火麻仁口服乳剂的制备及质量评价

    Preparation and Quality Evaluation of Oral Hemp Seed Emulsion

    • 摘要:
      目的 制备火麻仁口服乳剂,对处方和制备工艺进行优化并进行质量评价。
      方法 采用单因素考察及响应面优化,以粒径、粒径分布(particle size distribution,PDI)、Zeta电位值为指标,对火麻仁口服乳剂的处方和制备工艺进行优化;以火麻仁口服乳剂的外观、分层现象、稳定常数、pH值、粒径、Zeta电位等为指标,对其进行质量评价。
      结果 最佳处方为火麻仁11%、复配乳化剂(磷脂︰可溶性大豆多糖=6∶4) 0.79%、卡拉胶0.1%、NaHCO3 0.1%;最佳工艺为高速分散均质机15 000 r·min−1剪切5 min,均质压力、次数、温度分别为90 MPa、10次、60 ℃。所制备的火麻仁口服乳剂经4000 r·min−1离心15 min后无分层现象,乳剂pH值为7.81,粒径为(219.0±1.74)nm,PDI为(19.2±1.53)%,Zeta电位绝对值为(27.8±0.4)mV。
      结论 制备的火麻仁口服乳剂外观乳白均一,无分层现象,稳定性较好,符合药典对口服乳剂的规定,为火麻仁的综合开发利用提供参考。

       

      Abstract:
      OBJECTIVE To prepare hemp seed oral emulsion, optimize the formulation and preparation process, and evaluate its quality.
      MEDTHODS Single factor investigation and response surface optimization were used to optimize the formulation and preparation process of hemp seed oral emulsion with particle size, particle size distribution(PDI) and Zeta potential as indexes. The appearance, stratification, stability constant, pH value, particle size and Zeta potential of oral emulsion of hemp seed were used to evaluate its quality.
      RESULTS The best prescription was 11% of sesame seed, 0.79% of emulsifier(phospholipid∶soluble soybean polysaccharide=6∶4), 0.1% of carrageenan and 0.1% of NaHCO3. The optimal process was a high speed dispersing homogenizer 15 000 r·min−1 shear for 5 min with homogenizing pressure, times and temperature of 90 MPa, 10 times and 60 ℃, respectively. There was no delamination after centrifugation at 4000 r·min−1 for 15 min. The emulsion pH value was 7.81, the particle size was(219.0±1.74) nm, the PDI was(19.2±1.53)%, and the absolute value of Zeta potential was (27.8±0.4)mV.
      CONCLUSION The prepared oral emulsion of hemp seed has uniform appearance, no stratification phenomenon, and good stability. It conforms to the provisions of pharmacopoeia for oral emulsion, and provides a reference for comprehensive development and utilization of hemp seed.

       

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