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Detection method of compound danshen dripping pills

A technology of compound salvia miltiorrhiza and detection method, which is applied in the field of detection of compound salvia miltiorrhiza dripping pills, can solve problems affecting product production and quality assurance, simple quality control methods, and difficult control of product quality, achieving stable quality, good stability, curative effect

Active Publication Date: 2013-10-02
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Existing compound danshen dripping pills have the disadvantages of simple quality control method and difficult control of product quality, which will affect the production and quality assurance of products

Method used

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  • Detection method of compound danshen dripping pills
  • Detection method of compound danshen dripping pills
  • Detection method of compound danshen dripping pills

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Establishment of Fingerprint Analysis Method for Compound Danshen Dripping Pills

[0049] Liquid chromatography: Waters ultra-high performance liquid chromatography (UPLC)

[0050] Agilent Rapid Resolution Liquid Chromatograph (RRLC)

[0051] Shimadzu Ultrafast Liquid Chromatography (UFLC)

[0052] The above three liquid chromatographs use sub-2μm liquid chromatography technology, which has the same theory and principle as ordinary HPLC. The different sub-2μm liquid chromatography covers small particle packing, low system volume and rapid detection methods, etc. The new technology increases the throughput, sensitivity and chromatographic peak capacity of the analysis, making it more sensitive, with a higher theoretical plate number, better separation effect, shorter peak time, and at the same time reducing the use of toxic solvents. Conducive to environmental protection. Selecting sub-2μm liquid chromatography technology to develop fingerprints and content determinat...

Embodiment 2

[0091] Using thin-layer chromatography, notoginseng was used as the control medicinal material to identify the notoginseng in the prescription.

[0092] The preparation of need testing solution: get this product 20 balls, put in centrifuge tube, add dilute ammonia solution (8ml → 100ml) 9ml, sonication makes to dissolve, centrifugation, get supernatant, pass through D101 type macroporous adsorption resin column ( The inner diameter is 0.7cm, and the column height is 5cm), elute with 15ml of water, discard the water eluate, and then elute with methanol, discard about 0.4ml of the initial eluent, collect about 5ml of the subsequent eluent, and concentrate to about 2ml, as the test solution.

[0093] Preparation of the reference medicinal material solution: Take 0.5 g of the reference medicinal material of Panax notoginseng (batch number: 120941-200405), put it in a centrifuge tube, add 9 ml of dilute ammonia solution (8ml→100ml), sonicate for 15 minutes, centrifuge, take the sup...

Embodiment 3

[0102] Determination of Danshensu content

[0103] The content determination method of Danshensu:

[0104] The identification method is the same as that of the fingerprint, with Danshensu as the quantitative index, and the sub-2μm liquid chromatography technique is used to determine the content of Danshensu in the prescription.

[0105] Instruments and reagents

[0106] Instrument: Waters ACQUITY ultra-high performance liquid chromatography (UPLC)

[0107] Reference substance: Danshensu Sodium Reference substance: China Institute for the Control of Pharmaceutical and Biological Products, batch number: 110855-200608

[0108] Sample: Compound Danshen dripping pills were provided by Tianjin Tasly Pharmaceutical Co., Ltd. (batch numbers 20080705, 090201, 090202, 090203, 090204, 090205, 090206, 090207, 090208, 090209, 090210).

[0109] Acetonitrile: (chromatographically pure) German Merck company, batch number: I409030804

[0110] Phosphoric acid: (analytical pure) Tianjin Seco...

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Abstract

The invention relates to a detection method of compound danshen dripping pills, comprising the following contents of: observation of characters, discrimination of contents, inspection of contents, comparison of finger prints and assaying of contained components. The detection method provided by the invention comprises a discriminating method of the medicinal component panax notoginseng, the discriminating method adopts thin-layer chromatography, the reference materials adopt a panax notoginseng reference medicinal material, a ginsenoside Rg1 reference substance, a ginsenoside Re reference substance, a ginsenoside Rb1 reference substance and a panax notoginseng saponin R1 reference substance. The detection method provided by the invention also comprises a discriminating method and an assaying method of the medicinal component danshen, wherein the discriminating method adopts a sub-2 mu m liquid chromatography technology to perform chromatographic fingerprint discrimination, and adopts sodium danshensu as a reference material; and the assaying method adopts a sub-2 mu m liquid chromatography technology to perform assaying on the components such as danshensu, panax notoginseng saponin R1, ginsenoside Rg1 and ginsenoside Rb1 in the danshen.

Description

technical field [0001] The invention relates to a drug detection method, in particular to a detection method of compound danshen dripping pills. Background technique [0002] Compound Danshen Dripping Pills is a compound preparation composed of Danshen, Panax notoginseng and borneol. It has the effects of promoting blood circulation, removing blood stasis, regulating qi and relieving pain. The current quality standards are recorded in the first part of the "Chinese Pharmacopoeia" 2005 edition as follows: [0003] Table 1 [0004] [0005] Existing compound danshen dripping pills have the disadvantages of simple quality control method and difficult control of product quality, which will affect the production and quality assurance of products. [0006] In order to effectively control product quality, we have established the quality control method of the present invention. This method adopts the sub-2 μm liquid chromatography technology method for Junyao-Salvia miltiorrhiz...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/90A61K36/537A61P9/10G01N30/86G01N30/36G01N30/02A61K31/045
Inventor 孙巍高展徐丽媛孙玉侠
Owner TIANJIN TASLY PHARMA CO LTD
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