Method for indirectly measuring ligustilide content in traditional Chinese medicinal materials or Chinese patent medicines by chemical conversion method

Abstract

The invention discloses a method for indirectly measuring the accurate content of ligustilide in traditional Chinese medicinal materials or Chinese patent medicines by a chemical conversion method. The method comprises the steps of extracting and / or converting ligustilide in traditional Chinese medicinal materials or Chinese patent medicine powder; converting ligustilide with an unstable chemicalstructure in traditional Chinese medicinal materials or Chinese patent medicines into cyclopropylligustilide with a stable structure, directly measuring the content of cyclopropylligustilide through an HPLC external standard method, and then indirectly calculating the content of ligustilide in traditional Chinese medicinal materials or Chinese patent medicines through equimolar weight. The methodis used for quantitatively detecting the ligustilide content in medicines, the result is reliable, the accuracy is high, the stability and reproducibility of the method are good, and the direct targetof effectively controlling the medicine quality is achieved through application of the method.

Description

technical field [0001] The invention relates to a method for determining the content of ligustilide in Chinese medicinal materials or Chinese patent medicines, in particular to a method for indirectly calculating the accurate content of ligustilide in medicinal materials or medicines by measuring the content of ligustilide through chemical transformation, It belongs to the field of drug analysis. Background technique [0002] In the Umbelliferae plants, the plants of the genus Angelica and Ligusticum all contain phthalide compounds, such as Angelica and Rhizoma Chuanxiong and other medicinal plants. These compounds are the main components of plant volatile oils, and most of them have a strong aromatic smell. Has a rich content. These compounds have many structural types, and are generally chemically unstable, and they are easily oxidized or degraded by light, heat, and enzymes in the environment when they exist alone. However, such compounds generally have good pharmacolog...

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Problems solved by technology

[0005] Because ligustilide has a highly unsaturated conjugated system with 3 ethylenic bonds and 1 carbonyl double bond, but does not form a stable conjugated system with an aromatic ring, it has many reaction sites, strong reactivity, and relatively low free energy. Low, so Diels-Alder reactions of 1,2, 1,4 and 1,6 are easy to occur to form complex dimerization or trimerization compounds

Due to the instability of the natural chemical structure of this compound, the quality of the national pharmacopoeia standard product of ligustilide has not been well resolved, resulting in the technical problem of using ligustilide as a quantitative detection index has not been applied

[0007] Although the international standard of Angelica sinensis (ISO-22584, released in December 2019) does not limit the content of ligustilide, the British Pharmacopoeia (2017 edition) and the Hong Kong Pharmacopoeia have clearly defined the content of ligustilide regulations (UK: greater than or equal to 0.1%; Hong Kong: greater than or equal to 0.6%), especially the Hong Kong Pharmacopoeia only limits ligustilide and no longer controls the content requirements of the total volatile oil and ferulic acid. With the gradual improvement of medicinal material standards, the content limit of ligustilide has become an inevitable situation

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