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Method for detecting succinylation modified gelatin and combination succinic acid in its injection

A technology of succinylation and succinic acid, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of hydrolysis operation time, long separation and detection time, affecting the service life of C18 chromatographic column, and not specifying the control index of acylation degree , to achieve the effect of shortening the separation and detection time, good application prospects, and solving quality control problems

Inactive Publication Date: 2013-06-19
浙江康乐药业股份有限公司
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

The disadvantages are: ①The hydrolysis operation time and separation and detection time are long, which is not suitable for the quality control of intermediate products; ②The hydrolysis solution is directly injected, and the acidic solution affects the service life of the C18 chromatographic column; ③The detection sensitivity of succinic acid low
[0003] In addition, the current drug quality standards for polygeline peptide injections produced by the succinylation process do not specify the control index for the degree of acylation, and the quality standards are flawed and need to be improved

Method used

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  • Method for detecting succinylation modified gelatin and combination succinic acid in its injection
  • Method for detecting succinylation modified gelatin and combination succinic acid in its injection
  • Method for detecting succinylation modified gelatin and combination succinic acid in its injection

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Effect test

Embodiment 1

[0011] Embodiment 1: the selection test of inorganic acid removal method in the hydrolyzate

[0012] The recovery rate of the reference substance of succinic acid was used as the investigation index of the method selection test for the removal of inorganic acids in the hydrolyzed solution. Take an appropriate amount of succinic acid reference substance, add appropriate amount of concentrated hydrochloric acid and water, simulate the hydrolysis solution of the reference substance, and accurately measure 2ml, use water bath evaporation method and gas drying method to remove inorganic acid respectively, then wash with water and dilute to 10ml , followed by treatment with a 0.45 μm microporous filter, ODS extraction column, and SP extraction column, respectively injected into an ion chromatograph, separated and determined the content of succinic acid, and investigated the recovery rate of succinic acid. The suitable separation and determination conditions are: ion chromatography (...

Embodiment 2

[0014] Embodiment 2: Selection test of microwave hydrolysis temperature

[0015] The recovery rate of the succinic acid reference substance was used as the investigation index of the microwave hydrolysis temperature selection test. Precisely measure 1ml of the aqueous solution of succinic acid reference substance, put it in a microwave digestion tube, add 5ml of concentrated hydrochloric acid, carry out microwave hydrolysis at different temperatures and times, dry it with air at 70°C to remove the inorganic acid and treat it, inject it into an ion chromatograph for separation and determination, Investigate the recovery rate of succinic acid. Results (see Table 2): Succinic acid is stable when it is hydrolyzed by microwave at or below 170°C, and the recovery rate decreases when it is above 180°C. Therefore, this patent selects microwave hydrolyzed succinylated modified gelatin and its injection solution at a temperature of 170°C.

[0016] Table 2, the result table of microwav...

Embodiment 3

[0018] Embodiment 3: the selection test of microwave hydrolysis time

[0019] Precisely measure 1ml of succinylated gelatin injection, put it into a microwave digestion tube, add 5ml of concentrated hydrochloric acid, hydrolyze at 170°C for 15, 30, 45, 60, 90, and 120 minutes respectively, transfer each hydrolyzate and dilute to 25ml with a glass of water. Precisely measure 2ml, air-dry at 70°C to remove inorganic acid, wash with water and dilute to 10ml, treat with 0.45μm microporous filter, ODS extraction column, SP extraction column successively, and determine the content of succinic acid by ion chromatography. The experimental results (see Table 3) show that the bound succinic acid in the succinylated gelatin injection can be completely hydrolyzed by hydrolysis at 170°C for 60 minutes.

[0020] Microwave hydrolysis conditions Succinic acid content (mg / L) 170°C for 15 minutes 830.3 170°C for 30 minutes 832.2 170°C for 45 minutes 964.3 170°...

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Abstract

The invention relates to a method for detecting succinylation modified gelatin and combination succinic acid in its injection, which comprises the following steps: 1) using a microwave hydrolysis method to hydrolyze the succinylation modified gelatin and the combination succinic acid in its injection; and 2) detecting succinic acid in the solution obtained in the step (1) by a chromatography method.

Description

technical field [0001] The invention relates to a method for detecting succinylated modified gelatin and succinic acid in its injection solution. Background technique [0002] The modified gelatin injection prepared by modifying gelatin is a plasma substitute and has been widely used clinically. There are two types of gelatin injection modified by succinylation: "succinylated gelatin injection" and "polygeline injection". The degree of acylation reaction is an important quality indicator of this type of product. In the current succinylated gelatin injection drug quality standards for the determination of the degree of acylation, combined with succinic acid, the method of hydrolyzing the sample with hydrochloric acid at 110°C for 72 hours, followed by C18-HPLC-UV separation and determination. The disadvantages are: ①The hydrolysis operation time and separation and detection time are long, which is not suitable for the quality control of intermediate products; ②The hydrolysi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 刘利余泳华张随楷周飞陈经纬
Owner 浙江康乐药业股份有限公司
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