Preparation And Quality Research Of 0.01% Atropine Sulfate Eye Drops

Myopia has emerged as a worldwide eye disease,and most of the patients are children and adolescents.Atropine eye drops show clear effects in myopia control in children and adolescents.Low-dose atropine has few side effects and good compliance,inducing its widely clinical application in many countries and regions.Based on the analysis of the commercially available atropine eye drops,this thesis completed the formulation screening,preparation process and stability testing,and finally established quality standards.In this thesis,methods that used to detect the content and impurities of the atropine sulfate eye drops were established.The methods were fully validated and the result showed that the two methods both had good specificity,linear,precision,accuracy and durability meeting the requirements of the pharmaceutical analysis.The characteristics of the commercially available eye drops had been analyzed,including the instruction manual,pH,osmotic pressure,boron content,hydroxypropyl methyl cellulose(HPMC)content,and stability.Then the pH and stability were used as indicators to determine the buffer solution,the osmotic pressure was used as an indicator to determine the proportion of the osmotic medium,the viscosity was used as an indicator to screen the thickening agent,the content and stability were used as indicators to determine the content of ethylenediaminetetraacetic acid disodium salt(EDTA),the solution properties was used as an indicator to determine the stirring time and speed,the content was used as an indicator to optimize sterilization.Finally,the formulation and process had been determined.The final formulation of the atropine sulfate eye drops contained 0.01% atropine sulfate,1.116% boric acid,0.191% sodium borate,0.18%~0.30% sodium chloride,1.0% HPMC,0.01% EDTA,some hydrochloric acid.The eye drops were perpetrated in the following way.First,all of the inactive ingredients and atropine were dissolved by stirring at a speed of 300 r/min for 3 h and adjusted pH.Finally the eye drops were obtained after sterile filtration.When three batches of eye drops were prepared,their properties were studied,including pH,osmotic pressure,viscosity,content and impurities.The results showed that the self-made eye drops had good stability as well as the commercially available atropine eye drops.Based on the result,the quality standards had been established.The above research showed that the buffer system,the pH and sterilization process of the solution were the considerable factors affecting the quality of atropine eye drops.Self-made eye drops had stable quality and provided a reference for the development of atropine eye drops to myopia control.