Preparation And Quality Contril Of Benazepril Hydrochlorride Oral Cavity Film

Objective: Benazepril hydrochlorride oral cavity film was prepared to provide a new way for veterinary clinical treatment of hypertensive disease.Methods:(1)We prepared the blank film, according to the film-forming properties, Appearance,toughness and adhesion to conduct the preliminary screening of film-forming material; We prepared the benazepril hydrochlorride oral cavity film to screening composite film-forming material and determined the proportion of film-forming material; By changing the ratio of the drug and composite membrane materials,we optimized the prescription of benazepril hydrochloride oral cavity film and determined the optimal prescription of agent;(2) Adopt ultraviolet spectrometry to carry on the content measurement to drug,and put the appearance, pH, dissolved time, weight difference as detection index to carry on the quality appraisal of benazepril hydrochlorride oral cavity film;(3) By high temperature, high humidity, strong light irradiation, accelerate test to discuss the stability of benazepril hydrochlorride oral cavity film.Results: Benazepril hydrochlorride oral cavity film was transparent and homogeneous membrane;the film-forming materials are PVA(17~88) and PVA(05~88), when both ratio is 3 showed the best film-forming effect; optimal formulation of benazepril hydrochlorride oral cavity film : PVA(17~88) 9g, PVA(05~88) 3g, CMS-Na 0.3g,glycerol 1g, Tween-80 0.5g,0.4g, ultrapure water 74 g.(2) Benazepril hydrochlorride oral cavity film had smooth faces, uniform colour, thick thin uniform, no obvious bubble on the surface,strong adhesive and high stability. Its drug-loading rate was about 0.4mg/cm2,pH 4.59, thickness 145±5μm, and it spent 6.7 min completely dissolved in 37℃ water(without stirring). The best detection wavelength was 241 nm. As the concentrations of benazepril hydrochlorride ranged from 15μg·m L-1 to 60μg·mL-1, the concentrations and peak areas showed good linear relationship,the average recovery rate and relative standard deviation of benazepril hydrochlorride were 97.87%±1.00% and 1.02%, respectively, the precision of this benazepril hydrochlorride oral cavity film was well, the drug content was 102.47% of the labeled amount.(3) Benazepril hydrochlorride oral cavity film was stored under the temperature of 40℃ and humidity of 75% for three months, its stability was good,and its stability was bad in bright light.Conclusion: Polyvinyl alcohol film-forming material that the test chosen was strong flexibility, safe and nontoxic; Benazepril hydrochlorride oral cavity film had smooth faces, uniform colour, thick thin uniform, strong adhesive and high stability. Compared with the traditional tablet drugs, only to be put in mouth, it can be dissolved quickly in saliva, and solved the problem of difficulty in swallowing for the animals.