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目的:建立双黄消炎胶囊的质量控制方法。方法:采用薄层色谱法对制剂中三颗针和黄芩进行定性鉴别;对双黄消炎胶囊进行水分、装量差异、崩解时限、微生物限度、重金属及砷盐检查;采用高效液相法测定胶囊中黄芩苷和盐酸小檗碱的含量。结果:TCL鉴别出与黄芩苷、盐酸小檗碱对照品相对应的斑点。所有检查项均符合药典规定。HPLC法测定黄芩苷线性范围为6.8～40.8μg.mL-1(r=0.999 6,n=6),平均回收率为97.84%(RSD=0.49%);盐酸小檗碱线性范围为13.8～82.7μg.mL-1(r=0.999 4,n=6),平均回收率为98.07%(RSD=0.72%)。结论:本方法准确可靠,重现性好,可用于控制双黄消炎胶囊的质量。
Objective: To establish a quality control method of Shuanghuang anti-inflammatory capsule. Methods: TLC and TLC were used to qualitatively identify the three needles and Scutellaria baicalensis Georgi. The Shuanghuang anti-inflammatory capsule was tested for water content, loading capacity, disintegration time, microbial limit, heavy metal and arsenic salt. Capsule baicalin and berberine content. Results: TCL identified spots corresponding to baicalin and berberine hydrochloride reference standard. All check items are in accordance with Pharmacopoeia regulations. The linear range of baicalin was 6.8 ~ 40.8μg.mL-1 (r = 0.999 6, n = 6) with an average recovery of 97.84% (RSD = 0.49%). The linear range of berberine hydrochloride was 13.8 ~ 82.7 μg.mL-1 (r = 0.999 4, n = 6) with an average recovery of 98.07% (RSD = 0.72%). Conclusion: This method is accurate and reliable, reproducible, and can be used to control the quality of Shuanghuang anti-inflammatory capsule.