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Method for detecting eedysterone in medicine composition

A technology of ecdysterone and composition, which is applied in the direction of drug combination, pharmaceutical formula, measuring device, etc., and can solve the problems of difficulty in controlling the quality of finished products, large errors in content determination results, and poor reproducibility

Inactive Publication Date: 2009-08-12
湖南时代阳光药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The method is cumbersome to operate, has poor reproducibility, large error in content determination results, and is difficult to control the quality of finished products.

Method used

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  • Method for detecting eedysterone in medicine composition
  • Method for detecting eedysterone in medicine composition
  • Method for detecting eedysterone in medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] A Houyanqing oral liquid produced by the applicant company was used as a test sample, which was also made from the aforementioned four Chinese herbal medicines. The method of content determination is as follows:

[0066] Chromatographic conditions: Agilent TC-C column 18 (250mm×4.6mm×5 μm); the mobile phase is acetonitrile-water (15:85); the detection wavelength is 248nm; the column temperature is 30°C. The number of theoretical plates is not less than 2000 based on the peak of ecdysterone.

[0067] Preparation of reference substance solution: Accurately weigh an appropriate amount of ecdysterone reference substance, add dilute ethanol to make a solution containing 30 μg per 1 ml, and obtain.

[0068] Preparation of the test solution: Take a sample of Houyanqing Oral Liquid, mix it evenly, accurately measure 25ml, put it in a 50ml measuring bottle, add ethanol to dilute to the mark, shake well, filter, and take the filtrate to obtain the final product.

[0069] Deter...

Embodiment 2

[0075] According to the same method as in Example 1, the content of 10 batches of Achyranthes bidentata medicinal materials was measured, and each batch of samples was measured twice in parallel. The results are shown in Table 8.

[0076] Table 8 Determination results of ten batches of Achyranthes bidentata medicinal materials

[0077]

[0078]

[0079] According to the prescription quantity, 0.25 g of Achyranthes bidentata is needed to prepare 1 ml of Houyanqing Oral Liquid. After determination, the average content of 10 batches of Achyranthes bidentata medicinal materials is 0.04938% by weight. After testing 15 batches of Houyanqing oral liquid samples, the average content was 0.08383mg / ml, and the transfer rate was 67.9%.

[0080] After testing 15 batches of samples, the average content is 0.08383mg / ml, which is 0.058mg / ml converted by 70%, so the tentative content limit is: every 1ml of soil-containing Achyranthes bidentata is calculated as ecdysterone (C27H34O11), ...

Embodiment 3

[0082] Example 3 Quality Control in the Production Process of Houyanqing Oral Liquid

[0083] Add 20 times the amount of water to decoct the medicinal materials of the four flavors formula, and keep the volume of the decoction liquid constant during the decoction process. The concentration of ecdysterone in the decoction liquid was detected by high performance liquid chromatography. The detection conditions and operations are the same as in Example 1, wherein the decoction is taken, initially filtered, and 25ml is accurately measured, placed in a 50ml measuring bottle, diluted to the mark with ethanol, shaken up, filtered, and the subsequent filtrate is taken for sample detection. When detecting that the ecdysterone content in the sample reaches 0.01mg / ml, stop decocting. Each batch of test products was carried out twice, and in the products controlled by this method, the content of ecdysterone reached 0.075mg / ml. Under the conditions of this example, it usually takes only 1...

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Abstract

The invention provides a method for detecting content of ecdysterone in an ecdysterone containing medicinal composition. The method is characterized in that a chromatographic column is an octadecyl silicane bonded silica gel packed column; an ultraviolet visible light detector is adopted for detecting an analysis result; the detection wave length is between 240 and 255nm; a mobile phase can be acetonitrile-water; and the column temperature is between 25 and 35 DEG C. The invention also provides a method for controlling the product quality by tracking the concentration of the ecdysterone in extracting solution through high performance liquid chromatography in a decoction or extraction link of medicinal materials, wherein the decoction or extraction operation is stopped when a target value is reached. The method has the advantages of simple operation, strong specificity and good repeatability, and high accuracy of a content detection result, and can better control the product quality.

Description

technical field [0001] The invention relates to a method for detecting ecdysterone in a pharmaceutical composition. Background technique [0002] Ecdysterone, also known as β-ecdysone, β-ecdysone, has the functions of lowering blood sugar and cholesterol, anti-arrhythmia, anti-virus, anti-inflammation, anti-oxidation and immune promotion. Naturally present in Achyranthes bidentata Bl. and other plants. Many traditional Chinese medicine preparations use it as an active ingredient. For example, a kind of pharmaceutical composition prepared from Achyranthes bidentata, Malancao, plantain and Tianmingjing is to use Achyranthes bidentata as the monarch drug. Pharyngeal swelling and pain, fever, thirst, constipation, and the treatment or relief of acute tonsillitis, acute pharyngitis and other diseases. [0003] For the pharmaceutical composition containing ecdysterone, especially the above-mentioned pharmaceutical composition prepared from Achyranthes bidentata, Malancao, Plant...

Claims

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Application Information

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IPC IPC(8): G01N30/02A61K36/68A61P11/02A61K33/32
Inventor 朱光葵杜赫钟振平唐纯玉唐代凤
Owner 湖南时代阳光药业股份有限公司
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