阴道胶囊:一种用于递送 spp. 的可行替代方法
Vaginal Capsules: A Viable Alternative for the Delivery of spp.
作者信息
Lima Leandra Sá de, Pereira Lívia Custódio, Almeida Rosane Mansan, Nóbrega Yanna Karla de Medeiros
机构信息
Clinical Microbiology and Immunology Laboratory, Department of Pharmacy, University of Brasilia, Campus Darcy Ribeiro, Brasilia 70910-900, DF, Brazil.
Vulvar Pathology Clinic, Department of Gynecology, University Hospital of Brasilia, University of Brasilia, Brasilia 70910-900, DF, Brazil.
出版信息
Microorganisms. 2025 May 1;13(5):1056. doi: 10.3390/microorganisms13051056.
spp. and other beneficial bacteria are predominant in the vaginal microbiota and represent an opportunity to correct dysbiosis if administered intravaginally. Since no commercial formulations are available, developing magistral formulations is an option, provided that they ensure viability and therapeutic efficacy. To evaluate their stability and culturability, four magistral formulations containing 10 microorganisms were tested: vaginal capsules, vaginal ointment, gelatinous ovules, and waxy ovules. Certified strains of , , , , and , as well as a combination of the five, were used. The formulations were tested for pharmaco-technical stability using average weight and disintegration tests, as well as evaluation organoleptic. In addition, microbial recovery was evaluated by counting Colony-Forming Units (CFUs). All forms, except the gelatinous ovules, allowed microbial recovery at concentrations from 10 to 10 CFUs, ensuring stability for 60 days. The recovery varied depending on the strains and dosage forms employed, with the most favorable outcomes for vaginal capsules. This highlights the need for standardized strains and excipients in magistral formulations. Further studies are needed to evaluate the viability of other strains of different excipients, vehicles, or different storage; however, capsules have demonstrated efficacy and are an excellent candidate for vaginal use formulations of spp.
某些特定物种及其他有益细菌在阴道微生物群中占主导地位,如果通过阴道给药,它们代表了纠正生态失调的一个机会。由于没有可用的商业制剂,开发临方制剂是一种选择,前提是它们能确保生存能力和治疗效果。为了评估其稳定性和可培养性,测试了四种含有10种微生物的临方制剂:阴道胶囊、阴道软膏、凝胶状胚珠和蜡质胚珠。使用了经认证的特定物种、特定物种、特定物种、特定物种和特定物种的菌株,以及这五种菌株的组合。通过平均重量和崩解试验以及感官评估来测试制剂的药物技术稳定性。此外,通过计数菌落形成单位(CFU)来评估微生物回收率。除凝胶状胚珠外,所有剂型在10至10 CFU的浓度下都能实现微生物回收,确保60天的稳定性。回收率因所使用的菌株和剂型而异,阴道胶囊的结果最为有利。这突出了临方制剂中标准化菌株和辅料的必要性。需要进一步研究来评估不同辅料、载体或不同储存条件下其他菌株的生存能力;然而,胶囊已证明具有疗效,是用于某些特定物种阴道用制剂的极佳候选剂型。
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