Oleum fructus bruceae fat emulsion concentrated solution, preparation method and application thereof

Abstract

An oleum fructus bruceae fat emulsion concentrated solution, a preparation method and an application thereof belong to the field of pharmacology and pharmaceutics. According to the invention, the defect that a traditional fat emulsion preparation technology is complex and stability is poor is overcome. The preparation technology provided by the invention is simple; the general physical stirring process is only needed; and no homogenization technology is required. A product prepared in the invention can be sterilized through a 0.22-micron microfiltration membrane; in clinical use, the product can be spontaneously emulsified after diluted by the use of an aqueous solution such as normal saline or a glucose solution, etc. and slightly oscillated; and under optimized conditions, average particle size is about 0.2 micron, and injection fat emulsion characteristics are fully embodied. The product has good fluidity, will not be retained on the wall, is single-phase, transparent and clear in appearance, can undergo clarification detection, will not cause preparation stratification after multigelation and is used for treating diseases such as stomach cancer, esophagus cancer, primary hepatic carcinoma, colorectal cancer, pancreas cancer, lung cancer, cervical carcinoma, bladder cancer, prostate cancer and other solid tumor metastatic cancer, etc.

Description

technical field [0001] The invention belongs to the field of pharmacy and pharmacy, and relates to javanica javanica oil fat emulsion concentrate, its preparation method and application. Background technique [0002] Brucea javanica oil Yadanziyou Oleum Bruceae is a fatty oil obtained from the dried ripe fruit of Brucea javanica, a plant of the family Bitterwoodaceae, extracted with petroleum ether. The current clinical application of javanica javanica oil preparations is mainly provided in liquid form. For example, the oil-in-water type javanica javanica oil intravenous emulsion injection made with refined soybean lecithin as emulsifier is not only used for the treatment of lung cancer, brain metastases of lung cancer, liver cancer, gastric cancer and Breast cancer and other malignant tumors can also be used to treat non-tumor diseases such as chronic gastritis, colitis and sharp wet flow. [0003] Brucea javanica oil emulsion is the same as common fat emulsion preparation...

AI Technical Summary

Problems solved by technology

[0003] Brucea javanica oil emulsion is the same as common fat emulsion preparations, and there are the deficiencies of poor stability and complex preparation process: those skilled in the art understand that fat emulsion preparations such as javanica javanica oil emulsion appear as opaque milky white liquids in appearance, cannot Carry out clarity testing; oil-water stratification, coagulation, flocculation, etc. are prone to occur during product storage; it is a typical cold chain transport product and needs to be stored at 0-4°C or 4-8°C; the preparation process involves colostrum preparation, high-pressure Homogeneous, and the process is unstable, temperature, emulsification time and production equipment all have an impact on product quality, resulting in uneven milk particles; moreover, the existing fat emulsion requires special equipment to be sterilized under high pressure

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