Lactose for injection and preparation method thereof

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...

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

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