Quality-controllable isatis root extract and method for identifying raw medicinal material isatis root contained in Chinese patent medicine

A technology of Radix isatidis extract and Chinese patent medicine, which is applied in the field of Radix isatidis extract and identification of raw material Radix isatidis contained in Chinese patent medicine, achieving the effect of good specificity, good selectivity and good durability

Active Publication Date: 2021-03-26
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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  • Quality-controllable isatis root extract and method for identifying raw medicinal material isatis root contained in Chinese patent medicine
  • Quality-controllable isatis root extract and method for identifying raw medicinal material isatis root contained in Chinese patent medicine
  • Quality-controllable isatis root extract and method for identifying raw medicinal material isatis root contained in Chinese patent medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Example 1 Gas Chromatographic Identification Method of Radix Isatidis in Fengreganmao Granules

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

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

[0069] The preparation of need testing solution: get commercially available Fengreganmao granule 50g, put in distillation tube, add 20% sodium hydroxide solution ...

experiment example 1

[0076] Experimental example 1 Chromatographic column screening experiment

[0077] 1. Experimental method

[0078] With reference to the test method of Example 1, the DB-WAX (polyethylene glycol) capillary column (30m × 0.32mm × 0.50 μm) was replaced with a DB-WAX (polyethylene glycol) capillary column (30m × 0.53mm × 1.0 μm) respectively. μm) or HP-5 capillary column (30m × 0.32mm × 0.25μm), the rest of the detection conditions remain unchanged, and the resulting chromatograms are analyzed.

[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] The screening of experimental example 2 need testing product solution preparation method

[0082] 2.1 Screening of shaking extraction solvents

[0083] The test solution was prepared with reference to the method of Example 1, only petroleum ether (60-90° C.) was replaced with ethyl acetate. However, it was found that after shaking and extracting, the system could not be separated and the solvents were miscible.

[0084] Therefore, petroleum ether (60-90°C) was chosen as the shaking extraction solvent.

[0085] 2.2 Screening of extraction methods

[0086] With reference to the test method of embodiment 1, only the preparation method of need testing solution and contrast medicinal material solution is revised to following volatile oil extraction method:

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

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Abstract

The invention provides a quality-controllable isatis root extract and a method for identifying raw medicinal material isatis root contained in a Chinese patent medicine. The isatis root extract is detected by gas chromatography and at least contains the following characteristic peaks: peak 1: retention time of 9.46+/-0.050 min, and peak 2: retention time of 10.95+/-0.050 min; the gas chromatographic conditions are as follows: a chromatographic column is a DB-WAX capillary column; the carrier gas is nitrogen, and the flow rate of the carrier gas is 1-3 mL/min; the detector is an FID detector, and the detection temperature is 220-240 DEG C; the temperature of a sample inlet is 220-240 DEG C. Furthermore, the radix isatidis extract is used as a reference substance, the radix isatidis medicinal material in the Chinese patent medicine (such as wind-heat type common cold granules) can be accurately identified by adopting the gas chromatography condition, and the identification method is safe, environment-friendly, good in specificity, good in durability, good in selectivity and high in sensitivity; and a basis is provided for establishing the quality standard of the Chinese patent medicine containing the isatis root medicinal material.

Description

technical field [0001] The invention belongs to the field of quality control of extracts of traditional Chinese medicines and Chinese patent medicines, and in particular relates to a quality-controllable Radix isatidis extract and a method for identifying Radix isatidis, a raw material medicinal material contained in proprietary Chinese medicines. Background technique [0002] Banlangen is the dried root of Isatis indigotica Fort., a cruciferous plant. It is a traditional Chinese medicine with a long history. Since 1977, Radix isatidis has been included in the previous editions of the "Chinese Pharmacopoeia". It is not only used as a medicine 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 Radix is ​​extremely complex. In the past decades, many scholars have devoted themselves to the research of active ingredients of Radix Radix, and isolated as many...

Claims

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Application Information

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Patent Type & Authority Applications(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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