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HPLC quality control construction method and application of lung-heat clearing decoction preparation

A construction method and technology of Qingfei Decoction, which is applied in the quality control direction of commercially available Qingfei Decoction preparations, and the construction of HPLC quality control of Qingfei Decoction preparations, can solve the problems recorded in Qingfei Decoction, difficult separation of components with similar polarities, There are many problems such as the smell of medicine, to achieve the effect of promoting inheritance and development

Active Publication Date: 2021-03-30
天津同仁堂集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, quality control studies (assays or fingerprints) related to these preparations are relatively scarce, and there are no relevant reports or literature for reference so far
Moreover, there is no record of the preparation method of Qingfei Decoction prescription decoction in the original text "Wanbinghuichun" and related materials of Qingfei Decoction. There is no clear record of the granularity of Qingfei Decoction boiled down for the analysis of the word "上牉" in the original text; In addition, the prescription of Qingfei Decoction has many medicinal flavors and complex components, and it is difficult to separate components with similar polarity, so it is difficult to separate its chemical components

Method used

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  • HPLC quality control construction method and application of lung-heat clearing decoction preparation
  • HPLC quality control construction method and application of lung-heat clearing decoction preparation
  • HPLC quality control construction method and application of lung-heat clearing decoction preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0031] Embodiment 1 Qingfei decoction quality control construction method

[0032] In this embodiment, the Qingfei Decoction quality control construction method adopts the following steps:

[0033] 1. Extraction and processing of related preparations of Qingfei Decoction;

[0034] 2. Preparation of a mixed reference solution of 8 components including chlorogenic acid, amygdalin, geniposide, hesperidin, baicalin, wogonoside, ammonium glycyrrhizinate, and schisandrin A;

[0035] 3. Methodological investigation of high performance liquid chromatography content determination of 8 components in step 2, and methodological investigation of fingerprints.

[0036] That is, the quality control construction method in this embodiment covers two aspects: the determination of the content of active ingredients and the construction of fingerprints. The process of determining the content and the construction of fingerprints are basically the same, and will be described in a unified manner bel...

Embodiment 2

[0083] Example 2 Application of HPLC quality control construction method in the direction of quality control of commercially available Qingfei Decoction preparations

[0084] 1. Information on commercially available preparations of Qingfei Decoction:

[0085] Qingfei decoction concentrated tablets (manufacturer: Hong Kong Xianglan Pharmaceutical Co., Ltd., batch number: G26419), hereinafter referred to as preparation A; Qingfei decoction concentrated granules (manufacturer: Hong Kong Xianglan Pharmaceutical Co., Ltd., batch number: K09916), hereinafter Referred to as preparation B; Qingfei decoction extract granules (manufacturer: Japan Tsumura Pharmaceutical Co., Ltd., batch number: N34151), hereinafter referred to as preparation C; 18102431), hereinafter referred to as preparation D; Qingfei decoction concentrated powder (manufacturer: China Taiwan Xianfeng Co., Ltd., batch number: E073RR1), hereinafter referred to as preparation E, Qingfei decoction commercially available p...

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PUM

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Abstract

The invention relates to an HPLC quality control construction method and application of a lung-clearing decoction preparation.The method comprises the steps that at least one of chlorogenic acid, amygdalin, geniposide, hesperidin, baicalin, wogonoside, ammonium glycyrrhizinate and schizandrin serves as an effective component, and at least one process of HPLC content determination and HPLC fingerprint spectrum construction is conducted through the effective component. According to the invention, the HPLC quality control construction method is used for detecting and evaluating lung-heat clearingdecoction products which are sold in the market at home and abroad, so as to control the quality of the commercially available preparation of lung-heat clearing decoction, distinguish the source of the commercially available preparation of lung-heat clearing decoction and ensure the clinical curative effect of the commercially available preparation of lung-heat clearing decoction. According to the HPLC quality control construction method, the quality of the lung-heat clearing decoction preparation can be monitored, a reference basis is provided for ensuring the medication safety, stability and quality controllability of lung-heat clearing decoction, and the inheritance and development of traditional Chinese medicines are promoted.

Description

technical field [0001] The invention relates to the technical field of detection of active ingredients of Qingfei Decoction, in particular to a construction method for HPLC quality control of Qingfei Decoction preparations and its application in the direction of quality control of commercially available Qingfei Decoction preparations. Background technique [0002] Traditional Chinese medicine is an important part of my country's medical and health care, and the development of compound preparations of traditional Chinese medicine derived from ancient classic prescriptions is an important part of the development of Chinese medicine. [0003] The "Measures for the Administration of Drug Registration" implemented on October 1, 2007 and the "Supplementary Regulations on the Administration of Registration of Traditional Chinese Medicine" implemented on January 7, 2008 clearly defined that "Chinese medicine compound preparations derived from ancient classic prescriptions are still w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/8631G01N30/8686
Inventor 张彦森高桂琴苗淑杰王佳沈宇燕王瀚然于杰
Owner 天津同仁堂集团股份有限公司
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