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

A technology of active ingredients and content, which is applied in the field of simultaneous detection of four active ingredients in Zhikebao Tablets, can solve the problems of cumbersome experimental steps, poor control of experimental conditions, unsatisfactory repeatability and stability of the method, and achieve reproducible results. Good performance, simple and fast detection method, and the effect of improving the level of quality control

Active Publication Date: 2014-01-01
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] Simultaneously detect the content of schisandrin A, proseridin, prosertin and shionone in Zhikebao Tablets, the details are 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); dibassin reference substance (batch number: 111711-200602, provided by the China Institute for the Control of Pharmaceutical and Biological Products); , provided by China Institute for the Control of Pharmaceutical and Biological Products); Shivanone reference substance (batch number: 111581-200604, provided by China Institute for the Control of Pharmaceutical and Biological Products); .

[0052] 2. Instrument

[0053] High performance liquid chromatography Agilent1260Infinity, G1315D. Chromatographic column: Shiseido C18 (4.6×250mm, 5μm, column number: AKAD08072), one-hundred-thousandth grade electronic balance (model: 9ZSM-202A), ultrasonic i...

Embodiment 2

[0064] Simultaneously detect the content of schisandrin A, proseridin, prosertin and shionone in Zhikebao Tablets, the details are 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. Instrument

[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 and water as mobile phase B, and carry out gradient elution according to the regulations in Table 2 (wherein, Gradient 1 is isocratic elution, gradient 2 is the gradient elution in which the volume percentage of mobile phase A and B changes continuously from 40%:60% isokinetic to 90%:10% during the elution process, and gradient 3 is isocratic elution off), using variable wavelength de...

Embodiment 3

[0079] Simultaneously detect the content of schisandrin A, proseridin, prosertin and shionone in Zhikebao Tablets, the details are 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); others are the same as in Example 1

[0082] 2. Instrument

[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 and water as mobile phase B, and carry out gradient elution according to the regulations in Table 3 (wherein, Gradient 1 is isocratic elution, gradient 2 is the gradient elution in which the volume percentage of mobile phase A and B changes continuously from 65%: 35% isokinetic to 100%: 0% during the elution process, and gradient 3 is isocratic elution off), using variable wavelength ...

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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, schisandratin, schisandrin and shionone in Zhikebao Tablets by HPLC. Background technique [0002] Zhikebao Tablets are rich in a variety of Chinese herbal medicines, which have the effects of relieving the exterior and dispelling cold, clearing the lungs and removing phlegm, nourishing the lung qi and nourishing the lung yin, and have the functions of regulating the lung and eliminating phlegm, relieving cough and relieving asthma. The "Secret Recipe of Zhikebao Tablets" was selected into the Lingnan Traditional Chinese Medicine Cultural Heritage Protection List. [0003] The current standard of Zhikebao Tablets is recorded in the 2010 edition of the Chinese Pharmacopoeia, and its identification standard includes 1 physical and chemical identifi...

Claims

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Application Information

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