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Method for controlling polygonum multiflorum extra-heterogeneous hepatotoxicity

An idiosyncratic, Polygonum multiflorum technology, used in biochemical equipment and methods, microbial determination/inspection, material inspection products, etc.

Pending Publication Date: 2021-02-02
北京圆融科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in recent years, incidents of liver injury caused by Polygonum multiflorum and its preparations have occurred frequently. There have been reports of liver injury in Polygonum multiflorum in my country, South Korea, Japan, the United Kingdom and other countries, and its safety has attracted widespread attention at home and abroad.

Method used

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  • Method for controlling polygonum multiflorum extra-heterogeneous hepatotoxicity
  • Method for controlling polygonum multiflorum extra-heterogeneous hepatotoxicity
  • Method for controlling polygonum multiflorum extra-heterogeneous hepatotoxicity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Two. Embodiment 1: Determination of the dosage of EG on experimental rats

[0062] According to literature review, the median cumulative toxic dose of Radix Polygoni Multiflori is 205g clinically. (References: Tu Can, Ge Feilin, Guo Yuming, et al. Analysis of clinical characteristics and rationality of medication of Polygonum multiflorum-related liver injury [J]. Chinese Pharmacovigilance, 2019, 16(5): 270-276.) According to Pharmacological Experts Converted with the dose of experimental rats, the median cumulative toxic dose of Polygonum multiflorum to experimental rats is 18.45g / kg (205g×6.3÷70kg). (The conversion factor between humans and experimental rats is 6.3, and the adult body weight is 70kg.) Similarly, after consulting the literature and summarizing the EG content in 77 batches of Polygonum multiflorum, it was found that the content of EG in Polygonum multiflorum is not a fixed value , but in a fluctuation range, 0.41mg / g~6.04mg / g. (References: [1] Li Y X, ...

Embodiment 2

[0088] Example 2: Objective identification of liver injury induced by TSG combined with EG in experimental rats

[0089] 1. Method

[0090] 1. Sample Preparation

[0091] The preparation of emodin-8-O-glucoside solution calculates the amount of required emodin-8-O-glucoside according to the administration dose (64mg / kg), adopts 0.5% sodium carboxymethyl cellulose solution to vortex dissolve, Store at 4°C for later use;

[0092] Preparation of trans-stilbene glycoside solution Calculate the required amount of trans-stilbene glycoside according to the dosage (500 mg / kg), dissolve in 0.5% sodium carboxymethylcellulose solution by vortexing, and store at 4°C for later use;

[0093] Preparation of trans-stilbene glycoside and emodin-8-O-glucoside mixed solution Trans-stilbene glycoside TSG calculates the required amount according to the dosage (500 mg / kg) (trans-stilbene glycoside and rhubarb References for the dose ratio of prime-8-O-glucoside: Gao Dan, Li Xiaofei, Yin Ping, et...

Embodiment 3

[0139] Embodiment 3: content control limit of susceptible component EG

[0140] From the screening of the dosage of EG in the experimental rats by the embodiment 1, the median of the cumulative poisoning dose of Polygonum multiflorum in the experimental rats is 18.45g / kg; According to the objective identification of hepatic injury, the safe dosage of EG in rats is ≤32mg / kg; the content safety limit of susceptible component EG in Polygonum multiflorum is ≤1.7mg / g (32mg / kg÷18.45g / kg). That is, when the EG content is ≤0.17%, the risk of liver injury caused by Polygonum multiflorum is relatively small.

[0141] Combining the results of the screening of the dosage of EG in experimental rats in Example 1 and the objective identification of liver injury caused by TSG combined with EG in experimental rats in Example 2, it can be seen that EG may be an important susceptibility component of Polygonum multiflorum idiosyncratic liver injury, And TSG can aggravate the liver injury degre...

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Abstract

The invention discloses a method for controlling polygonum multiflorum extra-heterogeneous hepatotoxicity. The method comprises the following steps: determining dosage of emodin-8-O-glucoside; preparing an emodin-8-O-glucoside solution; giving the emodin-8-O-glucoside solution to a rat through intragastric administration, and collecting plasma and liver specimens; performing index detection; usingSPSS software for statistical analysis. The invention further provides application of the emodin-8-O-glucoside in preparation of a medicine which does not cause the special liver injury and application of the emodin-8-O-glucoside and the trans-stilbene glucoside in evaluation of the special liver injury. The invention also provides a safe content limit of emodin-8-O-glucoside so as to control theliver injury risk of polygonum multiflorum.

Description

technical field [0001] The invention relates to the field of safety and quality control of medicinal materials, in particular to a method for safety and quality control of Polygonum multiflorum idiosyncratic hepatotoxicity. Background technique [0002] Polygonum multiflorum is the dried tuber root of Polygonum multiflorum Thunb., a plant of the Polygonum family Polygonum multiflorum Thunb. Its clinical application is different for raw Radix Polygonum multiflorum Thunb. Its clinical application is extensive, traditionally not considered as a poisonous traditional Chinese medicine. However, incidents of liver injury caused by Polygonum multiflorum and its preparations have occurred frequently in recent years. Cases related to liver injury in Polygonum multiflorum have been reported in my country, South Korea, Japan, the United Kingdom and other countries, and its safety has attracted widespread attention at home and abroad. Contents of the invention [0003] The following ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50G01N33/68G01N21/84C12Q1/52G16H70/40
CPCG01N33/5014G01N21/84G01N33/6863G01N33/6866G01N33/6869G16H70/40C12Q1/52
Inventor 马永刚
Owner 北京圆融科技有限公司
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