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| 药用氯化丁基橡胶塞对不同pH注射剂不溶性微粒的影响 | |
| 引用本文： | 郭丙炎,黄宇,彭清,邱蓓.药用氯化丁基橡胶塞对不同pH注射剂不溶性微粒的影响[J].中国药业,2009,18(14):43-44. |
| 作者姓名： | 郭丙炎 黄宇 彭清 邱蓓 |
| 作者单位： | 1. 湖南省湘潭市药品检验所,湖南湘潭,411100 2. 湖南省湘潭市食品药品监督管理局,湖南湘潭,411100 3. 湖南一格制药有限公司,湖南湘潭,411100 |
| 摘 要： | 目的考察药用氯化丁基橡胶塞对不同pH注射剂不溶性微粒的影响。方法以光阻法测定样品的不溶性微粒。结果pH大于10的注射剂与药用氯化丁基橡胶塞接触后，每1mL样品中≥10μm和≥25μm的不溶性微粒均有显著性增加（P〈0．05）；与覆膜药用氯化丁基橡胶塞接触后，pH大于10的注射剂中不溶性微粒无显著增加（P〉0．05）。结论为避免氯化丁基橡胶塞对不溶性微粒的影响，应使用覆膜药用氯化丁基橡胶塞。 |
| 关 键 词： | 酸碱度 药用氯化丁基橡胶塞 注射剂 不溶性微粒 |
Study of Effect of Medicinal Chlorinated Butyl Rubber Stoppers on Insoluble Micro-Particles in Injections with Different pH Values |
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| Guo Bingyan,Huang Yu,Peng Qing,Qiu Bei.Study of Effect of Medicinal Chlorinated Butyl Rubber Stoppers on Insoluble Micro-Particles in Injections with Different pH Values[J].China Pharmaceuticals,2009,18(14):43-44. | |
| Authors: | Guo Bingyan Huang Yu Peng Qing Qiu Bei |
| Institution: | 1. Xiangtan Institute for Drug Control, Xiangtan, Hunan, China 411100; 2. Hunan Xiangtan Food and Drug Administration, Xiangtan, Hunan, China 411100; 3. Hunan Yige Pharmaceutical Co., Lid., Xiangtan, Hunan, China 411100) |
| Abstract: | Objective To study the effect of medicinal chlorinated butyl rubber stoppers on insoluble micro-particles in the injections with different pH value. Methods Insoluble micro- particles were determined by light- blockage method. Results In the injection with pH values more than 10, after contacting with medicinal chlorinated butyl rubber stoppers, insoluble micro-particles ≥ 10 μm and ≥25 μm in 1 mL sample increased obviously compared with those without contacting. But, contacting with film- coated medicinal chlorinated butyl rubber stoppers did not cause significant increase of insoluble micro-particles in the injections with pH value more than 10（P 〉 0. 05）. Conclusion The contact with medicinal chlorinated butyl rubber stoppers causes obvious increase of insoluble micro- particles in the injections with pH value more than 10. To avoid it, film- coated medicinal chlorinated butyl rubber stoppers are recommended. |
| Keywords: | pH medicinal chlorinated butyl rubber stoppers injection insoluble micro - particles |
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