Application of method for determining cloud point and free sugar buffer coefficient of iron- carbohydrate complex

A technology of carbohydrates and buffer coefficients, applied in the direction of testing pharmaceutical preparations, material inspection products, etc., can solve the problems of operator conditions and test environment influence, turbidity analysis equipment test value error, etc.

Active Publication Date: 2012-11-28
NANJING LIFENERGY R & D
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] The purpose of the present invention is to solve the problem that the determination of the cloud point of the iron-carbohydrate complex in the prior art is highly subjective, easily affected by the operator's conditions and the test environment, and the error of the test value of the turbidity analysis equipment at a lower range Larger defects, providing a method for accurately measuring turbidity and free sugar buffer coefficient by combining instrumental turbidity with data fitting

Method used

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  • Application of method for determining cloud point and free sugar buffer coefficient of iron- carbohydrate complex
  • Application of method for determining cloud point and free sugar buffer coefficient of iron- carbohydrate complex
  • Application of method for determining cloud point and free sugar buffer coefficient of iron- carbohydrate complex

Examples

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Embodiment 1

[0083] Example 1 Example of Determination Method for Iron Sucrose Cloud Point (PP) and Free Sugar Coefficient (n)

[0084] Preparation of iron sucrose test solution: Take 1 g of iron sucrose injection, put it in a 300ml beaker, add 200ml of water to dilute. Preparation of acid solution: Take concentrated hydrochloric acid and add purified water to prepare 0.1mol / L hydrochloric acid solution. Under the condition of continuous stirring, add 0.1 mol / L hydrochloric acid solution dropwise to the iron sucrose test solution. At different pH, the turbidimeter measures the turbidity of the solution, and records the pH and turbidity data respectively.

[0085] Table 1. Original data table of sucrose ferric acid degradation kinetics

[0086] pH 4.65 4.55 4.46 4.34 4.23 4.16 N 0.583 1.364 5.41 8.68 35.28 61.66 lgN -0.2343 0.1348 0.7332 0.9385 1.5475 1.7900

[0087] Take the logarithm of the measured turbidity value with the base of ten, and do th...

example 1

[0096] Taking the derivative of both sides of formula (d) with respect to pH, we get:

[0097] dN / dpH=-4.1144×10e (-4.1144×pH+18.915) (e)

[0098] Let dN / dpH=-11.4

[0099] Get -4.1144×10e (-4.1144×pH+18.915) = -11.4(f)

[0100] Solve formula (f) to get: pH=4.5775

[0101] That is, the sucrose iron cloud point PP=4.5775

example 2

[0103] dN / dpH=-4.1144×10e (-4.1144×pH+18.915) (e)

[0104] Let dN / dpH=-20

[0105] Get -4.1144×10e (-4.1144×pH+18.915)=-20(g)

[0106] Solve formula (g) to get: pH=4.5182

[0107] That is, the sucrose iron cloud point PP=4.5182

[0108] Secant method example 1

[0109] N=10e(-4.1144×pH+18.915)(d)

[0110] Let N=1, that is, 10e(-4.1144×pH+18.915)=1(h),

[0111] Solving for (h),

[0112] Get pH=4.5970

[0113] That is, the cloud point of iron sucrose PP=4.5970

[0114] Secant method example 2

[0115] N=10e(-4.1144×pH+18.915)(d)

[0116] Let N = 2, i.e. 10e(-4.1144 x pH + 18.915) = 1(i),

[0117] Solving for (i),

[0118] Get pH=4.5243

[0119] That is, the sucrose iron cloud point PP=4.5243

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Abstract

The invention relates to application of a method for determining a cloud point and a free sugar buffer coefficient of an iron-carbohydrate complex. The method for determining the cloud point and the free sugar buffer coefficient of the iron-carbohydrate complex comprises the following steps: (1), enabling a complex to be contacted with acid; (2), determining the hydrogen ion concentration and the solution concentration in the acid degradation process of the complex; and (3), carrying out mathematical fit on the data and mathematically processing the data to obtain the cloud pint of the complex and the free coefficient of the carbohydrate. If the cloud point value is between 4.4 and 5.3 and the free sugar buffer coefficient is greater than 2.5, the iron- carbohydrate complex has favorable safety. According to the application of the method provided by the invention, the cloud point of the iron-carbohydrate complex is successfully determined by using an instrument for determining for the first time and combining with a mathematical fit method, the free sugar buffer coefficient of the iron-carbohydrate complex is provided and determined and the method for evaluating the safety of the iron-carbohydrate complex is established by using the cloud point and the free sugar buffer coefficient.

Description

[0001] Case Description [0002] This application is a divisional application of a Chinese invention patent application with the application number 200910232202.8 and the filing date of 2009.12.09, entitled "A Method for Measuring the Cloud Point of Iron-carbohydrate Complex and the Buffer Coefficient of Free Sugar". technical field [0003] The invention belongs to the field of macromolecular analysis and measurement, and relates to the application of a method for measuring the cloud point of iron-carbohydrate complex and the buffer coefficient of free sugar. Background technique [0004] Iron is an essential trace element for the human body. Iron deficiency due to insufficient intake, limited utilization or other reasons is quite common. Iron deficiency anemia is the most widely distributed nutritional deficiency disease in the world today. Iron-carbohydrate complexes are currently widely used iron supplements against iron-deficiency anemia, especially for iron-deficiency ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15
Inventor 方文花传政杨洁何国新熊守军
Owner NANJING LIFENERGY R & D
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