附子理中丸质量标准的改进与提升研究

Study on Improvement and Promotion of Quality Standard of Fuzi Lizhong Pills

关键词:  附子理中丸  薄层色谱  高效液相色谱法  质量标准  6-姜辣素  蜂蜜

Key words:  Fuzi Lizhong pills  TLC  HPLC  quality standard  6-gingerol  honey

摘要:

目的 改进和提升附子理中丸质量标准。方法 采用薄层色谱法对制剂中的干姜鉴别进行方法改进，增加党参药材和白术内酯Ⅰ和白术内酯Ⅲ定性鉴别；采用HPLC测定6-姜辣素和辅料蜂蜜中4种糖成分的含量。结果 TLC鉴别图谱斑点清晰、专属性强；6-姜辣素在0.04~0.30 mg呈良好的线性（r=0.998 6），平均回收率为99.43%，RSD为1.5%（n=9）；果糖、D-无水葡萄糖、蔗糖、麦芽糖线性范围分别为75.003 0~375.015 0 μg（r=1.000 0），80.001 5 ~ 400.007 5 μg（r=1.000 0），10.056 0~50.030 0 μg（r=0.999 3），10.055 0~50.275 0 μg（r=0.994 4）；平均加样回收率分别为100.03%，99.34%，94.66%，97.46%，RSD（n=9）分别为1.33%，1.42%，1.25%，0.46%。结论 改进和提升后的质量标准科学可行，可用于附子理中丸的质量控制。

Abstract:

OBJECTIVE To improve and upgrad the quality standard of Fuzi Lizhong pills. METHODS TLC was used for improving qualitative identification of dried ginger in the preparation, adding qualitative identification of codonopsis, and alabaster Ⅰ and alabaster Ⅲ from Baizhu. The contents of 6-gingerol in Zingiberis Rhizoma and 4 kinds of sugar components in honey were determined by HPLC. RESULTS The TLC Chart showed clear spots and strong specificity. The 6-gingerol showed a good linear relationship in the linear range of 0.04-0.30 mg(r=0.998 6), the average recovery rate was 99.43%, and RSD was 1.5%(n=9). The calibration curves of fructose, D-anhydrous glucose, sucrose, maltose showed a good linear relationship over the range of 75.003 0-375.015 0 μg(r=1.000 0), 80.001 5-400.007 5 μg(r=1.000 0), 10.056 0-50.030 0 μg(r=0.999 3), 10.055 0-50.275 0 μg (r=0.994 4). The average recovery rate were 100.03%, 99.34%, 94.66%, 97.46% with RSD of 1.33%, 1.42%, 1.25%, 0.46%. CONCLUSION The improved and upgraded quality standard is scientific and feasible, and can be used for the quality control of Fuzi Lizhong pills.