论文部分内容阅读
目的:研制一种能同时起到多种作用的内窥镜检查用的口服制剂,并建立制剂的质量标准。方法:拟定内窥镜乳的处方组成与制备工艺,进行性状、鉴别、有关物质检查等质量控制方法,采用紫外分光光度法测定盐酸达克罗宁含量。结果:盐酸达克罗宁在4.0~24.0μg·m L-1范围内呈良好的线性关系。盐酸达克罗宁的平均回收率为99.7%(RSD=0.74%)。结论:本制剂制备工艺简便可行,质量稳定可控。
OBJECTIVE: To develop an oral preparation for endoscopy that can simultaneously perform multiple functions and to establish the quality standard of the preparation. Methods: Prescription composition and preparation process of endoscopic milk were formulated. Quality control methods such as characterization, identification and related substances examination were established. Content of dacronine hydrochloride was determined by ultraviolet spectrophotometry. Results: There was a good linear relationship between dacronine hydrochloride and 4.0 ~ 24.0μg · m L-1. The average recovery of dacronine hydrochloride was 99.7% (RSD = 0.74%). Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.