Quality control method of brucea javanica oil oral dry emulsion

Abstract

The invention relates to a detection method of a traditional Chinese medicine preparation, and in particular relates to a method used for detecting components used for controlling quality. The quality control detection method of a brucea javanica oil dry emulsion is a method for detecting contents of oleic acids and linoleic acids in the brucea javanica oil dry emulsion by using a gas chromatographic method. The quality control detection method of the brucea javanica oil dry emulsion comprises the following steps of: observing shape and properties, identifying, checking and testing contents. In order to control the quality of the brucea javanica oil dry emulsion comprehensively and accurately, the gas chromatographic method is used to identify the characteristic spectrum of the brucea javanica oil dry emulsion and / or composition of fatty acids of the brucea javanica oil oral dry emulsion and the contents of the oleic acids and linoleic acids in the brucea javanica oil dry emulsion are detected at the same time. Verified by an analytical method, the precision, the reproducibility, the stability and the recovery rate of the method meet requirements of the Verification Guideline for Traditional Chinese Medicine Quality Standard Analytical Methods which is an appendix of the 2010 version of Chinese pharmacopoeia.

Description

field of invention [0001] The invention relates to a quality control method of oral dry emulsion of javanica javanica oil, which belongs to the technical field of traditional Chinese medicine. Background of the invention [0002] The main component of Brucea javanica oil is oleic acid, which can inhibit the activity of topoisomerase (TOPOII), thereby inhibiting the synthesis and growth of cell DNA, and blocking the proliferation of cancer cells. Brucea javanica oil is selective to cancer cells, that is, selectively destroys membrane systems such as cancer cell membranes and mitochondria, making cancer cells degenerate and necrosis, but has no damage to normal cells. At the same time, javanica javanica oil is targeted to cancer cells, the drug concentration is concentrated after administration, and has a specific and tight affinity with cancer cells, which promotes both humoral immunity and cellular immunity, and has the hematopoietic function of bone marrow stem cells effec...

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Problems solved by technology

Due to the certain solubility of wood ginger seed oil in the emulsifier, and the emulsifier also has a certain solubility in the water phase, the presence of the emulsifier undoubtedly increases the solubility of the oil phase in water, making it difficult to extract completely.

Li Ping (post-column derivatization HPLC method is used to determine the related substances of alprostadil emulsion, China Medical Herald 2010, 7 (34): 47) adopts the method of pre-column derivatization to measure alprostadil emulsion, get rid of the interference of auxiliary materials, method Although it is feasible, the operation is too complicated, which is not conducive to practical application; Chinese patent CN101596161 introduces a method for the determination of alprostadil fat emulsion, adopts the method of freeze-drying to de-emulsify, makes the sample become oil, and then extracts the oil with organic solvent object, to obtain the test solution, this method is time-consuming, and the influence of the emulsifier in the extraction process is not well eliminated

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