丁香油滴丸的制备工艺优化
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篇名: 丁香油滴丸的制备工艺优化
TITLE:
摘要: 目的:建立测定丁香油滴丸中丁香酚含量的方法,并对其制备工艺进行优化。方法:采用紫外-可见分光光度法测定丁香油滴丸中丁香酚的含量。在单因素试验基础上,以药物质量占总质量的百分比、药液温度、冷凝液下落距离、药液滴距为因素,以滴丸圆整度、硬度、质量差异及综合得分为指标,采用L9(34)正交设计试验对制备工艺进行优化,并进行验证试验和滴丸质量考察。结果:丁香酚质量浓度线性范围为15.15~45.45 μg/mL(r=0.999 6);精密度、稳定性、重复性试验的RSD均小于1%;加样回收率为97.41%~100.59%(RSD=1.35%,n=6)。最优制备工艺为药物质量占总质量的百分比为5%,药液温度为80 ℃,冷凝液下落距离为13 cm,药液滴距为6 cm。在此条件下,所得丁香油滴丸外观完整光洁,硬度适宜,圆整度较好;丁香酚平均含量为4.073%(RSD=0.35%,n=6)。结论:所建含量测定方法操作简单、方便,可用于测定丁香油滴丸中丁香酚的含量;优化所得制备工艺稳定、可行。
ABSTRACT: OBJECTIVE: To establish the method for content determination of eugenol in Syzygium aromaticum oil dropping pills, and to optimize the preparation technology. METHODS: The content of eugenol in S. aromaticum oil dropping pills was determined by UV spectrophotometry. Based on single factor test, using the percentage of drugs in total amount, liquid temperature, falling distance of condensate, liquid drop distance as factors, taking the roundness, weight and hardness difference and comprehensive score as factors, L9(34) orthogonal design test was adopted to optimize the preparation process. RESULTS: The linear range of eugenol was 15.15-45.45 μg/mL(r=0.999 6); RSDs of precision, stability and reproducibility tests were all lower than 1%; the recoveries were 97.41%-100.59%(RSD=1.35%, n=6). The optimal preparation technology included that the percentage of drugs in total amount was 5%; liquid temperature was 80 ℃; falling distance of condensate was 13 cm; liquid drop distance was 6 cm. The dropping pills had smooth appearance, good roundness and moderate hardness; the average content of engenol was 4.073%(RSD=0.35%,n=6). CONCLUSIONS: The established method is simple, and can be used for the content determination of eugenol in S. aromaticum oil dropping pills. The optimal preparation technology is stable and feasible.
期刊: 2019年第30卷第24期
作者: 杜卓,余小姚,邝翠琼,莫玉芳,周宝珠,刘露,李海仪,郭嘉亮
AUTHORS: DU Zhuo,YU Xiaoyao,KUANG Cuiqiong,MO Yufang,ZHOU Baozhu,LIU Lu,LI Haiyi,GUO Jialiang
关键字: 丁香油滴丸;丁香酚;紫外-可见分光光度法;含量测定;制备工艺;优化;正交设计
KEYWORDS: Syzygium aromaticum oil dropping pills; Eugenol; UV spectrophotometry; Content determination; Preparation technology; Optimization; Orthogonal design
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