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Detection method for analyzing contents of 24 element impurities in insulin at one time

A technology for elemental impurities and detection methods, which is applied in the field of analysis and detection, can solve the problems of low detection efficiency and inability to detect multiple impurity elements at the same time, and achieve the effects of saving detection time, efficient detection methods, and reducing sensitization effects

Pending Publication Date: 2021-02-05
淄博高新技术产业开发区生物医药研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing detection methods cannot detect multiple impurity elements at the same time, and the detection efficiency is low.

Method used

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  • Detection method for analyzing contents of 24 element impurities in insulin at one time
  • Detection method for analyzing contents of 24 element impurities in insulin at one time
  • Detection method for analyzing contents of 24 element impurities in insulin at one time

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Linearity test:

[0043] (1) Prepare a linear stock solution, and the specific operations are shown in Table 5. Wherein, solvent A is 50mL of 5wt% hydrochloric acid mixed with 950mL ultrapure water; solvent B is 20mL of 5wt% hydrochloric acid, 30mL of 5wt% nitric acid and 950mL of ultrapure water mixed.

[0044] Table 5 Preparation operation of linear stock solution

[0045]

[0046]

[0047] (2) Prepare a linear solution:

[0048] Measure 0 μL, 10 μL, 50 μL, 100 μL, 150 μL, and 200 μL of the above-mentioned linear stock solution respectively, put them in a 10 mL measuring bottle, dilute to the mark with solvent A, and shake well to obtain linear solutions STD-0 (limit concentration 0%), STD -1 (limit concentration 10%), STD-2 (limit concentration 50%), STD-3 (limit concentration 100%), STD-4 (limit concentration 150%), STD-5 (limit concentration 200%). Concrete standard curve concentrations of each level are shown in Table 6, linear equation parameters and cor...

Embodiment 2

[0057] Precision test:

[0058] (1) Repeatability test:

[0059]Accurately weigh about 100 mg of the test product, place it in a 50 mL volumetric bottle, add 500 μL of linear stock solution, dilute to the mark with solvent A, shake well, and obtain. Prepare 6 replicate samples in the same way, and record them as samples 1-6.

[0060] The test results are shown in Table 8.

[0061] Table 8 Repeatability test results

[0062]

[0063]

[0064] Acceptance criteria: The %RSD of the measured concentration of each elemental impurity should not be greater than 20%. It can be seen from Table 8 that the detection system of the present invention meets the acceptance criteria.

[0065] (2) Accuracy test

[0066] Accuracy test is to determine the degree to which elemental impurities are detected by the determined method and the true value is close to the true value, and the standard recovery method is used for research. The concentration of sample addition recovery is selected...

Embodiment 3

[0078] The detection method of the present invention is used to measure the content of 24 kinds of element impurities in insulin aspart, and the preparation method of the sample solution to be tested is as follows:

[0079] Accurately weigh 100mg of the sample, place it in a 50mL measuring bottle, dilute to the mark with solvent A, and shake well to obtain the sample solution to be tested. Two copies are prepared in the same way for each batch.

[0080] The calculation formula is:

[0081] Where Conc.(ppb) is the detection result of the sample solution to be tested.

[0082] See Table 10 for the determination results of 24 elemental impurities in 4 batches of insulin aspart.

[0083] Table 10 Contents of 24 elemental impurities in insulin aspart

[0084]

[0085] "BQL" means the limit concentration below 10%, and the limit concentration of 10% is (unit: ppm):

[0086] Cd: 0.02; Pb: 0.05; As: 0.15; Hg: 0.03; Co: 0.05; V: 0.1; 0.1; Ru: 0.1; Se: 0.8; Ag: 0.1; Pt: 0.1; Li...

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Abstract

The invention relates to the technical field of analysis and detection, in particular to a detection method for analyzing the content of 24 element impurities in insulin at a time. According to the detection method for one-time analysis of the impurity content of 24 elements in insulin, inductively coupled plasma mass spectrometry and USP-233 are adopted for detection, an internal standard correction standard curve method is adopted for a quantitative analysis method, and to-be-detected elements are Cd, Pb, As, Hg, Co, V, Ni, T1, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn, andCr, and internal standard is 115In. According to the detection method, 24 impurity elements in insulin aspart can be detected at a time, the detection time is greatly saved, and the detection method is efficient and accurate.

Description

technical field [0001] The invention relates to the technical field of analysis and detection, in particular to a detection method for one-time analysis of the content of 24 elemental impurities in insulin. Background technique [0002] The main function of insulin is to reduce the blood sugar concentration, so that the blood sugar concentration returns to the normal range (80-120mg / dL). It can release energy by promoting the oxidation and decomposition of blood sugar, and at the same time promote the synthesis and storage of glycogen in blood sugar. It can also promote the conversion of blood sugar into fat, Amino acids and other non-sugar substances, so as to achieve the purpose of lowering blood sugar. Insulin aspart (Insulinaspart) is a commonly used drug for the treatment of diabetes, it is a colorless clear liquid. [0003] In the process of insulin synthesis and preparation of reagents, synthetic raw materials, production process components, insulin excipients, insul...

Claims

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Application Information

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IPC IPC(8): G01N27/62
CPCG01N27/62
Inventor 付亚冰荆玉琳潘晓倩任娜张帅
Owner 淄博高新技术产业开发区生物医药研究院