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目的:制备广藿香酮传递体并对其质量进行评价。方法:采用薄膜分散法制备广藿香酮传递体;以广藿香酮的累积透过量(Qn)、累积透过率(PR)为评价指标,筛选处方中表面活性剂种类、表面活性剂用量及广藿香酮用量;以最优处方制备广藿香酮传递体,观察其形态、粒径分布和Zeta电位并测定包封率。结果:广藿香酮传递体的最优处方为表面活性剂为胆酸钠,胆酸钠用量为0.25 g,广藿香酮用量为15 mg。最优处方制备的广藿香酮传递体呈乳白色混悬液,其平均粒径为(115.6±3.65) nm(RSD=3.20%,n=3),多分散系数(PDI)为0.185±0.008(RSD=4.30%,n=3),Zeta电位为(-13.76±0.225) mV(RSD=1.70%,n=3),广藿香酮的包封率为(46.01±0.40)%(RSD=0.87%,n=3),Qn为(378.76±0.61) μg/cm2(RSD=0.20%,n=3),PR为(89.02±0.96)%(RSD=1.10%,n=3)。结论:制备的广藿香酮传递体质量符合要求,可为后续广藿香酮新剂型的研究提供参考。
OBJECTIVE: To prepare pogostone transfersomes, and to evaluate its quality. METHODS: Film dispersion method was used to prepare pogostone transfersomes. Using the accumulative penetration volume (Qn) and accumulative penetration ratio (PR) of pogostone as evaluation indexes, the types of surfactant, formulation were screened in respects of the dosage of surfactant and the dosage of pogostone. The pogostone transfersomes were prepared with optimal formulation; the morphology, particle size distribution and Zeta potential were observed and the entrapment efficiency was measured. RESULTS: The optimal formulation was as follows as the sodium cholate was selected as surfactant; the dosage of sodium cholate was 0.25 g; the dosage of pogostone was 15 mg. The optimal pogostone transfersomes were ivory-white suspension; average particle size was (115.6±3.65) nm (RSD=3.20%,n=3); PDI was 0.185±0.008 (RSD=4.30%, n=3); Zeta potential was (-13.76±0.225) mV (RSD=1.70%,n=3); entrapment efficiency of pogostone was (46.01±0.40)% (RSD=0.87%,n=3); Qn was (378.76±0.61) μg/cm2 (RSD=0.20%,n=3); PR was (89.02±0.96)% (RSD=1.10%,n=3). CONCLUSIONS: Prepared pogostone transfersomes are in line with quality requirements, which can provide reference for the further study of new dosage form of pogostone.
广藿香酮传递体薄膜分散法制备包封率质量评价累积透过量
PogostoneTransfersomeFilm dispersion methodPreparationEntrapment efficiencyQuality evaluationAccumulative penetration volume
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