复方化瘀明目口服液的质量控制

Study on quality control of compound Huayu Mingmu oral liquid

目的：建立复方化瘀明目口服液的质量控制方法。方法：采用薄层色谱（TLC）法对方中的制何首乌、枸杞、丹参、赤芍进行定性鉴别,用高效液相色谱法（HPLC）对2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、丹酚酸B进行含量测定。结果：复方化瘀明目口服液中制何首乌、枸杞、丹参、赤芍的TLC斑点清晰,分离度良好,阴性无干扰;2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、丹酚酸B分别在1.264～15.17μg·ml^-1、5.730～68.76μg·ml^-1浓度范围内与峰面积呈良好的线性关系,平均回收率分别为100.52%、97.93%,RSD分别为1.77%、1.85%。结论：建立的质量控制方法简便、准确可靠,可用于复方化瘀明目口服液的质量控制。

OBJECTIVE To study the quality control of compound Huayu Mingmu oral liquid. METHODS TLC was adopted for the qualitative identification of Pol ygonum rnulti florum Thunb, L ycium barbarum L. , Salvia miltiorrhiza Bunge, Radix Paeoniae rubra. HPLC was used to determine the content of 2,3,5,4＇ tetrahydroxystilbene-2-O-β-D glucoside, salvianolic acid B. RESULTS TLC spots were clear and well separated without negative interference. The linear range of 2,3,5,4＇ tetra- hydroxystilbene-2-O-β-D-glucoside, salvianolic acid B was 1. 264 - 15.17 μg. mL^-1 , 5. 730 - 68. 76μg·mL^-1 , respectively. The average recoveries were 100. 52%, 97. 93% and RSDs were 1.77%, 1.85%, separately. CONCLUSION The method is simple, accurate and reliable, which can be used for the quality control of compound Huayu Mingmu oral liquid. KEY WORDS：compound Huayu Mingmu oral liquid; quality control; HPLC; TLC; 2,3,5,41-tetrahydroxystilbene-2-O-β-D glucoside; salvianolic acid B