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Anti-rheumatism traditional Chinese medicine quality evaluation method based on bioavailability

A technology for biological potency and quality evaluation, applied in biochemical equipment and methods, microbial determination/inspection, biological testing, etc. The method has not been reported and other issues

Pending Publication Date: 2016-05-04
周亚伟
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

For example, the content of triptolide in a single component cannot represent the quality of tripterygium wilfordii, nor can it reflect the antirheumatic activity of the compound preparation containing tripterygium wilfordii or its extracts
Taking the content of individual or some index components as an indicator of quality standards, although the amount of index components can be controlled, it is difficult to ensure the stability of all components only by controlling the amount of one or some of them It is more difficult to reflect the overall biological effect of traditional Chinese medicine and ensure the consistency of its clinical efficacy
[0004] However, at present, there are few reports on the research results of the biopotency assay in the field of Chinese herbal medicine, and for the assay method of the biopotency of the anti-rheumatic drugs of traditional Chinese medicine, or the quality evaluation or detection method of the anti-rheumatic traditional Chinese medicine measured based on the biopotency Not yet reported

Method used

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  • Anti-rheumatism traditional Chinese medicine quality evaluation method based on bioavailability
  • Anti-rheumatism traditional Chinese medicine quality evaluation method based on bioavailability
  • Anti-rheumatism traditional Chinese medicine quality evaluation method based on bioavailability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Example 1 Determination of related biological activities of Qufeng Zhitong Tablets, Tripterygium wilfordii Polyglycoside Tablets and Total Radix Paeony Capsules

[0065] 1. Nitric oxide (NO) kit method to determine the biological activity of drugs in inhibiting chondrocyte NO secretion

[0066] Through the chondrocyte method, based on the culture of primary chondrocytes, the degradation of the chondrocyte matrix was induced by interleukin (IL)-1β stimulation in vitro as a pharmacological model, and the nitric oxide (NO) nitrate reductase assay kit was used to detect NO content, the inhibition rate of chondrocyte NO secretion was used as an index.

[0067] Specific experimental method: Inoculate chondrocytes cultured in vitro into 96-well plates, add IL-1β at a concentration of 100ng / ml after 24 hours of culture, set 3 replicates for each concentration, set up a blank control group in parallel, and place at 37°C , 5% CO 2 Cultivate in the incubator for 24 hours and set...

Embodiment 2

[0102] Example 2 Determination of Biological Potency of Qufeng Zhitong Tablets Inhibiting COX-2 Activity

[0103] A. Reference substance solution preparation: take celecoxib as the reference substance, dissolve in the reaction system of 10 μl COX-2 (final concentration is 0.48U / μl)+100 μMAA+2.1mMTMPD, and filter;

[0104] B. Preparation of test solution: prepare Qufengzhitong tablet test solution as previously described;

[0105] C. need testing solution and reference substance solution are diluted into the dosage group of different concentration with same dose distance, dose distance is 0.5; The solvent used for dilution is 10 μ l COX-2 (final concentration is 0.48U / μ l)+100 μ MAA+2.1mMTMPD;

[0106] D. Data processing and potency calculation: The COX-2 activity inhibition rate of the different dose groups of the test product and the reference substance was respectively measured by using the microplate reader method described in Example 1, and the calculation of the test pro...

Embodiment 3

[0109] Example 3 Determination of biological potency of tripterygium glycosides tablets inhibiting chondrocyte NO secretion

[0110] A. preparation of reference substance solution: take dexamethasone as reference substance, use the DMEM culture fluid of 20% fetal bovine serum as solvent, be made into the reference substance solution of corresponding concentration, filter, standby;

[0111] B. preparation of test solution: prepare tripterygium wilfordii polyglycoside tablets need test solution as described above;

[0112] C. need testing solution and reference substance solution are diluted into dosage groups of different concentrations with the same dosage interval, dosage interval is 0.5, dilutes with the DMEM nutrient solution of 20% fetal bovine serum;

[0113] D. Data processing and titer calculation: adopt the nitric oxide (NO) kit method described in embodiment 1 to measure respectively the chondrocyte NO secretion inhibitory rate that test article and reference substanc...

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Abstract

The present invention relates to a traditional Chinese medicine quality evaluation method based on anti-rheumatism bioavailability. According to the quality evaluation method, bioavailability is adopted as an evaluation index, and particularly bioavailability for chondrocyte protection, bioavailability for COX-2 activity inhibition, and bioavailability for inflammatory factor secretion inhibition are adopted as the quality evaluation indices, wherein the bioavailability for chondrocyte protection is the bioavailability for chondrocyte NO secretion inhibition, and the inflammatory factor is TNF-alpha or IL-1. According to the present invention, the quality evaluation method can be adopted as the effective complement of the traditional chemical detection method, directly reflects the clinical effectiveness, and is the quality control and detection method which truly meets the traditional Chinese medicine theory, reflects the clinical application characteristics of the traditional Chinese medicine, and ensures the safety and the effectiveness of the traditional Chinese medicine.

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 anti-rheumatic activity of traditional Chinese medicines and a method for evaluating the biological quality of anti-rheumatic traditional Chinese medicines. Background technique [0002] Rheumatoid arthritis (RA) is one of difficult diseases, and the average incidence rate in our country is 0.3%. The main clinical manifestations are joint swelling, pain, limited mobility, and morning stiffness. In the later stage, joint ankylosis, deformity, loss of function and even disability are caused. Because of its wide range of lesions, high morbidity and disability rates, and the etiology and pathogenesis have not yet been clarified, so far the treatment of R...

Claims

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Application Information

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IPC IPC(8): C12Q1/26C12Q1/02G01N33/68
Inventor 周亚伟
Owner 周亚伟
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