Vancomycin hydrochloride medicine composition and method for preparing vancomycin hydrochloride medicine composition

Abstract

The invention discloses a vancomycin hydrochloride medicine composition and a method for preparing the same. The vancomycin hydrochloride medicine composition comprises 10-60% of vancomycin hydrochloride, 30-90% of matrixes and 0-10% of lubricants, and preferably comprises 30-40% of vancomycin hydrochloride, 50-70% of matrixes and 2-8% of lubricants. The matrixes are one or two types of PEG (polyethylene glycol) 1000-6000, stearic acid and poloxamer 188, and the lubricants are one or two types of micro-powder silica gel, talc powder, sodium stearyl fumarate, sodium dodecyl sulfate and magnesium stearate. The vancomycin hydrochloride medicine composition can be in one of dosage forms of soft capsules, hard capsules and tablets. The vancomycin hydrochloride medicine composition and the method have the advantages that components in the vancomycin hydrochloride medicine composition are easily matched with one another, and medicines are high in stability; hot melting technologies are adopted in the method for preparing the vancomycin hydrochloride medicine composition, processes for producing the vancomycin hydrochloride medicine composition are simple, can be implemented conveniently and quickly, are stable and can be scaled up advantageously, and service dosage forms of the vancomycin hydrochloride can be broadened.

Description

technical field [0001] The invention relates to a vancomycin hydrochloride pharmaceutical composition and a preparation method thereof, belonging to the technical field of pharmaceutical preparations and preparation methods thereof. Background technique [0002] Pseudomembranous colitis is caused by Clostridium difficile (Clostridium difficile), which infects more than 700,000 people in the United States every year. Once "Clostridium difficile" infects the lining of the large intestine, the toxin it produces can cause Severe diarrhea, large intestine inflammation and even death, and the infection rate of this strain has been increasing year by year, and in recent years, it often occurs in hospitals, nursing centers, communities and other places. Currently the only treatment for pseudomembranous colitis is oral vancomycin hydrochloride recommended by the FDA. [0003] The mechanism of action of vancomycin hydrochloride is to exert a quick-acting bactericidal effect by inhibi...

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Problems solved by technology

[0004] In the prior art, there have been some reports related to vancomycin hydrochloride preparations. In the report, vancomycin hydrochloride exists as an injection, but the injection needs to be dissolved in water to be prepared into a solution for use, and it causes severe pain during intramuscular injection. Phlebitis can be caused at the injection part during intravenous injection, and characteristic symptoms such as extreme skin flushing and erythema appear on the back of the neck, upper limbs and upper body of the human body during rapid intravenous infusion; Vancomycin hydrochloride exists in the dosage form of liquid capsules. When vancomycin hydrochloride exists in the dosage form of liquid capsules, it needs to cooperate with diluents, solvents, antioxidants and surfactants. The ingredients are more complicated and the steps of the preparation process are more. Among them, the uniformity of dissolution and mixing of vancomycin hydrochloride is very important, especially when the high-pressure emulsification method is adopted, the uniform emulsification of vancomycin hydrochloride is very important, so the dosage form of vancomycin hydrochloride is limited

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