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Construction method of HPLC specific chromatogram of wind-heat common cold granule

A kind of wind-heat-cold and characteristic map technology, which is applied in the field of medicine, can solve the problems that the uniform internal quality of the product and the stability of the curative effect cannot be guaranteed, it is difficult to reflect the overall quality of the sample, and the complex components are difficult to separate and identify, so as to achieve stable quality and reproducible Good performance, scientific method and reliable effect

Active Publication Date: 2017-05-10
吉林修正药业新药开发有限公司 +1
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current implementation standards are recorded in the Ministry of Chinese Patent Medicine Standards, the standard number is WS 3 -B-0044-89, the standard only includes routine inspection items such as properties and solubility of granules. Due to the low level of quality control, there may be under-investment or shoddy phenomena in the process of feeding medicinal materials, and the product cannot be guaranteed Uniform internal quality and stable curative effect, there are hidden dangers in quality and safety
In order to improve the quality of Fengreganmao Granules, research on quality testing methods has been carried out for the whole prescription. However, due to the characteristics of traditional Chinese medicine compound preparations with many medicinal flavors and complex components that are difficult to separate and identify, the existing technical testing is concentrated on TLC identification and content. In the study on the determination of a single index, qualitative identification and quantitative detection were only carried out on individual medicinal flavors such as forsythia and arctium in the prescription of Fengreganmao Granules. Due to the large number of medicinal flavors in the prescription of this product, it is difficult to reflect the overall quality of the sample.

Method used

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  • Construction method of HPLC specific chromatogram of wind-heat common cold granule
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  • Construction method of HPLC specific chromatogram of wind-heat common cold granule

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Embodiment 1

[0026] Example 1: Establishing a method for constructing a characteristic map of Fengremao Granules

[0027] 1 Instrument: UltiMate 3000 high performance liquid chromatograph, ultraviolet 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.); Lido Instrument Co., Ltd.), etc.

[0028] 2 Reagents: Methanol etc. are analytically pure, phosphoric acid and acetonitrile are chromatographically pure, and water is ultrapure water.

[0029] 2.1 Reagents: forsythin, arctiin, chlorogenic acid, hesperidin, adenosine (all from China Institute for Food and Drug Identification).

[0030] 3 Methods and Results

[0031] 3.1 Preparation of reference solution: Accurately weigh an appropriate amount of arctiin reference substance, add 50% methanol to make a solution containing 70 μg of arctiin per 1 ml, and obtain it.

[0032] 3.2 Preparation of the test solution: take F...

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Abstract

A construction method of an HPLC specific chromatogram of a wind-heat common cold granule includes the following steps: (1) preparation of a reference substance solution: precisely weighing a proper amount of an arctiin reference substance, adding 30-70% methanol to produce an arctiin methanol solution with concentration of the arctiin being 60-80 [mu]g / ml; (2) preparation of a test sample solution: finely grinding the wind-heat common cold granule, and precisely weighing about 1-3 g of the granule; (3) setting of chromatographic condition: employing a ZORBAX SB-C18 chromatographic column, employing a mixed solution of acetonitrile-0.1% phosphoric acid solution with ratio being 5-45:95-55 as a mobile phase, setting flow velocity to be 0.5-1.5 ml / min, preparing a DAD detector, wherein detection wavelength is set as 205-285 nm, setting column temperature to be 25-45 DEG C and setting number of theoretical plates to be not less than 10000; and (4) measurement: precisely sucking 5-20 [mu]l of each of the reference substance solution and the test sample solution, injecting the solutions into the liquid chromatographic instrument, and performing HPLC detection to obtain the HPLC specific chromatogram of the wind-heat common cold granule. The method can effectively monitor the quality of the wind-heat common cold granule in different batches. The method has high precision and good repeatability, and is used for comprehensively monitoring the quality of the product.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a method for constructing an HPLC characteristic map of Fengreganmao granules. Background technique [0002] Fengreganmao granule is a compound preparation of traditional Chinese medicine commonly used in clinical practice. It is composed of isatis root, forsythia, mint, nepeta panicle, mulberry leaf, reed root, burdock seed, chrysanthemum, bitter almond, mulberry branch, and Liushenqu. Detoxification, suitable for lung and sore throat. For cold body fever, nasal congestion, headache, cough, phlegm. The current implementation standards are recorded in the Ministry of Chinese Patent Medicine Standards, the standard number is WS 3 -B-0044-89, the standard only includes routine inspection items such as properties and solubility of granules. Due to the low level of quality control, there may be under-investment or shoddy phenomena in the process of feeding medicinal materials, a...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74G01N30/86
CPCG01N30/06G01N30/74G01N30/8686
Inventor 吴萍李双白冰徐建
Owner 吉林修正药业新药开发有限公司
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