Preparation And Quality Evaluation Of Benazepril Hydrochloride Oral Solution

Objective: This paper give a brief introduction to preparation of Benazepril Hydrochloride Oral Solution. Besides, the method of detection content of Benazepril Hydrochloride is established. The stability study of Benazepril Hydrochloride Oral Solution was carried out.The aim of this study is to provide a new type of oral drug to treatment the diseases of cardiovascular system of pets.Methods:(1) The method of formula screening of Benazepril Hydrochloride Oral Solution: First, we got the referenced dose of Benazepril Hydrochloride for canine and feline by dose conversion to design a target concentration of Benazepril Hydrochloride Oral Solution. Second, we preliminarily screened a reagent which has good solubility of Benazepril Hydrochloride, and combined it with distilled water. At the same time, we selected an appropriate chaotropic agent. The purpose is to improve the solubility of Benazepril Hydrochloride. Third, through the stability test, we chosed a formula with good stability, low viscosity and low irritation. Finally, we got the best formula of Benazepril Hydrochloride Oral Solution by added 0.1% Na2S2O3.(2) To evaluated the quality of Benazepril Hydrochloride Oral Solution : First, we tested the p H value of Benazepril Hydrochloride Oral Solution by p H meter, repeated three times to got the average; Second, we established detection method of content of Benazepril Hydrochloride Oral Solution, to detect the maximum absorption wavelength and establish the standard curve of concentration – absorbance. Moreover, we made the recovery, precision and repeatability test; Third, to take a series of affecting experiment including high temperature test and low temperature test, freezing test and illumination test. It was designed to study the effect of temperature and light on the stability; Finally, It was carried out of accelerate experiment. We analyzed the change of content of Benazepril Hydrochloride Oral Solution within three months at 60 ?, 70 ?, 80 ?, 90 ?. By using classical constant temperature acceleration method, through the Arrhenius law lnk = ln A – Ea/RT, we predicted the shelf life under the condition of 25 ? of Benazepril Hydrochloride Oral Solution.Results: The best formula of Benazepril Hydrochloride Oral Solution is :(1)Benazepril Hydrochloride 30wt%, anhydrous ethanol 29.95 wt %, tween-80 wt %, distilled water 29.95 wt %, Na2S2O4 0.1 wt %. Benazepril Hydrochloride Oral Solution is a pale yellow liquid with clear transparent and excellent fluidity.(2)The p H of Benazepril Hydrochloride Oral Solution is 3.62±0.02. By using ultraviolet spectrophotometry testing content, the standard curve of Benazepril Hydrochloride is A = 0.0227-0.0019 C(r = 0.9991), recovery is 99.26%±0.01%, RSD is 0.87%, the average recovery of precision test is 99.79%±0.027%(RSD = 0.027%), 98.95%±0.028%(RSD = 0.028%), 0.028%±0.012%(RSD = 0.012%), days of precision RSD are below 1%, and daytime precision RSD are below 5%. The solution was stayed in good when stored in high temperature(60 ?), low temperature(4 ?), frozen(20 ?), illumination conditions(4500 lx) days later. Save for five days, ten days, Solution properties of stability, Drug content changes are less than 5%. In the accelerated test, the regression equation of the lnk and 1 / T is lnk = – 10235(1/T)+ 20.657, r = 0.9955. It can be predicted that the shelf life of Benazepril Hydrochloride is about 47 months.Conclusion: Through a series of research, we developed Benazepril Hydrochloride Oral Solution. Benazepril Hydrochloride Oral Solution has good stability, and it can be stored for a relatively long period of time. Benazepril Hydrochloride Oral Solution meets the quality standards of Oral Solution.