首页|基于多指标成分定量的痛舒凝胶贴膏质量评价研究

基于多指标成分定量的痛舒凝胶贴膏质量评价研究

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目的 基于多指标成分TLC鉴别及HPLC定量分析评价痛舒凝胶贴膏质量.方法 采用TLC法对剂型改良后的痛舒凝胶贴膏中延胡索乙素、芍药苷、粉防己碱、乌药醚内酯以及苍术、枳壳进行定性鉴别;HPLC法测定该剂型中主要有效成分延胡索乙素、芍药苷、粉防己碱、乌药醚内酯的含量.结果 组方中6味药材TLC结果斑点清晰,显色良好且阴性无干扰.延胡索乙素、芍药苷、粉防己碱、乌药醚内酯分别在4.30～272.50 μg/mL(r=0.999 9)、21.10～1 350.00 μg/mL(r=0.999 8)、4.10～262.40 ng/mL(r=0.999 8)、3.60～232.50 μg/mL(r=0.998 6)的浓度范围内线性关系良好,平均加样回收率范围区间为98.96％～99.52％,RSD均≤ 1.54％(n=9).结论 所建立的多指标TLC定性鉴别及HPLC定量方法专属性高,操作简便易行,可用于该组方剂型改进后的质量评价.
Quality evaluation of Tongshu gel paste based on multi-index component quantification
Objective To evaluate the quality of Tongshu gel paste based on thin layer chromatography(TLC)identification and high performance liquid chromatography(HPLC)quantitative analysis of multi-index components.Methods Qualitative identification of tetrahydropalmatine,paeoniflorin,tetrandrine,linderane,Rhizoma atractylodis and Fructus aurantii in the modified Tongshu gel paste was carried out by TLC.The main active contents of tetrahydropalmatine,paeoniflorin,tetrandrine and linderane in the preparation were determined by HPLC.Results The TLC spots of the six herbs in the prescription were clear and negative without interference.The linear ranges of tetrahydropalmatine,paeoniflorin,tetrandrine and linderane were 4.30-272.50 μg/mL(r=0.999 9),21.10-1 350.00 μg/mL(r=0.999 8),4.10-262.40 μg/mL(r=0.999 8)and 3.60-232.50 μg/mL(r=0.998 6),respectively.The range of average recovery for each component was 98.96％-99.52％,and all RSDs were less than or equal to 1.54％(n=9).Conclusion The multi-index TLC qualitative identification and HPLC quantitative method established by research have high specificity,simple operation and can be used for quality evaluation of the improved formulation of this prescription.

Tongshu gel pasteThin layer chromatographyHigh performance liquid chromatographyQuality evaluation

管彤、杨雪、刘婧、于修沣、王艳宏

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黑龙江中医药大学药学院(哈尔滨 150040)

痛舒凝胶贴膏 薄层色谱法 高效液相色谱法 质量评价

国家自然科学基金面上项目

82074025

2024

10.12173/j.issn.1008-049X.202310044

中国药师
国家药品监督管理局高级研修学院,武汉医药（集团）股份有限公司

中国药师

CSTPCD
影响因子：0.944
ISSN：1008-049X
年,卷(期)：2024.27(1)
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