A quality-controllable Radix isatidis extract and a method for identifying the raw medicinal material Radix isatidis in Chinese patent medicines

A technology of Radix Isatidis extract and Chinese patent medicine, applied in the field of Radix Radix isatidis extract, identification of the raw medicinal material Radix isatidis in Chinese patent medicine

Active Publication Date: 2022-07-19
成都市药品检验研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no report on the identification of Radix isatidis in Chinese patent medicines containing Radix isatidis (such as Fengreganmao granules) using gas chromatography as a control.

Method used

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  • A quality-controllable Radix isatidis extract and a method for identifying the raw medicinal material Radix isatidis in Chinese patent medicines
  • A quality-controllable Radix isatidis extract and a method for identifying the raw medicinal material Radix isatidis in Chinese patent medicines
  • A quality-controllable Radix isatidis extract and a method for identifying the raw medicinal material Radix isatidis in Chinese patent medicines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Embodiment 1 The gas chromatographic identification method of Radix isatidis in Fengreganmao granules

[0067] According to gas chromatography ("Chinese Pharmacopoeia 2020 Edition" four general rules 0521) test, the specific steps are as follows:

[0068] Preparation of reference medicinal material solution: take 5 g of Radix isatidis reference medicinal material, add 100 mL of water to decoct for 2 hours, filter to obtain 50 mL of filtrate, put it in a distillation tube, add 10 g of sodium hydroxide, steam distillation, collect 250 mL of distillate, and place a volumetric flask (The volumetric flask was pre-filled with petroleum ether (60-90° C.) 5 mL), shaken for extraction, shaken well and left to stand, and the upper layer of petroleum ether solution was taken as the control medicinal material solution.

[0069] Preparation of the test solution: take 50g of commercially available Fengreganmao granules, put it in a distillation tube, add 50mL of 20% sodium hydroxide ...

experiment example 1

[0076] Experimental example 1 Column screening experiment

[0077] 1. Experimental method

[0078] Referring to the test method of Example 1, DB-WAX (polyethylene glycol) capillary column (30m×0.32mm×0.50μm) was replaced with DB-WAX (polyethylene glycol) capillary column (30m×0.53mm×1.0 μm) or HP-5 capillary column (30m×0.32mm×0.25μm), and other detection conditions remain unchanged, and analyze the obtained chromatogram.

[0079] 2. Experimental results

[0080] It was found that when DB-WAX (polyethylene glycol) capillary column (30m×0.32mm×0.50μm) was used, the number of theoretical plates was high, the resolution was the best, and the retention time was moderate. Therefore, DB-WAX (polyethylene glycol) capillary column (30m×0.32mm×0.50μm) was selected.

experiment example 2

[0081] Experimental example 2 Screening of the preparation method of the test solution

[0082] 2.1 Screening of Shaking Extraction Solvents

[0083] The test solution was prepared according to the method of Example 1, only petroleum ether (60-90° C.) was replaced with ethyl acetate. However, it was found that the system could not be layered and the solvent was miscible after being shaken for extraction and left to stand.

[0084] Therefore, petroleum ether (60~90℃) was chosen as the shaking extraction solvent.

[0085] 2.2 Screening of extraction methods

[0086] With reference to the test method of Example 1, only the preparation method of the test solution and the reference medicinal material solution was modified to the following volatile oil extraction method:

[0087] Preparation method of the test solution: take 50g of Fengreganmao granules, put it in the volatile oil extractor, connect the volatile oil extractor, add 350 mL of 20% sodium hydroxide solution, and add ...

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Abstract

The invention provides a quality-controllable Radix isatidis extract and a method for identifying the raw medicinal material Radix isatidis in Chinese patent medicines. The Radix Isatidis extract is detected by gas chromatography and contains at least the following characteristic peaks: peak 1: retention time is 9.46±0.050min, peak 2: retention time is 10.95±0.050min; the gas chromatography conditions are: chromatographic column: DB‑WAX capillary column; carrier gas: nitrogen, carrier gas flow rate 1~3mL / min; detector: FID detector, detection temperature: 220~240℃; injection port temperature: 220~240℃. Further using the above-mentioned Radix Isatidis extract as a reference substance, and using the above-mentioned gas chromatography conditions, the Radix Isatidis medicinal material in the Chinese patent medicine (for example, Fengreganmao granules) can be accurately identified. The identification method is safe and environmentally friendly, with good specificity, good durability, and selection It has good properties and high sensitivity, which provides a basis for the establishment of quality standards for Chinese patent medicines containing Radix isatidis.

Description

technical field [0001] The invention belongs to the field of quality control of traditional Chinese medicine extracts and Chinese patent medicines, and particularly relates to a quality-controllable Isatis root extract and a method for identifying the raw medicinal material isatidis root in traditional Chinese medicines. Background technique [0002] Isatis root is the dry root of the cruciferous plant Isatis indigotica Fort. It is a traditional Chinese medicine with a long history, which has the functions of clearing away heat and detoxifying, cooling blood, and soothing throat. Since 1977, Banlangen has been included in the previous editions of the "Chinese Pharmacopoeia". It is not only used in Chinese medicine prescriptions in the form of decoction pieces, but also an industrial raw material for various Chinese patent medicines. The chemical composition of Radix isatidis is extremely complex. In the past few decades, many scholars have devoted themselves to the research ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 刘莉李婷婷曾桢王欣孔卫东黄晓婧郑萍
Owner 成都市药品检验研究院
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