Objective To study the tolerance of Ice Gardenia Pain Aerosol with single and multiple dosing in healthy Chinese volunteers, evaluate the safe dosing range and the highest tolerance dose of human body, and supply proof for the dose amount in Phase-Ⅱ study.
Methods Forty subjects enrolled in Ward I of a national medicine clinical experiment institute between May and September 2014 were included in this study. For single dosing experiment, 28 eligible subjects were enrolled and assigned into 5 groups to receive a single dose of 2, 6, 10, 14 and 18 puffs per time, respectively. The patient number for each group was 4, 6, 6, 6 and 6, respectively with equal number of male and female patients in each group. For the multiple dosing treatment, 12 eligible subjects were enrolled and assigned into 2 groups to receive multiple dosing of 6 and 10 puffs per time per day, respectively, for 14 days. Both the two groups had 6 male and female patients. Tolerability was evaluated by monitoring adverse events, physical examinations, laboratory tests and electrocardiogram.
Results Totally, 40 subjects were enrolled and all of them completed the study. No adverse events or severe adverse events were observed or reported. No abnormal laboratory test was reported 1 hour, 2, 4, 8, 12 and 24 hours after the treatment of single dosing, and multiple dosing group had no abnormal indexes or adverse events, either. The maximum single tolerance dose was 18 puffs per time, and a single dose of 2-18 puffs per time was well tolerated; Multiple dosing of 6 and 10 puffs per day, once a day for 14 days was well tolerated.
Conclusions Single and multiple dosing of Ice Gardenia Pain Aerosol are considered to be well tolerated by healthy Chinese volunteers. The maximum single tolerance dose is 18 puffs per time; multiple dosing of 6 and 10 puffs per day, once a day for 14 days is well tolerated. We suggest that the above dosing range can be chosen in the following Phase-Ⅱ study.
Citation：
LuoZhu, LiMei, WangYing, ShuShiqing, LiangMaozhi, MiaoJia. Phase-Ⅰ Clinical Study on the Tolerance of Ice Gardenia Pain Aerosol in Healthy Chinese Volunteers. West China Medical Journal, 2016, 31(10): 1701-1704. doi: 10.7507/1002-0179.201600468
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Copyright © the editorial department of West China Medical Journal of West China Medical Publisher. All rights reserved
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- 1. 王淑静, 吕靖. 2010年版中国药典含马钱子的中成药分析[J].中医临床研究, 2014, 6(23): 9-10.
- 2. 屈艳格, 陈军, 蔡宝昌.士的宁的研究进展[J].中国实验方剂学杂志, 2011, 17(24): 247-251.
- 3. 余翔, 邓双连.马钱子的中毒防治研究进展[J].现代医院, 2006, 6(11): 49-50.
- 4. 贾旋旋, 李文, 李俊松, 等.马钱子的毒性研究进展[J].中国中药杂志, 2009, 34(18): 2396-2399.
- 5. 过振华, 马红梅, 张伯礼.马钱子药理毒理研究回顾及安全性研究展望[J].中西医结合学报, 2008, 6(6): 645-649.
- 6. 赵引利, 何燕宁, 杨宇杰, 等.马钱子及其制剂药动学研究进展[J].中草药, 2015, 46(11): 1710-1714.
- 7. 许凤全, 冯兴华.马钱子中毒及其安全使用[J].药物不良反应杂志, 2008, 10(6): 426-428, 431.
- 8. 杨蓉, 李寅珍.口服风湿马钱片和对硫磷农药中毒一例报告及药理分析[J].中国全科医学, 2010, 13(9): 1020-1021.
- 9. 徐金华, 陈军, 蔡宝昌.马钱子碱的研究进展[J].中国新药杂志, 2009, 18(3): 213-221.
- 10. 吕佳, 袁子民, 张振秋, 等.伤科喷雾剂中士的宁的体外透皮吸收[J].中国实验方剂学杂志, 2011, 17(8): 15-17.
- 11. 杨春光, 张令君, 李湘玲, 等.不同透皮促进剂对马钱子碱体外透皮吸收的影响[J].中南药学, 2014, 12(9): 882-884.
- 12. 李磊, 陈军, 蔡宝昌.马钱子总生物碱中其他生物碱对马钱子碱体外透皮吸收性质的影响[J].中国新药杂志, 2010, 19(17): 1517-1520.
- 13. 陈军, 李磊, 祁艳, 等.马钱子碱贴膏剂的制备与药物动力学研究[J].中药材, 2012, 35(8): 1295-1298.
- 14. 徐小国, 蒋萌, 熊宁宁, 等.几种外用中药制剂人体耐受性试验设计方法[J].中国临床药理学与治疗学, 2007, 12(2): 152-155.
- 15. 张锡玮.中药Ⅰ期临床耐受性试验的设计与实施[J].辽宁中医药大学学报, 2013, 15(8): 24-26.
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