Research on Quality Evaluation of Yiyi-Zhuye Powders Based on Fingerprint， Quality Value Transfer and Chemometrics

doi:10.19894/j.issn.1000-0518.230277

Chinese Journal of Applied Chemistry ›› 2024, Vol. 41 ›› Issue (3): 422-436.DOI: 10.19894/j.issn.1000-0518.230277

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Research on Quality Evaluation of Yiyi-Zhuye Powders Based on Fingerprint， Quality Value Transfer and Chemometrics

Ye-Chen WANG, Zhi-Dong QIU, Yan-Xu ZHANG, Li-Ying WANG, Mao-Xu WANG, Xue-Lian DONG()

School of Pharmcy，Changchun University of Chinese Medicine，Changchun 130117，China

Received:2023-09-13 Accepted:2023-12-29 Published:2024-03-01 Online:2024-04-09
Contact: Xue-Lian DONG
About author:dongxl@ccucm.edu.cn
Supported by:
Jilin Province Science and Technology Development Plan Item(20200602034ZP)

Abstract

Abstract:

High performance liquid chromatography（HPLC） fingerprints are established for external quality control， internal quality influencing factors are explored in combined with chemometrics， the stability of the preparation process is determined by the law of quantity value transfer， and the quality evaluation system of Yiyi-Zhuye Powder （YZP） is comprehensively improved. The fingerprints of 15 batches of YZP are mapped and evaluated by similarity Evaluation System of TCM Chromatographic Fingerprint （2012.130723 version）； Origin 2019b 64Bit is selected for cluster analysis （CA）， and SIMCA 14.1 is used for principal component analysis （PCA） and orthogonal partial least squares discriminant analysis （OPLS-DA） to obtain the main components that causes the quality difference； The contents of orientin and isoorientin in 15 batches of Lophatherum gracile and YZP are determined to investigate the law of quality value transfer in the process of sample preparation. A total of 21 peaks are obtained from 15 batches of YZP， of which 6 peaks are identified as peak 9 （isoorientin）， peak 10 （orientin）， peak 13 （vitexin）， peak 14 （isovitexin）， peak 15 （forsythiolate glycoside A） and peak 20 （forsythiin）. The similarity is between 0.956 and 0.995， which meets the relevant regulations. CA results show that 15 batches of YZP are divided into two categories. PCA obtains 3 principal components with a cumulative contribution rate of 82.4%， and OPLS-DA obtains 10 components with a large contribution rate， including peak 9， peak 13 and peak 20， which is conducive to further quality evaluation. The content ranges of orientin and isoorientin in 15 batches of Lophatherum Herb are 0.2156%~0.9923% and 0.530%~2.052%， while the content ranges of orientin and isoorientin in 15 batches of YZP are 0.022%~0.112% and 0.065%~0.312%. The transfer rates are 78.41%~119.54% and 74.57%~127.96%， respectively， and all are in the mean ±30% range， indicating that the preparation process is stable. A combined HPLC fingerprint and multi-index content determination method has been established to effectively control the external quality of YZP， and the internal factors affecting the quality are determined by chemometrics. The stable transfer rate determines that the preparation process is stable and reliable， which lays a foundation for the comprehensive quality evaluation of YZP.

Key words: Yiyi-zhuye Powder, Quality value transfer, Fingerprint, Chemometrics, Orientin, Isoorientin, Quality evaluation

CLC Number:

O657.3

Ye-Chen WANG, Zhi-Dong QIU, Yan-Xu ZHANG, Li-Ying WANG, Mao-Xu WANG, Xue-Lian DONG. Research on Quality Evaluation of Yiyi-Zhuye Powders Based on Fingerprint， Quality Value Transfer and Chemometrics[J]. Chinese Journal of Applied Chemistry, 2024, 41(3): 422-436.

