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Determining method for lentinan content in lentinan composition

A technology of lentinan and determination method, which is applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of being unable to meet the controllability requirements of drug quality, unable to accurately measure the content of lentinan, affecting the quality control and safety of drugs, etc. Achieve the effects of improving effectiveness and safety, high accuracy, and quality control

Inactive Publication Date: 2019-04-26
上海慈瑞通鑫医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The study found that none of the existing methods can accurately determine the content of lentinan in the preparation, and cannot meet the requirements of drug quality controllability, which seriously affects the quality control and safety of drugs

Method used

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  • Determining method for lentinan content in lentinan composition
  • Determining method for lentinan content in lentinan composition
  • Determining method for lentinan content in lentinan composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] The content determination of embodiment 1 lentinan freeze-dried powder injection

[0061] 1. Instruments and reagents:

[0062] Instrument: Shimadzu 20AD high performance liquid chromatography system; LCsolution chromatography workstation;

[0063] Reagents: anhydrous sodium acetate (Chinese medicine, analytically pure), water-high-purity water

[0064] Lentinan reference substance (raw material drug): batch number: slen141101 Shanghai Cirui Pharmaceutical Technology Co., Ltd.

[0065] Lentinan freeze-dried powder injection: batch number: ZJXS161201 Shanghai Cirui Pharmaceutical Technology Co., Ltd.

[0066] 2. Determination method and result:

[0067] (1) Preparation of reference substance for test solution: take 100 mg of lentinan reference substance, dry under reduced pressure at 60°C for 6 hours with phosphorus pentoxide as a desiccant, weigh it and place it in a 50mL beaker with 20mL of purified water in advance, then add 30mL purified water, 4000 rpm homogeniz...

Embodiment 2

[0074] Using the same instruments, reagents, and assay methods as in the examples, the difference is that the high-performance liquid chromatography conditions are: a chromatographic column connected in series with SRT SEC-500 and SRT SEC-300 is used instead. The high-performance liquid chromatogram of sample test solution is shown in figure 2 , the separation degree is 1.73, and the measured content of lentinan in lentinan freeze-dried powder injection ZJXS161201 is 98.9%.

Embodiment 3

[0086] Prepare and measure the content of lentinan in the lentinan freeze-dried powder injection ZJXS161201 in sequence according to the same method of implementation 1, the difference is: Agilent high performance liquid chromatography system; differential detector; chromatographic column is polymethacrylic acid resin cross-linked Agilent PL-AQUAGEL-OH MIXED-H columns for hydroxyether resins.

[0087] Chromatogram see Figure 9 , the separation degree is 2.51, and the measured content of lentinan in lentinan freeze-dried powder injection ZJXS161201 is 100.5%.

[0088] Methodological investigation:

[0089] 1. Linear relationship inspection:

[0090] The linear relationship refers to the extent to which the measured response value is proportional to the concentration of the analyte in the sample within the designed range (General Rule 9101 of Volume Four of the Chinese Pharmacopoeia of the 2015 edition).

[0091]In the concentration range of 80%-120% of the concentration o...

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Abstract

The invention discloses a determining method for the lentinan content in a lentinan composition. The method comprises the steps that an efficient liquid chromatography is adopted for performing elution on a lentinan composition sample test solution, and then the lentinan content is determined. The method can effectively remove the influence caused by auxiliary materials such as dextran on lentinancontent determination, the content measuring accuracy is improved, and the method is applicable to content measurement of various lentinan preparations.

Description

technical field [0001] The invention relates to a content determination method of lentinan in a lentinan composition, in particular to a content determination method of a lentinan preparation containing auxiliary materials that interfere with quantitative determination. Background technique [0002] Lentinan is a biologically active polysaccharide extracted from Lentinus edodes. Its primary structure is based on β-(1→3)-linked glucose as the main chain, and a single β- Dextran with D-glucosyl side chains. Lentinan is an immunomodulator used for adjuvant therapy of malignant tumors. Lentinan can inhibit a variety of tumors, especially those of the digestive tract. Lentinan was first reported in 1965 by Senhara Goro of Japan as having anti-tumor activity. In 1985, Japan first approved Lentinan for injection as a new anti-tumor drug. [0003] The lentinan preparations currently on the market are mainly injections, especially freeze-dried powder injections. Anthrone-sulfuric...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 朱益锋许洁董群
Owner 上海慈瑞通鑫医药技术有限公司