红砂软膏剂的质量评价研究

Study on Quality Evaluation of Reaumuria songarica Ointment

本研究的目的是对自制红砂软膏剂进行质量评价。首先按照2020版《中国药典》第四部通则0109对红砂软膏剂进行理化性质评价,考察内容包括外观、均一性、涂抹延展性、pH、粒度、稳定性;然后以葡萄糖为对照品,在490 nm处用苯酚-浓硫酸显色法定量测定红砂多糖含量。结果表明红砂软膏剂外观、均一性、涂抹延展性、pH、粒度、稳定性均符合2020版《中国药典》相关规定。以葡萄糖为对照测定的多糖含量为1.412 9 mg/g,回收率为96.06%~103.36%,相对标准偏差为2.67%。本软膏剂的理化性质稳定、细腻均匀以及各项检查指标均达标,本研究为红砂软膏剂质量评价与控制提供实验依据。

This research aimed at evaluating the quality of the Reaumuria songarica ointment.Firstly,according to the 2020 edition Pharmacopoeia of the People s Republic of China,the physical and chemical properties of the Reaumuria songarica ointment were conducted,including properties,irritation,evenness,pH value,particle size,stability.Then,with glucose as the reference,the content of polysaccharides was determined by phenol-sulfuric acid method at 490 nm.The results showed that the physical and chemical properties of Reaumuria songarica ointment conformed to the 2020 edition of Chinese Pharmacopoeia relevant provision.The polysaccharide content of the ointment was 1.4129 g/mg,polysaccharide recovery was 96.06%to 103.36%,relative standard deviation was 2.67%.It was suggested that the physical and chemical properties of the Reaumuria songarica ointment were stable,delicate and uniform,and all the examination indexes were up to standard.This experiment provided experimental basis for further study on the quality evaluation and control of Reaumuria songarica ointment.