阿苯达唑混悬剂的制备及其质量控制

发布时间：2018-03-02 08:51

本文关键词： 阿苯达唑混悬剂研制质量控制　出处：《西北农林科技大学》2015年硕士论文　论文类型：学位论文

【摘要】：寄生虫病严重制约着畜牧业的发展,因此研制高效、低毒的驱虫药物具有极其重大的意义。阿苯达唑是苯并咪唑类衍生物,抗虫谱很广、价格低廉、毒性很小且效果好,使其被广泛应用于临床实践,可预防和治疗人与动物的蛔虫病、绦虫病等。目的:本试验以阿苯达唑为主药,选择适当的助悬剂、润湿剂、絮凝剂和抗氧化剂等辅料制备混悬剂,研制出优质的阿苯达唑混悬剂,建立该混悬剂的质量控制方法,并对制备的混悬剂进行安全性试验,为临床合理用药及扩大生产提供科学的理论依据。方法:①采用递质研磨法制备阿苯达唑混悬剂,以单因素试验和正交试验筛选初步处方,以沉降容积比的测定、重新分散试验、有效药物含量等指标确定最终处方。②考察阿苯达唑混悬剂的药剂学特性,主要包括物理性状、沉降体积比、再分散性试验、稳定性试验。③以紫外全波段扫描法确定阿苯达唑的测定波长,以阿苯达唑标准品溶液的吸光度对浓度进行线性回归,制作标准曲线,以添量法测定回收率与精密度,建立阿苯达唑混悬剂含量的测定方法。④通过阿苯达唑混悬剂对小鼠的口服急性毒性效应(LD50)验证其安全性。结果:本试验所筛选制备出来的阿苯达唑混悬剂的最佳配方为:每25mL混悬剂中含有1.75g阿苯达唑,0.3g羧甲基纤维素钠,0.0125mL聚山梨酯-80,0.3g柠檬酸,0.075g苯甲酸钠。阿苯达唑混悬剂的药剂学特性检查结果符合《中国兽药典》对混悬剂的质量要求;紫外-可见分光光度法的测定结果表明,本试验制备的阿苯达唑混悬剂沉降体积比为0.94,再分散性良好,平均回收率为(99.60±1.47)%,变异系数为1.48%。结论:本试验确定的阿苯达唑混悬剂最优处方药剂学特性稳定,制剂的物理稳定性良好,符合混悬剂质量要求,且制备工艺简单,可以扩大生产广泛应用于兽医临床。
[Abstract]:Parasitosis seriously restricts the development of animal husbandry, so it is of great significance to develop high efficiency and low toxicity insecticides. Albendazole is a benzimidazole derivative with wide spectrum, low price, low toxicity and good effect. It has been widely used in clinical practice to prevent and treat ascariasis and tapeworm in human and animal. Objective: to select suitable suspension aid and wetting agent for albendazole. The suspension of albendazole suspension was prepared by flocculant and antioxidant. The quality control method of albendazole suspension was established, and the safety test of the suspension was carried out. Methods: Albendazole suspension was prepared by the method of transmitter grinding. The primary prescription was screened by single factor test and orthogonal test, the sedimentation volume ratio was measured, and the dispersion test was carried out. Determination of the final prescription .2 the pharmacological properties of albendazole suspension were investigated, including physical properties, sedimentation volume ratio, and redispersity test. Stability test .3 the determination wavelength of albendazole was determined by ultraviolet full-band scanning, the concentration of albendazole standard solution was linear regressed with absorbance of albendazole standard solution, the standard curve was made, and the recovery and precision of albendazole were determined by adding quantity method. A method for the determination of albendazole suspension was established. 4. The safety of albendazole suspension was verified by oral acute toxicity of albendazole suspension in mice. Results: the best albendazole suspension was selected in this experiment. The formula is as follows: 1.75 g albendazolium 0.3g sodium carboxymethyl cellulose 0.0125 mL polysorbite-0.3g citrate 0.075g sodium benzoate is contained in every 25 mL suspension. The pharmacological characteristics of albendazole suspension meet the quality requirements of Chinese Veterinary Pharmacopoeia. The results of UV-Vis spectrophotometry showed that the settling volume ratio of albendazole suspension was 0.94, and the redispersion of albendazole suspension was good. The average recovery of albendazole suspension was 99.60 卤1.47 and the coefficient of variation was 1.48.Conclusion: the optimum prescription of albendazole suspension determined by this experiment is stable in pharmacology, good in physical stability, good in quality of suspension, and simple in preparation process. It can be widely used in veterinary clinic.
【学位授予单位】：西北农林科技大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：S859.795

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