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神经酸口服乳剂的处方及制备工艺优化
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| 篇名： | 神经酸口服乳剂的处方及制备工艺优化 |
| TITLE： | Optimization of formulation and preparation technology of Neuritic acid oral emulsion |
| 摘要： | 目的 制备神经酸口服乳剂，对其处方及制备工艺进行优化，并考察其稳定性。方法通过机械法制备神经酸口服乳剂。在单因素实验的基础上，以乳剂外观、离心稳定性、离心稳定常数（Ke）、粒径为指标，采用正交实验设计，以油酸用量、辛基苯酚聚氧乙烯醚-10用量、丙二醇用量为因素，对其处方进行优化；以乳化温度、剪切时间、高压均质压力、高压均质循环次数为因素，对其制备工艺进行优化；采用高效液相色谱法测定神经酸含量，采用高温试验、加速试验和长期试验考察神经酸口服乳剂的稳定性。结果最优处方及制备工艺为神经酸原料药1g、油酸用量5％、辛基苯酚聚氧乙烯醚-10用量4％、丙二醇用量2％、乳化温度60℃、剪切时间2min、高压均质压力40MPa、高压均质循环2次。经3次实验验证，所得神经酸口服乳剂的平均粒径为158.05nm（RSD＝1.58％，n＝3），平均Ke为0.39（RSD＝1.49％，n＝3），外观呈均一乳白色，均无分层现象。高温试验结果显示，神经酸口服乳剂在高温环境中易出现分层现象，神经酸的含量有所增加；加速试验及长期试验结果显示，神经酸口服乳剂在室温下放置6个月的外观、神经酸含量均无明显变化。结论所得最优处方及制备工艺稳定、可行，可用于神经酸口服乳剂的制备；神经酸口服乳剂不适宜放置于高温环境中，在室温环境下放置6个月的稳定性较好。 |
| ABSTRACT： | O BJECTIVE To prepare Neuritic acid oral emulsion ，to optimize its formulation and preparation technology ，and to investigate its stability. METHODS Neuritic acid oral emulsion was prepared by mechanical method. On the basis of single factor experiment ，the appearance ，centrifugal stability ，centrifugal stability constant （Ke）and particle size of the emulsion as indexes，the formulation was optimized by orthogonal design ，taking the dosage of oleic acid ，octylphenol polyoxyethylene ether-10 and propylene glycol as factors ，the preparation technology was optimized by taking emulsification temperature ，shear time，pressure of high-pressure homogenization and cycle times of high-pressure homogenization as factors. The content of neuritic acid was determined by high performance liquid chromatography. The stability of Neuritic acid oral emulsion was investigated by high temperature test ，accelerated test and long-term test. RESULTS The optimal formulation and preparation technology were as follows：neuritic acid of 1 g，oleic acid of 5％ ，octylphenol polyoxyethylene ether- 10 of 4％ ，propylene glycol of 2％ ， emulsification temperature of 60 ℃ ，shear time of 2 min，homogenization pressure of 40 MPa and cycle times of twice. After three experiments ，the average particle size of Neuritic acid oral emulsion was 158.05 nm（RSD＝1.58％，n＝3），the average Ke was 0.39（RSD＝1.49％，n＝3），and the appearance was uniform milky white ，there was no stratification. The results of high temperature test showed that Neuritic acid oral emulsion was prone to stratification in high temperature environment ，and the content of neuritic acid increased. The results of accelerated test and long-term test showed that there was no significant change in the appearance or the content of neuritic acid when Neuritic acid oral emulsion was placed at room temperature for 6 months. CONCLUSIONS The formulation and preparation technology are stable and feasible ，and can be used for the preparation of Neuritic acid oral emulsion. Neuritic acid oral emulsion should not be placed in high temperature environment. It has good stability at room temperature for 6 months. |
| 期刊： | 2022年第33卷第04期 |
| 作者： | 陈文静，付加雷，孙丹丹，于蓓蓓，生立嵩，闫雪生 |
| AUTHORS： | CHEN Wenjing ，FU Jialei，SUN Dandan ，YU Beibei ，SHENG Lisong ，YAN Xuesheng |
| 关键字： | 神经酸口服乳剂；处方优化；制备工艺优化；正交实验设计；高效液相色谱法；样品稳定性 |
| KEYWORDS： | Neuritic acid oral emulsion ；formulation optimization ；preparation technology optimization ；orthogonal design ； |
| 阅读数： | 508 次 |
| 本月下载数： | 5 次 |
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