| 第 51 卷第 4 期 |  | Vol. 51 No. 4 | | 2021 年 8 月 | Aug 2021 |
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所屬欄目：醫藥及中間體
注射用尼可地爾的凍干工藝研究 |
| 劉 璽，邢建峰*
（西安交通大學(xué) 藥學(xué)院，陜西 西安 710061） |
| 摘 要：研究了注射用尼可地爾的處方及凍干生產(chǎn)工藝。采用單因素實(shí)驗方法，以?xún)龈煞坩槃┑男誀�、pH、含量及有關(guān)物質(zhì)等為考察指標，對處方中賦形劑的類(lèi)型、用量、pH范圍及凍干工藝參數進(jìn)行篩選及優(yōu)化。獲得了優(yōu)化處方及凍干工藝：制備規格為12 mg的注射用尼可地爾，甘露醇作為賦形劑，加入量為18 mg，pH范圍為6.5~7.5，選擇2次退火，退火溫度為-15 ℃，退火保持時(shí)間為2 h，制備的凍干粉針劑成型性好、易復溶。該制劑處方工藝設計合理，工藝路線(xiàn)可行，為注射用尼可地爾的處方及工藝篩選提供借鑒。 |
| 關(guān)鍵詞：注射用尼可地爾；處方；工藝研究；凍干；穩定性 |
| 中圖分類(lèi)號：O657 文獻標識碼：A 文章編號：1009-9212（2021）04-0013-04 |
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| Freeze-drying Technology for the Preparation of Injection-nicorandil |
| LIU Xi, XING Jian-feng*
(School of Pharmacy, Xi'an Jiaotong University, Xi'an 710061, China) |
| Abstract：The formulation and freeze-drying process of nicorandil used for injection were studied. Single factor experiment was used to optimize the excipient type, dosage, pH range and parameters for freeze-drying process. The optimal formulation and freeze-drying process were as followings: in 12 mg of nicorandil for injection, 18 mg of mannitol was used with a pH range between 6.5 and 7.5; a second annealing method was selected with a temperature of -15 ℃ and an annealing holding time of 2 h. The freeze-dried powder for injection has good formability and is easy to redissolve. The formulation process of the preparation is reasonable and feasible. This study provides a basis for the prescription and process screening of nicorandil for injection． |
| Key words：nicorandil for injection; prescription; formulation and preparation technique; freeze-drying; stability |
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基金項目：國家自然科學(xué)基金項目（81973253，81773663）。
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作者簡(jiǎn)介：劉 璽（1984—），女，陜西西安人，工程師，主要從事制劑研發(fā)及藥物分析工作（E-mail：404465438@qq.com）。
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聯(lián) 系 人：邢建峰，博士，教授，研究方向：新型藥物遞送系統研究研究與應用。
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收稿日期：2021-07-13
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