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西帕依麦孜彼子口服液的质量标准提高研究
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| 篇名： | 西帕依麦孜彼子口服液的质量标准提高研究 |
| TITLE： | |
| 摘要： | 目的：提高西帕依麦孜彼子口服液的质量标准。方法：采用薄层色谱法（TLC）对制剂中栀子、芡实、绵萆薢、金樱子和桑椹药材进行定性鉴别。采用高效液相色谱法测定制剂中栀子苷的含量，色谱柱为Waters Cosmosil C18，流动相为甲醇-水（梯度洗脱），流速为1.0 mL/min，检测波长为240 nm，柱温为30 ℃，进样量为10 μL。 结果：栀子、芡实、绵萆薢、金樱子和桑椹药材的TLC图斑点清晰，分离度好，阴性对照无干扰。栀子苷检测质量浓度线性范围为9.9～198.0 μg/mL（r＝0.999 9）；定量限为9.9 μg/mL；加样回收率为97.30％～101.09％（RSD＝1.35％，n＝6）；中间精密度、稳定性、重复性试验的RSD均小于2％；耐用性试验的RSD均小于2％。结论：该研究所建标准可用于西帕依麦孜彼子口服液的质量控制。 |
| ABSTRACT： | OBJECTIVE： To improve the quality standard of Xipayi mzibizi oral liquid. METHODS： TLC was used to identify Gardenia jasminoides，Euryale ferox， Dioscoreae Spongiosae Rhizoma， Rosa laevigata， Morus alba， qualitatively. The content of geniposide in the preparation was determined by HPLC. The determination was performed on Waters Cosmosil C18 column with mobile phase consisted of methanol-water （gradient elution） at the flow rate of 1.0 mL/min. The detection wavelength was set at 240 nm， and column temperature was 30 ℃. The sample size was 10 μL. RESULTS： TLC spots of G. jasminoides，E. ferox， Dioscoreae Spongiosae Rhizoma，R. laevigata， M. alba were clear and well-separated without interference from negative control. The linear range of geniposide were 9.9～198.0 μg/mL （r＝0.999 9）. The limit of quantitation was 9.9 μg/mL； the recoveries were 97.30％-101.09％ （RSD＝1.35％， n＝6）. RSDs of inter-precision， stability and reproducibility tests were all lower than 2％. RSDs of durability tests were lower than 2％. CONCLUSIONS： Established standard can be used for quality control of Xipayi mzibizi oral liquid. |
| 期刊： | 2018年第29卷第16期 |
| 作者： | 戎晓娟，康雨彤，贺金华，贺晓帆，王增慧 |
| AUTHORS： | RONG Xiaojuan，KANG Yutong，HE Jinhua，HE Xiaofan，WANG Zenghui |
| 关键字： | 西帕依麦孜彼子口服液； 薄层色谱法；高效液相色谱法；含量测定；栀子苷 |
| KEYWORDS： | Xipayi mzibizi oral liquid； TLC； HPLC； Content determination； Geniposide |
| 阅读数： | 341 次 |
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