痔疮外用熏洗剂制备及质量控制

Preparation and Quality Control of External Use Fumigant for Hemorrhoids

[目的]制备痔疮中药外用熏洗剂并制定质量控制标准。[方法]采用Thermo Syncronis C18(4.6×250mm,5μm)、Agilent ZORBAX SB-AQ(4.6×250mm,5μm)、SPOLAR C18(4.6×250mm,5μm);柱温:40℃;检测波长:280nm;流动相:甲醇-水-磷酸(45:55:0.2);流速:1.0mL/min。[结果]黄芩苷RSD=2.81%,供试品溶液在4h内稳定;苦参碱RSD=0.91%。黄芩苷平均含量为2.626mg/mL,RSD=1.96%,苦参碱为0.22mg/mL,RSD为1.8%。外观性状、pH值、相对密度、高效液相色谱等均无明显变化,均符合规定。黄芩苷RSD=2.40%;苦参碱RSD=1.80%。[结论]现代制药工艺研制工艺简单,组方合理,值得推广。

[Objective] To prepare external use fumigation lotion for hemorrhoids and formulate quality control standards. [Method] Thermo Syncronis C18（4.6×250 mm, 5 micron）, Agilent ZORBAX SB-AQ（4.6×250 mm,5 micron）, SPOLAR C18（4.6×250 mm, 5 micron）;Column temperature： 40 C; detection wavelength： 280 nm; mobile phase： methanol-water-phosphoric acid（45：55：0.2）; flow rate： 1.0 mL/min. [Results] Baicalin RSD=2.81% was stable in 4 H solution, matrine RSD=0.91%. The average content of baicalin was 2.626 mg/mL, RSD=1.96%, matrine was 0.22 mg/mL, RSD was 1.8%. Appearance, pH, relative density and high performance liquid chromatography showed no significant change, which all met the requirements. Baicalin RSD=2.40%; matrine RSD=1.80%. [Conclusion] the modern pharmaceutical technology is simple and reasonable, and is worthy of promotion.