Current studies on quality of Chinese patent drugs with consistency as core and discussions on new high-quality evaluation model

ZHAO An-yi1,2 NI Feng-yan1,3 CHEN Peng-yue1,4 LIU Yan1 LIU An1

(1.Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China 100700)
(2.School of Pharmacy, Shanxi Medical University, Taiyuan, Shanxi Province, China 030001)
(3.Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi Province, China 330004)
(4.College of Pharmaceutical Sciences, Hebei University, Baoding, Hebei Province, China 071002)
【Knowledge Link】Chinese patent drugs; bioequivalence

【Abstract】The quality consistency of Chinese patent drugs is a hotspot and difficulty in the control of traditional Chinese medicine preparations, and has become one of the bottlenecks restricting its internationalization. Based on the analysis of current studies on quality and problems of Chinese patent drugs, this paper explored the methods of quality evaluation on Chinese patent drugs and possible factors affecting the consistency of quality in the pharmaceutical cycle by consulting relevant literature about quality evaluation methods and consistency control techniques of large-scale Chinese patent drugs. And it put forward the evaluation system of high-quality Chinese patent drugs with “consistency” as the core, so as to promote the overall improvement of the quality of Chinese patent drugs, guide the rational price of Chinese patent drugs of the same species, and provide a new reference model for their quality evaluation.

【Keywords】 Chinese patent drugs; quality; consistency; high quality and excellent price;

【DOI】

【Funds】 National Major Science and Technology Special Project for “Significant New Drug Development” (2019ZX09201005) National Natural Science Foundation of China (81703948) Independent Project of the Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences (L2019005)

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    References

    [1] LIN J K, NIE L X, YAO L, et al. Discussion on a new quality evaluation model of compound Danshen tablets based on control preparations [J]. Chin J Pharm Anal, 2019, 39 (10): 1751 (in Chinese).

    [2] NIE L X, DAI Z, MA S C. Guidelines and technical requirements for the development of control preparations of traditional Chinese medicine [J]. China Journal of Chinese Materia Medica, 2017, 42 (19): 3672 (in Chinese).

    [3] SUN G X, SUN W Y, YAN H, et al. Construction of the overall quality control standard system and steps for consistency evaluation of traditional Chinese medicine [J]. Cent South Pharmacy, 2019, 17 (3): 321 (in Chinese).

    [4] SUN G X, ZHANG Y J, SUN W Y, et al. Key issues in the consistency evaluation of traditional Chinese medicine—Control mode of standard preparations of traditional Chinese medicine and quantitative fingerprint check items [J]. Cent South Pharmacy, 2016, 14 (10): 1026 (in Chinese).

    [5] ZOU H B. Fingerprint spectra-based mathematical theory in determining the intrinsic quality grade of biological system of Chinese medicine [J]. World Chin Med, 2016, 11 (9): 1876 (in Chinese).

    [6] XIONG H S. Study on evaluation method for quality and pharmaceutical process consistency of traditional Chinese medicine [D]. Hangzhou: Zhejiang University, 2013 (in Chinese).

    [7] YANG H. Study on quality control analysis method of Liuwei Dihuang Pills [D]. Changsha: Hunan Normal University, 2015 (in Chinese).

    [8] LIU C J. Study on quality evaluation system of Compound Danshen Tablets [D]. Jinan: Shandong University of Traditional Chinese Medicine, 2013 (in Chinese).

    [9] DAWA Z M, GAZANG Z M. Study on HPLC fingerprint of Jianwei Xiaoshi Tablets [J]. Chin J Ethnomed Ethnopharm, 2016, 25 (8): 14 (in Chinese).

    [10] LIANG W L, XIE D W, DING G, et al. Quantitative and qualitative evaluation on tablets of Ginkgo biloba leaves using fingerprint and LC-MS analysis [J]. China Journal of Chinese Materia Medica, 2015, 40 (9): 1738 (in Chinese).

