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Pharmaceutical lactose suitable for injection and preparation method thereof

A medicinal lactose, lactose technology, applied in the field of medicine, can solve the problems of restricting the application of lactose, urticaria, etc.

Active Publication Date: 2020-01-14
山东迪星生物技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is very easy to cause a series of adverse reactions such as urticaria, fever, and shock during injection, which greatly limits the application of lactose as an injection auxiliary material

Method used

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  • Pharmaceutical lactose suitable for injection and preparation method thereof
  • Pharmaceutical lactose suitable for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] 1. Preparation of medicinal lactose suitable for injection

[0057] (1) Dissolution: Put the lactose raw material into the water heated to about 40-45°C (when feeding, the weight ratio of lactose raw material to water is 1.5:1), and continue to heat the obtained lactose aqueous solution to 95-100°C , to lactose saturation;

[0058] (2) Adsorption: add medicinal activated carbon (the weight ratio of lactose aqueous solution to medicinal activated carbon is 100:0.1) to the lactose aqueous solution obtained in step (1), and heat for about 30 minutes to obtain a mixed solution of lactose and activated carbon;

[0059] (3), filtration: the mixed solution of lactose and gac obtained in step (2) is filtered through a titanium rod, and after confirming that the filtrate is clarified, the filtrate is collected to obtain a saturated aqueous solution of lactose;

[0060] (4) Crystallization: Transfer the saturated aqueous solution of lactose obtained in step (3) into a crystalliz...

Embodiment 2

[0098] The difference from Example 1 is that the weight ratio of lactose aqueous solution to activated carbon in the preparation step (2) of pharmaceutical lactose suitable for injection is 100:0.3.

[0099] The test results of this embodiment are shown in Table 1.

Embodiment 3

[0101] The difference from Example 1 is that the weight ratio of lactose aqueous solution to activated carbon in the preparation step (2) of pharmaceutical lactose suitable for injection is 100:0.5.

[0102] The test results of this embodiment are shown in Table 1.

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Abstract

The invention belongs to the field of medicines, and specifically relates to pharmaceutical lactose suitable for injection and a preparation method thereof. The inventor finds out that residual micro-proteins and other impurities in lactose can be removed by adopting a method combining activated carbon adsorption and titanium rod filtration; and then, the lactose can be purified so as to be used for injection products. That is to say, the pharmaceutical lactose suitable for injection prepared by the preparation method disclosed by the invention has a protein impurity content lower than or equal to 200 ppm; and preferably, the protein impurity content is lower than or equal to 100 ppm. Moreover, the endotoxin content in the lactose is lower than or equal to 5 EU / g; and preferably, the endotoxin content is lower than or equal to 0.5 EU / g. Thus, the pharmaceutical lactose is suitable for injection.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a medicinal lactose suitable for injection and a preparation method thereof. Background technique [0002] Lactose is a disaccharide with almost no physiological activity. It is a commonly used pharmaceutical excipient, mainly used as a filler or diluent in oral solid preparations, and also used for direct compression of oral solid preparations. It is used less in injections, but more in some freeze-dried preparations. Due to its high glass transition temperature, lactose does not crystallize during the freeze-drying process, but exists in an amorphous form, which has no damage to the main active ingredients. Therefore, in such freeze-dried preparations, lactose plays the role of "freeze-drying". Protector" role. [0003] Lactose is mainly derived from animal milk and is a subsidiary product of milk. Safety issues have become the biggest limitation for its application in pha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K9/00
CPCA61K47/26A61K9/0019
Inventor 庄贤韩王瑞云刘伦俊
Owner 山东迪星生物技术有限公司