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A construction method and application of Guilingji uplc fingerprint

A technology of fingerprints and construction methods, applied in instruments, measuring devices, scientific instruments, etc., to achieve the effects of convenient operation, improved product consistency rate, and guaranteed curative effect

Active Publication Date: 2021-03-02
山西广誉远国药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no literature report on the research on the HPLC fingerprint of Guilingji. In order to ensure the safety and effectiveness of medication for patients, the present invention establishes a fingerprint detection method suitable for the quality control of Guilingji.

Method used

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  • A construction method and application of Guilingji uplc fingerprint
  • A construction method and application of Guilingji uplc fingerprint
  • A construction method and application of Guilingji uplc fingerprint

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: Construction of Guilingji UPLC fingerprint

[0031] 1.1 Instrument

[0032] Waters Acquity UPLC H-Class ultra-high performance liquid chromatography system, Empower workstation with quaternary gradient pump, autosampler, PDA detector (Waters company); ultrasonic cleaner (KQ2200DB numerical control ultrasonic cleaner, Kunshan Ultrasonic Instrument Co., Ltd. company); balance (CPA225D electronic analytical balance, Sartorius Scientific Instrument Co., Ltd.); centrifuge (SC-3160 low-speed centrifuge, Anhui Zhongke Zhongjia Scientific Instrument Co., Ltd.); water bath (HH-ZK4 type, Gongyi Yuhua Instrument Co., Ltd.); Milli-Q Integral Water Purification System (Millipore, USA).

[0033] 1.2 Reagents and Reagents

[0034] 样品:龟龄集(山西广誉远国药有限公司),批号为20130201、20130302、20141112、20150101、20150507、20151212、103160203、103160407、103160508、103160917、103161018、103170305、103170408、103170510、103170714。

[0035] Reagents: ultrapure water; methanol and acetonitrile are chromat...

Embodiment 2

[0052] Example 2: Research on the Methodology of Guiling Collection Fingerprint

[0053] 2.1 Precision test

[0054] Accurately weigh the same batch of Guilingji, prepare the test solution according to the above-mentioned experimental method, continuously inject 6 times according to the above-mentioned chromatographic conditions, and record the chromatogram. The chromatogram obtained by the continuous injection of the same test sample for 6 times is carried out for similarity analysis, and the result shows that its similarity is 1. The relative retention time of 19 common peaks is investigated, and the RSD of the relative retention time of each chromatographic peak<0.13%, It shows that the precision of the instrument is good.

[0055] 2.2 Repeatability test

[0056] A total of 6 samples of the same batch of Guilingji were weighed, and 6 samples of the test solution were prepared in parallel according to the above-mentioned experimental method, measured according to the above...

Embodiment 3

[0059] Embodiment 3 Guiling set comparison feature map and similarity evaluation

[0060] A total of 15 batches of different batches of Guilingji were taken and analyzed respectively according to the established fingerprint analysis method of Guilingji to obtain the UPLC fingerprint overlay of 15 batches of medicinal materials (such as image 3 shown). Based on the chromatograms of the above-mentioned 15 batches of samples, use the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" (2008 edition) recommended by the Pharmacopoeia Committee to perform data processing to obtain a common pattern characteristic map, which is the Guiling set control characteristic map R (Such as figure 1 shown). The retention times of the main chromatographic peaks of the 15 batches of samples were basically the same, and the 19 peaks with larger peak areas and better separation under the detection conditions were determined to be their common chromatographic peaks. Calcu...

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Abstract

The invention discloses a construction method of Guilingji UPLC fingerprint and its application, which belongs to the technical field of traditional Chinese medicine. Psoralen, new psoralen isoflavone and oleanolic acid are selected as reference substances, and the test substances are precisely absorbed 2‑5 μL each of solution and reference solution were injected into ultra-high performance liquid chromatography for analysis, chromatographic conditions: chromatographic column filled with octadecylsilane-bonded silica gel, column temperature 25‑35 °C, flow rate 0.1‑0.3 mL / min, the detection wavelength is 203nm, and the mobile phase is eluted with a gradient of acetonitrile and water to obtain the UPLC fingerprint of Guilingji. The fingerprint of the tortoise set established by the invention can comprehensively reflect the material information of the tortoise set, has high precision and good reproducibility, and can accurately and effectively evaluate and control the quality of the tortoise set.

Description

technical field [0001] The invention relates to a method for constructing fingerprints of traditional Chinese medicines, in particular to a method for constructing UPLC fingerprints of Guilingji and its application in quality monitoring of Guilingji. Background technique [0002] Guilingji consists of red ginseng, velvet antler, hippocampus, medlar, clove, pangolin, finch brain, achyranthes bidentata, Cynomorium cynomorium, Rehmannia glutinosa, psoralen, dodder, Eucommia ulmoides, stone swallow, cistanche, licorice, asparagus, epimedium , Daqing salt, amomum and other 28 kinds of medicinal materials are processed and refined into a large compound prescription of traditional Chinese medicine (Pharmacopoeia of the People's Republic of China, 2015 edition, page 985). Its formula is huge and its ingredients are complex. In order to maintain the stable efficacy of different batches of this large compound Chinese medicine, it is necessary to formulate strict enterprise internal co...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/8686
Inventor 王佩义郝晋琪秦雪梅高晓霞史静超
Owner 山西广誉远国药有限公司
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