    [11] FENG H L, HUANG S, LI M R, et al. Content determination and fingerprint study of chemical components in Shuanghuanglian Oral Liquid [J]. Chin J Ethnomed Ethnopharm, 2017, 26 (5): 17 (in Chinese).

    [12] PAN L L, LI T T, YANG S, et al. Simultaneous determination of baicalin, baicalein, aloe-emodin, and emodin in Niuhuang Jiedu Tablets by HPLC [J]. Acta Chin Med and Pharmacology, 2015, 43 (1): 50 (in Chinese).

    [13] SHI H, ZHANG Q Y, YANG H T, et al. Simultaneous determination of 8 chemical components in Jianwei Xiaoshi Tablets by HPLC-MS/MS [J]. Chinese Chin J Pharm Anal, 2015, 35 (9): 1606 (in Chinese).

    [14] XIAO C X, HUANG X J, WEN Y S, et al. Simultaneous determination of adenosine and (R, S)-goitrin in Banlangen Granules by HPLC [J]. Chin J Drug Evaluation, 2017, 34 (2): 81 (in Chinese).

    [15] YAN B,YANG L P, MA D D, et al. Comprehensively evaluating the quality consistency of Liuwei Dihuang Pill by five-wavelength overall fused HPLC fingerprints combined with simultaneous determination and antioxidant activity [J]. J Chromatogr Sci, 2017, 55 (10): 1.

    [16] LUO F, CUI Y X, SHEN X M, et al. Content determination of three saponins in Compound Danshen Tablets by UPLC [J]. Acta Chin Med, 2015, 30 (4): 551 (in Chinese).

    [17] YANG L, LI T L. Study on quality control of Hugan Tablets based on HPLC fingerprint combined with chemical pattern recognition [J]. Chinese Herbal Medicines, 2019, 50 (14): 3351 (in Chinese).

    [18] WANG D Q, CHANG F M, WANG Y H, et al. Multi-wavelength HPLC chromatogram of Xiaochaihu Granules and drug-preparation peak matching analysis [J]. Journal of Chinese Medicinal Materials, 2016, 39 (4): 810 (in Chinese).

    [19] LI W T, MIAO S, ZHANG T, et al. Content uniformity of borneol in Compound Danshen Tablets [J]. Chin Tradit Patent Med, 2014, 36 (10): 2107 (in Chinese).

    [20] HUA Y Q, YUAN X H, WANG Y Y. Quality evaluation of Yinhuang Oral Liquid from different manufacturers [J]. Guangzhou Chemical Industry, 2017, 45 (5): 77 (in Chinese).

    [21] WENG X M, SHI S L, WU S X, et al. Comparison of of dissolution and drug releasing characteristics of Liuwei Dihuang Pills produced by different manufacturers [J]. Chin J Experimental Tradit Med Formulae, 2015, 21 (2): 44 (in Chinese).

    [22] ZHANG Y J, WU Q, NI J, et al. Dissolution of emodin and chrysophanol in Sanhuang Tablets from different manufacturers [J]. Chin J Experimental Tradit Med Formulae, 2012, 18 (9): 104 (in Chinese).

    [23] ZHANG X B. Quality comparative analysis of Liuweidihuang Concentrated Pills with different manufacturers [J]. Chin J Ethnomed Ethnopharm, 2016, 25 (10): 23 (in Chinese).

    [24] MENG S, MENG L, QIU F. Dissolution determination of Niuhuang Jiedu Tablets by HPLC [J]. Fujian Analysis Testing, 2018, 27 (6): 31 (in Chinese).

    [25] YAN T, HUANG F W, WANG Q J, et al. Study on the dissolution of Compound Danshen Tablets from different manufacturers [J]. Drug Eval Res, 2013, 36 (6): 442 (in Chinese).

    [26] TAN P, ZHANG H Z, ZHANG D K, et al. Quality evaluation of rhubarb dispensing granules based on multicomponent simultaneous quantitative analysis and bioassay [J]. China Journal of Chinese Materia Medica, 2017, 42 (14): 2683 (in Chinese).

