强骨胶囊正常人体耐受性研究

Study on tolerance of qianggu capsule on normal human body

目的：观察正常健康志愿者对强骨胶囊的耐受性。方法：健康受试者32例，其中单次给药耐受性试验20例，分为小剂量组(0．09g)4例，中剂量组(0．18g)6例，中大剂量组(0．36g)6例，大剂量组(0．72g)4例，晨服1次；连续给药耐受性试验12例，分为小剂量组(0．18g，tid，连续服药42d)和大剂量组(0．36g，tid，连续服药42d)，每组6例，分别比较单次给药和连续给药试验中给药前后受试者的临床症状和实验室化验结果的变化。结果：试验各组除连续给药耐受性试验的大剂量组中有1例出现轻度口干，1例出现便秘外，均末见到明显不良反应。各组用药前后心率、呼吸、体温、血压、心电图及血常规、尿常规、便常规、肝肾功能等指标均未见异常。结论：受试者对强骨胶囊具有较好的耐受性，推荐临床每次1粒(0．18g/粒)，tid，建议临床用量不超过每次2粒，tid。

Objective: To determine dose tolerance of Qianggu capsule in healthy volunteers. Methods:32 healthy volunteers were recruited,of which 20 were divided into 4 groups (4,6,6 and 4 volunteers per group) for the single dose tolerance test. Each group of the volunteers was administrated with a single dose of Qianggu capsule at 0.09,0.18,0.36 and 0.72g once in the morning,respectively. The other 12 volunteers were equally categorized into 2 groups for the multiple dose tolerance test. Each group received a multiple dose of Qianggu capsule at 0.18 and 0. 36g three times per day for 42 days. The clinical symptoms and lab test results prior to and post administration of Qianggu capsule were monitored in the single dose group and the multiple dose group,respectively. Results:Only 2 subjects in the multiple dose group (0. 36g) of Qianggu capsule were reported to experience mild dry mouth and constipation. Rest of volunteers in both groups had no adverse events reported. None of abnormality in heart beat rate, breath rate, body temperature,blood pressure,ECG,routine tests of blood, urine,stool,and functional tests of liver and kidney was found for all of tested volunteers. Conclusion: Qianggu capsule was well tolerated in the tested healthy volunteers. It is recommended that the optimal dose of Qianggu capsule is one capsule (0. 18g/each capsule) each time, three time per day, and themaximum dose is two capsules each time,three time per day.