Objective: To prepare the total saponins from Paris Polyphylla self-microemulsifying drug delivery system (SMEDDSs) and its solid fied granule, and investigate the in vitro release.Methods: The solubility of the total saponins from Paris Polyphylla in different excipients was investigated.The pseudo-ternary phase diagram composed of different oil phase, emulsifier and co-emulsifier was used to define the self-emulsifying area.The optimal formula of the total saponins from Paris Polyphylla SMEDDSs was prepared into granule.The appearance, morphology, particle size distribution, PdI and zeta potential of the microemulsion and the granule were determined by a dilution method.The drug release profile of the total saponins from Paris Polyphylla SMEDDSs and SMEDDSs granule were compared.Results: The optimal formula of SMEDDSs was as follows: propylene glycol monocaprylate as the oil phase, Tween-80 as the emulsifier and propylene glycol as the co-emulsifier with the optimum ratio of 7.0∶1.5∶1.5.After diluted by water,the total saponins from Paris PolyphyllaSMEDDSs and the granule formed a clear and transparent microemulsion solution with small homogeneous spheres as seen under a transmission electron microscope.The average particle size of the total saponins from Paris Polyphylla SMEDDSs and the granule was (58.6±16.4) nm and (68.1±12.1) nm with PdI of (0.183±0.04) and (0.209±0.05), respectively, and the zeta potential was (-20.2±1.9) mV and (-18.9±1.5) mV, respectively.The results of transmission electron microscopy showed the microemulsion was round, regular and spherical distribution.The in vitro release profile indicated that the accumulated release of the total saponins from Paris Polyphylla SMEDDSs and SMEDDSs granule was more than 85% in 45 min.Conclusion: The self-microemulsifying granule can significantly improve the in vitro dissolution rate of the total saponins from Paris Polyphylla, and the preparation process is simple and feasible.

Objective:To design and develop a formula of solid lipid nanoparticles containing the total saponins of Paris Polyphylla using a quality by design ( QbD) method. Methods:The target product profile of solid lipid nanoparticles was determined according to the properties of dosage form and administration. The risk assessment was carried out according to the theoretical knowledge and experi-ence to define the critical variables influencing the properties of solid lipid nanoparticles. Firstly, Plackett-Burman test was used to screen out the key variables significantly affecting the pharmacological properties of solid lipid nanoparticles, and then the Box-Behnken effect surface method was use to further optimize the selected variables. The physicochemical properties of solid lipid nanoparticles con-taining the total saponins of Paris Polyphylla were studied, such as the particle size distribution, polydispersity index ( PdI) , zeta po-tential, morphology and in vitro drug release behavior. Results: The optimum formula and preparation process were as follows: the concentration of glycerol monostearate was 5. 5％, the concentration of soybean phospholipid was 8. 0％, the number of homogenization was 6 times, the concentration of drug was 5. 0％, the surfactant was Tween 80, the mass pressure was 600 bar and the homogeneous temperature was 65℃. The mean particle size, PdI and zeta potential of the optimized solid lipid nanoparticles was (116. 5 ± 32. 1) nm, (0. 198 ± 0. 018) and ( -23. 6. 5 ± 0. 9) mV, respectively. Transmission electron microscopy showed that the solid lipid nanop-articles were spherical. The results of in vitro release showed a sustained release property, and the cumulative release was 63. 5％ in 24 h. Conclusion:It is feasible to design and develop solid lipid nanoparticles containing the total saponins of Paris Polyphylla by using the QbD method, which can ensure the product quality to meet the requirements.

Objective To investigate the prevalence,awareness,control status and associated risk factors of hypertension in a rural population in Xianghe county in North China.Methods A total of 830 adults (aged≥35) from Xianghe county were examined during July to August,2011.Blood pressure was obtained using a standardized sphygmomanometer after a 5-minute sitting rest.Information on gender,age,education level,marital status,smoking,drinking,income,family history of hypertension and use of antihypertensive medications was obtained.Results A total of 42.4％ of all subjects had hypertension.Among those with hypertension,the awareness rate was 54.8％ and 50.0％ of the patients were taking antihypertension medication with the control rate of 11.9％ [BP ＜ 140/90 mm Hg (1 mm Hg =0.133 kPa)].Lower age and education level,lower body mass index,negative family history of hypertension were associated with poor awareness of hypertension and worse compliance with the treatment.Older age,positive family history and alcohol consumption were associated with poor blood pressure control.Conclusions Hypertension is highly prevalent in Xianghe rural area.The awareness,treatment and control rate are all low.There is an urgent need for comprehensive strategies to improve prevention,screening,and treatment of hypertension in rural China.