香菊颗粒中黄芪甲苷含量测定方法的改进及其与原方成分的一致性研究
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篇名: 香菊颗粒中黄芪甲苷含量测定方法的改进及其与原方成分的一致性研究
TITLE:
摘要: 目的:改进香菊颗粒中黄芪甲苷的含量测定方法,并对相关制剂与原方成分的一致性进行评价,为中药复方的现代化制剂提供科学依据。方法:建立高效液相色谱-蒸发光散射法(HPLC-ELSD)测定香菊颗粒中黄芪甲苷的含量,并与原标准的薄层扫描法进行比较。以升麻素苷、阿魏酸、毛蕊异黄酮葡萄糖苷、甘草苷、甘草酸、迷迭香酸、蒙花苷、木兰脂素为对照品,采用HPLC法测定自制香菊颗粒、香菊胶囊、香菊片在水中的释放成分,并以《中药色谱指纹图谱相似度评价系统软件(2012版)》比较不同香菊制剂与原方干膏粉的指纹特征图谱;同时,采用HPLC-ELSD法测定并比较不同香菊制剂与原方干膏粉在水中的黄芪甲苷释放度。结果:所建立的黄芪甲苷含量测定HPLC-ELSD法专属性良好;黄芪甲苷检测质量浓度的线性范围为0.13~2.10 mg/mL;进样精密度、重复性、稳定性RSD均小于3%(n=6);平均加样回收率为97.66%(RSD=1.01%,n=6)。以此方法测得黄芪甲苷平均含量为0.398 mg/g(RSD=1.01%,n=3),较薄层扫描法偏差更小。特征指纹图谱比较结果显示,香菊颗粒、香菊胶囊、香菊片与原方干膏粉之间相似度均达0.850以上;香菊颗粒、香菊胶囊、香菊片和原方干膏粉在水中的黄芪甲苷平均释放度分别为0.392、0.358、0.349、0.389 mg;与原方干膏粉比较,香菊颗粒中黄芪甲苷的释放度差异无统计学意义(P>0.05),而香菊胶囊、香菊片中黄芪甲苷的释放度差异有统计学意义(P<0.01)。结论:所建立的HPLC-ELSD法准确、可行,可用于香菊颗粒中黄芪甲苷的含量测定;香菊颗粒与原方成分具有一致性。
ABSTRACT: OBJECTIVE:  To improve the method for the content determination of astragaloside Ⅳ in Xiangju granules, and to evaluate the consistency of relevant preparations with the components of original formulation, so as to provide evidence for the modern preparation of TCM compound. METHODS: HPLC-ELSD method was established for the content determination of astragaloside Ⅳ in Xiangju granules, and compared with original standard TLC scanning. Using critrinin, ferulic acid, calycosin glucoside, liquiritin, glycyrrhizic acid, rosmarinic acid, buddleoside and magnoline as control, HPLC method was used to determine the release components of self-made Xiangju granules, Xiangju capsules, Xiangju tablets in water. Fingerprint characteristics chromatogram of different Xiangju preparations and original formulation extract were compared by using Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 version). At the same time, HPLC-ELSD method was used to determine and compare the release rate of astragaloside Ⅳ from different Xiangju preparations and original formulation extract in water. RESULTS: Established HPLC-ELSD method was specific. The linear range of astragaloside Ⅳ was 0.13-2.10 mg/mL. RSDs of precision, repeatability and stability tests were all lower than 3% (n=6), and average recovery was 97.66% (RSD=1.01%,n=6). Average content of astragaloside Ⅳ by this method was 0.398 mg/g (RSD=1.01%, n=3), which had better reproducibility than TLC scanning. The comparative results of characteristic fingerprints showed that the similarity among Xiangju granules, Xiangju capsules, Xiangju tablets and the original formulation dry extract powder was more than 0.850. Average release rates of astragaloside Ⅳ in Xiangju granules, Xiangju capsules, Xiangju tablets and the original formulation extract were 0.392, 0.358, 0.349, 0.389 mg, respectively. Compared with original formulation extract, there was no statistical significance in release rate of astragaloside Ⅳ in Xiangju granules (P>0.05), while there was statistical significance in Xiangju capsules and Xiangju tablets (P<0.01). CONCLU- SIONS: Established HPLC-ELSD method is accurate and feasible, and is suitable for the content determination of astragaloside Ⅳ in Xiangju granules. The main components of Xiangju granules are consistent with original formulation.
期刊: 2019年第30卷第14期
作者: 孙晨曦,葛鼎,王素梅,郭康,王举涛
AUTHORS: SUN Chenxi,GE Ding,WANG Sumei,GUO Kang,WANG Jutao
关键字: 香菊颗粒;高效液相色谱-蒸发光散射法;黄芪甲苷;指纹图谱;含量测定;释放度;一致性
KEYWORDS: Xiangju granules; HPLC-ELSD; Astragaloside Ⅳ; Fingerprint; Content determination; Release rate; Consistency
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