Veterinary doxycycline hydrochloride freeze-dried preparation and preparation method thereof

Abstract

The invention discloses a veterinary doxycycline hydrochloride freeze-dried preparation and a preparation method thereof, the veterinary doxycycline hydrochloride freeze-dried preparation consists of an active component of doxycycline hydrochloride and medical excipients, the medical excipients comprise lysine, sodium sulfite and polyvinyl pyrrolidone, the weight ratio of doxycycline hydrochloride to lysine is 1:0.8-1:1, the weight ratio of doxycycline hydrochloride to sodium sulfite is 1:0.01-1:0.05 and the weight ratio of doxycycline hydrochloride to polyvinyl pyrrolidone is 1:0.05-1:0.1. The preparation method comprises the steps of adding lysine, sodium sulfite and polyvinyl pyrrolidone in doxycycline hydrochloride according to the weight ratio, placing solution after the filtration in a tube antibiotics glass vial after sub-packaging treatment, carrying out semi-tamponade and vacuum freeze-drying, thereby obtaining the veterinary doxycycline hydrochloride freeze-dried preparation. The preparation can lead the pH value to achieve 8-8.33 after re-dissolution, thereby thoroughly solving the problem of lower pH value of the doxycycline hydrochloride veterinary drug; and the prepration is non-toxic and has the advantages of easy transportation, long storage time, no degeneration, good stability, very small intramuscular injection stimulation, low manufacturing cost and the like.

Description

technical field [0001] The invention relates to doxycycline hydrochloride, which is a freeze-dried preparation of doxycycline hydrochloride for animals and a preparation method thereof. Background technique [0002] Doxycycline hydrochloride belongs to tetracycline antibiotics, which has strong antibacterial properties, few drug-resistant strains, and long half-life. Veterinary medicine is clinically used to treat mycoplasma disease, colibacillosis, salmonellosis, brucellosis, anthrax, Spirochet disease, acute respiratory infection, equine gangrene, equine blight and swine mycoplasma pneumonia embolism, its therapeutic effect is effective. At present, doxycycline hydrochloride veterinary drug preparation is applied clinically with powder and tablet, but, this preparation is lower to the absorption of medicine, and marked effect is slower, and bioavailability is lower, therefore, those skilled in the art in recent years Committed to the research of injection solution to impr...

AI Technical Summary

Problems solved by technology

At present, doxycycline hydrochloride veterinary drug preparation is applied clinically with powder and tablet, but, this preparation is lower to the absorption of medicine, and marked effect is slower, and bioavailability is lower, therefore, those skilled in the art in recent years Committed to the research of injection solution to improve the bioavailability of doxycycline hydrochloride

According to the reported data, most of these veterinary medicines are compound drugs, because some of the compound drugs need to use hormone drugs, which have a great impact on the meat quality of animals. In addition, this type of compound drugs have large side effects. Strong, affecting livestock and poultry eating

Therefore, it is difficult to promote the use of

[0003] In another disclosed injection, the organic solvent used is toxic, and the disodium ethylenediaminetetraacetate used is easily complexed with calcium ions in the blood after being injected into the body, which may lead to the loss of bone calcium.

At the same time, studies have shown that the injection made of doxycycline hydrochloride has poor solution stability and is prone to oxidative deterioration.

Therefore, the injection of doxycycline hydrochloride can not be used as a drug product at present.

[0004] Although the freeze-dried preparation of doxycycline hydrochloride for human has been disclosed, but because the human body is quite different from that of animals, the revelation between human medicine and veterinary medicine is quite different, so, The lyophilized preparation of veterinary doxycycline hydrochloride is one of the important topics studied by those skilled in the art in recent years

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