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A qualitative and quantitative detection method for Kangguxuansheng Tablets

A quantitative detection method and anti-bone hyperplasia technology, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of no qualitative and quantitative detection methods, cumbersome quality control methods, and high toxicity of reagents

Active Publication Date: 2016-12-28
JIUZHITANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The quality standard of this product is recorded in Volume 7 of "Drug Standards of the Ministry of Health of the People's Republic of China" Chinese Medicine Prescriptions, standard number WS 3 -B-1338-93, only the microscopic identification method of Spatholobus Spatholobus in this standard, without any qualitative and quantitative detection methods, which is not conducive to the control of the product quality of Kangguxuansheng Tablets
Modern Food and Drug Journal, Volume 16, No. 2, 2006, "Research on the Quality Standards of Kangguzengsheng Tablets", recorded the quality control methods of Kangguzengsheng Tablets, qualitatively identified Rhizoma Drynaria and Spatholobus Spatholobus, and icariin The content determination was carried out, and the qualitative method was complicated to operate and the reagents used were highly toxic
Strait Pharmacy, Volume 19, Issue 6, 2007, "Research on the Quality Standards of Kangguzengsheng Tablets", recorded the quality testing methods of Kangguzengsheng Tablets, qualitatively identified Cistanche and Epimedium, and determined the content of Icariin , its quality control method is cumbersome to operate
Chinese Journal of Experimental Formulas, Vol. 12, No. 7 "Research on Qualitative and Quantitative Methods of Kanggu Zengsheng Pills" records the qualitative and quantitative detection methods of Kangguzengsheng Pills. glycoside and echinacoside were determined, but the qualitative method is complex and the reagents used are highly toxic
The existing quality standards cannot effectively control the quality of Kangguxuansheng Tablets, which will affect the quality level of the product and its clinical efficacy

Method used

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  • A qualitative and quantitative detection method for Kangguxuansheng Tablets
  • A qualitative and quantitative detection method for Kangguxuansheng Tablets
  • A qualitative and quantitative detection method for Kangguxuansheng Tablets

Examples

Experimental program
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Effect test

Embodiment 1

[0104] Anti-bone hyperplasia tablets: batch number 20120318

[0105] (1) Take this product and observe under a microscope: the stone cells are round or oval, rectangular or polygonal, with thick walls, and the cell cavity contains orange-red or brown substances;

[0106] (2) Take 10 tablets of this product, grind them finely, add 20ml of petroleum ether (60-90°C), heat and reflux for 0.5 hours, let cool, filter, and use the filtrate for later use; add 20ml of ethyl acetate to the residue, heat and reflux for 0.5 hours, put Cool, filter, evaporate the filtrate to dryness, add 0.5ml of methanol to the residue to dissolve, and use it as the test solution; take icariin and naringin reference substances, add methanol respectively to make a solution containing 0.5mg per 1ml, and use it as the test solution. Reference substance solution; test according to thin-layer chromatography (Appendix VI B of Chinese Pharmacopoeia 2010 Edition), draw 10 μl of each of the above three solutions, ...

Embodiment 2

[0115] Anti-bone hyperplasia tablets: batch number 20120612

[0116] (1) Take this product and observe under a microscope: the stone cells are round or oval, rectangular or polygonal, with thick walls, and the cell cavity contains orange-red or brown substances;

[0117] (2) Take 20 tablets of this product, grind them finely, add 30ml of petroleum ether (60-90℃), heat and reflux for 1 hour, let cool, filter, and use the filtrate for later use; add 50ml of ethyl acetate to the residue, heat and reflux for 1 hour, put Cool, filter, evaporate the filtrate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test solution; take another reference substance of icariin and naringin, add methanol respectively to make a solution containing 0.5mg per 1ml, as a control product solution; according to thin-layer chromatography (Appendix VI B of Chinese Pharmacopoeia 2010 Edition), 5 µl of each of the above-mentioned three solutions was drawn, and they were respecti...

Embodiment 3

[0126] Anti-bone hyperplasia tablets: batch number 20120714

[0127] (1) Take this product and observe under a microscope: the stone cells are round or oval, rectangular or polygonal, with thick walls, and the cell cavity contains orange-red or brown substances;

[0128] (2) Take 30 tablets of this product, grind them finely, add 80ml of petroleum ether (60-90℃), heat and reflux for 2 hours, let cool, filter, and use the filtrate for later use; add 80ml of ethyl acetate to the residue, heat and reflux for 2 hours, put Cool, filter, evaporate the filtrate to dryness, add 2ml of methanol to the residue to dissolve, as the test solution; take icariin and naringin reference substances, add methanol respectively to make a solution containing 0.5mg per 1ml, as a control product solution; according to thin-layer chromatography (Appendix VI B of Chinese Pharmacopoeia 2010 Edition), 5 µl of each of the above-mentioned three solutions was drawn, and they were respectively spotted on the...

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Abstract

The present invention discloses a qualitative and quantitative detection method of anti-hyperostosis tablets, wherein the following schemes are added: (1) a thin-layer chromatography method is adopted and naringin is adopted as the control to identify whether the anti-hyperostosis tablet contains Rhizoma Drynariae; a Caulis Spatholobi control herb is adopted as the control to identify whether the anti-hyperostosis tablet contains Caulis Spatholobi; and icariin is adopted as the control to identify whether the anti-hyperostosis tablet contains epimedium; and (2) a high performance liquid chromatography method is adopted to determine the icariin content in the anti-hyperostosis tablet. Compared with the method in the prior art, the qualitative and quantitative detection method of the present invention has the following advantages that: the qualitative identification method is added, the effectively component content determination method is added, the revised quality standard is provided, the quality control level of the drug is increased, and the safety and the effectiveness of the medication are ensured. The qualitative and quantitative detection method of the present invention can be used for controlling the quality of the anti-hyperostosis tablets and controlling the quality of other dosage forms such as capsules, granules, pills and the like in the same prescription.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a quality control method of Kangguzengsheng Tablets. Background technique [0002] Kangguzengsheng Tablets are composed of Rehmannia glutinosa, Luniancao, Rhizoma Drynariae, Caulis Spatholobus, Epimedium, Cistanche, and Laifuzi. It has the functions of nourishing the kidney, promoting blood circulation, and relieving pain. It is used for hypertrophic spondylitis, cervical spondylosis, and Bone spurs, hypertrophic arthritis, Kashin-Beck disease. The quality standard of this product is recorded in Volume 7 of "Drug Standards of the Ministry of Health of the People's Republic of China" Chinese Medicine Prescriptions, standard number WS 3 -B-1338-93, in this standard there is only the microscopic identification method of Spatholobus Spatholobus, without any qualitative and quantitative detection methods, which is not conducive to the control of the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/90G01N30/02
Inventor 张妮瑜谷陟欣辛秀欧金秀郗瑞云刘淑妦袁莉朱丽
Owner JIUZHITANG