Construction method of Chinese herbal medicine Naoshuantong preparation high performance liquid chromatography (HPLC) finger-print and application thereof

Abstract

The invention discloses a construction method of a Chinese herbal medicine Naoshuantong preparation high performance liquid chromatography (HPLC) finger-print. The construction method of the Chinese herbal medicine Naoshuantong preparation HPLC finger-print comprises a Chinese herbal medicine Naoshuantong preparation HPLC finger-print one and a Chinese herbal medicine Naoshuantong preparation HPLC finger-print two. A complete finger-print feature of the Chinese herbal medicine Naoshuantong is formed through the HPLC finger-print one and preparation HPLC finger-print two. The invention also discloses a HPLC finger-print in the Chinese herbal medicine Naoshuantong and the application in the extract semi-finished product detection. The construction method adopts different mobile phase systems and different detection wavelengths, the Chinese herbal medicine Naoshuantong HPLC finger-print one and preparation HPLC finger-print two are respectively established to detect the whole five flavors of medicinal ingredients so that the quality of the Chinese herbal medicine Naoshuantong preparation semi-manufactured product and product thereof can be monitored overall, and the construction method can guarantee the stable, uniform and controllable quality.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for constructing an HPLC fingerprint of a Naoshuantong preparation prepared from natural plant medicinal materials and its application. Background technique [0002] The requirements of the international community for medicines are "safe, effective and controllable". According to the current quality standards of traditional Chinese medicine, the quality control of Chinese patent medicines is to determine the authenticity by traditional character identification and microscopic identification, and to evaluate the quality by physical and chemical identification. From the perspective of traditional Chinese medicine, the detection of any active ingredient cannot reflect the overall curative effect of the compound preparation. Traditional Chinese medicine uses the flavor of the medicine instead of a certain chemical ingredient for syndrome differentiation and treatment. ...

AI Technical Summary

Problems solved by technology

In the production process of Naoshuantong preparation, the 2 medicinal materials of Radix Paeoniae Rubra and Curcuma are extracted by alcohol, and the 3 medicinal materials of Puhuang, Gastrodia elata, and Loulu are extracted by water and alcohol-precipitated. Therefore, the ingredients in the finished product are both fat-soluble. The ingredients are water-soluble ingredients, the ingredients are complex, and the polarity is very different

However, the current quality standards for Naoshuantong preparations are not perfect, lack of comprehensive and effective quality control methods, and it is difficult to comprehensively monitor the quality of finished products and the stability of the production process

The item "identification" of the current quality standard uses thin-layer chromatography to identify the four medicinal materials of Puhuang, Gastrodia elata, red peony root, and leaking reed in the prescription, and the "content determination" item uses high-performance liquid chromatography to determine the medicinal materials of Radix Paeoniae Rubra in the prescription. However, the disadvantages are: the standard operation is cumbersome, and there is no detection of turmeric; the single determination method gives little information, and there is no comprehensive and systematic detection of the chemical components in the five flavors of medicinal materials.

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