| Simethicone is a nonionic surfactant formed by the combination of polydimethylsiloxane(also known as dimeticone)and silicon dioxide(SiO2).It has characteristics such as high temperature and light stability,odorlessness,insolubility in water and alcohol,and good solubility in solvents like ether and toluene.Simethicone primarily acts on bubble surfaces in the gastrointestinal tract,causing them to burst.As a physiologically and pharmacologically inert substance,simethicone is not absorbed by the body and is excreted through the digestive tract in its original form,making it safe and reliable.In clinical practice,simethicone is used to treat various diseases,such as functional dyspepsia,postoperative abdominal distension,irritable bowel syndrome,preparation before gastrointestinal endoscopy,infant feeding intolerance,diarrhea,and postoperative intestinal obstruction.However,the currently marketed simethicone emulsions in the domestic market have disadvantages,such as inconvenient transportation and poor stability.Therefore,the purpose of this study is to prepare simethicone oral dissolving films(40 mg)through the solidification of liquid medications to improve patient compliance.We used the casting method to prepare simethicone oral dissolving films,which have the advantages of easy portability,good stability,and no need for water administration,and have established corresponding quality standards.This article includes the following research contents:1.Formulation and preparation process of simethicone oral dissolving films.By conducting single-factor experiments to screen the types of auxiliary materials for the oral dissolving films and using orthogonal experiments to optimize the best dosage of each auxiliary material,the best preparation process was determined through experimentation.2.Establishment of analytical methods and quality standards for simethicone oral dissolving films.Three batches of simethicone oral dissolving films were prepared,and their quality was examined,including appearance,taste,thickness,disintegration time,drying loss,mechanical properties,weight difference,drug content,sorbic acid content,and defoaming ability.Stability experiments,including influencing factor experiments,accelerated experiments,and long-term experiments,were conducted.The results showed that the appearance,drug content,sorbic acid content,disintegration time,and defoaming ability of the simethicone oral dissolving films remained stable without significant changes.3.Preliminary pharmacodynamic evaluation of simethicone oral dissolving films.A mouse gastrointestinal bloating model was established,and an appropriate amount of the product was administered by gavage to observe its efficacy.The results showed no significant difference in efficacy compared to the marketed simethicone emulsion. |
