红景天制剂的标准化问题。

V. Kurkin, T. Ryazanova
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Experimental and industrial samples of liquid extract from Rhodiola rosea L. roots, as well as reference samples of rosavin and salidroside, were used as materials of the research. The HPLC analysis was carried out using a Milichrom-6 chromatograph (NPAO Nauchpribor) under the following conditions of reversed-phase chromatography in an isocratic mode: a steel column KAKH-6-80-4 (2 mm x 80 mm; Separon-C18 7 μm), a mobile phase – acetonitrile: 1% solution of acetic acid in water in the ratio of 14:86, the elution rate was 100 μL/min, the eluent volume was 2000 μL. The constituents were detected at the wavelength of 252 nm (rosavin) and 278 nm (salidroside).Results. An assay of rosavin and salidroside in the liquid extract of Rhodiola rosea L. was developed using the HPLC method. It was determined that the content of rosavin in the samples of the liquid extracts obtained from Rhodiola rosea L. rhizomes and roots of the pharmacopoeial quality, varied from 0.21%±0.03% to 0.32%±0.04%, salidroside – from 1.13% ±0.05% to 2.71%±0.12%, respectively. The results of statistical processing indicate that the relative error of the average result for the determination of rosavin and salidroside in the preparations of Rhodiola rosea L. with a confidence level of 95% does not exceed ±6.0%.Conclusion. Thus, methodological approaches to the analysis of medicinal preparations from Rhodiola rosea L. rhizomes and roots have been substantiated. 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引用次数: 2

摘要

红景天根茎和根是药典原料,在官方药物中用于获得具有适应活性的药物。从红景天根茎和根中生产药物的最常见问题之一是使用质量差的药用植物材料,这导致制剂中缺乏具有生物学意义的化合物。其中一个可能的原因是现有方法对红景天原料和制剂的标准化存在不足。本研究的目的是改进红景天根茎制剂和根茎制剂的标准化方法。材料和方法。以红景天根提取液的实验样品和工业样品,以及红景天苷和红景天苷的参比样品为研究材料。HPLC分析采用milichrome -6色谱仪(NPAO Nauchpribor),反相色谱条件为:钢柱KAKH-6-80-4 (2 mm x 80 mm;分离- c18 7 μm),流动相-乙腈:1%醋酸水溶液,比为14:86,洗脱速率为100 μL/min,洗脱液体积为2000 μL。在波长为252 nm(红景天苷)和278 nm(红景天苷)处检出。采用高效液相色谱法测定了红景天液体提取物中红景天苷和红景天苷的含量。测定得到的红景天根茎和根茎液体提取物样品中,红景天苷的含量分别为0.21%±0.03% ~ 0.32%±0.04%,红景天苷的含量分别为1.13%±0.05% ~ 2.71%±0.12%。统计处理结果表明,测定红景天制剂中红景天苷和红景天苷含量的平均结果相对误差不超过±6.0%,置信水平为95%。因此,分析红景天根茎和根茎药用制剂的方法学方法得到了证实。这些方法学方法包括定量测定主要和诊断意义显著的生物活性化合物-红景天苷和红景天苷。
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STANDARDIZATION PROBLEMS OF MEDICINAL PREPARATIONS FROM RHODIOLA ROSEA L.
Rhodiola rosea L. rhizomes and roots are pharmacopoeial raw materials, which are used in official medicine for obtaining medicines with adaptogenic activity. One of the most common problems in the production of medicines from Rhodiola rosea L. rhizomes and roots is the use of poor quality medicinal plant materials, which leads to the absence of biologically significant compounds in the preparations. One of the possible reasons is the shortcomings in the existing approaches to the standardization of Rhodiola rosea L. raw materials and preparations.The aim of the study is the improvement of approaches to the standardization of medicinal preparations from Rhodiola rosea L. rhizomes and roots.Materials and methods. Experimental and industrial samples of liquid extract from Rhodiola rosea L. roots, as well as reference samples of rosavin and salidroside, were used as materials of the research. The HPLC analysis was carried out using a Milichrom-6 chromatograph (NPAO Nauchpribor) under the following conditions of reversed-phase chromatography in an isocratic mode: a steel column KAKH-6-80-4 (2 mm x 80 mm; Separon-C18 7 μm), a mobile phase – acetonitrile: 1% solution of acetic acid in water in the ratio of 14:86, the elution rate was 100 μL/min, the eluent volume was 2000 μL. The constituents were detected at the wavelength of 252 nm (rosavin) and 278 nm (salidroside).Results. An assay of rosavin and salidroside in the liquid extract of Rhodiola rosea L. was developed using the HPLC method. It was determined that the content of rosavin in the samples of the liquid extracts obtained from Rhodiola rosea L. rhizomes and roots of the pharmacopoeial quality, varied from 0.21%±0.03% to 0.32%±0.04%, salidroside – from 1.13% ±0.05% to 2.71%±0.12%, respectively. The results of statistical processing indicate that the relative error of the average result for the determination of rosavin and salidroside in the preparations of Rhodiola rosea L. with a confidence level of 95% does not exceed ±6.0%.Conclusion. Thus, methodological approaches to the analysis of medicinal preparations from Rhodiola rosea L. rhizomes and roots have been substantiated. These methodological approaches consist of the quantitative determination of the dominant and diagnostically significant biologically active compounds – rosavin and salidroside.
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