本文選題：間苯三酚 + 薄膜衣片��； 參考：《中國(guó)新藥雜志》2017年17期

【摘要】：目的:制備具有氧化穩(wěn)定性間苯三酚薄膜衣片,并建立相應(yīng)的質(zhì)量控制方法。方法:通過(guò)加入抗氧劑和薄膜衣阻隔的雙重方法增加間苯三酚口服片劑的穩(wěn)定性,經(jīng)正交設(shè)計(jì)擬訂處方組成,篩選出符合要求的處方與制備工藝,采用高效液相色譜法測(cè)定間苯三酚含量,并通過(guò)影響因素試驗(yàn)考察間苯三酚薄膜衣片的穩(wěn)定性。結(jié)果:按照優(yōu)化出來(lái)的最佳處方及工藝制備的試樣品,其質(zhì)量及溶出度均合格。結(jié)論:制劑處方合理,制備工藝簡(jiǎn)單可行,產(chǎn)品溶出及穩(wěn)定性良好,質(zhì)量可控。
[Abstract]:Objective: to prepare mesoglucinol thin film with oxidative stability and establish a quality control method. Methods: the stability of oral mesoglucinol tablets was increased by adding antioxidant and membrane barrier. The prescription composition was formulated by orthogonal design, and the prescription and preparation process were selected. The content of phloroglucinol was determined by high performance liquid chromatography (HPLC), and the stability of phloroglucinol film was investigated by influence factor test. Results: the quality and dissolution of the samples were up to standard. Conclusion: the formulation is reasonable, the preparation process is simple and feasible, the dissolution and stability of the product are good, the quality is controllable.
【作者單位】： 中國(guó)人民解放軍第一六一醫(yī)院藥劑科;國(guó)家納米藥物工程技術(shù)研究中心;華中科技大學(xué)同濟(jì)醫(yī)學(xué)院附屬梨園醫(yī)院;
【分類號(hào)】：R943

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