    [27] FENG B, CAO B, TAN P, et al. Comparative study on the suitability of chemical fingerprints, blood-activating and anti-inflammatory biological potency in the overall quality evaluation of Xiaojin Pills [J]. Acta Pharm Sin, 2019, 54 (12): 2195 (in Chinese).

    [28] YANG G W, WANG L J, YAN A T. Simultaneous determination of Phthalic acid esters in Huoxiang Zhengqi Liquid by gas chromatography mass spectrometry [J]. J Clinical Med Literature (Electronic Edition), 2017, 4 (A0): 19603 (in Chinese).

    [29] WANG Q Q. Research on the quality uniformity control of traditional Chinese medicine by combination of dose-effect relationship and intelligent analysis software of fingerprint [D]. Beijing: China Academy of Chinese Medical Sciences, 2017 (in Chinese).

    [30] LIU Y G, YOU M W. Comparison of antibacterial effects of Huoxiang Zhengqi series products with different dosage forms from various manufacturers [J]. Asia-Pac Trad Med, 2017, 13 (1): 43 (in Chinese).

    [31] MENG S, BU C J, JIANG T Y, et al. Detection of rhaponticin in Niuhuang Jiedu Tablets by HPLC-DAD and HPLC/MS [J]. J North Pharmacy, 2015, 12 (12): 5 (in Chinese).

    [32] SUN G X, YANG T T. Quantitative evaluation of the quality and process differences of Liuwei Dihuang Pills with 4 different dosage forms by HPLC fingerprints [J]. Cent South Pharmacy, 2010, 8 (2): 148 (in Chinese).

    [33] YAN H, SUN G X, CHI H X, et al. Evaluation of the quality consistency of Compound Liquorice Tablets based on standard preparation control mode and quantitative fingerprints [J]. Chin J Chrom, 2019, 37 (11): 1200 (in Chinese).

    [34] ZHA Y F, NIE L X, YU J D, et al. Quality evaluation of borneol in Niuhuang Qingwei Pills based on control formulations [J]. Chin Tradit Patent Med, 2019, 41 (11): 2753 (in Chinese).

    [35] GUO Q, MU L, YANG Y, et al. Quality analysis of 217 batches of Compound Danshen Tablets [J]. Medical & Pharmaceutical J Chin PLA, 2012, 24 (11): 30 (in Chinese).

    [36] LI D M, LIU Y L, YUAN H. Determination of borneol content in Compound Danshen Tablets from different manufacturers by gas chromatography [J]. Chin Pharm, 2010, 19 (19): 30 (in Chinese).

    [37] LIU Y, ZHAO A Y, NI F Y, et al. Evaluation and analysis of product quality superiority of Liuwei Dihuang Pills [J]. China Journal of Chinese Materia Medica, 2020, 45 (5): 1194 (in Chinese).

    [38] WANG D M, XU L T, XIE J W, et al. Study on the dissolution of Qianliening Tablets [J]. Chin Tradit Patent Med, 1994, 16 (1): 6 (in Chinese).

    [39] LI L L, LIN Q Y, HUANG J. Comparison of in vitro dissolution of Compound Danshen Tablets from 44 different manufacturers [J]. Chinese Chin J Pharm Anal, 2013, 33 (6): 1054 (in Chinese).

    [40] BAI L, FANG X, REN W. Comparative analysis of the quality of Liuwei Dihuang Pills from different manufacturers [J]. Chin J Drug Application and Monitoring, 2011, 8 (5): 278 (in Chinese).

    [41] PANG J Y, WANG J B, MA Z J, et al. Quality evaluation and control of Polygoni Multiflori Radix based on chemical fingerprint and toxicity monitoring [J]. Chinese Traditional and Herbal Drugs, 2014, 45 (23): 3392 (in Chinese).

    [42] TAN P, WANG J B, ZHANG D K, et al. Application of effect constituent index in quality evaluation of traditional Chinese medicine Radix et Rhizoma Rhei [J]. Acta Pharm Sin, 2019, 54 (12): 2141 (in Chinese).

