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A method for determining the content of trace components in traditional Chinese medicine preparations

A method of determination, a trace technology, applied in the field of analytical chemistry

Active Publication Date: 2017-03-01
SHINEWAY PHARMA GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, experimental studies have shown that only a small fraction of components can be clearly detected and accurately determined

Method used

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  • A method for determining the content of trace components in traditional Chinese medicine preparations
  • A method for determining the content of trace components in traditional Chinese medicine preparations
  • A method for determining the content of trace components in traditional Chinese medicine preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Example 1 Establishment and Analysis of Danshen Injection Control Fingerprint

[0075] 1. Instruments and reagents

[0076] High-performance liquid chromatography system: Agilent 1100 Agilent Technologies, USA (configured with vacuum degasser, autosampler, quaternary pump, VWD G1314A, DAD G1315B; Agilent ChemStation A 10.02 chromatographic workstation).

[0077] Danshensu sodium reference substance, protocatechuic acid reference substance, and protocatechualdehyde reference substance were all purchased from China Institute for the Control of Pharmaceutical and Biological Products, rosmarinic acid reference substance, shikoninic acid reference substance, salvianolic acid B reference substance, caffeic acid The reference substance and the isoferulic acid reference substance were purchased from Shanghai Yousi Biotechnology Co., Ltd., and the salvianolic acid D reference substance was isolated from Salvia miltiorrhiza (self-made, with a purity of about 70%); phosphoric acid...

Embodiment 2

[0103] The establishment of embodiment 2 reference standard curve

[0104] 1. The apparatus and reagents are the same as in Example 1.

[0105] 2. Chromatographic conditions and system adaptability test

[0106] (1) The chromatographic conditions are the same as in Example 1.

[0107] (2) System adaptability test

[0108] Under the selected chromatographic conditions, the nine main phenolic acids, danshensu, protocatechuic acid, protocatechuic aldehyde, caffeic acid, isoferulic acid, salvianolic acid D, rosmarinic acid, shikonic acid and salvianolic acid The phenolic acid B has achieved baseline separation, the separation degree is greater than 1.5, the theoretical plate number of the chromatographic peak is not less than 30,000, and the symmetry factor is between 0.9-1.1.

[0109] Preparation of reference solution

[0110] Due to the large differences in the content and solubility of several main phenolic acid components in the sample, the components with similar content ...

Embodiment 3

[0188] The establishment of the standard curve of embodiment 3 reference substance

[0189] 1. Instruments and reagents

[0190] High-performance liquid chromatography system: Agilent 1100 Agilent Technologies, USA (configured with vacuum degasser, autosampler, quaternary pump, VWD G1314A, DAD G1315B; Agilent ChemStation A 10.02 chromatographic workstation).

[0191] Since salvianolic acid D is extremely unstable after purification, it is impossible to buy a reference substance that can be used for qualitative and quantitative analysis, so it is isolated from Danshen with a purity of about 70% (HPLC, peak area normalization method); phosphoric acid (85 %), formic acid (96%), and acetic acid were purchased from Tedia (USA), methanol and acetonitrile were purchased from Burdick & Jackson (Honeywell, USA), and water was prepared by Mili-Q ultrapure water apparatus.

[0192] 2. The chromatographic conditions are the same as in Example 1.

[0193] 3. Preparation of reference solu...

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Abstract

The invention relates to a determination method of trace component content in a traditional Chinese medicine preparation. The method comprises the following steps: (a) establishing a reference fingerprint; (b) pointing out a chromatographic peak of the reference fingerprint, and using the substance corresponding to the fingerprint peak as a reference substance; (c) combining with the reference fingerprint, comparing with the spectrum of the reference substance, classifying substances corresponding to the chromatographic peaks, determining a target substance and a corresponding reference substance thereof, wherein the target substance and the reference substance thereof have similar spectrum behaviors; (d) establishing a reference substance standard curve; (e) estimating the content of the target substance according to the reference substance standard curve. The method disclosed by the invention is suitable for content determination of the substance having an unclear structure or the micro or trace substance.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for determining the content of trace components in traditional Chinese medicine preparations. Background technique [0002] Traditional Chinese medicine has a rich composition of substances, commonly known as substance groups. The integrity and synergistic characteristics of traditional Chinese medicine are also derived from this. But because of this, it also brings great difficulties to the qualitative and quantitative analysis of active ingredients. Traditional Chinese medicine and its preparations, such as Danshen Injection, Shenmai Injection, and Banlangen Granules, have been confirmed by many studies. However, experimental studies have shown that only a small fraction of components can be clearly detected and accurately determined. However, the total weight of most trace or even trace ingredients accounts for the majority of the main active ingredient group. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 胡雪娇果德安杨敏陈昕王秋蓉李一丰张纲
Owner SHINEWAY PHARMA GRP LTD