兰索拉唑冻干粉针制备工艺及稳定性研究

doi:10.5246/jcps.2018.06.045

中国药学(英文版) ›› 2018, Vol. 27 ›› Issue (6): 442-450.DOI: 10.5246/jcps.2018.06.045

• 【研究论文】 • 上一篇

兰索拉唑冻干粉针制备工艺及稳定性研究

陆振宇¹, 徐蓉^1*, 戴巍², 林晶², 沈忱¹

1. 杭州康恩贝制药有限公司, 浙江杭州 310052
2. 杭州东祥医药科技有限公司, 浙江杭州 310051

收稿日期:2018-03-28 修回日期:2018-04-15 出版日期:2018-06-30 发布日期:2018-05-10
通讯作者: Tel.: +86-13588108593, E-mail: luke_63@163.com

Preparation and stability study of lansoprazole for injection

Zhenyu Lu¹, Rong Xu^1*, Wei Dai², Jing Lin², Chen Shen¹

1. Hangzhou CONBA Pharmaceutical CO., LTD, Hangzhou 310052, Zhejiang, China
2. Hangzhou DONGXIANG Medical science and Technology Co., Ltd. Hangzhou 310052, Zhejiang, China

Received:2018-03-28 Revised:2018-04-15 Online:2018-06-30 Published:2018-05-10
Contact: Tel.: +86-13588108593, E-mail: luke_63@163.com

摘要/Abstract

摘要：

研究兰索拉唑冻干粉针的制备方法, 并对其进行质量稳定性考察。运用冷冻干燥技术制备注射用兰索拉唑, 结合制剂的外观和稳定性考察结果, 证明该制备工艺的可行性。经过小试和中试放大生产的实践验证, 确定了以甘露醇为骨架剂、葡甲胺为增溶剂和pH稳定剂、氢氧化钠为pH调节剂组成的处方及其冻干粉针的制备工艺。该制备工艺合理, 质量可控, 产品稳定性好, 所制备的兰索拉唑冻干粉针能够满足制剂学及临床需要。

关键词: 兰索拉唑, 冻干粉针, 制备工艺, 稳定性考察

Abstract:

In the present study, we aimed to assess the preparation method of sterile lansoprazole powder for injection, as well as its quality and stability. By cryodesiccation technology in combination with the control of its quality and stability, the optimal formulation and preparation route were screened. Through small-scale and pilot-scale production validation, the formulation and preparation route were confirmed, in which mannitol was used as skeletal matter, meglumine was used as solubilizer and pH stabilizer, and sodium hydroxide was used as pH regulator. The formulation and preparation route were reasonable, showing good quality control and stability and fitting the pharmaceutical and clinical need.

Key words: Lansoprazole, Freeze-drying, Preparation route, Stability study

中图分类号:

R943

Supporting:

陆振宇, 徐蓉, 戴巍, 林晶, 沈忱. 兰索拉唑冻干粉针制备工艺及稳定性研究[J]. 中国药学(英文版), 2018, 27(6): 442-450.

Zhenyu Lu, Rong Xu, Wei Dai, Jing Lin, Chen Shen. Preparation and stability study of lansoprazole for injection[J]. Journal of Chinese Pharmaceutical Sciences, 2018, 27(6): 442-450.

参考文献

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[2] Xu, H.; Yu, L.P.; Wen, J.; Zhao, W.; Huang, Y.D.; Li, X.K. The study of lansoprazole against experimental gastric ulcer effect. Chin. J. Pathol. 2002, 18, 698-700.

[3] Zhou, T.X. Clinical observation of lansoprazole in the treatment of reflux esophagitis. Chin. J. Clin. Rational. Drug Use. 2008, 1, 74-75.

[4] Wang, S.S. The effect of lansoprazole in the treatment of duodenal bleeding. China Med. Herald. 2011, 8, 66-67.

[5] Zhou, A.J.; Xu, F.Z.; Hu, Y. Clinical study of lansoprazole in the treatment of duodenal ulcer. J. Clin. Med. Pract. 2008, 12, 49-50.

[6] Xue, R.H. Observation of lansoprazole in the treatment of Helicobacter pylori positive duodenal ulcer. Chin. Med. J. Commun. 2005, 19, 454-455.

[7] Jian, W.J.; Li, G. Lansoprazole injection in the treatment of upper gastrointestinal hemorrhage curative effect observation. Northwest Pharm. J. 2008, 23, 320-321.

[8] Wei, X.L.; Dai, X.B.; Jiang, N.; Ma, L. Lansoprazole injection in the prevention and treatment of stress ulcer hemorrhage clinical observation. Hebei Med. J. 2011, 33, 2461-2462.

[9] Sun, S.Q.; Zhang, Z.Y.; Li, X.X.; Zhang, Y.S.; Tang, G.D.; Zhu, Xuan.; Zhu, R.M.; Wang, Q.; Zhang, F.X. Clinical experiment report of treating duodenal ulcer and hemorrhage with Lansoprazole for injection. Anhui Med. Pharm. J. 2008, 12, 955-957.

[10] Cao, Y.A.; Liu, L.C.; Ji, T.Q.; Liu, Y.L. The preparation, quality control and stability of lansoprazole injection were investigated. Chin. J. Pharm. Anal. 2009, 9, 1510-1513.

[11] He, X.J.; Chen, G.; Ding, X.F. Safety evaluation of lansoprazole for injection. Acad. J. Guangdong Coll. Pharm. 2005, 21, 163-166. The Japanese Takeda Lansoprazole for Injection listed instructions.

[12] Lansoprazole for Injection Japan Takeda dispensatory.
[13] Lansoprazole for Injection FDA dispensatory.

兰索拉唑冻干粉针制备工艺及稳定性研究

Preparation and stability study of lansoprazole for injection

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