient elution. The detection wavelength was 265 nm,the flow rate was 1. 0 ml·min-1 ,the column temperature was 30℃ and the sample size was 20 μl. Results: The linear range of pueratin was 0. 121-1. 942 μg (r=0. 999 5)and that of balcalin was 0. 230-3. 686 μg(r=0. 999 5). The average recovery was 98. 10% and 98. 20%with RSD of 1. 34% and 1. 11%(n=6), respectively. Conclusion:The method is convenient and accurate, which can be used in the de-termination of pueraln and balcalin in Xiao’ er Shuangjie Zhixie granules.
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OBJECTIVE: To synthesize MCM41 mesoporous molecular sieves, prepare pueratin/MCM 41 assemblies, and study their pharmacokinetics in rats. METHODS: MCM-41 mesoporous molecular sieves were synthesized using TEOS as silicon source and CTAB as templates under basic condition. Pueratin was loaded into MCM-41 by immersion method. Pueratin-loaded MCM-41 (PU-MCM) was characterized by X-ray diffraction (XRD), N2 adsorption-desorption and FT-IR spectroscopy. Pharmacokinetic parameters were calculated from the plasma concentrations determined by HPLC after administration of pueratin suspension (PU-SUS) and PU-MCM orally to rats. RESULTS: Pueratin was loaded into the pores of MCM-41 successfully with a drug loading rate of 12.6%. The pharmacokinetic parameters in rats after administration of PU-SUN and PU-MCM were as follows: ρmax were (2.43 ± 0.75) and (3.98 ± 1.15) μg · mL-1, tmax were (0.79 ± 0.19) and (0.67 ± 0.20) h, and AUC0~t were (5.35 ± 1.42) and (10.41 ± 2.64) μg · h · mL-1, respectively. CONCLUSION: PU-MCM was prepared successfully, which showed significantly increased release rate, longer residence time and higher bioavailability than PU-SUS after administration in rats.
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Objective: To prepare pueratin (PU)-effervescent osmotic pump (controlled release) tablets (EOPT) based on the stable and sustained drug release dynamics of effervescent, and to study their in vitro release mechanism. Methods: The EOPT cores were prepared using sodium hydrogen carbonate and citric acid as effervescent and polyethylene oxide N80 as suspending agent. The PU monolayer osmotic pump tablets were prepared using acetyl cellulose as coating, diethyl phthalate as plasticizer, and PEG 400 as porogen. The single-factor test was used to optimize the formulation depending on drug release. Results: The types and amounts of effervescent agent, suspending agent, osmotic promoter, and the weight of coating substance showed the significant influence on the cumulative release rate, while the amount of plasticizer in the coating, the release media, and the rotation rate had no significant effects on the drug release. The drug release model was fitting and the results of in vitro release model simulation showed a good reproducibility. Conclusion: A successful method for the preparation of PU-EOPT is developed. More than 85% of PU is released from PU-EOPT within 12 h in vitro (r > 0.999 0) following with zero-order release and the preparation process is simple.