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Quality testing method of Shouhui Tongbian Capsules

A quality inspection method and Shouhui Tongbian technology, which can be applied to measuring devices, instruments, scientific instruments, etc., can solve the problems of quality control of Weishouhui Tongbian capsules, and achieve a scientific and reasonable detection method, strong specificity, and acceptable conditions. control effect

Active Publication Date: 2020-01-07
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 testing method of Shouhui Tongbian Capsules
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  • Quality testing method of Shouhui Tongbian Capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 HPLC methodological research of Atractylodes lactone I, Atractylodes lactone II and Atractylodes lactone III

[0058] 1) Drugs and reagents:

[0059] Atractylodes lactone I, Atractylodes lactone II, and Atractylodes lactone III content reference substance (Shanghai Eternal Biotechnology Co., Ltd.), acetonitrile was chromatographically pure, other reagents were analytically pure, and water was double distilled water.

[0060] 2) Instrument

[0061] AgiLent 1100 high performance liquid chromatograph, VWD detector.

[0062] 3) Sample determination

[0063] 3.1 Solution preparation

[0064] 3.1.1 Preparation of the test solution

[0065] Take the content of Shouhui Laxative Capsules, grind it finely, take about 1g, accurately weigh it, put it in a conical flask, add 30mL of acetonitrile-water (1:1, v / v) accurately, weigh it, and ultrasonicate it for 30 minutes. Cool, weigh again, make up the lost weight with acetonitrile-water (1:1, v / v), shake well, filter, ...

Embodiment 2

[0103] Example 2 Determination of Atractylodes Lactone I, Atractylodes Lide II and Atractylodes Lide III Contents in Shouhui Tongbian Capsules by High Performance Liquid Chromatography

[0104] 1) Chromatographic conditions and system suitability test: the same as in Example 1.

[0105] 2) Preparation of mixed reference solution: same as Example 1.

[0106] 3) Preparation of the test solution: take 20180103 batches of Shouhui Laxative Capsules, and the preparation method is the same as in Example 1.

[0107] 4) Determination method: respectively draw and mix 10 μL of the reference substance solution and the test solution, inject it into a liquid chromatograph, measure it, and obtain it.

[0108] 5) Results: All components reached the baseline analysis. The theoretical plate numbers of Atractylodes lactone I, Atractylodes lactone II, and Atractylodes lactone III were all greater than 10,000, and the separation degrees were all greater than 1.5; the content of Atractylodes lacton...

Embodiment 3-7

[0109] Example 3-7 Determination of Atractylodes lactone Ⅰ, Atractylodes Ⅱ and Atractylodes Ⅲ contents in different batches of Shouhui Tongbian Capsules by HPLC

[0110] 1) Chromatographic conditions and system suitability test: the same as in Example 1.

[0111] 2) Preparation of mixed reference solution: same as Example 1.

[0112] 3) Preparation of the test solution: take 20180109, 20180111, 20180203, 20180207, 20180212 batches of Shouhui Laxative Capsules, and the preparation method is the same as in Example 1.

[0113] 4) Determination method: Take 10 μL of the mixed reference substance solution and different batches of the test solution respectively, and inject them into the liquid chromatograph for determination.

[0114] 5) Results: The content is shown in Table 9 below. In addition, each component reached the baseline analysis. The number of theoretical plates of Atractylodes lactone I, Atractylodes lactone II and Atractylodes lactone III were all greater than 10,000...

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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 of Shouhui Tongbian capsules, a Chinese patent medicine, in particular to a quality detection method of Atractylodes macrocephala in Shouhui Tongbian capsules, and belongs to the field of analysis of traditional Chinese medicine preparations. Background technique [0002] Chinese patent CN100453105C discloses a composition and preparation method with laxative detoxification, weight loss and lipid-lowering functions, which has been approved for production, and the product is Shouhui Laxative Capsules. This product is a compound Chinese medicine preparation made from the eight flavors of Polygonum multiflorum, Aloe vera, Cassia seed, Lycium barbarum, Ejiao, ginseng, Atractylodes macrocephala, and Citrus aurantii. It can be used to treat functional constipation in a targeted manner. The prescription of Shouhui Tongbian Capsules is a prescription based on the clinical experience of a famous old Chinese me...

Claims

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Application Information

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Patent Type & Authority Patents(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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