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gastrodin (4-(hydroxymethyl) phenyl-P-D-Glucopyranoside) possess the effects of hypnosis, sedation, anticonvulsion, anti-epileptic, neuroprotection, anti-free radical and membrane protection. It has good clinically therapeutic effects on hypertension, coronary heart disease, vertigo, headache, insomnia, stroke, dyspepsia, etc. c Gastrodine injection, gastrodine tablets, gastrodine capsule dosage preparation formulations have been used commonly on the market at present. These dosage forms systemic distribution after administration, which have low blood concentration in local action to not achieve good treatment effect and low bioavailability due to the lack of tissue specificity and targeting. The dispersible tablet is taken more conveniently, more rapid dissolution and higher bioavailability. Prescription and technology of the dispersible tablet are same with tablet. The auxiliary materials used are most of the domestic production and supply. Therefore, dispersible tablet is a promising dosage forms. The prescription process, preparation stability and establishment of the content determination method have been researched in this study.Firstly, preformulation, dissolution, content and related substances determination had studied. The formulation and preparation process of gastrodin were explored by using orthogonal test, in which the best prescription and preparation process were established according to disintegration time. Three batches of gastrodin dispersible tablets were produced in best prescription and preparation process and evaluated by disintegration time and dissolution. The results showed that formulation was reasonable and preparation technology was stable.The quality standard including character, identify, dissolution, related substances and content determination method was established to ensure the quality reliable and controlled of gastrodin dispersible tablet. The rational prescriptions, rapid disintegration, good dissolution of gastrodin dispersible tablet were proved through comparing with gastrodin tablets in market.Finally the stability of gastrodin dispersible tablets was investigated in detail which including stress testing with strong light, high temperature and humidity which proved that gastrodin dispersible tablets meet terms except the slight rose of related substance which suggested that it should be preserved in confined and dry space. Meanwhile, related substance of gastrodin dispersible tablets had some rise but below mandatory standard through acceleration test and except that nothing had changed, which suggested that properties of the products are stable with keeping time extention. Therefore, the period of validity of gastrodin dispersible tablets was made with12months.What’s more, three sale-up experiments for gastrodin dispersible tablets were examined with the quality standard. The result showed that its appearance, weight difference, hardness, friability, dispersible uniformity, dissolution and content reached the standards of Chinese pharmacopoeia. It indicated that the preparative technology had a high recurrence and the product quality was easily controlled in this study, so that it could be industrially produced.In conclusion, this study lay a foundation of industrial product of gastrodin dispersible tables and provides systematic research methods for the preparation of dispersible tables, which have important significance in theoretical guide and practical application value.
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