Quality control methods of hairy holly root medicinal materials, extract or hairy holly root preparation

A quality control method, Mao Dongqing's technology, applied in the direction of drug combination, pharmaceutical formula, material separation, etc., can solve the problems of restricting application and promotion, failing to correctly reflect the internal quality of drugs, and affecting the effective use of Mao Dongqing

Active Publication Date: 2008-10-15
SHANGHAI LEIYUNSHANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This quality system cannot correctly reflect the internal quality of the drug, which objectively affects the effective clinical use of Mao Dongqing and limits its application and promotion in the international market. Therefore, it is necessary to improve and improve the quality of Mao Dongqing and its preparations. The system and specific control methods are practical problems that urgently need to be solved and dealt with

Method used

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  • Quality control methods of hairy holly root medicinal materials, extract or hairy holly root preparation
  • Quality control methods of hairy holly root medicinal materials, extract or hairy holly root preparation
  • Quality control methods of hairy holly root medicinal materials, extract or hairy holly root preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The separation of saponin monomer in the Radix Ilex extract of embodiment 1

[0030] Separation of monomer components in Ilex pubescens: Take an appropriate amount of Ilex pubescens extract, dissolve and disperse it with 2-5 times the amount of water, extract with an equal volume of n-butanol three times, combine the n-butanol phases, concentrate, and obtain yellow crude total saponins. Afterwards, through macroporous resin chromatography, silica gel column layer, RP-18 reversed-phase column layer and gel column layer, it was repeatedly separated and refined (the specific method is recorded by the following documents: Kazuyuki Hidaka et al NewTriterpens Saponins from Ilexpubescens Chem.Pharm.Bull. 35(2):524-529, 1987), to obtain monomers I, II, III and IV, respectively.

[0031] Monomer I: FAB-MS (m / z): 1351.72 (2M+Na), 1005.52 (2M-Glu+Na), 687.25 (M+Na), 663.49 (M-1); HRMS (m / z): 687.3723 (M+Na), theoretical value: 687.3720, molecular formula is C 36 h 56 o 11 . 1...

Embodiment 2

[0036] The preparation of embodiment 2 Ilex pubescens extract-water extraction

[0037] Take 100kg of decoction pieces of Maodongqing, add 600kg of water, heat and reflux for extraction for 3 hours, add 500kg of water for the second time, extract for 2 hours, combine the extracts, concentrate under reduced pressure to a relative density of 1.06-1.07 (70°C ± 10), pass through a container with 50kg macroporous resin aqueous chromatography column, washed with 150kg of water, then gradient eluted with 100kg of 20%, 40%, 60% and 80% ethanol solution, collected 40-60% ethanol fraction, concentrated under reduced pressure , vacuum-dried to obtain about 5kg of extract powder.

Embodiment 3

[0038] The preparation of embodiment 3 Ilex pubescens extract-alcohol extraction

[0039] Get 100kg of Herba Ilex decoction pieces, add 500kg of 50% ethanol, heat and reflux for extraction for 3 hours, extract for the second time for 2 hours, combine the extracts, concentrate under reduced pressure to a relative density of 1.06-1.07 (70°C ± 10), pass through a container 50kg macroporous resin aqueous chromatography column, washed with 100kg of water, then gradient eluted with 200kg of 40%, 60% and 80% ethanol solution, collected 40-60% ethanol fractions, concentrated under reduced pressure, vacuum Dried to obtain about 4.5kg of extract powder.

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Abstract

The invention discloses a quality control method of Ilex pubescens or the extract or the preparation thereof, belonging to the technology field of Chinese medicines. The method comprises the steps of taking Ilexsaponin B1 as reference and measuring the total saponin content of the Ilex pubescens . The quality control method is proposed after the deep research of the effective ingredients of Ilex pubescens and based on the features of the effective ingredients; and builds a solid foundation for safe and effective clinic application of various Ilex pubescens preparations.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicines, in particular to a method for quality control of holly holly extracts. Background technique [0002] Ilex pubescens (Ilex pubescens Hook.et Arn) is a plant under the genus Ilex in the Ilex family. It is an evergreen shrub about 3 meters high. Growing on hillsides, valleys, forests or thickets. Distributed in Guangdong, Guangxi, Anhui, Fujian, Zhejiang, Jiangxi, Taiwan and other places. The root of Mao Dongqing is a commonly used folk medicine in some provinces and regions in the south of the Yangtze River in my country. It has the effects of promoting blood circulation and unblocking the pulse, reducing swelling and pain, clearing away heat and detoxifying. The medicinal material standard of Maodongqing is based on its root as the medicinal part, which is recorded in the 77th edition of the Pharmacopoeia of the People's Republic of China (P: 107). Maodongqing capsules and injections...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/185G01N30/02G01N30/90G01N21/35A61P9/10A61P27/02A61P15/00A61P11/02A61P31/00A61K125/00
Inventor 张国明华菊根徐晓英胡馨袁华梁张英华
Owner SHANGHAI LEIYUNSHANG PHARMA
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