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�й�ҩѧ��־ 2014, Vol. 49 Issue (16) :1420-1425    DOI: 10.11669/cpj.2014.16.013
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Box-Behnken���-ЧӦ�淨�Ż�Ԫ��ֹʹ˫����͸��Ƭ�Ĵ���
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1. ���ݾ����人��ҽԺҩ���ƣ��人 430070��
2.������ҽҩ��ѧҩѧԺ���人 430065��
3.����ʡ�˶��е�һҽԺҩ���ƣ� ���� �˶� 443300
LIU Hui1, ZHANG Jing1, 2, ZHANG Yun1, 2, ZOU Qing-he3
1.Department of Pharmacy, Wuhan General Hospital of Guangzhou Military Command, Wuhan 430070, China;
2. College of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065, China;
3. Department of Pharmacy, The First Hospital of Yidu City, Yidu 443300, China

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Abstract�� OBJECTIVE To optimize the formulation of Yuanhu Zhitong push-pull osmotic�� pump tablets by Box-Behnken design-response surface method. METHODS The amounts of polyoxyethylene-N750 and sodium chloride in drug layer and coating weight were selected as factors and the 12 h accumulative drug release and fitting degree of release curves were selected as indexes, respectively. The effects of different factors on drug release were investigated by establishing multivariate linear model, and response surface of second order polynomial model was drawn to determine and validate the optimum formulation. RESULTS The second order polynomial model was the best fitting model. The optimum prescription was as follows: 88 mg of polyoxyethylene-N750 in drug layer and 27 mg of sodium chloride in drug layer per tablet and 7.7% of coating weight. The 12 h cumulative release and fitting degree r2 of drug releases of imperatiorin of three batches of optimized products were 78.68%, 79.01%, 78.93% and 0.985 2, 0.982 8, 0.991 8, respectively. The 12 h cumulative release and fitting degree r2 of drug releases of tetrahydropalmantin of three batches of optimized products were 79.12%, 78.96%, 79.35% and 0.984 7, 0.990 2, 0.985 8, respectively. The preparation was proved good in stability by influential factor test, accelerated test and long-term test. CONCLUSION The Box-Behnken design-response surface method can be used to optimize the formulation of Yuanhu Zhitong push-pull osmotic pump tablets.
Keywords�� Yuanhu Zhitong push-pull osmotic pump tablet,   Box-Behnken design,   response surface method,   stability tests     
�ո�����: 2014-09-03;
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LIU Hui-, ZHANG Jing-, etc .Optimization of Yuanhu Zhitong Push-Pull Osmotic Pump Tablets Formulation Using Box-Behnken Design-Response Surface Method[J]  Chinese Pharmaceutical Journal, 2014,V49(16): 1420-1425
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[1] i>Ch.P(2010) Vol II(�й�ҩ��2010���.����). 2010: 525. MALATERRE V, OGORKA J, LOGGIA N, et al. Approach to design push-pull osmotic pumps. Int J Pharm, 2009, 376(1-2): 56-62. VERMA R K, KRISHNA D M, GARG S. Formulation aspects in the development of osmotically controlled oral drug delivery systems . J Controlled Release, 2002, 79(3): 7-27. MALATERRE V, METZ H, OGORKA J, et al. Benchtop-magnetic resonance imaging (BT-MRI) characterization of push-pull osmotic controlled release system . J Controlled Release, 2009, 133(1): 31-36. LI J, YIN R L, LI D F, et al. Optimization of microporosity osmotic pump tablet prescription of total alkaloids from corydalis decumbens by central composite cesign-response surface methodology . China J Exp Tradit Med Form(�й�ʵ�鷽��ѧ��־), 2012, 18(16): 49-53. WU X J, LIU W N, WANG J, et al. Preparation of nefopam hydrochloride controlled porosity osmotic pump by central composite design . J Shenyang Pharm Univ(����ҩ�ƴ�ѧѧ��), 2009, 26(11): 863-867.
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