基于质量源于设计的反相高效液相色谱法测定大鼠血浆和粪便微生物群提取物中姜黄素的含量及基于粪便微生物群提取物的固体自微乳给药系统。
Quality by Design-based RP-HPLC Method for Estimation of Curcumin in Rat Plasma and Fecal Microbiota Extract-based Solid Self-nano Emulsifying Drug Delivery System.
机构信息
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara 144411 Punjab, India.
Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, Australia.
出版信息
Curr Drug Res Rev. 2023;15(3):272-285. doi: 10.2174/2589977515666230120140543.
BACKGROUND
Curcumin (CRM) is known to possess various therapeutic properties, such as anti-inflammatory and antidiabetic properties, and is, therefore, considered to be an effective therapeutic.
OBJECTIVE
A sensitive method for the estimation of CRM in plasma, as well as fecal matter-based solid self-nano emulsifying drug delivery system (S-SNEDDS), has been reported for the first time.
METHODS
A bioanalytical method was optimized using Box-Behnken Design having 13 runs and 3 responses. The optimized method was developed using methanol and water (70:30 v/v) with a flow rate of 1 mL/min. Quercetin was used as an internal standard. A specificity test was also performed for the developed CRM solid self-nano emulsifying drug delivery system.
RESULTS
The retention time of CRM was found to be 14.18 minutes. The developed method was validated and found to be linear in the range of 50-250 ng/mL with an R of 0.999. Accuracy studies indicated that CRM had a percentage recovery of less than 105% and more than 95%, respectively. Precision studies were carried out for inter, intraday, and inter-analyst precision, and the %RSD was found to be less than 2%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 3.37 ng/mL and 10.23 ng/mL, respectively. Stability studies for shortterm, long term and freeze-thaw cycles showed a %RSD of less than 2%, indicating the stability of CRM in the plasma matrix. Moreover, the blank fecal microbiota extract slurry did not show any peak at the retention time of CRM in a CRM-loaded solid nanoemulsifying drug delivery system containing fecal microbiota extract indicating its specificity.
CONCLUSION
Hence, the developed method can have clinical implications as it helps estimate CRM in blood samples and also provides a simple and sensitive method for the estimation of plant-based flavonoids along with fecal microbiota extract formulations.
背景
姜黄素（CRM）具有多种治疗特性，如抗炎和抗糖尿病特性，因此被认为是一种有效的治疗方法。
目的
首次报道了一种用于检测血浆中 CRM 以及粪便基础固体自纳米乳化药物传递系统（S-SNEDDS）的灵敏方法。
方法
使用 Box-Behnken 设计优化了生物分析方法，该设计有 13 次运行和 3 个响应。优化后的方法采用甲醇和水（70:30v/v）作为流动相，流速为 1mL/min。槲皮素用作内标。还对开发的 CRM 固体自纳米乳化药物传递系统进行了特异性测试。
结果
CRM 的保留时间为 14.18 分钟。所开发的方法经过验证，发现在线性范围为 50-250ng/mL 时，R 值为 0.999。准确度研究表明，CRM 的回收率均低于 105%和高于 95%。日内、日间和分析间精密度研究的 %RSD 均小于 2%。检测限（LOD）和定量限（LOQ）分别为 3.37ng/mL 和 10.23ng/mL。短期、长期和冻融循环稳定性研究表明，%RSD 小于 2%，表明 CRM 在血浆基质中的稳定性。此外，在含有粪便微生物群提取物的 CRM 负载固体纳米乳化药物传递系统中，空白粪便微生物群提取物浆液在 CRM 的保留时间处没有显示任何峰，表明其具有特异性。
结论
因此，所开发的方法具有临床意义，因为它有助于估计血液样本中的 CRM，并且还提供了一种简单灵敏的方法来估计基于植物的类黄酮以及粪便微生物群提取物配方。
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