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Purification method for insulin crystal or insulin analogue crystal

A technology for insulin analogs and purification methods, which is applied in the field of purification of insulin crystals or insulin analog crystals, can solve problems such as poor volatility, and achieve the effects of low solvent residue, uniform particles, and simple and quick operation

Active Publication Date: 2014-04-09
YICHANG HEC CHANGJIANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The market for insulin and insulin analogues is huge, and there are currently no literature reports on the removal of impurities in insulin crystals or insulin analogue crystals. Therefore, how to remove the residual poorly volatile and highly toxic organic solvents in insulin crystals or insulin analogue crystals to improve insulin and insulin resistance. The quality of insulin analog drugs is a major problem facing today's technology

Method used

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  • Purification method for insulin crystal or insulin analogue crystal
  • Purification method for insulin crystal or insulin analogue crystal
  • Purification method for insulin crystal or insulin analogue crystal

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Take insulin glargine crystals prepared with phenol, zinc chloride, etc., add about 10 times the volume of acetonitrile to wash the crystals for 10 minutes, stir to completely disperse the crystals, turn on the vacuum pump to filter, and then rinse with about 8 times the volume of acetonitrile 5min. After rinsing, drain completely, remove the crystals, and freeze-dry them in a freeze-drying tray. The phenol content in the insulin glargine crystals before and after the acetonitrile treatment was detected by HPLC, and the results are shown in Table 1. And the residual acetonitrile dissolved in the final insulin glargine crystalline freeze-dried product was detected by gas chromatography with reference to the national standard product, and the results are shown in Table 2.

[0032] Table 1 Phenol content in insulin glargine crystals before and after acetonitrile treatment

[0033]

[0034] The content of acetonitrile in the freeze-dried product of insulin glargine cry...

Embodiment 2

[0038] Take the insulin glargine crystals described in Example 1, add about 8 times the volume of absolute ethanol to rinse the crystals for 20 minutes, stir to completely disperse the crystals, turn on the vacuum pump for suction filtration, and rinse with about 5 times the volume of absolute ethanol for 8 minutes at the same time , after rinsing, drain completely, take out the crystals, and freeze-dry them in a freeze-drying tray. The phenol content in insulin glargine crystals before and after treatment with absolute ethanol detected by HPLC, the results are shown in Table 3, and the ethanol residue in the final freeze-dried product of insulin glargine crystals was detected by gas chromatography with reference to the national standard product, the results are shown in Table 3 4.

[0039] Table 3 Phenol content in insulin glargine crystals before and after absolute ethanol treatment

[0040]

[0041] Content of acetonitrile in the freeze-dried product of insulin glargine...

Embodiment 3

[0045] Take insulin crystals prepared with m-cresol and zinc chloride, add about 15 times the volume of 95% ethanol to wash the crystals for 15 minutes, stir to make them completely dispersed, turn on the vacuum pump to filter, and then use about 10 times the volume of 95% ethanol to rinse the crystals for 15 minutes. Rinse for 20 minutes, drain completely after rinsing, take out the crystals, put them in a freeze-drying tray, and soak in a small amount of ice water. The m-cresol content in insulin crystals before and after 95% ethanol treatment was detected by HPLC, and the results are shown in Table 5. The ethanol-dissolved residue in the final freeze-dried product of insulin crystals was detected by gas chromatography with reference to the national standard product, and the results are shown in Table 6.

[0046] Table 595% ethanol before and after the m-cresol content in the insulin crystals

[0047]

[0048] Table 6 Content of ethanol in the freeze-dried product of ins...

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Abstract

The invention belongs to the field of pharmaceutical chemistry, and discloses a purification method for a crystal of insulin or an analogue thereof. The purification method comprises: adopting an easy-volatilizing and low-toxicity organic solvent to rinse and leach an insulin crystal or an insulin analogue crystal in a short time so as to completely remove the trace poor-volatility and high-toxicity organic solvent remaining in the crystal, and drying to completely remove the good-volatility organic solvent introduced during rinsing and leaching after completing leaching so as to solve the problem of residue of the difficultly-volatilized organic solvent in the crystal. According to the purification method, the operation is simple and quick, the purified insulin crystal or insulin analogue crystal finished product has characteristics of high crystal purity, low solvent residue, uniform particle, good dispersity, and easy storage and sub-package compared with the untreated crystal.

Description

[0001] This application claims the priority of the Chinese patent application submitted to the China Patent Office on September 29, 2012, with the application number 201210380407.2, and the title of the invention is "A Purification Method for Insulin Crystal and Or Insulin Analogue Crystal", the entire content of which Incorporated in this application by reference. technical field [0002] The invention belongs to the field of medicinal chemistry and relates to a method for purifying insulin crystals or insulin analog crystals. Background technique [0003] Insulin is a protein hormone secreted by pancreatic β cells stimulated by endogenous or exogenous substances such as glucose, lactose, ribose, arginine, glucagon, etc. Insulin is the only hormone that lowers blood sugar in the body , while promoting glycogen, fat, protein synthesis. Insulin was first discovered in 1921 by Canadians F.G. Banting and C.H. Best. It began to be used clinically in 1922 to save the diabetic p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K14/62C07K1/14
CPCC07K14/62
Inventor 林小鹊章琛陈小锋
Owner YICHANG HEC CHANGJIANG PHARMA CO LTD
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