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Detection method for macromolecular substances in Shuxuening injection

A technology of macromolecular substances and detection methods, applied in the field of detection of macromolecular substances in Shuxuening injection, can solve problems such as complex chemical composition, and achieve the effect of improving safety

Inactive Publication Date: 2017-11-10
HEILONGJIANG ZBD PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Studies have shown that the chemical composition of Shuxuening injection is complex. Although the content of major components with clear structures (including total flavonol glycosides, ginkgolides, polysaccharides and amino acids) accounted for the majority of the total solids, the content of unknown components Whether it contains macromolecules, as well as the molecular weight and molecular weight arrangement of macromolecules are very important for the quality control and safety evaluation of Shuxuening injection. However, there is no effective detection of macromolecules in Shuxuening injection at present. Method for Molecular Weight of Substance

Method used

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  • Detection method for macromolecular substances in Shuxuening injection
  • Detection method for macromolecular substances in Shuxuening injection
  • Detection method for macromolecular substances in Shuxuening injection

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preparation example Construction

[0029] Further, when constructing the standard curve, the preparation method of the standard dextran solution includes: taking 1-3 mg of the standard dextran, dissolving it in water, distilling it to 1 mL, and filtering it with a microporous membrane. More specifically, the preparation method includes: accurately weighing 2 mg each of a series of standard dextran products, respectively dissolving them in water, distilling the volume to 1 mL, and filtering with a microporous membrane.

[0030] Further, when testing Shuxuening injection, the preparation method of the test solution includes: taking 1-2 mL of Shuxuening injection to be tested, diluting it with water for 2-20 times, and then filtering it with a microporous membrane. More specifically, the preparation method includes: taking 1 mL of the Shuxuening injection to be tested, diluting it with water 5-10 times, and then filtering it with a microporous membrane.

[0031] Optionally, the pore diameter of the microporous mem...

Embodiment 1

[0040] This embodiment provides a method for detecting macromolecular substances in Shuxuening injection, which includes:

[0041] a. Preparation of standard solution: Accurately weigh 2 mg of each dextran standard, add water to dissolve to 1 mL, and pass through a 0.45 μm microporous membrane to obtain. Among them, the standard dextran and its molecular weight are: D0-180, D1-2500, D2-4600, D3-7100, D4-10000, D5-21400, D6-41100, D7-84400, D8-133800, D2000-2000000 .

[0042] b. Preparation of the test solution: take 1 mL of the Shuxuening injection to be tested, dilute it with water 2-20 times, and filter it with a microporous membrane to obtain the product.

[0043] c. Establish standard curve: select gel chromatographic column (specification: 7.8mm*300mm), column temperature 40 ℃, mobile phase be the ammonium acetate of 5mM, flow rate be 0.5mL / min, evaporative light scattering detector (drift tube temperature is 115°C, the drying gas flow rate is 3.2 L / min), and the inject...

Embodiment 2

[0046] The present embodiment provides a detection method for macromolecular substances in Mailuoning injection, which includes:

[0047] a. Preparation of standard solution: Accurately weigh 1 mg of each dextran standard, add water to dissolve to 1 mL, and pass through a 0.45 μm microporous membrane to obtain. Among them, the standard dextran and its molecular weight are: D1-2500, D2-4600, D3-7100, D4-10000, D5-21400, D6-41100, D7-84400, D8-133800.

[0048] b. Preparation of the test solution: take 1 mL of the Shuxuening injection to be tested, dilute it with water 2 times, and filter it with a microporous membrane to obtain the product.

[0049] c. Establish standard curve: select gel chromatographic column (specification: 7.8mm*300mm), column temperature is 40 ℃, mobile phase is the ammonium acetate of 4mM, flow rate is 0.6mL / min, evaporative light scattering detector (drift tube temperature is 110°C, the drying gas flow rate is 3.4 L / min), and the injection volume is 20 μ...

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Abstract

The invention provides a detection method for macromolecular substances in a Shuxuening injection, belonging to the field of pharmaceutical analysis. The detection method comprises the following steps: constructing a standard curve by using high-performance liquid chromatography with a gel chromatographic column as a chromatographic column, an ammonium acetate solution as a mobile phase, an evaporative light scattering detector as a detector and dextran standards with a series of molecular weights as reference substances; and testing the Shuxuening injection under same conditions, and then acquiring the molecular weight distribution range of the macromolecular substances in the Shuxuening injection in virtue of the standard curve. The method provided by the invention can acquire the molecular weight distribution range of the macromolecular substances in the Shuxuening injection, which is beneficial for establishing quality control standards for the Shuxuening injection and improving the safety of the Shuxuening injection.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for detecting macromolecular substances in Shuxuening injection. Background technique [0002] Ginkgo biloba is the raw material of Shuxuening injection. Ginkgo biloba is the dried leaf of Ginkgo biloba, which is bitter, sweet and astringent, mild in nature and slightly poisonous. It has the effects of promoting blood circulation, removing blood stasis, dredging collaterals and relieving pain. The chemical composition of Ginkgo biloba is very complex. More than 170 compounds have been found so far, mainly flavonoids, terpenes, alcohols, alkaloids, polyisoprenes, polysaccharides and other active ingredients with pharmacological effects. For ginkgolic acid. Ginkgo biloba is extracted and prepared into injection, which is used for the treatment of lung deficiency cough, coronary heart disease, hyperlipidemia, depression, diabetes, neurological disease, memory impairment, peri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 方同华许照芹项彦华席桂才
Owner HEILONGJIANG ZBD PHARMA