快速稳定性分析仪评价乳液中乳粒的稳定性

doi:10.5246/jcps.2023.07.048

中国药学(英文版) ›› 2023, Vol. 32 ›› Issue (7): 574-586.DOI: 10.5246/jcps.2023.07.048

快速稳定性分析仪评价乳液中乳粒的稳定性

谢春燕¹^,²^,^*(), 岳峰¹^,²^,^*(), 余浩权¹^,², 黄灿中¹^,², 曾少群¹^,²

1. 广东嘉博制药有限公司, 广东清远 511517
2. 广东省静脉脂质乳中心, 广东清远 511356

收稿日期:2023-01-23 修回日期:2023-03-17 接受日期:2023-04-12 出版日期:2023-07-31 发布日期:2023-07-31
通讯作者: 谢春燕, 岳峰
作者简介:
+ E-mail: xcyyan@163.com
+ Tel.: +86-18688884632, E-mail: yuefeng@jiabopharm.com

Evaluation of the stability of droplets in emulsion using multisample analytical centrifugation

Chunyan Xie¹^,²^,^*(), Feng Yue¹^,²^,^*(), Haoquan Yu¹^,², Canzhong Huang¹^,², Shaoqun Zeng¹^,²

1 Guangdong Jiabo Pharmaceutical Co., Ltd. Qingyuan 511517, Guangdong, China
2 Guangdong Intravenous Lipid Emulsion Center, Qingyuan 511356, Guangdong, China

Received:2023-01-23 Revised:2023-03-17 Accepted:2023-04-12 Online:2023-07-31 Published:2023-07-31
Contact: Chunyan Xie, Feng Yue

摘要/Abstract

摘要：

本研究对乳液中乳粒在贮存过程中的稳定性进行了评价, 并区分了不同处方的乳粒稳定性。采用快速稳定性分析仪-LUMisizer, 评估冻融循环对乳粒的影响, 结合粒径参数、zeta电位和冷冻透射电镜观察。经过冻融循环后, 乳粒的性状、粒径参数和透光率发生显著变化。乳粒在冻融循环后破乳(可见浮油和乳化层)。不同丙泊酚含量(10:1和20:1, m/v) 的处方, 乳粒的稳定性有显著差异。快速稳定性分析仪可以区分加速破坏的乳粒从而评价其稳定性, 有效补充传统方法的不足, 可对脂肪乳中的乳粒进行更好的质量控制。

关键词: 乳粒, 脂肪乳, 稳定性分析, 多样本分析离心, 透光率, 冻融循环, 水包油

Abstract:

In the present study, we aimed to evaluate the stability of droplets in the emulsion during storage and distinguish the stability of different prescriptions. The multisample analytical centrifugation-LUMisizer was applied to evaluate the impact of freeze-thaw cycles on droplets, combined with droplet size parameters, zeta potential, and observation by cryo-transmission electronic microscopy. After freeze-thaw cycles, the droplets showed significant changes in characters, globule size distribution, and light transmission. After freeze-thaw cycles, the droplets were demulsified (oil droplets and creaming were observed). Formulations with different contents of propofol (10:1 and 20:1, m/v) showed significant differences in the behavior of the droplets. Droplets by accelerated destruction could be distinguished by LUMisizer, which could quickly identify the stability and effectively supplement the traditional methods, offering better quality control of droplets in the emulsion.

Key words: Droplet particle, Emulsion, Stability analysis, Multisample analytical centrifugation, Light transmission, Freeze-thaw cycle, Oil-in-water

Supporting:

谢春燕, 岳峰, 余浩权, 黄灿中, 曾少群. 快速稳定性分析仪评价乳液中乳粒的稳定性[J]. 中国药学(英文版), 2023, 32(7): 574-586.

Chunyan Xie, Feng Yue, Haoquan Yu, Canzhong Huang, Shaoqun Zeng. Evaluation of the stability of droplets in emulsion using multisample analytical centrifugation[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(7): 574-586.

图/表 13

Figure 1. Measurement scheme of the multisample analytical photo centrifuge. The light NIR-light source (1) passes through (2) the sample cells (3) lying on the rotor (4). The distribution of local transmission is recorded over the entire sample length by the CCD-Line detector (5).

Figure 2. Emulsions (after centrifugation) and typical profiles. The red line refers to the first profile, while the green is the last one.

Table 1. Particle size parameters and zeta potential.

Figure 3. Summary of sample particle size parameters.

Figure 4. Transmission profiles of emulsions (C-F1: control sample freeze-thaw 1 cycle; C-F2: control sample freeze-thaw 2 cycle; C-F3: control sample freeze-thaw 3 cycle).

Figure 5. Transmission profiles of emulsions after free-thaw cycles.

Table 2. Stability index.

Figure 6. Stability index of emulsions (a. Clarification rate; b. Integral light transmission).

Figure 7. Transmission profiles of emulsions by different homogenization cycles (a. Pre-emulsion; b. Homogenization cycle 1; c. Homogenization cycle 3; d. Homogenization cycle 5).

Figure 8. Stability index of emulsions by different homogenization cycles (a. Clarification index; b. Interface track-floating rate).

Figure 9. Stability index of emulsions by different homogenization cycles (a. Clarification index; b. Interface track-floating rate).

Table 3. Instability indexes and particle size parameters.

Figure 10. Typical photos of the emulsion by cryo-TEM (a. Sample 1; b.1-F3; c. Sample at the top of the cell; d. Sample in the middle of the cell; e. Sample at the bottom of the cell).

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快速稳定性分析仪评价乳液中乳粒的稳定性

Evaluation of the stability of droplets in emulsion using multisample analytical centrifugation

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