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Construction method and application of UPLC fingerprint of Dinghundan

A technology of fingerprint spectrum and construction method, which is applied to the construction of Dingkundan UPLC fingerprint spectrum and the application field of Dingkundan quality monitoring, to achieve the effect of improving product consistency rate, convenient operation and guarantee of curative effect.

Active Publication Date: 2019-01-01
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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  • Construction method and application of UPLC fingerprint of Dinghundan
  • Construction method and application of UPLC fingerprint of Dinghundan
  • Construction method and application of UPLC fingerprint of Dinghundan

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 construction method and application of the UPLC fingerprint of Dinghundan, belonging to the technical field of traditional Chinese medicines. According to the invention, a test solution and a reference solution are respectively subjected to ultra-high performance liquid chromatographic analysis under the following chromatographic conditions: formic acid-water with a concentration of 0.1% is used as a mobile phase A; formic acid-methanol with a concentration of 0.1% is used as a mobile phase B; gradient elution is performed; a column temperature is 30 DEG C; the sampleinlet amount is 5 [mu]mL; the flow rate is 0.2 mL / min; and detection wavelength is 280 nm. 22 common peaks are obtained through analysis of the fingerprint information of Dinghundan. According to theinvention, traditional Chinese medicine chromatographic fingerprint similarity evaluation system software developed by the National Pharmacopoeia Commission is adopted for data matching of the liquidchromatograms of the test solution and the reference solution to obtain a standard fingerprint chromatogram. The fingerprint of Dinghundan established by using the construction method provided by theinvention can comprehensively reflect substance information of Dinghundan, and can accurately and effectively evaluate and control the quality of Dinghundan.

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 Applications(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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