| 蟾酥脂质微球注射液的制备及其灭菌稳定性 |
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| 引用本文： | 王涛,李芳,姜维刚,何海冰,唐星. 蟾酥脂质微球注射液的制备及其灭菌稳定性[J]. 沈阳药科大学学报, 2008, 25(4): 249-254 |
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| 作者姓名： | 王涛 李芳 姜维刚 何海冰 唐星 |
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| 作者单位： | 1. 沈阳药科大学药学院,辽宁,沈阳,110015
2. 沈阳红期制药有限公司,辽宁,沈阳,110179 |
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| 摘 要： | 目的研究蟾酥脂质微球注射液的处方工艺并考察制剂的灭菌稳定性。方法采用两级高压均质法制备蟾酥脂质微球注射液,分别考察油相组成、乳化剂用量、pH、灭菌方式对制剂灭菌稳定性的影响。结果采用质量分数为10.00%的油相[注射用中链脂肪酸甘油酯(MCT)与注射用大豆油(LCT)等比例混合],质量分数为1.20%的豆磷脂,质量分数为0.06%的油酸钠,均质前调节pH6.5,采用100℃旋转水浴灭菌30 min,制备所得的蟾酥脂质微球注射液在灭菌后仍保持良好的物理化学稳定性。结论粒子界面荷电性、空间位阻作用、pH、灭菌方式是影响蟾酥脂质微球注射液的物理化学稳定性的重要因素。
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| 关 键 词： | 蟾酥 脂质微球注射液 处方 制备 灭菌稳定性 |
| 文章编号： | 1006-2858(2008)04-0249-06 |
| 收稿时间： | 2007-04-29 |
| 修稿时间： | 2007-04-29 |
Preparation and stability towards sterilization of Venenum Dufonis lipid microsphere for injection |
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| WANG Tao,LI Fang,JIANG Wei-gang,HE Hai-bing,TANG Xing. Preparation and stability towards sterilization of Venenum Dufonis lipid microsphere for injection[J]. Journal of Shenyang Pharmaceutical University, 2008, 25(4): 249-254 |
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| Authors: | WANG Tao LI Fang JIANG Wei-gang HE Hai-bing TANG Xing |
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| Affiliation: | 1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016，China;2. Shenyang hongqi pharmaceutical Co. Ltd. ,Shenyang 110179,China |
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| Abstract: | Objective To optimize the formulation and the preparation process of Venenum Dufonis lipid microsphere for injection and investigate the stability of various formulations towards sterilization. Methods A two stage pressure homogenizer was used to prepare Venenum Dufonis lipid microsphere for injection. The effects of oil phase，emulsifier，pH and sterilization method on the stability of lipid microsphere were investigated separately. Results The optimal formulation was LCT-MCT（1∶1, w total =10 %）,1.2 % soybean lecithin and 0.06% oleate sodium. pH was adjusted to 6.5 before homogenization. Finally, Venenum Dufonis lipid microsphere for injection was sterilized for 30 min in rotating water-bath at 100 ℃ and exhibited good stability after the procedure of sterilization. Conclusion Physiochemical stability of LM is affected by surface charge，stereospecific blockade，pH and sterilization. |
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| Keywords: | Venenum Dufonis；lipid microsphere injection；formulation；preparation sterilization stability |
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