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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2016  >  34(1): 36-40

SHEN Liru, LI Ruihong, WANG Tailiang. Simultaneous determination of peimine and peiminine in Xiaoer Baotaikang granules by HPLC-ELSD[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(4): 351-353. doi: 10.3969/j.issn.1006-0111.2016.04.017
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
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Gemcitabine hydrochloride thermosensitive gel injection preparation and contents determination

doi: 10.3969/j.issn.1006-0111.2016.01.010
  • 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
  • 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.
  • [1] 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.
    [10] 杨 梅，李井泉，汤致强。PLGA 吉西他滨缓释微球在荷胰腺 癌裸鼠体内的药动学研究[J].中国药学杂志，2010,45 (4): 295-299.
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Gemcitabine hydrochloride thermosensitive gel injection preparation and contents determination

doi: 10.3969/j.issn.1006-0111.2016.01.010
  • 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

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.

SHEN Liru, LI Ruihong, WANG Tailiang. Simultaneous determination of peimine and peiminine in Xiaoer Baotaikang granules by HPLC-ELSD[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(4): 351-353. doi: 10.3969/j.issn.1006-0111.2016.04.017
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
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