Pharmaceutical Research On Bupleurum Nasal Drops

Bupleurum chinense DC. is a well-known traditional Chinese medicine(TCM) that has been used for more than two thousand years.The results showed that some components including saikosaponin,flavonoid, essential oil and fatty acid possessed several proven pharmacological activities, including antipyretic, analgesic,hepato-protective, mild sedative and immunomodulatory effect.Bupleurum injection is a famous antipyretic preparation with a wide range of clinical apply, however, there are some drawbacks, including inconvenient administration and poor patient compliance. The study used some manufacturing methods and added appropriate excipients to prepare Bupleurum nasal drops and did its pharmaceutical research on the basis of Bupleurum injection,Objective: Combined the traditional herbs with advanced technology, the preparation technology, pharmacology and drug efficacy, quality standard and stability were studied, with a view to provide the appropriate reference to new drug application.Methods: To screen the optimal extraction, several parameters including herbal process method, extraction time and manner were studied with single factor experiment. Each sample was analyzed by gas chromatography. The peak area of volatile oil components in accept pool were used to study permeation enhancer penetration effect by horizontal diffusion cell and the vitro adhesion test was taken to screen adhesion promoter in pharmaceutical formulations with homemade vitro adhesion apparatus. Pharmacology and toxicology were carried out by doing some experiments including bullfrog cilia toxicity, rats nasal mucosa, preliminary efficacy and acute toxicity test of Bupleurum nasal drops. Based on Bupleurum injection quality standards, the analyses of Bupleurum volatile oil, aromatic water and nasal drops fingerprints were studied to establish a preliminary quality control method by gas chromatography. Stability tests were studied by investigating samples in 6 months under accelerated condition androom temperature.Results and conclusion: The optimum extraction process was:drying in 50?, the most coarse powder, the first water distillation for 6h. The formulation included identified 0.5% xanthan gum as an adhesive agent and 0.8% HP-?-CD as a penetration enhancer. The extraction and preparation process were reasonable and the active ingredients were stable. Pharmacology and toxicology experiments showed Bupleurum nasal drops was non-toxic to bullfrog cilia and rats nasal mucosa and its antipyretic effect was clear. The study established fingerprints of medicinal material, intermediate and preparation to control its quality and got quality standards draft of Bupleurum nasal drops. Stability experiments showed that Bupleurum nasal drops was stable and easily controlled.