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Method for detecting traditional Chinese medicine injection for treating cardiovascular and cerebrovascular diseases

A technology for cardiovascular and cerebrovascular diseases and detection methods, applied in the field of medicine, can solve problems such as weak method specificity, incomplete standard indicators, and inability to fully control internal quality, and achieve the effect of reducing quality risks and easy operation

Active Publication Date: 2014-07-23
SHANDONG DANHONG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The approval number of Danhong injection is Z20026866. For this Chinese medicine injection, we first applied for a patent with the publication number CN102233001A, which discloses the prescription preparation process and quality inspection method. Currently, the current quality of the Chinese medicine injection is The standard only controls the content of Danshensu sodium, protocatechuic aldehyde and total flavonoids. The standard indicators are not comprehensive, the method specificity is not strong, and the internal quality of this product cannot be fully controlled

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  • Method for detecting traditional Chinese medicine injection for treating cardiovascular and cerebrovascular diseases
  • Method for detecting traditional Chinese medicine injection for treating cardiovascular and cerebrovascular diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1: Chinese medicine injection identification method

[0058] (1) Take 5ml of this product, adjust the pH value to 2 with dilute hydrochloric acid, shake and extract with 10ml of ethyl acetate, separate the ethyl acetate solution, evaporate to dryness, add 2ml of absolute ethanol to the residue to dissolve, and use it as the test solution. In addition, 0.5 g of the reference medicinal material of Salvia miltiorrhiza was taken, added with 25 ml of water, refluxed in a water bath for 2 hours, allowed to cool, filtered, the filtrate was placed in a separatory funnel, the pH value was adjusted to 2 with dilute hydrochloric acid, extracted with 20 ml of ethyl acetate, and the acetic acid was separated. The ethyl ester solution was evaporated to dryness, and the residue was dissolved in 2 ml of absolute ethanol, which was used as a reference medicinal material solution. Then take an appropriate amount of Danshensu sodium, protocatechuic aldehyde and salvianolic acid...

Embodiment 2

[0060] Embodiment 2: Chinese medicine injection inspection method

[0061] ①5-Hydroxymethylfurfural (1) Take an appropriate amount of 5-hydroxymethylfurfural reference substance, accurately weigh it, add 0.2% glacial acetic acid in 10% methanol solution and dilute to make a solution containing 24 μg per 1ml, as the reference substance solution. (2) Chromatographic conditions: use octadecylsilane-bonded silica gel as filler; flow rate is 0.8ml per minute, column temperature is 40°C; detection wavelength is 288nm, and the number of theoretical plates calculated by salvianolic acid A peak should not be lower than 200000, take acetonitrile as mobile phase A, take 0.05% trifluoroacetic acid solution as mobile phase B, carry out gradient elution; at 0~65min, the volume ratio of acetonitrile is 2→30%, and use 0.05% trifluoroacetic acid solution The volume ratio of acetonitrile is 98→70%; the volume ratio of acetonitrile is 30% at 65 to 75 minutes, and the volume ratio of 0.05% triflu...

Embodiment 3

[0085] Embodiment 3: Determination of danshensu sodium, protocatechuic aldehyde, 4-coumaric acid, rosmarinic acid, salvianolic acid B and salvianolic acid A by high performance liquid phase

[0086] (1) Instruments and reagents

[0087] Agilent 1100 series high performance liquid chromatograph (Agilent Chemstation workstation) electronic analytical balance (model BP211D, Sartorius Balance Co., Ltd., Germany); ultrasonic cleaner (model: KQ-250DE, Kunshan Ultrasonic Instrument Co., Ltd.); Agilent ZORBAX Extend-C 18 Chromatographic column (250mm×4.6mm, 5μm); danshensu sodium reference substance, protocatechuic aldehyde reference substance, 4-coumaric acid reference substance, rosmarinic acid reference substance, salvianolic acid B reference substance and salvianolic acid A The reference substance was purchased from China Institute of Biological Products.

[0088] ⑵ test drug

[0089] 10 batches of traditional Chinese medicine injections of the present invention are all produce...

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Abstract

The invention relates to a method for detecting a traditional Chinese medicine injection for treating cardiovascular and cerebrovascular diseases. The detection method comprises a thin-layer identification method for medicinal materials including radix salviae miltiorrhizae and safflower carthamus, an inspection method for 5-hydroxymethyl furfural, total solids, heavy metals, harmful elements and the like, a high-performance liquid chromatography method of salvianic acid A sodium, protocatechu aldehyde, 4-cumaric acid, rosmarinic acid, danshinolic acid B and danshinolic acid A and an ultraviolet measurement method for measuring total phenols content. The method for detecting the quality of the traditional Chinese medicine injection provided by the invention is good in stability and repeatability, can be used for accurately qualitatively and quantitatively detecting the content of all effective components and impurity components and can be used for comprehensively and objectively evaluating the quality of the traditional Chinese medicine injection so as to finally guarantee the clinical medication safety and curative effect of the traditional Chinese medicine injection.

Description

technical field [0001] The invention relates to a detection method of traditional Chinese medicine injection for treating cardiovascular and cerebrovascular diseases, in particular to a detection method including an identification method, an inspection method, a high-performance liquid phase and a method for measuring the content of active components of traditional Chinese medicine injection with ultraviolet content, and belongs to the technical field of medicine. Background technique [0002] Cardiovascular and cerebrovascular diseases, including myocardial infarction, cerebral embolism, cerebral hemorrhage and cerebral vasospasm, are one of the diseases that seriously threaten human health. Traditional Chinese medicine has a long history in the treatment of cardiovascular and cerebrovascular diseases, and has obvious effects in prevention, treatment and rehabilitation. Traditional Chinese medicine injection is an original pharmaceutical dosage form in my country, which has...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/90
Inventor 赵涛赵超
Owner SHANDONG DANHONG PHARMA
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