    [43] CHEN M, CHEN J H, LIU W Q, et al. Study on bilirubin in Niuhuang Jiedu Tablets fed with different types of Calculus Bovis [J]. Lishizhen Medicine and Materia Medica Research, 2019, 30 (4): 901 (in Chinese).

    [44] LU J X, CHEN Y, HUANG Q W, et al. Study on standardized feeding of Flos Lonicerae in Yinqiao Jiedu Granules [J]. Chin J Modern Applied Pharm, 2019, 36 (13): 1669 (in Chinese).

    [45] MENG Y G, LI H Y, ZHANG Q B, et al. Quality analysis of borneol in series Xiaoer Huadu preparations [J]. Heilongjiang Med J, 2019, 32 (1): 1 (in Chinese).

    [46] ZHONG W, CHEN S, ZHANG J, et al. Which should be the focus, raw materials or process?— Discussion on quality consistency control method of Chin Tradit Patent Med with Gegen Qinlian Decoction as an example [J]. China Journal of Chinese Materia Medica, 2016, 41 (6): 1027 (in Chinese).

    [47] YANG C M, WEI J H, SUI C, et al. Progress and suggestions on the breeding of new varieties of traditional Chinese medicinal materials [J]. Modern Chin Med, 2013, 15 (9): 727 (in Chinese).

    [48] PAN W L, FAN M, SONG Z Q, et al. Research progress in standardization and normalization of traditional Chinese medicine processing [J]. Sci and Tech, 2016, 26 (25): 272 (in Chinese).

    [49] LIU L L, YU C, LI L, et al. Research progress in the rapid evaluation of therapeutic material basis in the feeding and releasing stage by near-infrared spectroscopy [J]. Cent South Pharmacy, 2019, 17 (9): 1421 (in Chinese).

    [50] YE H T, LI X L, CHAO Z. Preliminary study on the detection of gekko dosage in Jinlong Capsule formula based on fluorescence quantitative PCR [J]. China Journal of Chinese Materia Medica, 2018, 43 (23): 4582 (in Chinese).

    [51] SUN H M, YANG R, ZHANG C Y, et al. Chinese Pharmacopoeia (2015 Edition) promotes the scientific standard system of pharmaceutical excipients and strengthens drug quality in China [J]. Chin Pharm J, 2015, 50 (15): 1353 (in Chinese).

    [52] FAN L Y, YU Y, GAO J D, et al. Effects of different excipients on the hygroscopicity of Sanhuang Powder [J]. Chin Tradit Patent Med, 2015, 37 (12): 2764 (in Chinese).

    [53] LIU X X, HUANG J Z, SUN L L, et al. Quality investigation of excipient refined honey in Antai Pills (Dami Pills) [J]. Chin J Pharm Anal, 2017, 37 (12): 2279. (in Chinese).

    [54] HAN L M, FU Y, ZHANG L H, et al. Effects of new pharmaceutical excipients on the pharmacological properties and dissolution performance of Compound Danshen Tablets [J]. Fudan Univ J Med Sciences, 2011, 38 (3): 233 (in Chinese).

    [55] ZENG L H, WU Z F, WANG F, et al. Study on current problems and guarantee strategies for quality uniformity of traditional Chinese medicine preparations [J]. China Journal of Chinese Materia Medica, 2017, 42 (19): 3826 (in Chinese).

    [56] ZHOU Y H. Thoughts on the feeding methods of new compound Chinese medicine [J]. Chin Tradit Patent Med, 2009, 31 (10): 1588 (in Chinese).

    [57] HAO P B, FENG Y K, YANG Q, et al. Effect of Rhizoma Acori Tatarinowii feeding sequence on the quality of Compound Shexiang Injection [J]. Modern Chin Med, 2014, 16 (11): 931 (in Chinese).

