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Method for constructing standard fingerprint of Heiketong Tablet and method for determining its component content

A technology of standard fingerprint and construction method, which is applied in the field of construction of standard fingerprint of Heketong Tablet and determination of its component content, can solve the problems of simplicity, low content of ferulic acid, difficulty in comprehensively controlling product quality, etc., and achieve theoretical plate Good number, high product commonality, and the effect of improving product quality

Active Publication Date: 2022-04-08
湖南时代阳光药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing quality standard of this variety only quantitatively measures the ferulic acid in the prescription, the standard is relatively simple, and the ferulic acid content is low, it is difficult to fully control the product quality, and there is no quality evaluation standard that fits the characteristics of traditional Chinese medicine

Method used

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  • Method for constructing standard fingerprint of Heiketong Tablet and method for determining its component content
  • Method for constructing standard fingerprint of Heiketong Tablet and method for determining its component content
  • Method for constructing standard fingerprint of Heiketong Tablet and method for determining its component content

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Establishment of Standard Fingerprint of Heiketong Tablets

[0042] In order to make the medicinal materials sufficiently representative, medicinal materials from different origins or different commodity specifications and grades were collected as test samples.

[0043] Chromatographic conditions

[0044] Chromatographic column: InertSustain C18 (4.6×250mm, 5μm) Mobile phase: methanol-0.1 acetic acid water gradient elution: 0~10min: 20%~40% methanol; 10~20min: 40% methanol; 20~30min: 40%~ 42% methanol; 30-50min: 42%-47% methanol; 50-80min: 47%-60% methanol; 80-90min: 60%-90% methanol; 90-100min: 90% methanol. Detection wavelength: 300nm; flow rate: 1ml / min; column temperature: 25°C; injection volume: 10μl; theoretical plate number based on aloin is not less than 5000.

[0045] Solution preparation

[0046] Preparation of reference solution

[0047]Accurately weigh the appropriate amount of aloin, naringin, neohesperidin, echinacoside, rhein and aloe-emodin reference...

Embodiment 2

[0066] Embodiment 2 reference substance solvent stability investigation

[0067] Aloe vera reference substance solution ①: aloin reference substance 1.23mg (purity 94.4%) → 10ml (methanol)

[0068] Aloe vera reference substance solution ②: aloin reference substance 1.23mg (purity 94.4%) → 10ml (mobile phase)

[0069] Take the above-mentioned reference substance solution, inject and analyze at 0h, 2h, 4h, and 6h respectively, and calculate the degradation rate of aloin by comparing the peak areas. The results show that aloin is more stable in the mobile phase mixed solution than in methanol solution, and the literature shows that the aloin solution is more sensitive to light and heat, so the mobile phase should be used as the solvent when preparing the aloin reference solution, and it is necessary to avoid Light, low temperature preservation.

[0070] Table 3 Reference substance solution stability investigation

[0071]

[0072] Most of aloin is the sum of two optical iso...

Embodiment 3

[0074] Confirm the source of the common peaks. Take the appropriate amount of the 9 medicinal materials in the Ketong prescription, weigh them accurately, and prepare the medicinal material sample solution. Precisely draw separately, inject 10 μL each of the prepared test solution and 9 medicinal material sample solutions, inject into the high-performance liquid chromatograph, and record the chromatogram for 100 minutes. Analyze and compare the chromatographic peaks with consistent retention times, identify the relevant peaks in the fingerprints of the whole prescription and medicinal materials according to the ultraviolet spectrum information, and confirm the medicinal materials of the common peaks, see image 3 .

[0075] Through the study on the correlation between the Heiketong tablet compound and the whole prescription, the sources of 16 characteristic peaks in the HPLC fingerprint of the Heiketong tablet compound were confirmed. The fingerprint peaks were from Cistanche ...

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Abstract

The invention relates to a method for constructing standard fingerprints of Heiketong Tablets and a method for determining the component content of Heiketong Tablets, comprising the following steps: preparation of a test solution; preparation of a reference solution: mixing aloin with methanol and 0.1 % volume concentration of acetic acid water mixed solution is dissolved, and naringin, neohesperidin and echinacoside are dissolved with methanol respectively to obtain the reference substance solution respectively; high performance liquid chromatography detection: chromatographic conditions are: using mobile phase A as methanol , Mobile phase B is the aqueous acetic acid solution of 0.1% volume concentration, and total flow velocity is 1ml / min; Carry out gradient elution; Establish and pass the standard fingerprint of sheet; The peak type of fingerprint of the present invention is better, and separation degree, symmetry factor and the number of theoretical plates are good; the present invention can effectively separate the components with small structural differences, can improve the quality of standard products, and more accurately realize the simultaneous determination of the active ingredient content in the product.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for constructing a standard fingerprint of Heiketong Tablet and a method for determining its component content. Background technique [0002] Constipation is a common and frequently-occurring disease, and there is a lack of effective treatments for constipation. Relying on traditional Chinese medicine theories, developing innovative Chinese medicines mainly for the treatment of constipation is market demand-oriented and an important initiative to inherit and develop the tradition of Chinese medicine. The innovative Chinese medicine "Bianketong Tablet" is an innovative Chinese medicine mainly for the treatment of constipation. It has obtained approval for clinical research. The research and development of innovative Chinese medicine for Ketong Tablet has great strategic significance for the sustainable development of the Chinese medicine industry. The cantong...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/60
CPCG01N30/02G01N30/06G01N30/34G01N30/60G01N2030/045
Inventor 肖娟唐纯玉万丹梁雪娟唐代凤张水寒王雄龙周华荣李震
Owner 湖南时代阳光药业股份有限公司
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