基于投料规范值评价中药制剂质量风险

doi:10.3976/j.issn.1002-4026.2023.04.004

Abstract

Abstract:

The mathematical formula for calculating the value of the feeding standard was developed, and the mode of quality risk management in traditional Chinese medicine preparations was constructed. The contents of peucedane A and peucedane B in three preparations containing Peucedani Radix (eight batches from four manufacturers) were determined using high-performance liquid chromatography; the feeding standard values were calculated; and the quality risks of the preparations were evaluated. The quality risks of preparations were divided into four categories based on the value of the feeding standard, allowing for an effective evaluation of the risks of preparations. The established method can be used to evaluate the standardization of preparation feeding and detect quality risks in real time, providing a decision-making basis for risk classification management.

Key words: value of feeding standard, high-performance liquid chromatography, quality risk, Peucedani Radix, praeruptorin A, praeruptorin B

CLC Number:

R286

WU Weikui, YAN Qianru, GU Bingming, LIU Jia, SONG Wei. Quality risk evaluation of traditional Chinese medicine preparations based on the value of the feeding standard[J].Shandong Science, 2023, 36(4): 29-34.

Figures/Tables 3

References 17

Metrics

Comments

Recommended 0

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0), which permits third parties to freely share (i.e., copy and redistribute the material in any medium or format) and adapt (i.e., remix, transform, or build upon the material) the articles published in this journal, provided that appropriate credit is given, a link to the license is provided, and any changes made are indicated. The material may not be used for commercial purposes. For details of the CC BY-NC 4.0 license, please visit: https://creativecommons.org/licenses/by-nc/4.0

编号	样品	批号	生产企业	V_d/(mg·g^-1)		V_t/(mg·g^-1)		V_f/%		风险分类
编号	样品	批号	生产企业	PB	PA	PB	PA	PB	PA	风险分类
Y1	通宣理肺丸(浓缩丸)	1905008	重庆A企业	0.037	—	1.226	0.335	3.018	—	D
Y2	通宣理肺丸(浓缩丸)	2004005	重庆A企业	0.075	—	1.226	0.335	6.117	—	D
Y3	通宣理肺丸(浓缩丸)	2004007	重庆A企业	0.055	—	1.226	0.335	4.486	—	D
Y4	通宣理肺丸(水蜜丸)	22190803	内蒙古B企业	0.350	0.088	0.299	0.080	117.057	110.000	A
Y5	通宣理肺丸(水蜜丸)	22191101	内蒙古B企业	0.364	0.083	0.299	0.080	121.739	103.750	A
Y6	通宣理肺丸(水蜜丸)	20191202	山西C企业	0.520	0.124	0.299	0.080	173.913	155.000	A
Y7	通宣理肺丸(水蜜丸)	20200301	山西C企业	0.446	0.155	0.299	0.080	149.164	193.750	A
Y8	咳喘顺丸	L10007	广东D企业	0.497	0.112	0.506	0.135	98.221	82.963	B

