發(fā)布時(shí)間：2018-03-02 08:51

  本文關(guān)鍵詞： 阿苯達(dá)唑 混懸劑 研制 質(zhì)量控制　出處：《西北農(nóng)林科技大學(xué)》2015年碩士論文　論文類型：學(xué)位論文

【摘要】：寄生蟲病嚴(yán)重制約著畜牧業(yè)的發(fā)展,因此研制高效、低毒的驅(qū)蟲藥物具有極其重大的意義。阿苯達(dá)唑是苯并咪唑類衍生物,抗蟲譜很廣、價(jià)格低廉、毒性很小且效果好,使其被廣泛應(yīng)用于臨床實(shí)踐,可預(yù)防和治療人與動(dòng)物的蛔蟲病、絳蟲病等。目的:本試驗(yàn)以阿苯達(dá)唑?yàn)橹魉?選擇適當(dāng)?shù)闹鷳覄�、潤濕劑、絮凝劑和抗氧化劑等輔料制備混懸劑,研制出優(yōu)質(zhì)的阿苯達(dá)唑混懸劑,建立該混懸劑的質(zhì)量控制方法,并對制備的混懸劑進(jìn)行安全性試驗(yàn),為臨床合理用藥及擴(kuò)大生產(chǎn)提供科學(xué)的理論依據(jù)。方法:①采用遞質(zhì)研磨法制備阿苯達(dá)唑混懸劑,以單因素試驗(yàn)和正交試驗(yàn)篩選初步處方,以沉降容積比的測定、重新分散試驗(yàn)、有效藥物含量等指標(biāo)確定最終處方。②考察阿苯達(dá)唑混懸劑的藥劑學(xué)特性,主要包括物理性狀、沉降體積比、再分散性試驗(yàn)、穩(wěn)定性試驗(yàn)。③以紫外全波段掃描法確定阿苯達(dá)唑的測定波長,以阿苯達(dá)唑標(biāo)準(zhǔn)品溶液的吸光度對濃度進(jìn)行線性回歸,制作標(biāo)準(zhǔn)曲線,以添量法測定回收率與精密度,建立阿苯達(dá)唑混懸劑含量的測定方法。④通過阿苯達(dá)唑混懸劑對小鼠的口服急性毒性效應(yīng)(LD50)驗(yàn)證其安全性。結(jié)果:本試驗(yàn)所篩選制備出來的阿苯達(dá)唑混懸劑的最佳配方為:每25mL混懸劑中含有1.75g阿苯達(dá)唑,0.3g羧甲基纖維素鈉,0.0125mL聚山梨酯-80,0.3g檸檬酸,0.075g苯甲酸鈉。阿苯達(dá)唑混懸劑的藥劑學(xué)特性檢查結(jié)果符合《中國獸藥典》對混懸劑的質(zhì)量要求;紫外-可見分光光度法的測定結(jié)果表明,本試驗(yàn)制備的阿苯達(dá)唑混懸劑沉降體積比為0.94,再分散性良好,平均回收率為(99.60±1.47)%,變異系數(shù)為1.48%。結(jié)論:本試驗(yàn)確定的阿苯達(dá)唑混懸劑最優(yōu)處方藥劑學(xué)特性穩(wěn)定,制劑的物理穩(wěn)定性良好,符合混懸劑質(zhì)量要求,且制備工藝簡單,可以擴(kuò)大生產(chǎn)廣泛應(yīng)用于獸醫(yī)臨床。
[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 鹵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.
【學(xué)位授予單位】：西北農(nóng)林科技大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：S859.795

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本文編號：1555836