Rhizoma alismatis-largehead atractylodes rhizome tablet quality control method

A quality control method and technology of Zeshu tablets, applied in the field of medicine, can solve problems such as inability to meet quality control, and achieve the effects of ensuring safety and effectiveness, ensuring stability and good reproducibility

Inactive Publication Date: 2019-11-12
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The clinical efficacy of traditional Chinese medicine is inseparable from its material basis. The control of a single component can no longer meet the quality control of the current ...

Method used

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  • Rhizoma alismatis-largehead atractylodes rhizome tablet quality control method
  • Rhizoma alismatis-largehead atractylodes rhizome tablet quality control method
  • Rhizoma alismatis-largehead atractylodes rhizome tablet quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Chromatographic conditions and system suitability test: use C 18 Silica gel is used as a filler; the mobile phase is acetonitrile-water, and the gradient elution is carried out in the following table 10:

[0092] Table 10 gradient elution conditions

[0093]

[0094] Preparation of the test solution: Take 10 Zeshu Tablets, remove the coating layer, grind finely, accurately weigh, place in a stoppered Erlenmeyer flask, accurately add 25 mL of methanol, seal tightly, weigh, ultrasonically treat for 15 minutes, Allow to cool, weigh again, make up for the lost weight with methanol, shake well and let stand, take the supernatant through a 0.45 μm microporous membrane, and take the subsequent filtrate.

[0095]Preparation of reference substance solution: Accurately weigh the appropriate amount of 23-acetyl alisitol B reference substance, Atractylodes lactone Ⅰ, and Atractylodes lactone Ⅱ reference substance, and add methanol to make each 1ml contain 40.0 μg of 23-acetyl a...

Embodiment 2

[0098] Chromatographic conditions and system suitability test: use C 8 Silica gel is used as a filler; the mobile phase is acetonitrile-0.05% acetic acid, and the gradient elution is carried out according to the following table 11:

[0099] Table 11 gradient elution conditions

[0100]

[0101] Preparation of the test solution: take 10 Zeshu tablets, remove the coating layer, grind finely, accurately weigh, place in a stoppered Erlenmeyer flask, accurately add 25mL of 50% methanol, seal tightly, weigh, and ultrasonically treat for 30 Minutes, let cool, weighed again, supplemented with methanol to reduce the lost weight, shake well and let it stand still, take the supernatant to pass through a 0.45μm microporous membrane, and take the subsequent filtrate.

[0102] Preparation of reference substance solution: Accurately weigh the appropriate amount of 23-acetyl alisitol B reference substance, Atractylodes lactone Ⅰ, and Atractylodes lactone Ⅱ reference substance, and add met...

Embodiment 3

[0105] Chromatographic conditions and system suitability test: use C 8 Silica gel is used as a filler; the mobile phase is acetonitrile-0.05% phosphoric acid; gradient elution is carried out in the following table 12:

[0106] Table 12 gradient elution conditions

[0107]

[0108]

[0109] Preparation of the test solution: Take 10 Zeshu Tablets, remove the coating layer, grind finely, accurately weigh, place in a stoppered Erlenmeyer flask, accurately add 25mL of methanol, seal tightly, weigh, ultrasonically treat for 30 minutes, Allow to cool, weigh again, make up for the lost weight with methanol, shake well and let stand, take the supernatant through a 0.45 μm microporous membrane, and take the subsequent filtrate.

[0110] Preparation of reference substance solution: Accurately weigh the appropriate amount of 23-acetyl alisitol B reference substance, Atractylodes lactone Ⅰ, and Atractylodes lactone Ⅱ reference substance, and add methanol to make each 1ml contain 40....

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Abstract

The invention belongs to the technical field of medicine, and discloses a quality control method for detecting content of butenolide I, butenolide II and 23-acetyl alisol B in a rhizoma alismatis-largehead atractylodes rhizome tablet. The content of one or more components is determined simultaneously or separately by high performance liquid chromatography. C8 and C18 are used as fillers. Isocraticelution or gradient elution is carried out by using 0-100% acetonitrile or methanol as a mobile phase A and 100-0% ultrapure water or glacial acetic acid or a phosphoric acid solution as a mobile phase B. A flow rate is 0.1-2 ml/min, detection wavelength is 203-320 nm, and column temperature is 20-40 DEG C. The method of the invention controls the quality of active components of two medicinal materials in the prescription of the rhizoma alismatis-largehead atractylodes rhizome tablet, and so the quality control of the preparation is more comprehensive, accurate and effective, thereby helpingto ensure the medicine safety and validity. Moreover, the determination method has the advantages of simple operation, accurate result and good precision, stability and reproducibility, is an advancedquality control method and facilitates the standardized production of the medicine.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a quality control method of a traditional Chinese medicine compound. Specifically, the invention relates to a quality control method of Zezhu Tablets, especially one or more of Zezhu Tablet preparation prescriptions Alisma and Atractylodes Rhizoma. The content determination method of high performance liquid chromatography is carried out simultaneously or separately for two kinds of components. Background technique [0002] Cardiovascular and cerebrovascular diseases are a serious threat to human beings, characterized by high prevalence, high disability and high mortality. The number of people who die from cardiovascular and cerebrovascular diseases is as high as 15 million every year in the world, ranking first among various causes of death. Atherosclerosis is the main pathological basis of cardiovascular and cerebrovascular diseases, and hyperlipidemia is an important pathogenic...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 廖茂梁王淼郑雅楠王伟
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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