| 摘要: |
| 目的：建立对疏肝止痛片中三种有效成分同时进行含量测定的高效液相色谱（HPLC）方法。方法：参照《中国药典》2015 版所载方法，建立了同时测定疏肝止痛片中芍药苷、橙皮苷和柴胡皂苷 B2 含量的 HPLC 方法并进行方法学验证。采用 WondaSil C18 色谱柱（4.6 mm×250 mm，5 μm），以 0.3% 磷酸水溶液（A）- 乙腈（B）为流动相进行梯度洗脱，柱温为 38 ℃，流速为 1.0 mL/min，检测波长分别为 230 nm（芍药苷）、254 nm（柴胡皂苷 B2）、283 nm（橙皮苷）。结果：实验结果表明，方法专属性良好、各组分的分离度良好；芍药苷、柴胡皂苷 B2、橙皮苷 3 个成分在相应的浓度范围内线性关系良好，相关系数（r）不小于 0.9990，精密度实验所算得相对标准偏差（RSD）值均小于 2% ；加样回收率在95%~105%。方法的重复性和稳定性均符合《中国药典》2015 版的要求。结论：经方法学验证，建立的同时测定疏肝止痛片中芍药苷、柴胡皂苷 B2、橙皮苷三种有效成分的 HPLC 方法符合《中华人民共和国药典》2015 年版（四部 9101）中药品质量标准分析方法验证指导原则的要求。所以，本方法可用于疏肝止痛片中芍药苷、柴胡皂苷 B2、橙皮苷三个成分的含量测定。 |
| 关键词: 疏肝止痛片 芍药苷 柴胡皂苷 橙皮苷 高效液相色谱 |
| DOI：10.3969/j.issn.1007-6948.2019.06.033 |
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| 基金项目:天津市中医药管理局中医中西医结合科研课题（2015024） |
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| Simultaneous Determination of Three Effective Components in Shugan Zhitong Tablets by HPLC |
| LV Yue,TANG Yong,LI Li-yan |
| Department of Pharmacy, Tianjin Nankai Hospital, Tianjin (300100), China |
| Abstract: |
| Objective To establish a method of HPLC for simultaneous determination of three effective components in Shugan Zhitong Tablets. Methods According to the methods contained in the 2015 edition of Chinese Pharmacopoeia, a method of HPLC for simultaneous determination of paeoniflorin, hesperidin and saikosaponin in Shugan Zhitong Tablets was established and verified by methodology. The determination was performed on WondaSil C18 column (4.6 mm×250 mm, 5 μm) with mobile phase consisted of 0.3% phosphoric acid aqueous solution (A)-acetonitrile (B). The column temperature was 38 ℃ , the flow rate was 1.0 mL/min, and the detection wavelengths were 230 nm (paeoniflorin), 254 nm (saikosaponin) and 283nm (hesperidin), respectively. Results The experimental results showed that the method had good specificity and the separation degree of each component was good. Paeoniflorin, saikosaponin and hesperidin had good linear relationship in the corresponding concentration range, the correlation coefficient (r) was not less than 0.9990, and the RSD calculated by precision experiment was less than 2%; the recovery rate of sample addition was in the range of 95%–105%. The repeatability and stability of the method met the requirements of the 2015 edition of Chinese Pharmacopoeia. Conclusion The established HPLC method for simultaneous determination of paeoniflorin, saikosaponin and hesperidin in Shugan Zhitong Tablets is verified by the method of prescription law, and meets the requirements of the verification guiding principles of drug quality standard analysis methods in the 2015 edition of Chinese Pharmacopoeia (4 parts 9101). Therefore, this method can be used to determine the content of paeoniflorin, saikosaponin and hesperidin in Shugan Zhitong Tablets. |
| Key words: S h u g a n Z h i t o n g Ta b l e t s paeoniflorin saikosaponin hesperidin HPLC |
