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Quality detection method for Kunling Wan and application thereof

A detection method and Kunling technology, applied in the field of quality detection of Kunling pills, can solve the problems of unclear mechanism of action, complex chemical composition, and difficulty in ensuring the quality and stability of traditional Chinese medicine products.

Active Publication Date: 2016-04-13
TIANJIN TASLY PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Due to the complex chemical composition of traditional Chinese medicine and the unclear mechanism of action, it is difficult for the existing traditional Chinese medicine pharmaceutical technology to ensure the quality stability of traditional Chinese medicine products. The standard does not involve any qualitative and quantitative control items for the taste of the medicine, and the inventor has conducted research on the active ingredients of Kunling Pills

Method used

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  • Quality detection method for Kunling Wan and application thereof
  • Quality detection method for Kunling Wan and application thereof
  • Quality detection method for Kunling Wan and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0113] Example 1 Cortex Moutan Identification

[0114] Preparation of the test solution: Take 10g of Kunling pills, (10g of film-coated pills: containing about 0.5g of Moutan Cortex, Corydalis Corydalis, Angelica, Chuanxiong, and Radix Paeoniae Alba; about 0.35g of Ligusticum edulis; 15g of sugar-coated pills: containing Cortex Moutan, Corydalis Corydalis, Angelica, Rhizoma Chuanxiong, Radix Paeoniae Alba (approximately 0.4g; containing approximately 0.3g Ligusticum edulis), use the grinding method, add 2ml of dilute hydrochloric acid, add 30ml of ether, heat and reflux for 30min, filter, and recover the solvent from the filtrate to dryness , Add 2ml of ethyl acetate to the residue to dissolve it as the test solution.

[0115] Preparation of the reference medicinal material solution: Take 1.0 g of the reference medicinal material Cortex Moutan, add 1 ml of dilute hydrochloric acid, add 30 ml of ether, heat and reflux for 30 minutes, filter, recover the solvent from the filtrat...

Embodiment 2

[0119] Example 2 Identification of Angelica-Chuanxiong-Ligusticum edulis

[0120] Preparation of the test solution: the same as the preparation of the test solution of Cortex Moutan.

[0121] Preparation of the reference medicinal material solution: Take 1.0 g each of the reference medicinal materials of Angelica sinensis, Rhizoma Chuanxiong and Ligusticum edulis, respectively add 30ml of ether, reflux in the water bath for 30min, take it out, let it cool, filter, recover the filtrate with ether until dry, and add ether to the residue respectively. 1ml of ethyl acetate was used to dissolve, and used as the reference medicinal solution of angelica, the reference medicinal solution of Chuanxiong, and the reference medicinal solution of Ligusticum edulis.

[0122] Preparation of negative sample solution: according to the prescription ratio, take other medicinal materials except angelica, chuanxiong, and ligusticum, prepare samples according to the preparation process, and then pr...

Embodiment 3

[0124] Example 3 Corydalis identification

[0125] Preparation of the test solution: Take an appropriate amount of Kunling Pills, grind into a fine powder, weigh 2g, add 10ml of 0.2mol / L sodium hydroxide solution, after ultrasonication for 20min, add 10ml of ethyl acetate, shake and extract, 3000 rpm / min centrifuged for 5min, and the supernatant was taken.

[0126] Preparation of the reference medicinal material solution: take 0.5 g of the reference medicinal material Corydalis Corydalis in a 50 ml round bottom flask, add 0.5 ml of ammonia water to infiltrate, add 10 ml of dichloromethane, reflux in a water bath at 60°C for 1 hour, filter, evaporate to dryness, dissolve in 2 ml of methanol, and obtain .

[0127] Preparation of reference substance solution: take an appropriate amount of tetrahydropalmatine reference substance, add methanol to make a solution containing 0.2mg per 1ml, as the reference substance solution

[0128] Preparation of negative sample solution: Accord...

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Abstract

The invention provides a quality detection method for Kunling Wan. The method comprises steps of discrimination of Kunling Wan and determination of content; wherein a discrimination step employs a thin layer chromatography for discriminating traditional Chinese medicine composition of the Kunling Wan, and is used for discriminating tree peony bark, Chinese angelica-ligusticum wallichii-Chinese ligusticum rhizome, corydalis tuber, white peony root, red ginseng and cyperus rotundus; and a content determination step employs a high performance liquid chromatography for determining content of an active ingredient paeonol in the Kunling Wan. The method has the characteristics of simple process, fast speed, and good reappearance, the established standard discrimination and content determination steps can satisfy relative requirements through methodology validation, applicability is strong, quality status of the product can be comprehensively reflected, and the method provides an important basis for quality controlling and standard making.

Description

technical field [0001] The invention relates to a quality detection method of Kunling pills, which belongs to the technical field of drug analysis. Background technique [0002] Kunling Pill is a compound preparation of traditional Chinese medicine. Its functions and indications are regulating menstruation and nourishing blood, removing blood stasis and promoting regeneration. It is used for irregular menstruation, more or less, abdominal pain during menstruation, cold uterus, prolonged infertility, habitual miscarriage, red and white vaginal discharge, metrorrhagia, prolonged illness, qi deficiency, kidney deficiency and low back pain. [0003] The prescription of Kunling Pills is as follows: [0004] 【prescription】 [0005] (1) Rhizoma Cyperus (system) 37g licorice 7g Baiwei 14g Motherwort 14g Astragalus 14g Cockscomb 14g Ophiopogon japonicus 14g Schisandra 14g Rehmannia glutinosa 14g safflower 14g Akebia 10g Atractylodes macrocephala (fried) 14g red stone fat 14g Poria ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/90
Inventor 阚红玉高展孙志翠孙玉侠曹凤兰徐立元杨建会李建杨雪梅张淑玉
Owner TIANJIN TASLY PHARMA CO LTD
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