摘要
目的制备萘普伪麻双层缓释片并研究体外释药行为。方法采用固体分散技术,以羟丙甲纤维素为缓释骨架,二次压片制备萘普伪麻双层缓释片;并考察盐酸伪麻黄碱释放度的影响因素和释药特性。结果制备的萘普伪麻双层缓释片,萘普生钠在0.5h的溶出量大于85%,盐酸伪麻黄碱在0.5h的累积释放百分率20%～40%,2h为40%～60%,6h为60%～80%,8h为70%～90%,12h在90%以上。盐酸伪麻黄碱从缓释层释放行为符合Higuchi方程。结论制备的萘普伪麻双层缓释片具有明显的速释和缓释作用特征。
Abstract
OBJECTIVE To prepare naproxen sodium(NPS-Na) and pseudoephedrine hydrochloride(PSE-HCl) bilayed sustained-release tablets and study its release behavior in vitro.METHODS Naproxen sodium and pseudoephedrine hydrochloride bilayed sustaineded-release tablets were prepared by the solid dispersion method and twice compressing method using HPMC as the matrix material.The factors influencing on the release of PSE-HCl from matrix tablets and drug release characteristics were studied. RESULTS The PSE-HCl releasing rate from the sustained-layer followed the Higuchi equation. NPS-Na released more than 85% in 0.5 h,while PES released 20%～40% in 0.5 h,40%～60% in 2 h,60%～80% in 6 h, 70%～90% in 8 h and more than 90% in 12 h.CONCLUSION Naproxen sodium and pseudoephedrine hydrochloride bilayed sustained-release tablets exhibite sustained-release and rapid release characteristics in vitro.
关键词
盐酸伪麻黄碱 /
萘普生钠 /
双层缓释片
{{custom_keyword}} /
Key words
pseudoephedrine hydrochloride /
naproxen sodium /
bilayed sustained-release tablets /
solid dispersion
{{custom_keyword}} /
张涛;余春梅;蒲道俊;陈兰;邓履红.
萘普伪麻双层缓释片的制备及其体外释药行为研究[J]. 中国药学杂志, 2006, 41(23): 1799-1803
ZHNG To;YU Chun-mei;PU Do-jun;CHEN Ln;DENG Lu-hong.
Studies on Preparation of Naproxen Sodium and Pseudoephedrine Hydrochloride Bilayed Sustained-Release Tablets and Their Release Behavior in Vitro[J]. Chinese Pharmaceutical Journal, 2006, 41(23): 1799-1803
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] ChP Clinical Medication Information-Pharmaceutical Chemicals and Biologic Product(2005)(中华人民共和国药典临床用药须知——化学药和生物制品卷)[M] . Beijing： People’s Medical Publishing House，2005： 703-704.
[2] CHENG X Q，JING Y Y，TANG G.Modern Materia Medica(新编药物学)[M] .15th.ed. Beijing： People’s Medical Publishing House，2005：191-192.
[3] XIE Q C，LU Z F. Preparation of pseudoephedrine hydrochloride sustained release tablets[J] .Acad J Guangdong Coll Pharm(广东药学院学报)，2004，20(2)：112-116.
[4] PLATT，CHRIS. Timed release tablet comprising naproxen and pseudoephedrine： United States，5，859，060 [P] . 1999-01-12.
[5] LIKAR M D，MANSOUR H L，HARWOOD J W. Development and validation of a dissolution test for a once-a-day combination tablet of immediate-release cetirizine dihydrochloride and extended-release pseudoephedrine hydrochloride[J] .J Pharm Biomed Anal，2005，39：543-551.
[6] SUN Y，CHEN Z，SHI Y W，et al. Preparation of cetirizine and pseudoephedrine sustained-release tablets and their in vitro release behavior[J] .Prog Pharm Sci(药学进展)，2004，28(12)： 555-557.
[7] LIU H，BI D Z，WANG C L. Preparation of the compound sustained-release tablets of Yumameifen and study on the release mechanism of three drugs from the sustained-release tablets[J] .J Shenyang Pharm Univ(沈阳药科大学学报)，2004，21(1)：11-14.
[8] GU J，TU X D，YAN L L，et al. Studies on the bilayed sustained release compound tablet of ibuprofen and pseudoephedrine hydrochloride[J] .J Chin Pharm Univ(中国药科大学学报)，1996，27(12)：7l1-7l7.
[9] KENNETH C，WATERMAN，MICHAEL B，et al. Press-coating of immediate release powders onto coated controlled release tablets with adhesives[J] .J Controlled Release，2003，89(3)：387-395.
[10] CHO，PHILIP W K. Extended release oral dosage composition：United States，6，709，676[P] .2004-03-23.
[11] U.S.FDA.Approvals-March 2004[EB/OL] .http：//www.fda.gov/cder/ogd/approvals/ap0304.htm.
[12] ZHANG Z B，LIU S W，YANG Q，et al. Preparation of compound pseudoephedrine hydrochloride sustained-release inay tablets and its release in vitro[J] .West Chin J Pharm Sci(华西药学杂志)，2005，20(1)：18-20.
[13] Ch.P(2005) Vol(中国药典2005年版.二部)[S] .2005：73-75.
[14] ZHANG T，YANG Y，PU D J，et al. Study on the factors influencing tramadol hydrochloride release from matrix tablets[J] .Chin Pharm J(中国药学杂志)，2005，40(20)：1565-1569.
[15] KATIKANENI P R，UPADRASHTA S M，NEAU S H，et al. Ethylcellulose matrix controlled release tablets of a water-soluble drug[J] . Int J Pharm，1995，123(1)：119-125.
[16] ZHANG T，CHEN L，PENG Q N，et al. Influence of controlled release film-coating on release of tramadol hydrochloride controlled release tablets [J] .J Chin Pharm Univ(中国药科大学学报)，2005，36(4)：311-315.
[17] MAKHIJA S N，VAVIA P R.Controlled porosity osmotic pump-based controlled release systems of pseudoephedrine I. Cellulose acetate as a semipermeable membrane[J] .J Controlled Release，2003，89(1)：5-18.
[18] CHIDAMBARAM N，PORTER W，FLOOD K，et al. Formulation and characterization of new layered diffusional matrices for zero-order sustained release[J] .J Controlled Release，1998，52(1-2)：149-158.
[19] LU B.New Techniques and New Dosage Forms of Drugs(药物新剂型与新技术)[M] . 2th.ed.Beijing： People’s Medical Publishing House，2005：1-25.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
