Quality detection method of Shouhui bowel-relaxing capsule

A quality inspection method, Shouhui laxative technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the quality control problems of Weishouhui laxative capsules, and achieve scientific and reasonable detection methods, strong practicability, and stability high effect

Active Publication Date: 2019-03-22
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the prior art, the quality control of Shouhui Tongbian capsules uses HPLC to detect two single components in two medicinal materials. The method is simple and effective, but the quality of Shouhui Tongbian capsules has not been fully and effectively controlled.

Method used

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  • Quality detection method of Shouhui bowel-relaxing capsule
  • Quality detection method of Shouhui bowel-relaxing capsule
  • Quality detection method of Shouhui bowel-relaxing capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Example 1 HPLC methodology study of atractylide Ⅰ, atractylide Ⅱ, atractylide Ⅲ

[0055] 1) Drugs and reagents:

[0056] Atractylodes Lactone I, Atractylodes Lactone II, and Atractylodes Lactone III are the reference substances (Shanghai Eternal Biotechnology Co., Ltd.), acetonitrile is chromatographically pure, the rest of the reagents are analytically pure, and the water is double-distilled water.

[0057] 2) Instruments

[0058] AgiLent 1100 high performance liquid chromatograph with VWD detector.

[0059] 3) Sample determination

[0060] 3.1 Solution Preparation

[0061] 3.1.1 Preparation of the test solution

[0062] Take the content of Shouhui Tongbian Capsule, grind it, take about 1 g, accurately weigh it, put it in a conical flask, accurately add 30 mL of acetonitrile-water (1:1, v / v), weigh, and ultrasonically treat it for 30 minutes. Cool, weigh again, use acetonitrile-water (1:1, v / v) to make up the lost weight, shake well, filter, and the filtrate is th...

Embodiment 2

[0099] Example 2 Determination of Atractylodes Rhizoma Atractylodes Lactone I, Atractylodes Lactone II and Atractylodes Lactone III in Shouhui Tongbian Capsules by High Performance Liquid Chromatography

[0100] 1) Chromatographic conditions and system suitability test: the same as in Example 1.

[0101] 2) Preparation of mixed reference solution: same as Example 1.

[0102] 3) Preparation of the test solution: take Shouhui Tongbian Capsules of batch 20180103, and the preparation method is the same as that in Example 1.

[0103] 4) Determination method: respectively draw 10 μL of the mixed reference solution and the test solution, inject them into a liquid chromatograph, and measure.

[0104]5) Results: All components reached the baseline analysis, the theoretical plate number of Atractylodes Lactone I, Atractylodes Lactone II and Atractylodes Lactone III were all greater than 10,000, and the resolution was greater than 1.5; The content of lactone II was 0.30 mg, and the con...

Embodiment 3-7

[0105] Example 3-7 Determination of Atractylodes Rhizoma Atractylodes Lactone I, Atractylodes Lactone II and Atractylodes Lactone III in Different Batches of Shouhui Tongbian Capsules by High Performance Liquid Chromatography

[0106] 1) Chromatographic conditions and system suitability test: the same as in Example 1.

[0107] 2) Preparation of mixed reference solution: same as Example 1.

[0108] 3) Preparation of the test solution: take Shouhui Tongbian capsules from batches of 20180109, 20180111, 20180203, 20180207, and 20180212, and the preparation method is the same as that in Example 1.

[0109] 4) Determination method: respectively draw 10 μL of mixed reference solution and different batches of test solution, respectively, inject into liquid chromatograph, and measure.

[0110] 5) Results: The contents are shown in Table 9 below. In addition, each component reached the baseline analysis. The theoretical plate numbers of atractylide I, atractylide II, and atractylide II...

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Abstract

The invention discloses a quality detection method of a Shouhui bowel-relaxing capsule and belongs to the field of analysis of traditional Chinese medicinal preparations. The quality detection methodadopts a thin-layer chromatography to identify bighead atractylodes rhizome in the capsule and simultaneously adopts an HPLC to determine the contents of atractylenolide I, atractylenolide II and atractylenolide III in the capsule. The quality detection method disclosed by the invention is stable and reliable, strong in specificity, good in reproducibility and capable of fully and effectively controlling the quality of the euphorbia pulcherrima bowel-relaxing capsule, ensuring the safety and the effectiveness of clinical medication and better meeting the needs of patients and the market.

Description

technical field [0001] The invention relates to a quality detection method for Chinese patent medicine Shouhui Tongbian capsules, in particular to a quality detection method for Atractylodes Rhizoma in Shouhui Tongbian capsules, and belongs to the field of traditional Chinese medicine preparation analysis. Background technique [0002] Chinese patent CN100453105C discloses a composition and a preparation method with the functions of laxative and detoxification, weight loss and lipid-lowering, which have been approved for production, and the product is Shouhui Tongbian Capsules. This product is a compound traditional Chinese medicine preparation made from the eight-flavor traditional Chinese medicine prescription of Polygonum multiflorum, aloe vera, cassia seed, wolfberry fruit, donkey-hide gelatin, ginseng, atractylodes, and citrus aurantium, which can be targeted for the treatment of functional constipation. The prescription of Shouhui Tongbian Capsule is the clinical exper...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/02G01N30/74
CPCG01N30/02G01N30/74G01N30/90G01N2030/027
Inventor 马庆文沈强玉
Owner LUNAN PHARMA GROUP CORPORATION
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