Schizandrin A purity standard substance, preparation method thereof and application

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...

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

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