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Quality evaluation method of traditional Chinese medicines for resisting osteoporosis

An anti-osteoporosis, quality evaluation technology, applied in biochemical equipment and methods, microbial determination/inspection, etc., can solve problems such as quality evaluation or detection methods that have not been reported, and achieve the effect of promoting osteoblast proliferation

Pending Publication Date: 2016-05-18
周亚伟
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Problems solved by technology

[0003] However, at present, there are few research reports on the determination of biological potency in the field of Chinese herbal medicines, and for the determination of the biological potency of traditional Chinese medicine anti-osteoporosis drugs, or the quality evaluation of anti-osteoporosis Chinese medicines based on biological potency Or detection methods have not been reported yet

Method used

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  • Quality evaluation method of traditional Chinese medicines for resisting osteoporosis
  • Quality evaluation method of traditional Chinese medicines for resisting osteoporosis
  • Quality evaluation method of traditional Chinese medicines for resisting osteoporosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Firstly, relevant biological activities of Gushukang Granules and Epimedium were measured, and the experimental results are as follows:

[0066] 1. Determination of the biological activity of Gushukang Granules and Epimedium in inhibiting the growth of osteoclasts by MTT method

[0067] The osteoclasts cultured in vitro were mixed with α-MEM medium containing 20% ​​fetal bovine serum to make 1×10 5 / ml of cell suspension, seeded in 96-well plate, placed in 37 ° C, 5% CO 2 Cultivate in the incubator for 24 hours and set aside.

[0068] In the above-mentioned 96-well plate, a blank control group (no cells), a cell control group, a positive drug-conjugated estrogen group, and each dose group of the test product were set up. The blank control group and the positive drug group were respectively added with 100 μl of α-MEM culture solution to dissolve And filter-sterilized conjugated estrogen solution and 100 μl of α-MEM culture solution containing 20% ​​fetal bovine serum, ...

Embodiment 2

[0090] Determination of the biological potency of embodiment 2 Gushukang granule inhibiting osteoclast proliferation

[0091] A. preparation of reference substance solution: take conjugated estrogen as reference substance, use the α-MEM culture fluid of 20% fetal bovine serum as solvent, make the reference substance solution that concentration is 50 μ g / ml, filter, and set aside;

[0092] B. Preparation of test solution: prepare Gushukang test solution as described above;

[0093] C. need testing solution and reference substance solution are diluted into the dosage group of different concentration with same dosage distance, and dosage distance is 0.5, and the used solvent of dilution is the α-MEM culture fluid of 20% fetal bovine serum;

[0094] D. Data processing and potency calculation: adopt the MTT method described in embodiment 1 to measure respectively the osteoclast growth inhibition rate of different dosage groups test product and reference substance, compare test prod...

Embodiment 3

[0097] Example 3 Gushukang granule inhibits the determination of the biological potency of osteoclast differentiation

[0098] A. Preparation of reference substance solution: take denosumab as reference substance, use α-MEM culture solution of 20% fetal bovine serum as solvent, prepare a reference substance solution with a concentration of 50 μg / ml, filter, and set aside;

[0099] B. Preparation of test solution: prepare Gushukang test solution as described above;

[0100] C. need testing solution and reference substance solution are diluted into the dosage group of different concentration with same dosage distance, and dosage distance is 0.5, and the used solvent of dilution is the α-MEM culture fluid of 20% fetal calf serum;

[0101] D. Data processing and potency calculation: adopt the TRAP staining method described in embodiment 1 to measure respectively the osteoclast differentiation inhibition rate of different dosage groups test product and reference substance, compare ...

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Abstract

The invention provides a traditional Chinese medicine quality evaluation method based on determination of bioavailability for resisting osteoporosis, and the quality evaluation method employs bioavailability as an evaluation index; and concretely, bioavailability for inhibiting effects of osteoclast and bioavailability for promoting effects of osteoblast are used as evaluation indices. The quality evaluation method can be used for integral control of effects of medicine containing complex traditional Chinese medicine components, and can be used as an effective supplement of traditional chemical detection means, so that clinic efficacy is directly reflected; the method is a quality control and evaluation method which accords with the traditional theory of traditional Chinese medicine and pharmacy, embodies clinic application characteristics of traditional Chinese medicines, and guarantees safety and effectiveness of the traditional Chinese medicines.

Description

technical field [0001] The invention belongs to the technical field of quality control and detection of traditional Chinese medicines, and in particular relates to a quality detection method of traditional Chinese medicines based on biological potency determination, which is suitable for biological quality evaluation or drug research and development, clinical medication or mechanism research of anti-osteoporosis Chinese medicines. 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 medicine is mainly based on the qualitative and quantitative analysis of ch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/02
Inventor 周亚伟
Owner 周亚伟
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