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Study on High Concentration Praziquantel Injection

Author: LiuFen
Tutor: XueFeiQun;JiangShanXiang
School: Nanjing Agricultural College
Course: Basic Veterinary Science
Keywords: PZQ injection HPLC Quality Control Irritant Pharmacodynamics
CLC: S859
Type: Master's thesis
Year: 2009
Downloads: 26
Quote: 0
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Abstract


Preparation of praqiquantel injection and its detection methods, stability and pharmacodynamics were studied in this paper.1 Preparation of high concentration Praziquantel injectionAccording to the physico-chemical properties and biological characteristics of praziquantel, through analysis and comparison of different medicinal materials and solvent properties,use the orthogonal experimental design and uniform method of experimental design, prepared in propylene glycol as the main raw materials and other complex solvent, plus a small amount of stabilizer and the high concentration of cosolvent praziquantel non-water injection and process optimization, identified preparation for praziquantel injection to provide a basis for mass production.To establish two HPLC method for determining the content of PZQ in the injection.The DIKMA Diamonsil C18 (4.6×250,5μm) Column was adopted.The mobile phase was V (methanol):V (water) and V (acetonitrile):V (water), the detective wavelength was 263nm and 210nm,the flow rate was 1mL/min.The two method were both linear within (r=0.9998/0.9996).The mean recovery was 100.38% and 99.90%, RSD=1.13% and 1.1%(n=9).They turned out to be convienient method with good precision.These results showed that two methods both could be used to determine the content of PZQ in the injection.2 Quality Control of praziquantel injectionPraziquantel injection nearly colorless to light yellow oily liquid clarity, pH value of 3.5-4.5, UV-Vis spectrophotometer statutory identification:the praziquantel control and praziquantel injection reference substance have the same maximum absorption wavelength. HPLC method determinede the praziquantel content of praziquantel injection, the results show that:the marked percentage of praziquantel injection was 100.51%, RSD was 0.303%, in line with the preparation requirements.3 Study on The Stability of Praziquantel Injection at High ConcentrationTo study the stability of the 20% praziquantel injection in this paper, according to the new veterinary drugs to report to a higher authority technique guide,put 3 batch semi-works production at 40℃, humidity 75% in drug stability test chamber,6 months sequence, detect the external appearance、content、pH in every month, the result turned out,this external appearance characteristics and clarity were without change, the effective constituent didn’t obviously decrease,the pH is stable on the whole process,the injection stability is within requirement.4 study on the Pharmacodynamics and irritation of Praziquantel injection20% of self-Study praziquantel injection irritating on the part of New Zealand white rabbits by intramuscular injection, mainly by observing whether or not arising from the injection site swelling, hyperemia, exudation, degeneration or necrosis, such as evaluation of local reactions. The results showed that the injection site after preparation would produce a certain degree of muscle damage, but minor lesions, after a period of time to restore its own, does not affect the clinical application.The treatment test of mice artificial infected with Schistosoma japonicum by a new Praziquantel injection of 200mg/ml were carrled out. And three doses administered to the experimental therapy of Schistosoma japonicum in mice on the day 28 after infection with cercariae. The results showed that the praziquantel injection reached perfect therapy efficacy with the female reduction rate of 100% and the worm reduction rate of 97%,The effects obviously better than the control group.There were no pathological change of inflammation and necrosis at the administration site after a single intramuscular injection in mice. Therefore,the praziquantel injection would have a brilliant future in therapy of Schistosoma japonicum in animals.

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CLC: > Agricultural Sciences > Livestock, animal medicine,hunting,silkworm,bee > Animal Medicine ( Veterinary Medicine) > Veterinary Pharmacology
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