本文選題：雷貝拉唑鈉 + 腸溶微丸��； 參考：《中國(guó)藥房》2016年04期

【摘要】：目的:制備雷貝拉唑鈉腸溶微丸。方法:采用擠出滾圓-流化床包衣法制備雷貝拉唑鈉腸溶微丸。以微丸休止角、收率及釋放度為指標(biāo),以微晶纖維素、甘露醇、乳糖加入量和聚乙二醇6000(PEG6000)水溶液的濃度為因素,采用正交試驗(yàn)篩選微丸丸芯的最優(yōu)處方。以含量和釋放度為指標(biāo),篩選隔離層包衣增質(zhì)量;以耐酸力和釋放度為指標(biāo),篩選腸溶層包衣增質(zhì)量。對(duì)最優(yōu)處方工藝進(jìn)行驗(yàn)證,比較其與市售腸溶片和膠囊的耐酸力和釋放度。結(jié)果:丸芯最優(yōu)處方為微晶纖維素30%、甘露醇20%、乳糖15%、PEG6000水溶液的濃度15%,雷內(nèi)拉唑鈉10%,隔離層包衣增質(zhì)量為10%,腸溶層包衣增質(zhì)量為10%;所制3批樣品的丸芯休止角為16.93~17.17°、收率為65.24%~67.36%、樣品含量為96.7%~99.9%,耐酸力為99.66%~99.85%、30 min釋放度為90.13%~93.62%;與市售腸溶片和腸溶膠囊的耐酸力相當(dāng),釋放度介于二者間。結(jié)論:成功制得雷貝拉唑鈉腸溶微丸,且質(zhì)量穩(wěn)定、可控,制備工藝簡(jiǎn)單。
[Abstract]:Objective: to prepare Rabeprazole sodium enteric pellets. Methods: Rabeprazole sodium enteric pellets were prepared by extrusion round-fluidized bed coating method. The optimal formulation of microcrystalline cellulose, mannitol, lactose and PEG6000) solution was studied by orthogonal test, taking the angle of repose, yield and release degree of pellet as the index, and the concentration of microcrystalline cellulose, mannitol, lactose and PEG6000) as the factors. With the content and release degree as the index, the coating quality of the isolation layer was screened, and the acid tolerance and the release degree were used as the indexes to screen the coating quality of the intestinal coated layer. The optimum prescription process was verified and compared with that of enteric coated tablets and capsules. Results: the optimum formulation of the pill core was as follows: microcrystalline cellulose 30, mannitol 20, lactose 15 and PEG6000 water concentration 15, Reneprazole sodium 10, isolation coating 10, intestinal dissolved coating 10, the core angle of the three samples 16.9317.17 擄. The yield was 65.24 and 67.36.The content of the sample was 96.70.99. 9, and the acid tolerance was 99.6685 and 99.85. The release rate for 30 min was 90.13and 93.62um, which was comparable to the acid tolerance of the enteric-coated tablets and enteric-coated capsules sold on the market. The release rate was between the two. Conclusion: Rabeprazole sodium enteric pellets are successfully prepared, with stable quality, controllable quality and simple preparation process.
【作者單位】： 中國(guó)藥科大學(xué)藥學(xué)院;
【基金】：江蘇省高等學(xué)校大學(xué)生創(chuàng)新創(chuàng)業(yè)訓(xùn)練計(jì)劃項(xiàng)目(No.J1030830)
【分類(lèi)號(hào)】：TQ463

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