以聚乙二醇为基质配制的指甲花油阴道栓剂的处方、理化及微生物测定

Formulation, Physiochemical, and Microbial Assay of Henna Oil Vaginal Suppository Formulated with Polyethylene Glycol Bases.

作者信息

Khazaeli Payam, Mehrabani Mitra, Mosadegh Ahmad, Bios Soudabeh, Zareshahi Rahele, Moshafi Mohammad Hasan

机构信息

Department of Pharmaceutics, School of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran.

Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran.

出版信息

Iran J Med Sci. 2020 May;45(3):207-213. doi: 10.30476/IJMS.2019.44965.

DOI:10.30476/IJMS.2019.44965

PMID:32546887

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7253496/

Abstract

BACKGROUND

Persian Medicine is one of the oldest and richest complementary and alternative options in the field of medicine and has a comprehensive medical system. Henna oil is recommended in Persian Medicine for the treatment of numerous women's diseases such as cervicitis. To date, henna has been used for many medical purposes, including astringent, bleeding, cardioinhibitory, hypotension, and relaxation. Accordingly, the present study aimed to provide the formulation of a henna-oil-based vaginal suppository and examine its physicochemical and antimicrobial properties.

METHODS

The present study was approved and performed in accordance with the regulations of Research Council, Kerman University of Medical Sciences, Kerman, Iran, in July 2016. Different percentages of henna oil, glycerin, and gelatin, as well as henna oil and polyethylene glycol 400 and 4000, were mixed to achieve a formulation with proper appearance features and, particularly, without any oil leakage from the suppository surface. Uniformity of weight, uniformity of content, disintegration time, and dissolution test of the suppositories were evaluated. The growth-inhibiting activity of the suppositories and aqueous extract of henna was evaluated against bacteria, including the Gram-positive bacterium , , and group B .

RESULTS

The formulations had a smooth appearance without any cracks or fractures. Disintegration times for glycero-gelatin and polyethylene glycol suppositories were 60 and 10 min, respectively. 40% of the drug was released from polyethylene glycol suppositories after 60 min, but glycero-gelatin suppositories had no release after three hours. Minimum inhibitory concentration (MIC) of suppositories and aqueous extract were 0.4 mg/mL and 0.01 mg/mL, respectively.

CONCLUSION

Polyethylene glycol suppositories had acceptable physicochemical properties, and the henna extract and suppositories inhibited the three studied pathogens.

摘要

背景

波斯医学是医学领域最古老且最丰富的补充和替代医学选择之一，拥有一套完备的医疗体系。波斯医学推荐使用指甲花油治疗多种女性疾病，如宫颈炎。迄今为止，指甲花已被用于多种医学用途，包括收敛、止血、抑制心脏活动、降血压及松弛作用。因此，本研究旨在制备一种基于指甲花油的阴道栓剂，并检测其理化性质和抗菌性能。

方法

本研究于2016年7月获得伊朗克尔曼医科大学研究委员会的批准，并按照其规定进行。将不同比例的指甲花油、甘油和明胶，以及指甲花油与聚乙二醇400和4000混合，以获得具有适当外观特征的制剂，特别是栓剂表面无任何油泄漏。对栓剂的重量均匀度、含量均匀度、崩解时间和溶出度进行了评估。评估了栓剂和指甲花水提取物对细菌的生长抑制活性，包括革兰氏阳性菌、和B组。