Lactose for injection and preparation method thereof

A technology of lactose for injection and medicinal lactose, which is applied in the field of medicine, can solve problems such as urticaria, cough, fever, shock, failure to meet the quality standards of injection-grade lactose, and restrictions on the application of lactose, so as to solve adverse reactions and improve freezing. Dry protection efficiency, simple and feasible purification process

Pending Publication Date: 2019-11-22
HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to its special source, mainly derived from animal whey, which is an accessory product of milk, lactose prepared by traditional purification processes such as activated carbon adsorption, due to the existence of residual protein, colored impurities and endotoxins, will It is very easy to cause a series of adverse reactions such as urticaria, cough, fever, shock, etc., which greatly restricts the application of lactose with excellent performance in injection products
[0007] Patent 201510058373.9 provides a production method of compound lactose for injection. The lactose produced by this method is spray-dried lactose. This method uses ethanol crystallization, but there is no control report on the residue of ethanol, which is a high safety hazard when used for injection; The lactose produced by the method has been reported to control the residual glucose, fructose, galactose, amino acid, and protein in the crude lactose, and there is no specific data. The important index test shows that only the whole protein content is detected, and the α- There are no specific control methods and reports for whey protein and β-lactoglobulin single protein. For example, in the document "Ion-selective Kjeldahl Nitrogen Method Determination of Lactose Residual Protein Content for Injection" it is clear that whey protein is an allergen
[0008] The currently reported lactose preparation methods are still not up to the quality standards for the preparation of injection-grade lactose, so a new lactose preparation process is urgently needed to prepare a safe and reliable lactose for injection

Method used

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  • Lactose for injection and preparation method thereof
  • Lactose for injection and preparation method thereof
  • Lactose for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] (1) Weigh 100g of commercially available common lactose monohydrate or medicinal lactose, dissolve in purified water and set the volume to 1000mL, heat to 50°C to dissolve for 100min, and use 10KD membrane bag for ultrafiltration after cooling down to room temperature;

[0023] (2) Concentrated crystallization: Concentrate the ultra-filtered lactose solution at 80°C, heat and stir the concentrated solution at 18°C ​​for 13 hours, then stand at 8°C for 1 hour to crystallize;

[0024] (3) Drying: filter the lactose solution after static crystallization, and then vacuum dry at 90°C for 10 hours;

[0025] (4) Pulverization: After drying, the lactose is pulverized to obtain the product; the yield is 78.5%.

Embodiment 2

[0027] (1) Weigh 5Kg of commercially available common lactose monohydrate or medicinal lactose, dissolve in purified water and set the volume to 16.2L, heat to 90°C to dissolve for 20min, and use a 30KD membrane bag for ultrafiltration after cooling down to room temperature;

[0028] (2) Concentrated crystallization: Concentrate the ultra-filtered lactose solution at 70°C, heat and stir the concentrated solution at 28°C for 18 hours, then stand at 5°C for 6 hours;

[0029] (3) Drying: filter the lactose solution after static crystallization, and then vacuum dry at 70°C for 32 hours;

[0030] (4) Pulverization: After drying, the lactose is pulverized to obtain the product; the yield is 75.3%.

Embodiment 3

[0032] (1) Weigh 10Kg of commercially available common lactose monohydrate or medicinal lactose, dissolve it in purified water and set the volume to 24.4L, heat to 80°C to dissolve for 60min, and use 3KD membrane bag for ultrafiltration after cooling down to room temperature;

[0033] (2) Concentrated crystallization: Concentrate the ultra-filtered lactose solution at 80°C, heat and stir the concentrated solution at 20°C for 26 hours, and then stand at 2°C for 8 hours;

[0034] (3) Drying: filter the lactose solution after static crystallization, and then vacuum dry at 80°C for 24 hours;

[0035] (4) Pulverization: After drying, the lactose was pulverized to obtain the product; the yield was 82.1%.

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Abstract

The invention discloses lactose for injection and a preparation method thereof. The method includes the following steps of ultrafiltration, concentration and crystallization, drying and pulverization.It is shown through studies that the lactose prepared by means of the process can control the levels of residual protein (including alpha-whey protein, beta-lactoglobulin and whole milk protein), endotoxin and other colored impurities to be in accordance with quality standards for injection, and the prepared lactose is still lactose monohydrate and is available for injection products.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to lactose for injection and a preparation method thereof. [0002] technical background [0003] Lactose is a disaccharide, the English name is Lactose; it is connected by a molecule of β-D-galactose and a molecule of α-D-glucose at the β-1,4-position to form a glycosidic bond. Molecular formula C 12 h 22 o 11 , Molar mass 342.3. There are two anomers: α-lactose and β-lactose, which can be converted into each other in aqueous solution, and α-lactose is easy to combine with a molecule of crystal water. The structural formula is as follows: [0004] [0005] Lactose is a commonly used pharmaceutical excipient. It is rarely used in injections. It is mainly used as a filler in oral solid preparations or as a diluent in inhalants, but it is also used in some freeze-dried preparations and injections. The biggest difference between lactose as a freeze-drying excipient and other...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K9/00C13K5/00
CPCA61K47/26A61K9/0019C13K5/00
Inventor 陶言彬叶慧杨欢王磊郝变杜影影
Owner HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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