Gemcitabine hydrochloride thermosensitive gel injection preparation and contents determination
10.3969/j.issn.1006-0111.2016.01.010
- VernacularTitle:吉西他滨温敏凝胶注射剂的制备及其含量测定
- Author:
Zhongming WEI
1
;
Donghai MO
;
Qibin HUANG
;
Xueying DING
Author Information
1. 桂林华诺威基因药业有限公司
- Keywords:
gemcitabine hydrochloride;
PLGA-PEG-PLGA;
thermosensitive gel;
content determination
- From:
Journal of Pharmaceutical Practice
2016;(1):36-40
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare gemcitabine hydrochloride thermosensitive gel injection and to stablish the determina‐tion methods of its contents .Methods Gemcitabine hydrochloride thermosensitive gel injection was prepared using PLGA‐PEG‐PLGA as thermosensitive viecle .The contents of gemcitabine hydrochloride were determined by HPLC .Results The formulation contained 40 mg/ml gemcitabine and 20% (wt) PLGA‐PEG‐PLGA with phase‐transition temperature of (37 ± 0 .15) ℃ ,showing the best viscosity around human body temperature .Gemcitabine hydrochloride presented a good linearity in the range of 5‐500 μg/ml(r=0 .999 8) ,which had good precision and reproducibility .The recovery rate of low ,middle and high concentrations of gemcitabine hydrochloride were (99 .5 ± 3 .2)% ,(100 .4 ± 2 .4)% ,(102 .1 ± 2 .4)% ,n=3 ,respectively . The average contents of gemcitabine hydrochloride in three batches of sample were (101 .87 ± 2 .95)% ,(99 .4 ± 2 .73)% , (98 .98 ± 0 .71)% ,n=3 ,respectively .Conclusion The quality of gemcitabine hydrochloride thermosensitive gel injection with PLGA‐PEG‐PLGA as matrix could be controlled .It is a promising new drug for pancreatic cancer .
