Production method for composite lactose for injection

A production method and technology for injection, which are applied in the field of medicine, can solve the problems of not meeting the requirements of injections, insufficient freeze-drying protection efficiency, and low purity of lactose, and achieve a simple and feasible purification process, improve freeze-drying protection efficiency, and be environmentally friendly. Effect

Active Publication Date: 2015-05-13
HUNAN ER KANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem that the current medicinal lactose is not high in purity, there are residual proteins, and cannot meet the requirements of injections, and the freeze-drying protection efficiency is still insufficient, the present invention provides a lactose purification method, and the purified lactose can be used in injection products

Method used

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  • Production method for composite lactose for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1. Weigh 100g of crude lactose, add 400ml of purified water, stir and heat to 30°C, make it completely dissolve to form a lactose solution;

[0026] 2. Filter the crude lactose solution with an ultrafiltration column with a molecular weight cut-off of 3000MW;

[0027] 3. Perform nanofiltration on the ultrafiltered lactose solution;

[0028] 4. Add the filtered lactose into 150ml of purified water, stir and heat to 70°C to completely dissolve into a lactose solution;

[0029] 5. Add 450ml of ethanol to the lactose solution in step 4, stir and cool to 10°C to precipitate crystals, and keep this process for 0.5 hours;

[0030] 6. Centrifuge the solution with crystals in a filter bag centrifuge to collect the crystals;

[0031] 7. Take 99 grams of crystals and 100 ml of 1% hydroxypropyl methylcellulose solution, mix well, and then spray dry.

Embodiment 2

[0033] 1. Weigh 20Kg of crude lactose, add 62L of purified water, stir and heat to 40°C, make it completely dissolve to form a lactose solution;

[0034] 2. Filter the crude lactose solution with an ultrafiltration column with a molecular weight cut-off of 3000MW;

[0035] 3. Perform nanofiltration on the ultrafiltered lactose solution;

[0036] 4. Add the filtered lactose into 30L of purified water, stir and heat to 70°C to completely dissolve into a lactose solution;

[0037] 5. Add 100L of ethanol to the lactose solution in step 4, stir and cool to 10°C to precipitate crystals, and keep this process for 1 hour;

[0038] 6. Centrifuge the solution with crystals in a filter bag centrifuge to collect the crystals;

[0039] 7. Take 97 grams of crystals and 100ml of 3% hydroxypropyl methylcellulose solution, mix well and then spray dry.

Embodiment 3

[0041] 1. Weigh 20Kg of crude lactose, add 62L of purified water, stir and heat to 35°C to completely dissolve to form a lactose solution;

[0042] 2. Filter the crude lactose solution with an ultrafiltration column with a molecular weight cut-off of 3000MW;

[0043] 3. Perform nanofiltration on the ultrafiltered lactose solution;

[0044] 4. Add the filtered lactose into 32L of purified water, stir and heat to 70°C to completely dissolve into a lactose solution;

[0045] 5. Add 100L of ethanol to the lactose solution in step 4, stir and cool to 10°C to precipitate crystals, and keep this process for 1 hour;

[0046] 6. Centrifuge the solution with crystals in a filter bag centrifuge to collect the crystals;

[0047] 7. Take 98g of crystals and 100ml of 2% hydroxypropyl methylcellulose solution, mix well, and then spray dry.

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Abstract

The invention relates to a production technology for composite lactose for injection. According to the technology, ultrafiltration, nanofiltration and recrystallization are combined to remove residual glucose, fructose, galactose, amino acid and protein in lactose; and the prepared lactose conforms to the requirements for injection, and can be applied to an injection product. The production technology provided by the invention is simple, feasible, relatively high in yield, and suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a production method of compound lactose for injection. Background technique [0002] Lactose is a disaccharide composed of one molecule of glucose and one molecule of galactose. Under natural conditions, it exists in the milk of mammals. In industrial production, it is often extracted from whey. The crude lactose contains a small amount of glucose, Galactose, fructose, protein, amino acid. In the field of medicine, lactose has important applications. As a freeze-drying agent scaffold, the biggest difference between it and other commonly used freeze-drying agents (such as glucose, mannitol, etc.) is that the latter is a monosaccharide with a relatively low molecular weight. The glass transition temperature is also low when dry, and the freeze-drying process is also a crystallization process, which has a strong destructive effect on some relatively "fragile" freeze-drie...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/38C13K5/00
Inventor 帅放文王向峰章家伟
Owner HUNAN ER KANG PHARMA
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