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目的:研究中成药类卫生洗剂的体内外抑菌作用,并与传统栓剂剂型进行对比,探讨不同剂型女性卫生用品的抑菌药效学比较的体内外实验方法适用性。方法:体外抑菌试验:选用液体试管法检测样品对金黄色葡萄球菌、乙型溶血性链球菌、大肠埃希菌、铜绿假单胞菌、白色念珠菌的体外抑菌作用。体内抗菌试验:取SD大鼠建立念珠菌性阴道炎模型,卫生栓和卫生洗剂分别每天给药1次,连续8 d,观察大鼠阴道局部炎症反应并进行阴道病理检查。结果:体外抑菌试验:卫生栓剂和洗剂均能明显抑制细菌的生长,两种剂型的最低抑菌浓度(MIC)均为0.003 1 g·ml-1。体内抗菌试验:大鼠阴道肉眼观察结果显示卫生栓及卫生洗剂组炎症明显轻于模型组。阴道分泌物培养后涂片检查结果显示,与模型组比较,卫生栓及卫生洗剂组均出现不同程度白色念珠菌转阴,高剂量组抗菌效果优于低剂量组。病理检查大鼠阴道黏膜刺激试验评分结果显示,与正常组比较,模型组的评分显著增高(P<0.01)。卫生栓的高、中和低剂量组与模型组比价,评分显著降低(P<0.01或0.05),卫生洗剂的高、中和低剂量组与模型组比价,评分显著降低(P<0.01)。卫生洗剂的各剂量组与对应的旧剂型卫生栓的各剂量组间比较差异无统计学意义。结论:卫生洗剂与卫生栓的体外和体内抑菌作用没有差异。测定最低抑菌浓度的液体试管法和大鼠念珠菌性阴道炎模型稳定可靠,可考虑作为不同剂型女性卫生用品的药效对比的体外和体内首选实验方法。
OBJECTIVE: To study the bacteriostatic effect of Chinese medicinal lotion in vitro and in vivo, and to compare with traditional suppository dosage forms in order to explore the applicability of different antibacterial pharmacodynamics of different types of feminine hygiene products in vitro and in vivo. Methods: Bacteriostatic test in vitro: The antibacterial activity of the sample against Staphylococcus aureus, β hemolytic streptococcus, Escherichia coli, Pseudomonas aeruginosa and Candida albicans was tested by liquid tube method. Antibacterial test in vivo: The model of Candida vaginitis was established in SD rats. Sanitation suppository and sanitizer were administrated once a day for 8 consecutive days. The vaginal local inflammatory reaction was observed and vaginal pathological examination was performed. Results: In vitro antibacterial test: Sanitizer and lotion could significantly inhibit the growth of bacteria. The minimum inhibitory concentration (MIC) of the two formulations were 0.003 1 g · ml-1. In vivo antibacterial test: The results of the naked eye observation in the vagina of the rats showed that the inflammation of the tampon and the sanitary lotion group was obviously lighter than the model group. Vaginal secretions after smear test results showed that, compared with the model group, hygienic suppository and sanitary lotion groups were varying degrees of Candida albicans overcast, high-dose group antibacterial effect is better than low-dose group. The results of pathological examination of vaginal mucosa irritation test showed that the score of the model group was significantly higher than that of the normal group (P <0.01). The scores of hygienic suppository in high, medium and low dose group were significantly lower than those in model group (P <0.01 or 0.05), and the scores of hygienic lotion in high, middle and low dose group were significantly lower than those in model group (P <0.01) . There was no significant difference between each dose group of sanitary lotion and corresponding dose group of old dose type sanitary plug. Conclusion: Sanitary lotion and tampon have no difference in antibacterial activity in vitro and in vivo. Determination of the minimum inhibitory concentration of liquid test tube and rat Candida vaginitis model is stable and reliable, can be considered as different forms of feminine hygiene products efficacy comparison in vitro and in vivo preferred experimental method.