| Object:Ta zhi head wind side consists of two herbs, gastrodia, angelica dahurica, migraine treatment, good clinical curative effect. In order to make the drug bypass the blood brain barrier, direct central, play a better curative effect, made them in situ gels. This task useing the modern pharmaceutical technology, study preparation process, quality standard, nasal cilia toxicity of the preparation, for the development of drug for migraine novel drug delivery system to lay a solid foundation, and provide reference for later study traditional Chinese medicine (TCM) in situ gels.Methods:Using single factor and orthogonal test method, with the Gastrodine content and dry paste rate as indicators of gastrodia elata were examined by the extraction process, with the Imperatorin content and dry paste rate index is investigated for the extraction process of angelica dahurica. Using single factor method were investigated respectively macroporous resin purification Gastrodine, Imperatorin; Inspection the molding process with index of gastrodia elata, Imperatorin content; Using HPLC to determine the content of Gastrodine and Imperatorin,take methodology research.; Adopt aecelerating test and Long term test investigated the stability of the test produet;In vivo toad palate model method to evaluate Ta zhi nasal gel effect on cilia clearance function, using evaluation method for the rabbit eye irritant experiment Ta zhi nasal mucosa stimulating gels.Result:The gastrodia extraction process:gastrodia impregnated60%ethanol, soak for3h, reflux extraction twice,2hours every time, for the first time and alcohol quantity of8.2times, the second time and alcohol quantity is8times, filtering and collecting filtrate;The angelica dahurica extraction process:angelica dahurica mpregnated80%ethanol mix evenly, swelling, after30min loading diacolation container, add80%ethanol to stand for24h, collected8times the amount diacolation drops with2ml/min speed; Gtrodiae purification technology:Percolation liquid vacuum to remove ethanol alcohol flavor, add water dilute to per ml contains0.8g crude drugs, regulating PH8.0, as the column of liquid, in1-2BV/h velocity of adsorption, use1BV distilled water washing, abandon,then use6BV5%ethanol elution with the velocity of3～4BV/h, collect the eluent, decompression recycled eluent to remove ethanol alcohol flavor; angelica dahurica ethanol purification technology:decompression recycled (temperature60℃, the vacuum degree is0.08～0.1Mpa) to per ml contains0.2g crude drugs, as on a column of liquid,with3BV/h velocity of adsorption,6BV washing with distilled water first, again with10%ethanol washing until washing liquid colorless, again with80%ethanol8BV according to flow velocity for3～4BV/h elution, collect the eluent, decompression recycled the eluent (temperature60℃, the vacuum degree is0.08～0.1Mpa)to remove ethanol alcohol flavor; Enrichment process:pick up prescriptions of gastrodia elata purification liquid and angelica dahurica purification liquid blending, and decompression recycled eluent to remove ethanol alcohol flavor(temperature60℃, vacuum-0.08～0.1Mpa), extract relative density is1.10～1.20; Molding process:pick up prescriptions of Ta zhi extract adding0.15%sodium bisulfite,0.5%Dand mixtures,5%to acetyl gellan gum to add suitable amount of deionized water, heated to90℃dissolve, add8%polysorbate-80,5.0%C, fully dissolved, mixed solution, the mixture is added to the mixture solution, fully stirring, add in deionized water to total amount finally;The TLC is clear and have good separation,negative non-interferenee, Gastrodine content of In situ gels is not less than25.8mg, Imperatorin content of In situ gels is not less than8.9mg;The results of toxicity Preliminary evaluation showed that In situ gels nasal cilium toxicity is small, almost no irritant.Conclusion:Ta zhi nasal in situ gel preparation technology is reasonable and reliable, quality control method is feasible, safe and worthy of further in-depth study. |
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