【摘要】：目的:對比不同粉碎工藝制得的熊去氧膽酸原料有關(guān)物質(zhì)及膠囊體外溶出度,篩選最佳粉碎方式。方法:采用HPLC法對不同粉碎工藝制得的原料進(jìn)行有關(guān)物質(zhì)考察,選擇有關(guān)物質(zhì)符合要求的原料制備成膠囊進(jìn)行體外溶出度評價,確定最佳粉碎工藝,并將此工藝下制得的自制品和市售品進(jìn)行一致性評價。結(jié)果:通過粉碎原料有關(guān)物質(zhì)考察及合格原料制得膠囊體外溶出度評價,得到原料最佳粉碎工藝:即采用球磨機(jī)粉碎原料3min。結(jié)合一致性評價結(jié)果,在水、pH 1.2鹽酸溶液、pH 4.0磷酸鹽緩沖液、pH 7.5磷酸鹽緩沖液四種溶出介質(zhì)中溶出曲線相似因子f_2均大于50,驗證該粉碎工藝方法可行。結(jié)論:一致性評價結(jié)果表明,采用球磨機(jī)粉碎3 min原料制得的制劑與市售品體外溶出行為一致,說明該原料最佳粉碎方法合理,自制品與原研質(zhì)量相當(dāng)。
[Abstract]:Objective: to compare the dissolution of ursodeoxycholic acid (ursodeoxycholic acid) and the dissolution of ursodeoxycholic acid (ursodeoxycholic acid) prepared by different grinding processes in vitro, and to screen the best crushing method. Methods: HPLC method was used to investigate the related substances of the raw materials prepared by different grinding processes. The capsules prepared from the raw materials which met the requirements were selected to evaluate the dissolution in vitro, and the optimum grinding process was determined. The consistency of the self-made products and the market products prepared by this process is evaluated. Results: through the investigation of the related substances of the grinding raw materials and the evaluation of the dissolution of the capsules prepared from the qualified raw materials in vitro, the optimum grinding process of the raw materials was obtained: the ball mill was used to crush the raw materials for 3 min. Combined with the results of consistency evaluation, the similarity factor f 鈮，

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