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Quality control method of south schizandrol extract oral solid formulated product

A quality control method and the technology of Schisandra chinensis, which are applied in the field of detecting the dissolution of Schisandrin A in oral solid preparations of Schisandra chinensis extract, and can solve problems such as no research reports, patent documents, and no dissolution inspection items.

Inactive Publication Date: 2008-02-27
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current national drug quality standards for oral solid preparations of Schisandra Alcohol extract do not contain dissolution testing items, and there are no relevant research reports and patent documents.

Method used

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  • Quality control method of south schizandrol extract oral solid formulated product
  • Quality control method of south schizandrol extract oral solid formulated product
  • Quality control method of south schizandrol extract oral solid formulated product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0008] Determination according to high performance liquid chromatography (Appendix VID of Chinese Pharmacopoeia 2005 edition).

[0009] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; methanol-water (70:30) was used as mobile phase; detection wavelength was 250nm. The number of theoretical plates should not be less than 2000 based on the peak of schisandrin A.

[0010] Take about 10 mg of Schizandrin A reference substance, accurately weigh it, put it in a 50ml measuring bottle, add an appropriate amount of methanol, dissolve it by ultrasonic (40KHZ power 120W), and dilute to the mark with methanol. Precisely draw 3.0, 4.0, 5.0, 6.0, 7.0ml of the above solutions into 10ml measuring bottles respectively, dilute to the mark with methanol, shake well, and make standard solutions of serial concentrations. Inject 20 μl of samples respectively and record the chromatograms. The results are shown in Table 1.

[0011] Table...

Embodiment 2

[0017] Determination according to high performance liquid chromatography (Appendix VID of Chinese Pharmacopoeia 2005 edition).

[0018] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; methanol-water (70:30) was used as mobile phase; detection wavelength was 250nm. The number of theoretical plates should not be less than 2000 based on the peak of schisandrin A.

[0019] Take the Schizandrin A reference substance solution with a concentration of 100 μg / ml, and measure it at 0, 2, 4, 6, and 8 hours under the above-mentioned chromatographic conditions, and the results are shown in Table 2.

[0020] Table 2. Schizandrin A content determination solution stability test results

[0021] Placement time (h)

[0022] The results showed that the test solution was stable within 8 hours.

Embodiment 3

[0024] Determination according to high performance liquid chromatography (Appendix VID of Chinese Pharmacopoeia 2005 edition).

[0025] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; methanol-water (70:30) was used as mobile phase; detection wavelength was 250nm. The number of theoretical plates should not be less than 2000 based on the peak of schisandrin A.

[0026] Preparation of reference substance solution: Take an appropriate amount of Schisandrin A reference substance, accurately weigh it, add methanol to make a solution containing 100 μg per 1 ml, and obtain it.

[0027] The preparation of need testing solution: get the Schisandrin A reference substance that takes by prescription ratio and accurately weigh a certain amount and mix with adjuvant, take appropriate amount, accurately weigh, put in 10ml measuring bottle, add methanol appropriate amount, ultrasonic treatment (frequency 40KHZ, power 120W) for 20...

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PUM

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Abstract

The invention relates to a method for detecting dissolving rate of oral administration solid preparation which is prepared by using schisandra fruit extract as the active constituent, wherein ethanol solution, or thin hydrochloric acid or water is used as the dissolving out medium, and high performance liquid phase chromatographic method is employed to detect the dissolving quantity of Deoxyschizandrin in the oral administration solid preparation of schizandrol extract.

Description

technical field [0001] The invention relates to a dissolution detection method of an oral solid preparation prepared by taking the extract of Schisandra chinensis as the active ingredient. Method for the dissolution of schisandrin in oral solid preparations. Background technique [0002] The oral solid preparation of Schisandra schisandra extract is a drop pill prepared by taking the dried mature fruit of Schisandra Sphenanthera Rehd.et Wils of the Magnoliaceae plant Schisandra Sphenanthera Rehd. et Wils as the active ingredient. Oral solid preparations such as capsules, tablets, pills, pellets, granules, and dry suspensions have the effect of reducing serum alanine aminotransferase and are used for patients with elevated transaminase. One of the main components in Schisandrin extract is Schizandrin A. Therefore, controlling the dissolution of Schizandrin in oral solid preparations of Schisandrin extract is of great significance to ensure stable and controllable product qua...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/57G01N30/02A61P1/16A61P43/00A61K131/00
Inventor 钱进陶琳陈晓华刘冬梅龚春艳钟树英林亚伦
Owner HONGYI SCI & TECH CO LTD NANCHANG
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