黄潞嘉,吴琼珠.多剂量口服溶液开瓶扭矩影响因素的探究[J].包装工程,2020,41(9):81-84.
HUANG Lu-jia,WU Qiong-zhu.Factors Influencing the Cap Removal Torque of Multi-dose Oral Solution[J].Packaging Engineering,2020,41(9):81-84. |
| 多剂量口服溶液开瓶扭矩影响因素的探究 |
| Factors Influencing the Cap Removal Torque of Multi-dose Oral Solution |
| 投稿时间：2019-10-08 修订日期：2020-05-10 |
| DOI：10.19554/j.cnki.1001-3563.2020.09.012 |
| 中文关键词: 口服溶液 开瓶扭矩 质量检验 |
| 英文关键词: oral solution cap removal torque quality control |
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| 中文摘要: |
| 目的 研究对口服溶液开瓶扭矩产生影响的因素，作为制订口服溶液灌装、封盖和检验规程的理论基础。方法 运用单因素实验、独立样本t检验的研究和统计方法，对口服溶液开瓶扭矩的影响因素，即封盖扭矩、瓶盖内垫是否接触药液和封装完毕后药瓶的正立静置时间进行探究。结果 封盖扭矩在136~226 N•cm范围内时，开瓶扭矩随封盖扭矩的增大而增大；瓶盖内垫与药液接触1 h后，开瓶扭矩显著增大；以169 N•cm旋紧瓶盖后，开瓶扭矩随静置时间延长而增大。结论 口服溶液的开瓶扭矩受到多因素影响，包括封盖扭矩、瓶盖内垫与药液的接触和封瓶后的静置时间。在口服溶液的封装、检验、运输和储存中，应控制这些因素，使开瓶扭矩保持在合适范围内。除此以外，开瓶扭矩随封盖扭矩和时间变化的趋势可为生产过程的参数设置提供数据支持。 |
| 英文摘要: |
| The work aims to study the factors influencing the cap removal torque of oral solution and regard them as the theoretical basis for developing the specifications for filling, capping and test of oral solution. The above-mentioned influence factors included the capping torque, the contact between inner cap seal and solution and the duration after capping. Single-factor experiment and independent sample t-test were applied to study these influence factors. The results were as follows: Cap removal torque was increased with capping torque when capping torque was in the range of 136-226 N•cm. After the inner cap seal was in contact with solution for 1 h, the cap removal torque was increased significantly. After the cap was tightened with 169 N•cm, the cap removal torque was increased with the extended duration. In conclusion, the cap removal torque of oral solution is affected by many factors, including the capping torque, the contact between inner cap seal and solution and the duration after capping. To keep the cap removal torque in an appropriate range, these factors should be controlled during the packaging, inspection, transportation and storage of oral solution. In addition, the trend of cap removal torque varying with capping torque and duration can provide data support for the parameter setting of production process. |
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