Quality control method of compound inflammation-diminishing and gallbladder-benefiting formulation

A technology of compound anti-inflammatory and choleretic, quality control method, applied in digestive system, measuring device, pharmaceutical formula, etc., can solve the problems of backward quality control and identification method of compound anti-inflammatory and choleretic preparation, unable to comprehensively evaluate the quality of compound anti-inflammatory and choleretic preparation, etc.

Active Publication Date: 2009-02-11
JINAN UNIVERSITY
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0004] But, so far, the quality control and identification method of the compound anti-inflammatory and choleretic preparations composed of Andrographis paniculata, Xihuangcao, and bitter wood three flavors of traditional Chinese medicine is backward. In the tenth volume of preparations (WS3-B-2023-95), only the test tube reaction is used for identification of Compound Xiaoyan Lidan Tablets
And the content determination method only has the regulation of determining the content of andrographolide derived from Andrographis paniculata, and there is no requirement for the determination of the content of the characteristic components of the remaining two flavors of traditional Chinese medicine (Bitterwood, Xihuangcao).
Only using andrographolide as an index component cannot fully evaluate the quality of compound anti-inflammatory and choleretic preparations

Method used

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  • Quality control method of compound inflammation-diminishing and gallbladder-benefiting formulation
  • Quality control method of compound inflammation-diminishing and gallbladder-benefiting formulation
  • Quality control method of compound inflammation-diminishing and gallbladder-benefiting formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Example 1 Establishment of HPLC standard fingerprint of compound anti-inflammatory and choleretic preparation

[0072] Take 150g each of Andrographis paniculata and Bitterwood, chop and mix, heat and extract twice with 80% to 85% ethanol, filter, recover ethanol from the filtrate and concentrate it into a thick paste to obtain 43.5g of extract; take 150g of Xihuangcao and cut into pieces , add water to decoct twice, combine the filtrate, filter, the decoction is concentrated to an appropriate amount, add 5 times the amount of 70% ethanol, shake up, leave standstill, filter, the filtrate reclaims ethanol and concentrates into a thick paste to obtain 9g extract.

[0073] Take 5g of the mixed thick paste of Andrographis paniculata and bitter wood and 1.03g of Xihuangcao thick paste respectively, combine them, add 100mL of 70% methanol, dissolve them by ultrasonic, take 4mL and pass through a 0.45μm microporous membrane, and then take 1.5mL of the filtrate and use it with so...

Embodiment 2

[0085] Example 2 Separation and structural identification of chromatographic peaks

[0086] The three traditional Chinese medicines that make up the compound anti-inflammatory and choleretic preparation were extracted and separated respectively: Andrographis paniculata, Bitterwood, and Xihuangcao.

[0087] Take Andrographis paniculata 60% ethanol extract 500g, add water to suspend, extract with cyclohexane, ethyl acetate, n-butanol respectively. Carry out silica gel column separation to ethyl acetate extract part, carry out gradient elution with chloroform:methanol solvent system (100:0,99:1,98:2,95:5,90:10,80:20,50:50 , 0:100). The eluted similar fractions were combined to obtain ten fractions from APE-1 to APE-10. Each fraction was subjected to repeated silica gel column chromatography, and compounds II, IV to VIII were isolated and obtained.

[0088] Get Xihuangcao 60% ethanol extract 600g, add water to suspend, carry out macroporous resin HP-20 column separation to it, ...

Embodiment 3

[0111] Example 3 Inhibitory activity of andrographolide on release of NO, TNF-α and IL-6 from mouse mononuclear macrophage RAW 264.7 induced by lipopolysaccharide

[0112] 1. Inhibitory activity of lipopolysaccharide-induced release of nitric oxide (NO) from mouse macrophages

[0113] Mouse mononuclear macrophage RAW 264.7 (ATCC TIB-71) was cultured in 10% heat-inactivated (56°C, 30min) fetal bovine serum (FBS), 100 U / mL penicillin sodium (Gibco), 100 μg / mL streptavidin in RPMI 1640 (Gibco) medium, 37°C, 5% CO 2 grown in a constant temperature incubator.

[0114] Because NO is extremely unstable, it is quickly metabolized into nitrous acid (NO) in the cell culture supernatant. 2 - ), so the Griess method was used to measure NO in the sample 2 - concentration as an indicator of NO levels. Griess reagent A: 0.1% N-naphthalene diamine dihydrochloride dissolved in water; Griess reagent B: 1% sulfanilamide dissolved in 5% H 3 PO 4 middle. Mix reagents A and B in equal volu...

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Abstract

The invention relates to the quality control field of traditional Chinese medicine, in particular to a quality control method of a compound anti-inflammatory and cholagogic preparation and applications thereof. The method comprises the steps of: establishing a standard fingerprint, establishing a fingerprint of a sample and comparing the standard fingerprint with the fingerprint of the sample. The standard fingerprint of the compound anti-inflammatory and cholagogic preparation shows 15 main chromatographic peaks in 225nm and confirms the chemical structures of 8 chromatographic peaks in the 15 main chromatographic peaks. The active ingredients with anti-inflammatory effect of three ingredients comprising andrographolide, rosemarinic acid and nigakinone in the 8 chemical structures are further confirmed. As the supplementation of the method, the three ingredients or the combination of the three ingredients can be indicative ingredients used for carrying content measurement. The method has high repeatability, good stability and simple and convenient operating method, is scientific with evidences and can effectively control the quality of the compound anti-inflammatory and cholagogic preparation.

Description

technical field [0001] The invention relates to the field of quality control of traditional Chinese medicines, in particular to a quality control method of a compound anti-inflammatory and choleretic preparation containing three traditional Chinese medicines of Andrographis paniculata, Xihuangcao and bitter wood. Background technique [0002] The fingerprint of traditional Chinese medicine refers to the chromatogram or spectrum of the characteristic components of one or several kinds of Chinese medicinal materials. The fingerprint of traditional Chinese medicine is of great significance for effectively controlling the quality of Chinese medicinal materials or Chinese patent medicines. With the widespread promotion of traditional Chinese medicine, fingerprinting, as a quality control method for Chinese herbal medicines and their extracts, has now become an international consensus. However, at present, the fingerprints of traditional Chinese medicine often only involve the stu...

Claims

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Application Information

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IPC IPC(8): A61K36/53A61P1/16G01N30/02
Inventor 姚新生高昊赵峰李晨阳王国才焦伟华张龙贺飞戴毅姚志红周光雄叶文才
Owner JINAN UNIVERSITY
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