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.

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

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

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