Figures/Tables 15

References 27

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Number	Coicis Semen		Lophatheri Herba		Talci Pulvis		Forsythiae Fructus
Number	Origin	Batch number	Origin	Batch number	Origin	Batch number	Origin	Batch number
S1	Bozhou， Anhui	20220201	Changde， Hunan	CLB-20210906	Guilin， Guangxi	HS220605	Jincheng， Shanxi	220702
S2	Xingren， Guizhou	C608211101	Qujing， Yunnan	SES-20210813	Guilin， Guangxi	20211012	Linfen， Shanxi	C343210802
S3	Yunnan， Kunming	20220711	Guangning， Guangdong	HLB-20210930	Yunnan， Kunming	220501	Yunnan， Kunming	20211105
S4	Bozhou， Anhui	20220202	Dazhou， Sichuan	CSL-20200915	Guilin， Guangxi	20211016	Yunnan， Kunming	20211102
S5	Yunnan， Kunming	20220713	Lu′an， Anhui	GYX-20211007	Yunnan， Kunming	220601	Jincheng， Shanxi	220703
S6	Bozhou， Anhui	20220203	Changde， Hunan	CLB-20210908	Guilin， Guangxi	HS220602	Bozhou， Anhui	210301
S7	Xingren， Guizhou	220703	Qujing， Yunnan	SES-20210815	Guilin， Guangxi	20211015	Linfen， Shanxi	C343210801
S8	Yunnan， Kunming	20220714	Guangning， Guangdong	HLB-20210922	Guilin， Guangxi	HS220603	Lu′an， Anhui	210421
S9	Lu′an， Anhui	200602	Dazhou， Sichuan	CSL-20200913	Kunming Yunnan，	220607	Bozhou， Anhui	210303
S10	Lu′an， Anhui	200601	Dazhou， Sichuan	CSE-20201013	Kunming Yunnan，	220603	Jincheng， Shanxi	220701
S11	Yunnan， Kunming	20220712	Lu′an， Anhui	GYX-20210913	Guilin， Guangxi	HS220604	Kunming Yunnan，	20211103
S12	Anlong， Guizhou	220701	Qujing， Yunnan	SES-20210816	Guilin， Guangxi	20211011	Linfen， Shanxi	C343210806
S13	Lu′an， Anhui	200603	Guangning， Guangdong	HLB-20210926	Kunming Yunnan，	220609	Kunming Yunnan，	20211104
S14	Xingren， Guizhou	220704	Changde， Hunan	CLB-20210901	Guilin， Guangxi	HS220601	Kunming Yunnan，	20211101
S15	Anlong， Guizhou	C608211103	Lu′an， Anhui	GYX-20210911	Guilin， Guangxi	20211014	Linfen， Shanxi	C343210803

Number	Coicis Semen		Lophatheri Herba		Talci Pulvis		Forsythiae Fructus
Number	Origin	Batch number	Origin	Batch number	Origin	Batch number	Origin	Batch number
S1	Bozhou， Anhui	20220201	Changde， Hunan	CLB-20210906	Guilin， Guangxi	HS220605	Jincheng， Shanxi	220702
S2	Xingren， Guizhou	C608211101	Qujing， Yunnan	SES-20210813	Guilin， Guangxi	20211012	Linfen， Shanxi	C343210802
S3	Yunnan， Kunming	20220711	Guangning， Guangdong	HLB-20210930	Yunnan， Kunming	220501	Yunnan， Kunming	20211105
S4	Bozhou， Anhui	20220202	Dazhou， Sichuan	CSL-20200915	Guilin， Guangxi	20211016	Yunnan， Kunming	20211102
S5	Yunnan， Kunming	20220713	Lu′an， Anhui	GYX-20211007	Yunnan， Kunming	220601	Jincheng， Shanxi	220703
S6	Bozhou， Anhui	20220203	Changde， Hunan	CLB-20210908	Guilin， Guangxi	HS220602	Bozhou， Anhui	210301
S7	Xingren， Guizhou	220703	Qujing， Yunnan	SES-20210815	Guilin， Guangxi	20211015	Linfen， Shanxi	C343210801
S8	Yunnan， Kunming	20220714	Guangning， Guangdong	HLB-20210922	Guilin， Guangxi	HS220603	Lu′an， Anhui	210421
S9	Lu′an， Anhui	200602	Dazhou， Sichuan	CSL-20200913	Kunming Yunnan，	220607	Bozhou， Anhui	210303
S10	Lu′an， Anhui	200601	Dazhou， Sichuan	CSE-20201013	Kunming Yunnan，	220603	Jincheng， Shanxi	220701
S11	Yunnan， Kunming	20220712	Lu′an， Anhui	GYX-20210913	Guilin， Guangxi	HS220604	Kunming Yunnan，	20211103
S12	Anlong， Guizhou	220701	Qujing， Yunnan	SES-20210816	Guilin， Guangxi	20211011	Linfen， Shanxi	C343210806
S13	Lu′an， Anhui	200603	Guangning， Guangdong	HLB-20210926	Kunming Yunnan，	220609	Kunming Yunnan，	20211104
S14	Xingren， Guizhou	220704	Changde， Hunan	CLB-20210901	Guilin， Guangxi	HS220601	Kunming Yunnan，	20211101
S15	Anlong， Guizhou	C608211103	Lu′an， Anhui	GYX-20210911	Guilin， Guangxi	20211014	Linfen， Shanxi	C343210803

