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Preparation of Vecuronium Bromide for Injection

Author: WangChengGang
Tutor: ZhaoGuangRong;WangChunLong
School: Tianjin University
Course: Pharmaceutical Engineering
Keywords: vecuronium bromide injections freeze-drying content determination related substances stability
CLC: TQ463.2
Type: Master's thesis
Year: 2008
Downloads: 64
Quote: 0
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Abstract


Vecuronium bromide is a muscle relaxant used with anaesthetic, developed by Organon. It is launched as Norcuron in the Netherlands (1982).Vecuronium bromide for injection is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Due to its instability in solution,we prepared vecuronium bromide for Injection to solve the problem.After the excipients and buffer pH value of screening, the optimum formula was developed. The study also includes the CO2 removal process and the process of freeze-drying. An annealing step was applied in the freeze-drying cycle to ensure complete crystallization of mannitol. Lyophilization resulted in excellent cakes with water contents below 4%w/w. The results showed that the formula was reasonable, the technology was feasible and the quality of the product was stable. The injection was composed of mannitol, Citric Acid and sodium dihydrogen phosphate.This paper carried out vecuronium bromide quality study. The physicochemical properties, content, related substances and stability of vecuronium bromide were studied. An HPLC method was established to determine related substance of vecuronium bromide. The drugs were eluted with the mobile phase of methanol-perchloric acid solutiuon(750:250) at the flow rate of 1.0 ml?min-1 on a C18 column at 35 oC. The drugs were detected at the wavelength of 210nm. After validating, the method is convenient, rapid, accurate and reliable. An GC method was established to determine methanol and acetone.The HPLC method was established to determine related substance and content of lyophilized product. After validating, the method is convenient, rapid, accurate and reliable. The determination method established can be used the quality control of lyophilized product.The 6-month long-term stability data and accelerated stability data for three batches of vecuronium bromide and lyophilized product show that appearance, clarity of solution, pH value and purity of vecuronium bromide were no difference and related substances of vecuronium bromide had the increasing trends. Shoud conserve vecuronium bromide at low temperature.

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CLC: > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > Production of organic compounds in drug > Aliphatic compounds, drugs
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