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| Study on quality standard of Qizhen Jiangtang Granules |
| QIAN Cheng1,2,3 DING Liyu4 WANG Huanqing4 ZHANG Dan5 WU Fei1,2 FENG Yi1,2 |
1.Innovative Research Institute of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;
2.Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine, Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China;
3.Department of Pharmacy, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China;
4.Department of Pharmacy, Yueyang Hospital of Integrative Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China;
5.Department of Endocrinology, Yueyang Hospital of Integrative Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China |
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Abstract Objective To establish the quality standard for Qizhen Jiangtang Granules. Methods Astragali Radix were identified by thin layer chromatography (TLC). The contents of citric acid and specnuezhenide were determined by high performance liquid chromatography (HPLC). The columns were Agilent ZORBAX SB-Aq （4.6 mm×250 mm, 5 μm） and Kromasil 100-5 C18 (4.6 mm×250 mm, 5 μm) with 0.1%phosphoric acid-water、methanol-water（36∶64）as the mobile phases, the flow rate was 1.0 mL/min, the detection wavelengths were 210 nm, 224 nm, the column temperature was 30℃ and the injection volumes were 5.0, 10.0 μL. Results TLC spots of Astragali Radix were clear with good resolution and without interference of negative samples. HPLC showed that the citric acid and specnuezhenide had good linear relationship with peak area in the range of 0.098 28-24.57 μg (r = 1.0000) and 0.022 08-11.04 μg (r = 1.0000) respectively. The average sample recovery rates were 100.18%, 96.08% (n = 9), and the RSD were 2.3% and 2.8%, respectively. The average contents of citric acid and specnuezhenide were 46.9, 1.02 mg/g, respectively. Considering comprehensively, the contents of citric acid and specnuezhenide in each bag is not less than 400 mg and 12 mg respectively. Conclusion The method is accurate, simple and reproducible, and can control the quality of Qizhen Jiangtang Granules.
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