A quality control method, quality control spectrum and construction method of a traditional Chinese medicine composition

Abstract

The invention discloses a quality control method, a quality control spectrogram and a construction method of a traditional Chinese medicine composition. The traditional Chinese medicine composition includes watermelon cream, calcined borax, Phellodendron cortex, Coptis chinensis, Shandou root, Shegan, Fritillaria, Qingdai, Borneol, Sapinberry, Rhubarb, Radix Scutellariae, Glycyrrhiza and Menthol, the quality control method includes the simultaneous detection of Phellodendron Phellodendri, Coptidis Rhizoma, Scutellaria Radix, Shegan and Glycyrrhizae components in the Chinese medicine composition by using the HPLC method, and the conditions of the HPLC method are as follows: Octadecylsilane bonded silica gel is used as filler; methanol is used as mobile phase A, and 0.1% phosphoric acid solution is used as mobile phase B to perform gradient elution; the number of theoretical plates should not be less than 300,000 based on the baicalin peak. In the quality control method, based on the results of each component of the drug obtained through HPLC detection, a variety of reference substances and reference materials for reference materials were designed, and the characteristic peaks corresponding to the components of Phellodendron Phellodendron, Coptidis Rhizome, Scutellaria chinensis, Shegan and Licorice were obtained through comparative analysis. information, and can simultaneously determine the types of the above components in a single injection test.

Description

technical field [0001] The invention belongs to the field of medicine quality control, and in particular relates to a quality control method, a quality control spectrogram and a construction method of a traditional Chinese medicine composition. Background technique [0002] The traditional Chinese medicine composition involved in the present invention is composed of fourteen medicinal materials such as watermelon frost, calcined borax, cortex cortex, coptis, mountain bean root, shegan, Fritillaria chinensis, Qingdai, borneol, sapinberry, rhubarb, scutellaria, licorice, and menthol. The current drug standards mainly use thin-layer chromatography to realize the detection and identification of multi-flavor medicinal materials in prescriptions with the identification mode of single component or main spot. This mode requires repeated detection of samples by thin-layer chromatography, complex operation, heavy workload, and the method is easily affected by human beings, and the sta...

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Problems solved by technology

This mode requires repeated detection of samples by thin-layer chromatography, complex operation, heavy workload, and the method is easily affected by human beings, and the stability and repeatability of the results are not very good

At the same time, due to the complex components contained in Chinese medicinal materials, taking Phellodendron Phellodendron as an example, it contains a variety of alkaloids, so the characteristic peaks of several such medicinal materials in liquid chromatography are more complicated, specifically manifested as miscellaneous peaks, interference Peak, which affects the identification and judgment of the corresponding components of medicinal materials

[0003] In addition, the properties, polarity, and acidity and alkalinity of different medicinal materials are quite different, and it is difficult to reflect them simultaneously in the chromatogram of the same condition. The separate detection of multiple components will undoubtedly increase the complexity of quality control and detection. cost

[0004] The Chinese patent application number 201110105310.6 discloses a traditional Chinese medicine composition for the treatment of oral diseases, its preparation process, and its quality detection method. The detection method uses thin-layer chromatography and liquid chromatography to identify and analyze the ingredients in the medicine. , but only asiaticoside / hydroxyasiaticoside was detected in the liquid chromatography method. In view of the property difference and detection difficulty of other drugs, the identification analysis of the rest of the multi-flavored medicinal materials was not carried out.

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