基于化学谱峰匹配和图像感官评价的小儿感冒宁合剂稳定性研究  

Stability research of Xiaoer Ganmaoning Oral Liquid based on chromatographic peak matching and image sensory evaluation

作　　者：王琪 胡佳亮[2] 杜若飞[2] 吴飞[1,2] 林晓[1] 冯怡[2] WANG Qi;HU Jia-liang;DU Ruo-fei;WU Fei;LIN Xiao;FENG Yi(College of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学中药学院,上海201203 [2]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203

出　　处：《中国中药杂志》2022年第6期1573-1581,共9页China Journal of Chinese Materia Medica

基　　金：上海市卫健委科研基金项目(201940296)。

摘　　要：该文建立了小儿感冒宁合剂的高效液相色谱特征图谱,明确了特征峰的药材归属、指标成分及其与对照图谱的相似度范围。结果表明,10批小儿感冒宁合剂的特征图谱与对照图谱的相似度大于0.994;共标定18个特征峰,分别来源于黄芩、牛蒡子、金银花、栀子、连翘等药材;经过对照品比对,确认其中11个特征峰分别为绿原酸、新绿原酸、隐绿原酸、异绿原酸A、异绿原酸C、黄芩苷、黄芩素、汉黄芩素、野黄芩苷、连翘酯苷A、牛蒡苷。在此基础上,建立了沉淀物的HPLC特征图谱,10批沉淀物与对照图谱的相似度大于0.940;沉淀物中标定的14个特征峰与合剂的相对保留时间基本一致,且其指标性成分含量均低于合剂的5%;此外,过滤法结合Matlab图像感官评价技术,探究了小儿感冒宁合剂稳定性考察期间的沉淀变化情况,结果表明,沉淀物的质量、严重程度随着稳定性放置时间延长均显著增加。该研究以小儿感冒宁合剂稳定性研究为模型,采用HPLC特征图谱、沉淀的图像感官评价等技术手段,通过建立“药材-制剂-沉淀物”综合质控体系,为其量值传递关系研究奠定了基础。The high performance liquid chromatography(HPLC)characteristic chromatogram of Xiaoer Ganmaoning Oral Liquid(oral liquid for short)was established.The medicinal materials corresponding to characteristic peaks,their index components and ranges of similarity with the reference chromatograms were clarified.The similarity between the characteristic chromatograms of 10 batches of the oral liquid and the reference chromatogram was higher than 0.994.Eighteen characteristic peaks were identified,which were derived from different medicinal materials including Scutellariae Radix,Arctii Fructus,Lonicerae Japonicae Flos,Gardeniae Fructus and Forsythiae Fructus.Further,11 characteristic peaks were assigned by the comparison with reference substances as chlorogenic acid,neochlorogenic acid,cryptochlorogenic acid,isochlorogenic acid A,isochlorogenic acid C,baicalin,baicalein,wogonin,scutellarin,forsythiaside A and arctiin.Also,the characteristic chromatogram of precipitate in the oral liquid was established,and the similarity between characteristic chromatograms of 10 batches of the precipitate and the reference chromatogram was higher than 0.940.The 14 characteristic peaks originating from the precipitate and those from the oral liquid were consistent in retention time,and the content of all index components in the precipitate was lower than 5%of that in the oral liquid.Moreover,the stability of precipitate during the accelerated stability test was explored with filtration and Matlab-based image sensory evaluation.The precipitate mass and precipitation degree both increased over the stability test duration significantly.The stability of the oral liquid was used as a model system in this study to establish the integrated quality control system which related to medicinal materials,preparations and precipitate with HPLC characteristic chromatograms and image sensory evaluation,which lays a foundation for the exploration of the quantity value transfer of the oral liquid.

关 键 词：小儿感冒宁合剂 高效液相色谱法特征图谱 质量控制 图像处理 稳定性 沉淀 

分 类 号：R286.0[医药卫生—中药学]