DUAN Songleng1 LIU Min2 LIU Libin3 LIU Junli4 Tian Jiayi4 ZENG Weixin1▲
1.Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China;
2.Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Clinical Rational Drug Use, Beijing 100038, China;
3.International Cooperation & Joint Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing 100038, China
Abstract：Objective To establish the quality standard of Mastitis Granules. Methods Paeoniflorin content in Mastitis Granules was determined by high performance liquid chromatography (HPLC). Agilent EClipse SB-C18 column (4.6 mm×250 mm, 5 μm) was used as the column, methanol-0.05 mol/L potassium dihydrogen phosphate solution (40∶60) was used as the mobile phase, the volume flow rate of 1.0 mL/min, with the detection wavelength of 230 nm. The colomn temperature maintained at 30℃. The injection volume was 10 μL. The identification of Cyperus rotundus L., Angelica sinensis and Paeoniae Radix Rubra in Mastitis Granules were determined by thin-layer chromatography (TLC). The limits of heavy metals and arsenic salts in Mastitis Granules were determined by heavy metal test method and arsenate test separately. Results The content of paeoniflorin was determined by HPLC. The paeoniflorin in the range of 5.01-501 μg/mL(r = 0.9996) showed a good linear relationship with the peak area. The average recovery rate was 99.92%, RSD = 1.26% (n = 6). The spots of TLC samples were clear and there was no negative interference, the limit tests of heavy metals and arsenic salts in Mastitis Granules were in accordance with the regulations. Conclusion The results of determination by HPLC are accurate, sensitive and reproducible. TLC method is simple and easy to operate, with short test period and clear and reliable results. The current pharmacopoeia method for heavy metals and arsenic salts can be used for the limit examination of heavy metals and arsenic salts in Mastitis Granules. The above methods provide a basis for establishing the treatment standard of Mastitis Granules.
段松冷1 刘敏2 刘礼斌3 刘俊丽4 田佳懿4 曾蔚欣1▲. 乳腺炎冲剂质量标准研究[J]. 中国医药导报, 2019, 16(36): 111-114.
DUAN Songleng1 LIU Min2 LIU Libin3 LIU Junli4 Tian Jiayi4 ZENG Weixin1▲. Study on quality standard of Mastitis Granules. 中国医药导报, 2019, 16(36): 111-114.
2019, Vol. 16 
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