Sample	Similarity	Sample	Similarity
S1	0.995	S9	0.973
S2	0.971	S10	0.976
S3	0.956	S11	0.953
S4	0.962	S12	0.981
S5	0.966	S13	0.966
S6	0.956	S14	0.979
S7	0.972	S15	0.989
S8	0.982

Sample	Similarity	Sample	Similarity
S1	0.995	S9	0.973
S2	0.971	S10	0.976
S3	0.956	S11	0.953
S4	0.962	S12	0.981
S5	0.966	S13	0.966
S6	0.956	S14	0.979
S7	0.972	S15	0.989
S8	0.982

Sample	S1	S2	S3	S4	S5	S6	S7	S8	S9	S10	S11	S12	S13	S14	S15	S
S1	1	0.954	0.998	0.978	0.999	0.997	0.956	0.997	0.992	0.998	0.999	0.952	0.996	0.975	0.98	0.995
S2	0.954	1	0.951	0.97	0.952	0.951	0.999	0.948	0.941	0.95	0.953	0.998	0.948	0.967	0.981	0.971
S3	0.998	0.951	1	0.982	0.999	1	0.952	1	0.994	0.998	0.998	0.951	0.999	0.978	0.982	0.996
S4	0.978	0.97	0.982	1	0.98	0.982	0.97	0.982	0.986	0.981	0.982	0.973	0.983	0.999	0.987	0.992
S5	0.999	0.952	0.999	0.98	1	0.998	0.954	0.998	0.993	1	0.999	0.951	0.998	0.976	0.983	0.996
S6	0.997	0.951	1	0.982	0.998	1	0.952	1	0.993	0.998	0.998	0.951	1	0.978	0.983	0.996
S7	0.956	0.999	0.952	0.97	0.954	0.952	1	0.949	0.942	0.952	0.954	0.998	0.949	0.966	0.981	0.972
S8	0.997	0.948	1	0.982	0.998	1	0.949	1	0.994	0.998	0.998	0.949	1	0.978	0.981	0.996
S9	0.992	0.941	0.994	0.986	0.993	0.993	0.942	0.994	1	0.994	0.995	0.942	0.995	0.985	0.977	0.993
S10	0.998	0.95	0.998	0.981	1	0.998	0.952	0.998	0.994	1	0.998	0.95	0.997	0.978	0.982	0.996
S11	0.999	0.953	0.998	0.982	0.999	0.998	0.954	0.998	0.995	0.998	1	0.951	0.998	0.979	0.981	0.996
S12	0.952	0.998	0.951	0.973	0.951	0.951	0.998	0.949	0.942	0.95	0.951	1	0.949	0.97	0.982	0.971
S13	0.996	0.948	0.999	0.983	0.998	1	0.949	1	0.995	0.997	0.998	0.949	1	0.98	0.982	0.996
S14	0.975	0.967	0.978	0.999	0.976	0.978	0.966	0.978	0.985	0.978	0.979	0.97	0.98	1	0.984	0.99
S15	0.98	0.981	0.982	0.987	0.983	0.983	0.981	0.981	0.977	0.982	0.981	0.982	0.982	0.984	1	0.992
S	0.995	0.971	0.996	0.992	0.996	0.996	0.972	0.996	0.993	0.996	0.996	0.971	0.996	0.99	0.992	1

Research on Quality Evaluation of Yiyi-Zhuye Powders Based on Fingerprint， Quality Value Transfer and Chemometrics

