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Schizandrin A purity standard substance, preparation method thereof and application

A technology for schisandrin A and a standard substance, which is applied in the field of schisandrin A purity standard substance and its preparation, can solve the problem that it is difficult to meet the needs of pharmaceutical research and development of schisandra and its related products, and cannot effectively realize the verification of testing methods and arbitration of testing results. No traceability, etc.

Inactive Publication Date: 2019-11-22
上海诗丹德标准技术服务有限公司 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are some difficulties in the development of pharmaceutical use of schisandrin and the quality control research of schisandra and its related products. One of the main reasons is that the lack of standard substances for the purity of schisandrin has affected the standard formulation of schisandra and its related products and the implementation of existing standards have affected the progress of pharmaceutical research on schisandrin
The development system of Schizandrin A purity standard substance has not been reported yet
Most of the domestic pharmaceutical industry uses relevant foreign standard products, but these foreign standard products are not only expensive, but also have a long procurement cycle, and most of them are not traceable. They cannot effectively realize the verification of detection methods and the arbitration of test results. Demand for pharmaceutical research and development of related products

Method used

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  • Schizandrin A purity standard substance, preparation method thereof and application
  • Schizandrin A purity standard substance, preparation method thereof and application
  • Schizandrin A purity standard substance, preparation method thereof and application

Examples

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Embodiment 1

[0091] The raw material of schisandra chinensis is to crush the medicinal material of southern schisandra chinensis, add methanol at a mass ratio of 1:10, extract under reflux for 2 hours; concentrate the extract to a small volume until it has no alcohol smell, add an equal volume of n-hexane for extraction twice, and combine n-hexane The alkane layer was concentrated to a small volume; the n-hexane concentrated solution was mixed with silica gel and dried, and the silica gel column was packed with mobile phase n-hexane:ethyl acetate (6:1), and the mixed sample was dried and then pulverized and loaded. Alkanes: Ethyl acetate (6:1) for elution, point the plate to determine the elution components of the target and combine them; the combined elution components are concentrated to dryness, add 0.2-1L of methanol per gram and heat to dissolve, after standing there is Colorless square crystals are precipitated and filtered; the filtered square crystals are heated and dissolved by add...

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Abstract

The invention discloses a preparation method for a schizandrin A purity standard substance. The preparation method comprises the following steps: a candidate for preparing the schizandrin A purity standard substance is extracted from a schisandra chinensis medicinal material; purity analysis and structure identification of the candidate are carried out; the uniformity of the candidate is checked;the stability of the candidate is checked; the purity constant value of the candidate is detected; uncertainty evaluation is carried out; and if the purity analysis, the structure identification, theuniformity check, the stability check and the uncertainty evaluation all meet the requirements, the schizandrin A purity standard substance is prepared. The invention also provides the schizandrin A purity standard substance prepared by the above method and application thereof. The schisandrin A purity standard substance disclosed by the invention can be used as a standard substance for accuratelydetecting the content of the schisandrin A component in related products produced by taking schisandra chinensis and kadsura longepedunculata as raw materials, and provides a standard substance resource with traceability and a quantity value transmission function for realizing accurate quantification of the content of the schisandrin A component in China.

Description

technical field [0001] The invention relates to a standard substance of schisandrin A purity and its preparation method and application, belonging to the technical field of standard value transmission in stoichiometric measurement. Background technique [0002] Schisandra chinensis and Southern Schisandra chinensis have the effects of astringent and astringent, nourishing qi and promoting body fluid, tonifying kidney and calming heart. Schisandra chinensis and southern Schisandra chinensis contain a variety of chemical components, among which biphenyl cyclooctene lignans are the main active components, and schisandrin A is one of the important active components. Schisandrin A is a white crystalline powder with a CAS registration number of 61281-38-7 and a molecular formula of C 24 h 32 o 6 , the relative molecular weight is 416.51, soluble in chloroform, methanol, ethyl acetate, acetone, insoluble in water. Studies have found that Schizandrin A exhibits a variety of good...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28G01N24/08G01N30/02
CPCG01N1/28G01N24/08G01N30/02G01N2001/2893
Inventor 许纪锋潘雪格郑丁丁钱勇谢天培
Owner 上海诗丹德标准技术服务有限公司
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