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Bupleurum ie type gel nasal spray developed

Author: ChenEn
Tutor: JiangXinGuo；ZhuJianHua；ZhangQiZhi；ChenJun；JiangJianWei
School: Fudan University
Course: Pharmacy
Keywords: Radix Bupleuri Nasal delivery system In situ gel Poloxamer Carbopol Fever cooling Pharmacodynamics cAMP
CLC: TQ461
Type: Master's thesis
Year: 2008
Downloads: 60
Quote: 0
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Abstract

Radix Bupleuri is the umbelliferae bupleurum plant’s root or the entire grass. It is clinically used in treating the upper respiratory tract infection, pneumonia, flu and many other fever symptoms. In situ gel is refers to a kind of preparation prepared and given by the solution condition, and with the changement of the physiological environment of administration position, the phase changes and forms a gelatinous semi-solid preparation. Because it is with merits of both solution and gel, it has a broad application prospect in the research of drug carrier field. This article prepared the bupleurum chinensis volatile oil into the environment-sensitive nasel in situ gel. And made a comprehensive research on composition of prescription, preparation industry, nasal cavity irritation, pharmacodynamics and so on.The first part of this article choosed Poloxamer 407 (P407) as a temperature-sensitive in situ gel material. Evaluated the relationship between gelling temperature and different concentrations of P407 by adding PEG4000 to regulate the gelling temperature of P407. The results indicated that 20% P407 and 6% PEG4000 solution displayed trans-phase character under 30℃. The temperature was slightly lower than that in the intra-nasal. So, it is suitable for nasal administration. Rheological results showed that with the increase of shear rate , the viscosity of P407 solution showed a downward trend which was a pseudoplastic fluid characteristic. Corrosion tests showed that the gel dissolution in the body influenced by the contact area, cilia movement frequency, the content of the enzyme in nasal cavity and whether it was in the state of pathological state. The traditional toad palate mucosal ciliotoxicity test showed that the gel system had less affection to cilia, and the cilia’s sustained campaign time was similar to the normal saline group.The second part of this article prepared a Bupleurum nasal spray which was temperature-sensitive in situ gel, And to evaluate its quality, used water vapour distillation technology to extract Bupleurum volatile oil.Used clarify and ciliotoxicity to indicate the evaluation and make orthogonal experiment to screening Compound solvent to make volatile oil solubilization.The results showed that 10%Pharmasolve, 2% Tween-80 had significant effects on the solubilization of volatile oil and the cilia toxicity was little. Established a UV spectrophotometry to measure the content of volatile oil in samples.In vitro experiments showed that the in situ gel preparation release slowly compared to the solution one. It could achieve the purpose of long-term releasing. Using caproic acid content as the evaluation index, established the gas chromatography to evaluate the quality of preparation. Long-term tests showed that the preparation had good stability.The third part of this article prepared a Bupleurum pH-sensitive in situ gel nasal spray, and to evaluate its quality, used Carbopol 940 as the pH-sensitive gel materials, and used HPMC E50 to adjust its adhesive strength. The results showed that when the pH raise to the physiological condition, the viscosity significantly increased; Inspected the buffer capacity of the nasal cavity,the result showed that 0.05mol/L phosphate buffer solution had the same buffer capacity with the nasal cavity. The water hold and rheological test showed that the in situ gel system was suitable for nasal administrationThe fourth part of this article established a rabbit-fever model to evaluate the effects of two kinds of in situ gel preparations. The sesults showed the solution group reached the best cooling effect 5h after administration,but the effects decreased significantly after 6h. The solution group and the in situ gel group had almost the same effect in the first 5h after administration. But Compared to the solution group, the effective time of in situ gel could be extended to 24h.It indicated that Radix Bupleuri nasal in situ gel had a higher medical effect and a longer effective time; Established a rabbit rhinitis models to inspecting the pharmacodynamics in pathological state. The results showed that the pharmacodynamics was degrade in pathological state; organization inspect and toxicity cilia tests showed that the preparationg had good security.The fifth part of this article established a method of rabbit cerebrospinal fluid continuous acquisition to measure the concentrations of cAMP in the cerebrospinal fluid by method of radioimmunoassay. The results showed that concentrations of cAMP in cerebrospinal fluid and increasing temperature of ET fever rabbit was positively correlated (r = 0.9435, P <0.05). After given temperature-sensitive in situ gel 6h later, the concentrations of cAMP in cerebrospinal fluid of ET rabbits were significantly lower than those in the spray group. It confirmed that temperature -sensitive Bupleurum in situ gel applied in the nasal sprays had a longer residence and release time.

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