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Method for determination of components in Danhong Huayu preparation by one test and multiple evaluation method

A technology for removing blood stasis and preparation of Danhong, which is applied in measurement devices, material separation, and analysis of materials, etc., to achieve the effects of saving detection costs and time, comprehensive accuracy and sensitivity, and stable and controllable detection results.

Active Publication Date: 2022-08-05
GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the deficiencies of the existing single-component and multi-indicator content determination methods, the present invention provides a highly practical, simple operation, cost-saving, stable and controllable method for determining the component content of Danhong Huayu preparation by one test and multiple evaluation methods. Methods Using the more stable neohesperidin as the internal standard, the relative correction factors between neohesperidin and ginseng sodium, protocatechualdehyde, salvianolic acid D, naringin, and salvianolic acid B were established. Determine the content of neohesperidin, calculate the content of the other five components with the relative correction factor, establish a comprehensive and controllable quality standard for Danhong Huayu preparation, and the test results are more stable and controllable

Method used

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  • Method for determination of components in Danhong Huayu preparation by one test and multiple evaluation method
  • Method for determination of components in Danhong Huayu preparation by one test and multiple evaluation method
  • Method for determination of components in Danhong Huayu preparation by one test and multiple evaluation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The Danhong Huayu preparation in this example is Danhong Huayu Oral Liquid

[0033] Instrument: 2695 high performance liquid chromatograph from American Waters company; Diane U3000; chromatographic column: Waters XBridge (250mm×4.6mm, 5μm); CP225D type 1 / 100,000th balance (German Sartorius company); BT 214D type 1 / 10,000 One Balance (Sartorius, Germany)

[0034] Materials: A total of 30 batches of Danhong Huayu oral liquid samples were collected in the experiment, all of which were produced by Guangzhou Baiyunshan Hutchison Whampoa Traditional Chinese Medicine Co., Ltd., Danshensu sodium (batch number: 110855-201614, purity: 98.1%), protocatechuic aldehyde ( Batch number: 110810-201608, purity: 99.3%), hesperidin (batch number: 110721-201115, purity: 95.3%, batch number: 110721, purity: 96.2%), neohesperidin (batch number: 111857-201703, purity: 99.2%), salvianolic acid B (batch number: 111562-201716, purity: 94.1%), purchased from China Institute for the Control of Ph...

Embodiment 2

[0076] With reference to Example 1, the difference is that Danhong Huayu Oral Liquid is replaced by Danhong Huayu Decoction.

[0077] The active ingredients of Danhong Huayu Decoction are composed of Danshen, Angelica, Chuanxiong, Peach Kernel, Safflower, Bupleurum, and Citrus aurantium under the item of Danhong Huayu Oral Liquid on page 677 of the 2015 edition of the Chinese Pharmacopoeia:

[0078] The preparation method is as follows: add 7-flavor raw materials such as Salvia miltiorrhiza, add water to decoct twice, add 8-10 times the amount of water for the first time, decoct for half an hour, add 5-8 times the amount of water for the second time, decoct for 20 minutes, combine the two. The second filtrate is filtered to obtain Danhong Huayu Decoction. Or concentrated into a thick paste, namely Danhong Huayu paste.

Embodiment 3

[0080] With reference to Example 1, the difference is that Danhong Huayu Oral Liquid is replaced by Danhong Huayu Tablets.

[0081] Danhong Huayu Tablets, the active ingredients of which are composed of Danshen, Angelica, Chuanxiong, Peach Kernel, Safflower, Bupleurum, and Citrus aurantium under the item of Danhong Huayu Oral Liquid on page 677 of the 2015 edition of the Chinese Pharmacopoeia:

[0082] The preparation method is as follows: decocting raw materials such as Salvia miltiorrhiza with water twice, half an hour each time, filtering, combining the two filtrates, concentrating the filtrate to a thick paste at low temperature, or condensing it into a clear paste with a relative density of Appropriate amount, mix well, make into granules, and dry to obtain Danhong Huayu granules. Or compressed into tablets or film-coated to obtain Danhong Huayu Tablets.

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Abstract

The invention discloses a method for determining the content of components in Danhong Huayu preparations by one-measurement and multi-evaluation method. Neohesperidin is used as an internal standard to establish the relationship between neohesperidin, danshensu sodium, protocatechuic aldehyde and salvianolic acid D. The relative correction factor between , naringin and salvianolic acid B, by only measuring the content of neohesperidin, and using the relative correction factor to calculate the content of the other five components, to establish a comprehensive controllable Danhong Huayu preparation. Quality Standard.

Description

Technical field: [0001] The invention relates to a drug detection method, in particular to a method for determining the content of components of a Danhong Huayu preparation by a multi-evaluation method. Background technique: [0002] "Quantitative analysis of multi-components by single-marker" (QAMS) is a method that measures only a representative component (effective, cheap, and easy to obtain), and at the same time can calculate the effective A quality control method for the content of ingredients so that their calculated values ​​and actual values ​​meet the requirements of quantitative methodology. The "one test, multiple evaluation" method can better solve the bottleneck problem of lack of reference substances in the quality control of traditional Chinese medicine, and can better complete the quantitative evaluation of unstable components, which has the advantages of low detection cost and high analysis efficiency. [0003] Danhong Huayu preparations are mainly compose...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/04G01N30/06G01N30/34G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/04G01N30/34G01N30/36G01N30/74G01N2030/027G01N2030/042
Inventor 唐清匡艳辉林娟王德勤李楚源
Owner GUANGZHOU BAIYUSN HUTCHISON WHAMPOA CHINESE MEDICINE