| 引用本文: |
谷世平,段雪云,蔡权,李森,范恒.复方苦参合剂的稳定性试验研究[J].湖南中医药大学学报,2021,41(8):1211-1216[点击复制] |
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| 复方苦参合剂的稳定性试验研究 |
| 谷世平,段雪云,蔡权,李森,范恒 |
| (湖北省中医院/湖北省中医药研究院, 湖北 武汉 430061;湖北省黄石市第五医院, 湖北 黄石 435005;华中科技大学同济医学院附属协和医院, 湖北 武汉 430022) |
| 摘要: |
| 目的 研究复方苦参合剂的稳定性。方法 采用钠钙玻璃输液瓶包装，在高温（60℃）、高湿（90%±5%）、强光[（4 500±500） lx]照射下10 d；在室温自然贮存18个月；于（40±2）℃、相对湿度（75%±5%）条件下贮存6个月，按复方苦参合剂质量标准进行检测；采用观察、口尝法确定其性状；采用pH计测定pH值；比重瓶法测定相对密度；HPLC法测定含量；微生物限度检查法测定微生物限度。结果 与0月比较，影响因素试验（0、5、10 d）、加速试验（0、1、2、3、6个月）、长期试验（0、3、6、9、12、18个月）中各时间点，复方苦参合剂的性状、pH值含量、相对密度、微生物限度检查中各项指标均无明显变化（P>0.05），含量变化也在合格范围内。结论 复方苦参合剂的有效期暂定12个月，应储存于干燥阴凉处。 |
| 关键词: 复方苦参合剂 稳定性 影响因素试验 加速试验 长期试验 |
| DOI：10.3969/j.issn.1674-070X.2021.08.012 |
| 投稿时间：2020-08-10 |
| 基金项目:国家自然科学基金面上项目（81774093）。 |
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| Study on the Stability of Compound Sophorae Mixture |
| GU Shiping,DUAN Xueyun,CAI Quan,LI Sen,FAN Heng |
| (Hubei Provincial Hospital of Traditional Chinese Medicine/Hubei Province Academy of Traditional Chinese Medicine, Wuhan, Hubei 430061, China;The Fifth Hospital of Huangshi City, Huangshi, Hubei 435005, China;Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430022, China) |
| Abstract: |
| Objective To study the stability of Compound Sophorae Mixture. Methods Soda-lime glass infusion bottle was used for packaging; high temperature (60℃), high humidity (90%±5%), strong light[(4 500±500) lx] for 10 days; natural storage at room temperature for 18 months; at (40±2)℃, relative humidity (75%±5%) for 6 months; and Compound Sophorae Mixture was tested according to the quality standard of Compound Sophorae Mixture; observation, tasting method was used to determine traits; the pH value was determined by a pH meter; relative density was detected through the pyknometer method; HPLC method was used to detect the content; microbial limit test was used to determine microbial limit. Results Compared with 0 month, there were no significant changes (P>0.05) in the indicators of the traits, pH content, relative density and microbial limit inspection in each time point in influencing factor test (0, 5, 10 d), accelerated test (0, 1, 2, 3, 6 months) and long-term test (0, 3, 6, 9, 12, 18 months), and the content changes were within the qualified range. Conclusion The effective period of the Compound Sophorae Mixture is tentatively 12 months, and it should be stored in a dry and cool place. |
| Key words: Compound Sophorae Mixture stability influencing factor test accelerated test long-term test |
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