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The Development Of Dichlorobenzyl Alcohol Hand Disinfection Gel

Posted on:2017-05-25Degree:MasterType:Thesis
Country:ChinaCandidate:Y L WangFull Text:PDF
GTID:2284330485981246Subject:Pharmaceutical engineering
Abstract/Summary:PDF Full Text Request
The importance of hands disinfection was indicated by the various outbreak of contagious diseases since 2003. Especially for the hands disinfection of medical personnel and the general persons However, ethanol of 35-80% was mostly applied in the hand disinfectants as a bactericidal ingredient or auxiliary in the popular product. It is well known that the skin is easy to cause the side effects when long-term repeatedly contact with ethanol, such as dryness, exfoliation, cracking, dermatitis and so on. So it causes many people unlike to do hand disinfection.In order to eliminate the worry about the side effects of the hand disinfectant, a kind of gel which is safe and reliable, has the moisturizing effects, keeps a healthy skin barrier function, and requires no rinsing is needed. This study developed a kind of wash-free gels for hands disinfection containing sodium hyaluronate, and its evaluation method was established, formula was optimized, standards of quality were established, stability and safety were evaluated in this paper. According to the study aim, the experiments of moisture retention, transepidermal water loss, and volatile were investigated.In this paper, we established a method to test the disinfection effect of the hands disinfection gel. The results showed that the average killing log values of this disinfection gel to Staphylococcus aureus, Escherichia coli, Candida albicans were all larger than 3.00. The results meet the requirements of hand disinfectant technical standard. We also developed the detection method of dichlorobenzyl alcohol. The results showed that the other ingredients did not interfere with the determination of dichlorobenzyl alcohol content, and the concentration and peak area of dichlorobenzyl alcohol were linear correlation in 40.55-202.75 μg/mL, the return equation was A=29.708C-69.273, recovery for 101.0%, RSD was 1.24%, the precision of RSD was 0.81%, detection limit was 0.98 μg/ml. The results showed that the method could be used in the determination of dichlorobenzyl alcohol in this gel.We had applied sodium hyaluronate as a matrix, dichlorobenzyl alcohol as a disinfection component, ethanol as a solvent, polyethylene glycol 400 as a moisturizing agent in the wash-free hand disinfection gel, based on the selection of cosolvent, solubilizer, gel matrix and dichlorbenzyl alcohol concentration. By studying the stability of the samples with different pH value and skin tolerance range, we determined the pH value range of the product within 6.0 to 8.0. Based on the stability test of the products, the shelf life of the products was determined to be two years.Compared with the products in the market in skin stratum corneum water content, transepidermal water loss content and volatile time, the product which applied sodium hyaluronate as matrix was better in moisturizing properties and maintaining a healthy skin barrier function, and volatile test was similar with the marketed disinfectant gel.We have also conducted acute toxicity, skin irritation test and mutagenicity tests. The LD50 value of the product on male and female mouse was greater than 5000 mg/kg.bw, indicating the product belonged to actual nontoxic level based on the acute toxicity grading standard. The products showed no irritation to rabbit skin according to the skin irritation test criteria, and this products also showed no mutagenesis risk because no micro-nuclear had been found in mouse bone marrow polychromatic erythrocytes.In summary, dichlorobenzyl alcohol hand disinfection gel containing Sodium hyaluronate is safe and effective. In addition, it is an ideal hand disinfectant which has the efficacy of moisturizing and maintaining a healthy skin barrier. We also established the quality standard. The validity period of this gel is 24 months, which can meet the commercial demand. This gel can reduce the occurrence of bacterial infectious diseases and control the spread of infectious diseases. We believe that it will change the attitudes of customers about hand disinfectant and improve the rate of utilization.
Keywords/Search Tags:Sodium hyaluronate, dichlorobenzyl alcohol, hand disinfection gel, moisturizing
PDF Full Text Request
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