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目的:建立降黏胶囊的质量标准。方法:用TLC法对水蛭和地龙进行定性鉴别;用HPLC法测定丹参素、大黄素、丹参酮Ⅱ_A的含量。结果:薄层色谱图斑点清晰,阴性对照无干扰;丹参素钠、大黄素、丹参酮Ⅱ_A分别在18.12~543.60μg·ml~(-1)(r=0.999 6),4.86~145.92μg·ml~(-1)(r=0.999 8),8.99~269.58μg·ml~(-1)(r=0.999 4)范围内与峰面积呈良好线性关系,平均回收率分别为99.76%(RSD=0.71%,n=9),100.04%(RSD=1.48%,n=9),100.13%(RSD=1.16%,n=9)。结论:本方法简便、可靠、准确,可用于该制剂的质量控制。
Objective: To establish the quality standard of viscosity reducing capsule. Methods: TLC and HPLC were used to qualitatively identify leech and earthworm. The contents of danshensu, emodin and tanshinone Ⅱ_A were determined by HPLC. Results: The spots of the TLC were clear and the negative controls had no interference. The contents of sodium danshensu, emodin and tanshinone Ⅱ_A were 18.12 ~ 543.60μg · ml -1 (r = 0.999 6), 4.86 ~ 145.92μg · ml ~ (R = 0.999 8), and the peak area was linear with the range of 8.99-269.58 μg · ml -1 (r = 0.999 4). The average recoveries were 99.76% (RSD = 0.71% , n = 9), 100.04% (RSD = 1.48%, n = 9), 100.13% (RSD = 1.16%, n = 9). Conclusion: The method is simple, reliable and accurate and can be used for the quality control of the preparation.