    [58] LIU Y S, CAO M, CHEN Y Y, et al. Study on the mixed batch blending of Chinese herb extracts [J]. Chin J Chrom, 2006, 23 (2): 117 (in Chinese).

    [59] MA B, WANG J, LIU C B, et al. Comparative study on the effects of different extraction methods on the paeoniflorin content in Radix Paeoniae Rubra by HPLC [J]. Lishizhen Medicine and Materia Medica Research, 2013, 24 (8): 1820 (in Chinese).

    [60] SUN Y T, HAN C Y, WANG L Y, et al. Influence of different extraction methods on the content of active ingredients in Zhike Ningsou Capsules [J]. Jilin Norm Univ J (Nat Sci Ed), 2018, 39 (4): 81 (in Chinese).

    [61] ZHAO J, FENG L, WANG Y. Influence of different extraction methods on the anti-inflammatory effect of Shengyang Yiwei Decoction [J]. Global Tradit Chin Med, 2019, 12 (2): 189 (in Chinese).

    [62] DING F, LI C X, ZHOU Y, et al. Selection principles and methods of membrane separation process for traditional Chinese medicine based on the concept of “green design” [J]. Chinese Traditional and Herbal Drugs, 2019, 50 (8): 1759 (in Chinese).

    [63] ZHONG J M, SUN P X. Improving the matched filtering process to increase the feed/yield rate of traditional Chinese medicine oral liquid [J]. J Guangdong Pharmaceutical Univ, 1998, 14 (2): 57 (in Chinese).

    [64] DENG H X, PAN H Y, CHEN Z Q, et al. Study on the thermal degradation of linarin in the concentration process of 999 Ganmaoling [J]. China Journal of Chinese Materia Medica, 2016, 41 (8): 1380 (in Chinese).

    [65] LI S Y, WU Z F, YUE P F, et al. Current status and problem analysis of the concentration process and equipment of traditional Chinese medicine extracts [J]. Modernization of Trad Chin Med and Materia Medica—World Sci and Tech, 2016, 18 (10): 1782 (in Chinese).

    [66] MENGGEN D L, LIU S D, QING G L. Effect of alcohol precipitation process on the quality of Chin Tradit Patent Med [J]. Chin Tradit Patent Med, 1996, 18 (3): 51 (in Chinese).

    [67] ZHOU Y H. Investigation on the alcohol content of traditional Chinese medicine compound preparations by alcohol precipitation [J]. Chinese Traditional and Herbal Drugs, 2015, 46 (15): 2309 (in Chinese).

    [68] CHENG Z Q, LIU X C, GAO J R, et al. Effects of different drying methods on the content of astragaloside IV in the dry extract of Compound Qiyi Capsules [J]. Clinical Acta Chin Med and Pharmacology, 2014, 26 (9): 932 (in Chinese).

    [69] LIU X C, GAO J R, ZHANG Y Y, et al. Effects of different drying methods on the quality of dried liquid extracts of traditional Chinese medicine prescriptions [J]. Chin J Pharm Biotec, 2017, 24 (1): 33 (in Chinese).

    [70] FENG S J, WU Z F, WANG Y Q, et al. Research status and problem analysis of traditional Chinese medicine sterilization technology [J]. Chinese Traditional and Herbal Drugs, 2015, 46 (18): 2667 (in Chinese).

    [71] WANG D, LI L L, GUO L B, et al. Effects of different sterilization methods on the content of imperatorin in Baoji Pills and Radix Angelicae Dahuricae [J]. Chin J Experimental Tradit Med Formulae, 2012, 18 (15): 32 (in Chinese).

    [72] LI H Y. Comparison of high-speed agitation granulation, wet granulation, and dry granulation to prepare poria cocos polysaccharide tablets [C]. Tianjin: 2010 China Pharmacy Conference and 10th Chinese Pharmacists Week, 2010: 3 (in Chinese).

    [73] ZHAO Y J. Study on the molding process and quality standard of Chaigui Granule Preparation [D]. Taiyuan: Shanxi University, 2018 (in Chinese).

