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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 observe the tolerance of normal healthy volunteers to Qianggu Capsule. Methods: Thirty-two healthy subjects, including single dose tolerance test in 20 cases, were divided into low dose group (0.09g) 4 cases, middle dose group (0.18g) 6 cases, medium and large dose group ( 0.36g) 6 patients, 4 patients in the high-dose group (0.72g) and 1 in the morning; 12 patients in the continuous-dose tolerance test were divided into small-dose group (0.18g, tid, continuous medication for 42d) and High-dose group (0.36g, tid, continuous medication for 42d), 6 patients in each group, compared the changes of the clinical symptoms and laboratory test results of the subjects before and after administration in the single-dose and continuous-dose tests. RESULTS: One of the high-dose groups in each group except the continuous tolerance test had mild dry mouth, and 1 had constipation, and all had obvious adverse reactions. Before and after treatment, heart rate, respiration, body temperature, blood pressure, electrocardiogram, blood routine, urine routine, routine, and liver and kidney function did not show any abnormalities. Conclusion: The subjects have good tolerability to Qianggu capsule. It is recommended to use 1 clinical (0.18g/grain) and tid at one time. The recommended clinical dosage is no more than 2 capsules per time.