Chongqing Huapont Pharmaceutical Co. Ltd.

The surging costs of health care in China is highly related to the high expenses in pharmaceutical costs. Since the Government of China launched the health care reform in 2009, the issue of growing pharmaceutical expenditure continues to grasp policy makers' attention. Since 2015, an ongoing series of drug-related policies have been revised or developed, resulting in profound impact on the overall pharmaceutical market in China, and the dynamic is still evolving. As China has become the second largest pharmaceutical market in the world, any volatility in the Chinese pharmaceutical market may have great implications to multinational pharmaceutical markets that have had their products launched in China or plan to extend their business to the Chinese market. Based on a comprehensive analysis of the most recent health care reform policies in China, the objectives of this study were to identify the major opportunities appealed to and the challenges confronted by multinational pharmaceutical enterprises in the current Chinese pharmaceutical market.

The aim is to study pharmacokinetic profile of arotinoid trometamol(code name: FY-10) in mice.Blood concentrations of FY-10 were determined by HPLC-MS/MS using acitretin as internal standard 0.08, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 h after i.v. (16 μg/kg) and 0.25, 0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0 and 72.0 h after i.g. (4, 16 and 64 μg/kg) administration, at each time point with 8 mice; pharmacokinetic parameters were calculatedPlasma protein binding rates in vitro of FY-10(10, 20, 40 ng/mL) in plasma of mice were determinedZorbax Extend C₁₈ column was used with mobile phase of mixture [methanol-acetonitrile(50:50)]-20 mmol/L ammonium acetate(pH 8.5)(85:15) at flow rate of 0.8 mL/min.Column temperature was 35°C and sample size was 40 μl.Mass condition was as follows: ion spray voltage of -3500 V, multiple reaction monitoring, neg. ion detection mode, m/z values ranging from 347->303 for FY-10 and 325->266 for acitretin.Linear range of FY-10 was 0.05-40.0 ng/mL (r=0.997 3) with average recovery of (50.6±3.1)%-(67.6±1.0)%.Pharmacokinetic parameters of FY-10 after low-dose, medium-dose and high-dose intragastric administration were as follows: AUC(0->infinity):17.09, 64.08 and 133.99 ng·h/mL; c_max:1.54, 5.27 and 15.30 ng/mL; t₁/₂:15.7, 18.7 and 16.7 h, resp.Those after i.v. administration were as follows: AUC(0->infinity):70.80 ng·h/mL; t₁/₂:22.1 h; absolute bioavailability of FY-10 was 91.9%.The plasma protein binding rates in vitro of FY-10 at low, medium and high concentrations were (97.9±0.3)%, (99.3±0.1)% and (98.5±0.5)%, resp.Pharmacokinetics process of FY-10 was in line with one-compartment model after i.g. administration and two-compartment model after i.v. administration.In vivo and in vitro trials of mice showed high bioavailability and plasma protein binding rate.

The aim is to prepare esomeprazole magnesium enteric coated particle system type tablet, and to investigate release rate in vitro of it.The enteric coated particle system type tablet was prepared by direct compression process.Using pellets roundness, compressibility, hardness, flowability and accumulative release rate as index, fillers, materials and weight gain of enteric coating film, addnl. excipients were optimized to confirm the formulation.The optimal formulation was as follows: avicel PH101 as pellet core filler, particle size of 0.5-0.8 mm, mixture of acrylic resins Eudragit(R)NE30D and Eudragit(R)FS (2:1) as coating material, weight gain of 25%, avicel PROSOLV90 as addnl. excipients.Accumulative release rate of the samples was lower than 5% in pH 2.0 HCl solution within 2 h and more than 95% in pH 6.8 PBS within 30 min.The preparation formulation is reasonable and feasible, and the accumulative release rate of the preparation is in line with the requirements.