| 硫普罗宁葡萄糖注射液处方及工艺的研究 |
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| 引用本文： | 周光树,黄顺旺. 硫普罗宁葡萄糖注射液处方及工艺的研究[J]. 安徽医药, 2009, 13(9): 1023-1025 |
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| 作者姓名： | 周光树 黄顺旺 |
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| 作者单位： | 安徽省立友谊医院药剂科,安徽,合肥,230011;安徽省药物研究所,安徽,合肥,230022 |
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| 摘 要： | 目的研究硫普罗宁葡萄糖注射液的制备工艺。方法对抗氧剂和金属螯合剂用量、pH值、活性炭用量和灭菌条件进行了筛选。用高效液相色谱法测定硫普罗宁的含量和有关物质。结果加入0．05％甲硫氨酸和0．01％依地酸钙钠，调pH值在3．5～4．5，加入0．03％的活性炭，115℃热压灭菌30min。制剂质量符合药典有关注射剂的质量标准。结论本品制备工艺可靠，适于工业化生产，质量可控。
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| 关 键 词： | 硫普罗宁 制备工艺 注射剂 |
Preparative process of tiopronin and glucose injection |
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| ZHOU Guang-shu,HUANG Shun-wang. Preparative process of tiopronin and glucose injection[J]. Anhui Medical and Pharmaceutical Journal, 2009, 13(9): 1023-1025 |
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| Authors: | ZHOU Guang-shu HUANG Shun-wang |
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| Affiliation: | ZHOU Guang-shu1,HUANG Shun-wang2(1.Dept of Pharmacy,Anhui Provincial Friendship Hospital,Hefei 230011,2.Anhui Institute of Materia Medica,Hefei 230022) |
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| Abstract: | Aim To study the preparative process of tiopronin and glucose injection. Methods In the experiment, the ratio of antioxidant and metal chelate compound, pH, the ratio of activated charcoal to preparative solution in volume and sterlization condition experiment were selected respectively. Tiopronin content and ito related substances were determined by HPLC. Results The optimal conditions were established as follows： methionine 0.05% ,calcium disodium edetate 0.01% ,pH adjusted to 3.5 -4.5,0.03% activated charcoal add- ed, press heat sterlization at 115℃ for 30 min. The quality of the injection thus prepared conformed to the standard for injection in Chi- nese pharmacopoeia. Conclusion The preparation of tiopronin and glucose injection is reliable and suitable for industrial manufacture. Its quality can be controlled. |
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| Keywords: | tiopronin preparative process injection |
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