Method for controlling quality of Longdanxiegan Capsule

Abstract

The invention discloses a method for controlling the quality of the Longdanxiegan Capsule. The invention adopts the combined methods of character and thin layer chromatography discrimination and high efficiency liquid chromatography content measurement so as to control the quality of the Longdanxiegan Capsule, wherein during the operation of thin layer chromatography discrimination, characteristic spots of bupleurum, radix scutellariae, scutelloside, ferulic acid, glycyrrhiza and ammonium glycyrrhetate are respectively detected, the content of gentiamarin and geniposide is detected simultaneously by the high efficiency liquid chromatography under the condition of identical chromatogram through the mode of gradient elution, the content of the gentianella of each capsule is more than 0.07 mg according to gentiamarin, and the content of the gardenia of each capsule is more than 1.0 mg according to geniposide. The method respectively carries out the operation of thin layer chromatography discrimination on the characteristic components of the Longdanxiegan Capsule, can scientifically and comprehensively reflect the existence of monarch drugs, ministerial drugs, adjuvant and conductant drugs in the Longdanxiegan Capsule, simultaneously detects the content of the characteristic components of the gentianella and the gardenia; moreover, the method is simple, scientific and easy to operate, and is conducive to the comprehensive quality control of the Longdanxiegan Capsule.

Description

technical field [0001] The invention relates to a quality control method of a compound traditional Chinese medicine preparation, in particular to a quality control method of Longdan Xiegan Capsules. Background technique [0002] At present, the 2005 Pharmacopoeia’s quality control methods for Longdan Xiegan Pills mainly include microscopic identification, TLC identification of gentiopicroside and geniposide, and content determination of gentiopicroside by HPLC , but this method is very incomplete. During the TLC identification, only the characteristic spots of the monarch drug Gentian and the minister drug Gardenia were detected and identified, but the characteristic spots of other components could not be reflected. When the content was determined, Only the content of gentiopicroside was detected, and the content of geniposide was not detected; The iridoid glycoside components interfere with each other during chromatographic separation and are difficult to separate. Therefo...

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Problems solved by technology

[0002] At present, the 2005 Pharmacopoeia’s quality control methods for Longdan Xiegan Pills mainly include microscopic identification, TLC identification of gentiopicroside and geniposide, and content determination of gentiopicroside by HPLC , but this method is very incomplete. During TLC identification, only the characteristic spots of the monarch drug Gentian and the minister drug Gardenia were detected and identified, but the characteristic spots of other components could not be reflected. When the content was determined, Only the content of gentiopicroside was detected, and the content of geniposide was not detected; on the other hand, there were reports on the content detection of geniposide and gentiopicroside, but since both The iridoid glycoside components interfere with each other during chromatographic separation and are difficult to separate. Therefore, these two components are detected separately with different chromatographic conditions. The detection process is cumbersome and is not conducive to control.

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