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制剂凝胶的物理特性描述及稳定性研究。

Physical Characterisation and Stability Study of Formulated Gel.

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Universiti Teknologi MARA, Cawangan Selangor, 42300 Puncak Alam, Selangor, Malaysia.

Department of Pharmacology and Chemistry, Faculty of Pharmacy, Universiti Teknologi MARA, Cawangan Selangor, 42300 Puncak Alam, Selangor, Malaysia.

出版信息

Curr Drug Deliv. 2022;19(4):479-490. doi: 10.2174/1567201818666210419114809.

DOI:10.2174/1567201818666210419114809
PMID:33874872
Abstract

BACKGROUND

Formulation of topical products for skin delivery that fulfill good formulation criteria has always been a challenge for pharmaceutical scientists. Despite the challenges, gelbased drug delivery offers some advantages such that it is non-invasive, painless, involves avoidance of the first-pass metabolism, and has satisfactory patient compliance.

OBJECTIVES

In this study, C. odorata gel and quercetin gel (bioactive flavonoid compound) were successfully formulated and compared with placebo and conventional wound aid gel. The chromatographic profiling was conducted to screen the presence of phytoconstituents. Subsequently, all formulated gels were evaluated for physical characteristics and stability.

METHODS

Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) of C. odorata methanolic leaves extract showed a distinct compound separation at a retention time of 8.4min to 34.8 min at 254nm. All gels were characterised by evaluating their rheological properties, including storage modulus, loss modulus, and plastic viscosity. Besides, texture analysis was performed to measure the firmness, consistency, cohesiveness, and viscosity index of the gels.

RESULTS

According to the results, C. odorata gel demonstrated better spreadability as compared to the other gels, which required less work and was found to be favourable for application on the skin. Moreover, C. odorata gel showed no changes in organoleptic properties and proven to be stable after 30 days of accelerated stability study at 40°C ± 2°C with Relative Humidity (RH) of 75% ± 5%.

CONCLUSION

C. odorata gel was found to be stable, reflecting the combination of materials used in the formulation, which did not degrade throughout the study. This work suggests the potential of this gel as a vehicle to deliver the active ingredients of C. odorata to the skin, which can be further explored as a topical application for antimicrobial wound management or other skin diseases study.

摘要

背景

为皮肤给药而配制符合良好制剂标准的局部用制剂一直是制药科学家面临的挑战。尽管存在挑战,但基于凝胶的药物递送具有一些优势,例如非侵入性、无痛、避免首过代谢,并且患者顺应性良好。

目的

在这项研究中,成功配制了 C. odorata 凝胶和槲皮素凝胶(生物活性类黄酮化合物),并与安慰剂和常规伤口辅助凝胶进行了比较。进行了色谱分析以筛选植物成分的存在。随后,对所有配制的凝胶进行了物理特性和稳定性评估。

方法

C. odorata 甲醇叶提取物的反相高效液相色谱(RP-HPLC)显示,在 254nm 处,在 8.4 分钟至 34.8 分钟的保留时间有明显的化合物分离。通过评估流变特性,包括储能模量、损耗模量和塑性粘度,对所有凝胶进行了表征。此外,还进行了质地分析,以测量凝胶的硬度、稠度、内聚性和粘度指数。

结果

根据结果,与其他凝胶相比,C. odorata 凝胶具有更好的铺展性,所需工作量更少,有利于在皮肤上应用。此外,C. odorata 凝胶的感官特性没有变化,在 40°C±2°C、相对湿度(RH)为 75%±5%的加速稳定性研究 30 天后被证明是稳定的。

结论

C. odorata 凝胶被发现是稳定的,这反映了配方中使用的材料的组合,在整个研究过程中没有降解。这项工作表明,这种凝胶作为将 C. odorata 的活性成分递送到皮肤的载体具有潜力,可以进一步探索作为局部应用于抗菌性伤口管理或其他皮肤病研究。

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