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Method for Determination of Fingerprint of Huangshi Xiangsheng Pill Preparation and Its Standard Fingerprint

A technology of Huangshi Xiangsheng Pills and a determination method, which are applied in the fingerprint determination of Huangshi Xiangsheng Pills preparations and the fingerprints of Huangshi Xiangsheng Pills preparations, can solve problems that cannot be clarified and cannot guarantee the safety and effectiveness of medicines, traditional Chinese medicines and traditional Chinese medicine preparations. Non-compliance with requirements and other problems, to achieve the effect of improving quality control technology

Active Publication Date: 2016-09-07
WUXI JIYU SHANHE PHARM CO LTD
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  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

[0002] The components of traditional Chinese medicine and Chinese medicine preparations in my country are complex, and the content determination of general quality standards only involves 1 to 3 of them. It is difficult to effectively control their internal quality, so that the safety and effectiveness of medication cannot be guaranteed.
Due to the inability to clarify the basic material composition, Chinese medicine and Chinese medicine preparations do not meet the requirements of the international pharmaceutical market, and cannot open foreign markets

Method used

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  • Method for Determination of Fingerprint of Huangshi Xiangsheng Pill Preparation and Its Standard Fingerprint
  • Method for Determination of Fingerprint of Huangshi Xiangsheng Pill Preparation and Its Standard Fingerprint
  • Method for Determination of Fingerprint of Huangshi Xiangsheng Pill Preparation and Its Standard Fingerprint

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Step (1) The preparation method of the test solution is: get Huang's Xiangsheng pills, pulverize, get about 20g, accurately weigh, put in a round bottom flask, add 200ml of water, according to the volatile oil determination method (Chinese Pharmacopoeia 2010 edition one appendix XD) test, add water from the upper end of the measuring device to fill the scale part and overflow into the flask, add 3ml of cyclohexane, continuously reflux the condenser, heat to boil and keep slightly boiling for 4 hours, let cool, put the ring in the measuring device Move the hexane layer to a 10ml volumetric flask, wash the condenser tube, the inner wall of the volatile oil measuring device, and the water layer with cyclohexane several times and move them to the volumetric flask, and dilute the cyclohexane to obtain the sample solution, which is the test solution .

[0093] Step (2) The concentration of the reference substance solution preparation is respectively: the concentration of the ...

Embodiment 2

[0099] For the fingerprint determination of batch 130501 of Huangshi Xiangsheng Pills, the specific steps are as follows:

[0100] Step (1) The preparation method of the test solution is as follows: take Huangshi Xiangsheng Pill 130501, pulverize it, take about 20g, accurately weigh it, put it in a round bottom flask, add 200ml of water, and follow the volatile oil determination method (Chinese Pharmacopoeia 2010 Edition Part One) Appendix XD) test, add water from the upper end of the measuring device to fill the scale part and overflow into the flask, add 3ml of cyclohexane, continuously reflux the condenser tube, heat to boil and keep slightly boiling for 4 hours, let cool, put the water in the measuring device Move the cyclohexane layer to a 10ml volumetric flask, wash the condenser tube, the inner wall of the volatile oil detector, and the water layer with cyclohexane several times and move to the volumetric flask, and dilute the cyclohexane to obtain a sample solution, whi...

Embodiment 3

[0107] For the fingerprint determination of batch 130911 of Huangshi Xiangsheng Pills, the specific steps are as follows:

[0108] Step (1) The preparation method of the test solution is as follows: take Huangshi Xiangsheng Pill 130911, pulverize it, take about 20g, accurately weigh it, put it in a round bottom flask, add 200ml of water, and follow the volatile oil determination method (Chinese Pharmacopoeia 2010 Edition Part One) Appendix XD) test, add water from the upper end of the measuring device to fill the scale part and overflow into the flask, add 3ml of cyclohexane, continuously reflux the condenser tube, heat to boil and keep slightly boiling for 4 hours, let cool, put the water in the measuring device Move the cyclohexane layer to a 10ml volumetric flask, wash the condenser tube, the inner wall of the volatile oil detector, and the water layer with cyclohexane several times and move to the volumetric flask, and dilute the cyclohexane to obtain a sample solution, whi...

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Abstract

The invention relates to a determination method for a fingerprint chromatogram of a HuangShiXiangShengWan preparation and a standard fingerprint chromatogram thereof. The determination method comprises the steps of preparing a test article solution, preparing a reference product solution, injecting the test article solution and the reference product solution into a gas chromatograph to carry out determination, and on the basis of the standard fingerprint chromatogram, judging whether the quality of the obtained HuangShiXiangShengWan is qualified data by using the determination method. The determination method is simple, fast, accurate, stable and reliable, can be used for controlling the quality of a HuangShiXiangShengWan sample, can be used for evaluating the quality of the HuangShiXiangShengWan in a comprehensive, objective and scientific manner and can guarantee effectiveness of the preparation.

Description

technical field [0001] The invention relates to a method for analyzing the fingerprints of traditional Chinese medicines, in particular to a method for determining the fingerprints of Huangshi Xiangsheng Pill preparations, and the obtained fingerprints of Huangshi Xiangsheng Pills preparations. technical background [0002] The components of traditional Chinese medicine and Chinese medicine preparations in my country are complex, and the content determination of general quality standards only involves 1 to 3 of them. It is difficult to effectively control their internal quality, so that the safety and effectiveness of medication cannot be guaranteed. Due to the inability to clarify the basic material composition, traditional Chinese medicine and traditional Chinese medicine preparations do not meet the requirements of the international pharmaceutical market, and cannot open foreign markets. Therefore, only by continuously conducting scientific research on quality standards, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 刘薇薇甘国锋张禄
Owner WUXI JIYU SHANHE PHARM CO LTD
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