Finger-print detection method of traditional Chinese medicine composition for treating osteoproliferation

A technology of fingerprints and detection methods, which is applied in the field of quality detection of traditional Chinese medicine preparations, can solve problems such as incompleteness, and achieve the effects of convenient operation and objective conclusions

Active Publication Date: 2012-11-07
JIANGSU KANION PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

From the composition of the prescription, it can be found that the capsules of the traditional Chinese medicine composition are made of nine traditional Chinese medicines. However, in the Pharmacopoeia, only microscope observation, thin-layer chromatography is used to identify the medicinal materials, and high-performance liquid chromatography is used to detect the content of index components in one traditional Chinese medicine. It is obviously not comprehensive enough to control the quality of the whole Chinese medicine composition in this way

Method used

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  • Finger-print detection method of traditional Chinese medicine composition for treating osteoproliferation
  • Finger-print detection method of traditional Chinese medicine composition for treating osteoproliferation
  • Finger-print detection method of traditional Chinese medicine composition for treating osteoproliferation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The mensuration of embodiment 1 traditional Chinese medicine composition capsule and the acquisition of standard fingerprint

[0056] 1. Chinese medicine composition capsules are all produced by Jiangsu Kangyuan Pharmaceutical Co., Ltd. Eighteen batches were taken, and the batch numbers are: 031101, 031103, 031207, 040105, 040308, 040401, 040505, 040601, 040602, 040603, 050204, 050301 . Methanol 25mL, ultrasonic extraction 30min, filter, get continued filtrate as need testing solution; Then obtain the liquid phase chromatogram of 18 batches of Chinese medicine composition capsules according to the following chromatographic conditions, calculate similarity, with these 18 batches of need testing fingerprints Based on the atlas, adopt the 2004A version of the Chinese medicine chromatographic fingerprint similarity evaluation system provided by the National Pharmacopoeia Committee to calculate and obtain the common pattern as the standard fingerprint; Figure 7 Shown:

[...

Embodiment 2

[0059] Stability test of embodiment 2 traditional Chinese medicine composition capsule fingerprint chromatogram detection method

[0060] Get Jiangsu Kangyuan Pharmaceutical Co., Ltd. production batch number is the Chinese medicine composition capsule of 040505, prepare the test solution by the preparation method of the test solution described in the instructions, and then press the fingerprint of the test solution described in the instructions The analysis method measures the fingerprints every 3 hours, and measures 6 times in total. The similarity is calculated with the fingerprints obtained by sampling at 0 hours as a comparison. The specific experimental results are shown in Table 1:

[0061] Table 1 Stability test results of Chinese medicine composition capsule fingerprint detection method

[0062] Determination time of test solution (h)

[0063] The results in Table 1 show that the fingerprint similarity results of each detection are greater than 0.99, showing ...

Embodiment 3

[0064] The precision test of embodiment 3 traditional Chinese medicine composition capsule fingerprint chromatogram detection method

[0065] Get Jiangsu Kangyuan Pharmaceutical Co., Ltd. production batch number is the Chinese medicine composition capsule of 040505, prepare the test solution by the preparation method of the test solution described in the instructions, and then press the fingerprint of the test solution described in the instructions Analytical method, continuous sampling is measured 6 times, and concrete experimental result is as shown in table 2 and table 3; Table 2, 3 result shows, the retention time and main peak (accounting for total peak area 5% of total peak area) of each common peak in need testing solution. %) are basically the same (RSD<3%), and using the fingerprints obtained from the first sample injection as a control, the similarity of the fingerprints obtained from the next 5 injections is calculated, and the similarity results are all greater than...

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Abstract

The invention discloses a finger-print detection method of a traditional Chinese medicine composition for treating osteoproliferation, which comprises the steps of preparing a test solution, establishing a standard finger-print and detecting the finger-print of the test solution. The experimental verification shows that the finger-print detection method provided by the invention is high in flexibility and precision, good in stability and repeatability and high in similarity, and is capable of objectively, comprehensively and accurately evaluating the quality of the traditional Chinese medicine composition.

Description

technical field [0001] The invention relates to a quality detection method of a traditional Chinese medicine preparation, in particular to a fingerprint detection method of a traditional Chinese medicine composition for treating hyperosteogeny. Background technique [0002] The traditional Chinese medicine composition capsule involved in the present invention is recorded in "Chinese Pharmacopoeia" (2010 edition), "Prescription Preparation and Single Prescription Preparation". (steamed) 117 parts by weight, radish seed (fried) 58 parts by weight, dog spine (salt) 117 parts by weight, drynaria fortunei 117 parts by weight, privet fruit (salt) 58 parts by weight, achyranthes bidentata 117 parts by weight and Epimedium 117 parts by weight is made of nine herbs, which has the effects of nourishing the waist and kidneys, strengthening bones and muscles, promoting blood circulation and relieving pain, etc. It is used in modern clinics to treat diseases such as hyperplastic spondyli...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/36
Inventor 萧伟王振中毕宇安李家春秦建平章晨峰
Owner JIANGSU KANION PHARMA CO LTD
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