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-
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