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毛叶锡生藤软膏的安全性、有效性及理化特性:一种针对人头虱的社区配方制剂

Safety, Efficacy, and Physicochemical Characterization of Tinospora crispa Ointment: A Community-Based Formulation against Pediculus humanus capitis.

作者信息

Torre Gerwin Louis Tapan Dela, Ponsaran Kerstin Mariae Gonzales, de Guzman Angelica Louise Dela Peña, Manalo Richelle Ann Mallapre, Arollado Erna Custodio

机构信息

Institute of Pharmaceutical Sciences, National Institutes of Health, University of the Philippines Manila, Ermita, Manila 1000, the Philippines.

Department of Pharmacy, College of Pharmacy, University of the Philippines Manila, Ermita, Manila 1000, the Philippines.

出版信息

Korean J Parasitol. 2017 Aug;55(4):409-416. doi: 10.3347/kjp.2017.55.4.409. Epub 2017 Aug 31.

Abstract

The high prevalence of pediculosis capitis, commonly known as head lice (Pediculus humanus capitis) infestation, has led to the preparation of a community-based pediculicidal ointment, which is made of common household items and the extract of Tinospora crispa stem. The present study aimed to evaluate the safety, efficacy, and physicochemical characteristics of the T. crispa pediculicidal ointment. The physicochemical properties of the ointment were characterized, and safety was determined using acute dermal irritation test (OECD 404), while the efficacy was assessed using an in vitro pediculicidal assay. Furthermore, the chemical compounds present in T. crispa were identified using liquid-liquid extraction followed by ultra-performance liquid chromatography quadruple time-of-flight mass spectrometric (UPLC-qTOF/MS) analysis. The community-based ointment formulation was light yellow in color, homogeneous, smooth, with distinct aromatic odor and pH of 6.92±0.09. It has spreadability value of 15.04±0.98 g·cm/sec and has thixotropic behavior. It was also found to be non-irritant, with a primary irritation index value of 0.15. Moreover, it was comparable to the pediculicidal activity of the positive control Kwell®, a commercially available 1% permethrin shampoo (P>0.05), and was significantly different to the activity of the negative control ointment, a mixture of palm oil and candle wax (P<0.05). These findings suggested that the community-based T. crispa pediculicidal ointment is safe and effective, having acceptable physicochemical characteristics. Its activity can be attributed to the presence of compounds moupinamide and physalin I.

摘要

头虱(人头虱)感染即头虱病的高患病率促使人们制备了一种基于社区的杀虱软膏,该软膏由常见家居用品和毛叶嘉榄茎提取物制成。本研究旨在评估毛叶嘉榄杀虱软膏的安全性、有效性和理化特性。对该软膏的理化性质进行了表征,并通过急性皮肤刺激性试验(经合组织404)确定其安全性,同时使用体外杀虱试验评估其有效性。此外,通过液液萃取,然后进行超高效液相色谱四极杆飞行时间质谱(UPLC-qTOF/MS)分析,鉴定了毛叶嘉榄中存在的化合物。基于社区的软膏制剂呈浅黄色,均匀、光滑,有明显的芳香气味,pH值为6.92±0.09。其铺展性值为15.04±0.98 g·cm/秒,具有触变性。还发现它无刺激性,初级刺激指数值为0.15。此外,它与阳性对照产品Kwell®(一种市售的1%氯菊酯洗发水)的杀虱活性相当(P>0.05),与阴性对照软膏(一种棕榈油和石蜡的混合物)的活性有显著差异(P<0.05)。这些研究结果表明,基于社区的毛叶嘉榄杀虱软膏安全有效,具有可接受的理化特性。其活性可归因于存在化合物木兰酰胺和酸浆苦素I。

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