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Study on the Intelligent Thermosensitive Gel Nasal Mucosal Drug Delivery Systems of Breviscapine

Author: YaoQiaoYan
Tutor: DengShuHai
School: Shandong University
Course: Pharmaceutical Engineering
Keywords: Breviscapine HP-β- cyclodextrin Sustained-release Thermosensitive gel Nasal drug delivery system
CLC: R94
Type: Master's thesis
Year: 2009
Downloads: 76
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Abstract

Breviscapine purpose of this research project, select the active ingredients of traditional Chinese medicine (breviscapine) as a model drug the molecular inclusion technique made inclusion complex, intelligent gel as a carrier, made breviscapine intelligent temperature-sensitive coagulation plastic nasal drug delivery system. Phase transformation occur immediately after the nasal administration in a liquid state, liquid state into a semi-solid gel state, the nasal absorption directly into the brain tissue, explore breviscapine for cerebrovascular disease of the brain targeted therapeutic purposes, has important scientific value and clinical practical significance. Cardiovascular and cerebrovascular disease is a serious threat to human health and the life of the common diseases and frequently-occurring, high mortality rate. Breviscapine particularly cardiovascular diseases have a unique effect in the treatment of cerebrovascular disease, can increase cerebral blood flow, anti-platelet aggregation, improve cerebral blood circulation to promote the absorption of hematoma and edema and improve neurological function concern. Easily oxidized due breviscapine photolabile; are poorly water-soluble and fat-soluble, almost insoluble in water and organic solvents, the oral absorption difficulties, the bioavailability is very low; fast in vivo elimination half-life is short. The clinical application of oral tablet bioavailability is very low, to affect efficacy; injection due to the short half-life, multiple injections administered in patients with poor compliance. The modern pharmaceutical preparations of new technologies, new materials, the study made a new dosage form, explore a new route of administration, and reach the brain targeted drug delivery for therapeutic purposes is of great significance. Established ultraviolet spectrophotometry and HPLC determination Breviscapine HP-β-cyclodextrin inclusion complex as well as in situ gel delivery system content, the method is simple, sensitive, and accessories do not interfere with the content of the main drug, a linear relationship good (r = 0.9999), precision is higher the (intraday precision RSD% less than 1.07%, inter-day precision RSD% less than 2.93%), the recovery rate is high (greater than 99.8%, RSD% less than 1.02%) results are accurate and reliable, suitable for the determination of the content of this product. Select saturated aqueous solution prepared breviscapine HP-β-cyclodextrin inclusion complex single factor based on the solubility of breviscapine Evaluation orthogonal design to optimize screening breviscapine HP-β- cyclodextrin inclusion complex formulation and preparation process; the the cold prepared Breviscapine HP-β-cyclodextrin inclusion complex, thermosensitive gel nasal drug delivery systems, intelligent 32 ℃ situ condensate glue solidification time for evaluation index screening breviscapine sustained release gel the best prescription composition and process; vitro release percentage determination breviscapine HP-β-cyclodextrin inclusion complex gel using dynamic membrane dialysis method, using The mathematical model of the zero-order kinetics, first-order kinetics and Higuchi equation analysis of in vitro release kinetics; preliminary observation visits sustained release gel retention samples by impact factor test, accelerated testing and room temperature stability. Results breviscapine HP-β-cyclodextrin inclusion complex prescription process: breviscapine 2g, HP-β-cyclodextrin 2g EDTA-2Na 0.1g water bath temperature of 50 ℃, stirring speed 800r / min, stirring time 2h; breviscapine situ gel prescription composition and process: Poloxamer 407 15.5g Bre-HP-β-CD-INCP solution (2.5%) 80ml Nipagin 0.2g hydrogen sodium oxide solution was adjusted to pH 6.4 Purified water to 100mL. The Bre-HP-β-CD-INCP-TISG the in vitro release complies with biphasic kinetic equation, the equation for the 1-Q = 0.91916e ^{-0.1021t 0.55294e ^{-0.0371t (r _α = 0.99695; r _β = 0.99454). The Bre-HP-β-CD-INCP-TISG is kinetically stable system 3000r/min under centrifugal 30min no obvious change in appearance; illumination test showed, and the main light on the appearance of a Bre-HP-B-CD-INCP-TISG drug content greater impact; show that the high-temperature test, the Bre-HP-β-CD-INCP-TISG gelatinous Bre have a protective effect, but Bre content or slightly lower; accelerated testing to prove, at 40 ℃ in the course of the long-term placement, Bre-HP-β-CD-INCP-TISG significant stratification, significantly reduced the total amount of drug, gelling temperature increased significantly. Therefore, Bre-HP-β-CD-INCP-TISG should not be placed in a light, high temperature preservation. Leave sample test results to prove The Bre-HP-β-CD-INCP-TISG in 4 ℃ refrigerator more stable, three months after the appearance of the total amount of drugs and gelling temperature did not change. Conclusion Breviscapine intelligent the thermosensitive gel nasal drug delivery system in vitro release slowly, basically reached the requirements of the experimental design, because of the time, still need the in vivo distribution of pharmacokinetic studies.}}

Study on the Intelligent Thermosensitive Gel Nasal Mucosal Drug Delivery Systems of Breviscapine

Abstract

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