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Medicinal lactose, preparation method thereof, and purpose thereof

A technology for medicinal lactose and lactose, applied in the field of medicine, can solve problems such as removal of inapplicability

Inactive Publication Date: 2012-06-27
SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Reports on the purification of β-lactoglobulin in whey with ultrafiltration membranes are also common, but the purpose of these studies is only to collect a large number of β-lactoglobulin or other whey proteins, and the removal of trace proteins remaining in lactose not applicable

Method used

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  • Medicinal lactose, preparation method thereof, and purpose thereof
  • Medicinal lactose, preparation method thereof, and purpose thereof
  • Medicinal lactose, preparation method thereof, and purpose thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Analysis method of β-lactoglobulin content in lactose:

[0096] Reagent test kit: β-Lactoglobulin Assay (10-400ppb)

[0097] Microplate reader: Bio-Tek ELX800

[0098] The operation process was carried out according to the instructions of the kit, and the lactose solution was prepared with a concentration of 100 mg / ml. After measuring the results, calculate the β-lactoglobulin content in lactose according to the following formula:

[0099]

[0100] Analysis method of protein content in lactose:

[0101]The determination method is the Coomassie brilliant blue method (Bradford method) commonly used in the determination of protein content, for example: the Bradford microanalysis method described in "The Protein Protocols Handbook (SECOND EDITION)" edited by John M. Walker et al.

[0102] Analysis method of endotoxin content in lactose:

[0103] The analysis method of endotoxin content in lactose is carried out with reference to Chinese Pharmacopoeia II Appendix XI...

Embodiment 2

[0105] Preparation of Lactose 1

[0106] The preparation process is: take 3 kg of medicinal lactose containing β-lactoglobulin, such as Pharmatose 200 (see Table 4 for the manufacturer and model), dissolve it in 20 liters of boiling water, add 9 g of activated carbon, stir the solution, and maintain the temperature Above 97°C, after stirring for 30 minutes, cool to room temperature, and filter the solution with a 0.22 μm filter membrane to obtain solution 1A. Use 1M sodium hydroxide solution to adjust the pH of the solution to 6.5, and then pass through Capto Q anion exchange chromatography (12.7cm×Ф10cm). The operation process of the chromatography column is: the anion exchange resin is regenerated with sodium hydroxide in advance, and then washed with water After reaching pH 7-8, directly pass the lactose solution through the chromatographic column, and collect the effluent from the chromatographic column to obtain solution 1B. The collected chromatographic effluent is then...

Embodiment 3

[0108] Preparation of Lactose 2

[0109] Get the medicinal lactose containing β-lactoglobulin, such as Pharmatose 200 (manufacturer and model see Table 4) totally 3kg, be dissolved in 20 liters of water, carry out refining lactose with reference to embodiment 2, difference is that this experiment adopts 5KD The regenerated cellulose ultrafiltration membrane (Millipore) with molecular weight cut-off was used for ultrafiltration, and finally the lactose product (lactose 2) was obtained. The activated carbon-treated solution and the ion-exchange-treated solution were marked as 2A and 2B, respectively.

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Abstract

The invention provides medicinal lactose, a preparation method thereof, and a purpose thereof. Specifically, the invention provides medicinal lactose with low impurity protein (especially low beta-lactoglobulin) content and low endotoxin content. The invention also discloses the preparation method of the lactose, and a pharmaceutical purpose of the lactose.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a pharmaceutical lactose and its preparation method and application. Background technique [0002] Lactose is a kind of disaccharide, which is formed by the condensation of one molecule of glucose and one molecule of galactose. It is a common disaccharide in mammalian milk. Lactose is one of the main nutrients for children's growth and development. It is very important for the intellectual development of adolescents, especially for newborn babies. It is often used in the manufacture of baby food, candy, and artificial milk. It is often used as a flavoring agent, excipient, diluent, filler, dry powder inhalation carrier, stabilizer, etc. in medicine. It is widely used in tablets, capsules, granules, freeze-dried products, and dry powder inhalers. [0003] Lactose is widely used in pharmaceutical products because of its many good properties, but it has become the biggest limit...

Claims

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Application Information

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IPC IPC(8): C07H3/04C07H1/06A61K47/26
Inventor 洪云海陈磊季晓铭
Owner SHANGHAI TECHWELL BIOPHARMACEUTICALS CO LTD
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