WEI Zhongming, MO Donghai, HUANG Qibin, DING Xueying. Gemcitabine hydrochloride thermosensitive gel injection preparation and contents determination[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(1): 36-40. doi: 10.3969/j.issn.1006-0111.2016.01.010
| Citation:
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WEI Zhongming, MO Donghai, HUANG Qibin, DING Xueying. Gemcitabine hydrochloride thermosensitive gel injection preparation and contents determination[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(1): 36-40. doi: 10.3969/j.issn.1006-0111.2016.01.010
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Gemcitabine hydrochloride thermosensitive gel injection preparation and contents determination
- 1.
Guilin Pavay Gene Pharmaceutical Cor. Ltd, Guilin 541004, China
- 2.
Department of Clinical Pharmacy, Shanghai First People's Hospital, Shanghai Jiao Tong University, Shanghai 200080, China
- Received Date: 2014-09-12
- Rev Recd Date:
2015-07-09
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Abstract
Objective To prepare gemcitabine hydrochloride thermosensitive gel injection and to stablish the determination 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.
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