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香茅醇亚微乳的处方工艺优化研究
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| 篇名： | 香茅醇亚微乳的处方工艺优化研究 |
| TITLE： | Study on Optimization of Formulation and Technology of Citronellol Submicroemulsion |
| 摘要： | 目的：优化香茅醇亚微乳的制备工艺。方法：采用高效液相色谱法测定香茅醇亚微乳中的香茅醇含量；采用高速剪切分散-高压均质法制备香茅醇亚微乳，以离心稳定常数（ke）、粒径为指标，对其处方及工艺进行优化并进行验证；测定所得制剂的载药量的包封率。结果：香茅醇检测质量浓度的线性范围为4～64μg/mL（R2＝0.9999）；精密度、稳定性（24h）、重复性试验的RSD均小于3％；加样回收率为97.64％～101.97％（RSD＝2.28％，n＝3）、97.71％～99.50％（RSD＝1.29％，n＝3）、96.87％～101.48％（RSD＝2.86％，n＝3）。最优处方为大豆油+中链甘油三酯（1∶1，g/g）总质量3.75g，1.2％大豆磷脂0.6g，胆固醇0.06g，香茅醇1.25g，0.6％油酸钠0.3g，15-羟基硬脂酸聚乙二醇酯0.75g，泊洛沙姆1880.75g，加水至50mL。最优工艺为于4℃下以13000r/min高速剪切5min制得初乳后，经稀盐酸调pH至7，再以600Bar高压均质5min。按最优处方及工艺制备的3批香茅醇亚微乳的平均粒径为（91.05±0.26）nm，多分散系数为（0.20±0.01），Zeta电位为（－30.86±0.39）mV，ke值为9.23，香茅醇的平均含量为（100.21±0.01）％；载药量为（2.4817±0.0007）mg/mL，包封率为（99.27±0.03）％。结论：优化所得处方及工艺稳定、可行。 |
| ABSTRACT： | OBJECTIVE：To optimize the p reparation technology of citronellol submicroemulsion. METHODS ：The content of citronellol in Citronellol submicroemulsion was determined by HPLC. Citronellol submicroemulsion by high-speed shearing dispersion-high pressure homogenization method ，with centrifugation stability constant （ke） and particle size were used as evaluation indexes. Its formulation and preparation technology were optimized and validated. Drug-loading amount and encapsulation rate of the preparation were detected. RESULTS ：The linear range of citronellol were 4-64 μg/mL（R 2＝0.999 9）. RSDs of precision ，stability（24 h）and reproducibility tests were all lower than 3％. The recoveries were 97.64％-101.97％（RSD＝ 2.28％，n＝3），97.71％-99.50％（RSD＝1.29％，n＝3），96.87％-101.48％（RSD＝2.86％，n＝3）. The optimal formulation included that total weight of soybean oil and medium chain triglycerides （1 ∶ 1，g/g）was 3.75 g，1.2％ soybean phospholipid was 0.6 g， cholesterol was 0.06 g，citronellol was 1.25 g，0.6 ％ sodium oleate was 0.3 g，15-hydroxystearic acid polyethylene glycol ester was 0.75 g，poloxamer 188 was 0.75 g，water added to 50 mL. After prepared by optimal technology at 4 ℃ which contained shearing speed of 13 000 r/min，lasting for 5 min， primary emulsion was adjusted to pH 7 with dilute hydro- chloric acid ，and homogenized with 600 Bar high pressure for 1434412440@qq.com 5 min. The parameters of Citronellol submicroemulsion accor- ding to optimal formulation and technology contained mean particle size of （91.05±0.26）nm，PDI of （0.20±0.01）， Zeta-potential of （－30.86±0.39）mV，average content of 649511230@qq.com citronellol（100.21±0.01）％，the drug-loading amount was （2.481 7 ± 0.000 7） mg/mL，the encapsulation rate was （99.27 ± 0.03）％ . CONCLUSIONS ：The optimal formulation and technology is stable and feasible. |
| 期刊： | 2020年第31卷第14期 |
| 作者： | 杨佳佳，李婉蓉，彭剑青，肖婷，吴林菁，周雪，杨增秋，姜丰，丁杨，沈祥春，陶玲 |
| AUTHORS： | YANG Jiajia，LI Wanrong，PENG Jianqing，XIAO Ting，WU Linjing，ZHOU Xue，YANG Zengqiu，JIANG Feng，DING Yang，SHEN Xiangchun，TAO Ling |
| 关键字： | 香茅醇；亚微乳；高速剪切分散-高压均质法；处方；工艺；优化；高效液相色谱法；含量 |
| KEYWORDS： | Citronellol；Submicroemulsion；High-speed shearing dispersion-high pressure homogenization method ；Formula- |
| 阅读数： | 386 次 |
| 本月下载数： | 9 次 |
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