Study On Preparation Process And Quality Of Olopatadine Hydrochloride Eye Drops

Olopatadine Hydrochloride,which is a new generation of topical application of antihistamine medications,is not only a high selectivity of H₁ receptor antagonist,but also a mast cell membrane stabilizer,has a dual effect,so it has potent anti-allergic effects.Clinically,it could be useful for the treatment of allergicconjunctivitis.According to the Drug Registration Regulation and the related technical requirements,the prescription,the preparation process,qualitystandards,the stability of olopatadine hydrochloride eyedrops systematically were studied in this paper.1.Study on the preparation processAccording to the instructions of commercial olopatadine hydrochloride eyedrops and Rxlist?online prescription drug index?about the introduction of prescription,we identified the formulation,the specification,and the components of the prescription.Referring to the conventional dosages of the accessories and the physical-chemical properties of the commercial drugs,we optimized the best prescription by prescription screening.The results showed that we optimized production processes of the small test with the study of the amount of water for injection,dissolving time.On this basis,we expand the production to exam cycle-mixing time with the character,pH,and the content,and we finally determined the production process.2.Research on quality standardsIn accordance with the relevant requirements of Olopatadine Hydrochloride EyeDrops imported drug registration standards,we started the related research.The main indexes were the description,the identification,pH,the loading capacity,foreign particulates,microbial limits,total spray times per bottle and the weight per spray,the related substances,content,etc.The high performance liquid chromatography method to determine the related substance,the main medicine content,the content of preservative and the each spray content of the Olopatadine Hydrochloride EyeDrops were established and the methodology was validated.We established a set of control Olopatadine HydrochlorideEyeDrops quality testing standards.It provided the foundation for the drug's safety and effectiveness.Experimental results show that the main indicators of Olopatadine Hydrochloride EyeDrops are in line with regulations.3.Study on the stabilityWe inspected the rule of olopatadine hydrochloride eyedrops with time change under the influence of the temperature,the humidity,the light and the microorganism.Using stress test,a batche of samples removing the external packing were placed respectively for 10 days at high temperature?40??,high humidity?25?,90%±5%RH?,or strong light,and were tested at 0,5,10 days according to the key inspection projects of the stability.Using accelerated test,three batches of samples in commercial packaging were stored for six months at 40?±2?temperature,25%±5%relative humidity,and were tested at 0,1,2,3,6 months according to the key inspection projects of the stability.Adopting the long-term test,three batches of samples in commercial packaging were stored for eighteen months at 25?±2?temperature,60%±10%relative humidity,and were tested at 0,3,6,9,12,18 months according to the key inspection projects of the stability.The results:every inspection item conformed with the regulations and did not change significantly in the experiment period.The results indicated that the preparation had good stability.