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目的:配制含有多酸化合物的新型洗手液,并探讨其在人手部抗流感病毒的效果和安全性。方法:采用MDCK细胞流感病毒模型研究2种多酸化合物K10Na[(VO)3(SbW9O33)2]·26H2O(PM-1001)和K15[Pr(BW11O39)2]·28H2O(Pr-B)的体外抗病毒作用,选择3个适宜的多酸剂量配制成含高、中、低剂量多酸洗手液;依据美国标准方法进行洗手液抗病毒效果评价,含2种多酸化合物的洗手液各有5名志愿者参与实验,将每名志愿者的10个手指随机分成5组,在手指上涂0.02mL组织培养半数感染剂量(TCID50)为107.5/0.1mL的病毒悬液后,分别在加病毒后、病毒液晾干后和用不同洗手液处理后收集病毒,采用MDCK细胞培养法测定病毒滴度;检测流感病毒在手部晾干30和60min后的浓度和活力变化;选择含高浓度PM-1001的洗手液,按照《消毒技术规范》(2008版)利用昆明小鼠和白色家兔进行毒性评价。结果:PM-1001和Pr-B抗流感病毒的治疗指数(TI)分别为82.68和69.13;对照组的病毒浓度为104.33±0.66 TCID50/0.1mL,各洗手液处理组组织培养法均未检测到病毒,各洗手液处理组病毒浓度均低于对照组(P<0.001),30和60min收集的病毒浓度分别为103.98±0.42 TCID50/0.1mL和103.83±0.35 TCID50/0.1mL,与对照组比较差异无统计学意义(P>0.05);含高浓度PM-1001的洗手液对昆明小鼠的经口毒性实验半数致死浓度(LD50)大于5 000mg·kg-1(体质量),对家兔完整皮肤刺激指数为0.33,对3只家兔眼刺激的平均评分分别为0、0.67和0.33。结论:含多酸化合物的新型洗手液可有效抑制手部甲型流感病毒,属实际无毒级的物质,对家兔完整皮肤和眼无刺激性。
OBJECTIVE: To formulate a new type of hand sanitizer containing polyacid compounds and to explore its efficacy and safety in human hands against influenza virus. METHODS: Two polyacid compounds, K10Na [(VO) 3 (SbW9O33) 2] · 26H2O (PM-1001) and K15 [Pr (BW11O39) 2] · 28H2O (Pr-B) were studied in vitro using the MDCK cell influenza virus model Anti-virus effect, select the appropriate dose of 3 polyacid formulated with high, medium and low dose of multi-acid hand sanitizer; according to the American standard method of hand-washing liquid antiviral effect evaluation, with 2 kinds of polyacid compound of hand sanitizer each have 5 One volunteer was involved in the experiment. Ten fingers of each volunteer were randomly divided into five groups. 0.02 mL tissue culture half-infection dose (TCID50) of 107.5 / 0.1 mL virus suspension was applied to the fingers, , After the virus solution was dried and treated with different hand sanitizer, the virus was harvested and the virus titer was determined by MDCK cell culture. The concentration and viability of influenza virus after 30 and 60 min of dryness were tested. 1001 hand sanitizer, Kunming mice and white rabbits were evaluated for toxicity according to Disinfection Technical Specification (2008 edition). Results: The therapeutic index (TI) of PM-1001 and Pr-B anti-influenza virus were 82.68 and 69.13, respectively. The virus concentration of the control group was 104.33 ± 0.66 TCID50 / 0.1mL. The virus concentrations in the virus and the hand sanitizer groups were all lower than those in the control group (P <0.001). The virus concentrations collected at 30 and 60 min were 103.98 ± 0.42 TCID50 / 0.1 mL and 103.83 ± 0.35 TCID50 / 0.1 mL, respectively No statistical significance (P> 0.05). The oral toxicity test of high concentration PM-1001 hand-washing liquid to Kunming mice was more than 5 000 mg · kg-1 (LD50) The skin irritation index was 0.33 and the average eye irritation for 3 rabbits was 0, 0.67 and 0.33, respectively. CONCLUSION: A new hand sanitizer containing polyacid compounds can effectively inhibit influenza A virus in hands, which is an actual substance which is non-toxic. It is non-irritating to intact skin and eyes of rabbits.