| Bacterial infections are currently very common,and are susceptible to infections and occurrences,and the initial symptoms are not significant.Quinolone is mainly used to treat infectious diseases caused by various pathogens such as bacteria.One of the most used medicines,this kind of medicine has good resistance and inhibition to various bacteria and fungi.Moxifloxacin is the fourth-generation modified drug of this class of drugs.It has higher bacteriostatic effect and longer half-life than LEVO and CIP,which are the representative drugs of its modified third-generation drugs.It is also stronger than the previous three generations and is the first choice of quinolones in clinical applications.It has a good effect on the diagnosis and treatment of pathogen invasion,bacterial diseases of the respiratory tract and urinary system,subcutaneous fungal or bacterial diseases.In this subject,moxifloxacin hydrochloride is used as the main drug.The related literature is consulted and its active ingredient content is set to 0.5%.Boric acid is used as a buffering agent and a preservative.Its osmotic pressure is adjusted with Na Cl.The p H of eye drops is adjusted to a suitable value with Na OH,Initially developed moxifloxacin hydrochloride eye drops.Through research on its product prescription,process flow,quality standards and pilot test stability,the quality standards of moxifloxacin hydrochloride eye drops were formulated,and the following experimental studies were performed on them.:First chapter,relevant researches on the formulation process of moxifloxacin hydrochloride eye drops were carried out.According to the requirements of the eye drops,as well as the properties of main medicines and auxiliary foods To determine the preliminary prescription by looking for the relevant patents and literature of eye drops,and then taking the appearance of the preparation,p H,osmolality,and insoluble particulates for the prescription.Change the prescription amount of sodium chloride and boric acid,formulate a series of test prescriptions,and evaluate the various aspects of the prescription to select the best eye drop prescription.Second chapter,three batches of small sample eye drops were made,and various sample quality indicators were examined on the sample samples.With reference to the standard of moxifloxacin hydrochloride,Chinese Pharmacopoeia 2015 and USP38,the appearance,p H,osmotic concentration,insoluble particulates,loading amount of the homemade sample were measured.HPLC was used to test the relevant substances and contents of three batches of eye drops and Novartis preparations,which provided the basis for the quality control and formulation of moxifloxacin hydrochloride eye drops.In the third chapter,in order to ensure the safety and efficacy of the drug,a preliminary stability study was conducted on the self-made pilot eye drops.With reference to the guidelines of the Chinese Pharmacopoeia in 2015(9001),stability experiments were conducted in accordance with the requirements of the preparations in the Pharmacopoeia,mainly from the characteristics,p H,osmotic pressure,insoluble particles,the content of the main drug in thesample and related In terms of material conditions,the stability of self-made samples was investigated.Influencing factor experiments were carried out.Under two high-temperature conditions and light conditions,the stability test of the pilot test moxifloxacin hydrochloride eye drops was carried out on days0,5 and 10;Carry out accelerated test research at the end of 1,2,3,and 6 months;select the stability test at the 0th,3rd,and6 th months of the sample solution.The experimental results show that the stability of the moxifloxacin hydrochloride eye drops solution is good,but it is not suitable for storage under light and high temperature. |
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