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2 - hydroxypropyl -β-cyclodextrin prepared insoluble drug powder on the

Author: ZhangYongXin
Tutor: HeZhongGui
School: Shenyang Pharmaceutical University
Course: Pharmaceutical preparations
Keywords: 2 - hydroxypropyl -β - cyclodextrin (HPCD) Cinnarizine Meloxicam Pharmacokinetics
CLC: R94
Type: Master's thesis
Year: 2005
Downloads: 235
Quote: 0
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Abstract

Objective: cinnarizine , meloxicam as a model drug , study 2 - hydroxypropyl -β-cyclodextrin (HPCD) inclusion solubilization of insoluble drugs , do not add the organic solvent , the preparation of injection powder injection, optimize clinical application . Method: UV spectrophotometric determination at different pH values ??, the amount of different HPCD model drug solubility in water , to determine the possible destination formulations prepared inclusion complex stability constants and solubility isotherm method . Prescription screening and process investigated using in and prepared liquid, prepare two injectable powder for injection with a freeze- drying method . X- ray diffraction , differential scanning calorimetry and infrared spectroscopy to identify the inclusion complex . To establish a HPLC method for quality and stability test of two powder for injection , respectively . Reference to the guiding principles of chemical drugs irritant , allergic , and hemolytic technical preparation for injection safety evaluation . Meloxicam , for example , three groups of rabbits were intravenous injection of different amounts of the cavity of HPCD, (0 , the amount of powder for injection prescription proportion , the proportion of 20 times the prescription amount ) and the same amount of meloxicam meloxicam (0.5mg/kg), visits HPCD vivo kinetics of drugs . Determined by HPLC drug serum concentrations and pharmacokinetic parameters were calculated with 3P87 program . Results : HPCD solubilization of insoluble drugs effect a significant concentration of 10mg/mL (pH 3) makes of cinnarizine Merlot meloxicam 5mg/mL ( pH 8) . The prepared two freeze-dried powder specifications : injection Cinnarizine 20mg / support injection the meloxicam 7.5mg / branch ; visits of the quality indicators , as well as the stability of the results of the experiment are in line with the Chinese Pharmacopoeia on requirements for injection powder for injection ; injection security . Tests showed the drug to form inclusion complexes with HPCD . Pharmacokinetic trials , the group HPCD dose pharmacokinetic parameters , by t test there was no significant difference ( P > 0.05 ) . Conclusion: The resulting powder injection preparation safe, effective, stable and controllable quality . The with HPCD amount does not affect meloxicam pharmacokinetics in rabbits .

2 - hydroxypropyl -β-cyclodextrin prepared insoluble drug powder on the

Abstract

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