Vaginal formulations containing prebiotics and probiotics for treatment of bacterial vaginosis

Caixuan Wang, R. Malcolm, V. Kett, D. Gilpin
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Abstract

Bacterial vaginosis (BV) is a common dysbiosis of the human vagina in which commensal vaginal lactobacilli are displaced by mixed pathogenic bacterial populations. Current treatments by antibiotics result in short- term cure but often lead to recurrence. Lactobacilli are being actively developed as a probiotic treatment option for BV, given their ability to inhibit growth of pathogenic microorganisms and to maintain the health and stability of the vaginal tract microbiota. Therefore, incorporation of freeze-dried lactobacillus and metronidazole (MET) into matrix-type silicone elastomer vaginal rings (VR) is a long-effective novel treatment of BV which can also prevent recurrence. Here, MED-4870 matrix-type VRs containing four different lyoprotectants of three concentrations were manufactured by reaction injection molding, and Shore M Hardness test, compression test and twist test were applied to determine the impact of incorporation of lyoprotectants on mechanical characteristics of VRs. Results indicated that incorporation of lyoprotectants can increase the resistance force and decrease the rotational angles of the VRs. As the category and concentration of incorporated lyoprotectant also have impact on the releasing profile of MET and protecting ability of lactobacillus during freeze-drying process, more research such as in-vitro release tests and microbiology tests will be needed.
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含有治疗细菌性阴道病的益生元和益生菌的阴道制剂
细菌性阴道病(BV)是一种常见的人类阴道生态失调,其中共生阴道乳酸菌被混合致病菌群取代。目前的抗生素治疗能短期治愈,但经常导致复发。鉴于乳酸菌能够抑制致病微生物的生长并维持阴道微生物群的健康和稳定,目前正积极开发乳酸菌作为细菌性阴道炎的益生菌治疗选择。因此,将冷冻干燥的乳酸菌和甲硝唑(MET)掺入基质型有机硅弹性体阴道环(VR)是一种长期有效的治疗细菌性阴道炎的新方法,也可以预防复发。本文采用反应注射成型的方法制备了含有三种浓度的四种不同lyo保护剂的MED-4870基质型VRs,并通过邵氏硬度试验、压缩试验和捻度试验来确定lyo保护剂掺入对VRs力学特性的影响。结果表明,lyo保护剂的掺入可以增加vr的阻力,减小vr的旋转角度。由于掺入的冻干保护剂的种类和浓度也会影响乳酸菌在冷冻干燥过程中MET的释放特征和保护能力,因此需要进行更多的体外释放试验和微生物学试验等研究。
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