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ZHAO Jing, CAO Hong, XING Jun-bo. The fingerprint analysis on Chuanshentong injection by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(2): 137-139. doi: 10.3969/j.issn.1006-0111.2013.02.016
Citation:
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
Gemcitabine hydrochloride thermosensitive gel injection preparation and contents determination
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
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.
Cascium S, Craziano F, Catalana G. Chemotherapy for ad-vanced pancreatic cancer: It may no longer be ignored [J]. Ann Oncol,1999,10(1):105.
[2]
Saif MW.A new developments in the treatment of pancreatic cancer[J]. Highlights from the “ 44th ASCO Annual Meet-ing”.Chicago,IL,USA.May 30-June 3,2008.JOP 2008, 9:391-397.
[3]
Tanaka M,Javle M,Dong X, et al.Gemcitabine metabolic and transporter gene polymorphisms are associated with drug toxicity and efficacy in patients locally pancreatic cancer [J]. Cancer,2010,116(22):5325-5335.
[4]
Vervenne W,Bennouna J,Humblet Y,et al.A randomized, double blind,placebo controlled multicenter phase III trial to evaluate the efficacy and safety of adding bevacizumab to erlo-tinib and gemcitabine in patients with metastatic pancreatic cancer[J].J Clin Oncol,2008,26(suppl):4507.
[5]
Okino H, Maeyama R, Manabe T. Trans-tissue, sustained release of gemcitabine from photo cured gelatin gel inhibits the growth of heterotopic human pancreatic tumor in nude mice[J].Cli Cancer Res.2003,9 (15):5786-5793.
[6]
Rosemurgy AS,Serafini FM. New directions in systemic therapy of pancreatic cancer [J]. Cancer Control, 2000,7 (5):437-51.
[7]
Howell SB.Clinical applications of a novel sustained-release injectable drug delivery system: DepoFoamTM technology[J].Cancer J 2001,7(3):219-227.
[8]
Kim YJ, Kim SW. Controlled drug delivery from injectable biodegradable triblock copolymer [M]. Washington:Ameri-can Chemical Society,2003:300-311.
[9]
Jeong B,Bae YH.Biodegradable block copolymers as inject-able drug-delivery systems [J]. Nature,1997, 388 (6645): 860-862.
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.
ZHAO Jing, CAO Hong, XING Jun-bo. The fingerprint analysis on Chuanshentong injection by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(2): 137-139. doi: 10.3969/j.issn.1006-0111.2013.02.016
Citation:
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
Cascium S, Craziano F, Catalana G. Chemotherapy for ad-vanced pancreatic cancer: It may no longer be ignored [J]. Ann Oncol,1999,10(1):105.
[2]
Saif MW.A new developments in the treatment of pancreatic cancer[J]. Highlights from the “ 44th ASCO Annual Meet-ing”.Chicago,IL,USA.May 30-June 3,2008.JOP 2008, 9:391-397.
[3]
Tanaka M,Javle M,Dong X, et al.Gemcitabine metabolic and transporter gene polymorphisms are associated with drug toxicity and efficacy in patients locally pancreatic cancer [J]. Cancer,2010,116(22):5325-5335.
[4]
Vervenne W,Bennouna J,Humblet Y,et al.A randomized, double blind,placebo controlled multicenter phase III trial to evaluate the efficacy and safety of adding bevacizumab to erlo-tinib and gemcitabine in patients with metastatic pancreatic cancer[J].J Clin Oncol,2008,26(suppl):4507.
[5]
Okino H, Maeyama R, Manabe T. Trans-tissue, sustained release of gemcitabine from photo cured gelatin gel inhibits the growth of heterotopic human pancreatic tumor in nude mice[J].Cli Cancer Res.2003,9 (15):5786-5793.
[6]
Rosemurgy AS,Serafini FM. New directions in systemic therapy of pancreatic cancer [J]. Cancer Control, 2000,7 (5):437-51.
[7]
Howell SB.Clinical applications of a novel sustained-release injectable drug delivery system: DepoFoamTM technology[J].Cancer J 2001,7(3):219-227.
[8]
Kim YJ, Kim SW. Controlled drug delivery from injectable biodegradable triblock copolymer [M]. Washington:Ameri-can Chemical Society,2003:300-311.
[9]
Jeong B,Bae YH.Biodegradable block copolymers as inject-able drug-delivery systems [J]. Nature,1997, 388 (6645): 860-862.
ZHAO Jing, CAO Hong, XING Jun-bo. The fingerprint analysis on Chuanshentong injection by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(2): 137-139. doi: 10.3969/j.issn.1006-0111.2013.02.016
ZHAO Jing, CAO Hong, XING Jun-bo. The fingerprint analysis on Chuanshentong injection by HPLC[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(2): 137-139. doi: 10.3969/j.issn.1006-0111.2013.02.016
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