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Pharmaceutical Study on Flunarizine Hydrochloride Orally Disintegrating Tablets

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Tutor: LiuJunHong
School: Qingdao University of Science and Technology
Course: Biochemical Engineering
Keywords: flunarizine hydrochloride,orally disintegrating tablets,prescription design,disi
CLC: R94
Type: Master's thesis
Year:  2007
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Abstract:
Flunarizine hydrochloride is a selective calcium antagonist, which is the onlycalcium antagonist through blood brain barrier It prevents cellular calcium overload byreducing excessive transmembrane calcium influxes. It could expand vascular smoothmuscle and significantly improve cerebral circulation and coronary artery circulation, and preventembrittlement of blood vessel.It has little side effect and extensive clinical application. Comparewith other similar medicine,this type of orally disintegrating tablets offers theadvantage of taking with ease,good compliance of patients.There is no domesticresearch report about flunarizine hydrochloride orally disintegrating tablets.Prescription selection, preparation process and quality study of flunarizinehydrochloride orally disintegrating tablets were carried out in our research. As a result,flunarizine hydrochloride orally disintegrating tablets with good quality wereproduced, and conducted the quality research to settle a foundation for preparation ofsafety, effective and quality-controlled flunarizine hydrochloride orally disintegratingtablets; Finally the preliminary stability research of flunarizine hydrochloride orallydisintegrating tablets were studied and the most important influence factor to thestablility were obtained.The prescription of flunarizine hydrochloride orally disintegrating tablets madein our work is as follows: flunarizine hydrochloride, 5.9%; microcrystalline cellulose,25.0%;cross-linked polyvidone,5.0%;mannitol,48.0%; lactose ,12.0%;aerosil, 1.0%;french chalk,1.75%; magnesium stearate ,0.35%; sodium cyclamate, 1%.The preparation process of flunarizine hydrochloride orally disintegrating tabletsis as follows: comminuting, mixing and sifting of active and inactive ingredients;pressing directly tables under 3kg pressure to produce flunarizine hydrochloride orally disintegrating tablets.In this topic, the quality study contain characters, identification and examinationof dissolution, relative substances, microorganism limit and assay. According to theguide of preparation quality study for chemistry medicine, methodology studies ofidentification, examine of relative substances and assay were carded out to establishexamining methods with high accuracy, speciality and sensitivity.In this topic, we conducted the preliminary stability research on producedflunarizine hydrochloride orally disintegrating tablets. The main content was:influence factor experiment, acceleration test as well as long-term test. Theexperiment indicated that the humidity is the primary factor to affect the preparationstablility, and experiments obtained its critical relative humidity. The work settle afoundation for deposited condition of flunarizine hydrochloride orally disintegratingtablets.
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