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Method for constructing fingerprint of Yangweishu granules

A technology of fingerprint spectrum and construction method, applied in the field of drug analysis, can solve the problem of not being able to meet the quality evaluation well, and achieve the effects of easy realization of chromatographic conditions, improved effectiveness and safety, and good repeatability.

Active Publication Date: 2018-12-18
合肥华润神鹿药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the limitations of the experimental conditions at that time, the standard formulation was simple and could not meet the requirements of quality evaluation.
There is no report on the fingerprint research of Yangweishu Granules at home and abroad. In order to ensure the uniformity and stability of drug quality and the safety and effectiveness of patients' medication, a method that can comprehensively and quickly detect the quality of Yangweishu Granules is established. Its comprehensive quality inspection and overall quality control are of great significance

Method used

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  • Method for constructing fingerprint of Yangweishu granules
  • Method for constructing fingerprint of Yangweishu granules
  • Method for constructing fingerprint of Yangweishu granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Embodiment 1: the preparation of need testing solution

[0064] 1. Investigation of extraction solvent and injection volume

[0065] Take about 7.5g of Yangweishu granule samples (1705202), 4 parts, put them into 150mL conical flasks with stoppers, respectively add methanol, 75% methanol, 50% methanol, and 25mL of water, ultrasonically extract for 30min, put it at room temperature, Pass through a 0.45μm filter membrane, and take the subsequent filtrate. Inject 20 μL and 10 μL of the above test substances respectively. Compare the difference in peak area per unit mass of different solvents.

[0066] The results show that the peak shape of 20 μL injection is poor, the peak shape of 10 μL is better, and the theoretical pedal number is higher, so the injection volume of 10 μL is selected; the peak area of ​​the main chromatographic peak per unit mass of the test sample extracted by 50% methanol solution is larger , the extraction is relatively complete; extraction with m...

Embodiment 2

[0070] Embodiment 2: chromatographic condition optimization

[0071] 1. Inspection of detection wavelength

[0072] Referring to the literature "Simultaneous Determination of Chlorogenic Acid, Vitexin Rhamnoside and Hesperidin in Yangweishu Granules by HPLC", the maximum absorption wavelengths of chlorogenic acid, vitexin rhamnoside and hesperidin are respectively 327nm, 335nm, 283nm, using a PDA detector to measure the Yangweishu granule sample (1705202) in the wavelength range of 220nm-400nm, extract the chromatograms at 220nm, 254nm, 280nm, 300nm, 330nm respectively, and compare the above different wavelengths. The chromatographic peak information at 220nm and 280nm is the most abundant, and the baseline at 280nm is better and there are several main chromatographic peaks (RT = 39.745, 31.891, 39.954) that have maximum absorption near 280nm, so 280nm is selected as the detection of the fingerprint of Yangweishu Granules wavelength.

[0073] 2. Investigation of elution grad...

Embodiment 3

[0076] Example 3: Construction of Fingerprint of Yangweishu Granules

[0077] Take 10 batches of Yangweishu granule samples that have passed the current standard test, and the batch numbers are 1705202 (S1), 1704213 (S2), 1704208 (S3), 1703220 (S4), 1703216 (S5), 1703207 (S6), 1701219 (S7 ), 1701210(S8), 1701206(S9), 1701201(S10), according to the optimized detection conditions, the fingerprint detection of Yangweishu Granules is carried out, which specifically includes the following steps:

[0078] (1) Preparation of the test solution: take Yangweishu granule powder, accurately weigh 7.5g, add 25mL of methanol solution with a volume concentration of 50%, ultrasonically treat for 45min, let cool, filter, and take the subsequent filtrate to obtain the test solution product solution;

[0079] (2) Preparation of the reference substance solution: Accurately weigh the hesperidin reference substance, add methanol to prepare a 0.06 mg / mL reference substance solution as the reference...

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Abstract

The invention discloses a method for constructing a fingerprint of Yangweishu granules. The method comprises the steps of: extracting the Yangweishu granules as atest solution, determining at least 10batches of the Yangweishu granules according to an optimized chromatographic condition to obtain a corresponding chromatogram, and introducing the chromatogram into the similarity evaluation system of the traditional Chinese medicine chromatographic fingerprint prescribed by the Chinese Pharmacopoeia Commission to obtain the fingerprint of the Yangweishu granules. The method for constructing thefingerprint of the Yangweishu granuleshas the characteristics of convenience and simplicity in method, good stability, high precision and good reproducibility, can fully reflect material information of a traditional Chinese medicine preparation, and provides a new analytical method for quality inspection and quality control of the Yangweishu Granules.

Description

technical field [0001] The invention relates to a method for constructing fingerprints of Yangweishu granules, which can be used for quality evaluation of samples of different batches of Yangweishu granules, and belongs to the field of drug analysis. Background technique [0002] Traditional Chinese medicine fingerprint refers to the chromatogram or spectrum that can mark the characteristics of this kind of Chinese medicinal material or Chinese patent medicine obtained after proper processing and certain analysis methods. Among them, chromatographic methods are the main ones. [0003] Yangweishu granule is a new product developed according to the scientific research achievements of Professor Jin Naishi of the 105th Hospital of the People's Liberation Army and Professor Su Chunlang of Anhui College of Traditional Chinese Medicine, which won the National Chinese Medicine Major Scientific and Technological Achievement Award. It nourishes yin and nourishes the stomach. It is us...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 马雨涵秦海军张艳李涛于波韩亮黄夏宁马迅兵
Owner 合肥华润神鹿药业有限公司
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