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A method for determining the fingerprint of compound Nanlangen granules

A technology of compound Nanbanlan and Nanlangen, which is applied in the field of traditional Chinese medicine, can solve problems such as the inability to control product quality as a whole, complex components of traditional Chinese medicine compound, and inability to fully reflect the overall quality characteristics of the product, achieving stable baseline, high precision, Good stability and reproducibility

Active Publication Date: 2021-07-20
GUANGZHOU BAIYUNSHAN QIXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current quality standard of compound Nanlangen granule only uses thin-layer chromatography to qualitatively identify Nanlangen in the prescription, but the composition of traditional Chinese medicine compound is complex, and the existing quality standard cannot fully reflect the overall quality characteristics of the product, and cannot control the quality of the product as a whole. quality
[0003] As a Chinese patent medicine, compound Nanlangen granule is a multi-component complex system, so its quality evaluation should adopt detection methods that can provide rich identification information, but the current microscopic identification, physical and chemical identification, content determination, high performance liquid chromatography methods such as

Method used

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  • A method for determining the fingerprint of compound Nanlangen granules
  • A method for determining the fingerprint of compound Nanlangen granules
  • A method for determining the fingerprint of compound Nanlangen granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1: Establishment of the Fingerprint Determination Method for Compound Nanlangen Granules

[0048] 1. Wavelength selection

[0049] Instrument: Agilent1260 high performance liquid chromatograph, ML204 / 02 analytical balance.

[0050] Reagents: HPLC analytical reagents are chromatographically pure, other reagents are analytically pure, water is ultrapure water, and compound Nanlangen granules are provided by Guangzhou Baiyunshan Qixing Pharmaceutical Co., Ltd.

[0051] Preparation of the test solution: accurately weigh about 10 g of compound Nanlangen granules, accurately add 25 mL of methanol solution with a volume concentration of 75% for extraction, weigh the weight, extract by ultrasonic (power 250W, frequency 50kHz) for 45min, return to room temperature and then extract Weigh the weight, use 75% methanol solution to supplement the lost weight, shake well, filter, filter with a 0.45 μm microporous membrane, and get the subsequent filtrate to obtain the test ...

Embodiment 2

[0074] Example 2: Quality detection method of compound Nanlangen granules based on fingerprint

[0075] Instrument: Agilent1260 high performance liquid chromatograph, ML204 / 02 analytical balance.

[0076] Reagents: acetaminophen B reference substance (batch number 200506), caffeic acid reference substance (batch number D11808026) were purchased from China National Institute for the Control of Pharmaceutical and Biological Products, the liquid chromatography analysis reagents were chromatographically pure, the remaining reagents were analytically pure, and the water was ultrapure water , Compound Nanlangen Granules are provided by Guangzhou Baiyunshan Qixing Pharmaceutical Co., Ltd.

[0077] Preparation of the test solution: Accurately weigh about 10g of compound Nanlangen granules, add 25mL of methanol solution with a volume concentration of 50% for extraction, weigh the weight, extract by ultrasonic for 45min, return to room temperature and weigh again, use 50% Methanol so...

Embodiment 3

[0083] Embodiment 3: methodological investigation

[0084] 3.1 Stability test

[0085] Taking the same batch of test samples (Guangzhou Baiyunshan Qixing Pharmaceutical Co., Ltd.), according to the best method for establishing fingerprints of compound Nanlangen granules, the fingerprints were detected at 0, 2, 4, 8, 12, and 24 hours respectively. With fencetin (peak No. 2) as the reference peak, record the chromatogram, calculate the relative retention time and relative peak area of ​​each common peak chromatogram peak, the results are shown in Table 5 and Table 6, and the relative retention time RSD of each common peak is less than 1.0 %, the RSD of the relative peak area is less than 5.0%, indicating that the composition of the test solution is stable within 24h.

[0086] Table 5. Stability test-relative retention time ratio of main chromatographic peaks

[0087] Time / Peak ID 1 2 3 4 5 6 7 8 9 0h 0.715 1.000 1.063 1.122 1.500 1.590 1.692 1....

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Abstract

The invention provides a method for determining the fingerprint of compound Nanbanlangen granules. The construction method of fingerprint spectrum includes the following steps: preparation of test solution: taking compound Nanbanlangen granules, grinding, extracting with organic solvent, and filtering; preparation of reference solution: weighing qinpirin and caffeic acid, and dissolving in organic solvent; high-performance liquid phase Chromatographic detection: draw the test solution and reference solution, inject it into a high performance liquid chromatograph, and measure it according to high performance liquid chromatography to obtain the fingerprint of compound Nanbanlangen granules. The fingerprint spectrum is rich in information and rich in spectral peak information, including 9 common peaks, and the common peaks belong to different medicinal materials of Fufang Nanbanlangen Granules. Such spectral peak characteristics can effectively reflect the overall chemical characteristic information of Nanbanlangen Granules, Comprehensively reflect the quality of Nanbanlangen granules. In addition, the present invention maintains a stable baseline, high precision, and good stability and reproducibility under the condition that there are many peaks.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a method for determining the fingerprint of compound Nanlangen granules, in particular to a method for constructing the fingerprint of the compound Nanlangen granule and a quality detection method. Background technique [0002] Compound Nanlangen granules are made from three herbs of Nanlangen, Zihuadiding, Dandelion and auxiliary materials, which have the effect of anti-inflammatory and detoxification. For mumps, pharyngitis, mastitis, boils, swelling and pain. The current quality standard of compound Nanlangen granule only uses thin-layer chromatography to qualitatively identify Nanlangen in the prescription, but the composition of traditional Chinese medicine compound is complex, and the existing quality standard cannot fully reflect the overall quality characteristics of the product, and cannot control the quality of the product as a whole. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/36
CPCG01N30/02G01N30/36
Inventor 张春波伏宝香李锦灵周瑞彭中芳
Owner GUANGZHOU BAIYUNSHAN QIXING PHARMA
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