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Quality testing method of medicine composition

A quality detection method and composition technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as poor separation, complicated methods, and large interference, and achieve strong operability, good separation, and guaranteed quality Effect

Inactive Publication Date: 2014-04-16
广西厚德药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the shortcomings of thin-layer chromatography, such as low detection sensitivity, poor repeatability, large deviation, and complicated method, we have selected and established a high-performance liquid chromatography with good resolution, simple operation, and low cost for the drug composition. The active ingredients contained in Panax notoginseng were tested
In the 2010 edition of "Chinese Pharmacopoeia", the notoginseng medicinal material was determined by high performance liquid chromatography to determine the total amount of ginsenoside Rg1, ginsenoside Rb1 and notoginseng saponin R1, but the test solution prepared by this method had many impurities and poor separation. Not good, great interference, unable to accurately determine the content of ginsenoside Rg1, ginsenoside Rb1 and notoginsenoside R1 in the pharmaceutical composition

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0025] Preparation of Reference Substance Solution Accurately weigh 10.02mg of ginsenoside Rg1 reference substance, put it in a 5ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well (stock solution A); accurately weigh 10.01mg of ginsenoside Rb1 reference substance, put In a 5ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well (stock solution B); accurately weigh 10.19 mg of the reference substance of notoginseng saponin R1, put it in a 10ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well ( stock solution C). Precisely measure 2ml of stock solution A, 2ml of stock solution B, and 1ml of stock solution C into a 10ml measuring bottle, add methanol to make ginsenoside Rg10.4008mg, ginsenoside Rb10.4004mg and notoginsenoside R10.1019mg per 1ml Mix the solution, that is.

[0026] Preparation of the test solution Precisely measure 5ml of this product, put it on a water bath and steam until it is ...

Embodiment 1

[0036] Chromatographic conditions use octadecylsilane bonded silica gel as filler; acetonitrile-water as mobile phase, wherein acetonitrile is mobile phase A, water is mobile phase B, and elution is carried out according to the mobile phase gradient elution table; mobile phase speed 1.0ml / min; the detection wavelength is 203nm; the number of theoretical plates calculated based on notoginsenoside R1 should not be less than 4000;

[0037] Mobile phase gradient elution table:

[0038] time (minutes) Mobile Phase A(%) Mobile phase B(%) 0～12 19 81 12～60 19→36 81→64

[0039] Preparation of Reference Substance Solution Accurately weigh the appropriate amount of ginsenoside Rg1 reference substance, ginsenoside Rb1 reference substance and notoginsenoside R1 reference substance, add methanol to make each 1ml contains ginsenoside Rg10.4mg, ginsenoside Rb10.4mg and notoginsenoside The mixed solution of R10.1mg is ready;

[0040] Preparation of the test solut...

Embodiment 2

[0043] Chromatographic conditions use octadecylsilane bonded silica gel as filler; acetonitrile-water as mobile phase, wherein acetonitrile is mobile phase A, water is mobile phase B, and elution is carried out according to the mobile phase gradient elution table; mobile phase speed 1.0ml / min; the detection wavelength is 203nm; the number of theoretical plates calculated based on notoginsenoside R1 should not be less than 4000;

[0044] Mobile phase gradient elution table:

[0045] time (minutes) Mobile Phase A(%) Mobile phase B(%) 0～12 19 81 12～60 19→36 81→64

[0046] Preparation of Reference Substance Solution Accurately weigh the appropriate amount of ginsenoside Rg1 reference substance, ginsenoside Rb1 reference substance and notoginsenoside R1 reference substance, add methanol to make each 1ml contains ginsenoside Rg10.4mg, ginsenoside Rb10.4mg and notoginsenoside The mixed solution of R10.1mg is ready;

[0047] Preparation of the test solut...

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PUM

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Abstract

The invention discloses a quality testing method of a medicine composition. The BPCs (bulk pharmaceutical chemicals) of the medicine composition comprise pseudo-ginseng, the quality testing method adopts a high performance liquid chromatography to measure the contents of a ginsenoside Rg1, a ginsenoside Rb1 and a pseudo-ginseng saponin R1 in the medicine composition. The quality testing method provided by the invention has the advantages that the degree of separation is good, the cost is low, the operability is strong, the method is used for a medicine composition containing the pseudo-ginseng, the addition of the pseudo-ginseng in the medicine composition is controlled, the quality of a product is effectively guaranteed, and meanwhile, the application of the industrial production is beneficial.

Description

technical field [0001] The invention belongs to the technical field of quality detection of medicines, and in particular relates to a quality detection method of ginsenoside Rg1, ginsenoside Rb1 and notoginsenoside R1 in a pharmaceutical composition. Background technique [0002] Panax notoginseng, Panax notoginseng (Burk.) F. H. The dried roots and rhizomes of Chen have the effects of dispersing blood stasis and stopping bleeding, reducing swelling and relieving pain, and can be used for hemoptysis, hematemesis, epistaxis, blood in the stool, metrorrhagia, traumatic bleeding, chest and abdomen tingling pain, tumbling swelling pain, and is a commonly used famous and precious traditional Chinese medicine. , many pharmaceutical compositions contain this medicinal material. Before, our company has obtained the invention patent of "a pharmaceutical composition and its preparation method", the patent number is "ZL 2009 1 0113826.8". It is used as an adjuvant treatment for shou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 陈晓军廖厚知黄园阮碧芳莫少红梁月钊梁霞廖九明
Owner 广西厚德药业有限公司