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Method for detecting macromolecular substance in reduning injection

A technology for polymer substances and injections, which is used in measurement devices, material separation, and analysis of materials. High and stable effect

Inactive Publication Date: 2014-07-02
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But the mobile phase of this method is acetonitrile-0.83% trifluoroacetic acid solution (40: 60), according to the requirement of size exclusion chromatography of " Chinese Pharmacopoeia 2010 edition two ": organic phase ratio should not exceed 30% in the mobile phase, And the pH value of the solution should not exceed the tolerance of the chromatographic column. The organic phase ratio of this method exceeds 30%, and the acidity is too high, which exceeds the tolerance range of the chromatographic column and does not meet the technical requirements of "Chinese Pharmacopoeia". low credibility

Method used

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  • Method for detecting macromolecular substance in reduning injection
  • Method for detecting macromolecular substance in reduning injection
  • Method for detecting macromolecular substance in reduning injection

Examples

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Effect test

Embodiment 1

[0040] Embodiment 1 takes protein as the establishment of the reference substance HPLC method

[0041] 1.1 Optimal chromatographic conditions

[0042] 1.1.1 Determination of detection wavelength

[0043] Because proteins have better absorption at low wavelengths, 214nm was selected as the detection wavelength.

[0044] 1.1.2 mobile phase selection

[0045] Instrument: Agilent1100 (VWD);

[0046] Gel column: TSK G2000SWxl, 300mm×7.8mm, 5μm;

[0047] Column temperature: 30°C;

[0048] Detection wavelength: 214nm;

[0049] Mobile phase one: use 0.1mol / L sodium sulfate as the mobile phase, and the flow rate is 0.5ml / min;

[0050] Mobile phase two: use acetonitrile-0.05% trifluoroacetic acid (the volume ratio of acetonitrile and 0.05% trifluoroacetic acid is 30:70) as the mobile phase, and the flow rate is 0.7ml / min;

[0051] Mobile phase three: use acetonitrile-0.08% trifluoroacetic acid (the volume ratio of acetonitrile and 0.08% trifluoroacetic acid is 30:70) as the mobil...

Embodiment 2

[0094] Example 2 Determination of macromolecular substances

[0095] 2.1 Determination method Determination method of macromolecular substances in Reduning Injection—Tymosin α1 as reference substance

[0096] Precisely measure 1ml of Reduning injection, add mobile phase to dilute to 10ml, shake well, and use it as the test solution; take an appropriate amount of thymosin α1 standard substance, weigh it, dissolve and dilute with water to make a solution containing 0.025mg per 1ml As a reference solution. Precisely measure 10 μl each of the test solution and the reference solution and inject it into the liquid chromatograph, record the chromatogram, regard the peak that is prior to the peak time of thymosin α1 (molecular weight 3108) as a polymer substance, and calculate it by the area normalization method Its content, macromolecular substances shall not exceed 0.05%.

[0097] Chromatographic conditions and system suitability test chromatographic column: TSK G2000SWXL (300mm×7...

Embodiment 3

[0100] Embodiment 3 macromolecular substance determination

[0101] 3.1 Determination method Determination method of macromolecular substances in Reduning Injection—Tymosin α1 as reference substance

[0102] Precisely measure 1ml of Reduning injection, add mobile phase to dilute to 5ml, shake well, and use it as the test solution; take an appropriate amount of thymosin α1 standard substance, weigh it, dissolve and dilute with water to make a solution containing 0.05mg per 1ml As a reference solution. Precisely measure 10 μl each of the test solution and the reference solution and inject it into the liquid chromatograph, record the chromatogram, regard the peak that is prior to the peak time of thymosin α1 (molecular weight 3108) as a polymer substance, and calculate it by the area normalization method Its content, macromolecular substances shall not exceed 0.05%.

[0103] Chromatographic conditions and system suitability test chromatographic column: TSK G2000SWXL (300mm×7.8m...

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Abstract

The invention belongs to the field of the pharmaceutical detection and discloses a method for detecting a macromolecular substance in a reduning injection. The method for detecting the macromolecular substance in the reduning injection is established by taking thymosin alph1 as a reference and adopting a molecular exclusion chromatography by virtue of the characteristics of a reduning injection producing process. The method comprises the following steps: eluting components in a detected sample according to a molecular weight decreasing sequence, and with a peak appearing earlier than a peak appearance time of a reference substance as the macromolecular substance, and calculating the content of the macromolecular substance by adopting an area normalization method. Through the inspection of repeatability, degree of separation, detection limit, degree of precision, molecular weight logarithm-retention time curve and solution stability, the method for detecting the macromolecular substance in the reduning injection is proved to be simple and convenient to operate, high in sensitivity and good in repeatability, can be used as an quality internal control method of the reduning injection and plays a role in guiding the quality control of traditional Chinese medicine injections.

Description

technical field [0001] The invention belongs to the field of drug detection and relates to a method for detecting polymer substances in Reduning injection. Background technique [0002] Traditional Chinese medicine injection is an important achievement of my country's traditional Chinese medicine innovation. It has high bioavailability and rapid action, and has advantages in the treatment of acute and severe diseases, and is widely used in clinical practice. With the development of my country's adverse drug reaction monitoring work, the safety of traditional Chinese medicine injections has gradually emerged. There are many factors that cause adverse reactions, and some scholars believe that the presence of macromolecular substances is also one of the factors. The prescription of Reduning Injection (Z20050217, produced by Jiangsu Kangyuan Pharmaceutical Co., Ltd.) is composed of gardenia, honeysuckle and Artemisia annua. It has the functions of clearing away heat, dispelling...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 萧伟王振中毕宇安王雪李家春王永香徐丰果章晨峰徐海娟付小环
Owner JIANGSU KANION PHARMA CO LTD
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