Method for determining content of glucose in compound electrolyte glucose injection

A technology of glucose injection and compound electrolyte, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve problems such as undocumented, and achieve the effects of improving quality control, realizing separation, and simple and feasible determination methods.

Inactive Publication Date: 2019-12-03
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The prior art does not record the method of high-performance liquid chromatography-differential refraction detector method (HPLC-RI) to measure the glucose content in the compound glucose injection

Method used

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  • Method for determining content of glucose in compound electrolyte glucose injection
  • Method for determining content of glucose in compound electrolyte glucose injection
  • Method for determining content of glucose in compound electrolyte glucose injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1. Instruments and reagents

[0036] Thermo-Ultimate 3000 high performance liquid chromatograph (with differential refractive index detector), the chromatographic column is ShodexAsahipak NH2P-50 4E.

[0037] Glucose reference substance (batch number: R035J0, USP standard substance);

[0038] Glucose (batch number: 201711070, CSPC Shengxue Glucose Co., Ltd.);

[0039] Sodium chloride (batch number: 20170229, Jiangsu Province Qinfen Pharmaceutical);

[0040] Potassium chloride (batch number: 20170713-1, Jiangsu Province Qinfen Pharmaceutical);

[0041] Sodium lactate (batch number: 180102, Fuyue Industrial Co., Ltd.);

[0042] Compound electrolyte glucose MG3 injection (batch number: 8J74F11, China Otsuka Pharmaceutical Co., Ltd.);

[0043] Acetonitrile (Lot: 191994, Thermo Fisher)

[0044] 2. Method

[0045] 2.1 Preparation of reference solution

[0046] Accurately weigh 100mg of glucose reference substance, put it in a 10ml measuring bottle, add ultrapure water ...

Embodiment 2

[0078] 1. Instruments and reagents

[0079] Thermo-Ultimate 3000 high performance liquid chromatograph (with differential refractive index detector), the chromatographic column is ShodexAsahipak NH2P-50 4E.

[0080] Glucose reference substance (batch number: R035J0, USP standard substance);

[0081] Glucose (batch number: 201711070, CSPC Shengxue Glucose Co., Ltd.);

[0082] Sodium chloride (batch number: 20170229, Jiangsu Province Qinfen Pharmaceutical);

[0083] Potassium chloride (batch number: 20170713-1, Jiangsu Province Qinfen Pharmaceutical);

[0084] Sodium lactate (batch number: 180102, Fuyue Industrial Co., Ltd.);

[0085] Calcium chloride (batch number: 03170509, Tianjin Haiguang Pharmaceutical);

[0086] Compound sodium lactate glucose injection (batch number: 9D72F1, China Otsuka Pharmaceutical Co., Ltd.)

[0087] Acetonitrile (Lot: 191994, Thermo Fisher)

[0088] 2. Method

[0089] 2.1 Preparation of reference solution

[0090] Accurately weigh 100mg of g...

Embodiment 3

[0107] Durability test: Take the reference substance solution and adjust it according to the chromatographic conditions under "2.4", respectively flow rate 1.4ml / min, 1.6ml / min; column temperature 28°C, 32°C; test on the machine, see the results Figure 7-10 , within the adjusted range of chromatographic conditions, the tailing factor of the glucose chromatographic peak in the reference solution is not greater than 2.0, which is applicable to the detection of glucose.

[0108] 4. Discussion

[0109] 4.1 The content of glucose in the compound electrolyte glucose MG3 injection was determined by optical polarimetry. However, in practical applications, it is found that compound preparations often contain a variety of compounds with optical activity, and the traditional optical rotation method is not suitable for the determination of glucose content in compound preparations. In order to improve the quality standard of the product, an accurate, convenient and stable high-performanc...

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Abstract

The invention discloses a method for determining the content of glucose in a compound electrolyte glucose injection. The method comprises the following steps of (1) preparing a reference substance solution, namely weighing a glucose standard substance, adding ultrapure water to dissolve, dilute and uniformly shake to obtain the reference substance solution, (2) preparing a test sample solution, namely measuring and taking the compound electrolyte glucose injection, adding ultrapure water to dilute and shake uniformly to obtain the test sample solution, wherein the ratio of the concentration ofglucose in the reference substance solution in the step (1) to the concentration of glucose in the test sample solution is 1 to 1, and (3) detecting and reading the chromatographic peak areas of thereference substance solution and the test sample solution through a high-performance liquid chromatographic instrument and calculating the glucose concentration by combining the concentration of the reference substance solution and adopting an external standard method. The method has the advantages of high measurement precision and simple and convenient operation.

Description

technical field [0001] The invention relates to a method for measuring glucose content, in particular to a method for measuring glucose content in compound electrolyte glucose injection. Background technique [0002] At present, the method for determining the content of glucose in the compound electrolyte glucose MG3 injection has the optical rotation method, which is to determine the glucose content in the compound preparation by the optical rotation of the sample to be tested and the known specific optical rotation of the pure substance. This method is harmful to the environment. The temperature control requirements are high, and the determination is easily affected by environmental factors; secondly, when the preparation contains multiple compounds with optical activity, the optical polarimetry method cannot accurately determine the content of glucose. Many compound glucose preparations currently on the market contain two or more compounds with optical activity at the sam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/74
CPCG01N30/02G01N30/74
Inventor 涂家生孙春萌周沐野张悦
Owner CHINA PHARM UNIV
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