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Construction method for HPLC fingerprint of Chinese patent medicine erosion-removal suppository

A fingerprint and construction method technology, applied in the field of construction of HPLC fingerprint of Chinese patent medicine, can solve the problems of controlling product quality, difficult to react the product as a whole, achieving good reproducibility, reducing the possibility of sample quality meeting the standard, The effect of accurate and reliable control

Active Publication Date: 2018-10-12
TONGYAO PHARMA GROUP CORP
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its quality standards only control the content determination of one component of the blind medicine and the qualitative identification of a single component, which makes it difficult to reflect the quality of the product as a whole or to control the quality of the product as a whole
[0003] Traditional Chinese medicine and its preparations are multi-component complex systems, so the evaluation of their quality should adopt detection methods that are suitable for it and can provide rich identification information, but the current methods of microscopic identification, physical and chemical identification and content determination are not enough solve this problem

Method used

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  • Construction method for HPLC fingerprint of Chinese patent medicine erosion-removal suppository
  • Construction method for HPLC fingerprint of Chinese patent medicine erosion-removal suppository
  • Construction method for HPLC fingerprint of Chinese patent medicine erosion-removal suppository

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1: The quality control method of Xiaomishuan based on fingerprint.

[0033] Instruments: UltiMate 3000 HPLC, UV DAD detector; Mettler AE240 1 / 100,000 analytical balance (Shanghai Mettler-Toledo Instrument Co., Ltd.); AB204-E electronic balance (Shanghai Mettler-Toledo Instrument Co., Ltd.), etc.

[0034] Reagents: methanol, etc. are analytically pure, phosphoric acid and acetonitrile are chromatographically pure, and water is ultrapure water.

[0035] Test drugs: catechin, epicatechin, matrine, berberine hydrochloride (all from China National Institutes for Food and Drug Identification), and "Xiaomishuan" provided by Tongyao Pharmaceutical Group Co., Ltd.

[0036] Preparation of the test solution: remove the mita suppository sample, cut it into pieces, take about 3g, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 50mL of 50% methanol aqueous solution precisely, weigh it, and heat it in a water bath at 50°C. Fully dissolve, take out, let cool,...

Embodiment 2

[0043] Example 2: The quality control method of Xiaomishuan based on fingerprint.

[0044] Instrument: L3000-Rigol high performance liquid chromatography, ultraviolet detector; MS205DU analytical balance (Shanghai Mettler-Toledo Instrument Co., Ltd.);

[0045] Reagents: methanol, etc. are analytically pure, phosphoric acid and acetonitrile are chromatographically pure, and water is ultrapure water.

[0046] Test drugs: catechin, epicatechin, matrine, berberine hydrochloride (all from China National Institutes for Food and Drug Identification), and "Xiaomishuan" provided by Tongyao Pharmaceutical Group Co., Ltd.

[0047] Preparation of the test solution: cancel the mitobolus sample, cut it into pieces, take about 5g, accurately weigh it, put it in a stoppered Erlenmeyer flask, accurately add 100mL of 50% methanol aqueous solution, weigh it, and heat it in a water bath at 70°C. Fully dissolve, take out, let cool, ultrasonic treatment (power 250W, frequency 50kHZ) 60min, let coo...

Embodiment 3

[0054] Example 3: Establishment of a fingerprint method for a Chinese patent medicine "Xiaomishuan".

[0055] Instrument: Agilent 1200 high performance liquid chromatography, ultraviolet detector; MS205DU analytical balance (Shanghai Mettler-Toledo Instrument Co., Ltd.);

[0056] Reagents: methanol, etc. are analytically pure, phosphoric acid and acetonitrile are chromatographically pure, and water is ultrapure water.

[0057] Test drugs: catechin, epicatechin, matrine, berberine hydrochloride (all from China National Institutes for Food and Drug Identification), and "Xiaomishuan" provided by Tongyao Pharmaceutical Group Co., Ltd.

[0058] Preparation of the test solution: cancel the mitobolus sample, cut it into pieces, take about 2g, weigh it accurately, put it in a stoppered Erlenmeyer flask, add 25mL of 20% methanol aqueous solution precisely, weigh it, and heat it in a water bath at 70°C. Fully dissolve, take out, let cool, ultrasonic treatment (power 250W, frequency 50k...

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Abstract

The invention relates to a construction method for the HPLC fingerprint of a Chinese patent medicine, i.e., an erosion-removal suppository. The construction method comprises the following steps: preparing a test sample solution, preparing a reference sample solution, defining chromatographic conditions, precisely sucking 10 [mu]l of test sample solutions respectively, injecting the test sample solutions into a liquid chromatograph, and carrying out determination by using high performance liquid chromatography so as to obtain the HPLC fingerprint. The construction method provided by the invention has the following positive effects: chemical components of a plurality of medicinal materials are simultaneously detected under same chromatographic conditions, and quality consistency between different batches of the medicinal materials is judged from similarity of the fingerprint; moreover, sources can be traced, and problems in process operation are searched; the similarity between the fingerprint and control fingerprint is larger than 0.9, so qualities of different batches of a finished product can be effectively reflected, and comprehensive monitoring of the quality of a product can beeasily realized; singularity and one-sidedness of quality control are avoided; meanwhile, the construction method provided by the invention has the characteristics of convenience, rapidness, stability, precision, good reproducibility, etc.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a method for constructing HPLC fingerprints of Chinese patent medicines. Background technique [0002] The 2015 edition of the Chinese Pharmacopoeia discloses the quality control methods of the heat-clearing and detoxifying Chinese patent medicine (trade name: Xiaomishuan) composed of ginseng stem and leaf saponins, comfrey, Phellodendron Phellodendron, Sophora flavescens, dried alum, borneol, and catechu seven flavors, including Properties of suppositories; TLC identification of borneol and catechu bark; content determination of ginsenoside Re. Its quality standards only control the content determination of one component of the blind medicine and the qualitative identification of a single component, which is difficult to reflect the quality of the product as a whole or to control the quality of the product as a whole. [0003] Traditional Chine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 高嵩白冰邢成徐建闫立成肖俊美于艳辉
Owner TONGYAO PHARMA GROUP CORP
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