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Related substance analysis method for terlipressin for injection

A technology for terlipressin and related substances, which is applied in the directions of analysis materials, material separation, measuring devices, etc., can solve the problem that the detection efficiency of terlipressin for injection has not been compared and studied, and achieve effective product quality and control. Product quality, high precision effect

Active Publication Date: 2016-02-03
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above-mentioned published analytical methods have not undergone comparative studies on the detection efficiency of related substances of terlipressin for injection.

Method used

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  • Related substance analysis method for terlipressin for injection
  • Related substance analysis method for terlipressin for injection
  • Related substance analysis method for terlipressin for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

11.0mg

[0090] Preparation Process:

[0091] 1. Respectively weigh the raw material terlipressin acetate and the auxiliary materials mannitol and hydrochloric acid for the prescription quantity;

[0092] 2. Take the prescribed amount of 70% (w / w) water for injection, and dissolve the prescribed amount of mannitol;

[0093] 3. Add medicinal charcoal at 0.1% (w / w), stir and adsorb for 15 minutes, use a 0.45 μm titanium rod filter element for decarbonization and filtration, and decarbonize the cycle for 5 minutes.

[0094] 4. Weigh the prescribed amount of terlipressin acetate, dissolve it, add water for injection to the prescribed amount (w / w), and stir for 5 minutes;

[0095] 5. Adjust the pH to 3.5-4.0 with 6mol / L hydrochloric acid;

[0096] 6 Intermediate detection, detection of properties, content, pH, endotoxin;

[0097] 7 Filter with a microporous filter element of 0.22 μm polyethersulfone, three times;

[0098] 8. Fill the obtained drug-containing solution i...

Embodiment 2

[0102] The liquid chromatography conditions are as follows:

[0103] Chromatographic column: Agilent Poroshell120EC-C18 (4.6×100mm, 2.7μm);

[0104] Mobile phase A: 0.1mol / L sodium dihydrogen phosphate (phosphoric acid to adjust the pH value to 3.5)-acetonitrile (92:8, v / v);

[0105] Mobile phase B: 0.1mol / L sodium dihydrogen phosphate (phosphoric acid to adjust the pH value to 3.5)-acetonitrile (80:20, v / v);

[0106] Detection wavelength: 210nm;

[0107] Flow rate: 1.2ml / min

[0108] Column temperature: 40°C

[0109] The gradient elution program is shown in the table below:

[0110] time (min)

[0111] 4

[0112] Among them, step 1, preparation of the test solution: take des-Gly1 terlipressin, des-Gly1, Gly2 terlipressin, des-Gly1, Gly2, Gly3 terlipressin, [AC-Gly1] Terlipressin, [D-Phe6]Terlipressin, [Glu7]Terlipressin, [Asp8,Gly12-OH]Terlipressin, [β-Asp8]Terlipressin, [Gly12-OH] terlipressin, [Glu7,Gly12-OH] terlipressin, δAva10 terlipressin, [Des...

Embodiment 3

[0117] The liquid chromatography conditions are as follows:

[0118] Chromatographic column: Agilent Poroshell120EC-C18 (4.6×100mm, 2.7μm);

[0119] Mobile phase A: 0.1mol / L sodium dihydrogen phosphate (phosphoric acid to adjust the pH value to 3.5)-acetonitrile (92:8, v / v);

[0120] Mobile phase B: 0.1mol / L sodium dihydrogen phosphate (phosphoric acid to adjust the pH value to 3.5)-acetonitrile (80:20, v / v);

[0121] Detection wavelength: 210nm;

[0122] Flow rate: 1.2ml / min

[0123] Column temperature: 40°C

[0124] The gradient elution program is shown in the table below:

[0125] time (min)

Mobile phase A(%)

Mobile phase B(%)

0

100

0

4

100

0

18

65

35

42

0

100

42.1

100

0

50

100

0

[0126] Wherein, step 1, preparation of the test solution: the method is as follows: take 5 terlipressin injections, dissolve with water and dilute to 25ml, shake well, and prepar...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a related substance analysis method for terlipressin for injection. The content detection method for the terlipressin for injection includes the following steps: (Step 1) preparation of test solvent: the terlipressin for injection is prepared into the test solvent; (Step 2) preparation of self-control solvent: the test solvent is diluted, so that the self-control solvent is prepared; (Step 3) related substance content calculation: the control solvent and the test solvent are respectively injected into high-performance liquid chromatographs, so that chromatograms are obtained, and the related substance content in the test solvent is obtained by calculation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for analyzing related substances of terlipressin for injection. Background technique [0002] The main active ingredient of terlipressin for injection is terlipressin (triglycine-8-lysine-vasopressin), which is a chemically synthesized polypeptide compound. The pharmacological effects of terlipressin are: reduce portal hypertension, reduce blood flow in the portal vein area, contract esophageal smooth muscle, and continuously compress esophageal varices. Terlipressin for injection is mainly used for the treatment of bleeding from esophageal varices. [0003] Polypeptide compounds are an important class of biologically active molecules. The development of peptide and other biotechnology drug research technologies, such as peptide solid-phase synthesis technology and high-performance liquid chromatography purification and analysis technology, has made the de...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
Inventor 许磊王桂梅吴文锁阚晓臣郭嘉林董凯孙长海姚小青
Owner TIANJIN CHASE SUN PHARM CO LTD
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