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目的:建立牛黄清感胶囊内容物包衣粉末的定量控制标准。方法:采用高效液相色谱法在274nm处测定包衣粉末中黄芩苷的含量,十八烷基硅烷键合硅胶为填充剂;以甲醇:水:磷酸(40:60:0.2)为流动相;流速0.8ml/min。结果:包衣粉水分控制在2%以下,稳定性良好;黄芩苷含量控制在每粒含10mg以上,黄芩苷在46.88~140.6μg/ml浓度范围内与峰面积有良好线性关系,r=0.9998,回收率为98.9%,RSD为1.3%。结论:用此方法控制包衣粉的质量,操作简便、方法可靠,有良好重现性。
Objective: To establish a quantitative control standard for the content of bezoar capsule. Methods: The content of baicalin in the coating powder was determined by high performance liquid chromatography (HPLC) at 274 nm. Octadecylsilane bonded silica gel was used as the filler. The mobile phase consisted of methanol: water and phosphoric acid (40: 60: 0.2) Flow rate 0.8ml / min. Results: The content of baicalin was controlled below 2% and the content of baicalin was above 10mg. The linearity of baicalin with peak area was 46.88 ~ 140.6μg / ml, r = 0.9998 , The recovery rate was 98.9%, RSD was 1.3%. Conclusion: This method is used to control the quality of coated powder. The method is simple, reliable, and reproducible.