目的:制备复方积雪草苷凝胶,并建立其质量控制方法。方法:以卡波姆-940为凝胶的主要基质,建立酸碱度、卫生学、含量测定等质量控制方法,并进行刺激性实验、高速离心实验、耐热耐寒实验和室温留样观察等。采用高效液相色谱法,选用HypersilODS柱(250 mm×4.6 mm,5μm),甲醇-水(58∶42)为流动相,检测波长为205 nm,柱温为35℃,流速为1.0 mL.m in-1,测定复方积雪草苷凝胶中积雪草苷的含量。结果:复方积雪草苷溶液pH值为6.5~7.0,卫生学检查符合规定,积雪草苷浓度在0.05~0.9 mg.mL-1范围内峰面积与浓度呈良好线性关系(r=0.999 7),平均回收率为99.05%,RSD为0.62%。结论:该凝胶剂制备工艺简单,质量稳定,质量控制方法准确可靠。 Objective: To prepare compound asiaticoside gel and establish its quality control method. Methods: Carbomer-940 was used as the main matrix of the gel to establish quality control methods of pH, hygiene and content determination. The stimulating experiments, high-speed centrifugation experiments, heat-resistant and cold-tolerant experiments and observation of room-temperature samples were also conducted. Hypersil ODS column (250 mm × 4.6 mm, 5 μm) and methanol-water (58:42) were used as the mobile phase at a detection wavelength of 205 nm with a column temperature of 35 ℃ and a flow rate of 1.0 mL · m in-1, the content of asiaticoside in compound asiaticoside gel was determined. Results: Asiaticoside solution had a pH value of 6.5-7.0. Hygienic examination was in accordance with regulations. There was a good linear relationship between the peak area and the concentration of asiaticoside at a concentration range of 0.05-0.9 mg.mL-1 (r = 0.999 7 ), The average recovery was 99.05%, RSD was 0.62%. Conclusion: The gel preparation process is simple, stable quality, accurate and reliable quality control methods.