Quality evaluation method of blood-fat-reducing traditional Chinese medicines on the basis of bio-titer

A technology of biological potency and quality evaluation, applied in biological testing, testing pharmaceutical preparations, material testing products, etc., can solve problems such as the inability to evaluate the characteristics and strength of lipid-lowering activity, and the inability to reflect the strength of biological activity, and achieve perfection. Quality management mode, stable and reliable sensitivity, huge economic and social benefits

Inactive Publication Date: 2016-02-10
周亚伟
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Problems solved by technology

The biological effect ratio can only reflect the level of the biological effect of the sample and the reference product; it cannot reflect the strength of the biological activity of the tested drug compared with other similar drugs, nor can it evaluate the characteristics of the lipid-lowering activity of the medicinal material or compound preparation among similar drugs and intensity

Method used

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  • Quality evaluation method of blood-fat-reducing traditional Chinese medicines on the basis of bio-titer
  • Quality evaluation method of blood-fat-reducing traditional Chinese medicines on the basis of bio-titer
  • Quality evaluation method of blood-fat-reducing traditional Chinese medicines on the basis of bio-titer

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Experimental program
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Effect test

Embodiment 1

[0083] Firstly, the biological activity of Jiangzhitongmai Capsules and Curcuma longa was determined, and the experimental results are as follows:

[0084] 1. Determination of the biological activity of Jiangzhitongmai capsules and turmeric in inhibiting cholesterol absorption

[0085] Add a certain amount of cholesterol and different concentrations of Jiangzhitongmai Capsule test solution, turmeric test solution and ezetimibe solution to differentiated mature Caco-2 cells (differentiated for 17 days) for 24 hours, then absorb the cells The supernatant was used to detect the changes of extracellular free cholesterol to evaluate the effect of Jiangzhitongmai capsules and turmeric on inhibiting cholesterol absorption. Three replicate wells were set up in each group, and the blank control group, model group, cholesterol group and positive control group were set up in parallel, and repeated three times. The cholesterol absorption inhibition rate was calculated according to the fo...

Embodiment 2

[0156] Example 2 Determination of Biological Potency of Jiangzhi Tongmai Capsules in Inhibiting the Intestinal Absorption of Cholesterol

[0157] A. Preparation of reference solution: 3 grains of ezetimibe (10mg), dissolved in 5mL of MEM culture solution, and repeated pipetting and mixing, ultrasonication for 30min, the obtained liquid was filtered through coarse filter paper and 0.22M filter membrane successively, and the final filtrate was collected. That is the ezetimibe solution with a concentration of 6mg / ml, stored at 4°C, and used as a reference solution for later use;

[0158] B. Preparation of test solution: prepare Jiangzhitongmai capsule test solution as previously described;

[0159] C. The test solution and the reference solution are diluted into dose groups of different concentrations with the same dose distance, and the dose distance is 0.5; the solvent used for dilution is MEM medium;

[0160] D. Data processing and potency calculation: respectively measure th...

Embodiment 3

[0164] Example 3 Determination of Biological Potency of Jiangzhitongmai Capsules Inhibiting Triglyceride Intestinal Absorption

[0165] A. Preparation of reference substance solution: use Saini as a reference substance, use deionized water as a solvent, prepare a reference substance solution of corresponding concentration, filter, and set aside;

[0166] B. Preparation of test solution: prepare Jiangzhitongmai capsule test solution as previously described;

[0167] C. The test solution and the reference solution are diluted into dose groups of different concentrations with the same dosage interval, and the dosage interval is 0.5;

[0168] D. Data processing and potency calculation: respectively measure the pancreatic lipase activity inhibition rate obtained by the dosage groups of different concentrations of the test product and the reference product, and compare the test product and the reference product to achieve substantially the same pancreatic lipase activity inhibition ...

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Abstract

The invention relates to a quality evaluation method of blood-fat-reducing traditional Chinese medicines on the basis of bio-titer, wherein the quality evaluation method employs the bio-titer as an evaluation index, and particularly, the bio-titer of reducing cholesterol and/or the bio-titer of reducing triglyceride is employed as the evaluation index. The bio-titer of reducing cholesterol includes the bio-titers of inhibiting absorption and synthesis of cholesterol or promoting metabolism or excretion of the cholesterol; and the bio-titer of reducing triglyceride includes the bio-titers of inhibiting absorption and synthesis of triglyceride or promoting excretion of the triglyceride. The quality evaluation method can be used as effective supplement of a traditional chemical detection method, can directly reacts clinical validity, and is a quality control and evaluation method which really satisfies traditional Chinese medicine theory, shows clinical application characters of traditional Chinese medicines and ensures safety and effect of the traditional Chinese medicines.

Description

technical field [0001] The invention belongs to the technical field of quality control and evaluation of traditional Chinese medicines, and in particular relates to a method for evaluating the quality of traditional Chinese medicines based on the determination of biological potency, more particularly, a method for detecting the blood lipid-lowering activity of traditional Chinese medicines and a method for evaluating the biological quality of traditional Chinese medicines for reducing blood lipids. Background technique [0002] Compared with chemical medicines, the ingredients of traditional Chinese medicines are very complex, and the modernization and internationalization of its quality standards have always been the core of the development of traditional Chinese medicines. The key to establishing sound quality standards is to establish scientific and reliable quality control and evaluation methods. At present, the quality control and evaluation of traditional Chinese medici...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N33/92
Inventor 周亚伟
Owner 周亚伟
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