Study on the improvement of quality standard for Niushanggui capsules
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Study on the improvement of quality standard for Niushanggui capsules
China PharmacyVol. 33, Issue 6, (2022)
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Published:2022,
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HUANG Ping, FENG Youlong, ZHOU Juanjuan, et al. Study on the improvement of quality standard for Niushanggui capsules. [J]. China Pharmacy 33(6).(2022)
DOI:
HUANG Ping, FENG Youlong, ZHOU Juanjuan, et al. Study on the improvement of quality standard for Niushanggui capsules. [J]. China Pharmacy 33(6).(2022)DOI:
Study on the improvement of quality standard for Niushanggui capsules
OBJECT IVE To provide reference for the improvement of the quality standard for Niushanggui capsules. METHODS Based on the previous quality standard ,thin-layer chromatography (TLC)identification methods were established for Angelicae dahurica and Anemarrhenae asphodeloides . High performance liquid chromatography (HPLC)method was established to determine the contents of 5 components simultaneously ,such as mangiferin ,prim-O-glucosylcimifugin,naringin,neohesperidin and 5-O-methylvisammioside. The limits were confirmed. RESULTS TLC chromatogram of Niushanggui capsules showed the same color spots in the same position as the corresponding (mixed)substance control or reference medicinal material of A. dahuricae and A. asphodeloides ,while the negative samples had no interference. The linear range of mangiferin ,prim-O-glucosylcimifugin, naringin,neohesperidin and 5-O-methylvisammioside were 7.98-127.63,6.74-107.84,53.06-848.96,39.31-628.90,13.54-216.62 μg/mL,respectively(all r=0.999 9). RSDs of precision ,stability(24 h)and repeatability tests were all no more than 1.20%(n= 6). The average recoveries were 95.00%,105.16%,97.16%,101.00% and 104.97%(RSD≤1.50%,n=6). In 4 batches of samples,the average contents of the above 5 components were 0.842,0.696,6.951,5.755 and 1.106 mg/g respectively ;the limits of A. asphodeloides ,Saposhnikovia divaricata and Citrus aurantium were based on the contents of mangiferin ,the total content of prim-O-glucosylcimmifugin and 5-O-methylvisammioside,naringin and neohesperidin ,which would not be less than 0.42,0.90 and 6.36 mg/grain,respectively. CONCLUSIONS TLC identification methods of A. dahurica and A. asphodeloides and the content determination methods of 5 components as mangiferin in Niushanggui capsules are established in this study ,and the limits of A. asphodeloides ,S. divaricata and C. aurantium are confirmed.
关键词
扭伤归胶囊鉴别含量测定质量标准提升
Keywords
Niushanggui c apsulesIdentificationContent determinationimprovement of quality standard