1.Study on the improvement of quality standard for Niushanggui capsules
Ping HUANG ; Youlong FENG ; Juanjuan ZHOU ; Pei SHI ; Qingshui SHI
China Pharmacy 2022;33(6):718-723
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.
2.Progress in residual DNA in biological products
Shuqiang ZHAO ; Jingyuan GAO ; Doudou LOU ; Qinglin PANG ; Qingshui SHI ; Yihong LU
Drug Standards of China 2024;25(5):437-442
Host cell residue DNA is one of the most common impurity which can affect the safety of biological products,therefore,domestic and international regulatory agencies have required the limit for host cell residue DNA in different biological products,either at the final product qualification or the appropriate intermediate control stage.The removal effect is verified by monitoring the residue DNA of products in different production stages,which is beneficial for assuring the scientificity and stability of the production process.In order to strengthen the understanding of control strategy about host cell residual DNA,the paper reviews progress in host cell residual DNA in biological products by authors'work experience and other's research,which provides reference for future work.