Quality control method of brucea javanica oil oral dry emulsion

A quality control method, the technology of javanica javanica oil, applied in the direction of measuring device, chemical analysis by titration method, instrument, etc., can solve the problems of complicated operation, increasing the solubility of oil phase, and the influence of emulsifier is not well eliminated

Inactive Publication Date: 2014-01-15
吕拓 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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

Method used

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  • Quality control method of brucea javanica oil oral dry emulsion
  • Quality control method of brucea javanica oil oral dry emulsion
  • Quality control method of brucea javanica oil oral dry emulsion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0100] Identification: Take 1 g of the sample, add 10 ml of absolute ethanol to dissolve, filter, and measure the filtrate according to UV-Vis spectrophotometry (Appendix VA of "Chinese Pharmacopoeia" 2010 Edition), and there is a maximum absorption at a wavelength of 270 nm.

[0101] Inspection: Take 10 bags of samples for the difference in filling volume, accurately weigh the weight of the contents of each bag respectively, compare the weight of the contents of each bag with the marked amount, and the difference limit of the filling volume shall not exceed ±5.0%. More than 2 bags, and 1 bag must not exceed twice the limit of difference in loading. (Appendix IC of "Chinese Pharmacopoeia" 2010 Edition)

[0102] Particle size: take 5 bags of the finished product in single-dose packaging, weigh the weight and sieve it in a medicine sieve, keep it level when sieving, and sieve lightly back and forth for 3 minutes, if it cannot pass through the No. 1 sieve and can pass through the...

Embodiment 2

[0120] Identification: Take 1 g of the sample, add 10 ml of absolute ethanol to dissolve, filter, and measure the filtrate according to UV-Vis spectrophotometry (Appendix VA of "Chinese Pharmacopoeia" 2010 Edition), and there is a maximum absorption at a wavelength of 270 nm.

[0121] examine:

[0122] Loading difference: take 10 bags of samples, accurately weigh the weight of the contents of each bag, compare the weight of the contents of each bag with the marked amount, the difference limit of the filling amount shall not exceed ±5.0%, and the difference limit of the loading amount shall not be much Among the 2 bags, one bag must not exceed twice the limit of difference in filling volume. (Appendix IC of "Chinese Pharmacopoeia" 2010 Edition)

[0123] Particle size: take 5 bags of the finished product in single-dose packaging, weigh the weight and sieve it in a medicine sieve, keep it level when sieving, and sieve lightly back and forth for 3 minutes, if it cannot pass thro...

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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...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N31/16G01N30/06
Inventor 吕拓方成玲黄汉泉
Owner 吕拓
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