Study On Preparation Process And Quality Of Loteprednol Etabonate And Tobramycin Eye Drops

Loteprednol Etabonate and Tobramycin Eye Drops is a new type of broad-spectrum antibiotic and glucocorticoid combined medicine that is designed according to the principle of "soft drug".It not only can reduce the potential side effects of glucocorticoid drugs to a minimum,but also has higher safety and better antibacterial and anti-inflammatory effects.Can be used for clinical treatment of bacterial conjunctivitis.This paper use loteprednol etabonate and tobramycin as active ingredients of suspension eye drop,the specification is 5ml: 25 mg Loteprednol and 15 mg Tobramycin.With glycerol,EDTA-2Na,benzalkonium chloride,povidone K30,tyloxapol,polysorbate 80 as excipients,water as solvent,sulfuric acid or sodium hydroxide as PH regulator,the prescription,preparation process,quality standard and stability of imitation Loteprednol Etabonate and Tobramycin Eye Drop were systematically studied.First,we studied the prescription process of Loteprednol Etabonate and Tobramycin Eye Drops: Select composition of the appropriate preservative,suspending agent and isotonic regulator,etc.And the dosage of povidone K30 and polysorbate 80 were screened by using the evaluation indicators of appearance character,pH,particle size,sedimentation rate and its redispersion,which in accordance with the ChinesePharmacopoeia(2015 edition)of quality requirements of ophthalmic drug,the optimum prescription and preparation process were selected.Second,a series of study was carried out on the basis of the requirements of suspension and compound preparation characteristics,the main inspection items were the appearance character,the identification,the examination and the content.The content of loteprednol etabonate was determined by HPLC method;Content of tobramycin was determined by biological potency of antibiotics;Benzalkonium chloride was determined by Docusate sodium titration liquid and eosin Y indicator.The HPLC method of the content of loteprednol etabonate was proved practicable by methodology validation,and a standard for the quality control was established.For efficacy and safety of drug use,it provides a experimental basis.The experimental results show that the main indicators of homemade Loteprednol Etabonate and Tobramycin Eye Drops are in accordance with the regulations.Finally,we carried out the studies on the stability of Loteprednol Etabonate and Tobramycin Eye Drops.Under the influence of temperature,humidity,light and microorganism,the Regularity change with time of Loteprednol Etabonate and Tobramycin Eye Drops was investigated.The test of influencing factors,respectively under the condition of high temperature(60?),high humidity(25?,90%±5%RH),light(intensity of 4500lx±500lx)to placed 10 days,sampling in 0 days,5 days and 10 days,according to the stability the main items for detection;accelerated test,at a temperature of 40?±2?,relative humidity of 75%±5% for 6 months,respectively sampling in 0 month,1 month,2 month,3 month,6 month,according to the stability the main items for detection;long term test,at a temperature of 25?±2?,relative humidity of 60%±10%,for 6 months,respectively,sampling in 0 month,3 month,6month,according to the stability the main items for detection;Open package stability test,at room temperature,every night open once,sampling in 0 days,7 days and 14 days,according to the stability the main items for detection.The experimental results show that the results are consistent with the requirements,and the preparation is stable.