口卫士新型亮白健齿片活性与质量的研究  

The activity and quality research of liangbaijianchi tablets, the new compound preparation of kavass

作　　者：李宇茜 孙嘉茵 熊小平 樊淑宏 罗婷婷 徐小平[1] 

机构地区：[1]四川大学华西药学院,成都610041

出　　处：《中国抗生素杂志》2018年第1期109-114,共6页Chinese Journal of Antibiotics

摘　　要：目的评价口卫士亮白健齿片祛牙斑、抑菌和安全性和建立本品的质量控制方法。方法采用陈旧性牙斑牙为模型,测试祛牙斑的清除力;采用金色葡萄球菌、大肠埃希菌、肺炎双球菌和白念珠菌为菌种,验证本品的抑菌能力;采用急毒验证其安全性;采用分光光度法分别测定醋酸氯苯胍葶和过碳酰胺的含量。结果亮白健齿片可在刷洗约2min后逐渐除去色斑牙的色斑,随着刷洗次数增多,色斑清除越明显;对金色葡球菌和大肠埃希菌的最低抑菌浓度(minimal inhibititory concentration,MIC)为6.25μg/m L;最大给药量18g/kg;醋酸氯苯胍葶和过碳酰胺分别在5.50~17.40μg/m L和0.12~0.45mg/m L范围内线性关系良好,线性方程分别为y=0.0508x-0.0729(R2=0.9993)和y=1.7245x+0.0185(R2=0.9991),醋酸氯苯胍葶的重复性和中间精密度分别为0.65%和0.72%,平均回收率为99.60%;过碳酰胺的重复性和中间精密度分别为0.29%和0.41%,平均回收率为100.4%。结论口卫士亮白健齿片不仅能清除牙釉质表面色素沉着,抑制口腔细菌,且质量稳定,安全性良好。Objective To evaluate the efficacy of removing plaque, bacteriostasis and safety of Liangbaijianchi tablets and establish the method of quality control of this product. Methods The model of dental plaque was used to examine the capacity of removing the plaque. Staphylococcus aureus, Escherichia coli, Pneumococcus and Candida albicans were used as bacterium to verify the antibacterial capacity of the product. The acute toxicity was adopted to verify its safety. The moments of chlorobenzene guanidine and urea hydrogen peroxide were measured by ultraviolet spectroscopy. Results The tablets could remove spots gradually after brushing about 2 minutes. With the number of scrubbing increased, the brightness of stain teeth would be improved obviously. The MIC of Staphylococcus aureus and Escherichia coli were 6.25 μg/mL, and the maximum dose was 18g/kg .The linear ranges for the concentration of chlorhexidine guanidine and urea hydrogen peroxide were 5.50-17.40μg/mL and 0.12-0.45mg/mL, respectively. The linear equations were y= 0.0508x-0.0729（r=0.9996） and y=l.7245x＋0.0185（r=0.9995）, respectively. The repeatabilities, the intermediate precisions and the average recoveries for chlorhexidine acetate and urea hydrogen peroxide were 0.65% and 0.29%, 0.72% and 0.41%, and 99.60% and 100.4%, respectively. Conclusion The tablets could clear enamel surface pigmentation and inhibitbacteria in the mouth, and were also of high stability and safety.

关 键 词：抑菌 质量控制 醋酸氯苯胍葶 过碳酰胺 

分 类 号：R978.1[医药卫生—药品]