玉竹咽炎颗粒的质量标准研究

doi:10.5246/jcps.2026.07.049

摘要/Abstract

摘要：

为建立玉竹咽炎颗粒的质量标准，采用薄层色谱法(TLC)对制剂中甘草、玄参和北豆根进行定性鉴别，并用高效液相色谱法(HPLC)测定玉竹咽炎颗粒中蒙花苷的含量。其中HPLC条件为色谱柱: Kromasil C₁₈ (4.6 mm × 250 mm, 5 μm); 流动相: 甲醇–1%醋酸溶液(49:51, v/v)，检测波长: 334 nm，柱温: 30 °C，流速: 1.0 mL/min，进样量为10 µL。结果表明甘草、玄参和北豆根的TLC斑点清晰，且阴性对照无干扰。蒙花苷在进样量0.0087–0.4344 µg范围内与其峰面积有良好的线性关系(n = 6)，相关系数r = 0.9999，精密度、稳定性、重现性试验结果的RSD均小于2.0% (n = 6); 该法平均回收率100.8%，RSD为1.50% (n = 9)，三批玉竹咽炎颗粒中蒙花苷平均含量为0.28 mg/g (n = 3)。玉竹咽炎颗粒中蒙花苷的含量应不低于0.22 mg/g。综上，本研究建立了一种操作简便，专属性强，稳定可靠且重现性良好的检测方法，可用于玉竹咽炎颗粒的质量控制。

关键词: 玉竹咽炎颗粒, 薄层色谱法, 含量测定, 质量标准, 蒙花苷

Abstract:

To establish a robust quality control standard for Yuzhu pharyngitis granules, thin-layer chromatography (TLC) was employed for the qualitative identification of Glycyrrhizae Radix et Rhizoma, Scrophulariae Radix, and Menispermi Rhizoma, while high-performance liquid chromatography (HPLC) was utilized for the quantitative determination of buddleoside. Chromatographic separation was achieved on an Agilent 1260 system equipped with a Kromasil C₁₈ column (4.6 mm × 250 mm, 5 μm). The mobile phase consisted of methanol and 1% acetic acid solution (49:51, v/v), delivered at a flow rate of 1.0 mL/min. Detection was performed at a wavelength of 334 nm, with the column temperature maintained at 30 °C and an injection volume of 10 µL. The TLC profiles of Glycyrrhizae Radix et Rhizoma, Scrophulariae Radix, and Menispermi Rhizoma exhibited distinct, well-resolved spots without interference from the negative control, indicating high specificity of the method. The calibration curve for buddleoside demonstrated excellent linearity over the range of 0.0087–0.4344 µg (n = 6), with a correlation coefficient (r) of 0.9999. The relative standard deviations (RSDs) for precision, stability, and repeatability were all below 2.0% (n = 6), confirming the method’s reliability. The average recovery was 100.8% with an RSD of 1.5% (n = 9), reflecting high accuracy. Analysis of three independent batches yielded a mean buddleoside content of 0.28 mg/g (n = 3), and it was recommended that the content in Yuzhu pharyngitis granules should not be less than 0.22 mg/g. Overall, the established method demonstrated excellent stability, accuracy, and reproducibility, and was therefore suitable for application as a standardized quality control protocol for Yuzhu pharyngitis granules.

Key words: Yuzhu pharyngitis granules, TLC, Content determination, Quality standard, Buddleoside

Supporting:

彭军, 蔡立文, 张彬, 凌云. 玉竹咽炎颗粒的质量标准研究[J]. 中国药学(英文版), 2026, 35(7): 681-689.

Jun Peng, Liwen Cai, Bin Zhang, Yun Ling. Study on the quality standard of Yuzhu pharyngitis granules[J]. Journal of Chinese Pharmaceutical Sciences, 2026, 35(7): 681-689.

图/表 7

Figure 1. TLC identification of Glycyrrhizae Radix et Rhizoma. Spot 1, 3, 5: Yuzhu pharyngitis granules (Batch Nos. 20240701, 20240702, 20240703); Spot 2: Negative control; Spot 4: Glycyrrhizae Radix et Rhizoma reference standard.

Figure 2. TLC identification of Scrophulariae Radix. Spot 1, 3, 5: Yuzhu pharyngitis granules (Batch Nos. 20240701, 20240702, 20240703); Spot 2: Negative control; Spot 4: Scrophulariae Radix reference standard.

Figure 3. TLC identification of Menispermi Rhizoma. Spot 1, 3, 5: Yuzhu pharyngitis granules (Batch Nos. 20240701, 20240702, 20240703); Spot 2: Menispermi Rhizoma reference standard; Spot 4: Negative control.

Figure 4. Linear relationship of buddleoside (n = 6).

Figure 5. Chromatograms of the specificity test. (A) Negative control solution; (B) Reference solution; (C) Test solution.

Table 1. Recovery rate test of buddleoside (n = 9).

Table 2. Content of buddleoside in Yuzhu pharyngitis granules (n = 3).

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