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Sample	Number of the peaks
Sample	1	2	3	4	5	6	7	8	9	10	11
1	0.095	0.050	0.107	0.077	0.143	0.138	0.097	0.052	0.035	0.093	0.029
2	0.494	0.101	0.267	0.184	0.407	0.399	0.045	0.295	0.518	0.192	0.112
3	0.080	0.033	0.094	0.075	0.093	0.174	0.021	0.025	0.022	0.127	0.085
4	0.110	0.044	0.075	0.035	0.081	0.131	0.274	0.084	0.018	0.097	0.032
5	0.090	0.041	0.082	0.059	0.104	0.259	0.031	0.022	0.019	0.247	0.019
6	0.079	0.032	0.028	0.078	0.106	0.248	0.024	0.023	0.019	0.147	0.084
7	0.469	0.104	0.091	0.178	0.425	0.601	0.043	0.291	0.504	0.294	0.122
8	0.072	0.022	0.068	0.014	0.094	0.221	0.028	0.024	0.098	0.162	0.076
9	0.089	0.036	0.059	0.038	0.082	0.103	0.392	0.023	0.106	0.106	0.030
10	0.082	0.034	0.058	0.054	0.088	0.242	0.044	0.024	0.115	0.284	0.029
11	0.085	0.042	0.082	0.072	0.086	0.112	0.095	0.023	0.105	0.103	0.018
12	0.367	0.097	0.206	0.166	0.376	0.460	0.034	0.255	0.407	0.362	0.095
13	0.080	0.030	0.082	0.078	0.085	0.201	0.052	0.014	0.069	0.135	0.069
14	0.109	0.041	0.060	0.036	0.084	0.122	0.140	0.019	0.100	0.095	0.028
15	0.476	0.101	0.227	0.186	0.421	0.571	0.040	0.300	0.497	0.290	0.111
RSD/%	91.1	55.5	65.8	66.9	80.8	62.2	116.9	120.6	111.5	49.3	60.4
Sample	Number of the peaks
Sample	12	13	14	15	16	17	18	19	20	21
1	1.412	0.276	0.389	7.042	1.000	0.054	0.285	0.078	0.754	0.063
2	1.644	0.396	0.777	8.490	1.000	0.462	0.078	0.125	0.745	2.397
3	1.239	0.216	0.370	5.682	1.000	0.035	0.168	0.016	0.789	0.079
4	0.819	0.225	0.335	5.282	1.000	0.022	0.091	0.115	0.988	0.905
5	1.185	0.272	0.330	6.283	1.000	0.041	0.194	0.061	0.727	0.064
6	1.227	0.246	0.387	5.658	1.000	0.036	0.165	0.016	0.802	0.074
7	1.914	0.432	0.891	10.128	1.000	0.545	0.069	0.050	0.725	2.730
8	1.196	0.255	0.396	5.624	1.000	0.035	0.168	0.035	0.802	0.047
9	0.783	0.248	0.333	5.096	1.000	0.022	0.119	0.076	0.920	0.040
10	1.117	0.285	0.343	6.075	1.000	0.043	0.222	0.073	0.704	0.066
11	1.176	0.250	0.323	5.912	1.000	0.044	0.203	0.062	0.712	0.073
12	1.412	0.350	0.638	7.286	1.000	0.374	0.079	0.085	0.748	2.107
13	1.148	0.246	0.420	5.319	1.000	0.032	0.155	0.036	0.814	0.058
14	0.827	0.251	0.350	5.128	1.000	0.022	0.108	0.110	0.985	0.911
15	1.738	0.418	0.837	8.866	1.000	0.474	0.097	0.107	0.687	2.629
RSD/%	26.2	24.6	42.7	23.6	—	133.3	42.6	50.1	12.2	132.0

