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香砂和中丸的质量标准改进研究
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| 篇名： | 香砂和中丸的质量标准改进研究 |
| TITLE： | Study on Quality Standard Improvement for Xiangsha Hezhong Pills |
| 摘要： | 目的：提高香砂和中丸的药品质量标准。方法：在香砂和中丸原质量标准的基础上，修订性状观察和显微鉴定项目；建立组方药材姜厚朴、广藿香、苍术（土炒）的薄层色谱法（TLC）鉴定方法；建立橙皮苷、厚朴酚、和厚朴酚的高效液相色谱法（HPLC）含量测定方法。结果：香砂和中丸的外观性状描述修改为“黄棕色或棕褐色的水丸”。对显微鉴别项目的表述进行了少量调整。姜厚朴、广藿香、苍术（土炒）的TLC图谱均与相应的对照品或对照药材在相同位置上显现相同颜色的斑点，且阴性样品无干扰。HPLC法采用色谱柱为PhenomenexLunaC18柱，柱温为30℃，流动相分别为甲醇-水（40∶60，V/V，橙皮苷）、乙腈-1％冰醋酸（52∶48，V/V，厚朴酚、和厚朴酚），流速为1.0mL/min，检测波长分别为284nm（橙皮苷）、294nm（厚朴酚、和厚朴酚）。橙皮苷、厚朴酚、和厚朴酚进样量分别在0.2018～2.018、0.0357～0.3574、0.0282～0.2824μg范围内线性关系良好（r均为0.9999）；检测限分别为2.0、0.72、0.45ng，定量限分别为7.0、2.45、1.61ng；精密度、重复性、稳定性、耐用性试验的RSD均小于3％；平均回收率分别为99.92％、100.49％、102.08％，RSD均小于3％。结论：本研究在香砂和中丸原质量标准基础上修订了性状观察、显微鉴别项目的表述，增加了姜厚朴、苍术（土炒）、广藿香的TLC鉴别方法，并采用HPLC法测定了橙皮苷、厚朴酚、和厚朴酚的含量，能够有效地提高该制剂的质量控制标准。 |
| ABSTRACT： | OBJECTIVE：To improve the quality standard of Xiangsha hezhong pills. METHODS ：Based on previous quality standard of Xiangsha hezhong pills ，the items of property observation and microscopic identification were revised. TLC identification methods were established for ginger-processed Magnolia officinalis ，Pogostemon cablin and Atractylodes Lancea （stir-fried with earth ）. HPLC methods were adopted for contents determination of hesperidin ，magnolol and honokiol. RESULTS ： The description of the appearance of Xiangsha hezhong pills should be modified to “yellow brown or brown water pill ”. The description of microscopical identification was adjusted slightly. TLC chromatogram of ginger-processed M. officinalis ，P. cablin and Atractylodes Lancea （stir-fried with earth ）all showed the same color spots in the same position as the corresponding substance control or reference medicinal material ，and the negative samples had no interference. The contents determination were performed on Phenomenex Luna C 18 column with mobile phase consisted of methanol-water （40 ∶ 60，V/V，hesperidin）or acetonitrile- 1％ glacial acetic acid （52∶48，V/V，magnolol and honokiol ）at the flow rate of 1.0 mL/min. The column temperature was 30 ℃. The detection wavelengths were set at 284 nm（hesperidin）or 294 nm（magnolol and honokiol ）. The linear ranges of hesperidin ， magnolol and honokiol were 0.201 8-2.018 μg，0.035 7-0.357 4 μg and 0.028 2-0.282 4 μg（all r＝0.999 9）. The detection limits were 2.0，0.72，0.45 ng；the limits of quantitation were 7.0，2.45，1.61 ng. RSDs of precision ，reproducibility，stability and durability tests were all lower than 3％. The average recoveries were 99.92％，100.49％ and 102.08％（all RSD ＜3％）. CONCLUSIONS ：The study verifies the description of character observation and microscopical identification ，adds TLC identification methods for ginger-processed M. officinalis ，P. cablin and Atractylodes Lancea （stir-fried with earth ）based on previous quality standard of Xiangsha hezhong pills. HPLC methods were adopted to determine the contents of hesperidin ，magnolol and honokiol ，and can effectively improve the quality control standard of the preparation. |
| 期刊： | 2020年第31卷第02期 |
| 作者： | 王晓伟，王艳伟，王海波，宋汉敏，刘瑞新，石岩 |
| AUTHORS： | WANG Xiaowei ，WANG Yanwei ，WANG Haibo，SONG Hanmin ，LIU Ruixin ，SHI Yan |
| 关键字： | 香砂和中丸；鉴别；含量测定；薄层色谱法；高效液相色谱法；质量标准 |
| KEYWORDS： | Xiangsha hezhong pills ；Identification；Content determination ；TLC；HPLC；Quality standard |
| 阅读数： | 266 次 |
| 本月下载数： | 9 次 |
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