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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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Executive Summary

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.

Full-text Catalog

Abstract     3-4
ABSTRACT     4-8
the first chapter of literature review     8-14
1.1 Vecuronium bromide     8-9
1.1.1 vecuronium ammonium physical and chemical properties and overseas development R \u0026 D    
1.1.2 Vecuronium bromide mechanism of action and clinical applications     8-9
1.1.3 vecuronium pharmacokinetics dynamics     9
1.2 freeze-drying technology     9-12
1.2.1 freeze-drying history     9-10
1.2.2 lyophilized principle is     10
1.2.3 pre-freeze and heat treatment     10-11
1.2.4 pre-freezing speed     11
1.2.5 sublimation process of heating     11
1.2.6 sublimation process in vacuum     11-12
1.2.7 sublimation period of time     12
1.3 This study is the meaning and content of     12-14
1.3.1 Significance     12
1.3.2 research     12-14
quality of the API     14-29
2.1 Instruments and materials     14
2.1.1 Instrument     14
2.1.2 reagent is     14
2.2 Experimental methods and results     14-28
2.2.1 solubility test     14-15
2.2.2 Specific rotation     15
2.2.3 hygroscopicity     15-16
2.2.4 melting point determination     16
2.2.5 identify     16
2.2.6 related substances     16-21
2.2.7 residual solvents - methanol, and acetone     21-24
2.2.8 dry weight loss     24
2.2.9 acidity     24-25
2.2.10 ignition residue     25
2.2.11 heavy metal     25
2.2.12 Determination of     25-28
2.2.13 influencing factors of the drug substance test     28
2.3 Summary     28-29
injection of vecuronium preparation process     29-36
3.1 Instruments and materials     29-30
3.1.1 Instrument     29
3.1.2 Drugs and reagents     29-30
3.2 Experimental methods and results     30-35
3.2.1 formulation design and screening     30-31
3.2.2 liquid filling concentration to determine     31
3.2.3 activated carbon dosage investigated     31-32
3.2.4 and charcoal liquid storage time     32
3.2.5 decarbonization of pH, content of visits     32-33
3.2.6 freeze-dried before and after the pH investigated     33
3.2.7 lyophilized curve     33-34
3.2.8 production scale-    34-35
3.3 Summary     35-36
Chapter IV injection of vecuronium quality     36-48
4.1 Instruments and materials     36
4.1.1 Instrument     36
4.1.2 Drugs and reagents     36
4.2 Experimental methods and results     36-47
4.2.1 color identification     36-37
4.2.2 precipitation identification     37-38
4.2.3 to clarify the degree     38
4.2.4 clarity     38-39
4.2.5 insoluble particles     39
4.2.6 acidity     39
4.2.7 Loss on drying     39-40
4.2.8 related substances     40-44
4.2.9 content determination method to establish     44-46
4.2.10 Determination of content and content uniformity     46-47
4.3 Summary     47-48
vecuronium and the injection of vecuronium stability     48-52
5.1 Instruments and materials     48-49
5.1.1 Instrument     48
5.1.2 Drugs and reagents     48-49
5.2 experimental methods     49
5.2.1 raw materials     49
5.2.2 preparation     49
5.3 Results and discussion     49-51
5.3.1 raw materials     49-50
5.3.2 preparation     50-51
5.4 Summary     51-52
Chapter VI Conclusion     52-54
References     54-59
papers and to participate in the research situation description     59-60
Acknowledgements     60

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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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