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Quality control method of danggui sini decoction composition

A quality control method, the technology of Sini Decoction, is applied in the quality standard detection of traditional Chinese medicine compound granules, and in the field of quality control of Danggui Sini Decoction compositions, which can solve the problems of many components, single quality control, few indicators, etc., and reach an objective conclusion. , control the quality of the preparation, the effect of convenient operation

Active Publication Date: 2018-08-28
CHINA RESOURCES SANJIU MEDICAL & PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Therefore, the technical problem to be solved in the present invention is to overcome that the traditional Chinese medicine compound preparation in the prior art basically only has one or two index components in content control, the quality control is single, the index is few, and it is difficult to fully reflect that there are many flavors and many components. , The defects of the quality status of the Danggui Sini Decoction composition with many targets, thereby providing a quality control method for the Danggui Sini Decoction composition

Method used

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  • Quality control method of danggui sini decoction composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1. The preparation of Angelica Sini Decoction composition

[0062] Take Angelica 375g; Guizhi 375g; Paeoniae Alba 375g; Asarum 125g; Radix Glycyrrhiza 250g; Filtrate, concentrate the filtrate to a clear paste with a relative density of 1.20-1.25 (60° C.), add an appropriate amount of maltodextrin, mix well, dry, and granulate to make 1000 g to obtain the composition of Angelica Sini Decoction.

Embodiment 2

[0063] Example 2. Research on Fingerprint of Danggui Sini Decoction Composition

[0064] Instruments and reagents

[0065] Chromatography instrument: American Agilent 1100 series (G1322A online vacuum degasser, G1311A quaternary gradient pump, G1313A autosampler, G1316A column thermostat, G1315B diode array detector);

[0066] Chromatographic column: Kromasil 100-5-C18 4.6×250mm 5μm;

[0067] Reagents: methanol, Tianjin Damao Chemical Reagent Factory, chromatographically pure, batch number: 20160310; acetonitrile, Tianjin Biaoshiqi Technology Development Co., Ltd., chromatographically pure, batch number: AC-12060107; phosphoric acid, Tianjin Tongguang Fine Chemical Company, analysis Pure, batch number: 20150712; water, Millipore ultrapure water;

[0068] Danggui Sini Decoction Composition Medicinal Materials: Three batches of Danggui Sini Decoction composition 160501, 160502, 160504 were provided by China Resources Sanjiu Group for trial production according to the steps of ...

Embodiment 3

[0109] Example 3. Determination of Angelica, Guizhi, Radix Glycyrrhiza and Radix Paeoniae Alba in the composition of Danggui Sini Decoction by HPLC

[0110] Instruments and reagents:

[0111] instrument:

[0112] High performance liquid chromatography Agilent 1100 chromatographic system, including quaternary pump, automatic sampler, diode array detector, chromatographic workstation;

[0113] Test drug:

[0114] Acetonitrile was chromatographically pure from Tianjin Biaoshiqi Technology Development Co., Ltd.; phosphoric acid was analytically pure from Beijing Beihua Fine Chemicals Co., Ltd.; water was self-made from double distilled water.

[0115] The reference substance of paeoniflorin was purchased from the China Institute for the Control of Pharmaceutical and Biological Products, which met the requirements of the reference substance for content determination. Batch number 110736-201604; Liquiritin reference substance, purchased from China Institute for the Control of Pha...

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Abstract

The invention discloses a quality control method of a danggui sini decoction composition, wherein the method belongs to the field of traditional Chinese medicine analysis. According to the method of the invention, a fingerprint spectrum is established by means of high-efficiency liquid chromatography; a chromatographic column is a octadecylsilane chemically bonded silica chromatographic column; the column temperature is 25-35 DEG C; the flow velocity is 0.9-1.1ml / min; the detecting wavelength is 220nm; acetonitrile (A)-0.1% phosphoric acid solution (B) is used as a mobile phase, and gradient elution is performed according to a sequence which is represented in the description. The fingerprint spectrum according to the invention comprehensively reflects quality information of the danggui sini decoction composition, thereby realizing a purpose of more comprehensively and effectively controlling the quality of the danggui sini decoction composition.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine analysis, and relates to a quality standard detection method of Chinese medicine compound granules, in particular to a quality control method of Danggui Sini Decoction composition. Background technique [0002] Traditional Chinese medicine decoction is the mainstream of clinical medicine, but because of decoction and inconvenient to carry, the quality of the decoction prepared by decoction often varies greatly depending on the person and the decoction utensils. The use of modern science and technology to develop traditional Chinese medicine preparations that are easy to carry and easy to take is not only the inheritance of traditional Chinese medicine, but also a better promotion of classic famous prescriptions. Clinical application. The preparation process of granules is relatively simple, easy to shape, easy to take and carry, and the form of taking is most consistent with traditiona...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/90
CPCG01N30/88G01N30/90
Inventor 林丽娜刘英陈周全刘志刚谭沛马鹏岗高雅高云佳屠鹏飞
Owner CHINA RESOURCES SANJIU MEDICAL & PHARMA
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