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Method for detecting glossy ganoderma spore oil content in glossy ganoderma oil preparation

A technology of Ganoderma lucidum spore oil and a detection method is applied in the field of detection of the content of Ganoderma lucidum spore oil in a Ganoderma lucidum spore oil preparation, which can solve the problems of unfavorable control and monitoring of drug quality, poor reproducibility of measurement results, unstable measurement results, etc. The effect of no interference, perfect quality standard and high recovery rate

Active Publication Date: 2009-05-27
江苏海王健康生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because this method adopts ursolic acid as a reference substance in the assay process of total triterpenoids, but in the research results of the triterpenoid components of Ganoderma lucidum, Ganoderma lucidum spore powder, and Ganoderma spore oil, no ursolic acid is found to exist, In the determination process, it is more appropriate to use the representative components of the triterpenes as reference substances; Determination, in the determination process, along with the time of color development, the temperature of color development, the time of determination etc., the difference of the measurement results is relatively large, the reproducibility of the measurement results is poor, and the measurement results are unstable; During the determination of triterpenoids, the total triterpenes were not separated, and Ganoderma lucidum spore oil was directly used to oxidize color with perchloric acid, and a large number of long-chain aliphatic hydrocarbons in Ganoderma lucidum spore oil could also be detected by high chloride Acid oxidizes and develops color, thus causing false positive results in the determination. Using this method to determine other edible vegetable oils can also detect higher levels, which cannot form a one-to-one correspondence with the content of triterpenoids in Ganoderma lucidum spore oil in drugs. Ganoderma lucidum spore oil is directly oxidized with perchloric acid to detect the content of triterpenoids in the ganoderma spore oil preparation. It is easily interfered by other components of the ganoderma spore oil, which is not conducive to the control and monitoring of drug quality in production.

Method used

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  • Method for detecting glossy ganoderma spore oil content in glossy ganoderma oil preparation
  • Method for detecting glossy ganoderma spore oil content in glossy ganoderma oil preparation
  • Method for detecting glossy ganoderma spore oil content in glossy ganoderma oil preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0030] Example 1 Determination of the content of ganoderic acid E in ganoderma lucidum spore oil

[0031] (1) Instruments and reagents

[0032] High performance liquid chromatograph, including Waters 1525 pump, 2487 dual-channel UV detector, Waters column thermostat, Breeze liquid chromatography workstation, Brasson ultrasonic cleaner. Ganoderma acid E reference substance (obtained from the extraction and separation of Ganoderma lucidum spores, after mp, IR, UV, MS, 1 It was identified as ganoderic acid E by H-NMR, and the purity was 99.6% by HPLC normalization method). Acetonitrile was chromatographically pure American Tedia, water was ultrapure water, and other reagents were analytically pure. The drug sample to be tested is Ganoderma lucidum spore oil soft capsule (batch number: 051114, 051217, 060123).

[0033] (2) Chromatographic conditions

[0034] Chromatographic column: Kromasil C18, 4.6mm×250mm, 5μm; column temperature: 30°C; mobile phase: acetonitrile-0.1% formic acid so...

Embodiment 2

[0073] Example 2 Determination of total ganoderic acid content in ganoderma lucidum spore oil

[0074] (1) Instruments and reagents

[0075] UV Agilent8453 ultraviolet-visible spectrophotometer (Agilent Technology Co., Ltd., USA). The drug samples to be tested are Ganoderma lucidum spore oil soft capsules (batch numbers: 051114, 051217, 060123), ganoderic acid E reference substance (self-made, with a purity of 99.6%); the reagents used are all analytically pure.

[0076] (2) Preparation of reference solution

[0077] Accurately weigh 5.36mg of ganoderic acid E reference substance, put it in a 25ml measuring flask, and add saturated NaHCO 3 The solution is dissolved and diluted to the mark as a reference solution.

[0078] (3) Preparation of test solution

[0079] Take 3g of the content of the test product, accurately weigh it, add 50ml petroleum ether to dissolve it, add it to the treated silica gel column (8g, 18mm×400mm), add 150ml ethyl acetate: petroleum ether (60~90℃)=25 Elut...

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Abstract

The measuring method measures contents of general ganoderma lucidum acid, ganoderma lucidum acid E in spore oil preparation of ganoderma lucidum. The testing standard is as following: in each 1.0g of spore oil preparation of ganoderma lucidum (equivalent to 5g of crude drugs of ganoderma lucidum spore), general ganoderma lucidum acid contained is not allowed less than 1.0mg counted by ganoderma lucidum acid E (C30H54O7); content of ganoderma lucidum acid E is between 0.001mg-0.050mg, i.e. content of ganoderma lucidum acid E is between 0.010%-0.50%. The invention makes stable testing and controlling quality of spore oil preparation of ganoderma lucidum.

Description

Technical field [0001] The invention relates to the field of drug detection methods, in particular to a method for detecting the content of ganoderma lucidum spore oil in a ganoderma lucidum spore oil preparation. Background technique [0002] Ganoderma lucidium spores are extremely small spores ejected from the cap during the growth and maturity of Ganoderma. They are the germ cells of Ganoderma lucidum and possess all the genetically active substances of Ganoderma lucidum. The pharmacological effects of Ganoderma lucidum spores mainly include anti-tumor, immune regulation, regulation of blood lipids, and regulation and improvement of the nervous, cardiovascular and respiratory systems. Ganoderma lucidum spore oil is an oily extract of Ganoderma lucidum spores obtained by breaking the wall by supercritical extraction or organic solvent extraction. The chemical composition of Ganoderma lucidum spore oil is complex, mainly containing oils, fatty acids, sterols and triterpenes. Mod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N1/28G01N30/86
Inventor 吴敏李颖黄光华
Owner 江苏海王健康生物科技有限公司
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