Preparation And Evaluation Of Ozone Oil Inclusion Compound Gel

Objective:To address the issues of low stability,poor water solubility,unpleasant odor,and strong irritation of ozone oil,this article first uses inclusion technology to prepare ozone oil into inclusion complexes and characterize them;Then,the ozone oil inclusion compound is used as the intermediate,and carbome-940 is used as the gel matrix to prepare the ozone oil gel.The purpose is to develop an external preparation that is easy for patients to accept,can reduce irritation,increase drug stability,and maintain the antibacterial ability of ozone oil,so as to provide reference for the development of external preparation of ozone oil.Method:（1）Using hydroxypropyl-β-Cyclodextrin（HP-β-CD）is the inclusion material,and the peroxide value is the evaluation index of the inclusion effect.The preparation method of ozone oil inclusion compound is selected,and the optimal preparation process of the inclusion compound is optimized through single factor experiments and Box Behnken response surface method.（2）Scanning electron microscopy（SEM）,Fourier transform infrared spectroscopy（FT-IR）,nuclear magnetic resonance hydrogen spectroscopy（¹HNMR）and other analysis methods were used to characterize the ozone oil inclusion complex and investigate its stability.（3）With the ozone oil inclusion compound as the intermediate,carbome-940 as the gel matrix,and the formability,spread,viscosity,and greasy degree of the gel as the evaluation indicators,the best prescription was selected by single factor test combined with L₉（3⁴）orthogonal design,and the quality of the prescription was evaluated,including appearance properties,p H value,peroxide value,viscosity,moisture retention rate,rheology properties and stability.（4）According to the bacteriostatic ring test in the Evaluation Method for Antibacterial and Bacteriostatic Effects（WS/T 650-2019）and the dissolution bacteriostatic test in the Hygienic Standard for Disposable Hygienic Products（GB15979-2002）,the prepared ozone oil gel was tested qualitatively and quantitatively for its bacteriostatic effect in vitro.（5）The biological safety of gel was evaluated by vaginal mucosa irritation test,skin sensitization test and acute systemic toxicity test.Result:（1）The selection of preparation methods for inclusion complexes showed that the single-phase solution method had the best inclusion effect,and the optimal preparation process was ultimately selected as follows:ozone and HP-β-The CD oil mass ratio is 1:10,the encapsulation temperature is 45℃,and the encapsulation time is 1.3 hours.Under the optimal process conditions,the average peroxide value of the ozone oil inclusion complex is 6.81g/100g.（2）The analysis methods such as SEM,FT-IR,and ¹HNMR showed that the inclusion complex had formed,and the stability results showed that the stability of the ozone oil inclusion complex was better than that of the mixture.（3）The optimal formulation of ozone oil gel was 0.4%carbopol-940,8%glycerol,0.6 times triethanolamine,and 10%inclusion compound.The appearance of the optimized gel is clear,no graininess,uniform,fine and glossy;PH（5.45±0.10）;The viscosity is（46.78±0.18）Pa·s;The moisture retention rate was（96.69±0.75）%,（95.84±0.44）%and（94.12±0.89）%respectively after the gel was placed for 24,36 and 48 hours;Good rheology properties;The stability test showed that ozone oil gel should not be stored at high temperature.（4）Antibacterial ring test showed that ozone oil gel had good antibacterial effect;The quantitative bacteriostasis test results showed that the average bacteriostasis rate of ozone oil gel against Staphylococcus aureus and Escherichia coli reached more than 98%after 20 minutes of action,and the average bacteriostasis rate against Candida albicans reached more than 89%after 20 minutes of action,indicating that the ozone oil gel has a strong bacteriostasis effect.（5）The biosafety test results of ozone oil gel showed that the ozone oil gel had no vaginal mucosa irritation,skin sensitization and acute systemic toxicity.Conclusion:The process of preparing ozone oil gel by this method is simple,feasible and easy to operate.At the same time,the stability of ozone oil is improved and its bad smell is covered,and the original antibacterial activity of ozone oil is retained.It has certain promotion value and application prospect in the field of biomedicine,which lays an experimental foundation for further promotion and application of ozone oil.