Number		Sample mass/mg	Sample content/%	Hydration/%	Absolute content/%	Tansfer rate/%	Average/%
Decoction pieces	CSL-20200913	11.25	0.276 1	5.5	0.292	-	-
	CSL-20200915	11.27	0.271 1	4.6	0.284
	CSE-20201013	11.19	0.274 7	4.7	0.288
	SES-20210813	11.26	0.992 3	3.4	1.027
	SES-20210815	11.20	0.987 9	3.9	1.028
	SES-20210816	11.24	0.990 5	4.8	1.040
	CLB-20210901	11.23	0.419 9	5.2	0.443
	CLB-20210906	11.20	0.421 6	5.1	0.444
	CLB-20210908	11.22	0.425 5	4.8	0.447
	HLB-20210922	11.27	0.215 6	3.8	0.224
	HLB-20210926	11.19	0.217 1	4.3	0.227
	HLB-20210930	11.23	0.220 8	4.3	0.231
	GYX-20211007	11.21	0.447 8	5.1	0.472
	GYX-20211009	11.23	0.436 6	4.6	0.458
	GYX-20211011	11.28	0.428 8	5.5	0.454
YZP sample	S1	89.90	0.032	7.2	0.034	94.31	94.32
	S2	89.65	0.030	8.6	0.033	91.88
	S3	89.72	0.034	8.9	0.037	103.81
	S4	89.70	0.109	7.8	0.118	91.68
	S5	89.75	0.105	8.0	0.114	88.97
	S6	89.63	0.112	7.1	0.121	92.40
	S7	89.97	0.051	8.2	0.056	100.49
	S8	89.84	0.049	8.2	0.053	96.38
	S9	89.88	0.045	7.4	0.049	87.10
	S10	89.70	0.031	7.9	0.034	119.54
	S11	89.65	0.030	8.8	0.033	116.17
	S12	89.76	0.022	8.9	0.024	83.66
	S13	89.84	0.046	7.3	0.050	84.28
	S14	89.54	0.041	8.9	0.045	78.41
	S15	89.96	0.045	7.8	0.049	85.78

Group	Ingredient	Regression equation	r	Linearity range/（μg·mL^-1）
Lophatheri Herba	orientin	Y=28.221X-53.991	0.999 6	12.00~100.02
Lophatheri Herba	Isoorientin	Y=18.775X+35.963	0.999 5	11.98~99.80
YZP	orientin	Y=23.817X+21.64	0.999 3	17.18~122.70
YZP	Isoorientin	Y=27.574X+246.21	0.999 7	39.46~246.60

Lophatheri Herba	Sample mass/g	Known sample content/mg	Standard addition quantity/mg	Measured quantity/mg	Recovery/%	Average recovery/%	RSD/%
1	1.000 5	0.168 1	0.168 0	0.336 0	99.93	99.43	1.53
2	1.000 4	0.168 1	0.168 0	0.338 6	101.54
3	1.000 2	0.168 0	0.168 0	0.331 5	97.31
4	1.000 1	0.168 0	0.168 0	0.335 0	99.41
5	1.000 8	0.168 1	0.168 0	0.336 6	100.26
6	1.000 1	0.168 0	0.168 0	0.332 8	98.11
YZP	Sample mass/g	Known sample content/mg	Standard addition quantity/mg	Measured quantity/mg	Recovery/%	Average recovery/%	RSD/%
1	2.500 5	0.096 5	0.138 0	0.232 1	98.28	100.53	1.60
2	2.500 6	0.096 5	0.138 0	0.233 6	99.36
3	2.500 9	0.096 5	0.138 0	0.234 9	100.32
4	2.500 5	0.096 5	0.138 0	0.238 3	102.76
5	2.500 4	0.096 5	0.138 0	0.236 6	101.55
6	2.500 0	0.096 5	0.138 0	0.236 1	101.19

Lophatheri Herba	Sample mass/g	Known sample content/mg	Standard addition quantity/mg	Measured quantity/mg	Recovery/%	Average recovery/%	RSD/%
1	1.000 5	0.566 3	0.540 0	1.089 2	96.83	96.84	0.69
2	1.000 6	0.566 3	0.540 0	1.094 1	97.73
3	1.000 4	0.566 2	0.540 0	1.086 5	96.33
4	1.000 5	0.566 3	0.540 0	1.084 1	95.90
5	1.000 7	0.566 4	0.540 0	1.092 2	97.39
6	1.000 6	0.566 3	0.540 0	1.089 5	96.89
YZP	Sample mass/g	Known sample content/mg	Standard addition quantity/mg	Measured quantity/mg	Recovery/%	Average recovery/%	RSD/%
1	2.500 5	0.183 1	0.175 0	0.356 0	98.28	100.68	1.16
2	2.500 6	0.183 1	0.175 0	0.358 2	99.36
3	2.500 9	0.183 1	0.175 0	0.359 2	100.32
4	2.500 5	0.183 1	0.175 0	0.361 9	102.76
5	2.500 4	0.183 1	0.175 0	0.360 0	101.55
6	2.500 0	0.183 1	0.175 0	0.360 6	101.19

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