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妇科再造丸的体外溶出度测定
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| 篇名： | 妇科再造丸的体外溶出度测定 |
| TITLE： | |
| 摘要： | 目的：建立测定妇科再造丸体外溶出度的方法。方法：采用高效液相色谱法测定制剂中黄芩苷和橙皮苷的含量，色谱柱为WondaSil-C18，流动相为0.2％甲酸溶液-乙腈（梯度洗脱），流速为1.0 mL/min，检测波长为280 nm，柱温为30 ℃，进样量为10 μL；采用桨法测定制剂的累积溶出度，溶出介质为磷酸盐缓冲液（pH 6.8），转速为100 r/min，温度为（37±0.5）℃，取样量为2 mL。结果：黄芩苷和橙皮苷检测质量浓度线性范围分别为6.936～23.12 μg/mL（r＝0.999 8）、0.620～3.10 μg/mL（r＝0.999 0）；定量限分别为4.624、0.620 μg/mL，检测限分别为2.312、0.155 μg/mL；精密度、稳定性、重复性试验的RSD均小于2％；加样回收率分别为95.28％～99.22％（RSD＝0.97％，n＝9）、96.10％～99.84％（RSD＝1.98％，n＝9）。样品中黄芩苷和橙皮苷10 h时的平均累积溶出度分别为（97.10±0.09）％、（78.50±0.08）％；溶出63.2％所需时间（TD）分别为（1.88±0.12）、（3.26±0.10）h，溶出50％所需时间（T50）分别为（0.88±0.09）、（1.67±0.14）h。结论：该方法操作简便、准确，可用于妇科再造丸的体外溶出度测定。 |
| ABSTRACT： | OBJECTIVE： To establish a method for the determination of in vitro dissolution of Fuke zaizao pills. METHODS： HPLC method was adopted to determine the contents of baicalin and hesperidin in preparation. The determination was performed on WondaSil-C18 column with mobile phase consisted of 0.2％ formic acid-acetonitrile （gradient elution） at the flow rate of 1.0 mL/min. The detection wavelength was set at 280 nm， and column temperature was 30 ℃. The sample size was 10 μL. The dissolution of the preparation was determined by paddle method using phosphate buffer solution （pH 6.8） as dissolution medium with rotate speed of 100 r/min，temperature was （37±0.5）℃， sample size was 2 mL. RESULTS： The linear range of baicalin and hesperidin were 6.936-23.12 μg/mL （r＝0.999 8） and 0.620-3.10 μg/mL （r＝0.999 0）， respectively. Limits of quantitation were 4.624， 0.620 μg/mL， limits of detection were 2.312， 0.155 μg/mL， respectively. RSDs of precision， stability and repeatability tests were all lower than 2％； the recoveries were 95.28％-99.22％ （RSD＝0.97％，n＝9） and 96.10％-99.84％ （RSD＝1.98％，n＝9）， respectively. The accumulative dissolution rates of baicalin and hesperidin in sample were （97.10±0.09）％ and （78.50±0.08）％ at 10 h， respectively. TD were （1.88±0.12）、（3.26±0.10）h，T50 were （0.88±0.09）、（1.67±0.14）h， respectively. CONCLUSIONS： The method is simple and accurate， and can be used for the determination of in vitro dissolution of Fuke zaizao pills. |
| 期刊： | 2018年第29卷第18期 |
| 作者： | 郑晓霞，徐剑，田洪星，胡蝶，刘慧 |
| AUTHORS： | ZHENG Xiaoxia，XU Jian，TIAN Hongxing，HU Die，LIU Hui |
| 关键字： | 妇科再造丸；桨法；体外溶出度 |
| KEYWORDS： | Fuke zaizao pill； Paddle method； in vitro dissolution rate |
| 阅读数： | 311 次 |
| 本月下载数： | 3 次 |
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