安神解郁胶囊质量控制方法的研究

目的建立安神解郁胶囊定性、定量检测方法。方法采用薄层色谱（TLC）法鉴别方中酸枣仁、丹参、黄连、石菖蒲,采用高效液相色谱（HPLC）法测定酸枣仁皂苷A和B的含量。色谱条件：色谱柱为I nertsil ODS-SP（4.6 mm×250 mm,5μm）,流动相为乙腈-水（65∶35）,流速为1.0 mL/min,柱温30℃,漂移管温度为40℃,空气压力为340 kPa,检测器为蒸发光检测器。结果定性鉴别薄层色谱特征明显;HPLC法测得酸枣仁皂苷A和B的线性范围分别为0.516~10.320μg/mL（r=0.999 6）、0.248~4.970μg/mL（r=0.999 3）,平均加样回收率（n=6）分别为97.40%（RSD=1.20%）、95.97%（RSD=1.70%）。结论 TLC方法操作简单,结果可靠,重现性好,可有效地控制该制剂的质量。

Research of quality control standard for Anshenjieyu Capsule

Objective To establish the qualitative and quantitative methods for Anshenjieyu Capsule. Meth- ods Ziziphi Spinosa Semen, Salviae Miltiorrhizae Radix et Rhizoma, Coptidis Rhizoma and Acori Tatarinowii Rhizo- ma were identified by TLC. The content of Jujuboside A and Jujuboside B were determined by HPLC. HPLC method was performed on a Inertsil ODS-SP （4.6 mm×250mm, 5 μm） with the mobile phase of acetonitrile-water （65 ： 35） and flow rate of 1.0 mL/min. The column temperature was 30 ℃. The temperature of drift tube was 40 ℃. The air pressure was 340 kPa and evaporative light detector was used. Results Characteristics of qualitati- on identification were obvious. The linear ranges of Jujuboside A and Jujuboside B were 0. 516 - 10. 320 μg/mL （r=0.999 6） and 248 -4. 970μg/mL（r=0. 999 3）. The average recoveries （n=6） were 97.40% （RSD= 1.20% ） and 95.97% （RSD = 1.70% ） respectively. Conclusion The method is good reproducibility. It is accu- rate and suitable in controlling quality of Anshenjieyu Capsule availably.