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Method for simultaneously detecting contents of four effective ingredients in antitussive tablet

A technology for active ingredients and contents, applied in the field of simultaneous detection of the contents of four active ingredients in Zhikebao tablets, can solve the problems of unsatisfactory repeatability and stability of the method, cumbersome experimental steps, and difficult control of experimental conditions, and achieves the detection method. Simple and fast, good reproducibility, and the effect of improving the level of quality control

Active Publication Date: 2013-04-17
TEYI PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through the research, it is found that there is negative interference between the TLC of various medicinal flavors, and there is no effective separation method to identify its active ingredients, resulting in the failure of the existing quality control methods to effectively control the product quality
Moreover, the existing detection methods have shortcomings such as cumbersome experimental steps and poor control of experimental conditions, and the repeatability and stability of the method are not ideal.

Method used

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  • Method for simultaneously detecting contents of four effective ingredients in antitussive tablet
  • Method for simultaneously detecting contents of four effective ingredients in antitussive tablet
  • Method for simultaneously detecting contents of four effective ingredients in antitussive tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] At the same time, the method for detecting the content of schisandrin A, schisandrin, schidrin and asterone in Zhikebao tablets is described in detail as follows (3 elution gradients):

[0050] 1. Experimental samples and reference substances

[0051] Zhikebao Tablets (manufactured by Guangdong Taicheng Pharmaceutical Co., Ltd., batch number: 20121101); Amphetamine reference substance (batch number: 111711-200602, provided by China Institute for the Control of Pharmaceutical and Biological Products); Amphetamine reference substance (batch number: 111904-201102) , China Institute for the Control of Pharmaceutical and Biological Products); Asterone reference substance (batch number: 111581-200604, provided by China Institute for the Control of Pharmaceutical and Biological Products); Schisandrol A reference substance (batch number: 110857-201010, provided by China Institute for the Control of Pharmaceutical and Biological Products) .

[0052] 2. Instruments

[0053] Hig...

Embodiment 2

[0064] At the same time, the method for detecting the content of schisandrin A, schisandrin, schidrin and asterone in Zhikebao tablets is described in detail as follows (3 elution gradients):

[0065] 1. Experimental samples and reference substances

[0066] Zhikebao Tablets (produced by Guangdong Taicheng Pharmaceutical Co., Ltd., batch number: 20121102); others are the same as in Example 1

[0067] 2. Instruments

[0068] Same as Example 1

[0069] 3. Detection method

[0070] 3.1 Chromatographic conditions and system suitability test: use octadecylsilane-bonded silica gel as filler; use acetonitrile as mobile phase A, use water as mobile phase B, and carry out gradient elution as specified in Table 2 (wherein, Gradient 1 is isocratic elution, gradient 2 is the gradient elution in which the volume percentages of mobile phases A and B are continuously changed from 40%: 60% to 90%: 10% during the elution process, and gradient 3 is isocratic washing. The number of theoretic...

Embodiment 3

[0079] At the same time, the method for detecting the content of schisandrin A, schisandrin, schidrin and asterone in Zhikebao tablets is described in detail as follows (3 elution gradients):

[0080] 1. Experimental samples and reference substances

[0081] Zhikebao Tablets (produced by Guangdong Taicheng Pharmaceutical Co., Ltd., batch number: 20121103); the others are the same as in Example 1

[0082] 2. Instruments

[0083] Same as Example 1

[0084] 3. Detection method

[0085] 3.1 Chromatographic conditions and system suitability test: use octadecylsilane-bonded silica gel as filler; use acetonitrile as mobile phase A, use water as mobile phase B, and carry out gradient elution as specified in Table 3 (wherein, Gradient 1 is isocratic elution, gradient 2 is gradient elution in which the volume percentages of mobile phases A and B are continuously changed from 65%: 35% to 100%: 0% during the elution process, and gradient 3 is isocratic washing. The number of theoretic...

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Abstract

The invention provides a method for simultaneously detecting contents of four effective ingredients (including schisandrin, praeruptorin A, praeruptorin and shionone) in an officinal antitussive tablet. The method comprises the steps of applying a modern high performance liquid chromatography technology, and taking octodecyl silane bonded silica gel as a filling agent; taking acetonitrile as a mobile phase A, and water as a mobile phase B; and calculating the number of theoretical plates to be not less than 5000 according to a schisandrin peak. In an elution process, gradient elution that allows a concentration proportion of the mobile phase A to the mobile phase B to change gradually is combined with isocratic elution that allows a proportion of the mobile phase A to the mobile phase B to be constant, so that a specific gradient elution procedure is formed; two or three gradient elutions are conducted; and the change detection is conducted on wavelength in a gradient elution process. The method can simultaneously detect the contents of schisandrin, praeruptorin A, praeruptorin and shionone in the antitussive tablet qualitatively and quantitatively, is simple, convenient, quick and high in specificity, and can raise the quality control level of the antitussive tablet effectively.

Description

technical field [0001] The invention relates to a method for simultaneously detecting the contents of four active ingredients in Zhikebao tablets, in particular to a method for simultaneously detecting the contents of schisandrin A, schisandrin, sphenoidin and asterone in Zhikebao tablets by HPLC. Background technique [0002] Zhikebao Tablet is rich in a variety of Chinese herbal medicines, which have the functions of relieving the exterior and dispelling cold, dispelling the lungs and removing phlegm, benefiting the lungs and qi and nourishing the yin of the lungs. "The Secret Recipe of Relieving Cough Tablets" was selected into the Lingnan Traditional Chinese Medicine Cultural Heritage Protection List. [0003] The current standard of Zhikebao tablets is included in the 2010 edition of the Chinese Pharmacopoeia, and its identification standards include 1 physical and chemical identification and 3 thin-layer identifications, and there are 14 herbs in the prescription of Zh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34
Inventor 许丹青
Owner TEYI PHARMACEUTICAL GROUP CO LTD
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