| 汪安,程桂林,蒲婧哲,等.小儿珍贝散质量标准提升研究[J].安徽医药,2022,26(6):1094-1098. |
| 小儿珍贝散质量标准提升研究 |
| Improvment of quality standard of Xiaoerzhenbei powder |
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| DOI：10.3969/j.issn.1009-6469.2022.06.007 |
| 中文关键词: 中草药 质量控制 胆红素 小儿珍贝散 色谱法，薄层 色谱法，高压液相 质量标准 人工牛黄 胆南星 沉香 |
| 英文关键词: Drugs, Chinese herbal Quality control Bilirubin Xiaoerzhenbei powder Chromatography, thin layer Chromatography, high pressure liquid Quality standard Artificial cow-bezoar Cholanacin Aloes |
| 基金项目:安徽省自然科学基金项目( 2108085MB63) |
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| 中文摘要: |
| 目的从显微鉴别、薄层鉴别、含量测定 3个方面，对小儿珍贝散标准进行完善与提高。方法该研究起止时间为 2020年 1—10月。采用显微鉴别方法对珍珠、川贝母、沉香进行定性鉴别；采用薄层色谱法( TLC)，对人工牛黄、沉香、川贝母进行定性鉴别；采用高效液相色谱法( HPLC)，以胆红素作为质控指标，进行含量测定。结果薄层色谱法能有效地鉴别小儿珍贝散中的人工牛黄、沉香、川贝母，阴性无干扰；胆红素在 0.004~0.160 μg范围内线性关系良好，回归方程为 Y=31 476X? |
| 英文摘要: |
| Objective To improve the standard of Xiaoerzhenbei powder from three aspects: microscopic identification, thin-layer identification, and content determination.Methods This study lasted from January 2020 to October 2020. Microscopic identificationmethods were used to qualitatively identify pearl, Fritillaria cirrhosa and Agarwood; thin layer chromatography (TLC) was used to qualitatively identify artificial bezoar, agarwood and Fritillaria cirrhosa; high performance liquid method (HPLC) was employed for contentdetermination, with bilirubin as a quality control index .Results TLC could effectively identify the artificial bezoar, agarwood, and Fritillaria in Xiaoerzhenbei powder, negative without interference; bilirubin had a good linear relationship in the range of 0.004~0.160μg,and the regression equation was Y=31 476X?984.42. The average recovery was 102.78%, and the relative standard deviation (RSD)was 1.2%. The mean content of 17 batches of bilirubin was 0.548 4 mg/g.Conclusions The newly established quality standard has increased the quality control research of pearl, artificial bezoar, fritillaria cirrhosa and agarwood in the prescription. The experimentalmethod is accurate and reliable, simple and fast, and has good applicability. It can be used for the quality control and quality evaluationof the preparation. |
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