| 蚂蟥冻干粉针的制备及质量研究 |
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| 引用本文： | 钟山,杨得坡,崔征.蚂蟥冻干粉针的制备及质量研究[J].时珍国医国药,2009,20(11). |
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| 作者姓名： | 钟山 杨得坡 崔征 |
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| 作者单位： | 1. 中山大学药学院,广东,广州,510080
2. 沈阳药科大学中药学院,辽宁,沈阳,110016 |
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| 基金项目： | 广东省自然科学基金项目 |
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| 摘 要： | 目的 制备蚂蟥冻干粉针并建立其质量控制方法 .方法 筛选赋形剂的种类和用量,得出最佳处方和制备工艺;以高效液相色谱(HPLC)法测定蚂蟥多肽(whitmanin)的含量,并以此作为主要指标考察制剂质量.另通过长期实验考察其稳定性.结果 使用5%甘露醇作为赋形剂效果较好;含量测定中平均加样回收率为99.8%(RSD = 1.8%);其室温留样12个月稳定性良好.结论 所制蚂蟥冻干粉针处方合理,制备工艺可行,质量可控.
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| 关 键 词： | 蚂蟥 冻干粉针 蚂蟥多肽 制备工艺 |
Study on the Preparation Technique and Quality of Mahuang Freeze-dried Sterile Injection Powder |
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| ZHONG Shan,YANG De-po,CUI Zheng.Study on the Preparation Technique and Quality of Mahuang Freeze-dried Sterile Injection Powder[J].Lishizhen Medicine and Materia Medica Research,2009,20(11). |
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| Authors: | ZHONG Shan YANG De-po CUI Zheng |
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| Abstract: | Objective To prepare Mahuang freeze - dried sterile injection powder and establish a quality control for this drug. Methods The best formulation and preparation technique of the powder for injection was optimized by screening the variety and quantity of whitmanin. The contents, which were determined by HPLC, were taken as the main indexes to study the quality. The stability was observed through test. Results Taking the 5% mannitol as excipient,the mean recovery result was 99. 8% (RSD = 1.8%), and the preparation was stable after 12 months storage at room temperature. Conclusion The formulation is reasonable, the preparation technique is feasible and the quality is controllable. |
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| Keywords: | Leech Sterile injection powder Whitmanin Preparation technique |
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