    [74] ZHENG Y P, ZHANG X, XIAN J C, et al. Effect of extrusion process on the quality of pellets based on the texture properties of extrudates [J]. Chinese Traditional and Herbal Drugs, 2017, 48 (16): 3288 (in Chinese).

    [75] ZHOU F S. Effects of different granulation methods on the quality of Ganmaokang Capsules [J]. Strait Pharm J, 2008, 20 (2): 16 (in Chinese).

    [76] FENG Y, HONG Y L, XIAN J C, et al. Discussion on the research and development model of new Chinese medicine molding process based on QbD concept [J]. China Journal of Chinese Materia Medica, 2014, 39 (17): 3404 (in Chinese).

    [77] YANG M, WU Z F, WANG F, et al. Strategies and suggestions for green and intelligent manufacturing of traditional Chinese medicine [J]. Chin J Pharm, 2016, 47 (9): 1205 (in Chinese).

    [78] YANG M, WU Z F, WANG Y Q, et al. Analysis on the policy, current situation and approach of technological upgrading of Chinese pharmaceutical equipment [J]. Chinese Traditional and Herbal Drugs, 2013, 44 (3): 247 (in Chinese).

    [79] WU Q. Study on quality control standards of pharmaceutical packaging materials and containers [D]. Nanchang: Jiangxi University of Traditional Chinese Medicine, 2019 (in Chinese).

    [80] ZHOU J Q, MEI D. Effect of drug packaging materials on drug quality and safety [J]. ADRJ, 2011, 13 (1): 27 (in Chinese).

    [81] WU W Y, GUO D A. Ideas and methods for building an overall quality control standard system of traditional Chinese medicine [J]. China Journal of Chinese Materia Medica, 2014, 39 (3): 351 (in Chinese).

    [82] LIANG X Y, CHEN S X, WU Y. Development trend of research on quality control of traditional Chinese medicine preparations [J]. China Pharmacy, 2014, 25 (3): 280 (in Chinese).

    [83] YANG S, ZHANG D K, SU Z T, et al. Study on the quality control of traditional Chinese medicine compound preparations [J]. Chin Med Biotechnol, 2010, 5 (5): 387 (in Chinese).

    [84] ZHOU Y S, LIANG J, XIN C X, et al. Quality evaluation methods of traditional Chinese medicine compound preparations [J]. Chinese Acta Chin Med and Pharmacology, 2019, 37 (3): 589 (in Chinese).

    [85] XU B, SHI X Y, WU Z S, et al. Quality by design approaches for traditional Chinese medicine [J]. China Journal of Chinese Materia Medica, 2017, 42 (6): 1015 (in Chinese).

    [86] WANG Y Q, JIAO J J, WU Z F, et al. Discussion on the quality process control system of traditional Chinese medicine preparations based on “holistic view” [J]. China Journal of Chinese Materia Medica, 2018, 43 (1): 197 (in Chinese).

    [87] HE Y. Establishment and application of quality consistency evaluation model of traditional Chinese medicine [D]. Tianjin: Tianjin University, 2011 (in Chinese).

    [88] TAO X B, HUANG Y Q, HONG B, et al. Exploration of the quality consistency evaluation of traditional Chinese medicine [J]. World Science and Technology—Modernization of Traditional Chinese Medicine, 2017, 19 (11): 1781 (in Chinese).

    [89] MA F L. Common sterilization techniques and their effect on the quality of traditional Chinese medicine preparations [J]. Chinese Acta Chin Med and Pharmacology, 2010, 28 (12): 2640 (in Chinese).

This Article

ISSN:1001-5302

CN:11-2272/R

Vol 45, No. 15, Pages 3740-3748

August 2020

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Abstract

  • 1 Current status of research on quality evaluation of Chinese patent drugs
  • 2 Factors influencing the quality of Chinese patent drugs and current status of related control techniques
  • 3 Discussion on the new model for the quality evaluation of Chinese patent drugs
  • 4 Summary and outlook
  • References