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发明公开
CN107308127A 双氯芬酸钠多单元缓释微丸片 审中-实审

双氯芬酸钠多单元缓释微丸片
摘要：
本发明涉及药物制剂领域，具体涉及一种双氯芬酸钠多单元缓释微丸片，其由双氯芬酸钠缓释微丸和填充辅料压片而成，其中双氯芬酸钠缓释微丸是由含药丸芯通过非水溶性可供药物渗透的聚合物膜包衣制成，膜中还含有水溶性的聚合物，双氯芬酸钠缓释微丸包衣增重10%-30%，填充辅料为微晶纤维素、玉米淀粉、乳糖、交联聚维酮、交联羧甲基纤维素钠、羧甲基淀粉钠、羟丙甲纤维素、聚维酮、硬脂酸、硬脂酸镁、胶体二氧化硅和滑石粉中的一种或几种，其中填充辅料占总片重40%-60%。该双氯芬酸钠缓释微丸片可以在消化液中迅速崩解成独立的微丸小单元，这些微丸单元可以在胃肠道中达到12h缓释的效果。
摘要（英）：

The invention relates to the field of medicinal preparations, in particular to a diclofenac sodium multi-unit sustained-release micro-pill. The diclofenac sodium multi-unit sustained-release micro-pill is formed by tabletting a diclofenac sodium sustained-release micro-pill and a filling auxiliary material, the diclofenac sodium sustained-release micro-pill is prepared by coating a drug-containing pill core with a water insoluble polymer film for drug permeation, and a water soluble polymer is also contained in the film, so that the weight of the coated polymer is increased by 10-30 percent; the filling auxiliary material is one or more of microcrystalline cellulose, corn starch, lactose, cross-linked povidone, cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, hydroxypropyl methylcellulose, povidone, stearic acid, magnesium stearate, colloidal silicon dioxide and talcum powder, and occupies 40-60 percent of the total pill weight. The diclofenac sodium sustained-release micro-pill can be quickly disintegrated into separate small micro-pill units in digestive fluid, and the micro-pill units can reach a 12-hour sustained release effect in a gastrointestinal tract.

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