Quality Evaluation and Research of Yigan Jiedu Capsules
LIN Lin1, LIU Hong-chao1, YU Feng-rui1, ZHOU Qian-qian1, DAI Zhong2, LIN Yong-qiang1*, MA Shuang-cheng2*
1. Shandong Provincial Insititute for Food and Drug Control, Jinan 250101, China; 2. National Insititutes for Food and Drug Control, Beijing 100050, China
Abstract：OBJECTIVE To analyze and evaluate the quality status of Yigan Jiedu Capsules for providing evidence for its standard improvement and standardized production.METHODS According to the problems found in the standard test, combined with the quality status of the original medicinal materials, exploratory research was carried out from the aspects of authenticity, safety, consistency and effectiveness of the drug, and a number of detection methods were established to analyze the quality of the preparations and the original medicinal materials.RESULTS The qualified rate of inspection was 99.2%. The results of exploratory research indicated that some manufacturers may have problems such as false material feeding and insufficient material feeding.CONCLUSION The overall quality of Yigan Jiedu Capsules is generally good, and the quality standard needs to be improved.
林林, 刘洪超, 于凤蕊, 周倩倩, 戴忠, 林永强, 马双成. 乙肝解毒胶囊质量评价与研究[J]. 中国药学杂志, 2019, 54(22): 1882-1887.
LIN Lin, LIU Hong-chao, YU Feng-rui, ZHOU Qian-qian, DAI Zhong, LIN Yong-qiang, MA Shuang-cheng. Quality Evaluation and Research of Yigan Jiedu Capsules. Chinese Pharmaceutical Journal, 2019, 54(22): 1882-1887.
BAI M, LIU W P, LI S Z. HPLC Determination of astilbin and engeletin in Smilax glabra from different producing areas[J]. Chin J Pharm Anal(药物分析杂志), 2013, 33(8):1352-1354.
[2]
ZHANG Y G, ZHAO L, YANG X Y. Study on the quality of commercially avallable HPLC fingerprint and determination of principal component of Smilacis Rhizoma[J]. J China Pharm(中国药房), 2016, 27(36):5143-5146.
[3]
TIAN X, DING R X, BA G N, et al. Fingerprinting and multi-indicator quantitative analysis of Mongolian drug Digeda-4 decoction [J]. Chin J Chin Mater Med(中国中药杂志), 2018, 43(19):3962-3969.
[4]
LI E Z, LIU Y F, LIU Y J, et al. Simultaneous determination of six components in Scutellaria baicalensis Georgi from different districts by HPLC [J]. Chin J Hosp Pharm(中国医院药学杂志), 2018, 38(9):946-948.
[5]
ZHANG J M, ZHANG Z W, LI Y M, et al. Determination of 4 chemical constituents in wine-processed Radix Scutellariae from 13 different habitats by HPLC[J]. China Pharm(中国药师), 2018, 21(2):253-256.
[6]
SUN Y T, SONG Y H, ZHAOL, et al. Simultaneous determination of 6 components in Niuhuang Ninggong Tablets by HPLC[J]. J China Pharm(中国药房), 2017, 28(27):3862-3864.
[7]
SHUI D, WANG Y Q, GENG R W. Simultaneous determination of 13 effective components in Sanhaung Qinxin Tang by HPLC[J]. Chin J Hosp Pharm(中国医院药学杂志), 2018, 38(9):2235-2239.
[8]
ZHAO D, ZHOU T Q, ZHANGL, et al. Simultaneous determination of 11 components in Zhizi Jinhua pills by HPLC[J]. Chin Tradit Pat Med(中成药), 2018, 40(10):2194-2197.
[9]
GUO Q, WANG H B, LI X Y, et al. Simultaneous determination of 14 components in Lidan Paishi Tablets by HPLC[J]. Chin J Pharm Anal(药物分析杂志), 2017, 37(4):631-638.
[10]
LIN L, LIU G Z, YU F R, et al. Simultaneous determination of twelve constituents in Nvjin Pill by HPLC wavelength switching [J]. Chin Pharm J(中国药学杂志), 2018,53(17):1511-1515.
[11]
NIE L X, LIU Y, LU J, et al. Quality evaluation and research of Huoxuezhitong preparations[J]. Chin Pharm J(中国药学杂志), 2015, 50(4):131-139.
[12]
HU X R, YANG M L, WANG M J, et al. Quality evaluation of Sanqi shangyao tablets[J]. Chin Pharm J(中国药学杂志), 2015, 50(4):299-304.
2019, Vol. 54 