[1]	国家药典委员会. 中华人民共和国药典2020版一部[M], 北京: 中国医药科技出版社, 2020.
[2]	张佳, 杨怀瑾, 马丽霞, 等. 中药品质传递过程评价技术与方法研究进展[J]. 中草药, 2021, 52(15): 4711-4721.DOI:10.7501/j.issn.0253-2670.2021.15.030. doi: 10.7501/j.issn.0253-2670.2021.15.030
[3]	国家药品监督管理局药品审评中心. 按古代经典名方目录管理的中药复方制剂药学研究技术指导原则(试行)[EB/OL]. (2021-08-31) [2022-02-17]. https://www.cde.org.cn/main/news/viewInfoCommon/1c18dd163e7c9221786e5469889367d0.html.
[4]	中华人民共和国工业和信息化部. “十四五”医药工业发展规划[EB/OL].(2021-12-22)[2022-07-12].https://www.miit.gov.cn/jgsj/ghs/zlygh/art/2022/art_5d5e4f4a945346c7ab261a9fd2669cb5.html.
[5]	刘昌孝. 中药质量标志物(Q-Marker)研究发展的5年回顾[J]. 中草药, 2021, 52(9):2511-2518.DOI:10.7501/j.issn.0253-2670.2021.09.001. doi: 10.7501/j.issn.0253-2670.2021.09.001
[6]	张伟, 吴孟华. 天麻丸中独活虚假投料及羌活劣药投料的检测[J]. 中成药, 2022, 44(1):160-165.DOI:10.3969/j.issn.1001-1528.2022.01.030. doi: 10.3969/j.issn.1001-1528.2022.01.030
[7]	王小林, 朱敏凤, 刘超, 等. 液质联用法监测元胡止痛胶囊原料药的投料分析研究[J]. 国际中医中药杂志, 2018, 40(7): 639-644. DOI: 10.3760/cma.j.issn.1673-4246.2018.07.014. doi: 10.3760/cma.j.issn.1673-4246.2018.07.014
[8]	李昀泽, 姚阳婧, 裔楠, 等. 清肺饮治疗新型冠状病毒肺炎合并高血压病患者152例临床疗效分析[J]. 浙江中医药大学学报, 2020, 44(8): 729-733. DOI: 10.16466/j.issn1005-5509.2020.08.006. doi: 10.16466/j.issn1005-5509.2020.08.006
[9]	刘源, 刘金豹, 彭伟. 人参败毒散治疗新型冠状病毒肺炎(COVID-19)作用机制的网络药理学探讨[J]. 中药材, 2020, 43(6): 1531-1539. DOI:10.13863/j.issn1001-4454.2020.06.046. doi: 10.13863/j.issn1001-4454.2020.06.046
[10]	曹欢, 袁杨, 林林, 等. 基于延胡索投料情况研究宫炎康颗粒质量现状[J]. 中成药, 2020, 42(6): 1592-1595.DOI:10.3969/j.issn.1001-1528.2020.06.039. doi: 10.3969/j.issn.1001-1528.2020.06.039
[11]	孟云阁, 李慧勇, 张清波, 等. 小儿化毒系列制剂中冰片投料质量分析[J]. 黑龙江医药, 2019, 32(1): 1-5. DOI:10.14035/j.cnki.hljyy.2019.01.001. doi: 10.14035/j.cnki.hljyy.2019.01.001
[12]	郭晓晗, 张萍, 荆文光, 等. 从2020年国家药品抽检专项有关问题谈中药材及中药饮片监管[J]. 中国现代中药, 2021, 23(10): 1679-1685. DOI: 10.13313/j.issn.1673-4890.20210622002. doi: 10.13313/j.issn.1673-4890.20210622002
[13]	谌宇, 刘宇文, 邹耀华, 等. 市售前胡中香豆素类成分的质量分析[J]. 中成药, 2022, 44(1): 318-321. DOI: 10.3969/j.issn.1001-1528.2022.01.062. doi: 10.3969/j.issn.1001-1528.2022.01.062
[14]	周泽琴, 蔡延渠, 张雄飞, 等. 中药水提取有效成分转移率低的问题分析[J]. 中草药, 2014, 45(23): 3478-3485. DOI: 10.7501/j.issn.0253-2670.2014.23.023. doi: 10.7501/j.issn.0253-2670.2014.23.023
[15]	丁浩然, 刘峰, 王梦月, 等. 基于一测多评法的急支糖浆质量评价方法的建立及验证[J]. 中国中药杂志, 2022, 47(10): 2668-2675. DOI: 10.19540/j.cnki.cjcmm.20211025.302. doi: 10.19540/j.cnki.cjcmm.20211025.302
[16]	徐放, 朴善花, 李明珠, 等. ⁶⁰Co-γ射线辐照对小儿清肺丸中5种有效成分的影响[J]. 中草药, 2018, 49(17): 4058-4063.DOI:10.7501/j.issn.0253-2670.2018.17.014. doi: 10.7501/j.issn.0253-2670.2018.17.014
[17]	阳长明, 陈霞, 赵巍, 等. 基于源头控制的中药制剂质量研究[J]. 中草药, 2021, 52(2): 321-326.DOI:10.7501/j.issn.0253-2670.2021.02.002. doi: 10.7501/j.issn.0253-2670.2021.02.002

[1]	ZHU Heng, DING Hui, WANG Xiao, LI Lili. Quantitative analysis of seven major ginsenoside components of Panaxquinquefolius L. from different origins [J]. Shandong Science, 2025, 38(5): 1-9.
[2]	ZHANG Xiaodan, HE Xiaodong, GAO Yan, YANG Longfei, ZHANG Guanqun, YU Zixiang, LIU Mingjun, WANG Yafei, GENG Zangjia, ZHAO Bonian. A study on the quality standards of Huanglian Hupo Qingxin pills [J]. Shandong Science, 2024, 37(4): 17-25.

Quality risk evaluation of traditional Chinese medicine preparations based on the value of the feeding standard

RichHTML

PDF (PC)

Like

Knowledge

Abstract

Cite this article

share this article

Figures/Tables 3

References 17

Related Articles 2

Metrics

Comments

Recommended 0