Veterinary drug bromhexine hydrochloride soluble powder and preparation method thereof

Abstract

The invention relates to veterinary drug bromhexine hydrochloride soluble powder and a preparation method thereof, the veterinary drug bromhexine hydrochloride soluble powder is soluble powder prepared by using coated bromhexine hydrochloride as an active ingredient and matching with other pharmaceutically acceptable filler and cosolvent, and the dosage of each component is as follows: 1-2.5% of coated bromhexine hydrochloride, 8-12% of cosolvent and the balance of filler. The raw materials are prepared into high-concentration coated bromhexine hydrochloride, and then the high-concentration coated bromhexine hydrochloride is diluted and mixed, so that the content uniformity problem is effectively solved, the industrial mass production can be smoothly realized, the continuity is good, and the efficiency is high; after the raw materials are subjected to coating treatment by adopting a common water-soluble coating material, the raw materials are not in contact with the saccharide auxiliary materials any more, so that the Maillard reaction is fundamentally avoided, and the stability of the preparation is good after the preparation is placed in a long-term and accelerated manner.

Description

technical field [0001] The invention relates to a veterinary drug bromhexine hydrochloride soluble powder and a preparation method, and belongs to the technical field of medicine. Background technique [0002] Bromhexine hydrochloride, as a non-antibiotic expectorant with definite curative effect and safety, is widely used in the adjuvant treatment of human respiratory diseases at home and abroad. Bromhexine hydrochloride raw material is insoluble in water, so making soluble powder can solve its solubility problem. In 2004, bromhexine hydrochloride soluble powder has been approved for use in cattle, pigs, chickens, ducks with chronic bronchitis, asthma, etc. The treatment of sticky phlegm that is not easy to cough up. In the field of domestic veterinary drugs, there are very few related preparation products, and there is no legal standard method for the detection of this soluble powder. [0003] Bromhexine hydrochloride is a tertiary amine compound, which is prone to Maill...

AI Technical Summary

Problems solved by technology

Bromhexine hydrochloride soluble powder for livestock and poultry published by Chinese patent document CN111789817A and its preparation method and application, is to use the cosolvent of ultrafine powder and bromhexine hydrochloride of ultrafine powder to fully mix first, and then add soluble filler The product is made after mixing, increasing the solubility problem of bromhexine hydrochloride

[0005] Although the above methods solve the problems of dissolution and content uniformity to a certain extent, they cannot fundamentally eliminate the Maillard reaction between raw materials and sugar excipients

[0006] In addition, in terms of the detection of this preparation, there is no statutory detection method for the content of bromhexine hydrochloride soluble powder in CP, USP, EP, JP, IP and other domestic and foreign pharmacopoeias, and there is no relevant patent at present, only raw materials or tablets Due to the acidic co-solvent that has to be used in the formulation, the matrix effect leads to poor peak shape

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