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发明公开
CN101716159A 一种稳定的兰索拉唑片及其制备方法 失效 - 权利终止

一种稳定的兰索拉唑片及其制备方法
摘要：
本发明公开了一种稳定的兰索拉唑片，包括片芯、隔离衣层和肠溶衣层，其中，所述的片芯是由兰索拉唑、乳糖、预胶化淀粉、交联羧甲基纤维素钠、十二烷基硫酸钠和硬脂酸镁组成；所述隔离衣层是由欧巴代Y-1-7000、乙醇、纯化水制成；和所述肠溶衣层是由欧巴代OY-P 91S型和乙醇制成。此外，本发明还公开了该兰索拉唑片的制备方法。经人体生物利用度试验、稳定性试验以及稳定性对照试验，证明本发明兰索拉唑片生物利用度高，质量稳定。
摘要（英）：

The invention discloses a stable lansoprazole tablet. The tablet comprises a tablet core, an isolated coat layer and an enteric coat layer, wherein the tablet core consists of lansoprazole, lactose, pregelatinized starch, croscarmellose sodium, lauryl sodium sulfate and magnesium stearate; the isolated coat layer is made from Opadry Y-1-7000, ethanol and purified water; and the enteric coat layer is made from Opadry OY-P91 S-type and ethanol. In addition, the invention also discloses a preparation method of the lansoprazole tablet. Through the bioavailability test, the stability test and the stability contrast test of a human body, the lansoprazole tablet of the invention is proven to have high bioavailability and stable quality.

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