A method for establishing the fingerprint of a traditional Chinese medicine composition

A technique for fingerprinting and establishing methods, which can be used in measuring devices, instruments, scientific instruments, etc., and can solve the problems of inability to fully characterize the chemical characteristics and quality of Shujinjianyao Pills

Active Publication Date: 2018-08-24
GUANGZHOU BAIYUNSHAN CHENLIJI PHARMA FAB CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The above-mentioned drug standards are for the identification of individual ingredients, and the physical and chemical reactions only indicate the presence of alkaloid ingredients, which cannot fully characterize the chemical characteristics and quality of Shujinjianyao Pills

Method used

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  • A method for establishing the fingerprint of a traditional Chinese medicine composition
  • A method for establishing the fingerprint of a traditional Chinese medicine composition
  • A method for establishing the fingerprint of a traditional Chinese medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Example 1 Establishment of the method for preparing the test solution

[0096] 1.1 Selection of extraction solvent:

[0097] Get 5g of the Shujinjianyaopill sample of batch number D23095, pulverize, accurately weigh, place in 50ml tool stopper conical flask, add 25ml methanol, 75% methanol (volume percent concentration), 50% methanol (volume percent concentration) respectively accurately Concentration), 95% ethanol (volume percentage concentration), dilute ethanol (volume percentage concentration 50%), after ultrasonic 30min, allow to cool to room temperature, weigh, make up the lost weight with extraction solvent respectively, acquired.

[0098] Under the following chromatographic conditions, measure the test solution prepared by different extraction solvents respectively, and record the chromatogram of 0-170min:

[0099] Chromatographic column: Waters Atlantis chromatographic column, 250×4.6mm, the average particle size of the stationary phase is 5μm;

[0100] Mob...

Embodiment 2

[0110] Example 2 Establishment of Chromatographic Conditions

[0111] 2.1 Determination of mobile phase

[0112] According to the preferred preparation method of the test solution in Example 1, about 5 g of the sample of batch number D23095 was taken to prepare the test solution. Column temperature is 30°C, injection volume is 10 μl, flow rate: 1ml / min, acetonitrile-water, acetonitrile-0.1% phosphoric acid, methanol-0.1% phosphoric acid and acetonitrile-methanol-0.1% phosphoric acid are used as mobile phases, and the elution time is 170 minutes , investigate the chromatogram of need testing solution under 254nm. Wherein, the volume percentage of the organic phase of the two-phase system changes from 5% to 90% at a constant speed, and the volume percentage of the water or phosphoric acid solution changes from 95% to 10% at a corresponding uniform speed.

[0113] The results showed that acetonitrile-0.1% phosphoric acid was used as the mobile phase, the baseline was stable a...

Embodiment 3

[0119] Example 3 Composition testing of Shujinjianyao Pills

[0120] 1. Chromatographic column: Waters Atlantis chromatographic column (5μm, 250×4.6mm);

[0121] 2. Mobile phase: use acetonitrile-0.1% phosphoric acid as the mobile phase, and the volume percentage of acetonitrile in the mobile phase increases from 5% to 90% at a constant speed in 0-170 minutes;

[0122] 3. Flow rate: 1.0mL / min;

[0123] 4. Detection wavelength: 254nm;

[0124] 5. Column temperature: 30°C;

[0125] 6. the preparation of need testing solution: prepare according to the preferred method of embodiment 1;

[0126] 7. Preparation of reference solution: Precisely weigh protocatechuic acid, protocatechualdehyde, privetin, schizandrin A, acetyl schisandrin A, (2′S)-schisandrin lignin The reference substance, made by adding methanol, has a concentration of 90 μg / ml protocatechuic acid, 30 μg / ml protocatechuic aldehyde, 50 μg / ml privetin, 20 μg / ml schizandrin A, and 20 μg / ml acetylated schisandrin A ...

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Abstract

The invention provides an establishing method of the fingerprint of a traditional Chinese medicinal composition, and a technology for detecting the components of the traditional Chinese medicinal composition by using the fingerprint established through the method. The raw materials of the traditional Chinese medicinal composition comprise Rhizoma Cibotii, Fructus Rosae Laevigatae, Caulis Spatholobi, Philippine flemingia root, Kadsura coccinea, Millettia specisoa Champ, steamed Ligustri Lucidi Fructus, steamed Chinese Taxillus Twig, brine processed semen cuscutae, processed Rhizoma Corydalis, Zanthoxylum nitidum, processed Boswellia carteri and processed myrrh. The establishing method of the fingerprint is characterized in that the retention time of every compound and every medicinal material in the traditional Chinese medicinal composition is detected through high performance liquid chromatography; and the conditions of the high performance liquid chromatography are as follows: octadecylsilane bonded silica is adopted as a stationary phase, a mobile phase comprises acetonitrile and an aqueous phosphoric acid solution with the weight percentage concentration of 0.1%, the volume percentage of the acetonitrile in the mobile phase uniformly increases to 90% from 5% at 0-170 min, the flow velocity is 1 ml / min, the column temperature is 30 DEG C, and the ultraviolet detection wavelength is 254 nm.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for establishing a fingerprint of a traditional Chinese medicine composition. The traditional Chinese medicine composition is Shujin Jianyao Wan. Background technique [0002] Traditional Chinese medicine compositions (Chinese patent medicines) based on the theory of traditional Chinese medicine generally have a variety of medicinal flavor components; during the preparation process of the pharmaceutical composition, different components may react with each other, resulting in more complex components of the pharmaceutical composition. It is difficult to reflect the chemical characteristics of the composition as a whole due to the limited amount of information only by qualitative or quantitative detection of one or several components. With the development of modern analytical techniques, fingerprints have become an effective means to evaluate the overall qua...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 何风雷王亚琦杨能英彭富全
Owner GUANGZHOU BAIYUNSHAN CHENLIJI PHARMA FAB CO LTD
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