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A kind of construction method and application of Dingkundan uplc fingerprint

A fingerprint and construction method technology, applied in the quality monitoring of Dingkun Dan, the construction field of Dingkun Dan UPLC fingerprint, to achieve the effect of improving product consistency, curative effect guarantee, and convenient operation

Active Publication Date: 2021-02-02
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 HPLC fingerprint research of Dingkun Dan. In order to ensure the safety and effectiveness of medication for patients, the present invention establishes a fingerprint detection method suitable for quality control of Dingkun Dan.

Method used

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  • A kind of construction method and application of Dingkundan uplc fingerprint
  • A kind of construction method and application of Dingkundan uplc fingerprint
  • A kind of construction method and application of Dingkundan uplc fingerprint

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1: the construction of Dingkundan UPLC fingerprint

[0039] 1.1 Instrument

[0040] 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); one ten thousandth balance (CPA225D electronic analytical balance, Sartorius Scientific Instrument Co., Ltd.); Milli-Q Integral Water Purification System (Millipore, USA).

[0041] 1.2 Reagents and Reagents

[0042] 样品:定坤丹(山西广誉远国药有限公司),批号为139170643、139170644、139170645、139170647、139170648、139170649、139170650、139170651、139170652、139170653、139170654、139170655、139170656、139170657、139170658、139170659、139170661 , 139170662, 139170663.

[0043] Reagents: ultrapure water; methanol and formic acid are chromatographically pure (Fisher, USA); other reagents are analytically pure.

[0044] 1.3 Pre...

Embodiment 2

[0053] Example 2: Dingkundan control characteristic map and similarity evaluation

[0054] A total of 19 batches of Dingkundan were taken from different production batches, analyzed respectively according to the established Dingkundan fingerprint analysis method, and the UPLC fingerprint superimposition diagrams of 19 batches of samples were obtained (such as image 3 shown). Based on the chromatograms of the above-mentioned 19 batches of samples, use the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System" (2008 Edition) recommended by the Pharmacopoeia Commission to perform data processing to obtain a common pattern characteristic spectrum, which is the Dingkundan control characteristic spectrum R (Such as figure 1 shown). The retention times of the main chromatographic peaks of the 19 batches of samples were basically the same, and the 22 peaks with good separation under the detection conditions were determined to be their common chromatographic pea...

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Abstract

The invention discloses a method for constructing Dingkundan UPLC fingerprint and its application, belonging to the technical field of traditional Chinese medicine. The test solution and the reference solution were subjected to ultra-high performance liquid chromatography analysis, and the chromatographic conditions were 0.1% formic acid water as mobile phase A, 0.1% formic acid methanol as mobile phase B, gradient elution, column temperature 30 ° C , the injection volume was 5 μL, the flow rate was 0.2 mL / min, and the detection wavelength was 280 nm. A total of 22 common peaks were obtained by analyzing the fingerprint information of Dingkundan. Using the Chinese medicine chromatographic fingerprint similarity evaluation system software formulated by the National Pharmacopoeia Commission, the liquid chromatographic data of the test solution and the reference solution were matched to obtain the standard fingerprint. The Dingkundan fingerprint spectrum established by the invention can comprehensively reflect the material information of the Dingkundan, and can accurately and effectively evaluate and control the quality of the Dingkundan.

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 Dingkundan and its application in quality monitoring of Dingkundan. Background technique [0002] Dingkundan is composed of red ginseng, velvet antler, saffron, Panax notoginseng, white peony root, rehmannia glutinosa, angelica, Atractylodes macrocephala, medlar, scutellaria baicalensis, Cyperus cyperi, Fructus chinensis, Chuanxiong, antler cream, donkey-hide gelatin, Corydalis Corydalis, etc. The processed large honey pill can nourish qi and blood, regulate menstruation and relieve depression. The formula is very complicated and has many medicinal flavors. In order to maintain the stable efficacy of different batches of this large compound Chinese medicine, it is necessary to formulate strict internal control quality standards. The 2015 edition of "Chinese Pharmacopoeia" stipulates that the ...

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 王佩义张爱荣郝晋琪秦雪梅王楠高晓霞
Owner 山西广誉远国药有限公司
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